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TDMS Study 88032-05 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                        OXYMETHOLONE                                     DATE: 11/24/97       
EXPERIMENT: 88032 TEST: 05                                                                                     TIME: 11:27:30       
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:    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 PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                        OXYMETHOLONE                                     DATE: 11/24/97       
EXPERIMENT: 88032 TEST: 05                                                                                     TIME: 11:27:30       
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       




                                                    RATS(FISCHER344)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
                                                                    

                                                    ----------------

                                                    Adrenal Cortex
                                                    Adrenal Medulla
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Clitoral/Preputial Gland
                                                    Epididymis
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                        OXYMETHOLONE                                     DATE: 11/24/97       
EXPERIMENT: 88032 TEST: 05                                                                                     TIME: 11:27:30       
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 Medulla               Pheochromocytoma Benign
                                            Pheochromocytoma: Benign, Complex, Malignant, NOS
              Lung                          Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
              Pituitary Gland: Pars Distalis or Unspecified Site
                                            Adenoma
              Skin                          Fibroma
                                            Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma
              Testes                        Adenoma
              All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
                                            Benign Tumors
                                            Malignant Tumors
                                            Malignant and Benign Tumors

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

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

              Liver                         Hepatocellular Adenoma
                                            Hepatocellular Carcinoma
                                            Hepatocellular Carcinoma or Hepatocellular Adenoma
                                            Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
              Lung                          Alveolar/Bronchiolar Adenoma
                                            Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
              Mammary Gland                 Fibroadenoma
                                            Fibroma, Fibroadenoma, Carcinoma, or Adenoma
              Pituitary Gland: Pars Distalis or Unspecified Site
                                            Adenoma
              Skin                          Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal
                                             Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma
                                            Squamous Cell Carcinoma, Basal Cell Carcinoma, Basosquamous Tumor
                                             (malignant or NOS), or Carcinoma
                                            Squamous Cell Papilloma
              Uterus                        Polyp Stromal
                                            Sarcoma Stromal or Polyp Stromal
              All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
                                            Benign Tumors
                                            Malignant and Benign Tumors

              ====================================================================================================
         DATE: 11/24/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE   1
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS 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 Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 19/51 (37%)  25/50 (50%)  21/50 (42%)  29/49 (59%) |  7/50 (14%)   4/50 (8%)    2/50 (4%)   10/49 (20%) |
|ADJUSTED (b)           |  72.8%        77.3%        78.4%        93.2%      |  22.1%        12.3%         4.8%        32.3%      |
|TERMINAL (d)           |  9/15 (60%)   8/15 (53%)   9/14 (64%)  18/20 (90%) |  2/25 (8%)    2/29 (7%)    0/30 (0%)   10/31 (32%) |
|FIRST INCIDENCE (DAYS) |   519          485          564          577       |   589          665          561          728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.355      P=0.295      P=0.488      P=0.266    |  P=0.111      P=0.214N     P=0.064N     P=0.460    |
|INCIDENTAL TUMOR       |  P=0.031 *    P=0.168      P=0.456      P=0.029 *  |  P=0.056      P=0.179N     P=0.074N     P=0.374    |
|LOGISTIC REGRESSION    |  P=0.042 *    P=0.206      P=0.554N     P=0.043 *  |  P=0.071      P=0.155N     P=0.058N     P=0.383    |
|COCHRAN-ARMITAGE       |  P=0.038 *                                         |  P=0.061                                           |
|FISHER EXACT           |               P=0.138      P=0.388      P=0.023 *  |               P=0.262N     P=0.080N     P=0.282    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 19/51 (37%)  25/50 (50%)  21/50 (42%)  29/49 (59%) |  7/50 (14%)   5/50 (10%)   2/50 (4%)   10/49 (20%) |
|ADJUSTED (b)           |  72.8%        77.3%        78.4%        93.2%      |  22.1%        14.4%         4.8%        32.3%      |
|TERMINAL (d)           |  9/15 (60%)   8/15 (53%)   9/14 (64%)  18/20 (90%) |  2/25 (8%)    2/29 (7%)    0/30 (0%)   10/31 (32%) |
|FIRST INCIDENCE (DAYS) |   519          485          564          577       |   589          579          561          728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.355      P=0.295      P=0.488      P=0.266    |  P=0.151      P=0.312N     P=0.064N     P=0.460    |
|INCIDENTAL TUMOR       |  P=0.031 *    P=0.168      P=0.456      P=0.029 *  |  P=0.065      P=0.313N     P=0.074N     P=0.374    |
|LOGISTIC REGRESSION    |  P=0.042 *    P=0.206      P=0.554N     P=0.043 *  |  P=0.097      P=0.263N     P=0.058N     P=0.383    |
|COCHRAN-ARMITAGE       |  P=0.038 *                                         |  P=0.087                                           |
|FISHER EXACT           |               P=0.138      P=0.388      P=0.023 *  |               P=0.380N     P=0.080N     P=0.282    |
|=================================================================================================================================|
         DATE: 11/24/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE   2
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS 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                                                                                                                            |
|     Astrocytoma Malignant                                                                                                       |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR 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%        14.3%         0.0%      |   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) |   ---          ---          728 (T)      ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.551N       (e)        P=0.221        (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.551N       (e)        P=0.221        (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.551N       (e)        P=0.221        (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.632N                                          |    (e)                                             |
