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TDMS Study 89006-04 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                          AZT/INTERFERON A/INTERFERON AD                            DATE: 07/12/96       
EXPERIMENT: 89006 TEST: 04                                                                                     TIME: 15:47:36       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-85225                              ROUTE: GAVAGE                                                  NTP C#: C89006       
PATHOLOGIST: R.B. THOMPSON                                                                                     CAS: 30516-871       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                             CORE STUDY                                                             
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                          AZT/INTERFERON A/INTERFERON AD                            DATE: 07/12/96       
EXPERIMENT: 89006 TEST: 04                                                                                     TIME: 15:47:36       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-85225                              ROUTE: GAVAGE                                                  NTP C#: C89006       
PATHOLOGIST: R.B. THOMPSON                                                                                     CAS: 30516-871       


                                                    MICE(B6C3F1)
                                              ----------------------------
             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
                                                    Epididymis
                                                    Gallbladder
                                                    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: Southern Research Inst                          AZT/INTERFERON A/INTERFERON AD                            DATE: 07/12/96       
EXPERIMENT: 89006 TEST: 04                                                                                     TIME: 15:47:36       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-85225                              ROUTE: GAVAGE                                                  NTP C#: C89006       
PATHOLOGIST: R.B. THOMPSON                                                                                     CAS: 30516-871       


                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                 IN THE ANALYSIS OF THE STUDY OF AZT/INTERFERON A/INTERFERON AD
              ====================================================================================================
                                                           MALE MICE
                                                          -------------
                  ORGAN                               MORPHOLOGY
                 -------                             ------------
              Harderian Gland               Adenoma
                                            Carcinoma or Adenoma
              All Organs                    Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated
                                             Cell Type
                                            Malignant Tumors
              ====================================================================================================
                                                           FEMALE MICE
                                                          -------------
                  ORGAN                               MORPHOLOGY
                 -------                             ------------
              Liver                         Hepatocellular Adenoma
              Lung                          Alveolar/Bronchiolar Adenoma
              Pituitary Gland: Pars Distalis or Unspecified Site
                                            Adenoma
              Skin                          Hemangiosarcoma
              Vagina                        Squamous Cell Carcinoma
              All Organs                    Hemangiosarcoma or Hemangioma
                                            Benign Tumors
              ====================================================================================================
         DATE: 07/12/96                     EXPERIMENT: 89006 TEST: 04                                                 PAGE   1
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |
|                       |   CONTROL      5000 U       5000 U       5000 U    |   CONTROL      5000 U       5000 U       5000 U    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/49 (4%)    6/50 (12%)   3/50 (6%)    4/50 (8%)  |  0/50 (0%)    0/49 (0%)    1/50 (2%)    1/49 (2%)  |
|ADJUSTED (b)           |   6.2%        16.2%         8.6%        10.7%      |   0.0%         0.0%         2.8%         3.1%      |
|TERMINAL (d)           |  1/31 (3%)    5/35 (14%)   3/35 (9%)    2/34 (6%)  |  0/37 (0%)    0/38 (0%)    1/36 (3%)    1/32 (3%)  |
|FIRST INCIDENCE (DAYS) |   724          554          729 (T)      632       |   ---          ---          730 (T)      730 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.472      P=0.169      P=0.552      P=0.361    |  P=0.206        (e)        P=0.495      P=0.471    |
|INCIDENTAL TUMOR       |  P=0.458      P=0.136      P=0.476      P=0.254    |  P=0.206        (e)        P=0.495      P=0.471    |
|LOGISTIC REGRESSION    |  P=0.438      P=0.134      P=0.527      P=0.333    |  P=0.206        (e)        P=0.495      P=0.471    |
|COCHRAN-ARMITAGE       |  P=0.455                                           |  P=0.233                                           |
|FISHER EXACT           |               P=0.141      P=0.510      P=0.349    |                 (e)        P=0.500      P=0.495    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/48 (2%)    2/50 (4%)    0/50 (0%)    0/50 (0%)  |  2/50 (4%)    1/49 (2%)    0/50 (0%)    1/49 (2%)  |
|ADJUSTED (b)           |   3.2%         5.7%         0.0%         0.0%      |   5.2%         2.2%         0.0%         3.1%      |
|TERMINAL (d)           |  1/31 (3%)    2/35 (6%)    0/35 (0%)    0/34 (0%)  |  1/37 (3%)    0/38 (0%)    0/36 (0%)    1/32 (3%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      ---          ---       |   701          638          ---          730 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.174N     P=0.543      P=0.476N     P=0.482N   |  P=0.403N     P=0.489N     P=0.243N     P=0.549N   |
|INCIDENTAL TUMOR       |  P=0.174N     P=0.543      P=0.476N     P=0.482N   |  P=0.358N     P=0.525N     P=0.263N     P=0.500N   |
|LOGISTIC REGRESSION    |  P=0.174N     P=0.543      P=0.476N     P=0.481N   |  P=0.376N     P=0.516N     P=0.248N     P=0.531N   |
