National Toxicology Program

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TDMS Study 89006-02 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                          AZT/INTERFERON A/INTERFERON AD                            DATE: 08/21/96       
EXPERIMENT: 89006 TEST: 02                                                                                     TIME: 12:06:39       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-85225                              ROUTE: GAVAGE                                                  NTP C#: C89006       
PATHOLOGIST: JAMES E. HEATH                                                                                    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: 08/21/96       
EXPERIMENT: 89006 TEST: 02                                                                                     TIME: 12:06:39       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-85225                              ROUTE: GAVAGE                                                  NTP C#: C89006       
PATHOLOGIST: JAMES E. HEATH                                                                                    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
                 -------                             ------------

              Adrenal Cortex                Adenoma
              Liver                         Hepatocellular Carcinoma
                                            Hepatocellular Carcinoma or Hepatoblastoma
                                            Hepatocellular Carcinoma or Hepatocellular Adenoma
                                            Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
              Lung                          Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
              Thyroid Gland: Follicular Cell
                                            Adenoma
                                            Carcinoma or Adenoma
              All Organs                    Malignant and Benign Tumors

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

                                                           FEMALE MICE
                                                          -------------
                  ORGAN                               MORPHOLOGY
                 -------                             ------------

              Liver                         Hemangiosarcoma
                                            Hepatocellular Adenoma
                                            Hepatocellular Carcinoma
                                            Hepatocellular Carcinoma or Hepatoblastoma
              Vagina                        Squamous Cell Carcinoma
              All Organs                    Hemangiosarcoma
                                            Histiocytic Sarcoma
                                            Malignant Tumors

              ====================================================================================================
         DATE: 08/21/96                     EXPERIMENT: 89006 TEST: 02                                                 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      500 U        500 U        500 U     |   CONTROL      500 U        500 U        500 U     |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    1/50 (2%)    3/50 (6%)  |  1/49 (2%)    0/50 (0%)    0/50 (0%)    0/49 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         2.6%         8.3%      |   3.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/36 (0%)    0/27 (0%)    1/38 (3%)    2/35 (6%)  |  1/33 (3%)    0/32 (0%)    0/32 (0%)    0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          731 (T)      727       |   729 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.027 *      (e)        P=0.511      P=0.120    |  P=0.207N     P=0.506N     P=0.506N     P=0.564N   |
|INCIDENTAL TUMOR       |  P=0.025 *      (e)        P=0.511      P=0.127    |  P=0.207N     P=0.506N     P=0.506N     P=0.564N   |
|LOGISTIC REGRESSION    |  P=0.024 *      (e)        P=0.511      P=0.113    |  P=0.207N     P=0.506N     P=0.506N     P=0.564N   |
|COCHRAN-ARMITAGE       |  P=0.021 *                                         |  P=0.184N                                          |
|FISHER EXACT           |                 (e)        P=0.500      P=0.121    |               P=0.495N     P=0.495N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |  0/49 (0%)    0/49 (0%)    2/49 (4%)    0/48 (0%)  |
|ADJUSTED (b)           |   2.0%         0.0%         0.0%         0.0%      |   0.0%         0.0%         6.3%         0.0%      |
|TERMINAL (d)           |  0/36 (0%)    0/27 (0%)    0/38 (0%)    0/35 (0%)  |  0/33 (0%)    0/31 (0%)    2/32 (6%)    0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   374          ---          ---          ---       |   ---          ---          729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.186N     P=0.513N     P=0.508N     P=0.496N   |  P=0.320        (e)        P=0.231        (e)      |
|INCIDENTAL TUMOR       |  P=0.284N     P=0.500N       (e)        P=0.557N   |  P=0.320        (e)        P=0.231        (e)      |
|LOGISTIC REGRESSION    |  P=0.150N     P=0.289N     P=0.324N     P=0.557N   |  P=0.320        (e)        P=0.231        (e)      |
|COCHRAN-ARMITAGE       |  P=0.185N                                          |  P=0.371                                           |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.500N   |                 (e)        P=0.247        (e)      |
|=================================================================================================================================|
         DATE: 08/21/96                     EXPERIMENT: 89006 TEST: 02                                                 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      500 U        500 U        500 U     |   CONTROL      500 U        500 U        500 U     |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |  0/49 (0%)    1/49 (2%)    2/49 (4%)    0/48 (0%)  |
|ADJUSTED (b)           |   2.0%         0.0%         0.0%         0.0%      |   0.0%         3.2%         6.3%         0.0%      |
|TERMINAL (d)           |  0/36 (0%)    0/27 (0%)    0/38 (0%)    0/35 (0%)  |  0/33 (0%)    1/31 (3%)    2/32 (6%)    0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   374          ---          ---          ---       |   ---          729 (T)      729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.186N     P=0.513N     P=0.508N     P=0.496N   |  P=0.431      P=0.488      P=0.231        (e)      |
|INCIDENTAL TUMOR       |  P=0.284N     P=0.500N       (e)        P=0.557N   |  P=0.431      P=0.488      P=0.231        (e)      |
|LOGISTIC REGRESSION    |  P=0.150N     P=0.289N     P=0.324N     P=0.557N   |  P=0.431      P=0.488      P=0.231        (e)      |