|FISHER EXACT           |                 (e)        P=0.243        (e)      |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    2/49 (4%)    2/50 (4%)    0/49 (0%)  |  4/50 (8%)    4/48 (8%)    2/50 (4%)    2/50 (4%)  |
|ADJUSTED (b)           |   0.0%         9.1%        14.3%         0.0%      |  14.5%        13.8%         6.7%         6.5%      |
|TERMINAL (d)           |  0/15 (0%)    1/15 (7%)    2/14 (14%)   0/20 (0%)  |  3/25 (12%)   4/29 (14%)   2/30 (7%)    2/31 (6%)  |
|FIRST INCIDENCE (DAYS) |   ---          597          728 (T)      ---       |   621          728 (T)      728 (T)      728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.257N     P=0.252      P=0.221        (e)      |  P=0.190N     P=0.562N     P=0.257N     P=0.245N   |
|INCIDENTAL TUMOR       |  P=0.258N     P=0.205      P=0.221        (e)      |  P=0.230N     P=0.615N     P=0.350N     P=0.354N   |
|LOGISTIC REGRESSION    |  P=0.308N     P=0.236      P=0.221        (e)      |  P=0.200N     P=0.604N     P=0.289N     P=0.285N   |
|COCHRAN-ARMITAGE       |  P=0.325N                                          |  P=0.240N                                          |
|FISHER EXACT           |               P=0.238      P=0.243        (e)      |               P=0.619      P=0.339N     P=0.339N   |
|=================================================================================================================================|
         DATE: 11/24/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE   3
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS 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/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/51 (6%)    2/49 (4%)    0/50 (0%)    1/49 (2%)  |  1/50 (2%)    3/48 (6%)    1/50 (2%)    3/50 (6%)  |
|ADJUSTED (b)           |  15.3%         7.0%         0.0%         2.7%      |   4.0%         9.8%         2.1%         8.7%      |
|TERMINAL (d)           |  2/15 (13%)   0/15 (0%)    0/14 (0%)    0/20 (0%)  |  1/25 (4%)    2/29 (7%)    0/30 (0%)    2/31 (6%)  |
|FIRST INCIDENCE (DAYS) |   479          321          ---          629       |   728 (T)      705          478          659       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.301N     P=0.494N     P=0.127N     P=0.244N   |  P=0.418      P=0.352      P=0.747N     P=0.386    |
|INCIDENTAL TUMOR       |  P=0.310N     P=0.436N     P=0.182N     P=0.408N   |  P=0.443      P=0.357      P=0.738      P=0.386    |
|LOGISTIC REGRESSION    |  P=0.332N     P=0.519N     P=0.119N     P=0.321N   |  P=0.379      P=0.337      P=0.749N     P=0.345    |
|COCHRAN-ARMITAGE       |  P=0.354N                                          |  P=0.375                                           |
|FISHER EXACT           |               P=0.519N     P=0.125N     P=0.324N   |               P=0.293      P=0.753N     P=0.309    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/51 (6%)    4/49 (8%)    2/50 (4%)    1/49 (2%)  |  5/50 (10%)   7/48 (15%)   3/50 (6%)    5/50 (10%) |
|ADJUSTED (b)           |  15.3%        15.5%        14.3%         2.7%      |  18.4%        23.2%         8.7%        15.0%      |
|TERMINAL (d)           |  2/15 (13%)   1/15 (7%)    2/14 (14%)   0/20 (0%)  |  4/25 (16%)   6/29 (21%)   2/30 (7%)    4/31 (13%) |
|FIRST INCIDENCE (DAYS) |   479          321          728 (T)      629       |   621          705          478          659       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.129N     P=0.513      P=0.522N     P=0.244N   |  P=0.363N     P=0.480      P=0.277N     P=0.493N   |
|INCIDENTAL TUMOR       |  P=0.130N     P=0.530      P=0.607N     P=0.408N   |  P=0.393N     P=0.438      P=0.385N     P=0.599N   |
|LOGISTIC REGRESSION    |  P=0.185N     P=0.476      P=0.458N     P=0.321N   |  P=0.408N     P=0.436      P=0.346N     P=0.559N   |
|COCHRAN-ARMITAGE       |  P=0.183N                                          |  P=0.442N                                          |
|FISHER EXACT           |               P=0.477      P=0.509N     P=0.324N   |               P=0.351      P=0.357N     P=0.630N   |
|=================================================================================================================================|
         DATE: 11/24/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE   4
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS 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/Preputial Gland                                                                                                         |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    0/49 (0%)    0/50 (0%)    0/49 (0%)  |  2/50 (4%)    0/48 (0%)    1/50 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   5.9%         0.0%         3.3%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  1/25 (4%)    0/29 (0%)    1/30 (3%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   478          ---          728 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.291N     P=0.226N     P=0.465N     P=0.223N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.269N     P=0.295N     P=0.504N     P=0.216N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.301N     P=0.251N     P=0.497N     P=0.220N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.304N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.258N     P=0.500N     P=0.247N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/49 (8%)    2/48 (4%)    2/50 (4%)    1/48 (2%)  |  0/49 (0%)    1/49 (2%)    0/49 (0%)    1/49 (2%)  |
|ADJUSTED (b)           |  18.0%         9.1%         6.2%         5.0%      |   0.0%         3.4%         0.0%         2.9%      |
|TERMINAL (d)           |  1/15 (7%)    1/15 (7%)    0/14 (0%)    1/20 (5%)  |  0/25 (0%)    1/29 (3%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   591          597          564          728 (T)   |   ---          728 (T)      ---          704       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.181N     P=0.310N     P=0.288N     P=0.126N   |  P=0.516      P=0.530        (e)        P=0.525    |
|INCIDENTAL TUMOR       |  P=0.205N     P=0.331N     P=0.246N     P=0.157N   |  P=0.505      P=0.530        (e)        P=0.523    |
|LOGISTIC REGRESSION    |  P=0.227N     P=0.315N     P=0.301N     P=0.154N   |  P=0.506      P=0.530        (e)        P=0.515    |
|COCHRAN-ARMITAGE       |  P=0.230N                                          |  P=0.489                                           |
|FISHER EXACT           |               P=0.349N     P=0.329N     P=0.187N   |               P=0.500        (e)        P=0.500    |
|=================================================================================================================================|
         DATE: 11/24/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE   5
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS 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     |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/49 (0%)    0/48 (0%)    2/50 (4%)    0/48 (0%)  |  0/49 (0%)    0/49 (0%)    0/49 (0%)    0/49 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         7.1%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          669          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.619N       (e)        P=0.299        (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.698N       (e)        P=0.324        (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.628N       (e)        P=0.267        (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.634N                                          |    (e)                                             |
