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TDMS Study 88032-05 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                                        OXYMETHOLONE                                     DATE: 11/25/97       
EXPERIMENT: 88032 TEST: 05                                                                                     TIME: 07:29:33       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-05295                              ROUTE: GAVAGE                                                  NTP C#: 88032B       
PATHOLOGIST: YARRINGTON, J.                                                                                    CAS: 434-07-01       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                             CORE STUDY                                                             
                                                                                                                                    

               REASONS FOR REMOVAL:    25022 Accidently Killed                                                                      
                                       25018 Dosing Accident                                                                        
                                       25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25026 Other                                                                                  
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                                        OXYMETHOLONE                                     DATE: 11/25/97       
EXPERIMENT: 88032 TEST: 05                                                                                     TIME: 07:29:33       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-05295                              ROUTE: GAVAGE                                                  NTP C#: 88032B       
PATHOLOGIST: YARRINGTON, J.                                                                                    CAS: 434-07-01       




                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                          IN THE ANALYSIS OF THE STUDY OF OXYMETHOLONE

              ====================================================================================================

                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------

                             Adrenal Cortex                Vacuolization Cytoplasmic
                             Bone                          Fibrous Osteodystrophy
                             Heart                         Degeneration Chronic
                             Kidney                        Cyst
                                                           Mineralization
                                                           Nephropathy
                             Liver                         Basophilic Focus
                                                           Clear Cell Focus
                                                           Hyperplasia
                                                           Inflammation Chronic
                                                           Vacuolization Cytoplasmic
                             Lung                          Mineralization
                             Mammary Gland                 Dilatation
                                                           Galactocele
                                                           Hyperplasia
                             Pancreas                      Atrophy
                             Preputial Gland               Inflammation Chronic
                             Prostate                      Inflammation Chronic
                             Spleen                        Fibrosis
                             Testes                        Degeneration
                                                           Hyperplasia
                                                           Mineralization
                             Thymus                        Atrophy
                             Thyroid Gland                 Ultimobranchial Cyst

              ====================================================================================================
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                                        OXYMETHOLONE                                     DATE: 11/25/97       
EXPERIMENT: 88032 TEST: 05                                                                                     TIME: 07:29:33       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-05295                              ROUTE: GAVAGE                                                  NTP C#: 88032B       
PATHOLOGIST: YARRINGTON, J.                                                                                    CAS: 434-07-01       




                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                          IN THE ANALYSIS OF THE STUDY OF OXYMETHOLONE

              ====================================================================================================

                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------

                             Adrenal Cortex                Angiectasis
                                                           Hypertrophy
                                                           Vacuolization Cytoplasmic
                             Adrenal Medulla               Hyperplasia
                             Clitoral Gland                Inflammation Chronic
                             Heart                         Degeneration Chronic
                                                           Inflammation Chronic
                             Intestine Large, Rectum       Parasite Metazoan
                             Kidney                        Mineralization
                                                           Nephropathy
                             Liver                         Clear Cell Focus
                                                           Degeneration Cystic
                                                           Hepatodiaphragmatic Nodule
                                                           Hyperplasia
                                                           Inflammation Chronic
                                                           Mixed Cell Focus
                             Lung                          Inflammation Chronic
                                                           Mineralization
                             Lymph Node, Mesenteric        Ectasia
                             Mammary Gland                 Dilatation
                             Mesentery                     Inflammation Chronic
                             Ovary                         DYSGENESIS
                             Pituitary Gland               Cyst
                             Uterus                        Cyst

              ====================================================================================================
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE   1
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Angiectasis                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    0/50 (0%)    0/50 (0%)    0/49 (0%)  | 21/50 (42%)  26/50 (52%)  15/50 (30%)   3/49 (6%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |  77.6%        86.6%        50.0%         9.7%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  | 19/25 (76%)  25/29 (86%)  15/30 (50%)   3/31 (10%) |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   684          705          728 (T)      728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P<0.001N**   P=0.424      P=0.018N*    P<0.001N** |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P<0.001N**   P=0.451      P=0.015N*    P<0.001N** |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P<0.001N**   P=0.385      P=0.024N*    P<0.001N** |
|COCHRAN-ARMITAGE       |    (e)                                             |  P<0.001N**                                        |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.212      P=0.149N     P<0.001N** |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Hemorrhage                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    2/50 (4%)    0/50 (0%)    0/49 (0%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/49 (0%)  |
|ADJUSTED (b)           |   0.0%        10.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    1/15 (7%)    0/14 (0%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          692          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.353N     P=0.266        (e)          (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.376N     P=0.261        (e)          (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.365N     P=0.265        (e)          (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.390N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.243        (e)          (e)      |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE   2
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Hypertrophy                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    0/50 (0%)    0/50 (0%)    0/49 (0%)  |  0/50 (0%)    5/50 (10%)   0/50 (0%)    0/49 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%        17.2%         0.0%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  0/25 (0%)    5/29 (17%)   0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          728 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.077N     P=0.045 *      (e)          (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.077N     P=0.045 *      (e)          (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.077N     P=0.045 *      (e)          (e)      |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.098N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.028 *      (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Pigmentation                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    0/50 (0%)    0/50 (0%)    0/49 (0%)  |  0/50 (0%)    0/50 (0%)    2/50 (4%)    0/49 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         0.0%         4.3%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          ---          478          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.703N       (e)        P=0.225        (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.620N       (e)        P=0.142        (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.644N       (e)        P=0.329        (e)      |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.697N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |                 (e)        P=0.247        (e)      |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE   3
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Vacuolization Cytoplasmic                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 22/51 (43%)  23/50 (46%)  40/50 (80%)  33/49 (67%) |  4/50 (8%)    5/50 (10%)  21/50 (42%)  36/49 (73%) |
|ADJUSTED (b)           |  59.9%        65.8%        94.8%        79.9%      |  11.8%        11.5%        48.3%        85.4%      |
|TERMINAL (d)           |  5/15 (33%)   5/15 (33%)  12/14 (86%)  12/20 (60%) |  0/25 (0%)    0/29 (0%)    8/30 (27%)  25/31 (81%) |
|FIRST INCIDENCE (DAYS) |   316          408          353          116       |   533          523          118          490       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.311      P=0.543N     P=0.021 *    P=0.218    |  P<0.001 **   P=0.570      P=0.002 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.004 **   P=0.377      P<0.001 **   P=0.002 ** |  P<0.001 **   P=0.371      P<0.001 **   P<0.001 ** |
|LOGISTIC REGRESSION    |  P=0.002 **   P=0.461      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.423      P<0.001 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P=0.023 *                                         |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.464      P<0.001 **   P=0.013 *  |               P=0.500      P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 15/51 (29%)  17/50 (34%)  20/50 (40%)  15/49 (31%) |  5/50 (10%)   1/50 (2%)    3/50 (6%)   13/49 (27%) |
|ADJUSTED (b)           |  53.7%        58.0%        66.4%        48.7%      |  15.3%         3.4%         8.0%        39.0%      |
|TERMINAL (d)           |  5/15 (33%)   5/15 (33%)   6/14 (43%)   6/20 (30%) |  2/25 (8%)    1/29 (3%)    1/30 (3%)   11/31 (35%) |
|FIRST INCIDENCE (DAYS) |   464          408          353          629       |   478          728 (T)      638          659       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.213N     P=0.526      P=0.322      P=0.350N   |  P<0.001 **   P=0.089N     P=0.292N     P=0.086    |
|INCIDENTAL TUMOR       |  P=0.478N     P=0.423      P=0.307      P=0.482    |  P<0.001 **   P=0.095N     P=0.357N     P=0.078    |
|LOGISTIC REGRESSION    |  P=0.453N     P=0.435      P=0.257      P=0.575    |  P<0.001 **   P=0.103N     P=0.356N     P=0.043 *  |
|COCHRAN-ARMITAGE       |  P=0.447N                                          |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.389      P=0.182      P=0.534    |               P=0.102N     P=0.357N     P=0.030 *  |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE   4
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Blood Vessel                                                                                                                     |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/51 (6%)    5/50 (10%)   6/50 (12%)   7/48 (15%) |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/49 (0%)  |
|ADJUSTED (b)           |   9.7%        22.1%        31.6%        23.5%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    2/14 (14%)   1/20 (5%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   471          692          680          629       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.319      P=0.416      P=0.277      P=0.250    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.081      P=0.385      P=0.269      P=0.067    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.192      P=0.367      P=0.284      P=0.139    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.170                                           |    (e)                                             |
|FISHER EXACT           |               P=0.346      P=0.234      P=0.135    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone                                                                                                                             |
|     Fibrous Osteodystrophy                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/51 (4%)    8/49 (16%)  13/50 (26%)  15/50 (30%) |  0/50 (0%)    0/50 (0%)    0/49 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   7.7%        33.8%        49.8%        46.7%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    1/15 (7%)    3/14 (21%)   5/20 (25%) |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   611          692          605          577       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.033 *    P=0.079      P=0.008 **   P=0.006 ** |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.001 **   P=0.064      P=0.006 **   P<0.001 ** |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.005 **   P=0.062      P=0.005 **   P<0.001 ** |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.005 **                                        |    (e)                                             |
|FISHER EXACT           |               P=0.040 *    P=0.002 **   P<0.001 ** |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE   5
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone                                                                                                                             |
|     Osteosclerosis                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/51 (2%)    0/49 (0%)    0/50 (0%)    0/50 (0%)  |  2/50 (4%)    2/50 (4%)    0/49 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   3.4%         0.0%         0.0%         0.0%      |   7.2%         6.7%         0.0%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  1/25 (4%)    1/29 (3%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   646          ---          ---          ---       |   705          725          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.586N     P=0.480N     P=0.474N     P=0.480N   |  P=0.110N     P=0.643N     P=0.213N     P=0.206N   |
|INCIDENTAL TUMOR       |  P=0.646N     P=0.461N     P=0.439N     P=0.531N   |  P=0.107N     P=0.626N     P=0.187N     P=0.193N   |
|LOGISTIC REGRESSION    |  P=0.595N     P=0.504N     P=0.501N     P=0.504N   |  P=0.109N     P=0.653N     P=0.209N     P=0.205N   |
|COCHRAN-ARMITAGE       |  P=0.592N                                          |  P=0.125N                                          |
|FISHER EXACT           |               P=0.510N     P=0.505N     P=0.505N   |               P=0.691N     P=0.253N     P=0.247N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone Marrow                                                                                                                      |
|     Myelofibrosis                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/48 (2%)    2/49 (4%)    0/50 (0%)    0/49 (0%)  |  0/50 (0%)    2/50 (4%)    2/49 (4%)    0/49 (0%)  |
|ADJUSTED (b)           |   6.7%         9.7%         0.0%         0.0%      |   0.0%         6.1%         6.7%         0.0%      |
|TERMINAL (d)           |  1/15 (7%)    1/15 (7%)    0/14 (0%)    0/20 (0%)  |  0/25 (0%)    1/29 (3%)    2/30 (7%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   728 (T)      675          ---          ---       |   ---          665          728 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.210N     P=0.540      P=0.514N     P=0.443N   |  P=0.311N     P=0.266      P=0.279        (e)      |