|COCHRAN-ARMITAGE       |  P=0.185N                                          |  P=0.495                                           |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.500N   |               P=0.500      P=0.247        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    3/50 (6%)    1/50 (2%)    2/50 (4%)  |  0/50 (0%)    2/50 (4%)    1/50 (2%)    0/49 (0%)  |
|ADJUSTED (b)           |   7.2%        10.4%         2.1%         5.7%      |   0.0%         6.3%         3.1%         0.0%      |
|TERMINAL (d)           |  1/36 (3%)    2/27 (7%)    0/38 (0%)    2/35 (6%)  |  0/33 (0%)    2/32 (6%)    1/32 (3%)    0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   618          708          563          731 (T)   |   ---          729 (T)      729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.255N     P=0.542      P=0.300N     P=0.506N   |  P=0.571N     P=0.231      P=0.494        (e)      |
|INCIDENTAL TUMOR       |  P=0.233N     P=0.615N     P=0.187N     P=0.435N   |  P=0.571N     P=0.231      P=0.494        (e)      |
|LOGISTIC REGRESSION    |  P=0.266N     P=0.622      P=0.280N     P=0.503N   |  P=0.571N     P=0.231      P=0.494        (e)      |
|COCHRAN-ARMITAGE       |  P=0.271N                                          |  P=0.505N                                          |
|FISHER EXACT           |               P=0.661N     P=0.309N     P=0.500N   |               P=0.247      P=0.500        (e)      |
|=================================================================================================================================|
         DATE: 08/21/96                     EXPERIMENT: 89006 TEST: 02                                                 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      500 U        500 U        500 U     |   CONTROL      500 U        500 U        500 U     |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/49 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         5.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/36 (0%)    0/27 (0%)    0/38 (0%)    1/35 (3%)  |  0/33 (0%)    0/32 (0%)    0/32 (0%)    0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          632       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.066        (e)          (e)        P=0.242    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.060        (e)          (e)        P=0.310    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.056        (e)          (e)        P=0.228    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.056                                           |    (e)                                             |
|FISHER EXACT           |                 (e)          (e)        P=0.247    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    3/50 (6%)    1/50 (2%)    4/50 (8%)  |  0/50 (0%)    2/50 (4%)    1/50 (2%)    0/49 (0%)  |
|ADJUSTED (b)           |   7.2%        10.4%         2.1%        10.6%      |   0.0%         6.3%         3.1%         0.0%      |
|TERMINAL (d)           |  1/36 (3%)    2/27 (7%)    0/38 (0%)    3/35 (9%)  |  0/33 (0%)    2/32 (6%)    1/32 (3%)    0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   618          708          563          632       |   ---          729 (T)      729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.532      P=0.542      P=0.300N     P=0.497    |  P=0.571N     P=0.231      P=0.494        (e)      |
|INCIDENTAL TUMOR       |  P=0.551N     P=0.615N     P=0.187N     P=0.607    |  P=0.571N     P=0.231      P=0.494        (e)      |
|LOGISTIC REGRESSION    |  P=0.506      P=0.622      P=0.280N     P=0.493    |  P=0.571N     P=0.231      P=0.494        (e)      |
|COCHRAN-ARMITAGE       |  P=0.500                                           |  P=0.505N                                          |
|FISHER EXACT           |               P=0.661N     P=0.309N     P=0.500    |               P=0.247      P=0.500        (e)      |
|=================================================================================================================================|
         DATE: 08/21/96                     EXPERIMENT: 89006 TEST: 02                                                 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      500 U        500 U        500 U     |   CONTROL      500 U        500 U        500 U     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    5/50 (10%)   4/50 (8%)    4/50 (8%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    2/49 (4%)  |
|ADJUSTED (b)           |   7.5%        16.4%        10.1%        10.1%      |   0.0%         0.0%         0.0%         6.6%      |
|TERMINAL (d)           |  1/36 (3%)    3/27 (11%)   3/38 (8%)    2/35 (6%)  |  0/33 (0%)    0/32 (0%)    0/32 (0%)    1/24 (4%)  |
|FIRST INCIDENCE (DAYS) |   675          663          685          638       |   ---          ---          ---          597       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.491      P=0.231      P=0.520      P=0.487    |  P=0.046 *      (e)          (e)        P=0.198    |
|INCIDENTAL TUMOR       |  P=0.472      P=0.341      P=0.386      P=0.577    |  P=0.070        (e)          (e)        P=0.308    |
|LOGISTIC REGRESSION    |  P=0.547N     P=0.282      P=0.498      P=0.502    |  P=0.053        (e)          (e)        P=0.227    |
|COCHRAN-ARMITAGE       |  P=0.454                                           |  P=0.055                                           |
|FISHER EXACT           |               P=0.357      P=0.500      P=0.500    |                 (e)          (e)        P=0.242    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 16/50 (32%)  16/50 (32%)  19/50 (38%)  18/50 (36%) | 11/50 (22%)  17/50 (34%)  14/50 (28%)  14/49 (29%) |
|ADJUSTED (b)           |  40.5%        46.5%        47.3%        48.3%      |  31.1%        51.5%        42.4%        49.0%      |
|TERMINAL (d)           | 13/36 (36%)   9/27 (33%)  17/38 (45%)  16/35 (46%) |  9/33 (27%)  16/32 (50%)  13/32 (41%)  10/24 (42%) |
|FIRST INCIDENCE (DAYS) |   477          518          563          638       |   649          667          713          617       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.394      P=0.261      P=0.406      P=0.380    |  P=0.103      P=0.097      P=0.282      P=0.096    |
|INCIDENTAL TUMOR       |  P=0.340      P=0.400      P=0.287      P=0.414    |  P=0.162      P=0.039 *    P=0.257      P=0.168    |
|LOGISTIC REGRESSION    |  P=0.368      P=0.414      P=0.331      P=0.429    |  P=0.173      P=0.052      P=0.239      P=0.161    |
|COCHRAN-ARMITAGE       |  P=0.297                                           |  P=0.340                                           |
|FISHER EXACT           |               P=0.585N     P=0.338      P=0.417    |               P=0.133      P=0.322      P=0.301    |
|=================================================================================================================================|