|FISHER EXACT           |                 (e)        P=0.253        (e)      |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/49 (8%)    2/48 (4%)    4/50 (8%)    1/48 (2%)  |  0/49 (0%)    1/49 (2%)    0/49 (0%)    1/49 (2%)  |
|ADJUSTED (b)           |  18.0%         9.1%        12.8%         5.0%      |   0.0%         3.4%         0.0%         2.9%      |
|TERMINAL (d)           |  1/15 (7%)    1/15 (7%)    0/14 (0%)    1/20 (5%)  |  0/25 (0%)    1/29 (3%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   591          597          564          728 (T)   |   ---          728 (T)      ---          704       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.161N     P=0.310N     P=0.553N     P=0.126N   |  P=0.516      P=0.530        (e)        P=0.525    |
|INCIDENTAL TUMOR       |  P=0.195N     P=0.331N     P=0.500N     P=0.157N   |  P=0.505      P=0.530        (e)        P=0.523    |
|LOGISTIC REGRESSION    |  P=0.200N     P=0.315N     P=0.594N     P=0.154N   |  P=0.506      P=0.530        (e)        P=0.515    |
|COCHRAN-ARMITAGE       |  P=0.203N                                          |  P=0.489                                           |
|FISHER EXACT           |               P=0.349N     P=0.631N     P=0.187N   |               P=0.500        (e)        P=0.500    |
|=================================================================================================================================|
         DATE: 11/24/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE   6
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS 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                                                                                                             |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    1/50 (2%)    0/50 (0%)    2/49 (4%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    1/49 (2%)  |
|ADJUSTED (b)           |   0.0%         2.4%         0.0%        10.0%      |   0.0%         0.0%         0.0%         3.2%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    2/20 (10%) |  0/25 (0%)    0/29 (0%)    0/30 (0%)    1/31 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          561          ---          728 (T)   |   ---          ---          ---          728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.214      P=0.520        (e)        P=0.302    |  P=0.235        (e)          (e)        P=0.543    |
|INCIDENTAL TUMOR       |  P=0.209      P=0.460        (e)        P=0.302    |  P=0.235        (e)          (e)        P=0.543    |
|LOGISTIC REGRESSION    |  P=0.150      P=0.502        (e)        P=0.302    |  P=0.235        (e)          (e)        P=0.543    |
|COCHRAN-ARMITAGE       |  P=0.151                                           |  P=0.211                                           |
|FISHER EXACT           |               P=0.495        (e)        P=0.238    |                 (e)          (e)        P=0.495    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/51 (2%)    1/50 (2%)    1/50 (2%)    0/49 (0%)  |  1/50 (2%)    1/50 (2%)    1/50 (2%)    8/49 (16%) |
|ADJUSTED (b)           |   6.7%         2.2%         7.1%         0.0%      |   4.0%         3.4%         3.3%        24.5%      |
|TERMINAL (d)           |  1/15 (7%)    0/15 (0%)    1/14 (7%)    0/20 (0%)  |  1/25 (4%)    1/29 (3%)    1/30 (3%)    7/31 (23%) |
|FIRST INCIDENCE (DAYS) |   728 (T)      424          728 (T)      ---       |   728 (T)      728 (T)      728 (T)      659       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.295N     P=0.756      P=0.749      P=0.443N   |  P<0.001 **   P=0.729N     P=0.721N     P=0.037 *  |
|INCIDENTAL TUMOR       |  P=0.383N     P=0.705      P=0.749      P=0.443N   |  P<0.001 **   P=0.729N     P=0.721N     P=0.035 *  |
|LOGISTIC REGRESSION    |  P=0.343N     P=0.762      P=0.749      P=0.443N   |  P<0.001 **   P=0.729N     P=0.721N     P=0.028 *  |
|COCHRAN-ARMITAGE       |  P=0.344N                                          |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.748      P=0.748      P=0.510N   |               P=0.753N     P=0.753N     P=0.014 *  |
|=================================================================================================================================|
         DATE: 11/24/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE   7
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS 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                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    1/50 (2%)    0/50 (0%)    0/49 (0%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    2/49 (4%)  |
|ADJUSTED (b)           |   0.0%         4.8%         0.0%         0.0%      |   0.0%         0.0%         0.0%         6.5%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    2/31 (6%)  |
|FIRST INCIDENCE (DAYS) |   ---          707          ---          ---       |   ---          ---          ---          728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.574N     P=0.520        (e)          (e)      |  P=0.051        (e)          (e)        P=0.286    |
|INCIDENTAL TUMOR       |  P=0.666N     P=0.539        (e)          (e)      |  P=0.051        (e)          (e)        P=0.286    |
|LOGISTIC REGRESSION    |  P=0.599N     P=0.525        (e)          (e)      |  P=0.051        (e)          (e)        P=0.286    |
|COCHRAN-ARMITAGE       |  P=0.616N                                          |  P=0.039 *                                         |
|FISHER EXACT           |               P=0.495        (e)          (e)      |                 (e)          (e)        P=0.242    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/51 (2%)    2/50 (4%)    1/50 (2%)    0/49 (0%)  |  1/50 (2%)    1/50 (2%)    1/50 (2%)   10/49 (20%) |
|ADJUSTED (b)           |   6.7%         6.8%         7.1%         0.0%      |   4.0%         3.4%         3.3%        30.8%      |
|TERMINAL (d)           |  1/15 (7%)    0/15 (0%)    1/14 (7%)    0/20 (0%)  |  1/25 (4%)    1/29 (3%)    1/30 (3%)    9/31 (29%) |
|FIRST INCIDENCE (DAYS) |   728 (T)      424          728 (T)      ---       |   728 (T)      728 (T)      728 (T)      659       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.200N     P=0.507      P=0.749      P=0.443N   |  P<0.001 **   P=0.729N     P=0.721N     P=0.012 *  |
|INCIDENTAL TUMOR       |  P=0.281N     P=0.464      P=0.749      P=0.443N   |  P<0.001 **   P=0.729N     P=0.721N     P=0.012 *  |
|LOGISTIC REGRESSION    |  P=0.246N     P=0.492      P=0.749      P=0.443N   |  P<0.001 **   P=0.729N     P=0.721N     P=0.009 ** |
|COCHRAN-ARMITAGE       |  P=0.243N                                          |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.492      P=0.748      P=0.510N   |               P=0.753N     P=0.753N     P=0.003 ** |
|=================================================================================================================================|
         DATE: 11/24/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE   8
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS 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                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/51 (2%)    2/50 (4%)    1/50 (2%)    0/49 (0%)  |  1/50 (2%)    1/50 (2%)    1/50 (2%)   10/49 (20%) |
|ADJUSTED (b)           |   6.7%         6.8%         7.1%         0.0%      |   4.0%         3.4%         3.3%        30.8%      |
|TERMINAL (d)           |  1/15 (7%)    0/15 (0%)    1/14 (7%)    0/20 (0%)  |  1/25 (4%)    1/29 (3%)    1/30 (3%)    9/31 (29%) |
|FIRST INCIDENCE (DAYS) |   728 (T)      424          728 (T)      ---       |   728 (T)      728 (T)      728 (T)      659       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.200N     P=0.507      P=0.749      P=0.443N   |  P<0.001 **   P=0.729N     P=0.721N     P=0.012 *  |
|INCIDENTAL TUMOR       |  P=0.281N     P=0.464      P=0.749      P=0.443N   |  P<0.001 **   P=0.729N     P=0.721N     P=0.012 *  |