|COCHRAN-ARMITAGE       |  P=0.182N                                          |  P=0.370N                                          |
|FISHER EXACT           |               P=0.515      P=0.490N     P=0.490N   |               P=0.508N     P=0.247N     P=0.508N   |
|=================================================================================================================================|
         DATE: 07/12/96                     EXPERIMENT: 89006 TEST: 04                                                 PAGE   2
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |
|                       |   CONTROL      5000 U       5000 U       5000 U    |   CONTROL      5000 U       5000 U       5000 U    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/48 (2%)    2/50 (4%)    1/50 (2%)    1/50 (2%)  |  3/50 (6%)    1/49 (2%)    0/50 (0%)    1/49 (2%)  |
|ADJUSTED (b)           |   3.2%         5.7%         2.9%         2.9%      |   7.3%         2.2%         0.0%         3.1%      |
|TERMINAL (d)           |  1/31 (3%)    2/35 (6%)    1/35 (3%)    1/34 (3%)  |  1/37 (3%)    0/38 (0%)    0/36 (0%)    1/32 (3%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      729 (T)      729 (T)   |   618          638          ---          730 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.509N     P=0.543      P=0.735N     P=0.741N   |  P=0.226N     P=0.300N     P=0.130N     P=0.348N   |
|INCIDENTAL TUMOR       |  P=0.509N     P=0.543      P=0.735N     P=0.741N   |  P=0.197N     P=0.309N     P=0.179N     P=0.294N   |
|LOGISTIC REGRESSION    |  P=0.509N     P=0.543      P=0.735N     P=0.741N   |  P=0.197N     P=0.332N     P=0.116N     P=0.312N   |
|COCHRAN-ARMITAGE       |  P=0.520N                                          |  P=0.203N                                          |
|FISHER EXACT           |               P=0.515      P=0.742N     P=0.742N   |               P=0.316N     P=0.121N     P=0.316N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone Marrow                                                                                                                      |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    2/50 (4%)    1/50 (2%)    1/50 (2%)  |  1/50 (2%)    0/50 (0%)    1/50 (2%)    0/48 (0%)  |
|ADJUSTED (b)           |   0.0%         5.7%         2.3%         2.9%      |   2.7%         0.0%         2.4%         0.0%      |
|TERMINAL (d)           |  0/31 (0%)    2/35 (6%)    0/35 (0%)    1/34 (3%)  |  1/37 (3%)    0/38 (0%)    0/36 (0%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      581          729 (T)   |   730 (T)      ---          648          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.510      P=0.265      P=0.491      P=0.518    |  P=0.426N     P=0.495N     P=0.752      P=0.529N   |
|INCIDENTAL TUMOR       |  P=0.569      P=0.265      P=0.500      P=0.518    |  P=0.386N     P=0.495N     P=0.737      P=0.529N   |
|LOGISTIC REGRESSION    |  P=0.497      P=0.265      P=0.563      P=0.518    |  P=0.412N     P=0.495N     P=0.763      P=0.529N   |
|COCHRAN-ARMITAGE       |  P=0.500                                           |  P=0.413N                                          |
|FISHER EXACT           |               P=0.247      P=0.500      P=0.500    |               P=0.500N     P=0.753N     P=0.510N   |
|=================================================================================================================================|
         DATE: 07/12/96                     EXPERIMENT: 89006 TEST: 04                                                 PAGE   3
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |
|                       |   CONTROL      5000 U       5000 U       5000 U    |   CONTROL      5000 U       5000 U       5000 U    |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    9/50 (18%)   3/50 (6%)    4/50 (8%)  |  3/50 (6%)    2/50 (4%)    1/50 (2%)    1/50 (2%)  |
|ADJUSTED (b)           |   7.9%        22.9%         8.6%        11.8%      |   8.1%         5.3%         2.8%         3.1%      |
|TERMINAL (d)           |  1/31 (3%)    6/35 (17%)   3/35 (9%)    4/34 (12%) |  3/37 (8%)    2/38 (5%)    1/36 (3%)    1/32 (3%)  |
|FIRST INCIDENCE (DAYS) |   613          528          729 (T)      729 (T)   |   730 (T)      730 (T)      730 (T)      730 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.396N     P=0.082      P=0.633N     P=0.527    |  P=0.239N     P=0.488N     P=0.315N     P=0.358N   |
|INCIDENTAL TUMOR       |  P=0.388N     P=0.050 *    P=0.637      P=0.501    |  P=0.239N     P=0.488N     P=0.315N     P=0.358N   |
|LOGISTIC REGRESSION    |  P=0.432N     P=0.064      P=0.644      P=0.484    |  P=0.239N     P=0.488N     P=0.315N     P=0.358N   |
|COCHRAN-ARMITAGE       |  P=0.419N                                          |  P=0.199N                                          |
|FISHER EXACT           |               P=0.061      P=0.661N     P=0.500    |               P=0.500N     P=0.309N     P=0.309N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    9/50 (18%)   4/50 (8%)    4/50 (8%)  |  4/50 (8%)    2/50 (4%)    2/50 (4%)    1/50 (2%)  |
|ADJUSTED (b)           |   7.9%        22.9%        11.0%        11.8%      |  10.8%         5.3%         5.6%         3.1%      |
|TERMINAL (d)           |  1/31 (3%)    6/35 (17%)   3/35 (9%)    4/34 (12%) |  4/37 (11%)   2/38 (5%)    2/36 (6%)    1/32 (3%)  |
|FIRST INCIDENCE (DAYS) |   613          528          665          729 (T)   |   730 (T)      730 (T)      730 (T)      730 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.418N     P=0.082      P=0.519      P=0.527    |  P=0.172N     P=0.324N     P=0.349N     P=0.225N   |
|INCIDENTAL TUMOR       |  P=0.441N     P=0.050 *    P=0.409      P=0.501    |  P=0.172N     P=0.324N     P=0.349N     P=0.225N   |
|LOGISTIC REGRESSION    |  P=0.448N     P=0.064      P=0.481      P=0.484    |  P=0.172N     P=0.324N     P=0.349N     P=0.225N   |
|COCHRAN-ARMITAGE       |  P=0.437N                                          |  P=0.137N                                          |
|FISHER EXACT           |               P=0.061      P=0.500      P=0.500    |               P=0.339N     P=0.339N     P=0.181N   |
|=================================================================================================================================|
         DATE: 07/12/96                     EXPERIMENT: 89006 TEST: 04                                                 PAGE   4
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |
|                       |   CONTROL      5000 U       5000 U       5000 U    |   CONTROL      5000 U       5000 U       5000 U    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    4/50 (8%)    4/50 (8%)    5/50 (10%) |  1/50 (2%)    1/50 (2%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   6.3%        10.3%        10.4%        12.5%      |   2.7%         2.6%         0.0%         0.0%      |