         DATE: 08/21/96                     EXPERIMENT: 89006 TEST: 02                                                 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      500 U        500 U        500 U     |   CONTROL      500 U        500 U        500 U     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 13/50 (26%)  20/50 (40%)  17/50 (34%)  14/50 (28%) | 13/50 (26%)   4/50 (8%)    5/50 (10%)  10/49 (20%) |
|ADJUSTED (b)           |  31.9%        52.9%        40.1%        32.2%      |  35.4%        11.8%        14.7%        32.5%      |
|TERMINAL (d)           |  9/36 (25%)  11/27 (41%)  13/38 (34%)   7/35 (20%) | 10/33 (30%)   3/32 (9%)    3/32 (9%)    5/24 (21%) |
|FIRST INCIDENCE (DAYS) |   477          376          598          527       |   649          628          707          589       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.435N     P=0.029 *    P=0.316      P=0.483    |  P=0.473N     P=0.025N*    P=0.047N*    P=0.573    |
|INCIDENTAL TUMOR       |  P=0.527      P=0.090      P=0.285      P=0.537    |  P=0.299N     P=0.041N*    P=0.050N     P=0.438N   |
|LOGISTIC REGRESSION    |  P=0.511N     P=0.087      P=0.245      P=0.481    |  P=0.357N     P=0.026N*    P=0.041N*    P=0.448N   |
|COCHRAN-ARMITAGE       |  P=0.527                                           |  P=0.287N                                          |
|FISHER EXACT           |               P=0.101      P=0.257      P=0.500    |               P=0.016N*    P=0.033N*    P=0.337N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatoblastoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 13/50 (26%)  21/50 (42%)  17/50 (34%)  14/50 (28%) | 13/50 (26%)   4/50 (8%)    5/50 (10%)  10/49 (20%) |
|ADJUSTED (b)           |  31.9%        54.5%        40.1%        32.2%      |  35.4%        11.8%        14.7%        32.5%      |
|TERMINAL (d)           |  9/36 (25%)  11/27 (41%)  13/38 (34%)   7/35 (20%) | 10/33 (30%)   3/32 (9%)    3/32 (9%)    5/24 (21%) |
|FIRST INCIDENCE (DAYS) |   477          376          598          527       |   649          628          707          589       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.411N     P=0.019 *    P=0.316      P=0.483    |  P=0.473N     P=0.025N*    P=0.047N*    P=0.573    |
|INCIDENTAL TUMOR       |  P=0.503N     P=0.065      P=0.285      P=0.537    |  P=0.299N     P=0.041N*    P=0.050N     P=0.438N   |
|LOGISTIC REGRESSION    |  P=0.481N     P=0.057      P=0.245      P=0.481    |  P=0.357N     P=0.026N*    P=0.041N*    P=0.448N   |
|COCHRAN-ARMITAGE       |  P=0.500N                                          |  P=0.287N                                          |
|FISHER EXACT           |               P=0.069      P=0.257      P=0.500    |               P=0.016N*    P=0.033N*    P=0.337N   |
|=================================================================================================================================|
         DATE: 08/21/96                     EXPERIMENT: 89006 TEST: 02                                                 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      500 U        500 U        500 U     |   CONTROL      500 U        500 U        500 U     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 24/50 (48%)  31/50 (62%)  33/50 (66%)  29/50 (58%) | 20/50 (40%)  20/50 (40%)  18/50 (36%)  22/49 (45%) |
|ADJUSTED (b)           |  56.8%        75.0%        74.9%        65.4%      |  53.6%        58.7%        52.9%        65.9%      |
|TERMINAL (d)           | 18/36 (50%)  17/27 (63%)  27/38 (71%)  20/35 (57%) | 16/33 (48%)  18/32 (56%)  16/32 (50%)  13/24 (54%) |
|FIRST INCIDENCE (DAYS) |   477          376          563          527       |   649          628          707          589       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.307      P=0.016 *    P=0.112      P=0.213    |  P=0.099      P=0.499      P=0.478N     P=0.092    |
|INCIDENTAL TUMOR       |  P=0.189      P=0.066      P=0.060      P=0.252    |  P=0.220      P=0.294      P=0.521N     P=0.218    |
|LOGISTIC REGRESSION    |  P=0.194      P=0.050 *    P=0.043 *    P=0.226    |  P=0.198      P=0.360      P=0.533N     P=0.191    |
|COCHRAN-ARMITAGE       |  P=0.152                                           |  P=0.393                                           |
|FISHER EXACT           |               P=0.114      P=0.053      P=0.212    |               P=0.581N     P=0.418N     P=0.386    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 24/50 (48%)  32/50 (64%)  33/50 (66%)  29/50 (58%) | 20/50 (40%)  20/50 (40%)  18/50 (36%)  22/49 (45%) |
|ADJUSTED (b)           |  56.8%        75.8%        74.9%        65.4%      |  53.6%        58.7%        52.9%        65.9%      |
|TERMINAL (d)           | 18/36 (50%)  17/27 (63%)  27/38 (71%)  20/35 (57%) | 16/33 (48%)  18/32 (56%)  16/32 (50%)  13/24 (54%) |
|FIRST INCIDENCE (DAYS) |   477          376          563          527       |   649          628          707          589       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.328      P=0.011 *    P=0.112      P=0.213    |  P=0.099      P=0.499      P=0.478N     P=0.092    |
|INCIDENTAL TUMOR       |  P=0.205      P=0.045 *    P=0.060      P=0.252    |  P=0.220      P=0.294      P=0.521N     P=0.218    |
|LOGISTIC REGRESSION    |  P=0.213      P=0.030 *    P=0.043 *    P=0.226    |  P=0.198      P=0.360      P=0.533N     P=0.191    |
|COCHRAN-ARMITAGE       |  P=0.167                                           |  P=0.393                                           |
|FISHER EXACT           |               P=0.079      P=0.053      P=0.212    |               P=0.581N     P=0.418N     P=0.386    |
|=================================================================================================================================|
         DATE: 08/21/96                     EXPERIMENT: 89006 TEST: 02                                                 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      500 U        500 U        500 U     |   CONTROL      500 U        500 U        500 U     |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 10/49 (20%)   4/50 (8%)    9/50 (18%)   8/50 (16%) |  1/50 (2%)    3/50 (6%)    1/50 (2%)    1/49 (2%)  |
|ADJUSTED (b)           |  26.4%        14.8%        23.7%        22.0%      |   3.0%         9.4%         3.1%         4.2%      |
|TERMINAL (d)           |  8/35 (23%)   4/27 (15%)   9/38 (24%)   7/35 (20%) |  1/33 (3%)    3/32 (9%)    1/32 (3%)    1/24 (4%)  |
|FIRST INCIDENCE (DAYS) |   660          731 (T)      731 (T)      682       |   729 (T)      729 (T)      729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.416N     P=0.174N     P=0.430N     P=0.399N   |  P=0.526N     P=0.293      P=0.755      P=0.689    |
|INCIDENTAL TUMOR       |  P=0.428N     P=0.138N     P=0.484N     P=0.376N   |  P=0.526N     P=0.293      P=0.755      P=0.689    |
|LOGISTIC REGRESSION    |  P=0.432N     P=0.128N     P=0.463N     P=0.374N   |  P=0.526N     P=0.293      P=0.755      P=0.689    |
|COCHRAN-ARMITAGE       |  P=0.484N                                          |  P=0.433N                                          |