|LOGISTIC REGRESSION    |  P=0.246N     P=0.492      P=0.749      P=0.443N   |  P<0.001 **   P=0.729N     P=0.721N     P=0.009 ** |
|COCHRAN-ARMITAGE       |  P=0.243N                                          |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.492      P=0.748      P=0.510N   |               P=0.753N     P=0.753N     P=0.003 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/51 (8%)    1/50 (2%)    0/50 (0%)    3/47 (6%)  |  0/50 (0%)    0/50 (0%)    6/50 (12%)   1/49 (2%)  |
|ADJUSTED (b)           |  18.3%         6.3%         0.0%        15.0%      |   0.0%         0.0%        18.4%         3.2%      |
|TERMINAL (d)           |  2/15 (13%)   0/15 (0%)    0/14 (0%)    3/20 (15%) |  0/25 (0%)    0/29 (0%)    5/30 (17%)   1/31 (3%)  |
|FIRST INCIDENCE (DAYS) |   549          720          ---          728 (T)   |   ---          ---          441          728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.560      P=0.179N     P=0.060N     P=0.369N   |  P=0.502        (e)        P=0.027 *    P=0.543    |
|INCIDENTAL TUMOR       |  P=0.513      P=0.193N     P=0.067N     P=0.402N   |  P=0.525        (e)        P=0.022 *    P=0.543    |
|LOGISTIC REGRESSION    |  P=0.436      P=0.168N     P=0.057N     P=0.481N   |  P=0.449        (e)        P=0.018 *    P=0.543    |
|COCHRAN-ARMITAGE       |  P=0.402                                           |  P=0.444                                           |
|FISHER EXACT           |               P=0.187N     P=0.061N     P=0.546N   |                 (e)        P=0.013 *    P=0.495    |
|=================================================================================================================================|
         DATE: 11/24/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE   9
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS 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                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/51 (10%)   1/50 (2%)    0/50 (0%)    3/47 (6%)  |  0/50 (0%)    0/50 (0%)    7/50 (14%)   1/49 (2%)  |
|ADJUSTED (b)           |  22.0%         6.3%         0.0%        15.0%      |   0.0%         0.0%        21.7%         3.2%      |
|TERMINAL (d)           |  2/15 (13%)   0/15 (0%)    0/14 (0%)    3/20 (15%) |  0/25 (0%)    0/29 (0%)    6/30 (20%)   1/31 (3%)  |
|FIRST INCIDENCE (DAYS) |   549          720          ---          728 (T)   |   ---          ---          441          728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.599N     P=0.097N     P=0.030N*    P=0.240N   |  P=0.522        (e)        P=0.015 *    P=0.543    |
|INCIDENTAL TUMOR       |  P=0.593      P=0.105N     P=0.031N*    P=0.288N   |  P=0.542        (e)        P=0.012 *    P=0.543    |
|LOGISTIC REGRESSION    |  P=0.543      P=0.093N     P=0.028N*    P=0.333N   |  P=0.467        (e)        P=0.010 **   P=0.543    |
|COCHRAN-ARMITAGE       |  P=0.506                                           |  P=0.458                                           |
|FISHER EXACT           |               P=0.107N     P=0.030N*    P=0.404N   |                 (e)        P=0.006 **   P=0.495    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)  |  3/50 (6%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         2.0%         0.0%      |  12.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  3/25 (12%)   0/29 (0%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          353          ---       |   728 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.783N       (e)        P=0.496        (e)      |  P=0.154N     P=0.095N     P=0.090N     P=0.085N   |
|INCIDENTAL TUMOR       |  P=0.553N       (e)        P=0.638        (e)      |  P=0.154N     P=0.095N     P=0.090N     P=0.085N   |
|LOGISTIC REGRESSION    |  P=0.601N       (e)        P=0.505        (e)      |  P=0.154N     P=0.095N     P=0.090N     P=0.085N   |
|COCHRAN-ARMITAGE       |  P=0.767N                                          |  P=0.175N                                          |
|FISHER EXACT           |                 (e)        P=0.495        (e)      |               P=0.121N     P=0.121N     P=0.121N   |
|=================================================================================================================================|
         DATE: 11/24/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  10
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS 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                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/51 (8%)    1/50 (2%)    1/50 (2%)    2/50 (4%)  | 21/50 (42%)  11/50 (22%)   1/50 (2%)    4/50 (8%)  |
|ADJUSTED (b)           |  16.2%         5.0%         5.0%         4.8%      |  60.0%        34.0%         2.9%         9.5%      |
|TERMINAL (d)           |  1/15 (7%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  | 12/25 (48%)   8/29 (28%)   0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   471          709          706          561       |   506          652          693          387       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.502N     P=0.170N     P=0.178N     P=0.279N   |  P<0.001N**   P=0.013N*    P<0.001N**   P<0.001N** |
|INCIDENTAL TUMOR       |  P=0.636      P=0.201N     P=0.198N     P=0.456N   |  P<0.001N**   P=0.016N*    P<0.001N**   P<0.001N** |
|LOGISTIC REGRESSION    |  P=0.569N     P=0.181N     P=0.179N     P=0.342N   |  P<0.001N**   P=0.016N*    P<0.001N**   P<0.001N** |
|COCHRAN-ARMITAGE       |  P=0.567N                                          |  P<0.001N**                                        |
|FISHER EXACT           |               P=0.187N     P=0.187N     P=0.348N   |               P=0.026N*    P<0.001N**   P<0.001N** |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/51 (8%)    1/50 (2%)    2/50 (4%)    2/50 (4%)  | 23/50 (46%)  11/50 (22%)   1/50 (2%)    4/50 (8%)  |
|ADJUSTED (b)           |  16.2%         5.0%         6.9%         4.8%      |  66.1%        34.0%         2.9%         9.5%      |
|TERMINAL (d)           |  1/15 (7%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  | 14/25 (56%)   8/29 (28%)   0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   471          709          353          561       |   506          652          693          387       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.473N     P=0.170N     P=0.334N     P=0.279N   |  P<0.001N**   P=0.004N**   P<0.001N**   P<0.001N** |
|INCIDENTAL TUMOR       |  P=0.532N     P=0.201N     P=0.310N     P=0.456N   |  P<0.001N**   P=0.005N**   P<0.001N**   P<0.001N** |
|LOGISTIC REGRESSION    |  P=0.504N     P=0.181N     P=0.397N     P=0.342N   |  P<0.001N**   P=0.005N**   P<0.001N**   P<0.001N** |
|COCHRAN-ARMITAGE       |  P=0.530N                                          |  P<0.001N**                                        |
|FISHER EXACT           |               P=0.187N     P=0.348N     P=0.348N   |               P=0.010N**   P<0.001N**   P<0.001N** |
|=================================================================================================================================|
         DATE: 11/24/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  11
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS 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     |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |
|     Papilloma Squamous or Papilloma                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/51 (6%)    1/50 (2%)    0/50 (0%)    1/50 (2%)  |  0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |  10.4%         6.7%         0.0%         5.0%      |   0.0%         3.4%         0.0%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    1/15 (7%)    0/14 (0%)    1/20 (5%)  |  0/25 (0%)    1/29 (3%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   591          728 (T)      ---          728 (T)   |   ---          728 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.401N     P=0.264N     P=0.088N     P=0.248N   |  P=0.524N     P=0.530        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.438N     P=0.290N     P=0.088N     P=0.308N   |  P=0.524N     P=0.530        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.456N     P=0.300N     P=0.123N     P=0.307N   |  P=0.524N     P=0.530        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.457N                                          |  P=0.547N                                          |