|TERMINAL (d)           |  1/31 (3%)    2/35 (6%)    2/35 (6%)    1/34 (3%)  |  1/37 (3%)    1/38 (3%)    0/36 (0%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   727          661          581          565       |   730 (T)      730 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.202      P=0.373      P=0.380      P=0.227    |  P=0.257N     P=0.756N     P=0.505N     P=0.529N   |
|INCIDENTAL TUMOR       |  P=0.143      P=0.244      P=0.241      P=0.188    |  P=0.257N     P=0.756N     P=0.505N     P=0.529N   |
|LOGISTIC REGRESSION    |  P=0.154      P=0.327      P=0.319      P=0.224    |  P=0.257N     P=0.756N     P=0.505N     P=0.529N   |
|COCHRAN-ARMITAGE       |  P=0.194                                           |  P=0.236N                                          |
|FISHER EXACT           |               P=0.339      P=0.339      P=0.218    |               P=0.753N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 19/50 (38%)  17/50 (34%)  15/50 (30%)  17/50 (34%) | 19/50 (38%)  10/50 (20%)  14/50 (28%)  15/50 (30%) |
|ADJUSTED (b)           |  57.0%        47.0%        40.1%        43.9%      |  46.0%        24.6%        36.8%        45.1%      |
|TERMINAL (d)           | 17/31 (55%)  16/35 (46%)  13/35 (37%)  13/34 (38%) | 15/37 (41%)   8/38 (21%)  12/36 (33%)  14/32 (44%) |
|FIRST INCIDENCE (DAYS) |   613          661          488          498       |   589          638          722          630       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.304N     P=0.254N     P=0.151N     P=0.311N   |  P=0.495      P=0.038N*    P=0.229N     P=0.437N   |
|INCIDENTAL TUMOR       |  P=0.310N     P=0.298N     P=0.187N     P=0.296N   |  P=0.494N     P=0.038N*    P=0.268N     P=0.360N   |
|LOGISTIC REGRESSION    |  P=0.433N     P=0.428N     P=0.322N     P=0.467N   |  P=0.487N     P=0.035N*    P=0.234N     P=0.329N   |
|COCHRAN-ARMITAGE       |  P=0.381N                                          |  P=0.396N                                          |
|FISHER EXACT           |               P=0.418N     P=0.263N     P=0.418N   |               P=0.038N*    P=0.198N     P=0.263N   |
|=================================================================================================================================|
         DATE: 07/12/96                     EXPERIMENT: 89006 TEST: 04                                                 PAGE   5
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |
|                       |   CONTROL      5000 U       5000 U       5000 U    |   CONTROL      5000 U       5000 U       5000 U    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 19/50 (38%)  24/50 (48%)  18/50 (36%)  16/50 (32%) | 14/50 (28%)  15/50 (30%)  14/50 (28%)  12/50 (24%) |
|ADJUSTED (b)           |  41.7%        58.0%        45.3%        38.0%      |  35.7%        36.5%        34.6%        32.4%      |
|TERMINAL (d)           |  6/31 (19%)  18/35 (51%)  14/35 (40%)   9/34 (26%) | 12/37 (32%)  12/38 (32%)  10/36 (28%)   8/32 (25%) |
|FIRST INCIDENCE (DAYS) |   462          528          386          526       |   651          656          488          630       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.171N     P=0.321      P=0.434N     P=0.331N   |  P=0.496N     P=0.535      P=0.553      P=0.555N   |
|INCIDENTAL TUMOR       |  P=0.121N     P=0.104      P=0.529      P=0.398N   |  P=0.338N     P=0.488      P=0.530      P=0.442N   |
|LOGISTIC REGRESSION    |  P=0.139N     P=0.134      P=0.561      P=0.274N   |  P=0.386N     P=0.532      P=0.524      P=0.465N   |
|COCHRAN-ARMITAGE       |  P=0.169N                                          |  P=0.325N                                          |
|FISHER EXACT           |               P=0.210      P=0.500N     P=0.338N   |               P=0.500      P=0.588N     P=0.410N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatoblastoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 20/50 (40%)  24/50 (48%)  18/50 (36%)  16/50 (32%) | 14/50 (28%)  15/50 (30%)  14/50 (28%)  12/50 (24%) |
|ADJUSTED (b)           |  43.2%        58.0%        45.3%        38.0%      |  35.7%        36.5%        34.6%        32.4%      |
|TERMINAL (d)           |  6/31 (19%)  18/35 (51%)  14/35 (40%)   9/34 (26%) | 12/37 (32%)  12/38 (32%)  10/36 (28%)   8/32 (25%) |
|FIRST INCIDENCE (DAYS) |   462          528          386          526       |   651          656          488          630       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.137N     P=0.384      P=0.369N     P=0.273N   |  P=0.496N     P=0.535      P=0.553      P=0.555N   |
|INCIDENTAL TUMOR       |  P=0.099N     P=0.134      P=0.580      P=0.354N   |  P=0.338N     P=0.488      P=0.530      P=0.442N   |
|LOGISTIC REGRESSION    |  P=0.104N     P=0.180      P=0.533N     P=0.209N   |  P=0.386N     P=0.532      P=0.524      P=0.465N   |
|COCHRAN-ARMITAGE       |  P=0.130N                                          |  P=0.325N                                          |
|FISHER EXACT           |               P=0.273      P=0.418N     P=0.266N   |               P=0.500      P=0.588N     P=0.410N   |
|=================================================================================================================================|
         DATE: 07/12/96                     EXPERIMENT: 89006 TEST: 04                                                 PAGE   6
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |
|                       |   CONTROL      5000 U       5000 U       5000 U    |   CONTROL      5000 U       5000 U       5000 U    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 35/50 (70%)  33/50 (66%)  28/50 (56%)  29/50 (58%) | 24/50 (48%)  23/50 (46%)  23/50 (46%)  23/50 (46%) |
|ADJUSTED (b)           |  77.3%        78.3%        67.8%        65.5%      |  58.3%        54.6%        55.9%        63.4%      |
|TERMINAL (d)           | 21/31 (68%)  26/35 (74%)  22/35 (63%)  19/34 (56%) | 20/37 (54%)  19/38 (50%)  18/36 (50%)  19/32 (59%) |
|FIRST INCIDENCE (DAYS) |   462          528          386          498       |   589          638          488          630       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.104N     P=0.268N     P=0.082N     P=0.145N   |  P=0.334      P=0.450N     P=0.547N     P=0.415    |
|INCIDENTAL TUMOR       |  P=0.067N     P=0.515N     P=0.145N     P=0.154N   |  P=0.504      P=0.489N     P=0.549      P=0.544    |
|LOGISTIC REGRESSION    |  P=0.097N     P=0.460N     P=0.138N     P=0.150N   |  P=0.489      P=0.460N     P=0.555      P=0.561    |
|COCHRAN-ARMITAGE       |  P=0.104N                                          |  P=0.471N                                          |
|FISHER EXACT           |               P=0.415N     P=0.107N     P=0.149N   |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 36/50 (72%)  33/50 (66%)  28/50 (56%)  29/50 (58%) | 24/50 (48%)  23/50 (46%)  23/50 (46%)  23/50 (46%) |