|INCIDENTAL TUMOR       |  P=0.225N     P=0.523      P=0.514N     P=0.443N   |  P=0.308N     P=0.281      P=0.279        (e)      |
|LOGISTIC REGRESSION    |  P=0.230N     P=0.550      P=0.514N     P=0.443N   |  P=0.324N     P=0.250      P=0.279        (e)      |
|COCHRAN-ARMITAGE       |  P=0.248N                                          |  P=0.350N                                          |
|FISHER EXACT           |               P=0.508      P=0.490N     P=0.495N   |               P=0.247      P=0.242        (e)      |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE   6
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain                                                                                                                            |
|     Hemorrhage                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%        10.7%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    1/14 (7%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          693          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.583N       (e)        P=0.255        (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.622N       (e)        P=0.265        (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.606N       (e)        P=0.271        (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.632N                                          |    (e)                                             |
|FISHER EXACT           |                 (e)        P=0.243        (e)      |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain                                                                                                                            |
|     Necrosis                                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/51 (4%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   7.0%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   464          ---          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.353N     P=0.229N     P=0.240N     P=0.229N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.545N     P=0.271N     P=0.295N     P=0.464N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.340N     P=0.240N     P=0.269N     P=0.232N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.359N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.252N     P=0.252N     P=0.252N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE   7
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral Gland                                                                                                                   |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)   |  6/50 (12%)   6/48 (13%)   5/50 (10%)   2/50 (4%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |  18.3%        20.7%        15.8%         5.4%      |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  2/25 (8%)    6/29 (21%)   4/30 (13%)   1/31 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   562          728 (T)      693          511       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.063N     P=0.529N     P=0.408N     P=0.107N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.080N     P=0.607N     P=0.516N     P=0.202N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.075N     P=0.608N     P=0.480N     P=0.136N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.080N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.591      P=0.500N     P=0.134N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral Gland                                                                                                                   |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)   |  7/50 (14%)   8/48 (17%)  11/50 (22%)  18/50 (36%) |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |  22.3%        22.8%        31.8%        44.7%      |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  4/25 (16%)   5/29 (17%)   8/30 (27%)  10/31 (32%) |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   548          556          229          177       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.010 **   P=0.602      P=0.318      P=0.040 *  |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.002 **   P=0.415      P=0.299      P=0.015 *  |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.003 **   P=0.464      P=0.217      P=0.010 ** |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.003 **                                        |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.465      P=0.218      P=0.010 ** |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE   8
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Epididymis                                                                                                                       |
|     Atypia Cellular                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    2/50 (4%)    1/50 (2%)    0/49 (0%)  |  0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)   |
|ADJUSTED (b)           |   0.0%         4.5%         2.1%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   ---          485          437          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.359N     P=0.238      P=0.504        (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.848N     P=0.128      P=0.318        (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.222N     P=0.263      P=0.451        (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.355N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.243      P=0.495        (e)      |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Eye: Lens                                                                                                                        |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/1 (0%)     1/2 (50%)    0/2 (0%)     2/3 (67%)  |  1/2 (50%)    1/1 (100%)   0/0 (0%)     0/0 (0%)   |
|ADJUSTED (b)           |   0.0%         5.3%         0.0%       100.0%      |   3.8%       100.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/0          0/1 (0%)     0/0          2/2 (100%) |  0/0          1/1 (100%)   0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   ---          709          ---          728 (T)   |   708          728 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.546      P=0.511        (e)          (e)      |  P=0.493N     P=0.465N     P=0.465N     P=0.452N   |
|INCIDENTAL TUMOR       |  P=0.364        (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.466        (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.295                                           |  P=1.000                                           |
|FISHER EXACT           |               P=0.667        (e)        P=0.500    |               P=0.667      P=1.000N     P=1.000N   |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE   9
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Eye: Retina                                                                                                                      |
|     Degeneration                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/1 (100%)   1/2 (50%)    0/2 (0%)     2/3 (67%)  |  1/2 (50%)    1/1 (100%)   0/0 (0%)     0/0 (0%)   |
|ADJUSTED (b)           |   2.0%         5.3%         0.0%       100.0%      |   3.8%       100.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/0          0/1 (0%)     0/0          2/2 (100%) |  0/0          1/1 (100%)   0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   384          709          ---          728 (T)   |   708          728 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.686      P=0.759N     P=0.504N     P=0.521N   |  P=0.493N     P=0.465N     P=0.465N     P=0.452N   |
|INCIDENTAL TUMOR       |  P=0.364        (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.518        (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.563                                           |  P=1.000                                           |
|FISHER EXACT           |               P=0.667N     P=0.333N     P=0.750N   |               P=0.667      P=1.000N     P=1.000N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Heart                                                                                                                            |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/51 (6%)    5/49 (10%)   8/50 (16%)   5/47 (11%) |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/49 (0%)  |
|ADJUSTED (b)           |   9.7%        22.1%        37.3%        17.3%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    2/14 (14%)   1/20 (5%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   471          692          680          629       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.530N     P=0.416      P=0.135      P=0.448    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.307      P=0.376      P=0.130      P=0.192    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.512      P=0.356      P=0.131      P=0.316    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.473                                           |    (e)                                             |
|FISHER EXACT           |               P=0.335      P=0.094      P=0.312    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  10
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Heart                                                                                                                            |
|     Thrombosis                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    1/49 (2%)    0/50 (0%)    2/47 (4%)  |  0/50 (0%)    0/50 (0%)    1/50 (2%)    0/49 (0%)  |
|ADJUSTED (b)           |   0.0%         6.7%         0.0%         7.1%      |   0.0%         0.0%         2.6%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    1/15 (7%)    0/14 (0%)    1/20 (5%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          728 (T)      ---          145       |   ---          ---          670          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.201      P=0.500        (e)        P=0.256    |  P=0.774N       (e)        P=0.528        (e)      |
|INCIDENTAL TUMOR       |  P=0.301      P=0.500        (e)        P=0.439    |  P=0.792N       (e)        P=0.564        (e)      |
|LOGISTIC REGRESSION    |  P=0.186      P=0.500        (e)        P=0.290    |  P=0.789N       (e)        P=0.500        (e)      |
|COCHRAN-ARMITAGE       |  P=0.144                                           |  P=0.789N                                          |
|FISHER EXACT           |               P=0.490        (e)        P=0.227    |                 (e)        P=0.500        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Heart: Epicardium                                                                                                                |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    0/49 (0%)    0/50 (0%)    0/47 (0%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    2/49 (4%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         4.2%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          ---          ---          177       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.041 *      (e)          (e)        P=0.235    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.064        (e)          (e)        P=0.500    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.051        (e)          (e)        P=0.573    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.039 *                                         |
|FISHER EXACT           |                 (e)          (e)          (e)      |                 (e)          (e)        P=0.242    |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  11
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Heart: Myocardium                                                                                                                |
|     Degeneration Chronic                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 43/51 (84%)  43/49 (88%)  48/50 (96%)  42/47 (89%) | 29/50 (58%)  34/50 (68%)  40/50 (80%)  45/49 (92%) |
|ADJUSTED (b)           |  97.5%        95.5%       100.0%       100.0%      |  84.8%        84.5%        95.2%       100.0%      |
|TERMINAL (d)           | 14/15 (93%)  13/15 (87%)  14/14 (100%) 20/20 (100%)| 20/25 (80%)  23/29 (79%)  28/30 (93%)  31/31 (100%)|
|FIRST INCIDENCE (DAYS) |   316          146          281          114       |   548          523          229          387       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.104N     P=0.401N     P=0.475      P=0.138N   |  P=0.036 *    P=0.521      P=0.196      P=0.057    |
|INCIDENTAL TUMOR       |  P=0.537N     P=0.527      P=0.105      P=0.633N   |  P<0.001 **   P=0.320      P=0.067      P<0.001 ** |
|LOGISTIC REGRESSION    |  P=0.225      P=0.399      P=0.093      P=0.217    |  P<0.001 **   P=0.331      P=0.040 *    P<0.001 ** |
|COCHRAN-ARMITAGE       |  P=0.441                                           |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.419      P=0.049 *    P=0.332    |               P=0.204      P=0.015 *    P<0.001 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Large, Colon                                                                                                           |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/48 (2%)    2/49 (4%)    0/46 (0%)    0/47 (0%)  |  0/46 (0%)    0/46 (0%)    0/49 (0%)    0/48 (0%)  |
|ADJUSTED (b)           |   4.8%         8.8%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   702          703          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.227N     P=0.558      P=0.482N     P=0.465N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.295N     P=0.569      P=0.461N     P=0.531N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.234N     P=0.548      P=0.482N     P=0.474N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.255N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.508      P=0.511N     P=0.505N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  12
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Large, Colon                                                                                                           |
|     Parasite Metazoan                                                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/48 (6%)    0/49 (0%)    2/46 (4%)    3/47 (6%)  |  1/46 (2%)    0/46 (0%)    3/49 (6%)    0/48 (0%)  |
|ADJUSTED (b)           |  20.0%         0.0%        11.6%        15.0%      |   4.0%         0.0%        10.0%         0.0%      |
|TERMINAL (d)           |  3/15 (20%)   0/15 (0%)    1/14 (7%)    3/20 (15%) |  1/25 (4%)    0/29 (0%)    3/30 (10%)   0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   728 (T)      ---          705          728 (T)   |   728 (T)      ---          728 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.450      P=0.116N     P=0.521N     P=0.525N   |  P=0.416N     P=0.470N     P=0.371      P=0.457N   |
|INCIDENTAL TUMOR       |  P=0.428      P=0.116N     P=0.508N     P=0.525N   |  P=0.416N     P=0.470N     P=0.371      P=0.457N   |
|LOGISTIC REGRESSION    |  P=0.418      P=0.116N     P=0.500N     P=0.525N   |  P=0.416N     P=0.470N     P=0.371      P=0.457N   |
|COCHRAN-ARMITAGE       |  P=0.300                                           |  P=0.447N                                          |
|FISHER EXACT           |               P=0.117N     P=0.520N     P=0.651    |               P=0.500N     P=0.333      P=0.489N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Large, Rectum                                                                                                          |
|     Parasite Metazoan                                                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/49 (2%)    3/47 (6%)    1/47 (2%)    1/46 (2%)  |  2/44 (5%)    5/47 (11%)   5/46 (11%)  10/50 (20%) |
|ADJUSTED (b)           |   6.7%        17.1%         2.3%         5.0%      |   8.0%        17.2%        16.7%        32.3%      |
|TERMINAL (d)           |  1/15 (7%)    2/15 (13%)   0/14 (0%)    1/20 (5%)  |  2/25 (8%)    5/29 (17%)   5/30 (17%)  10/31 (32%) |
|FIRST INCIDENCE (DAYS) |   728 (T)      706          577          728 (T)   |   728 (T)      728 (T)      728 (T)      728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.343N     P=0.316      P=0.752N     P=0.698N   |  P=0.022 *    P=0.275      P=0.292      P=0.032 *  |
|INCIDENTAL TUMOR       |  P=0.378N     P=0.328      P=0.730      P=0.698N   |  P=0.022 *    P=0.276      P=0.292      P=0.032 *  |
|LOGISTIC REGRESSION    |  P=0.416N     P=0.348      P=0.762      P=0.698N   |  P=0.022 *    P=0.276      P=0.292      P=0.032 *  |
|COCHRAN-ARMITAGE       |  P=0.448N                                          |  P=0.022 *                                         |
|FISHER EXACT           |               P=0.293      P=0.742      P=0.737    |               P=0.245      P=0.236      P=0.024 *  |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  13
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small, Duodenum                                                                                                        |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/48 (4%)    1/49 (2%)    0/49 (0%)    0/47 (0%)  |  0/47 (0%)    0/48 (0%)    0/49 (0%)    0/49 (0%)  |
|ADJUSTED (b)           |   7.7%         4.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   611          703          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.224N     P=0.444N     P=0.211N     P=0.203N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.264N     P=0.450N     P=0.195N     P=0.249N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.241N     P=0.473N     P=0.223N     P=0.236N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.246N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.492N     P=0.242N     P=0.253N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney                                                                                                                           |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/51 (2%)    7/50 (14%)   4/50 (8%)    6/49 (12%) |  0/50 (0%)    0/50 (0%)    0/50 (0%)    1/49 (2%)  |