|FISHER EXACT           |               P=0.068N     P=0.480N     P=0.379N   |               P=0.309      P=0.753N     P=0.747    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/49 (12%)   2/50 (4%)    7/50 (14%)   6/50 (12%) |  0/50 (0%)    2/50 (4%)    1/50 (2%)    1/49 (2%)  |
|ADJUSTED (b)           |  15.6%         7.4%        17.8%        15.8%      |   0.0%         6.3%         2.6%         3.1%      |
|TERMINAL (d)           |  4/35 (11%)   2/27 (7%)    6/38 (16%)   4/35 (11%) |  0/33 (0%)    2/32 (6%)    0/32 (0%)    0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   542          731 (T)      699          672       |   ---          729 (T)      647          673       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.399      P=0.224N     P=0.552      P=0.612    |  P=0.345      P=0.231      P=0.485      P=0.451    |
|INCIDENTAL TUMOR       |  P=0.357      P=0.194N     P=0.363      P=0.613N   |  P=0.408      P=0.231      P=0.450      P=0.500    |
|LOGISTIC REGRESSION    |  P=0.389      P=0.165N     P=0.513      P=0.599N   |  P=0.390      P=0.231      P=0.500      P=0.489    |
|COCHRAN-ARMITAGE       |  P=0.352                                           |  P=0.405                                           |
|FISHER EXACT           |               P=0.128N     P=0.516      P=0.606N   |               P=0.247      P=0.500      P=0.495    |
|=================================================================================================================================|
         DATE: 08/21/96                     EXPERIMENT: 89006 TEST: 02                                                 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      500 U        500 U        500 U     |   CONTROL      500 U        500 U        500 U     |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 16/49 (33%)   6/50 (12%)  14/50 (28%)  14/50 (28%) |  1/50 (2%)    4/50 (8%)    2/50 (4%)    2/49 (4%)  |
|ADJUSTED (b)           |  40.3%        22.2%        35.8%        36.4%      |   3.0%        12.5%         5.6%         7.2%      |
|TERMINAL (d)           | 12/35 (34%)   6/27 (22%)  13/38 (34%)  11/35 (31%) |  1/33 (3%)    4/32 (13%)   1/32 (3%)    1/24 (4%)  |
|FIRST INCIDENCE (DAYS) |   542          731 (T)      699          672       |   729 (T)      729 (T)      647          673       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.479N     P=0.063N     P=0.330N     P=0.421N   |  P=0.385      P=0.169      P=0.484      P=0.398    |
|INCIDENTAL TUMOR       |  P=0.521N     P=0.040N*    P=0.506N     P=0.391N   |  P=0.428      P=0.169      P=0.464      P=0.427    |
|LOGISTIC REGRESSION    |  P=0.494N     P=0.031N*    P=0.379N     P=0.369N   |  P=0.445      P=0.169      P=0.495      P=0.451    |
|COCHRAN-ARMITAGE       |  P=0.493                                           |  P=0.492                                           |
|FISHER EXACT           |               P=0.012N*    P=0.388N     P=0.388N   |               P=0.181      P=0.500      P=0.492    |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Cystadenoma                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  0/49 (0%)    4/49 (8%)    0/49 (0%)    2/49 (4%)  |
|ADJUSTED (b)           |                                                    |   0.0%        12.5%         0.0%         6.7%      |
|TERMINAL (d)           |                                                    |  0/33 (0%)    4/32 (13%)   0/31 (0%)    1/24 (4%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   ---          729 (T)      ---          604       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.336      P=0.058        (e)        P=0.193    |
|INCIDENTAL TUMOR       |                                                    |  P=0.399      P=0.058        (e)        P=0.308    |
|LOGISTIC REGRESSION    |                                                    |  P=0.395      P=0.058        (e)        P=0.231    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.426                                           |
|FISHER EXACT           |                                                    |               P=0.059        (e)        P=0.247    |
|=================================================================================================================================|
         DATE: 08/21/96                     EXPERIMENT: 89006 TEST: 02                                                 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      500 U        500 U        500 U     |   CONTROL      500 U        500 U        500 U     |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/48 (0%)    0/43 (0%)    0/48 (0%)    1/47 (2%)  |  7/50 (14%)   3/47 (6%)    4/48 (8%)    5/47 (11%) |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         3.1%      |  18.3%         9.4%        10.9%        17.9%      |
|TERMINAL (d)           |  0/35 (0%)    0/24 (0%)    0/38 (0%)    1/32 (3%)  |  4/33 (12%)   3/32 (9%)    2/31 (6%)    3/24 (13%) |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          731 (T)   |   593          729 (T)      436          589       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.194        (e)          (e)        P=0.482    |  P=0.480N     P=0.190N     P=0.299N     P=0.562N   |
|INCIDENTAL TUMOR       |  P=0.194        (e)          (e)        P=0.482    |  P=0.339N     P=0.173N     P=0.233N     P=0.344N   |
|LOGISTIC REGRESSION    |  P=0.194        (e)          (e)        P=0.482    |  P=0.385N     P=0.196N     P=0.285N     P=0.456N   |
|COCHRAN-ARMITAGE       |  P=0.188                                           |  P=0.365N                                          |
|FISHER EXACT           |                 (e)          (e)        P=0.495    |               P=0.185N     P=0.286N     P=0.424N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/48 (0%)    0/43 (0%)    0/48 (0%)    1/47 (2%)  |  8/50 (16%)   3/47 (6%)    4/48 (8%)    5/47 (11%) |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         3.1%      |  20.7%         9.4%        10.9%        17.9%      |
|TERMINAL (d)           |  0/35 (0%)    0/24 (0%)    0/38 (0%)    1/32 (3%)  |  4/33 (12%)   3/32 (9%)    2/31 (6%)    3/24 (13%) |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          731 (T)   |   593          729 (T)      436          589       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.194        (e)          (e)        P=0.482    |  P=0.364N     P=0.129N     P=0.214N     P=0.457N   |
|INCIDENTAL TUMOR       |  P=0.194        (e)          (e)        P=0.482    |  P=0.231N     P=0.149N     P=0.171N     P=0.244N   |
|LOGISTIC REGRESSION    |  P=0.194        (e)          (e)        P=0.482    |  P=0.276N     P=0.130N     P=0.198N     P=0.350N   |
|COCHRAN-ARMITAGE       |  P=0.188                                           |  P=0.258N                                          |