|ADJUSTED (b)           |  77.9%        78.3%        67.8%        65.5%      |  58.3%        54.6%        55.9%        63.4%      |
|TERMINAL (d)           | 21/31 (68%)  26/35 (74%)  22/35 (63%)  19/34 (56%) | 20/37 (54%)  19/38 (50%)  18/36 (50%)  19/32 (59%) |
|FIRST INCIDENCE (DAYS) |   462          528          386          498       |   589          638          488          630       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.082N     P=0.220N     P=0.063N     P=0.115N   |  P=0.334      P=0.450N     P=0.547N     P=0.415    |
|INCIDENTAL TUMOR       |  P=0.052N     P=0.450N     P=0.118N     P=0.128N   |  P=0.504      P=0.489N     P=0.549      P=0.544    |
|LOGISTIC REGRESSION    |  P=0.068N     P=0.375N     P=0.096N     P=0.105N   |  P=0.489      P=0.460N     P=0.555      P=0.561    |
|COCHRAN-ARMITAGE       |  P=0.076N                                          |  P=0.471N                                          |
|FISHER EXACT           |               P=0.333N     P=0.072N     P=0.104N   |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
         DATE: 07/12/96                     EXPERIMENT: 89006 TEST: 04                                                 PAGE   7
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |
|                       |   CONTROL      5000 U       5000 U       5000 U    |   CONTROL      5000 U       5000 U       5000 U    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/50 (12%)   8/50 (16%)   7/50 (14%)   6/50 (12%) |  4/50 (8%)    4/50 (8%)    0/50 (0%)    2/50 (4%)  |
|ADJUSTED (b)           |  16.2%        22.9%        20.0%        16.1%      |   9.4%         9.9%         0.0%         5.1%      |
|TERMINAL (d)           |  3/31 (10%)   8/35 (23%)   7/35 (20%)   4/34 (12%) |  2/37 (5%)    3/38 (8%)    0/36 (0%)    1/32 (3%)  |
|FIRST INCIDENCE (DAYS) |   474          729 (T)      729 (T)      600       |   575          592          ---          557       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.448N     P=0.458      P=0.567      P=0.592N   |  P=0.197N     P=0.631N     P=0.074N     P=0.382N   |
|INCIDENTAL TUMOR       |  P=0.442N     P=0.402      P=0.474      P=0.608N   |  P=0.183N     P=0.603N     P=0.110N     P=0.331N   |
|LOGISTIC REGRESSION    |  P=0.511N     P=0.371      P=0.467      P=0.615N   |  P=0.144N     P=0.617      P=0.048N*    P=0.284N   |
|COCHRAN-ARMITAGE       |  P=0.486N                                          |  P=0.162N                                          |
|FISHER EXACT           |               P=0.387      P=0.500      P=0.620N   |               P=0.643N     P=0.059N     P=0.339N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    4/50 (8%)    3/50 (6%)    0/50 (0%)  |  2/50 (4%)    1/50 (2%)    3/50 (6%)    1/50 (2%)  |
|ADJUSTED (b)           |   6.5%        10.6%         7.9%         0.0%      |   5.4%         2.2%         7.6%         3.1%      |
|TERMINAL (d)           |  2/31 (6%)    2/35 (6%)    2/35 (6%)    0/34 (0%)  |  2/37 (5%)    0/38 (0%)    2/36 (6%)    1/32 (3%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      683          562          ---       |   730 (T)      598          344          730 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.127N     P=0.386      P=0.540      P=0.218N   |  P=0.521N     P=0.491N     P=0.484      P=0.551N   |
|INCIDENTAL TUMOR       |  P=0.163N     P=0.293      P=0.544      P=0.218N   |  P=0.445N     P=0.476N     P=0.685      P=0.551N   |
|LOGISTIC REGRESSION    |  P=0.143N     P=0.328      P=0.487      P=0.218N   |  P=0.439N     P=0.512N     P=0.546      P=0.551N   |
|COCHRAN-ARMITAGE       |  P=0.137N                                          |  P=0.474N                                          |
|FISHER EXACT           |               P=0.339      P=0.500      P=0.247N   |               P=0.500N     P=0.500      P=0.500N   |
|=================================================================================================================================|
         DATE: 07/12/96                     EXPERIMENT: 89006 TEST: 04                                                 PAGE   8
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |
|                       |   CONTROL      5000 U       5000 U       5000 U    |   CONTROL      5000 U       5000 U       5000 U    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  8/50 (16%)  12/50 (24%)  10/50 (20%)   6/50 (12%) |  6/50 (12%)   5/50 (10%)   3/50 (6%)    3/50 (6%)  |
|ADJUSTED (b)           |  22.2%        32.2%        27.4%        16.1%      |  14.5%        11.8%         7.6%         8.2%      |
|TERMINAL (d)           |  5/31 (16%)  10/35 (29%)   9/35 (26%)   4/34 (12%) |  4/37 (11%)   3/38 (8%)    2/36 (6%)    2/32 (6%)  |
|FIRST INCIDENCE (DAYS) |   474          683          562          600       |   575          592          344          557       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.198N     P=0.307      P=0.479      P=0.357N   |  P=0.212N     P=0.487N     P=0.269N     P=0.302N   |
|INCIDENTAL TUMOR       |  P=0.216N     P=0.215      P=0.400      P=0.363N   |  P=0.161N     P=0.448N     P=0.200N     P=0.263N   |
|LOGISTIC REGRESSION    |  P=0.248N     P=0.208      P=0.361      P=0.388N   |  P=0.134N     P=0.532N     P=0.193N     P=0.221N   |
|COCHRAN-ARMITAGE       |  P=0.228N                                          |  P=0.162N                                          |
|FISHER EXACT           |               P=0.227      P=0.398      P=0.387N   |               P=0.500N     P=0.243N     P=0.243N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Cystadenoma                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  3/50 (6%)    0/49 (0%)    2/49 (4%)    1/50 (2%)  |
|ADJUSTED (b)           |                                                    |   8.1%         0.0%         5.6%         2.6%      |
|TERMINAL (d)           |                                                    |  3/37 (8%)    0/37 (0%)    2/36 (6%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   730 (T)      ---          730 (T)      676       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.381N     P=0.121N     P=0.513N     P=0.351N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.350N     P=0.121N     P=0.513N     P=0.308N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.360N     P=0.121N     P=0.513N     P=0.324N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.336N                                          |
|FISHER EXACT           |                                                    |               P=0.125N     P=0.510N     P=0.309N   |
|=================================================================================================================================|
         DATE: 07/12/96                     EXPERIMENT: 89006 TEST: 04                                                 PAGE   9
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |
|                       |   CONTROL      5000 U       5000 U       5000 U    |   CONTROL      5000 U       5000 U       5000 U    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/47 (0%)    0/43 (0%)    0/48 (0%)    0/43 (0%)  |  8/49 (16%)   7/44 (16%)   6/48 (13%)   2/44 (5%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |  19.9%        20.6%        16.6%         5.6%      |
|TERMINAL (d)           |  0/29 (0%)    0/33 (0%)    0/34 (0%)    0/32 (0%)  |  5/36 (14%)   7/34 (21%)   5/35 (14%)   1/31 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   618          730 (T)      729          658       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.053N     P=0.536N     P=0.411N     P=0.075N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.049N*    P=0.582N     P=0.490N     P=0.068N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.050N*    P=0.572N     P=0.436N     P=0.070N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.044N*                                         |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.591N     P=0.403N     P=0.065N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Intermedia                                                                                                 |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/47 (0%)    0/43 (0%)    0/48 (0%)    1/43 (2%)  |  2/49 (4%)    0/44 (0%)    1/48 (2%)    0/44 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         3.1%      |   5.6%         0.0%         2.4%         0.0%      |
|TERMINAL (d)           |  0/29 (0%)    0/33 (0%)    0/34 (0%)    1/32 (3%)  |  2/36 (6%)    0/34 (0%)    0/35 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          729 (T)   |   730 (T)      ---          620          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.203        (e)          (e)        P=0.520    |  P=0.204N     P=0.251N     P=0.512N     P=0.272N   |
|INCIDENTAL TUMOR       |  P=0.203        (e)          (e)        P=0.520    |  P=0.227N     P=0.251N     P=0.626N     P=0.272N   |
|LOGISTIC REGRESSION    |  P=0.203        (e)          (e)        P=0.520    |  P=0.200N     P=0.251N     P=0.513N     P=0.272N   |
|COCHRAN-ARMITAGE       |  P=0.190                                           |  P=0.200N                                          |
|FISHER EXACT           |                 (e)          (e)        P=0.478    |               P=0.275N     P=0.508N     P=0.275N   |
|=================================================================================================================================|
         DATE: 07/12/96                     EXPERIMENT: 89006 TEST: 04                                                 PAGE  10
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |
|                       |   CONTROL      5000 U       5000 U       5000 U    |   CONTROL      5000 U       5000 U       5000 U    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    2/50 (4%)    0/50 (0%)    0/50 (0%)  |  2/50 (4%)    1/50 (2%)    2/50 (4%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%         4.3%         0.0%         0.0%      |   4.9%         2.6%         5.1%         2.0%      |
|TERMINAL (d)           |  0/31 (0%)    0/35 (0%)    0/35 (0%)    0/34 (0%)  |  1/37 (3%)    1/38 (3%)    1/36 (3%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          439          ---          ---       |   625          730 (T)      648          501       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.410N     P=0.233        (e)          (e)      |  P=0.478N     P=0.491N     P=0.677      P=0.517N   |
|INCIDENTAL TUMOR       |  P=0.291N     P=0.208        (e)          (e)      |  P=0.411N     P=0.476N     P=0.610      P=0.499N   |
|LOGISTIC REGRESSION    |  P=0.367N     P=0.337        (e)          (e)      |  P=0.416N     P=0.506N     P=0.695N     P=0.426N   |
|COCHRAN-ARMITAGE       |  P=0.405N                                          |  P=0.444N                                          |
|FISHER EXACT           |               P=0.247        (e)          (e)      |               P=0.500N     P=0.691N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    2/50 (4%)    0/50 (0%)    0/50 (0%)  |  1/50 (2%)    1/50 (2%)    2/50 (4%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%         4.3%         0.0%         0.0%      |   2.3%         2.6%         5.1%         2.0%      |
|TERMINAL (d)           |  0/31 (0%)    0/35 (0%)    0/35 (0%)    0/34 (0%)  |  0/37 (0%)    1/38 (3%)    1/36 (3%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          439          ---          ---       |   625          730 (T)      648          501       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.410N     P=0.233        (e)          (e)      |  P=0.564      P=0.755N     P=0.483      P=0.760    |
|INCIDENTAL TUMOR       |  P=0.291N     P=0.208        (e)          (e)      |  P=0.600N     P=0.740N     P=0.398      P=0.743N   |
|LOGISTIC REGRESSION    |  P=0.367N     P=0.337        (e)          (e)      |  P=0.617N     P=0.752      P=0.519      P=0.693N   |
|COCHRAN-ARMITAGE       |  P=0.405N                                          |  P=0.591                                           |
|FISHER EXACT           |               P=0.247        (e)          (e)      |               P=0.753N     P=0.500      P=0.753N   |
|=================================================================================================================================|
         DATE: 07/12/96                     EXPERIMENT: 89006 TEST: 04                                                 PAGE  11
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |
|                       |   CONTROL      5000 U       5000 U       5000 U    |   CONTROL      5000 U       5000 U       5000 U    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    2/50 (4%)    0/50 (0%)    0/50 (0%)  |  2/50 (4%)    1/50 (2%)    2/50 (4%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%         4.3%         0.0%         0.0%      |   4.9%         2.6%         5.1%         2.0%      |
|TERMINAL (d)           |  0/31 (0%)    0/35 (0%)    0/35 (0%)    0/34 (0%)  |  1/37 (3%)    1/38 (3%)    1/36 (3%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          439          ---          ---       |   625          730 (T)      648          501       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.410N     P=0.233        (e)          (e)      |  P=0.478N     P=0.491N     P=0.677      P=0.517N   |
|INCIDENTAL TUMOR       |  P=0.291N     P=0.208        (e)          (e)      |  P=0.411N     P=0.476N     P=0.610      P=0.499N   |
|LOGISTIC REGRESSION    |  P=0.367N     P=0.337        (e)          (e)      |  P=0.416N     P=0.506N     P=0.695N     P=0.426N   |
|COCHRAN-ARMITAGE       |  P=0.405N                                          |  P=0.444N                                          |