|ADJUSTED (b)           |   6.7%        31.6%        22.6%        24.0%      |   0.0%         0.0%         0.0%         3.2%      |
|TERMINAL (d)           |  1/15 (7%)    3/15 (20%)   2/14 (14%)   3/20 (15%) |  0/25 (0%)    0/29 (0%)    0/30 (0%)    1/31 (3%)  |
|FIRST INCIDENCE (DAYS) |   728 (T)      146          696          644       |   ---          ---          ---          728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.415      P=0.041 *    P=0.182      P=0.111    |  P=0.235        (e)          (e)        P=0.543    |
|INCIDENTAL TUMOR       |  P=0.352      P=0.057      P=0.203      P=0.077    |  P=0.235        (e)          (e)        P=0.543    |
|LOGISTIC REGRESSION    |  P=0.403      P=0.074      P=0.211      P=0.077    |  P=0.235        (e)          (e)        P=0.543    |
|COCHRAN-ARMITAGE       |  P=0.244                                           |  P=0.211                                           |
|FISHER EXACT           |               P=0.028 *    P=0.175      P=0.050 *  |                 (e)          (e)        P=0.495    |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  14
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney                                                                                                                           |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/51 (12%)   6/50 (12%)   9/50 (18%)  25/49 (51%) | 27/50 (54%)  31/50 (62%)  35/50 (70%)  36/49 (73%) |
|ADJUSTED (b)           |  20.5%        23.8%        40.9%        69.7%      |  76.1%        74.4%        84.9%        81.4%      |
|TERMINAL (d)           |  1/15 (7%)    0/15 (0%)    3/14 (21%)  11/20 (55%) | 17/25 (68%)  19/29 (66%)  24/30 (80%)  23/31 (74%) |
|FIRST INCIDENCE (DAYS) |   464          600          437           34       |   478          299          118          177       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.566N     P=0.335      P=0.001 ** |  P=0.290      P=0.546      P=0.329      P=0.333    |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.596      P=0.249      P<0.001 ** |  P=0.083      P=0.383      P=0.206      P=0.085    |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.613      P=0.295      P<0.001 ** |  P=0.044 *    P=0.304      P=0.268      P=0.038 *  |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.044 *                                         |
|FISHER EXACT           |               P=0.606      P=0.274      P<0.001 ** |               P=0.272      P=0.074      P=0.035 *  |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney                                                                                                                           |
|     Nephropathy                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 43/51 (84%)  47/50 (94%)  50/50 (100%) 48/49 (98%) | 32/50 (64%)  26/50 (52%)  38/50 (76%)  41/49 (84%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  83.8%        75.8%        94.9%        97.5%      |
|TERMINAL (d)           | 15/15 (100%) 15/15 (100%) 14/14 (100%) 20/20 (100%)| 19/25 (76%)  21/29 (72%)  28/30 (93%)  30/31 (97%) |
|FIRST INCIDENCE (DAYS) |   316          321          281           80       |   533          556          478          394       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.256N     P=0.483      P=0.361      P=0.390N   |  P=0.060      P=0.049N*    P=0.530      P=0.382    |
|INCIDENTAL TUMOR       |  P=0.043 *    P=0.077      P=0.010 **   P=0.051    |  P=0.003 **   P=0.060N     P=0.235      P=0.076    |
|LOGISTIC REGRESSION    |  P=0.007 **   P=0.072      P=0.009 **   P=0.007 ** |  P<0.001 **   P=0.061N     P=0.186      P=0.024 *  |
|COCHRAN-ARMITAGE       |  P=0.058                                           |  P=0.002 **                                        |
|FISHER EXACT           |               P=0.106      P=0.003 **   P=0.018 *  |               P=0.156N     P=0.138      P=0.022 *  |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  15
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney                                                                                                                           |
|     Pigmentation Hemosiderin                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/51 (8%)    4/50 (8%)    2/50 (4%)    4/49 (8%)  |  5/50 (10%)   7/50 (14%)   4/50 (8%)    3/49 (6%)  |
|ADJUSTED (b)           |  16.9%        15.1%         5.3%        10.8%      |  15.1%        17.8%        10.5%         7.6%      |
|TERMINAL (d)           |  1/15 (7%)    1/15 (7%)    0/14 (0%)    0/20 (0%)  |  2/25 (8%)    2/29 (7%)    1/30 (3%)    1/31 (3%)  |
|FIRST INCIDENCE (DAYS) |   600          563          577          551       |   533          537          561          490       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.597N     P=0.574N     P=0.298N     P=0.546N   |  P=0.149N     P=0.463      P=0.434N     P=0.295N   |
|INCIDENTAL TUMOR       |  P=0.504      P=0.618N     P=0.275N     P=0.607    |  P=0.254N     P=0.299      P=0.585N     P=0.389N   |
|LOGISTIC REGRESSION    |  P=0.484      P=0.632N     P=0.329N     P=0.619    |  P=0.376N     P=0.351      P=0.499N     P=0.367N   |
|COCHRAN-ARMITAGE       |  P=0.533                                           |  P=0.184N                                          |
|FISHER EXACT           |               P=0.631      P=0.348N     P=0.620    |               P=0.380      P=0.500N     P=0.369N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Accumulation, Hyaline Droplet                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/51 (4%)    0/50 (0%)    0/50 (0%)    0/49 (0%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/49 (0%)  |
|ADJUSTED (b)           |   8.8%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   646          ---          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.334N     P=0.229N     P=0.226N     P=0.208N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.408N     P=0.194N     P=0.172N     P=0.270N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.359N     P=0.225N     P=0.215N     P=0.230N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.363N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.252N     P=0.252N     P=0.258N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  16
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/51 (6%)    2/50 (4%)    3/50 (6%)    1/49 (2%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/49 (0%)  |
|ADJUSTED (b)           |  20.0%        10.4%        12.4%         4.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  3/15 (20%)   1/15 (7%)    1/14 (7%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   728 (T)      703          644          703       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.203N     P=0.479N     P=0.657N     P=0.213N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.233N     P=0.482N     P=0.644      P=0.243N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.251N     P=0.448N     P=0.595N     P=0.227N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.290N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.509N     P=0.652      P=0.324N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Angiectasis                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/51 (2%)    2/50 (4%)    0/50 (0%)    0/49 (0%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/49 (0%)  |
|ADJUSTED (b)           |   6.7%         8.9%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/15 (7%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   728 (T)      706          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.214N     P=0.528      P=0.514N     P=0.443N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.258N     P=0.545      P=0.514N     P=0.443N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.228N     P=0.549      P=0.514N     P=0.443N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.255N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.492      P=0.505N     P=0.510N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  17
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Basophilic Focus                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 23/51 (45%)  29/50 (58%)  41/50 (82%)  38/49 (78%) | 37/50 (74%)  40/50 (80%)  37/50 (74%)  41/49 (84%) |
|ADJUSTED (b)           |  95.4%        86.4%        97.5%       100.0%      |  92.0%        97.5%        92.4%        97.6%      |
|TERMINAL (d)           | 14/15 (93%)  11/15 (73%)  13/14 (93%)  20/20 (100%)| 22/25 (88%)  28/29 (97%)  27/30 (90%)  30/31 (97%) |
|FIRST INCIDENCE (DAYS) |   553          321          517          434       |   478          556          478          510       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.296      P=0.263      P=0.007 **   P=0.100    |  P=0.388N     P=0.424N     P=0.213N     P=0.366N   |
|INCIDENTAL TUMOR       |  P=0.003 **   P=0.169      P<0.001 **   P<0.001 ** |  P=0.148      P=0.362      P=0.597N     P=0.143    |
|LOGISTIC REGRESSION    |  P=0.001 **   P=0.195      P<0.001 **   P<0.001 ** |  P=0.189      P=0.415      P=0.565N     P=0.197    |
|COCHRAN-ARMITAGE       |  P=0.005 **                                        |  P=0.205                                           |
|FISHER EXACT           |               P=0.136      P<0.001 **   P<0.001 ** |               P=0.318      P=0.590N     P=0.176    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Clear Cell Focus                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/51 (4%)    2/50 (4%)    6/50 (12%)  12/49 (24%) |  5/50 (10%)  11/50 (22%)   6/50 (12%)  14/49 (29%) |
|ADJUSTED (b)           |  13.3%        13.3%        32.5%        56.1%      |  20.0%        36.0%        20.0%        45.2%      |
|TERMINAL (d)           |  2/15 (13%)   2/15 (13%)   4/14 (29%)  11/20 (55%) |  5/25 (20%)  10/29 (34%)   6/30 (20%)  14/31 (45%) |
|FIRST INCIDENCE (DAYS) |   728 (T)      728 (T)      517          561       |   728 (T)      579          728 (T)      728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.002 **   P=0.701      P=0.126      P=0.010 ** |  P=0.073      P=0.136      P=0.631      P=0.047 *  |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.701      P=0.089      P=0.009 ** |  P=0.058      P=0.117      P=0.631      P=0.047 *  |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.701      P=0.180      P=0.009 ** |  P=0.066      P=0.123      P=0.631      P=0.047 *  |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.035 *                                         |
|FISHER EXACT           |               P=0.684      P=0.128      P=0.003 ** |               P=0.086      P=0.500      P=0.017 *  |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  18
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Degeneration Cystic                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    4/50 (8%)    0/50 (0%)    0/49 (0%)  |  0/50 (0%)    0/50 (0%)    1/50 (2%)    3/49 (6%)  |
|ADJUSTED (b)           |   0.0%        19.0%         0.0%         0.0%      |   0.0%         0.0%         3.3%         9.7%      |
|TERMINAL (d)           |  0/15 (0%)    1/15 (7%)    0/14 (0%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    1/30 (3%)    3/31 (10%) |
|FIRST INCIDENCE (DAYS) |   ---          692          ---          ---       |   ---          ---          728 (T)      728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.154N     P=0.082        (e)          (e)      |  P=0.029 *      (e)        P=0.536      P=0.160    |
|INCIDENTAL TUMOR       |  P=0.195N     P=0.082        (e)          (e)      |  P=0.029 *      (e)        P=0.536      P=0.160    |
|LOGISTIC REGRESSION    |  P=0.162N     P=0.078        (e)          (e)      |  P=0.029 *      (e)        P=0.536      P=0.160    |
|COCHRAN-ARMITAGE       |  P=0.185N                                          |  P=0.020 *                                         |
|FISHER EXACT           |               P=0.056        (e)          (e)      |                 (e)        P=0.500      P=0.117    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Eosinophilic Focus                                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/51 (12%)   4/50 (8%)    4/50 (8%)    2/49 (4%)  |  8/50 (16%)   6/50 (12%)   3/50 (6%)    3/49 (6%)  |
|ADJUSTED (b)           |  36.8%        19.8%        18.0%         7.3%      |  26.6%        19.0%        10.0%         8.5%      |
|TERMINAL (d)           |  5/15 (33%)   2/15 (13%)   1/14 (7%)    1/20 (5%)  |  5/25 (20%)   4/29 (14%)   3/30 (10%)   2/31 (6%)  |
|FIRST INCIDENCE (DAYS) |   707          692          609          561       |   562          702          728 (T)      511       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.087N     P=0.330N     P=0.373N     P=0.063N   |  P=0.070N     P=0.297N     P=0.062N     P=0.064N   |
|INCIDENTAL TUMOR       |  P=0.116N     P=0.327N     P=0.336N     P=0.079N   |  P=0.097N     P=0.327N     P=0.108N     P=0.128N   |
|LOGISTIC REGRESSION    |  P=0.129N     P=0.275N     P=0.268N     P=0.091N   |  P=0.093N     P=0.334N     P=0.084N     P=0.103N   |
|COCHRAN-ARMITAGE       |  P=0.165N                                          |  P=0.103N                                          |
|FISHER EXACT           |               P=0.383N     P=0.383N     P=0.148N   |               P=0.387N     P=0.100N     P=0.106N   |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  19
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hematopoietic Cell Proliferation                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    2/50 (4%)    2/50 (4%)    0/49 (0%)  |  2/50 (4%)    1/50 (2%)    0/50 (0%)    0/49 (0%)  |
|ADJUSTED (b)           |   0.0%        10.3%         4.0%         0.0%      |   8.0%         3.4%         0.0%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    1/15 (7%)    0/14 (0%)    0/20 (0%)  |  2/25 (8%)    1/29 (3%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          693          281          ---       |   728 (T)      728 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.310N     P=0.263      P=0.235        (e)      |  P=0.164N     P=0.448N     P=0.198N     P=0.192N   |
|INCIDENTAL TUMOR       |  P=0.157N     P=0.261      P=0.362        (e)      |  P=0.164N     P=0.448N     P=0.198N     P=0.192N   |
|LOGISTIC REGRESSION    |  P=0.232N     P=0.265      P=0.187        (e)      |  P=0.164N     P=0.448N     P=0.198N     P=0.192N   |
|COCHRAN-ARMITAGE       |  P=0.327N                                          |  P=0.189N                                          |
|FISHER EXACT           |               P=0.243      P=0.243        (e)      |               P=0.500N     P=0.247N     P=0.253N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatodiaphragmatic Nodule                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/51 (14%)   3/50 (6%)    2/50 (4%)    6/49 (12%) | 12/50 (24%)   6/50 (12%)   4/50 (8%)    9/49 (18%) |
|ADJUSTED (b)           |  29.4%        17.1%         5.8%        23.3%      |  32.5%        17.3%        11.7%        25.5%      |
|TERMINAL (d)           |  3/15 (20%)   2/15 (13%)   0/14 (0%)    3/20 (15%) |  4/25 (16%)   4/29 (14%)   2/30 (7%)    6/31 (19%) |
|FIRST INCIDENCE (DAYS) |   429          706          644          563       |   478          501          665          659       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.510      P=0.147N     P=0.071N     P=0.346N   |  P=0.489N     P=0.075N     P=0.022N*    P=0.203N   |
|INCIDENTAL TUMOR       |  P=0.373      P=0.181N     P=0.094N     P=0.537N   |  P=0.510      P=0.170N     P=0.060N     P=0.440N   |
|LOGISTIC REGRESSION    |  P=0.341      P=0.147N     P=0.080N     P=0.519N   |  P=0.534      P=0.112N     P=0.028N*    P=0.331N   |
|COCHRAN-ARMITAGE       |  P=0.344                                           |  P=0.534                                           |
|FISHER EXACT           |               P=0.167N     P=0.085N     P=0.531N   |               P=0.096N     P=0.027N*    P=0.331N   |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  20
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  9/51 (18%)   4/50 (8%)    3/50 (6%)    1/49 (2%)  | 17/50 (34%)  13/50 (26%)  10/50 (20%)   5/49 (10%) |
|ADJUSTED (b)           |  33.4%        24.4%        13.9%         5.0%      |  46.2%        39.6%        30.5%        15.3%      |
|TERMINAL (d)           |  3/15 (20%)   3/15 (20%)   1/14 (7%)    1/20 (5%)  |  8/25 (32%)  10/29 (34%)   8/30 (27%)   4/31 (13%) |
|FIRST INCIDENCE (DAYS) |   316          714          527          728 (T)   |   478          582          478          680       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.016N*    P=0.121N     P=0.066N     P=0.006N** |  P=0.002N**   P=0.165N     P=0.054N     P=0.002N** |
|INCIDENTAL TUMOR       |  P=0.022N*    P=0.108N     P=0.077N     P=0.005N** |  P=0.006N**   P=0.272N     P=0.150N     P=0.011N*  |
|LOGISTIC REGRESSION    |  P=0.031N*    P=0.122N     P=0.080N     P=0.012N*  |  P=0.005N**   P=0.249N     P=0.088N     P=0.005N** |
|COCHRAN-ARMITAGE       |  P=0.030N*                                         |  P=0.005N**                                        |
|FISHER EXACT           |               P=0.125N     P=0.065N     P=0.009N** |               P=0.257N     P=0.088N     P=0.004N** |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Mixed Cell Focus                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/51 (4%)    1/50 (2%)    4/50 (8%)    4/49 (8%)  |  2/50 (4%)    7/50 (14%)   9/50 (18%)   7/49 (14%) |
|ADJUSTED (b)           |  13.3%         6.7%        20.0%        18.5%      |   8.0%        22.7%        30.0%        22.6%      |
|TERMINAL (d)           |  2/15 (13%)   1/15 (7%)    2/14 (14%)   3/20 (15%) |  2/25 (8%)    6/29 (21%)   9/30 (30%)   7/31 (23%) |
