TDMS Study 89006-08 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst INTERFERON A/INTERFERON AD DATE: 12/30/96 EXPERIMENT: 89006 TEST: 08 TIME: 17:10:48 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-85225 ROUTE: SUBCUTANEOUS NTP C#: C89001 PATHOLOGIST: MISSING CAS: 76543-88-9 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst INTERFERON A/INTERFERON AD DATE: 12/30/96 EXPERIMENT: 89006 TEST: 08 TIME: 17:10:48 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-85225 ROUTE: SUBCUTANEOUS NTP C#: C89001 PATHOLOGIST: MISSING CAS: 76543-88-9 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 INTERFERON A/INTERFERON AD DATE: 12/30/96 EXPERIMENT: 89006 TEST: 08 TIME: 17:10:48 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-85225 ROUTE: SUBCUTANEOUS NTP C#: C89001 PATHOLOGIST: MISSING CAS: 76543-88-9 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF 9 INTERFERON A/INTERFERON AD ==================================================================================================== MALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Spleen Hemangiosarcoma All Organs Malignant and Benign Tumors ==================================================================================================== FEMALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma ==================================================================================================== DATE: 12/30/96 EXPERIMENT: 89006 TEST: 08 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 9 INTERFERON A/INTERFERON AD MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 500 U 5000 U 5000 U A | VEHICLE 500 U 5000 U 5000 U A | | | CONTROL A/D A/D | CONTROL A/D A/D | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/49 (2%) 4/50 (8%) 3/49 (6%) | 1/50 (2%) 1/49 (2%) 0/50 (0%) 0/49 (0%) | |ADJUSTED (b) | 3.7% 3.6% 12.8% 10.9% | 3.3% 2.4% 0.0% 0.0% | |TERMINAL (d) | 1/27 (4%) 1/28 (4%) 3/28 (11%) 2/26 (8%) | 0/25 (0%) 0/32 (0%) 0/25 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | 728 (T) 728 (T) 572 723 | 699 685 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.381 P=0.754N P=0.185 P=0.302 | P=0.462N P=0.706N P=0.521N P=0.464N | |INCIDENTAL TUMOR | P=0.385 P=0.754N P=0.201 P=0.304 | P=0.698N P=0.670 P=0.550N P=0.718N | |LOGISTIC REGRESSION | P=0.419 P=0.754N P=0.170 P=0.312 | P=0.489N P=0.759 P=0.511N P=0.507N | |COCHRAN-ARMITAGE | P=0.397 | P=0.487N | |FISHER EXACT | P=0.747 P=0.181 P=0.301 | P=0.747 P=0.500N P=0.505N | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 2/49 (4%) 0/50 (0%) 1/49 (2%) | 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/49 (0%) | |ADJUSTED (b) | 2.9% 6.8% 0.0% 3.8% | 0.0% 0.0% 4.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 1/28 (4%) 0/28 (0%) 1/26 (4%) | 0/25 (0%) 0/32 (0%) 1/25 (4%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | 673 667 --- 728 (T) | --- --- 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.699N P=0.462 P=0.512N P=0.759 | P=0.707N (e) P=0.500 (e) | |INCIDENTAL TUMOR | P=0.634N P=0.386 P=0.571N P=0.745N | P=0.707N (e) P=0.500 (e) | |LOGISTIC REGRESSION | P=0.698N P=0.491 P=0.496N P=0.761N | P=0.707N (e) P=0.500 (e) | |COCHRAN-ARMITAGE | P=0.709N | P=0.728N | |FISHER EXACT | P=0.500 P=0.495N P=0.753N | (e) P=0.500 (e) | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 89006 TEST: 08 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 9 INTERFERON A/INTERFERON AD MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 500 U 5000 U 5000 U A | VEHICLE 500 U 5000 U 5000 U A | | | CONTROL A/D A/D | CONTROL A/D A/D | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 2/49 (4%) 0/50 (0%) 1/49 (2%) | 1/50 (2%) 0/49 (0%) 2/50 (4%) 0/49 (0%) | |ADJUSTED (b) | 2.9% 6.8% 0.0% 3.8% | 2.0% 0.0% 6.7% 0.0% | |TERMINAL (d) | 0/27 (0%) 1/28 (4%) 0/28 (0%) 1/26 (4%) | 0/25 (0%) 0/32 (0%) 1/25 (4%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | 673 667 --- 728 (T) | 409 --- 659 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.699N P=0.462 P=0.512N P=0.759 | P=0.374N P=0.496N P=0.486 P=0.500N | |INCIDENTAL TUMOR | P=0.634N P=0.386 P=0.571N P=0.745N | P=0.343N P=0.638N P=0.393 P=0.419N | |LOGISTIC REGRESSION | P=0.698N P=0.491 P=0.496N P=0.761N | P=0.374N P=0.946N P=0.561 P=0.335N | |COCHRAN-ARMITAGE | P=0.709N | P=0.380N | |FISHER EXACT | P=0.500 P=0.495N P=0.753N | P=0.505N P=0.500 P=0.505N | |=================================================================================================================================| | | |Bone Marrow | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 5.4% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/28 (0%) 0/28 (0%) 0/27 (0%) | 0/25 (0%) 0/32 (0%) 0/25 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | --- 615 --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.474N P=0.215 (e) (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.579N P=0.280 (e) (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.514N P=0.259 (e) (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.485N | (e) | |FISHER EXACT | P=0.247 (e) (e) | (e) (e) (e) | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 89006 TEST: 08 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 9 INTERFERON A/INTERFERON AD MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 500 U 5000 U 5000 U A | VEHICLE 500 U 5000 U 5000 U A | | | CONTROL A/D A/D | CONTROL A/D A/D | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 5/50 (10%) 4/50 (8%) 3/50 (6%) | 2/50 (4%) 5/50 (10%) 3/50 (6%) 3/50 (6%) | |ADJUSTED (b) | 7.4% 17.0% 12.8% 9.5% | 8.0% 15.6% 10.9% 8.9% | |TERMINAL (d) | 2/27 (7%) 4/28 (14%) 3/28 (11%) 2/27 (7%) | 2/25 (8%) 5/32 (16%) 2/25 (8%) 2/31 (6%) | |FIRST INCIDENCE (DAYS) | 728 (T) 661 583 567 | 729 (T) 729 (T) 672 642 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.510N P=0.220 P=0.345 P=0.496 | P=0.499N P=0.323 P=0.487 P=0.567 | |INCIDENTAL TUMOR | P=0.526N P=0.193 P=0.366 P=0.477 | P=0.495N P=0.323 P=0.477 P=0.648 | |LOGISTIC REGRESSION | P=0.471N P=0.190 P=0.321 P=0.505 | P=0.556N P=0.323 P=0.467 P=0.503 | |COCHRAN-ARMITAGE | P=0.501N | P=0.562N | |FISHER EXACT | P=0.218 P=0.339 P=0.500 | P=0.218 P=0.500 P=0.500 | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 5.6% 3.6% 3.6% 2.5% | 3.0% 5.2% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 1/28 (4%) 1/28 (4%) 0/27 (0%) | 0/25 (0%) 1/32 (3%) 0/25 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 671 728 (T) 728 (T) 640 | 681 610 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.573N P=0.542N P=0.513N P=0.491N | P=0.345N P=0.564 P=0.519N P=0.477N | |INCIDENTAL TUMOR | P=0.558N P=0.635N P=0.601N P=0.509N | P=0.341N P=0.491 P=0.550N P=0.718N | |LOGISTIC REGRESSION | P=0.586N P=0.513N P=0.509N P=0.508N | P=0.352N P=0.469 P=0.505N P=0.500N | |COCHRAN-ARMITAGE | P=0.596N | P=0.352N | |FISHER EXACT | P=0.500N P=0.500N P=0.500N | P=0.500 P=0.500N P=0.500N | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 89006 TEST: 08 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 9 INTERFERON A/INTERFERON AD MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 500 U 