|FISHER EXACT           |               P=0.247        (e)          (e)      |               P=0.500N     P=0.691N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |  3/50 (6%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   3.2%         0.0%         0.0%         0.0%      |   8.1%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/31 (3%)    0/35 (0%)    0/35 (0%)    0/34 (0%)  |  3/37 (8%)    0/38 (0%)    0/36 (0%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          ---       |   730 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.296N     P=0.476N     P=0.476N     P=0.482N   |  P=0.054N     P=0.116N     P=0.126N     P=0.147N   |
|INCIDENTAL TUMOR       |  P=0.296N     P=0.476N     P=0.476N     P=0.482N   |  P=0.054N     P=0.116N     P=0.126N     P=0.147N   |
|LOGISTIC REGRESSION    |  P=0.296N     P=0.476N     P=0.476N     P=0.482N   |  P=0.054N     P=0.116N     P=0.126N     P=0.147N   |
|COCHRAN-ARMITAGE       |  P=0.306N                                          |  P=0.047N*                                         |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.500N   |               P=0.121N     P=0.121N     P=0.121N   |
|=================================================================================================================================|
         DATE: 07/12/96                     EXPERIMENT: 89006 TEST: 04                                                 PAGE  12
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |
|                       |   CONTROL      5000 U       5000 U       5000 U    |   CONTROL      5000 U       5000 U       5000 U    |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/48 (2%)    2/50 (4%)    4/50 (8%)    4/49 (8%)  |  3/49 (6%)    0/49 (0%)    1/49 (2%)    1/49 (2%)  |
|ADJUSTED (b)           |   3.2%         5.2%        10.4%         9.9%      |   8.1%         0.0%         2.4%         3.2%      |
|TERMINAL (d)           |  1/31 (3%)    1/35 (3%)    2/35 (6%)    1/34 (3%)  |  3/37 (8%)    0/38 (0%)    0/36 (0%)    1/31 (3%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      661          581          565       |   730 (T)      ---          648          730 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.117      P=0.525      P=0.210      P=0.179    |  P=0.341N     P=0.116N     P=0.318N     P=0.370N   |
|INCIDENTAL TUMOR       |  P=0.152      P=0.487      P=0.163      P=0.297    |  P=0.304N     P=0.116N     P=0.330N     P=0.370N   |
|LOGISTIC REGRESSION    |  P=0.114      P=0.507      P=0.181      P=0.188    |  P=0.312N     P=0.116N     P=0.321N     P=0.370N   |
|COCHRAN-ARMITAGE       |  P=0.115                                           |  P=0.296N                                          |
|FISHER EXACT           |               P=0.515      P=0.194      P=0.187    |               P=0.121N     P=0.309N     P=0.309N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/50 (12%)   2/50 (4%)    1/50 (2%)    5/49 (10%) |  2/49 (4%)    4/50 (8%)    6/50 (12%)   2/50 (4%)  |
|ADJUSTED (b)           |  17.2%         5.7%         2.9%        14.7%      |   5.6%        10.5%        16.7%         6.3%      |
|TERMINAL (d)           |  4/31 (13%)   2/35 (6%)    1/35 (3%)    5/34 (15%) |  2/36 (6%)    4/38 (11%)   6/36 (17%)   2/32 (6%)  |
|FIRST INCIDENCE (DAYS) |   677          729 (T)      729 (T)      729 (T)   |   730 (T)      730 (T)      730 (T)      730 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.510N     P=0.112N     P=0.051N     P=0.454N   |  P=0.536      P=0.361      P=0.132      P=0.652    |
|INCIDENTAL TUMOR       |  P=0.559      P=0.146N     P=0.082N     P=0.576N   |  P=0.536      P=0.361      P=0.132      P=0.652    |
|LOGISTIC REGRESSION    |  P=0.563N     P=0.139N     P=0.065N     P=0.533N   |  P=0.536      P=0.361      P=0.132      P=0.652    |
|COCHRAN-ARMITAGE       |  P=0.549N                                          |  P=0.528N                                          |
|FISHER EXACT           |               P=0.134N     P=0.056N     P=0.514N   |               P=0.349      P=0.141      P=0.684N   |
|=================================================================================================================================|
         DATE: 07/12/96                     EXPERIMENT: 89006 TEST: 04                                                 PAGE  13
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |
|                       |   CONTROL      5000 U       5000 U       5000 U    |   CONTROL      5000 U       5000 U       5000 U    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/50 (12%)   3/50 (6%)    1/50 (2%)    5/49 (10%) |  2/49 (4%)    4/50 (8%)    6/50 (12%)   2/50 (4%)  |
|ADJUSTED (b)           |  17.2%         8.6%         2.9%        14.7%      |   5.6%        10.5%        16.7%         6.3%      |
|TERMINAL (d)           |  4/31 (13%)   3/35 (9%)    1/35 (3%)    5/34 (15%) |  2/36 (6%)    4/38 (11%)   6/36 (17%)   2/32 (6%)  |
|FIRST INCIDENCE (DAYS) |   677          729 (T)      729 (T)      729 (T)   |   730 (T)      730 (T)      730 (T)      730 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.453N     P=0.203N     P=0.051N     P=0.454N   |  P=0.536      P=0.361      P=0.132      P=0.652    |
|INCIDENTAL TUMOR       |  P=0.532N     P=0.252N     P=0.082N     P=0.576N   |  P=0.536      P=0.361      P=0.132      P=0.652    |
|LOGISTIC REGRESSION    |  P=0.508N     P=0.249N     P=0.065N     P=0.533N   |  P=0.536      P=0.361      P=0.132      P=0.652    |
|COCHRAN-ARMITAGE       |  P=0.494N                                          |  P=0.528N                                          |
|FISHER EXACT           |               P=0.243N     P=0.056N     P=0.514N   |               P=0.349      P=0.141      P=0.684N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  0/50 (0%)    3/50 (6%)    0/50 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |                                                    |   0.0%         7.3%         0.0%         3.1%      |
|TERMINAL (d)           |                                                    |  0/37 (0%)    2/38 (5%)    0/36 (0%)    1/32 (3%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   ---          598          ---          730 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.600      P=0.128        (e)        P=0.471    |
|INCIDENTAL TUMOR       |                                                    |  P=0.604      P=0.135        (e)        P=0.471    |
|LOGISTIC REGRESSION    |                                                    |  P=0.630      P=0.114        (e)        P=0.471    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.634                                           |
|FISHER EXACT           |                                                    |               P=0.121        (e)        P=0.500    |