|FISHER EXACT           |                 (e)          (e)        P=0.495    |               P=0.120N     P=0.199N     P=0.318N   |
|=================================================================================================================================|
         DATE: 08/21/96                     EXPERIMENT: 89006 TEST: 02                                                 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      500 U        500 U        500 U     |   CONTROL      500 U        500 U        500 U     |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Intermedia                                                                                                 |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/48 (2%)    0/43 (0%)    0/48 (0%)    0/47 (0%)  |  0/50 (0%)    0/47 (0%)    2/48 (4%)    1/47 (2%)  |
|ADJUSTED (b)           |   2.9%         0.0%         0.0%         0.0%      |   0.0%         0.0%         4.5%         2.8%      |
|TERMINAL (d)           |  1/35 (3%)    0/24 (0%)    0/38 (0%)    0/32 (0%)  |  0/33 (0%)    0/32 (0%)    0/31 (0%)    0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   731 (T)      ---          ---          ---       |   ---          ---          597          617       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.185N     P=0.575N     P=0.484N     P=0.518N   |  P=0.141        (e)        P=0.242      P=0.469    |
|INCIDENTAL TUMOR       |  P=0.185N     P=0.575N     P=0.484N     P=0.518N   |  P=0.301        (e)        P=0.395      P=0.695    |
|LOGISTIC REGRESSION    |  P=0.185N     P=0.575N     P=0.484N     P=0.518N   |  P=0.147        (e)        P=0.226      P=0.492    |
|COCHRAN-ARMITAGE       |  P=0.186N                                          |  P=0.142                                           |
|FISHER EXACT           |               P=0.527N     P=0.500N     P=0.505N   |                 (e)        P=0.237      P=0.485    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Intermedia                                                                                                 |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/48 (2%)    1/43 (2%)    0/48 (0%)    0/47 (0%)  |  0/50 (0%)    0/47 (0%)    2/48 (4%)    1/47 (2%)  |
|ADJUSTED (b)           |   2.9%         2.1%         0.0%         0.0%      |   0.0%         0.0%         4.5%         2.8%      |
|TERMINAL (d)           |  1/35 (3%)    0/24 (0%)    0/38 (0%)    0/32 (0%)  |  0/33 (0%)    0/32 (0%)    0/31 (0%)    0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   731 (T)      296          ---          ---       |   ---          ---          597          617       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.171N     P=0.712      P=0.484N     P=0.518N   |  P=0.141        (e)        P=0.242      P=0.469    |
|INCIDENTAL TUMOR       |  P=0.167N     P=0.678N     P=0.484N     P=0.518N   |  P=0.301        (e)        P=0.395      P=0.695    |
|LOGISTIC REGRESSION    |  P=0.161N     P=0.700N     P=0.484N     P=0.518N   |  P=0.147        (e)        P=0.226      P=0.492    |
|COCHRAN-ARMITAGE       |  P=0.170N                                          |  P=0.142                                           |
|FISHER EXACT           |               P=0.725      P=0.500N     P=0.505N   |                 (e)        P=0.237      P=0.485    |
|=================================================================================================================================|
         DATE: 08/21/96                     EXPERIMENT: 89006 TEST: 02                                                 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      500 U        500 U        500 U     |   CONTROL      500 U        500 U        500 U     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    1/50 (2%)    0/50 (0%)    1/50 (2%)  |  1/50 (2%)    4/50 (8%)    2/50 (4%)    1/49 (2%)  |
|ADJUSTED (b)           |   2.8%         2.3%         0.0%         2.9%      |   2.5%        10.9%         5.7%         2.6%      |
|TERMINAL (d)           |  1/36 (3%)    0/27 (0%)    0/38 (0%)    1/35 (3%)  |  0/33 (0%)    2/32 (6%)    1/32 (3%)    0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   731 (T)      542          ---          731 (T)   |   688          467          656          603       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.482N     P=0.721      P=0.489N     P=0.756    |  P=0.517N     P=0.158      P=0.472      P=0.721    |
|INCIDENTAL TUMOR       |  P=0.552N     P=0.729      P=0.489N     P=0.756    |  P=0.365N     P=0.191      P=0.437      P=0.647N   |
|LOGISTIC REGRESSION    |  P=0.503N     P=0.751N     P=0.489N     P=0.756    |  P=0.446N     P=0.179      P=0.498      P=0.759    |
|COCHRAN-ARMITAGE       |  P=0.500N                                          |  P=0.443N                                          |
|FISHER EXACT           |               P=0.753N     P=0.500N     P=0.753N   |               P=0.181      P=0.500      P=0.747    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    1/50 (2%)    0/50 (0%)    1/50 (2%)  |  1/50 (2%)    4/50 (8%)    2/50 (4%)    1/49 (2%)  |
|ADJUSTED (b)           |   0.0%         2.3%         0.0%         2.9%      |   2.5%        10.9%         5.7%         2.6%      |
|TERMINAL (d)           |  0/36 (0%)    0/27 (0%)    0/38 (0%)    1/35 (3%)  |  0/33 (0%)    2/32 (6%)    1/32 (3%)    0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          542          ---          731 (T)   |   688          467          656          603       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.391      P=0.487        (e)        P=0.494    |  P=0.517N     P=0.158      P=0.472      P=0.721    |
|INCIDENTAL TUMOR       |  P=0.316      P=0.500        (e)        P=0.494    |  P=0.365N     P=0.191      P=0.437      P=0.647N   |
|LOGISTIC REGRESSION    |  P=0.364      P=0.578        (e)        P=0.494    |  P=0.446N     P=0.179      P=0.498      P=0.759    |
|COCHRAN-ARMITAGE       |  P=0.375                                           |  P=0.443N                                          |
|FISHER EXACT           |               P=0.500        (e)        P=0.500    |               P=0.181      P=0.500      P=0.747    |
|=================================================================================================================================|
         DATE: 08/21/96                     EXPERIMENT: 89006 TEST: 02                                                 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      500 U        500 U        500 U     |   CONTROL      500 U        500 U        500 U     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    1/50 (2%)    0/50 (0%)    1/50 (2%)  |  1/50 (2%)    4/50 (8%)    2/50 (4%)    1/49 (2%)  |
|ADJUSTED (b)           |   2.8%         2.3%         0.0%         2.9%      |   2.5%        10.9%         5.7%         2.6%      |