|FIRST INCIDENCE (DAYS) |   728 (T)      728 (T)      666          708       |   728 (T)      639          728 (T)      728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.340      P=0.500N     P=0.355      P=0.475    |  P=0.356      P=0.119      P=0.047 *    P=0.135    |
|INCIDENTAL TUMOR       |  P=0.286      P=0.500N     P=0.360      P=0.438    |  P=0.310      P=0.098      P=0.047 *    P=0.135    |
|LOGISTIC REGRESSION    |  P=0.261      P=0.500N     P=0.408      P=0.446    |  P=0.335      P=0.107      P=0.047 *    P=0.135    |
|COCHRAN-ARMITAGE       |  P=0.196                                           |  P=0.239                                           |
|FISHER EXACT           |               P=0.508N     P=0.329      P=0.320    |               P=0.080      P=0.026 *    P=0.075    |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  21
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Necrosis                                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/51 (6%)    1/50 (2%)    1/50 (2%)    1/49 (2%)  |  1/50 (2%)    2/50 (4%)    0/50 (0%)    1/49 (2%)  |
|ADJUSTED (b)           |   9.0%         2.7%         7.1%         4.2%      |   4.0%         5.5%         0.0%         2.9%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    1/14 (7%)    0/20 (0%)  |  1/25 (4%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   479          598          728 (T)      708       |   728 (T)      639          ---          695       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.370N     P=0.281N     P=0.280N     P=0.260N   |  P=0.503N     P=0.550      P=0.464N     P=0.719N   |
|INCIDENTAL TUMOR       |  P=0.519N     P=0.370N     P=0.362N     P=0.504N   |  P=0.636N     P=0.491      P=0.464N     P=0.723N   |
|LOGISTIC REGRESSION    |  P=0.428N     P=0.311N     P=0.326N     P=0.320N   |  P=0.541N     P=0.515      P=0.464N     P=0.742N   |
|COCHRAN-ARMITAGE       |  P=0.427N                                          |  P=0.547N                                          |
|FISHER EXACT           |               P=0.316N     P=0.316N     P=0.324N   |               P=0.500      P=0.500N     P=0.747    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Regeneration                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    0/50 (0%)    0/50 (0%)    0/49 (0%)  |  0/50 (0%)    1/50 (2%)    0/50 (0%)    2/49 (4%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         3.3%         0.0%         5.8%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          725          ---          695       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.196      P=0.536        (e)        P=0.288    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.149      P=0.545        (e)        P=0.259    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.171      P=0.526        (e)        P=0.251    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.157                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.500        (e)        P=0.242    |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  22
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver: Bile Duct                                                                                                                 |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 29/51 (57%)  27/50 (54%)  24/50 (48%)   0/49 (0%)  |  1/50 (2%)    3/50 (6%)    6/50 (12%)   0/49 (0%)  |
|ADJUSTED (b)           |  86.2%        76.2%        75.0%         0.0%      |   4.0%         9.5%        16.6%         0.0%      |
|TERMINAL (d)           | 11/15 (73%)   8/15 (53%)   8/14 (57%)   0/20 (0%)  |  1/25 (4%)    2/29 (7%)    3/30 (10%)   0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   316          479          517          ---       |   728 (T)      665          561          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001N**   P=0.324N     P=0.179N     P<0.001N** |  P=0.159N     P=0.354      P=0.092      P=0.457N   |
|INCIDENTAL TUMOR       |  P<0.001N**   P=0.444N     P=0.178N     P<0.001N** |  P=0.243N     P=0.367      P=0.029 *    P=0.457N   |
|LOGISTIC REGRESSION    |  P<0.001N**   P=0.423N     P=0.154N     P<0.001N** |  P=0.190N     P=0.340      P=0.061      P=0.457N   |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |  P=0.197N                                          |
|FISHER EXACT           |               P=0.464N     P=0.244N     P<0.001N** |               P=0.309      P=0.056      P=0.505N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver: Centrilobular                                                                                                             |
|     Necrosis                                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/51 (2%)    3/50 (6%)    1/50 (2%)    1/49 (2%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    1/49 (2%)  |
|ADJUSTED (b)           |   2.9%         8.1%         2.7%         2.7%      |   0.0%         0.0%         0.0%         2.4%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   600          588          629          629       |   ---          ---          ---          659       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.399N     P=0.334      P=0.716N     P=0.724N   |  P=0.240        (e)          (e)        P=0.543    |
|INCIDENTAL TUMOR       |  P=0.435N     P=0.222      P=0.766      P=0.744    |  P=0.208        (e)          (e)        P=0.523    |
|LOGISTIC REGRESSION    |  P=0.431N     P=0.297      P=0.746      P=0.754    |  P=0.211        (e)          (e)        P=0.495    |
|COCHRAN-ARMITAGE       |  P=0.443N                                          |  P=0.211                                           |
|FISHER EXACT           |               P=0.301      P=0.748      P=0.742    |                 (e)          (e)        P=0.495    |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  23
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver: Centrilobular                                                                                                             |
|     Vacuolization Cytoplasmic                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  9/51 (18%)   6/50 (12%)  10/50 (20%)   2/49 (4%)  |  7/50 (14%)   8/50 (16%)   6/50 (12%)   3/49 (6%)  |
|ADJUSTED (b)           |  27.2%        17.6%        33.3%         7.4%      |  21.1%        18.6%        14.0%         9.7%      |
|TERMINAL (d)           |  1/15 (7%)    1/15 (7%)    2/14 (14%)   1/20 (5%)  |  2/25 (8%)    1/29 (3%)    1/30 (3%)    3/31 (10%) |
|FIRST INCIDENCE (DAYS) |   479          321          605          577       |   533          523          118          728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.026N*    P=0.264N     P=0.559N     P=0.021N*  |  P=0.071N     P=0.586      P=0.429N     P=0.110N   |
|INCIDENTAL TUMOR       |  P=0.038N*    P=0.340N     P=0.495      P=0.075N   |  P=0.123N     P=0.373      P=0.433N     P=0.153N   |
|LOGISTIC REGRESSION    |  P=0.084N     P=0.299N     P=0.481      P=0.031N*  |  P=0.076N     P=0.456      P=0.463N     P=0.155N   |
|COCHRAN-ARMITAGE       |  P=0.034N*                                         |  P=0.087N                                          |
|FISHER EXACT           |               P=0.303N     P=0.481      P=0.030N*  |               P=0.500      P=0.500N     P=0.167N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 12/51 (24%)  13/50 (26%)  11/50 (22%)  14/47 (30%) |  8/50 (16%)  12/50 (24%)   7/50 (14%)  17/49 (35%) |
|ADJUSTED (b)           |  46.2%        43.3%        41.5%        41.4%      |  28.2%        35.3%        22.5%        44.7%      |
|TERMINAL (d)           |  4/15 (27%)   3/15 (20%)   3/14 (21%)   5/20 (25%) |  6/25 (24%)   8/29 (28%)   6/30 (20%)  11/31 (35%) |
|FIRST INCIDENCE (DAYS) |   429          146          353          114       |   506          299          708          177       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.549      P=0.573      P=0.422N     P=0.565N   |  P=0.069      P=0.330      P=0.365N     P=0.098    |
|INCIDENTAL TUMOR       |  P=0.460      P=0.586N     P=0.375N     P=0.526    |  P=0.065      P=0.412      P=0.365N     P=0.121    |
|LOGISTIC REGRESSION    |  P=0.303      P=0.477      P=0.458N     P=0.327    |  P=0.045 *    P=0.258      P=0.412N     P=0.031 *  |
|COCHRAN-ARMITAGE       |  P=0.283                                           |  P=0.024 *                                         |
|FISHER EXACT           |               P=0.477      P=0.522N     P=0.318    |               P=0.227      P=0.500N     P=0.028 *  |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  24
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 19/51 (37%)  25/50 (50%)  27/50 (54%)  28/47 (60%) | 15/50 (30%)  23/50 (46%)  33/50 (66%)  33/49 (67%) |
|ADJUSTED (b)           |  63.3%        78.9%        80.8%        83.7%      |  52.0%        66.8%        86.4%        86.6%      |
|TERMINAL (d)           |  6/15 (40%)   9/15 (60%)   9/14 (64%)  15/20 (75%) | 12/25 (48%)  18/29 (62%)  25/30 (83%)  26/31 (84%) |
|FIRST INCIDENCE (DAYS) |   366          146          353          145       |   540          562          229          490       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.471      P=0.288      P=0.197      P=0.292    |  P=0.010 **   P=0.176      P=0.003 **   P=0.004 ** |
|INCIDENTAL TUMOR       |  P=0.100      P=0.189      P=0.092      P=0.028 *  |  P<0.001 **   P=0.103      P=0.001 **   P<0.001 ** |
|LOGISTIC REGRESSION    |  P=0.046 *    P=0.162      P=0.093      P=0.022 *  |  P=0.001 **   P=0.118      P<0.001 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P=0.056                                           |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.138      P=0.068      P=0.022 *  |               P=0.074      P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Pigmentation                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    0/50 (0%)    0/50 (0%)    0/47 (0%)  |  2/50 (4%)    1/50 (2%)    1/50 (2%)    0/49 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   6.3%         3.4%         3.3%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  1/25 (4%)    1/29 (3%)    1/30 (3%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   561          728 (T)      728 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.188N     P=0.458N     P=0.455N     P=0.214N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.245N     P=0.517N     P=0.595N     P=0.368N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.209N     P=0.499N     P=0.499N     P=0.242N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.211N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.500N     P=0.500N     P=0.253N   |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  25
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Vacuolization Cytoplasmic                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/51 (12%)   7/50 (14%)   7/50 (14%)   4/47 (9%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/49 (0%)  |
|ADJUSTED (b)           |  36.2%        28.8%        25.9%        14.8%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  5/15 (33%)   2/15 (13%)   1/14 (7%)    2/20 (10%) |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   666          561          564          577       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.144N     P=0.566      P=0.571      P=0.223N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.229N     P=0.546      P=0.584      P=0.271N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.235N     P=0.585      P=0.609      P=0.317N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.278N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.485      P=0.485      P=0.424N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung: Alveolar Epithelium                                                                                                        |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/51 (2%)    1/50 (2%)    3/50 (6%)    2/47 (4%)  |  4/50 (8%)   10/50 (20%)   4/50 (8%)    9/49 (18%) |
|ADJUSTED (b)           |   6.7%         2.8%        14.8%         7.3%      |  16.0%        31.1%        12.0%        26.8%      |
|TERMINAL (d)           |  1/15 (7%)    0/15 (0%)    1/14 (7%)    1/20 (5%)  |  4/25 (16%)   8/29 (28%)   3/30 (10%)   7/31 (23%) |
|FIRST INCIDENCE (DAYS) |   728 (T)      600          666          563       |   728 (T)      562          560          659       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.551      P=0.754N     P=0.323      P=0.578    |  P=0.382      P=0.119      P=0.551N     P=0.217    |
|INCIDENTAL TUMOR       |  P=0.486      P=0.738      P=0.348      P=0.556    |  P=0.287      P=0.106      P=0.640N     P=0.205    |
|LOGISTIC REGRESSION    |  P=0.445      P=0.759N     P=0.360      P=0.491    |  P=0.305      P=0.101      P=0.595N     P=0.179    |
|COCHRAN-ARMITAGE       |  P=0.436                                           |  P=0.257                                           |
|FISHER EXACT           |               P=0.748      P=0.301      P=0.469    |               P=0.074      P=0.643N     P=0.109    |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  26
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung: Interstitium                                                                                                               |
|     Fibrosis                                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/51 (2%)    2/50 (4%)    0/50 (0%)    0/47 (0%)  |  1/50 (2%)    0/50 (0%)    0/50 (0%)    0/49 (0%)  |
|ADJUSTED (b)           |   2.0%         8.4%         0.0%         0.0%      |   2.1%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   384          692          ---          ---       |   533          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.243N     P=0.535      P=0.504N     P=0.521N   |  P=0.528N     P=0.500N     P=0.513N     P=0.513N   |
|INCIDENTAL TUMOR       |  P=0.395N     P=0.487      P=0.682N     P=0.923N   |  P=0.469N     P=0.638N     P=0.581N     P=0.500N   |
|LOGISTIC REGRESSION    |  P=0.251N     P=0.493      P=0.527N     P=0.383N   |  P=0.492N     P=0.466N     P=0.439N     P=0.444N   |
|COCHRAN-ARMITAGE       |  P=0.263N                                          |  P=0.521N                                          |
|FISHER EXACT           |               P=0.492      P=0.505N     P=0.520N   |               P=0.500N     P=0.500N     P=0.505N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Lymph Node                                                                                                                       |
|     Ectasia                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/4 (25%)    2/4 (50%)    0/0 (0%)     0/2 (0%)   |  1/4 (25%)    0/1 (0%)     0/1 (0%)     0/1 (0%)   |
|ADJUSTED (b)           |   3.2%       100.0%         0.0%         0.0%      | 100.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/1 (0%)     2/2 (100%)   0/0          0/0        |  1/1 (100%)   0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   611          728 (T)      ---          ---       |   728 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.588N     P=0.702      P=0.459N     P=0.465N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.644N     P=0.599        (e)        P=0.638N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.644N     P=0.599        (e)        P=0.638N   |  P=0.251N     P=0.493        (e)        P=0.383N   |
|COCHRAN-ARMITAGE       |  P=0.374N                                          |  P=0.691N                                          |
|FISHER EXACT           |               P=0.500      P=1.000N     P=0.667N   |               P=0.800N     P=0.800N     P=0.800N   |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  27
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Lymph Node, Mandibular                                                                                                           |
|     Congestion                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    0/47 (0%)    0/50 (0%)    0/49 (0%)  |  2/49 (4%)    0/48 (0%)    0/48 (0%)    0/48 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   8.3%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  2/24 (8%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   728 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.262N     P=0.197N     P=0.190N     P=0.183N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.262N     P=0.197N     P=0.190N     P=0.183N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.262N     P=0.197N     P=0.190N     P=0.183N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.291N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.253N     P=0.253N     P=0.253N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Lymph Node, Mandibular                                                                                                           |
|     Ectasia                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/51 (4%)    2/47 (4%)    2/50 (4%)    1/49 (2%)  |  0/49 (0%)    1/48 (2%)    1/48 (2%)    2/48 (4%)  |
|ADJUSTED (b)           |  13.3%        10.3%         5.1%         5.0%      |   0.0%         3.4%         3.3%         6.5%      |
|TERMINAL (d)           |  2/15 (13%)   1/15 (7%)    0/14 (0%)    1/20 (5%)  |  0/24 (0%)    1/29 (3%)    1/30 (3%)    2/31 (6%)  |
|FIRST INCIDENCE (DAYS) |   728 (T)      693          517          728 (T)   |   ---          728 (T)      728 (T)      728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.314N     P=0.677N     P=0.678N     P=0.398N   |  P=0.249      P=0.538      P=0.545      P=0.296    |
|INCIDENTAL TUMOR       |  P=0.415N     P=0.679N     P=0.633      P=0.398N   |  P=0.249      P=0.538      P=0.545      P=0.296    |
|LOGISTIC REGRESSION    |  P=0.389N     P=0.649N     P=0.687N     P=0.398N   |  P=0.249      P=0.538      P=0.545      P=0.296    |
|COCHRAN-ARMITAGE       |  P=0.392N                                          |  P=0.205                                           |