|FISHER EXACT           |               P=0.316N     P=0.125N     P=0.316N   |               P=0.500        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/51 (6%)    1/50 (2%)    0/50 (0%)    1/50 (2%)  |  0/50 (0%)    2/50 (4%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |  10.4%         6.7%         0.0%         5.0%      |   0.0%         6.9%         0.0%         0.0%      |
|TERMINAL (d)           |  0/15 (0%)    1/15 (7%)    0/14 (0%)    1/20 (5%)  |  0/25 (0%)    2/29 (7%)    0/30 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   591          728 (T)      ---          728 (T)   |   ---          728 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.401N     P=0.264N     P=0.088N     P=0.248N   |  P=0.301N     P=0.271        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.438N     P=0.290N     P=0.088N     P=0.308N   |  P=0.301N     P=0.271        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.456N     P=0.300N     P=0.123N     P=0.307N   |  P=0.301N     P=0.271        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.457N                                          |  P=0.326N                                          |
|FISHER EXACT           |               P=0.316N     P=0.125N     P=0.316N   |               P=0.247        (e)          (e)      |
|=================================================================================================================================|
         DATE: 11/24/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  12
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS 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     |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Mucosa                                                                                                                      |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/51 (4%)    1/50 (2%)    0/50 (0%)    0/50 (0%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   7.0%         6.7%         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) |   591          728 (T)      ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.219N     P=0.460N     P=0.188N     P=0.209N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.231N     P=0.501N     P=0.206N     P=0.257N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.243N     P=0.495N     P=0.247N     P=0.243N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.242N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.508N     P=0.252N     P=0.252N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 30/51 (59%)  32/50 (64%)  30/50 (60%)  19/49 (39%) | 27/50 (54%)  26/50 (52%)  18/49 (37%)  14/50 (28%) |
|ADJUSTED (b)           |  76.4%        83.0%        89.4%        57.7%      |  69.2%        65.7%        44.9%        43.6%      |
|TERMINAL (d)           |  8/15 (53%)   9/15 (60%)  11/14 (79%)   7/20 (35%) | 14/25 (56%)  16/29 (55%)   9/30 (30%)  13/31 (42%) |
|FIRST INCIDENCE (DAYS) |   316          408          437          434       |   478          537          478          695       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.004N**   P=0.551N     P=0.428N     P=0.015N*  |  P=0.002N**   P=0.291N     P=0.033N*    P=0.002N** |
|INCIDENTAL TUMOR       |  P=0.019N*    P=0.307      P=0.523      P=0.159N   |  P=0.003N**   P=0.500N     P=0.106N     P=0.008N** |
|LOGISTIC REGRESSION    |  P=0.007N**   P=0.376      P=0.563      P=0.165N   |  P=0.003N**   P=0.471N     P=0.063N     P=0.005N** |
|COCHRAN-ARMITAGE       |  P=0.006N**                                        |  P=0.003N**                                        |
|FISHER EXACT           |               P=0.371      P=0.533      P=0.035N*  |               P=0.500N     P=0.064N     P=0.007N** |
|=================================================================================================================================|
         DATE: 11/24/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  13
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS 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     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal                                                       |
|     Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/51 (8%)    2/50 (4%)    2/50 (4%)    2/50 (4%)  |  0/50 (0%)    0/50 (0%)    4/50 (8%)    5/50 (10%) |
|ADJUSTED (b)           |  22.5%         7.6%         7.6%        10.0%      |   0.0%         0.0%        13.3%        15.6%      |
|TERMINAL (d)           |  3/15 (20%)   0/15 (0%)    0/14 (0%)    2/20 (10%) |  0/25 (0%)    0/29 (0%)    4/30 (13%)   4/31 (13%) |
|FIRST INCIDENCE (DAYS) |   611          600          680          728 (T)   |   ---          ---          728 (T)      725       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.332N     P=0.320N     P=0.310N     P=0.217N   |  P=0.013 *      (e)        P=0.087      P=0.056    |
|INCIDENTAL TUMOR       |  P=0.382N     P=0.353N     P=0.307N     P=0.229N   |  P=0.013 *      (e)        P=0.087      P=0.056    |
|LOGISTIC REGRESSION    |  P=0.411N     P=0.307N     P=0.272N     P=0.261N   |  P=0.013 *      (e)        P=0.087      P=0.052    |
|COCHRAN-ARMITAGE       |  P=0.438N                                          |  P=0.008 **                                        |
|FISHER EXACT           |               P=0.348N     P=0.348N     P=0.348N   |                 (e)        P=0.059      P=0.028 *  |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    5/50 (10%)   2/50 (4%)    2/50 (4%)  |  0/50 (0%)    0/50 (0%)    1/50 (2%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%        22.7%        12.0%         6.0%      |   0.0%         0.0%         3.3%         3.2%      |
|TERMINAL (d)           |  0/15 (0%)    2/15 (13%)   1/14 (7%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    1/30 (3%)    1/31 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          479          707          434       |   ---          ---          728 (T)      728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.471N     P=0.042 *    P=0.232      P=0.251    |  P=0.339        (e)        P=0.536      P=0.543    |
|INCIDENTAL TUMOR       |  P=0.576      P=0.032 *    P=0.265      P=0.050 *  |  P=0.339        (e)        P=0.536      P=0.543    |
|LOGISTIC REGRESSION    |  P=0.564N     P=0.035 *    P=0.266      P=0.245    |  P=0.339        (e)        P=0.536      P=0.543    |
|COCHRAN-ARMITAGE       |  P=0.556N                                          |  P=0.307                                           |
|FISHER EXACT           |               P=0.027 *    P=0.243      P=0.243    |                 (e)        P=0.500      P=0.500    |
|=================================================================================================================================|
         DATE: 11/24/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  14
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS 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     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    7/50 (14%)   2/50 (4%)    2/50 (4%)  |  0/50 (0%)    1/50 (2%)    1/50 (2%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%        26.9%        12.0%         6.0%      |   0.0%         2.2%         3.3%         3.2%      |