|TERMINAL (d)           |  1/36 (3%)    0/27 (0%)    0/38 (0%)    1/35 (3%)  |  0/33 (0%)    2/32 (6%)    1/32 (3%)    0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   731 (T)      542          ---          731 (T)   |   688          467          656          603       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.482N     P=0.721      P=0.489N     P=0.756    |  P=0.517N     P=0.158      P=0.472      P=0.721    |
|INCIDENTAL TUMOR       |  P=0.552N     P=0.729      P=0.489N     P=0.756    |  P=0.365N     P=0.191      P=0.437      P=0.647N   |
|LOGISTIC REGRESSION    |  P=0.503N     P=0.751N     P=0.489N     P=0.756    |  P=0.446N     P=0.179      P=0.498      P=0.759    |
|COCHRAN-ARMITAGE       |  P=0.500N                                          |  P=0.443N                                          |
|FISHER EXACT           |               P=0.753N     P=0.500N     P=0.753N   |               P=0.181      P=0.500      P=0.747    |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/50 (0%)    0/50 (0%)    2/50 (4%)  |  1/50 (2%)    2/50 (4%)    1/50 (2%)    1/49 (2%)  |
|ADJUSTED (b)           |   2.8%         0.0%         0.0%         5.7%      |   3.0%         6.3%         3.1%         3.0%      |
|TERMINAL (d)           |  1/36 (3%)    0/27 (0%)    0/38 (0%)    2/35 (6%)  |  1/33 (3%)    2/32 (6%)    1/32 (3%)    0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   731 (T)      ---          ---          731 (T)   |   729 (T)      729 (T)      729 (T)      662       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.320      P=0.557N     P=0.489N     P=0.490    |  P=0.578      P=0.489      P=0.755      P=0.700    |
|INCIDENTAL TUMOR       |  P=0.320      P=0.557N     P=0.489N     P=0.490    |  P=0.557N     P=0.489      P=0.755      P=0.725    |
|LOGISTIC REGRESSION    |  P=0.320      P=0.557N     P=0.489N     P=0.490    |  P=0.544N     P=0.489      P=0.755      P=0.743    |
|COCHRAN-ARMITAGE       |  P=0.301                                           |  P=0.506N                                          |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.500    |               P=0.500      P=0.753N     P=0.747    |
|=================================================================================================================================|
         DATE: 08/21/96                     EXPERIMENT: 89006 TEST: 02                                                 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      500 U        500 U        500 U     |   CONTROL      500 U        500 U        500 U     |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/50 (0%)    0/50 (0%)    2/50 (4%)  |  1/50 (2%)    1/50 (2%)    1/50 (2%)    1/49 (2%)  |
|ADJUSTED (b)           |   2.8%         0.0%         0.0%         5.7%      |   3.0%         3.1%         3.1%         3.0%      |
|TERMINAL (d)           |  1/36 (3%)    0/27 (0%)    0/38 (0%)    2/35 (6%)  |  1/33 (3%)    1/32 (3%)    1/32 (3%)    0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   731 (T)      ---          ---          731 (T)   |   729 (T)      729 (T)      729 (T)      662       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.320      P=0.557N     P=0.489N     P=0.490    |  P=0.516      P=0.755      P=0.755      P=0.700    |
|INCIDENTAL TUMOR       |  P=0.320      P=0.557N     P=0.489N     P=0.490    |  P=0.546      P=0.755      P=0.755      P=0.725    |
|LOGISTIC REGRESSION    |  P=0.320      P=0.557N     P=0.489N     P=0.490    |  P=0.556      P=0.755      P=0.755      P=0.743    |
|COCHRAN-ARMITAGE       |  P=0.301                                           |  P=0.584                                           |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.500    |               P=0.753N     P=0.753N     P=0.747    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    2/50 (4%)    0/50 (0%)    1/49 (2%)  |  1/50 (2%)    0/50 (0%)    0/50 (0%)    1/49 (2%)  |
|ADJUSTED (b)           |  11.1%         7.4%         0.0%         2.9%      |   3.0%         0.0%         0.0%         2.8%      |
|TERMINAL (d)           |  4/36 (11%)   2/27 (7%)    0/38 (0%)    1/35 (3%)  |  1/33 (3%)    0/32 (0%)    0/32 (0%)    0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   731 (T)      731 (T)      ---          731 (T)   |   729 (T)      ---          ---          617       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.038N*    P=0.475N     P=0.056N     P=0.187N   |  P=0.586      P=0.506N     P=0.506N     P=0.707    |
|INCIDENTAL TUMOR       |  P=0.038N*    P=0.475N     P=0.056N     P=0.187N   |  P=0.562N     P=0.506N     P=0.506N     P=0.692N   |
|LOGISTIC REGRESSION    |  P=0.038N*    P=0.475N     P=0.056N     P=0.187N   |  P=0.617      P=0.506N     P=0.506N     P=0.752    |
|COCHRAN-ARMITAGE       |  P=0.044N*                                         |  P=0.621                                           |
|FISHER EXACT           |               P=0.339N     P=0.059N     P=0.187N   |               P=0.500N     P=0.500N     P=0.747    |
|=================================================================================================================================|
         DATE: 08/21/96                     EXPERIMENT: 89006 TEST: 02                                                 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      500 U        500 U        500 U     |   CONTROL      500 U        500 U        500 U     |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    2/50 (4%)    0/50 (0%)    1/49 (2%)  |  1/50 (2%)    0/50 (0%)    0/50 (0%)    2/49 (4%)  |
|ADJUSTED (b)           |  11.1%         7.4%         0.0%         2.9%      |   3.0%         0.0%         0.0%         6.8%      |
|TERMINAL (d)           |  4/36 (11%)   2/27 (7%)    0/38 (0%)    1/35 (3%)  |  1/33 (3%)    0/32 (0%)    0/32 (0%)    1/24 (4%)  |
|FIRST INCIDENCE (DAYS) |   731 (T)      731 (T)      ---          731 (T)   |   729 (T)      ---          ---          617       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.038N*    P=0.475N     P=0.056N     P=0.187N   |  P=0.251      P=0.506N     P=0.506N     P=0.409    |
|INCIDENTAL TUMOR       |  P=0.038N*    P=0.475N     P=0.056N     P=0.187N   |  P=0.324      P=0.506N     P=0.506N     P=0.545    |
|LOGISTIC REGRESSION    |  P=0.038N*    P=0.475N     P=0.056N     P=0.187N   |  P=0.286      P=0.506N     P=0.506N     P=0.470    |
|COCHRAN-ARMITAGE       |  P=0.044N*                                         |  P=0.297                                           |
|FISHER EXACT           |               P=0.339N     P=0.059N     P=0.187N   |               P=0.500N     P=0.500N     P=0.492    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  4/50 (8%)    0/50 (0%)    3/50 (6%)    2/49 (4%)  |
|ADJUSTED (b)           |                                                    |  10.7%         0.0%         8.7%         7.4%      |