|FISHER EXACT           |               P=0.660      P=0.684      P=0.515N   |               P=0.495      P=0.495      P=0.242    |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  28
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Lymph Node, Mesenteric                                                                                                           |
|     Ectasia                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    5/49 (10%)   3/49 (6%)    5/48 (10%) |  0/50 (0%)    1/48 (2%)    3/49 (6%)    4/49 (8%)  |
|ADJUSTED (b)           |  15.7%        29.6%        16.4%        25.0%      |   0.0%         3.4%         9.5%        12.9%      |
|TERMINAL (d)           |  2/15 (13%)   4/15 (27%)   2/14 (14%)   5/20 (25%) |  0/25 (0%)    1/29 (3%)    2/30 (7%)    4/31 (13%) |
|FIRST INCIDENCE (DAYS) |   589          703          605          728 (T)   |   ---          728 (T)      698          728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.585      P=0.370      P=0.661N     P=0.502    |  P=0.061      P=0.530      P=0.151      P=0.092    |
|INCIDENTAL TUMOR       |  P=0.563      P=0.357      P=0.644      P=0.493    |  P=0.059      P=0.530      P=0.166      P=0.092    |
|LOGISTIC REGRESSION    |  P=0.438      P=0.432      P=0.616N     P=0.435    |  P=0.058      P=0.530      P=0.143      P=0.092    |
|COCHRAN-ARMITAGE       |  P=0.374                                           |  P=0.043 *                                         |
|FISHER EXACT           |               P=0.346      P=0.651      P=0.335    |               P=0.490      P=0.117      P=0.056    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Dilatation                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 31/51 (61%)  24/48 (50%)  23/49 (47%)  23/50 (46%) | 27/50 (54%)  34/50 (68%)  13/49 (27%)  17/50 (34%) |
|ADJUSTED (b)           |  80.9%        73.7%        66.5%        61.8%      |  70.0%        75.1%        33.7%        48.8%      |
|TERMINAL (d)           |  9/15 (60%)   8/15 (53%)   6/14 (43%)   8/20 (40%) | 14/25 (56%)  18/29 (62%)   6/30 (20%)  14/31 (45%) |
|FIRST INCIDENCE (DAYS) |   316          424          281           80       |   478          501          497          177       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.108N     P=0.122N     P=0.084N     P=0.047N*  |  P=0.002N**   P=0.375      P=0.003N**   P=0.010N** |
|INCIDENTAL TUMOR       |  P=0.138N     P=0.238N     P=0.109N     P=0.053N   |  P=0.003N**   P=0.111      P=0.006N**   P=0.023N*  |
|LOGISTIC REGRESSION    |  P=0.181N     P=0.181N     P=0.137N     P=0.088N   |  P=0.002N**   P=0.123      P=0.004N**   P=0.032N*  |
|COCHRAN-ARMITAGE       |  P=0.192N                                          |  P=0.002N**                                        |
|FISHER EXACT           |               P=0.190N     P=0.117N     P=0.098N   |               P=0.109      P=0.005N**   P=0.035N*  |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  29
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Galactocele                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/51 (2%)    4/48 (8%)    1/49 (2%)    7/50 (14%) |  2/50 (4%)    1/50 (2%)    3/49 (6%)    2/50 (4%)  |
|ADJUSTED (b)           |   6.7%        23.5%         7.1%        27.5%      |   8.0%         3.4%         9.5%         5.6%      |
|TERMINAL (d)           |  1/15 (7%)    3/15 (20%)   1/14 (7%)    4/20 (20%) |  2/25 (8%)    1/29 (3%)    2/30 (7%)    1/31 (3%)  |
|FIRST INCIDENCE (DAYS) |   728 (T)      706          728 (T)      563       |   728 (T)      728 (T)      698          659       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.060      P=0.184      P=0.749      P=0.068    |  P=0.590      P=0.448N     P=0.575      P=0.614N   |
|INCIDENTAL TUMOR       |  P=0.046 *    P=0.183      P=0.749      P=0.052    |  P=0.588      P=0.448N     P=0.595      P=0.614N   |
|LOGISTIC REGRESSION    |  P=0.027 *    P=0.202      P=0.753      P=0.037 *  |  P=0.567      P=0.448N     P=0.566      P=0.655N   |
|COCHRAN-ARMITAGE       |  P=0.022 *                                         |  P=0.529                                           |
|FISHER EXACT           |               P=0.163      P=0.742      P=0.028 *  |               P=0.500N     P=0.490      P=0.691N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Hyperplasia Focal                                                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    0/48 (0%)    1/49 (2%)    1/50 (2%)  |  3/50 (6%)    0/50 (0%)    1/49 (2%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         7.1%         5.0%      |  12.0%         0.0%         2.7%         3.2%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    1/14 (7%)    1/20 (5%)  |  3/25 (12%)   0/29 (0%)    0/30 (0%)    1/31 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          728 (T)      728 (T)   |   728 (T)      ---          671          728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.449        (e)        P=0.486      P=0.557    |  P=0.447N     P=0.095N     P=0.249N     P=0.230N   |
|INCIDENTAL TUMOR       |  P=0.449        (e)        P=0.486      P=0.557    |  P=0.447N     P=0.095N     P=0.233N     P=0.230N   |
|LOGISTIC REGRESSION    |  P=0.449        (e)        P=0.486      P=0.557    |  P=0.463N     P=0.095N     P=0.266N     P=0.230N   |
|COCHRAN-ARMITAGE       |  P=0.373                                           |  P=0.494N                                          |
|FISHER EXACT           |                 (e)        P=0.490      P=0.495    |               P=0.121N     P=0.316N     P=0.309N   |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  30
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/51 (4%)    4/48 (8%)    3/49 (6%)    2/50 (4%)  |  0/50 (0%)    0/50 (0%)    0/49 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   5.2%        17.3%        19.6%         5.8%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    2/14 (14%)   0/20 (0%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   471          692          720          629       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.336N     P=0.390      P=0.505      P=0.640N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.507N     P=0.313      P=0.432      P=0.523    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.413N     P=0.317      P=0.497      P=0.695N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.412N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.310      P=0.481      P=0.684    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland: Lobular                                                                                                           |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    0/48 (0%)    4/49 (8%)   35/50 (70%) |  0/50 (0%)    1/50 (2%)    0/49 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%        16.3%        87.3%      |   0.0%         3.4%         0.0%         2.6%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    1/14 (7%)   15/20 (75%) |  0/25 (0%)    1/29 (3%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          597          115       |   ---          728 (T)      ---          663       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **     (e)        P=0.083      P<0.001 ** |  P=0.516      P=0.530        (e)        P=0.528    |
|INCIDENTAL TUMOR       |  P<0.001 **     (e)        P=0.079      P<0.001 ** |  P=0.517      P=0.530        (e)        P=0.545    |
|LOGISTIC REGRESSION    |  P<0.001 **     (e)        P=0.071      P<0.001 ** |  P=0.495      P=0.530        (e)        P=0.499    |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.490                                           |
|FISHER EXACT           |                 (e)        P=0.054      P<0.001 ** |               P=0.500        (e)        P=0.500    |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  31
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Mesentery: Fat                                                                                                                   |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 10/14 (71%)   4/6 (67%)    5/5 (100%)   3/3 (100%) |  2/5 (40%)    3/3 (100%)  10/12 (83%)  10/10 (100%)|
|ADJUSTED (b)           |  75.5%       100.0%       100.0%         9.0%      | 100.0%       100.0%        85.5%       100.0%      |
|TERMINAL (d)           |  2/3 (67%)    2/2 (100%)   2/2 (100%)   0/0        |  1/1 (100%)   2/2 (100%)   5/6 (83%)    5/5 (100%) |
|FIRST INCIDENCE (DAYS) |   479          479          538          563       |   574          299          229          177       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.277N     P=0.084N     P=0.130N     P=0.075N   |  P=0.065      P=0.741N     P=0.184      P=0.144    |
|INCIDENTAL TUMOR       |  P=0.194      P=0.563N     P=0.244      P=0.262    |  P=0.101        (e)        P=0.246      P=0.122    |
|LOGISTIC REGRESSION    |  P=0.258      P=0.628N     P=0.238      P=0.385    |  P=0.051      P=0.184      P=0.112      P=0.020 *  |
|COCHRAN-ARMITAGE       |  P=0.251                                           |  P=0.052                                           |
|FISHER EXACT           |               P=0.613N     P=0.258      P=0.421    |               P=0.179      P=0.117      P=0.022 *  |
|=================================================================================================================================|
|                                                                                                                                 |
|Mesentery: Fat                                                                                                                   |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/14 (36%)   2/6 (33%)    3/5 (60%)    0/3 (0%)   |  1/5 (20%)    0/3 (0%)     3/12 (25%)   5/10 (50%) |
|ADJUSTED (b)           |  42.0%        51.7%        52.7%         0.0%      |   3.2%         0.0%        35.0%        62.2%      |
|TERMINAL (d)           |  1/3 (33%)    1/2 (50%)    1/2 (50%)    0/0        |  0/1 (0%)     0/2 (0%)     2/6 (33%)    3/5 (60%)  |
|FIRST INCIDENCE (DAYS) |   486          675          538          ---       |   693          ---          659          659       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.111N     P=0.219N     P=0.339N     P=0.053N   |  P=0.063      P=0.488N     P=0.633      P=0.359    |
|INCIDENTAL TUMOR       |  P=0.458N     P=0.633N     P=0.362      P=0.390N   |  P=0.088        (e)        P=0.686N     P=0.399    |
|LOGISTIC REGRESSION    |  P=0.294N     P=0.659N     P=0.329      P=0.293N   |  P=0.076      P=0.611N     P=0.745      P=0.397    |
|COCHRAN-ARMITAGE       |  P=0.288N                                          |  P=0.076                                           |
|FISHER EXACT           |               P=0.664N     P=0.336      P=0.324N   |               P=0.625N     P=0.670      P=0.294    |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  32
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Mesentery: Fat                                                                                                                   |
|     Necrosis                                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/14 (14%)   2/6 (33%)    1/5 (20%)    0/3 (0%)   |  2/5 (40%)    0/3 (0%)     2/12 (17%)   1/10 (10%) |
|ADJUSTED (b)           |   7.1%        51.7%         3.3%         0.0%      |   6.5%         0.0%        19.3%         2.5%      |
|TERMINAL (d)           |  0/3 (0%)     1/2 (50%)    0/2 (0%)     0/0        |  0/1 (0%)     0/2 (0%)     1/6 (17%)    0/5 (0%)   |
|FIRST INCIDENCE (DAYS) |   605          675          669          ---       |   693          ---          708          659       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.207N     P=0.673N     P=0.412N     P=0.204N   |  P=0.523N     P=0.229N     P=0.518N     P=0.453N   |
|INCIDENTAL TUMOR       |  P=0.430N     P=0.343      P=0.523      P=0.472N   |  P=0.321N       (e)        P=0.246N     P=0.309N   |
|LOGISTIC REGRESSION    |  P=0.459N     P=0.359      P=0.661      P=0.611N   |  P=0.325N     P=0.303N     P=0.212N     P=0.226N   |
|COCHRAN-ARMITAGE       |  P=0.438N                                          |  P=0.343N                                          |
|FISHER EXACT           |               P=0.343      P=0.624      P=0.669N   |               P=0.357N     P=0.330N     P=0.242N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Nose                                                                                                                             |
|     Inflammation                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    6/49 (12%)   3/50 (6%)    2/50 (4%)  |  1/49 (2%)    3/50 (6%)    0/49 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |  15.2%        30.4%        12.5%         6.9%      |   4.0%         8.7%         0.0%         0.0%      |
|TERMINAL (d)           |  1/15 (7%)    3/15 (20%)   0/14 (0%)    0/20 (0%)  |  1/25 (4%)    1/29 (3%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   519          588          644          666       |   728 (T)      652          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.122N     P=0.396      P=0.443N     P=0.262N   |  P=0.116N     P=0.352      P=0.464N     P=0.457N   |
|INCIDENTAL TUMOR       |  P=0.203N     P=0.363      P=0.486N     P=0.475N   |  P=0.110N     P=0.399      P=0.464N     P=0.457N   |
|LOGISTIC REGRESSION    |  P=0.165N     P=0.399      P=0.474N     P=0.338N   |  P=0.127N     P=0.332      P=0.464N     P=0.457N   |
|COCHRAN-ARMITAGE       |  P=0.166N                                          |  P=0.131N                                          |
|FISHER EXACT           |               P=0.357      P=0.500N     P=0.339N   |               P=0.316      P=0.500N     P=0.495N   |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  33
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Nose                                                                                                                             |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    0/49 (0%)    2/50 (4%)    1/50 (2%)  |  0/49 (0%)    0/50 (0%)    0/49 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |  11.1%         0.0%         9.1%         4.5%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/15 (7%)    0/15 (0%)    1/14 (7%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   464          ---          517          715       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.431N     P=0.125N     P=0.491N     P=0.267N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.637N     P=0.161N     P=0.662N     P=0.435N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.478N     P=0.130N     P=0.541N     P=0.306N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.484N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.125N     P=0.500N     P=0.309N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     DYSGENESIS                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  0/50 (0%)    1/49 (2%)   43/50 (86%)  49/49 (100%)|
|ADJUSTED (b)           |                                                    |   0.0%         3.0%        97.7%       100.0%      |
|TERMINAL (d)           |                                                    |  0/25 (0%)    0/29 (0%)   29/30 (97%)  31/31 (100%)|
|FIRST INCIDENCE (DAYS) |                                                    |   ---          702          441          177       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P<0.001 **   P=0.519      P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |                                                    |  P<0.001 **   P=0.523      P<0.001 **   P<0.001 ** |
|LOGISTIC REGRESSION    |                                                    |  P<0.001 **   P=0.512      P<0.001 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |                                                    |  P<0.001 **                                        |
|FISHER EXACT           |                                                    |               P=0.495      P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  34
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary: Follicle                                                                                                                  |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  0/50 (0%)    2/49 (4%)    1/50 (2%)    1/49 (2%)  |
|ADJUSTED (b)           |                                                    |   0.0%         6.9%         3.3%         3.2%      |
|TERMINAL (d)           |                                                    |  0/25 (0%)    2/29 (7%)    1/30 (3%)    1/31 (3%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   ---          728 (T)      728 (T)      728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.640N     P=0.271      P=0.536      P=0.543    |
|INCIDENTAL TUMOR       |                                                    |  P=0.640N     P=0.271      P=0.536      P=0.543    |
|LOGISTIC REGRESSION    |                                                    |  P=0.640N     P=0.271      P=0.536      P=0.543    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.653                                           |
|FISHER EXACT           |                                                    |               P=0.242      P=0.500      P=0.495    |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary: Periovarian Tissue                                                                                                        |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  4/50 (8%)    0/49 (0%)    4/50 (8%)    2/49 (4%)  |
|ADJUSTED (b)           |                                                    |  12.0%         0.0%        10.1%         6.1%      |