|TERMINAL (d)           |  0/15 (0%)    2/15 (13%)   1/14 (7%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    1/30 (3%)    1/31 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          479          707          434       |   ---          562          728 (T)      728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.316N     P=0.015 *    P=0.232      P=0.251    |  P=0.536      P=0.519      P=0.536      P=0.543    |
|INCIDENTAL TUMOR       |  P=0.596N     P=0.007 **   P=0.265      P=0.050 *  |  P=0.417      P=0.410      P=0.536      P=0.543    |
|LOGISTIC REGRESSION    |  P=0.387N     P=0.009 **   P=0.266      P=0.245    |  P=0.510      P=0.513      P=0.536      P=0.543    |
|COCHRAN-ARMITAGE       |  P=0.381N                                          |  P=0.510                                           |
|FISHER EXACT           |               P=0.006 **   P=0.243      P=0.243    |               P=0.500      P=0.500      P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    2/50 (4%)    0/50 (0%)    0/50 (0%)  |  0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         5.4%         0.0%         0.0%      |   0.0%         2.2%         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) |   ---          485          ---          ---       |   ---          562          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.382N     P=0.277        (e)          (e)      |  P=0.546N     P=0.519        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.581N     P=0.203        (e)          (e)      |  P=0.806N     P=0.410        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.362N     P=0.235        (e)          (e)      |  P=0.528N     P=0.513        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.386N                                          |  P=0.547N                                          |
|FISHER EXACT           |               P=0.243        (e)          (e)      |               P=0.500        (e)          (e)      |
|=================================================================================================================================|
         DATE: 11/24/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  15
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS 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     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/51 (8%)    1/50 (2%)    1/50 (2%)    1/50 (2%)  |  0/50 (0%)    0/50 (0%)    4/50 (8%)    0/50 (0%)  |
|ADJUSTED (b)           |  22.5%         5.0%         4.3%         5.0%      |   0.0%         0.0%        13.3%         0.0%      |
|TERMINAL (d)           |  3/15 (20%)   0/15 (0%)    0/14 (0%)    1/20 (5%)  |  0/25 (0%)    0/29 (0%)    4/30 (13%)   0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   611          709          703          728 (T)   |   ---          ---          728 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.234N     P=0.169N     P=0.174N     P=0.107N   |  P=0.563N       (e)        P=0.087        (e)      |
|INCIDENTAL TUMOR       |  P=0.270N     P=0.180N     P=0.174N     P=0.115N   |  P=0.563N       (e)        P=0.087        (e)      |
|LOGISTIC REGRESSION    |  P=0.284N     P=0.146N     P=0.136N     P=0.135N   |  P=0.563N       (e)        P=0.087        (e)      |
|COCHRAN-ARMITAGE       |  P=0.317N                                          |  P=0.609N                                          |
|FISHER EXACT           |               P=0.187N     P=0.187N     P=0.187N   |                 (e)        P=0.059        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Carcinoma, Basal Cell Carcinoma, Basosquamous Tumor                                                           |
|     (malignant or NOS), or Carcinoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    1/50 (2%)    1/50 (2%)    0/50 (0%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)  |
|ADJUSTED (b)           |   0.0%         2.8%         3.4%         0.0%      |   0.0%         0.0%         0.0%         6.5%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    0/20 (0%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    2/31 (6%)  |
|FIRST INCIDENCE (DAYS) |   ---          600          680          ---       |   ---          ---          ---          728 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.498N     P=0.511      P=0.555        (e)      |  P=0.051        (e)          (e)        P=0.286    |
|INCIDENTAL TUMOR       |  P=0.529N     P=0.460      P=0.561        (e)      |  P=0.051        (e)          (e)        P=0.286    |
|LOGISTIC REGRESSION    |  P=0.511N     P=0.496      P=0.520        (e)      |  P=0.051        (e)          (e)        P=0.286    |
|COCHRAN-ARMITAGE       |  P=0.509N                                          |  P=0.041 *                                         |
|FISHER EXACT           |               P=0.495      P=0.495        (e)      |                 (e)          (e)        P=0.247    |
|=================================================================================================================================|
         DATE: 11/24/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  16
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS 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     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         5.0%      |   0.0%         0.0%         0.0%         6.3%      |
|TERMINAL (d)           |  0/15 (0%)    0/15 (0%)    0/14 (0%)    1/20 (5%)  |  0/25 (0%)    0/29 (0%)    0/30 (0%)    1/31 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          728 (T)   |   ---          ---          ---          725       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.292        (e)          (e)        P=0.557    |  P=0.053        (e)          (e)        P=0.292    |
|INCIDENTAL TUMOR       |  P=0.292        (e)          (e)        P=0.557    |  P=0.049 *      (e)          (e)        P=0.289    |
|LOGISTIC REGRESSION    |  P=0.292        (e)          (e)        P=0.557    |  P=0.050        (e)          (e)        P=0.282    |
|COCHRAN-ARMITAGE       |  P=0.233                                           |  P=0.041 *                                         |
|FISHER EXACT           |                 (e)          (e)        P=0.495    |                 (e)          (e)        P=0.247    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/51 (8%)    1/50 (2%)    2/50 (4%)    2/50 (4%)  |  0/50 (0%)    0/50 (0%)    4/50 (8%)    3/50 (6%)  |
|ADJUSTED (b)           |  22.5%         5.0%         7.6%        10.0%      |   0.0%         0.0%        13.3%         9.4%      |
|TERMINAL (d)           |  3/15 (20%)   0/15 (0%)    0/14 (0%)    2/20 (10%) |  0/25 (0%)    0/29 (0%)    4/30 (13%)   2/31 (6%)  |
|FIRST INCIDENCE (DAYS) |   611          709          680          728 (T)   |   ---          ---          728 (T)      725       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.411N     P=0.169N     P=0.310N     P=0.217N   |  P=0.100        (e)        P=0.087      P=0.166    |
|INCIDENTAL TUMOR       |  P=0.472N     P=0.180N     P=0.307N     P=0.229N   |  P=0.098        (e)        P=0.087      P=0.164    |
|LOGISTIC REGRESSION    |  P=0.486N     P=0.146N     P=0.272N     P=0.261N   |  P=0.098        (e)        P=0.087      P=0.158    |
|COCHRAN-ARMITAGE       |  P=0.530N                                          |  P=0.073                                           |
|FISHER EXACT           |               P=0.187N     P=0.348N     P=0.348N   |                 (e)        P=0.059      P=0.121    |
|=================================================================================================================================|
         DATE: 11/24/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  17
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS 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     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, or Keratoacanthoma                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/51 (8%)    1/50 (2%)    1/50 (2%)    2/50 (4%)  |  0/50 (0%)    0/50 (0%)    4/50 (8%)    2/50 (4%)  |