|TERMINAL (d)           |                                                    |  2/33 (6%)    0/32 (0%)    2/32 (6%)    1/24 (4%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   593          ---          656          699       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.477N     P=0.076N     P=0.518N     P=0.461N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.372N     P=0.076N     P=0.497N     P=0.330N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.415N     P=0.067N     P=0.504N     P=0.382N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.388N                                          |
|FISHER EXACT           |                                                    |               P=0.059N     P=0.500N     P=0.349N   |
|=================================================================================================================================|
         DATE: 08/21/96                     EXPERIMENT: 89006 TEST: 02                                                 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      500 U        500 U        500 U     |   CONTROL      500 U        500 U        500 U     |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  4/50 (8%)    0/50 (0%)    3/50 (6%)    3/49 (6%)  |
|ADJUSTED (b)           |                                                    |  10.7%         0.0%         8.7%        10.9%      |
|TERMINAL (d)           |                                                    |  2/33 (6%)    0/32 (0%)    2/32 (6%)    1/24 (4%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   593          ---          656          699       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.454      P=0.076N     P=0.518N     P=0.633N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.535N     P=0.076N     P=0.497N     P=0.496N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.516      P=0.067N     P=0.504N     P=0.559N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.549                                           |
|FISHER EXACT           |                                                    |               P=0.059N     P=0.500N     P=0.511N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Vagina                                                                                                                           |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  0/50 (0%)    0/50 (0%)    5/50 (10%)   6/49 (12%) |
|ADJUSTED (b)           |                                                    |   0.0%         0.0%        15.6%        21.1%      |
|TERMINAL (d)           |                                                    |  0/33 (0%)    0/32 (0%)    5/32 (16%)   3/24 (13%) |
|FIRST INCIDENCE (DAYS) |                                                    |   ---          ---          729 (T)      631       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P<0.001 **     (e)        P=0.030 *    P=0.008 ** |
|INCIDENTAL TUMOR       |                                                    |  P<0.001 **     (e)        P=0.030 *    P=0.017 *  |
|LOGISTIC REGRESSION    |                                                    |  P<0.001 **     (e)        P=0.030 *    P=0.011 *  |
|COCHRAN-ARMITAGE       |                                                    |  P=0.001 **                                        |
|FISHER EXACT           |                                                    |                 (e)        P=0.028 *    P=0.012 *  |
|=================================================================================================================================|
         DATE: 08/21/96                     EXPERIMENT: 89006 TEST: 02                                                 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      500 U        500 U        500 U     |   CONTROL      500 U        500 U        500 U     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    6/50 (12%)   5/50 (10%)   4/50 (8%)  |  0/50 (0%)    0/50 (0%)    2/50 (4%)    2/49 (4%)  |
|ADJUSTED (b)           |   7.5%        18.7%        12.7%        10.1%      |   0.0%         0.0%         6.3%         6.6%      |
|TERMINAL (d)           |  1/36 (3%)    3/27 (11%)   4/38 (11%)   2/35 (6%)  |  0/33 (0%)    0/32 (0%)    2/32 (6%)    1/24 (4%)  |
|FIRST INCIDENCE (DAYS) |   675          624          685          638       |   ---          ---          729 (T)      597       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.497      P=0.145      P=0.381      P=0.487    |  P=0.038 *      (e)        P=0.231      P=0.198    |
|INCIDENTAL TUMOR       |  P=0.489      P=0.285      P=0.262      P=0.577    |  P=0.053        (e)        P=0.231      P=0.308    |
|LOGISTIC REGRESSION    |  P=0.532N     P=0.191      P=0.355      P=0.502    |  P=0.050 *      (e)        P=0.231      P=0.227    |
|COCHRAN-ARMITAGE       |  P=0.456                                           |  P=0.055                                           |
|FISHER EXACT           |               P=0.243      P=0.357      P=0.500    |                 (e)        P=0.247      P=0.242    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    6/50 (12%)   5/50 (10%)   4/50 (8%)  |  1/50 (2%)    0/50 (0%)    2/50 (4%)    2/49 (4%)  |
|ADJUSTED (b)           |   7.5%        18.7%        12.7%        10.1%      |   2.9%         0.0%         6.3%         6.6%      |
|TERMINAL (d)           |  1/36 (3%)    3/27 (11%)   4/38 (11%)   2/35 (6%)  |  0/33 (0%)    0/32 (0%)    2/32 (6%)    1/24 (4%)  |
|FIRST INCIDENCE (DAYS) |   675          624          685          638       |   710          ---          729 (T)      597       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.497      P=0.145      P=0.381      P=0.487    |  P=0.160      P=0.518N     P=0.486      P=0.430    |
|INCIDENTAL TUMOR       |  P=0.489      P=0.285      P=0.262      P=0.577    |  P=0.226      P=0.795N     P=0.464      P=0.582    |
|LOGISTIC REGRESSION    |  P=0.532N     P=0.191      P=0.355      P=0.502    |  P=0.189      P=0.518N     P=0.477      P=0.478    |
|COCHRAN-ARMITAGE       |  P=0.456                                           |  P=0.204                                           |
|FISHER EXACT           |               P=0.243      P=0.357      P=0.500    |               P=0.500N     P=0.500      P=0.492    |
|=================================================================================================================================|
         DATE: 08/21/96                     EXPERIMENT: 89006 TEST: 02                                                 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      500 U        500 U        500 U     |   CONTROL      500 U        500 U        500 U     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Histiocytic Sarcoma                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    2/50 (4%)    0/50 (0%)    0/50 (0%)  |  3/50 (6%)    3/50 (6%)    1/50 (2%)    0/49 (0%)  |
|ADJUSTED (b)           |   4.7%         4.6%         0.0%         0.0%      |   7.8%         8.0%         2.5%         0.0%      |