|TERMINAL (d)           |                                                    |  0/25 (0%)    0/29 (0%)    1/30 (3%)    1/31 (3%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   562          ---          478          704       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.536N     P=0.051N     P=0.593N     P=0.275N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.586      P=0.081N     P=0.503      P=0.519N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.570N     P=0.070N     P=0.622N     P=0.347N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.578N                                          |
|FISHER EXACT           |                                                    |               P=0.061N     P=0.643N     P=0.349N   |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  35
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/49 (4%)    0/48 (0%)    0/50 (0%)    0/48 (0%)  |  0/50 (0%)    0/49 (0%)    2/49 (4%)    0/49 (0%)  |
|ADJUSTED (b)           |   8.7%         0.0%         0.0%         0.0%      |   0.0%         0.0%         6.7%         0.0%      |
|TERMINAL (d)           |  1/15 (7%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    2/30 (7%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   464          ---          ---          ---       |   ---          ---          728 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.334N     P=0.245N     P=0.247N     P=0.217N   |  P=0.661N       (e)        P=0.279        (e)      |
|INCIDENTAL TUMOR       |  P=0.457N     P=0.295N     P=0.345N     P=0.388N   |  P=0.661N       (e)        P=0.279        (e)      |
|LOGISTIC REGRESSION    |  P=0.346N     P=0.248N     P=0.255N     P=0.238N   |  P=0.661N       (e)        P=0.279        (e)      |
|COCHRAN-ARMITAGE       |  P=0.360N                                          |  P=0.695N                                          |
|FISHER EXACT           |               P=0.253N     P=0.242N     P=0.253N   |                 (e)        P=0.242        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas: Acinus                                                                                                                 |
|     Atrophy                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 11/49 (22%)   7/48 (15%)  11/50 (22%)   4/48 (8%)  |  8/50 (16%)   7/49 (14%)   5/49 (10%)   3/49 (6%)  |
|ADJUSTED (b)           |  42.4%        21.8%        45.3%        18.5%      |  26.9%        19.9%        16.0%         9.7%      |
|TERMINAL (d)           |  4/15 (27%)   1/15 (7%)    5/14 (36%)   3/20 (15%) |  5/25 (20%)   3/29 (10%)   4/30 (13%)   3/31 (10%) |
|FIRST INCIDENCE (DAYS) |   429          479          538          708       |   506          576          698          728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.032N*    P=0.200N     P=0.520N     P=0.021N*  |  P=0.052N     P=0.390N     P=0.187N     P=0.054N   |
|INCIDENTAL TUMOR       |  P=0.097N     P=0.315N     P=0.496      P=0.092N   |  P=0.075N     P=0.471N     P=0.239N     P=0.084N   |
|LOGISTIC REGRESSION    |  P=0.066N     P=0.238N     P=0.542N     P=0.044N*  |  P=0.072N     P=0.484N     P=0.237N     P=0.087N   |
|COCHRAN-ARMITAGE       |  P=0.064N                                          |  P=0.080N                                          |
|FISHER EXACT           |               P=0.232N     P=0.574N     P=0.049N*  |               P=0.517N     P=0.290N     P=0.106N   |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  36
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Parathyroid Gland                                                                                                                |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 10/46 (22%)  14/44 (32%)  17/48 (35%)  15/43 (35%) |  0/47 (0%)    0/46 (0%)    2/42 (5%)    0/38 (0%)  |
|ADJUSTED (b)           |  50.2%        57.1%        58.6%        48.9%      |   0.0%         0.0%         7.1%         0.0%      |
|TERMINAL (d)           |  5/13 (38%)   5/14 (36%)   4/14 (29%)   5/18 (28%) |  0/23 (0%)    0/27 (0%)    2/28 (7%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   471          588          605          629       |   ---          ---          728 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.539N     P=0.347      P=0.189      P=0.414    |  P=0.696N       (e)        P=0.282        (e)      |
|INCIDENTAL TUMOR       |  P=0.284      P=0.291      P=0.169      P=0.163    |  P=0.696N       (e)        P=0.282        (e)      |
|LOGISTIC REGRESSION    |  P=0.357      P=0.328      P=0.213      P=0.214    |  P=0.696N       (e)        P=0.282        (e)      |
|COCHRAN-ARMITAGE       |  P=0.244                                           |  P=0.738N                                          |
|FISHER EXACT           |               P=0.200      P=0.108      P=0.127    |                 (e)        P=0.220        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland                                                                                                                  |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/51 (4%)    2/50 (4%)    3/50 (6%)    3/49 (6%)  | 10/50 (20%)   9/50 (18%)   4/49 (8%)    1/50 (2%)  |
|ADJUSTED (b)           |   8.7%         7.4%        11.1%        15.0%      |  34.4%        29.1%        12.5%         3.2%      |
|TERMINAL (d)           |  1/15 (7%)    0/15 (0%)    1/14 (7%)    3/20 (15%) |  7/25 (28%)   8/29 (28%)   3/30 (10%)   1/31 (3%)  |
|FIRST INCIDENCE (DAYS) |   479          692          517          728 (T)   |   548          523          674          728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.533      P=0.650N     P=0.512      P=0.601    |  P=0.001N**   P=0.376N     P=0.042N*    P=0.002N** |
|INCIDENTAL TUMOR       |  P=0.287      P=0.685      P=0.249      P=0.450    |  P=0.001N**   P=0.420N     P=0.044N*    P=0.003N** |
|LOGISTIC REGRESSION    |  P=0.416      P=0.695      P=0.442      P=0.507    |  P=0.002N**   P=0.418N     P=0.049N*    P=0.003N** |
|COCHRAN-ARMITAGE       |  P=0.424                                           |  P=0.003N**                                        |
|FISHER EXACT           |               P=0.684      P=0.491      P=0.481    |               P=0.500N     P=0.080N     P=0.004N** |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  37
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland                                                                                                                  |
|     Hemorrhage                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    0/50 (0%)    0/50 (0%)    0/49 (0%)  |  1/50 (2%)    0/50 (0%)    2/49 (4%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   3.0%         0.0%         6.1%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    1/30 (3%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   678          ---          693          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.445N     P=0.494N     P=0.542      P=0.483N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.441N     P=0.455N     P=0.595      P=0.455N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.464N     P=0.497N     P=0.518      P=0.498N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.472N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.500N     P=0.492      P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland                                                                                                                  |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/51 (4%)    2/50 (4%)    0/50 (0%)    1/49 (2%)  |  3/50 (6%)    2/50 (4%)    2/49 (4%)    1/50 (2%)  |
|ADJUSTED (b)           |   8.5%        10.7%         0.0%         3.1%      |   9.2%         4.9%         6.7%         3.0%      |
|TERMINAL (d)           |  1/15 (7%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  1/25 (4%)    0/29 (0%)    2/30 (7%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   366          707          ---          646       |   533          562          728 (T)      713       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.409N     P=0.688N     P=0.252N     P=0.470N   |  P=0.253N     P=0.465N     P=0.451N     P=0.264N   |
|INCIDENTAL TUMOR       |  P=0.602N     P=0.685      P=0.345N     P=0.690N   |  P=0.286N     P=0.548N     P=0.482N     P=0.249N   |
|LOGISTIC REGRESSION    |  P=0.475N     P=0.688      P=0.283N     P=0.500N   |  P=0.280N     P=0.518N     P=0.499N     P=0.304N   |
|COCHRAN-ARMITAGE       |  P=0.473N                                          |  P=0.280N                                          |
|FISHER EXACT           |               P=0.684      P=0.252N     P=0.515N   |               P=0.500N     P=0.510N     P=0.309N   |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  38
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland                                                                                                                  |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/51 (4%)    1/50 (2%)    0/50 (0%)    0/49 (0%)  |  0/50 (0%)    0/50 (0%)    1/49 (2%)    1/50 (2%)  |
|ADJUSTED (b)           |   6.4%         5.6%         0.0%         0.0%      |   0.0%         0.0%         3.3%         2.9%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    1/30 (3%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   611          714          ---          ---       |   ---          ---          728 (T)      695       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.215N     P=0.482N     P=0.202N     P=0.202N   |  P=0.336        (e)        P=0.536      P=0.531    |
|INCIDENTAL TUMOR       |  P=0.256N     P=0.524N     P=0.234N     P=0.256N   |  P=0.334        (e)        P=0.536      P=0.545    |
|LOGISTIC REGRESSION    |  P=0.248N     P=0.500N     P=0.250N     P=0.247N   |  P=0.322        (e)        P=0.536      P=0.511    |
|COCHRAN-ARMITAGE       |  P=0.246N                                          |  P=0.308                                           |
|FISHER EXACT           |               P=0.508N     P=0.252N     P=0.258N   |                 (e)        P=0.495      P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland                                                                                                                  |
|     Necrosis                                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/51 (4%)    0/50 (0%)    0/50 (0%)    0/49 (0%)  |  0/50 (0%)    0/50 (0%)    0/49 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   8.6%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   657          ---          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.342N     P=0.195N     P=0.203N     P=0.198N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.408N     P=0.194N     P=0.172N     P=0.270N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.359N     P=0.225N     P=0.215N     P=0.231N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.363N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.252N     P=0.252N     P=0.258N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  39
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis                                                                                                   |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    0/50 (0%)    0/50 (0%)    1/49 (2%)  |  1/50 (2%)    2/50 (4%)    2/49 (4%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         5.0%      |   4.0%         5.9%         6.7%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    1/20 (5%)  |  1/25 (4%)    1/29 (3%)    2/30 (7%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          728 (T)   |   728 (T)      646          728 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.292        (e)          (e)        P=0.557    |  P=0.198N     P=0.554      P=0.564      P=0.457N   |
|INCIDENTAL TUMOR       |  P=0.292        (e)          (e)        P=0.557    |  P=0.199N     P=0.560      P=0.564      P=0.457N   |
|LOGISTIC REGRESSION    |  P=0.292        (e)          (e)        P=0.557    |  P=0.214N     P=0.525      P=0.564      P=0.457N   |
|COCHRAN-ARMITAGE       |  P=0.230                                           |  P=0.232N                                          |
|FISHER EXACT           |                 (e)          (e)        P=0.490    |               P=0.500      P=0.492      P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Preputial Gland                                                                                                                  |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/51 (6%)    2/49 (4%)    0/50 (0%)    0/49 (0%)  |  0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)   |
|ADJUSTED (b)           |  11.2%         5.5%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/15 (7%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   429          408          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.111N     P=0.476N     P=0.117N     P=0.107N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.189N     P=0.602N     P=0.180N     P=0.200N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.094N     P=0.511N     P=0.146N     P=0.119N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.117N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.519N     P=0.125N     P=0.129N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  40
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Preputial Gland                                                                                                                  |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 45/51 (88%)  37/49 (76%)  42/50 (84%)  36/49 (73%) |  0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)   |
|ADJUSTED (b)           |  93.4%        89.8%        93.0%        91.6%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           | 12/15 (80%)  11/15 (73%)  11/14 (79%)  17/20 (85%) |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   316          146          353           80       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.051N     P=0.111N     P=0.257N     P=0.024N*  |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.194N     P=0.084N     P=0.309N     P=0.108N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.188N     P=0.077N     P=0.352N     P=0.068N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.119N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.081N     P=0.372N     P=0.051N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Preputial Gland                                                                                                                  |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    2/49 (4%)    0/50 (0%)    0/49 (0%)  |  0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)   |
|ADJUSTED (b)           |   0.0%        10.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   ---          703          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.345N     P=0.264        (e)          (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.439N     P=0.280        (e)          (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.364N     P=0.265        (e)          (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.388N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.238        (e)          (e)      |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  41
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Prostate                                                                                                                         |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 10/51 (20%)   5/50 (10%)   0/50 (0%)    0/49 (0%)  |                                                    |
|ADJUSTED (b)           |  33.0%        20.2%         0.0%         0.0%      |                                                    |
|TERMINAL (d)           |  3/15 (20%)   0/15 (0%)    0/14 (0%)    0/20 (0%)  |                                                    |
|FIRST INCIDENCE (DAYS) |   316          703          ---          ---       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.003N**   P=0.124N     P=0.002N**   P=0.001N** |                                                    |
|INCIDENTAL TUMOR       |  P=0.007N**   P=0.144N     P=0.004N**   P=0.003N** |                                                    |
|LOGISTIC REGRESSION    |  P=0.004N**   P=0.142N     P=0.003N**   P=0.001N** |                                                    |
|COCHRAN-ARMITAGE       |  P=0.004N**                                        |                                                    |
|FISHER EXACT           |               P=0.141N     P<0.001N**   P<0.001N** |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Prostate                                                                                                                         |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    1/50 (2%)    0/50 (0%)    2/49 (4%)  |                                                    |
|ADJUSTED (b)           |   0.0%         4.0%         0.0%         7.6%      |                                                    |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    1/20 (5%)  |                                                    |
|FIRST INCIDENCE (DAYS) |   ---          703          ---          629       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.204      P=0.545        (e)        P=0.296    |                                                    |
|INCIDENTAL TUMOR       |  P=0.160      P=0.539        (e)        P=0.260    |                                                    |
|LOGISTIC REGRESSION    |  P=0.156      P=0.523        (e)        P=0.239    |                                                    |
|COCHRAN-ARMITAGE       |  P=0.151                                           |                                                    |
|FISHER EXACT           |               P=0.495        (e)        P=0.238    |                                                    |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  42
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Salivary Glands                                                                                                                  |