|=================================================================================================================================|
         DATE: 07/12/96                     EXPERIMENT: 89006 TEST: 04                                                 PAGE  14
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |
|                       |   CONTROL      5000 U       5000 U       5000 U    |   CONTROL      5000 U       5000 U       5000 U    |
|=================================================================================================================================|
|                                                                                                                                 |
|Vagina                                                                                                                           |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  0/50 (0%)    0/50 (0%)    5/50 (10%)   4/50 (8%)  |
|ADJUSTED (b)           |                                                    |   0.0%         0.0%        13.9%        12.5%      |
|TERMINAL (d)           |                                                    |  0/37 (0%)    0/38 (0%)    5/36 (14%)   4/32 (13%) |
|FIRST INCIDENCE (DAYS) |                                                    |   ---          ---          730 (T)      730 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.009 **     (e)        P=0.031 *    P=0.046 *  |
|INCIDENTAL TUMOR       |                                                    |  P=0.009 **     (e)        P=0.031 *    P=0.046 *  |
|LOGISTIC REGRESSION    |                                                    |  P=0.009 **     (e)        P=0.031 *    P=0.046 *  |
|COCHRAN-ARMITAGE       |                                                    |  P=0.016 *                                         |
|FISHER EXACT           |                                                    |                 (e)        P=0.028 *    P=0.059    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)  |  2/50 (4%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         2.9%      |   5.1%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/31 (0%)    0/35 (0%)    0/35 (0%)    1/34 (3%)  |  1/37 (3%)    0/38 (0%)    0/36 (0%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          729 (T)   |   682          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.203        (e)          (e)        P=0.518    |  P=0.125N     P=0.234N     P=0.243N     P=0.268N   |
|INCIDENTAL TUMOR       |  P=0.203        (e)          (e)        P=0.518    |  P=0.106N     P=0.257N     P=0.263N     P=0.210N   |
|LOGISTIC REGRESSION    |  P=0.203        (e)          (e)        P=0.518    |  P=0.118N     P=0.237N     P=0.247N     P=0.243N   |
|COCHRAN-ARMITAGE       |  P=0.198                                           |  P=0.115N                                          |
|FISHER EXACT           |                 (e)          (e)        P=0.500    |               P=0.247N     P=0.247N     P=0.247N   |
|=================================================================================================================================|
         DATE: 07/12/96                     EXPERIMENT: 89006 TEST: 04                                                 PAGE  15
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |
|                       |   CONTROL      5000 U       5000 U       5000 U    |   CONTROL      5000 U       5000 U       5000 U    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/50 (10%)   5/50 (10%)   4/50 (8%)    6/50 (12%) |  5/50 (10%)   2/50 (4%)    1/50 (2%)    1/50 (2%)  |
|ADJUSTED (b)           |  15.6%        13.0%        10.4%        15.2%      |  13.5%         5.3%         2.4%         3.1%      |
|TERMINAL (d)           |  4/31 (13%)   3/35 (9%)    2/35 (6%)    2/34 (6%)  |  5/37 (14%)   2/38 (5%)    0/36 (0%)    1/32 (3%)  |
|FIRST INCIDENCE (DAYS) |   727          661          581          565       |   730 (T)      730 (T)      648          730 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.452      P=0.571N     P=0.440N     P=0.526    |  P=0.078N     P=0.205N     P=0.112N     P=0.138N   |
|INCIDENTAL TUMOR       |  P=0.385      P=0.585      P=0.564N     P=0.513    |  P=0.069N     P=0.205N     P=0.117N     P=0.138N   |
|LOGISTIC REGRESSION    |  P=0.426      P=0.619      P=0.530N     P=0.493    |  P=0.068N     P=0.205N     P=0.114N     P=0.138N   |
|COCHRAN-ARMITAGE       |  P=0.437                                           |  P=0.060N                                          |
|FISHER EXACT           |               P=0.630N     P=0.500N     P=0.500    |               P=0.218N     P=0.102N     P=0.102N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/50 (10%)   5/50 (10%)   4/50 (8%)    7/50 (14%) |  7/50 (14%)   2/50 (4%)    1/50 (2%)    1/50 (2%)  |
|ADJUSTED (b)           |  15.6%        13.0%        10.4%        17.8%      |  18.3%         5.3%         2.4%         3.1%      |
|TERMINAL (d)           |  4/31 (13%)   3/35 (9%)    2/35 (6%)    3/34 (9%)  |  6/37 (16%)   2/38 (5%)    0/36 (0%)    1/32 (3%)  |
|FIRST INCIDENCE (DAYS) |   727          661          581          565       |   682          730 (T)      648          730 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.324      P=0.571N     P=0.440N     P=0.413    |  P=0.023N*    P=0.076N     P=0.038N*    P=0.051N   |
|INCIDENTAL TUMOR       |  P=0.263      P=0.585      P=0.564N     P=0.393    |  P=0.017N*    P=0.081N     P=0.041N*    P=0.041N*  |
|LOGISTIC REGRESSION    |  P=0.296      P=0.619      P=0.530N     P=0.368    |  P=0.019N*    P=0.073N     P=0.038N*    P=0.041N*  |
|COCHRAN-ARMITAGE       |  P=0.306                                           |  P=0.016N*                                         |
|FISHER EXACT           |               P=0.630N     P=0.500N     P=0.380    |               P=0.080N     P=0.030N*    P=0.030N*  |
|=================================================================================================================================|
         DATE: 07/12/96                     EXPERIMENT: 89006 TEST: 04                                                 PAGE  16
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |
|                       |   CONTROL      5000 U       5000 U       5000 U    |   CONTROL      5000 U       5000 U       5000 U    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Histiocytic Sarcoma                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/50 (0%)    1/50 (2%)    0/50 (0%)  |  2/50 (4%)    1/50 (2%)    1/50 (2%)    1/50 (2%)  |
|ADJUSTED (b)           |   3.2%         0.0%         2.4%         0.0%      |   5.4%         2.3%         2.1%         2.9%      |