|TERMINAL (d)           |  0/36 (0%)    0/27 (0%)    0/38 (0%)    0/35 (0%)  |  1/33 (3%)    1/32 (3%)    0/32 (0%)    0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   600          518          ---          ---       |   675          561          634          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.057N     P=0.644      P=0.240N     P=0.248N   |  P=0.064N     P=0.606      P=0.339N     P=0.179N   |
|INCIDENTAL TUMOR       |  P=0.052N     P=0.472N     P=0.191N     P=0.154N   |  P=0.018N*    P=0.567      P=0.290N     P=0.138N   |
|LOGISTIC REGRESSION    |  P=0.055N     P=0.626N     P=0.224N     P=0.261N   |  P=0.045N*    P=0.658      P=0.216N     P=0.137N   |
|COCHRAN-ARMITAGE       |  P=0.057N                                          |  P=0.044N*                                         |
|FISHER EXACT           |               P=0.691N     P=0.247N     P=0.247N   |               P=0.661N     P=0.309N     P=0.125N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated                                               |
|     Cell Type                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/50 (14%)   8/50 (16%)   5/50 (10%)   6/50 (12%) | 13/50 (26%)   8/50 (16%)  12/50 (24%)  11/49 (22%) |
|ADJUSTED (b)           |  18.8%        25.2%        12.5%        15.6%      |  34.6%        19.6%        32.5%        34.9%      |
|TERMINAL (d)           |  6/36 (17%)   5/27 (19%)   4/38 (11%)   4/35 (11%) |  9/33 (27%)   2/32 (6%)    8/32 (25%)   5/24 (21%) |
|FIRST INCIDENCE (DAYS) |   716          579          624          522       |   675          441          514          604       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.278N     P=0.290      P=0.345N     P=0.517N   |  P=0.365      P=0.232N     P=0.547N     P=0.477    |
|INCIDENTAL TUMOR       |  P=0.296N     P=0.421      P=0.330N     P=0.518N   |  P=0.446N     P=0.214N     P=0.544N     P=0.472N   |
|LOGISTIC REGRESSION    |  P=0.292N     P=0.383      P=0.374N     P=0.492N   |  P=0.528      P=0.177N     P=0.525N     P=0.551N   |
|COCHRAN-ARMITAGE       |  P=0.319N                                          |  P=0.490N                                          |
|FISHER EXACT           |               P=0.500      P=0.380N     P=0.500N   |               P=0.163N     P=0.500N     P=0.430N   |
|=================================================================================================================================|
         DATE: 08/21/96                     EXPERIMENT: 89006 TEST: 02                                                 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      500 U        500 U        500 U     |   CONTROL      500 U        500 U        500 U     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 26/50 (52%)  20/50 (40%)  26/50 (52%)  30/50 (60%) | 23/50 (46%)  25/50 (50%)  23/50 (46%)  20/49 (41%) |
|ADJUSTED (b)           |  63.0%        58.4%        64.8%        76.8%      |  57.2%        75.7%        59.8%        61.1%      |
|TERMINAL (d)           | 21/36 (58%)  13/27 (48%)  24/38 (63%)  26/35 (74%) | 16/33 (48%)  24/32 (75%)  17/32 (53%)  12/24 (50%) |
|FIRST INCIDENCE (DAYS) |   477          518          563          638       |   593          667          436          589       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.243      P=0.569      P=0.478N     P=0.230    |  P=0.352      P=0.329      P=0.516      P=0.366    |
|INCIDENTAL TUMOR       |  P=0.187      P=0.354N     P=0.583      P=0.281    |  P=0.420N     P=0.137      P=0.579N     P=0.450N   |
|LOGISTIC REGRESSION    |  P=0.207      P=0.341N     P=0.582N     P=0.283    |  P=0.437N     P=0.180      P=0.559      P=0.539N   |
|COCHRAN-ARMITAGE       |  P=0.141                                           |  P=0.291N                                          |
|FISHER EXACT           |               P=0.158N     P=0.579N     P=0.273    |               P=0.421      P=0.579N     P=0.376N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 30/50 (60%)  33/50 (66%)  29/50 (58%)  33/50 (66%) | 23/50 (46%)  23/50 (46%)  28/50 (56%)  28/49 (57%) |
|ADJUSTED (b)           |  63.7%        74.2%        64.3%        67.3%      |  57.2%        52.9%        64.9%        71.3%      |
|TERMINAL (d)           | 19/36 (53%)  16/27 (59%)  22/38 (58%)  19/35 (54%) | 16/33 (48%)  12/32 (38%)  17/32 (53%)  13/24 (54%) |
|FIRST INCIDENCE (DAYS) |   374          296          598          522       |   649          441          436          589       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.484N     P=0.081      P=0.418N     P=0.347    |  P=0.025 *    P=0.461      P=0.190      P=0.036 *  |
|INCIDENTAL TUMOR       |  P=0.402      P=0.421      P=0.520      P=0.431    |  P=0.130      P=0.474      P=0.131      P=0.151    |
|LOGISTIC REGRESSION    |  P=0.401      P=0.313      P=0.529N     P=0.446    |  P=0.081      P=0.521      P=0.190      P=0.135    |
|COCHRAN-ARMITAGE       |  P=0.397                                           |  P=0.096                                           |
|FISHER EXACT           |               P=0.339      P=0.500N     P=0.339    |               P=0.579N     P=0.212      P=0.182    |
|=================================================================================================================================|
         DATE: 08/21/96                     EXPERIMENT: 89006 TEST: 02                                                 PAGE  19
                       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      500 U        500 U        500 U     |   CONTROL      500 U        500 U        500 U     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 40/50 (80%)  41/50 (82%)  42/50 (84%)  47/50 (94%) | 35/50 (70%)  39/50 (78%)  38/50 (76%)  36/49 (73%) |
|ADJUSTED (b)           |  83.3%        89.1%        89.4%        95.9%      |  81.3%        90.6%        84.4%        89.9%      |
|TERMINAL (d)           | 28/36 (78%)  22/27 (81%)  33/38 (87%)  33/35 (94%) | 25/33 (76%)  28/32 (88%)  25/32 (78%)  20/24 (83%) |
|FIRST INCIDENCE (DAYS) |   374          296          563          522       |   593          441          436          589       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.272      P=0.064      P=0.559      P=0.121    |  P=0.059      P=0.178      P=0.280      P=0.052    |
|INCIDENTAL TUMOR       |  P=0.038 *    P=0.426      P=0.238      P=0.060    |  P=0.371      P=0.104      P=0.288      P=0.277    |
|LOGISTIC REGRESSION    |  P=0.044 *    P=0.293      P=0.311      P=0.043 *  |  P=0.232      P=0.110      P=0.295      P=0.160    |
|COCHRAN-ARMITAGE       |  P=0.031 *                                         |  P=0.407                                           |
|FISHER EXACT           |               P=0.500      P=0.398      P=0.036 *  |               P=0.247      P=0.326      P=0.437    |
|=================================================================================================================================|

 (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).
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.