|     Atrophy                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    2/49 (4%)    0/50 (0%)    0/49 (0%)  |  0/50 (0%)    0/49 (0%)    0/50 (0%)    0/49 (0%)  |
|ADJUSTED (b)           |   0.0%         6.4%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          598          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.374N     P=0.273        (e)          (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.407N     P=0.225        (e)          (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.390N     P=0.231        (e)          (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.388N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.238        (e)          (e)      |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Epidermis                                                                                                                  |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/51 (4%)    1/50 (2%)    0/49 (0%)    0/50 (0%)  |  0/50 (0%)    0/50 (0%)    1/50 (2%)    1/50 (2%)  |
|ADJUSTED (b)           |   5.3%         3.8%         0.0%         0.0%      |   0.0%         0.0%         2.3%         3.2%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    1/31 (3%)  |
|FIRST INCIDENCE (DAYS) |   429          693          ---          ---       |   ---          ---          560          728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.233N     P=0.475N     P=0.220N     P=0.229N   |  P=0.322        (e)        P=0.509      P=0.543    |
|INCIDENTAL TUMOR       |  P=0.337N     P=0.559N     P=0.336N     P=0.437N   |  P=0.178        (e)        P=0.243      P=0.543    |
|LOGISTIC REGRESSION    |  P=0.223N     P=0.505N     P=0.290N     P=0.204N   |  P=0.309        (e)        P=0.542      P=0.543    |
|COCHRAN-ARMITAGE       |  P=0.242N                                          |  P=0.307                                           |
|FISHER EXACT           |               P=0.508N     P=0.258N     P=0.252N   |                 (e)        P=0.500      P=0.500    |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  43
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Congestion                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    2/50 (4%)    0/50 (0%)    0/48 (0%)  |  0/50 (0%)    1/49 (2%)    0/50 (0%)    0/49 (0%)  |
|ADJUSTED (b)           |   0.0%         9.5%         0.0%         0.0%      |   0.0%         3.3%         0.0%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    1/15 (7%)    0/14 (0%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          629          ---          ---       |   ---          725          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.339N     P=0.250        (e)          (e)      |  P=0.521N     P=0.536        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.354N     P=0.218        (e)          (e)      |  P=0.549N     P=0.545        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.387N     P=0.247        (e)          (e)      |  P=0.528N     P=0.526        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.394N                                          |  P=0.549N                                          |
|FISHER EXACT           |               P=0.243        (e)          (e)      |               P=0.495        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Fibrosis                                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/51 (14%)   3/50 (6%)    2/50 (4%)    0/48 (0%)  |  1/50 (2%)    1/49 (2%)    3/50 (6%)    0/49 (0%)  |
|ADJUSTED (b)           |  37.3%        20.0%        14.3%         0.0%      |   4.0%         2.8%         9.1%         0.0%      |
|TERMINAL (d)           |  5/15 (33%)   3/15 (20%)   2/14 (14%)   0/20 (0%)  |  1/25 (4%)    0/29 (0%)    1/30 (3%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   600          728 (T)      728 (T)      ---       |   728 (T)      665          693          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.008N**   P=0.140N     P=0.075N     P=0.003N** |  P=0.297N     P=0.734N     P=0.371      P=0.457N   |
|INCIDENTAL TUMOR       |  P=0.008N**   P=0.160N     P=0.084N     P=0.004N** |  P=0.313N     P=0.719N     P=0.398      P=0.457N   |
|LOGISTIC REGRESSION    |  P=0.015N*    P=0.109N     P=0.047N*    P=0.006N** |  P=0.323N     P=0.752N     P=0.349      P=0.457N   |
|COCHRAN-ARMITAGE       |  P=0.023N*                                         |  P=0.337N                                          |
|FISHER EXACT           |               P=0.167N     P=0.085N     P=0.008N** |               P=0.747      P=0.309      P=0.505N   |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  44
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hematopoietic Cell Proliferation                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/51 (6%)    3/50 (6%)    2/50 (4%)    3/48 (6%)  |  2/50 (4%)    6/49 (12%)   0/50 (0%)    3/49 (6%)  |
|ADJUSTED (b)           |  16.3%         8.8%         9.0%        15.0%      |   6.1%        15.4%         0.0%         7.6%      |
|TERMINAL (d)           |  2/15 (13%)   0/15 (0%)    1/14 (7%)    3/20 (15%) |  1/25 (4%)    2/29 (7%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   646          321          353          728 (T)   |   540          537          ---          659       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.546N     P=0.629N     P=0.509N     P=0.541N   |  P=0.414N     P=0.182      P=0.224N     P=0.566    |
|INCIDENTAL TUMOR       |  P=0.465N     P=0.568N     P=0.430N     P=0.562N   |  P=0.532N     P=0.080      P=0.262N     P=0.553    |
|LOGISTIC REGRESSION    |  P=0.560      P=0.653      P=0.514N     P=0.581N   |  P=0.559      P=0.083      P=0.232N     P=0.489    |
|COCHRAN-ARMITAGE       |  P=0.561                                           |  P=0.467N                                          |
|FISHER EXACT           |               P=0.652      P=0.509N     P=0.632    |               P=0.128      P=0.247N     P=0.490    |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen: Lymphoid Follicle                                                                                                        |
|     Depletion Cellular                                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/51 (2%)    1/50 (2%)    1/50 (2%)    2/48 (4%)  |  1/50 (2%)    1/49 (2%)    1/50 (2%)    2/49 (4%)  |
|ADJUSTED (b)           |   2.1%         2.2%         4.8%         4.3%      |   3.0%         2.9%         2.0%         5.3%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   429          424          705          115       |   678          691          118          511       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.359      P=0.748      P=0.755N     P=0.466    |  P=0.380      P=0.747N     P=0.754N     P=0.533    |
|INCIDENTAL TUMOR       |  P=0.312      P=0.647      P=0.705      P=0.680    |  P=0.468      P=0.716N     P=0.436N     P=0.528    |
|LOGISTIC REGRESSION    |  P=0.658N     P=0.705N     P=0.724      P=0.608N   |  P=0.431      P=0.761N     P=0.582N     P=0.494    |
|COCHRAN-ARMITAGE       |  P=0.353                                           |  P=0.356                                           |
|FISHER EXACT           |               P=0.748      P=0.748      P=0.477    |               P=0.747      P=0.753N     P=0.492    |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  45
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Edema                                                                                                                       |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/51 (4%)    0/50 (0%)    0/49 (0%)    0/48 (0%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   4.8%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   519          ---          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.351N     P=0.240N     P=0.220N     P=0.229N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.506N     P=0.320N     P=0.336N     P=0.454N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.321N     P=0.223N     P=0.289N     P=0.217N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.367N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.252N     P=0.258N     P=0.263N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Hyperkeratosis                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/51 (2%)    0/50 (0%)    0/49 (0%)    2/48 (4%)  |  1/50 (2%)    0/50 (0%)    0/50 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |   2.4%         0.0%         0.0%         6.8%      |   2.1%         0.0%         0.0%         2.3%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   519          ---          ---          577       |   533          ---          ---          539       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.188      P=0.505N     P=0.482N     P=0.537    |  P=0.498      P=0.500N     P=0.513N     P=0.748    |
|INCIDENTAL TUMOR       |  P=0.055      P=0.602N     P=0.682N     P=0.268    |  P=0.578      P=0.638N     P=0.581N     P=0.771    |
|LOGISTIC REGRESSION    |  P=0.162      P=0.483N     P=0.551N     P=0.483    |  P=0.550      P=0.466N     P=0.439N     P=0.718N   |
|COCHRAN-ARMITAGE       |  P=0.154                                           |  P=0.511                                           |
|FISHER EXACT           |               P=0.505N     P=0.510N     P=0.477    |               P=0.500N     P=0.500N     P=0.753N   |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  46
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/51 (6%)    3/50 (6%)    9/49 (18%)   4/48 (8%)  |  1/50 (2%)    1/50 (2%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |  15.5%        11.7%        30.2%        12.1%      |   3.8%         2.6%         0.0%         0.0%      |
|TERMINAL (d)           |  2/15 (13%)   1/15 (7%)    1/14 (7%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   549          598          644          639       |   708          652          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.519N     P=0.648N     P=0.110      P=0.606    |  P=0.282N     P=0.725N     P=0.459N     P=0.452N   |
|INCIDENTAL TUMOR       |  P=0.546      P=0.618      P=0.089      P=0.498    |  P=0.285N     P=0.716N     P=0.436N     P=0.455N   |
|LOGISTIC REGRESSION    |  P=0.544      P=0.662N     P=0.076      P=0.480    |  P=0.307N     P=0.759N     P=0.481N     P=0.480N   |
|COCHRAN-ARMITAGE       |  P=0.543                                           |  P=0.307N                                          |
|FISHER EXACT           |               P=0.652      P=0.052      P=0.466    |               P=0.753N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/51 (2%)    2/50 (4%)    2/49 (4%)    2/48 (4%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   3.1%         9.1%         9.5%         6.4%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   611          629          680          629       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.597      P=0.521      P=0.551      P=0.563    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.465      P=0.476      P=0.558      P=0.460    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.520      P=0.501      P=0.517      P=0.480    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.515                                           |    (e)                                             |
|FISHER EXACT           |               P=0.492      P=0.485      P=0.477    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  47
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Perforation                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    0/50 (0%)    2/49 (4%)    0/48 (0%)  |  1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%        10.0%         0.0%      |   3.8%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    1/14 (7%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          666          ---       |   708          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.583N       (e)        P=0.268        (e)      |  P=0.493N     P=0.465N     P=0.459N     P=0.452N   |
|INCIDENTAL TUMOR       |  P=0.621N       (e)        P=0.259        (e)      |  P=0.501N     P=0.455N     P=0.436N     P=0.455N   |
|LOGISTIC REGRESSION    |  P=0.621N       (e)        P=0.262        (e)      |  P=0.508N     P=0.482N     P=0.481N     P=0.480N   |
|COCHRAN-ARMITAGE       |  P=0.641N                                          |  P=0.517N                                          |
|FISHER EXACT           |                 (e)        P=0.238        (e)      |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Ulcer                                                                                                                       |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/51 (12%)   2/50 (4%)    4/49 (8%)    5/48 (10%) |  2/50 (4%)    2/50 (4%)    1/50 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |  21.6%         8.9%        17.9%        18.0%      |   6.0%         5.5%         2.0%         0.0%      |
|TERMINAL (d)           |  2/15 (13%)   1/15 (7%)    1/14 (7%)    1/20 (5%)  |  1/25 (4%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   384          561          681          639       |   533          652          118          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.543      P=0.136N     P=0.335N     P=0.382N   |  P=0.134N     P=0.657N     P=0.487N     P=0.223N   |
|INCIDENTAL TUMOR       |  P=0.330      P=0.206N     P=0.445N     P=0.556    |  P=0.102N     P=0.691      P=0.262N     P=0.216N   |
|LOGISTIC REGRESSION    |  P=0.400      P=0.141N     P=0.406N     P=0.543N   |  P=0.106N     P=0.685      P=0.297N     P=0.234N   |
|COCHRAN-ARMITAGE       |  P=0.403                                           |  P=0.142N                                          |
|FISHER EXACT           |               P=0.141N     P=0.396N     P=0.543N   |               P=0.691N     P=0.500N     P=0.247N   |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  48
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach: Epithelium                                                                                                 |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    0/50 (0%)    2/49 (4%)    2/48 (4%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%        14.3%         9.1%      |   0.0%         0.0%         0.0%         3.2%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    2/14 (14%)   1/20 (5%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    1/31 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          728 (T)      712       |   ---          ---          ---          728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.255        (e)        P=0.221      P=0.300    |  P=0.235        (e)          (e)        P=0.543    |
|INCIDENTAL TUMOR       |  P=0.216        (e)        P=0.221      P=0.253    |  P=0.235        (e)          (e)        P=0.543    |
|LOGISTIC REGRESSION    |  P=0.218        (e)        P=0.221      P=0.282    |  P=0.235        (e)          (e)        P=0.543    |
|COCHRAN-ARMITAGE       |  P=0.156                                           |  P=0.215                                           |
|FISHER EXACT           |                 (e)        P=0.238      P=0.233    |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Glandular                                                                                                               |
|     Erosion                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/51 (4%)    0/50 (0%)    1/49 (2%)    0/48 (0%)  |  0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   8.8%         0.0%         2.7%         0.0%      |   0.0%         2.1%         0.0%         0.0%      |
|TERMINAL (d)           |  1/15 (7%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   486          ---          629          ---       |   ---          537          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.295N     P=0.245N     P=0.476N     P=0.211N   |  P=0.556N     P=0.504        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.404N     P=0.295N     P=0.609N     P=0.388N   |  P=0.497N     P=0.362        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.333N     P=0.243N     P=0.536N     P=0.249N   |  P=0.521N     P=0.531        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.338N                                          |  P=0.547N                                          |
|FISHER EXACT           |               P=0.252N     P=0.515N     P=0.263N   |               P=0.500        (e)          (e)      |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  49
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Glandular                                                                                                               |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/51 (12%)   6/50 (12%)   7/49 (14%)   7/48 (15%) |  0/50 (0%)    1/50 (2%)    1/50 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |  21.2%        25.8%        34.1%        23.5%      |   0.0%         3.4%         3.3%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    2/14 (14%)   1/20 (5%)  |  0/25 (0%)    1/29 (3%)    1/30 (3%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   471          692          680          629       |   ---          728 (T)      728 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.555N     P=0.546N     P=0.562      P=0.591N   |  P=0.479N     P=0.530      P=0.536        (e)      |
|INCIDENTAL TUMOR       |  P=0.265      P=0.575N     P=0.561      P=0.323    |  P=0.479N     P=0.530      P=0.536        (e)      |
|LOGISTIC REGRESSION    |  P=0.455      P=0.605N     P=0.543      P=0.466    |  P=0.479N     P=0.530      P=0.536        (e)      |
|COCHRAN-ARMITAGE       |  P=0.418                                           |  P=0.511N                                          |