|ADJUSTED (b)           |  22.5%         5.0%         4.3%        10.0%      |   0.0%         0.0%        13.3%         6.3%      |
|TERMINAL (d)           |  3/15 (20%)   0/15 (0%)    0/14 (0%)    2/20 (10%) |  0/25 (0%)    0/29 (0%)    4/30 (13%)   1/31 (3%)  |
|FIRST INCIDENCE (DAYS) |   611          709          703          728 (T)   |   ---          ---          728 (T)      725       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.442N     P=0.169N     P=0.174N     P=0.217N   |  P=0.234        (e)        P=0.087      P=0.292    |
|INCIDENTAL TUMOR       |  P=0.492N     P=0.180N     P=0.174N     P=0.229N   |  P=0.231        (e)        P=0.087      P=0.289    |
|LOGISTIC REGRESSION    |  P=0.522N     P=0.146N     P=0.136N     P=0.261N   |  P=0.232        (e)        P=0.087      P=0.282    |
|COCHRAN-ARMITAGE       |  P=0.567N                                          |  P=0.189                                           |
|FISHER EXACT           |               P=0.187N     P=0.187N     P=0.348N   |                 (e)        P=0.059      P=0.247    |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 33/51 (65%)  20/50 (40%)   0/50 (0%)    0/49 (0%)  |                                                    |
|ADJUSTED (b)           |  96.9%        72.3%         0.0%         0.0%      |                                                    |
|TERMINAL (d)           | 14/15 (93%)   8/15 (53%)   0/14 (0%)    0/20 (0%)  |                                                    |
|FIRST INCIDENCE (DAYS) |   479          485          ---          ---       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001N**   P=0.012N*    P<0.001N**   P<0.001N** |                                                    |
|INCIDENTAL TUMOR       |  P<0.001N**   P=0.002N**   P<0.001N**   P<0.001N** |                                                    |
|LOGISTIC REGRESSION    |  P<0.001N**   P<0.001N**   P<0.001N**   P<0.001N** |                                                    |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |                                                    |
|FISHER EXACT           |               P=0.011N*    P<0.001N**   P<0.001N** |                                                    |
|=================================================================================================================================|
         DATE: 11/24/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  18
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS 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: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/51 (10%)   4/48 (8%)    5/50 (10%)   4/49 (8%)  |  5/50 (10%)   8/49 (16%)   7/50 (14%)   4/49 (8%)  |
|ADJUSTED (b)           |  18.1%        18.3%        25.9%        16.4%      |  17.2%        25.2%        21.1%        11.1%      |
|TERMINAL (d)           |  1/15 (7%)    2/15 (13%)   3/14 (21%)   2/20 (10%) |  2/25 (8%)    6/29 (21%)   5/30 (17%)   2/31 (6%)  |
|FIRST INCIDENCE (DAYS) |   486          588          538          675       |   684          652          665          490       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.386N     P=0.447N     P=0.580N     P=0.387N   |  P=0.181N     P=0.369      P=0.495      P=0.407N   |
|INCIDENTAL TUMOR       |  P=0.557N     P=0.538N     P=0.561      P=0.607N   |  P=0.181N     P=0.397      P=0.554      P=0.407N   |
|LOGISTIC REGRESSION    |  P=0.517N     P=0.524N     P=0.623N     P=0.520N   |  P=0.222N     P=0.343      P=0.459      P=0.490N   |
|COCHRAN-ARMITAGE       |  P=0.507N                                          |  P=0.250N                                          |
|FISHER EXACT           |               P=0.539N     P=0.617      P=0.526N   |               P=0.264      P=0.380      P=0.513N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/51 (10%)   4/48 (8%)    6/50 (12%)   4/49 (8%)  |  5/50 (10%)   8/49 (16%)   7/50 (14%)   4/49 (8%)  |
|ADJUSTED (b)           |  18.1%        18.3%        27.8%        16.4%      |  17.2%        25.2%        21.1%        11.1%      |
|TERMINAL (d)           |  1/15 (7%)    2/15 (13%)   3/14 (21%)   2/20 (10%) |  2/25 (8%)    6/29 (21%)   5/30 (17%)   2/31 (6%)  |
|FIRST INCIDENCE (DAYS) |   486          588          538          675       |   684          652          665          490       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.363N     P=0.447N     P=0.559      P=0.387N   |  P=0.181N     P=0.369      P=0.495      P=0.407N   |
|INCIDENTAL TUMOR       |  P=0.529N     P=0.538N     P=0.431      P=0.607N   |  P=0.181N     P=0.397      P=0.554      P=0.407N   |
|LOGISTIC REGRESSION    |  P=0.494N     P=0.524N     P=0.502      P=0.520N   |  P=0.222N     P=0.343      P=0.459      P=0.490N   |
|COCHRAN-ARMITAGE       |  P=0.483N                                          |  P=0.250N                                          |
|FISHER EXACT           |               P=0.539N     P=0.486      P=0.526N   |               P=0.264      P=0.380      P=0.513N   |
|=================================================================================================================================|
         DATE: 11/24/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  19
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS 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                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  4/50 (8%)    8/50 (16%)   2/50 (4%)    0/50 (0%)  |
|ADJUSTED (b)           |                                                    |  13.4%        24.4%         6.1%         0.0%      |
|TERMINAL (d)           |                                                    |  2/25 (8%)    6/29 (21%)   1/30 (3%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   533          576          693          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.006N**   P=0.258      P=0.281N     P=0.048N*  |
|INCIDENTAL TUMOR       |                                                    |  P=0.009N**   P=0.172      P=0.280N     P=0.047N*  |
|LOGISTIC REGRESSION    |                                                    |  P=0.008N**   P=0.193      P=0.326N     P=0.062N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.009N**                                        |
|FISHER EXACT           |                                                    |               P=0.178      P=0.339N     P=0.059N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  5/50 (10%)   9/50 (18%)   2/50 (4%)    0/50 (0%)  |
|ADJUSTED (b)           |                                                    |  17.2%        26.3%         6.1%         0.0%      |
|TERMINAL (d)           |                                                    |  3/25 (12%)   6/29 (21%)   1/30 (3%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   533          576          693          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.003N**   P=0.288      P=0.168N     P=0.023N*  |
|INCIDENTAL TUMOR       |                                                    |  P=0.004N**   P=0.203      P=0.166N     P=0.022N*  |
|LOGISTIC REGRESSION    |                                                    |  P=0.004N**   P=0.211      P=0.200N     P=0.031N*  |
|COCHRAN-ARMITAGE       |                                                    |  P=0.004N**                                        |
|FISHER EXACT           |                                                    |               P=0.194      P=0.218N     P=0.028N*  |
|=================================================================================================================================|
         DATE: 11/24/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  20
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS 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     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 21/51 (41%)  15/50 (30%)   7/50 (14%)   4/50 (8%)  | 12/50 (24%)  11/50 (22%)  11/50 (22%)   5/50 (10%) |