|TERMINAL (d)           |  1/31 (3%)    0/35 (0%)    0/35 (0%)    0/34 (0%)  |  2/37 (5%)    0/38 (0%)    0/36 (0%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          605          ---       |   730 (T)      640          318          713       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.409N     P=0.476N     P=0.755N     P=0.482N   |  P=0.441N     P=0.491N     P=0.511N     P=0.543N   |
|INCIDENTAL TUMOR       |  P=0.331N     P=0.476N     P=0.747N     P=0.482N   |  P=0.311N     P=0.476N     P=0.244N     P=0.487N   |
|LOGISTIC REGRESSION    |  P=0.402N     P=0.476N     P=0.758N     P=0.482N   |  P=0.352N     P=0.503N     P=0.391N     P=0.530N   |
|COCHRAN-ARMITAGE       |  P=0.405N                                          |  P=0.409N                                          |
|FISHER EXACT           |               P=0.500N     P=0.753N     P=0.500N   |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated                                               |
|     Cell Type                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    3/50 (6%)    6/50 (12%)   3/50 (6%)  |  8/50 (16%)  12/50 (24%)   8/50 (16%)   6/50 (12%) |
|ADJUSTED (b)           |   4.7%         7.7%        14.9%         7.8%      |  18.7%        28.3%        21.3%        15.6%      |
|TERMINAL (d)           |  0/31 (0%)    2/35 (6%)    2/35 (6%)    1/34 (3%)  |  4/37 (11%)   8/38 (21%)   7/36 (19%)   2/32 (6%)  |
|FIRST INCIDENCE (DAYS) |   670          473          605          586       |   589          592          604          557       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.384      P=0.516      P=0.140      P=0.487    |  P=0.301N     P=0.260      P=0.574      P=0.462N   |
|INCIDENTAL TUMOR       |  P=0.310      P=0.426      P=0.037 *    P=0.274    |  P=0.182N     P=0.220      P=0.464      P=0.298N   |
|LOGISTIC REGRESSION    |  P=0.395      P=0.526      P=0.054      P=0.309    |  P=0.215N     P=0.217      P=0.585      P=0.358N   |
|COCHRAN-ARMITAGE       |  P=0.389                                           |  P=0.204N                                          |
|FISHER EXACT           |               P=0.500      P=0.134      P=0.500    |               P=0.227      P=0.607N     P=0.387N   |
|=================================================================================================================================|
         DATE: 07/12/96                     EXPERIMENT: 89006 TEST: 04                                                 PAGE  17
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |
|                       |   CONTROL      5000 U       5000 U       5000 U    |   CONTROL      5000 U       5000 U       5000 U    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 28/50 (56%)  30/50 (60%)  26/50 (52%)  31/50 (62%) | 36/50 (72%)  24/50 (48%)  24/50 (48%)  22/50 (44%) |
|ADJUSTED (b)           |  71.1%        74.6%        68.1%        73.5%      |  78.1%        56.7%        61.5%        60.3%      |
|TERMINAL (d)           | 20/31 (65%)  25/35 (71%)  23/35 (66%)  23/34 (68%) | 27/37 (73%)  20/38 (53%)  21/36 (58%)  18/32 (56%) |
|FIRST INCIDENCE (DAYS) |   474          528          488          498       |   575          592          620          557       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.464      P=0.534N     P=0.254N     P=0.484    |  P=0.063N     P=0.017N*    P=0.029N*    P=0.040N*  |
|INCIDENTAL TUMOR       |  P=0.427      P=0.433      P=0.439N     P=0.345    |  P=0.022N*    P=0.009N**   P=0.042N*    P=0.008N** |
|LOGISTIC REGRESSION    |  P=0.292      P=0.358      P=0.536N     P=0.282    |  P=0.016N*    P=0.011N*    P=0.024N*    P=0.006N** |
|COCHRAN-ARMITAGE       |  P=0.358                                           |  P=0.009N**                                        |
|FISHER EXACT           |               P=0.420      P=0.421N     P=0.342    |               P=0.012N*    P=0.012N*    P=0.004N** |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 28/50 (56%)  34/50 (68%)  29/50 (58%)  26/50 (52%) | 32/50 (64%)  28/50 (56%)  33/50 (66%)  28/50 (56%) |
|ADJUSTED (b)           |  58.1%        72.3%        64.4%        55.3%      |  69.4%        60.8%        74.7%        61.6%      |
|TERMINAL (d)           | 11/31 (35%)  22/35 (63%)  19/35 (54%)  13/34 (38%) | 23/37 (62%)  20/38 (53%)  25/36 (69%)  15/32 (47%) |
|FIRST INCIDENCE (DAYS) |   462          439          386          517       |   589          592          318          501       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.251N     P=0.323      P=0.538N     P=0.399N   |  P=0.448      P=0.262N     P=0.431      P=0.517N   |
|INCIDENTAL TUMOR       |  P=0.323N     P=0.026 *    P=0.138      P=0.557    |  P=0.286N     P=0.252N     P=0.411      P=0.246N   |
|LOGISTIC REGRESSION    |  P=0.182N     P=0.064      P=0.273      P=0.451N   |  P=0.357N     P=0.299N     P=0.419      P=0.283N   |
|COCHRAN-ARMITAGE       |  P=0.226N                                          |  P=0.321N                                          |
|FISHER EXACT           |               P=0.151      P=0.500      P=0.421N   |               P=0.270N     P=0.500      P=0.270N   |
|=================================================================================================================================|
         DATE: 07/12/96                     EXPERIMENT: 89006 TEST: 04                                                 PAGE  18
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |   VEHICLE      30 MG/KG     60 MG/KG     120MG/KG  |
|                       |   CONTROL      5000 U       5000 U       5000 U    |   CONTROL      5000 U       5000 U       5000 U    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 41/50 (82%)  44/50 (88%)  40/50 (80%)  43/50 (86%) | 44/50 (88%)  40/50 (80%)  41/50 (82%)  39/50 (78%) |
|ADJUSTED (b)           |  83.7%        91.7%        87.0%        89.6%      |  91.7%        85.1%        91.0%        86.5%      |
|TERMINAL (d)           | 23/31 (74%)  31/35 (89%)  29/35 (83%)  29/34 (85%) | 33/37 (89%)  31/38 (82%)  32/36 (89%)  26/32 (81%) |
|FIRST INCIDENCE (DAYS) |   462          439          386          498       |   575          592          318          501       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.497N     P=0.554N     P=0.337N     P=0.560N   |  P=0.432      P=0.225N     P=0.445N     P=0.562N   |
|INCIDENTAL TUMOR       |  P=0.369      P=0.076      P=0.302      P=0.254    |  P=0.212N     P=0.158N     P=0.476N     P=0.203N   |
|LOGISTIC REGRESSION    |  P=0.483      P=0.247      P=0.390      P=0.370    |  P=0.247N     P=0.169N     P=0.515N     P=0.200N   |
|COCHRAN-ARMITAGE       |  P=0.448                                           |  P=0.160N                                          |
|FISHER EXACT           |               P=0.288      P=0.500N     P=0.393    |               P=0.207N     P=0.288N     P=0.143N   |
|=================================================================================================================================|
 (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).