|FISHER EXACT           |               P=0.606      P=0.469      P=0.453    |               P=0.500      P=0.500        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Glandular                                                                                                               |
|     Ulcer                                                                                                                       |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    0/50 (0%)    0/49 (0%)    1/48 (2%)  |  0/50 (0%)    0/50 (0%)    3/50 (6%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         5.0%      |   0.0%         0.0%         6.6%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    1/20 (5%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          728 (T)   |   ---          ---          118          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.292        (e)          (e)        P=0.557    |  P=0.639N       (e)        P=0.130        (e)      |
|INCIDENTAL TUMOR       |  P=0.292        (e)          (e)        P=0.557    |  P=0.563N       (e)        P=0.227        (e)      |
|LOGISTIC REGRESSION    |  P=0.292        (e)          (e)        P=0.557    |  P=0.525N       (e)        P=0.239        (e)      |
|COCHRAN-ARMITAGE       |  P=0.227                                           |  P=0.642N                                          |
|FISHER EXACT           |                 (e)          (e)        P=0.485    |                 (e)        P=0.121        (e)      |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  50
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Degeneration                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  9/51 (18%)   9/50 (18%)  37/50 (74%)  28/49 (57%) |                                                    |
|ADJUSTED (b)           |  29.4%        38.2%        97.3%        86.5%      |                                                    |
|TERMINAL (d)           |  1/15 (7%)    3/15 (20%)  13/14 (93%)  16/20 (80%) |                                                    |
|FIRST INCIDENCE (DAYS) |   486          675          353          551       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.017 *    P=0.503N     P<0.001 **   P=0.004 ** |                                                    |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.562N     P<0.001 **   P<0.001 ** |                                                    |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.582N     P<0.001 **   P<0.001 ** |                                                    |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |                                                    |
|FISHER EXACT           |               P=0.584      P<0.001 **   P<0.001 ** |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 17/51 (33%)  10/50 (20%)  33/50 (66%)  19/49 (39%) |                                                    |
|ADJUSTED (b)           |  54.6%        40.5%        87.6%        63.2%      |                                                    |
|TERMINAL (d)           |  4/15 (27%)   3/15 (20%)  10/14 (71%)  10/20 (50%) |                                                    |
|FIRST INCIDENCE (DAYS) |   549          485          437          563       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.478N     P=0.079N     P=0.026 *    P=0.446N   |                                                    |
|INCIDENTAL TUMOR       |  P=0.216      P=0.076N     P=0.002 **   P=0.467    |                                                    |
|LOGISTIC REGRESSION    |  P=0.258      P=0.073N     P=0.002 **   P=0.418    |                                                    |
|COCHRAN-ARMITAGE       |  P=0.273                                           |                                                    |
|FISHER EXACT           |               P=0.098N     P<0.001 **   P=0.360    |                                                    |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  51
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes: Interstitial Cell                                                                                                        |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 16/51 (31%)  22/50 (44%)   0/50 (0%)    0/49 (0%)  |                                                    |
|ADJUSTED (b)           |  40.2%        61.2%         0.0%         0.0%      |                                                    |
|TERMINAL (d)           |  2/15 (13%)   5/15 (33%)   0/14 (0%)    0/20 (0%)  |                                                    |
|FIRST INCIDENCE (DAYS) |   366          424          ---          ---       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001N**   P=0.266      P<0.001N**   P<0.001N** |                                                    |
|INCIDENTAL TUMOR       |  P<0.001N**   P=0.039 *    P<0.001N**   P=0.002N** |                                                    |
|LOGISTIC REGRESSION    |  P<0.001N**   P=0.031 *    P<0.001N**   P<0.001N** |                                                    |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |                                                    |
|FISHER EXACT           |               P=0.135      P<0.001N**   P<0.001N** |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thymus                                                                                                                           |
|     Atrophy                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/42 (14%)   3/42 (7%)    7/38 (18%)   7/39 (18%) |  3/45 (7%)    2/47 (4%)    7/44 (16%)   6/42 (14%) |
|ADJUSTED (b)           |  13.4%         8.5%        25.4%        21.0%      |   7.9%         4.3%        17.1%        12.8%      |
|TERMINAL (d)           |  0/15 (0%)    0/14 (0%)    0/12 (0%)    0/16 (0%)  |  0/23 (0%)    0/27 (0%)    1/27 (4%)    0/26 (0%)  |
|FIRST INCIDENCE (DAYS) |   384          485          527          434       |   533          501          118          387       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.356      P=0.236N     P=0.570      P=0.566    |  P=0.148      P=0.465N     P=0.194      P=0.258    |
|INCIDENTAL TUMOR       |  P=0.029 *    P=0.328N     P=0.247      P=0.069    |  P=0.214      P=0.647      P=0.189      P=0.263    |
|LOGISTIC REGRESSION    |  P=0.083      P=0.384N     P=0.276      P=0.101    |  P=0.091      P=0.499N     P=0.170      P=0.102    |
|COCHRAN-ARMITAGE       |  P=0.238                                           |  P=0.096                                           |
|FISHER EXACT           |               P=0.241N     P=0.421      P=0.441    |               P=0.479N     P=0.148      P=0.208    |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  52
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland                                                                                                                    |
|     Ultimobranchial Cyst                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/51 (2%)    6/48 (13%)   3/50 (6%)    0/49 (0%)  |  2/50 (4%)    1/49 (2%)    0/50 (0%)    2/49 (4%)  |
|ADJUSTED (b)           |   6.7%        21.2%        11.4%         0.0%      |   4.3%         3.4%         0.0%         4.7%      |
|TERMINAL (d)           |  1/15 (7%)    2/15 (13%)   0/14 (0%)    0/20 (0%)  |  0/25 (0%)    1/29 (3%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   728 (T)      321          622          ---       |   533          728 (T)      ---          394       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.052N     P=0.063      P=0.335      P=0.443N   |  P=0.498      P=0.483N     P=0.252N     P=0.686    |
|INCIDENTAL TUMOR       |  P=0.060N     P=0.044 *    P=0.355      P=0.443N   |  P=0.569      P=0.645N     P=0.323N     P=0.694N   |
|LOGISTIC REGRESSION    |  P=0.057N     P=0.044 *    P=0.349      P=0.443N   |  P=0.545      P=0.621N     P=0.165N     P=0.627N   |
|COCHRAN-ARMITAGE       |  P=0.064N                                          |  P=0.488                                           |
|FISHER EXACT           |               P=0.047 *    P=0.301      P=0.510N   |               P=0.508N     P=0.247N     P=0.684    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/51 (2%)    0/48 (0%)    0/50 (0%)    0/49 (0%)  |  0/50 (0%)    0/49 (0%)    2/50 (4%)    0/49 (0%)  |
|ADJUSTED (b)           |   3.0%         0.0%         0.0%         0.0%      |   0.0%         0.0%         6.7%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    2/30 (7%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   605          ---          ---          ---       |   ---          ---          728 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.577N     P=0.488N     P=0.462N     P=0.472N   |  P=0.661N       (e)        P=0.279        (e)      |
|INCIDENTAL TUMOR       |  P=0.588N     P=0.564N     P=0.500N     P=0.519N   |  P=0.661N       (e)        P=0.279        (e)      |
|LOGISTIC REGRESSION    |  P=0.585N     P=0.516N     P=0.522N     P=0.506N   |  P=0.661N       (e)        P=0.279        (e)      |
|COCHRAN-ARMITAGE       |  P=0.594N                                          |  P=0.695N                                          |
|FISHER EXACT           |               P=0.515N     P=0.505N     P=0.510N   |                 (e)        P=0.247        (e)      |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  53
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Urinary Bladder                                                                                                                  |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/51 (2%)    1/50 (2%)    0/50 (0%)    2/49 (4%)  |  0/50 (0%)    3/50 (6%)    1/49 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |   4.2%         2.1%         0.0%         7.1%      |   0.0%        10.3%         3.2%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    1/20 (5%)  |  0/25 (0%)    3/29 (10%)   0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   660          408          ---          145       |   ---          728 (T)      713          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.329      P=0.735N     P=0.443N     P=0.544    |  P=0.198N     P=0.147      P=0.543        (e)      |
|INCIDENTAL TUMOR       |  P=0.316      P=0.729      P=0.439N     P=0.690    |  P=0.202N     P=0.147      P=0.545        (e)      |
|LOGISTIC REGRESSION    |  P=0.444      P=0.755N     P=0.492N     P=0.552    |  P=0.203N     P=0.147      P=0.520        (e)      |
|COCHRAN-ARMITAGE       |  P=0.301                                           |  P=0.230N                                          |
|FISHER EXACT           |               P=0.748      P=0.505N     P=0.485    |               P=0.121      P=0.495        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Urinary Bladder: Transitional Epithelium                                                                                         |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    0/50 (0%)    0/50 (0%)    1/49 (2%)  |  0/50 (0%)    0/50 (0%)    2/49 (4%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         2.7%      |   0.0%         0.0%         5.3%         2.8%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          629       |   ---          ---          638          680       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.257        (e)          (e)        P=0.542    |  P=0.385        (e)        P=0.277      P=0.523    |
|INCIDENTAL TUMOR       |  P=0.231        (e)          (e)        P=0.481    |  P=0.256        (e)        P=0.129      P=0.545    |
|LOGISTIC REGRESSION    |  P=0.229        (e)          (e)        P=0.491    |  P=0.358        (e)        P=0.233      P=0.503    |
|COCHRAN-ARMITAGE       |  P=0.230                                           |  P=0.358                                           |
|FISHER EXACT           |                 (e)          (e)        P=0.490    |                 (e)        P=0.242      P=0.500    |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  54
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Hemorrhage                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  1/50 (2%)    1/50 (2%)    2/50 (4%)    0/50 (0%)  |
|ADJUSTED (b)           |                                                    |   4.0%         3.3%         4.8%         0.0%      |
|TERMINAL (d)           |                                                    |  1/25 (4%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   728 (T)      725          560          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.307N     P=0.723N     P=0.543      P=0.457N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.391N     P=0.719N     P=0.421      P=0.457N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.330N     P=0.732N     P=0.501      P=0.457N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.330N                                          |
|FISHER EXACT           |                                                    |               P=0.753N     P=0.500      P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Hydrometra                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  3/50 (6%)    4/50 (8%)    5/50 (10%)   6/50 (12%) |
|ADJUSTED (b)           |                                                    |  10.4%        13.8%        15.7%        19.4%      |
|TERMINAL (d)           |                                                    |  2/25 (8%)    4/29 (14%)   4/30 (13%)   6/31 (19%) |
|FIRST INCIDENCE (DAYS) |                                                    |   573          728 (T)      671          728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.290      P=0.579      P=0.447      P=0.347    |
|INCIDENTAL TUMOR       |                                                    |  P=0.246      P=0.535      P=0.372      P=0.250    |
|LOGISTIC REGRESSION    |                                                    |  P=0.262      P=0.546      P=0.392      P=0.298    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.215                                           |
|FISHER EXACT           |                                                    |               P=0.500      P=0.357      P=0.243    |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  55
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus: Endometrium                                                                                                              |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  1/50 (2%)    1/50 (2%)    9/50 (18%)   3/50 (6%)  |
|ADJUSTED (b)           |                                                    |   4.0%         2.4%        27.5%         9.3%      |
|TERMINAL (d)           |                                                    |  1/25 (4%)    0/29 (0%)    7/30 (23%)   2/31 (6%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   728 (T)      582          671          713       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.388      P=0.726N     P=0.020 *    P=0.391    |
|INCIDENTAL TUMOR       |                                                    |  P=0.327      P=0.729      P=0.022 *    P=0.386    |
|LOGISTIC REGRESSION    |                                                    |  P=0.344      P=0.758      P=0.016 *    P=0.370    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.309                                           |
|FISHER EXACT           |                                                    |               P=0.753N     P=0.008 **   P=0.309    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus: Endometrium                                                                                                              |
|     Hyperplasia Cystic                                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  1/50 (2%)    0/50 (0%)    4/50 (8%)    3/50 (6%)  |
|ADJUSTED (b)           |                                                    |   3.3%         0.0%        11.9%         8.5%      |
|TERMINAL (d)           |                                                    |  0/25 (0%)    0/29 (0%)    3/30 (10%)   2/31 (6%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   705          ---          441          511       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.171      P=0.487N     P=0.218      P=0.351    |
|INCIDENTAL TUMOR       |                                                    |  P=0.202      P=0.455N     P=0.210      P=0.367    |
|LOGISTIC REGRESSION    |                                                    |  P=0.143      P=0.484N     P=0.179      P=0.305    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.143                                           |
|FISHER EXACT           |                                                    |               P=0.500N     P=0.181      P=0.309    |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  56
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT 104 WEEKS
                                                                           

 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (d)  Observed incidence at terminal kill.
 (f)  Beneath the control incidence are the P-values associated with the trend 
      test.  Beneath the dosed group incidence are the P-values corresponding to 
      pairwise comparisons between the controls and that dosed group.  The life
      table analysis regards tumors in animals dying  prior to terminal kill as
      being (directly or indirectly) the cause of death.  The incidental tumor 
      test regards these lesions as non-fatal.  Logistic regression is an alternative
      method for analyzing the incidence of non-fatal tumors.  The Cochran-Armitage
      and Fisher's exact tests compare directly the overall incidence rates.  
      For all tests, a negative trend is indicated by "N".
 (e)  Value of Statistic cannot be computed. 
 (I)  Interim sacrifice
 (T)  Terminal sacrifice
  #   Tumor rates based on number of animals necropsied.

  *   To the right of any statistical result, indicates significance at (P<=0.05).
  **  To the right of any statistical result, indicates significance at (P<=0.01).