|ADJUSTED (b)           |  71.7%        51.3%        25.8%        11.5%      |  36.1%        27.8%        27.9%        13.4%      |
|TERMINAL (d)           |  8/15 (53%)   5/15 (33%)   2/14 (14%)   0/20 (0%)  |  6/25 (24%)   4/29 (14%)   4/30 (13%)   2/31 (6%)  |
|FIRST INCIDENCE (DAYS) |   486          408          577          551       |   533          523          441          539       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001N**   P=0.121N     P=0.002N**   P<0.001N** |  P=0.031N*    P=0.379N     P=0.371N     P=0.032N*  |
|INCIDENTAL TUMOR       |  P<0.001N**   P=0.164N     P=0.002N**   P<0.001N** |  P=0.049N*    P=0.577N     P=0.565N     P=0.076N   |
|LOGISTIC REGRESSION    |  P<0.001N**   P=0.134N     P=0.001N**   P<0.001N** |  P=0.084N     P=0.512N     P=0.498N     P=0.053N   |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |  P=0.039N*                                         |
|FISHER EXACT           |               P=0.167N     P=0.002N**   P<0.001N** |               P=0.500N     P=0.500N     P=0.054N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated                                               |
|     Cell Type                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/51 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |  0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         0.0%         4.9%         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) |   ---          ---          ---          ---       |   ---          ---          638          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.673N       (e)        P=0.286        (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.683        (e)        P=0.135        (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.692N       (e)        P=0.238        (e)      |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.693N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |                 (e)        P=0.247        (e)      |
|=================================================================================================================================|
         DATE: 11/24/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  21
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS 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     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma: Benign, Malignant, NOS                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/51 (4%)    2/50 (4%)    0/50 (0%)    1/50 (2%)  |  0/50 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |   9.4%         8.3%         0.0%         5.0%      |   0.0%         0.0%         3.3%         0.0%      |
|TERMINAL (d)           |  1/15 (7%)    0/15 (0%)    0/14 (0%)    1/20 (5%)  |  0/25 (0%)    0/29 (0%)    1/30 (3%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   600          622          ---          728 (T)   |   ---          ---          728 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.390N     P=0.675N     P=0.226N     P=0.421N   |  P=0.765N       (e)        P=0.536        (e)      |
|INCIDENTAL TUMOR       |  P=0.423N     P=0.676      P=0.247N     P=0.433N   |  P=0.765N       (e)        P=0.536        (e)      |
|LOGISTIC REGRESSION    |  P=0.462N     P=0.688N     P=0.225N     P=0.479N   |  P=0.765N       (e)        P=0.536        (e)      |
|COCHRAN-ARMITAGE       |  P=0.466N                                          |  P=0.785N                                          |
|FISHER EXACT           |               P=0.684      P=0.252N     P=0.508N   |                 (e)        P=0.500        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 50/51 (98%)  45/50 (90%)  40/50 (80%)  39/50 (78%) | 44/50 (88%)  40/50 (80%)  29/50 (58%)  33/50 (66%) |
|ADJUSTED (b)           | 100.0%        97.8%        97.3%        95.1%      |  97.7%        92.9%        69.9%        82.2%      |
|TERMINAL (d)           | 15/15 (100%) 14/15 (93%)  13/14 (93%)  18/20 (90%) | 24/25 (96%)  26/29 (90%)  18/30 (60%)  24/31 (77%) |
|FIRST INCIDENCE (DAYS) |   316          146          437          434       |   478          537          441          387       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.016N*    P=0.194N     P=0.061N     P=0.008N** |  P=0.011N*    P=0.089N     P=0.001N**   P=0.003N** |
|INCIDENTAL TUMOR       |  P=0.040N*    P=0.116N     P=0.003N**   P=0.012N*  |  P=0.009N**   P=0.132N     P<0.001N**   P=0.002N** |
|LOGISTIC REGRESSION    |  P=0.038N*    P=0.123N     P<0.001N**   P=0.005N** |  P=0.014N*    P=0.117N     P<0.001N**   P=0.005N** |
|COCHRAN-ARMITAGE       |  P=0.011N*                                         |  P=0.018N*                                         |
|FISHER EXACT           |               P=0.098N     P=0.004N**   P=0.002N** |               P=0.207N     P<0.001N**   P=0.008N** |
|=================================================================================================================================|
         DATE: 11/24/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  22
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS 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     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 28/51 (55%)  22/50 (44%)  16/50 (32%)   7/50 (14%) | 17/50 (34%)  18/50 (36%)  16/50 (32%)  12/50 (24%) |
|ADJUSTED (b)           |  82.7%        61.3%        49.7%        22.5%      |  50.6%        41.7%        38.1%        31.9%      |
|TERMINAL (d)           | 10/15 (67%)   5/15 (33%)   4/14 (29%)   2/20 (10%) | 10/25 (40%)   6/29 (21%)   6/30 (20%)   7/31 (23%) |
|FIRST INCIDENCE (DAYS) |   366          321          281          551       |   533          523          441          539       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001N**   P=0.147N     P=0.019N*    P<0.001N** |  P=0.079N     P=0.485N     P=0.339N     P=0.093N   |
|INCIDENTAL TUMOR       |  P<0.001N**   P=0.192N     P=0.010N**   P<0.001N** |  P=0.157N     P=0.405      P=0.581N     P=0.161N   |
|LOGISTIC REGRESSION    |  P<0.001N**   P=0.174N     P=0.016N*    P<0.001N** |  P=0.234N     P=0.500      P=0.498N     P=0.166N   |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |  P=0.109N                                          |
|FISHER EXACT           |               P=0.185N     P=0.017N*    P<0.001N** |               P=0.500      P=0.500N     P=0.189N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 51/51 (100%) 48/50 (96%)  44/50 (88%)  40/50 (80%) | 45/50 (90%)  45/50 (90%)  37/50 (74%)  37/50 (74%) |
|ADJUSTED (b)           | 100.0%        98.0%        97.5%        95.2%      |  97.8%        93.8%        78.7%        85.8%      |
|TERMINAL (d)           | 15/15 (100%) 14/15 (93%)  13/14 (93%)  18/20 (90%) | 24/25 (96%)  26/29 (90%)  20/30 (67%)  25/31 (81%) |
|FIRST INCIDENCE (DAYS) |   316          146          281          434       |   478          523          441          387       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.012N*    P=0.275N     P=0.126N     P=0.009N** |  P=0.021N*    P=0.239N     P=0.033N*    P=0.014N*  |
|INCIDENTAL TUMOR       |  P=0.004N**   P=0.353N     P=0.009N**   P=0.016N*  |  P=0.011N*    P=0.635N     P=0.030N*    P=0.014N*  |
|LOGISTIC REGRESSION    |  P=0.050N     P=0.273N     P=0.017N*    P=0.003N** |  P=0.014N*    P=0.572N     P=0.035N*    P=0.026N*  |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |  P=0.015N*                                         |
|FISHER EXACT           |               P=0.243N     P=0.013N*    P<0.001N** |               P=0.630N     P=0.033N*    P=0.033N*  |
|=================================================================================================================================|
         DATE: 11/24/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  23
                              STATISTICAL ANALYSIS OF PRIMARY TUMORS 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).