5000 U 5000 U A | VEHICLE 500 U 5000 U 5000 U A | | | CONTROL A/D A/D | CONTROL A/D A/D | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 6/50 (12%) 5/50 (10%) 4/50 (8%) | 3/50 (6%) 7/50 (14%) 3/50 (6%) 3/50 (6%) | |ADJUSTED (b) | 12.6% 20.4% 16.3% 11.8% | 10.8% 20.5% 10.9% 8.9% | |TERMINAL (d) | 2/27 (7%) 5/28 (18%) 4/28 (14%) 2/27 (7%) | 2/25 (8%) 6/32 (19%) 2/25 (8%) 2/31 (6%) | |FIRST INCIDENCE (DAYS) | 671 661 583 567 | 681 610 672 642 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.440N P=0.353 P=0.500 P=0.638N | P=0.319N P=0.266 P=0.643 P=0.595N | |INCIDENTAL TUMOR | P=0.445N P=0.275 P=0.467 P=0.620 | P=0.314N P=0.232 P=0.624 P=0.617N | |LOGISTIC REGRESSION | P=0.413N P=0.328 P=0.480 P=0.643N | P=0.381N P=0.195 P=0.632 P=0.661 | |COCHRAN-ARMITAGE | P=0.443N | P=0.373N | |FISHER EXACT | P=0.370 P=0.500 P=0.643N | P=0.159 P=0.661N P=0.661N | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 4/50 (8%) 4/50 (8%) 4/50 (8%) | 0/49 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | |ADJUSTED (b) | 11.5% 11.6% 11.5% 11.7% | 0.0% 2.7% 3.0% 3.2% | |TERMINAL (d) | 1/27 (4%) 1/28 (4%) 2/28 (7%) 2/27 (7%) | 0/25 (0%) 0/32 (0%) 0/25 (0%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | 503 615 571 532 | --- 701 667 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.598N P=0.609 P=0.630 P=0.629N | P=0.642 P=0.549 P=0.467 P=0.543 | |INCIDENTAL TUMOR | P=0.599N P=0.589 P=0.616 P=0.586N | P=0.497 P=0.446 P=0.461 P=0.543 | |LOGISTIC REGRESSION | P=0.595 P=0.624N P=0.625N P=0.630 | P=0.621 P=0.510 P=0.505 P=0.543 | |COCHRAN-ARMITAGE | P=0.616 | P=0.624 | |FISHER EXACT | P=0.643N P=0.643N P=0.643N | P=0.505 P=0.505 P=0.505 | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 89006 TEST: 08 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 9 INTERFERON A/INTERFERON AD MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 500 U 5000 U 5000 U A | VEHICLE 500 U 5000 U 5000 U A | | | CONTROL A/D A/D | CONTROL A/D A/D | |=================================================================================================================================| | | |Liver | | Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 3/50 (6%) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 5.8% 3.4% 3.6% 10.6% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/27 (4%) 0/28 (0%) 1/28 (4%) 2/27 (7%) | 0/25 (0%) 0/32 (0%) 0/25 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 566 720 728 (T) 723 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.257 P=0.503N P=0.499N P=0.503 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.280 P=0.541N P=0.468N P=0.485 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.272 P=0.499N P=0.501N P=0.505 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.253 | (e) | |FISHER EXACT | P=0.500N P=0.500N P=0.500 | (e) (e) (e) | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 14/50 (28%) 14/50 (28%) 16/50 (32%) 19/50 (38%) | 24/49 (49%) 25/50 (50%) 22/50 (44%) 22/50 (44%) | |ADJUSTED (b) | 43.3% 45.5% 48.3% 55.6% | 73.8% 65.1% 63.0% 59.2% | |TERMINAL (d) | 10/27 (37%) 12/28 (43%) 12/28 (43%) 13/27 (48%) | 17/25 (68%) 19/32 (59%) 13/25 (52%) 16/31 (52%) | |FIRST INCIDENCE (DAYS) | 503 540 556 547 | 597 553 506 575 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.157 P=0.579N P=0.430 P=0.208 | P=0.227N P=0.249N P=0.476N P=0.168N | |INCIDENTAL TUMOR | P=0.137 P=0.545N P=0.424 P=0.187 | P=0.423N P=0.409N P=0.443N P=0.420N | |LOGISTIC REGRESSION | P=0.203 P=0.521 P=0.374 P=0.205 | P=0.429N P=0.456N P=0.492N P=0.394N | |COCHRAN-ARMITAGE | P=0.163 | P=0.382N | |FISHER EXACT | P=0.588N P=0.414 P=0.198 | P=0.540 P=0.384N P=0.384N | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 89006 TEST: 08 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 9 INTERFERON A/INTERFERON AD MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 500 U 5000 U 5000 U A | VEHICLE 500 U 5000 U 5000 U A | | | CONTROL A/D A/D | CONTROL A/D A/D | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 18/50 (36%) 23/50 (46%) 14/50 (28%) 19/50 (38%) | 16/49 (33%) 12/50 (24%) 13/50 (26%) 18/50 (36%) | |ADJUSTED (b) | 45.4% 57.3% 40.8% 47.2% | 42.9% 34.8% 43.8% 47.5% | |TERMINAL (d) | 7/27 (26%) 12/28 (43%) 9/28 (32%) 8/27 (30%) | 7/25 (28%) 10/32 (31%) 9/25 (36%) 12/31 (39%) | |FIRST INCIDENCE (DAYS) | 586 405 585 524 | 533 645 581 563 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.545 P=0.200 P=0.308N P=0.519 | P=0.262 P=0.121N P=0.384N P=0.564 | |INCIDENTAL TUMOR | P=0.532N P=0.135 P=0.331N P=0.520 | P=0.186 P=0.208N P=0.362N P=0.475 | |LOGISTIC REGRESSION | P=0.510 P=0.218 P=0.453N P=0.469 | P=0.152 P=0.212N P=0.360N P=0.431 | |COCHRAN-ARMITAGE | P=0.513 | P=0.171 | |FISHER EXACT | P=0.208 P=0.260N P=0.500 | P=0.232N P=0.306N P=0.445 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 20/50 (40%) 24/50 (48%) 15/50 (30%) 21/50 (42%) | 16/49 (33%) 12/50 (24%) 13/50 (26%) 18/50 (36%) | |ADJUSTED (b) | 49.2% 58.7% 43.9% 51.7% | 42.9% 34.8% 43.8% 47.5% | |TERMINAL (d) | 8/27 (30%) 12/28 (43%) 10/28 (36%) 9/27 (33%) | 7/25 (28%) 10/32 (31%) 9/25 (36%) 12/31 (39%) | |FIRST INCIDENCE (DAYS) | 566 405 585 524 | 533 645 581 563 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.490 P=0.257 P=0.251N P=0.519 | P=0.262 P=0.121N P=0.384N P=0.564 | |INCIDENTAL TUMOR | P=0.546 P=0.176 P=0.252N P=0.513 | P=0.186 P=0.208N P=0.362N P=0.475 | |LOGISTIC REGRESSION | P=0.451 P=0.284 P=0.329N P=0.486 | P=0.152 P=0.212N P=0.360N P=0.431 | |COCHRAN-ARMITAGE | P=0.448 | P=0.171 | |FISHER EXACT | P=0.273 P=0.201N P=0.500 | P=0.232N P=0.306N P=0.445 | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 89006 TEST: 08 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 9 INTERFERON A/INTERFERON AD MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 500 U 5000 U 5000 U A | VEHICLE 500 U 5000 U 5000 U A | | | CONTROL A/D A/D | CONTROL A/D A/D | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 28/50 (56%) 30/50 (60%) 26/50 (52%) 33/50 (66%) | 33/49 (67%) 31/50 (62%) 29/50 (58%) 34/50 (68%) | |ADJUSTED (b) | 67.1% 73.9% 70.9% 79.4% | 86.1% 77.1% 75.7% 82.8% | |TERMINAL (d) | 14/27 (52%) 18/28 (64%) 18/28 (64%) 19/27 (70%) | 20/25 (80%) 23/32 (72%) 16/25 (64%) 24/31 (77%) | |FIRST INCIDENCE (DAYS) | 503 405 556 524 | 533 553 506 563 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.212 P=0.386 P=0.447N P=0.282 | P=0.542 P=0.082N P=0.376N P=0.293N | |INCIDENTAL TUMOR | P=0.168 P=0.357 P=0.463N P=0.216 | P=0.204 P=0.212N P=0.344N P=0.459 | |LOGISTIC REGRESSION | P=0.166 P=0.404 P=0.469N P=0.209 | P=0.213 P=0.221N P=0.328N P=0.478 | |COCHRAN-ARMITAGE | P=0.144 | P=0.300 | |FISHER EXACT | P=0.420 P=0.421N P=0.206 | P=0.365N P=0.226N P=0.558 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 30/50 (60%) 31/50 (62%) 26/50 (52%) 34/50 (68%) | 33/49 (67%) 31/50 (62%) 29/50 (58%) 34/50 (68%) | |ADJUSTED (b) | 70.3% 74.8% 70.9% 80.1% | 86.1% 77.1% 75.7% 82.8% | |TERMINAL (d) | 15/27 (56%) 18/28 (64%) 18/28 (64%) 19/27 (70%) | 20/25 (80%) 23/32 (72%) 16/25 (64%) 24/31 (77%) | |FIRST INCIDENCE (DAYS) | 503 405 556 524 | 533 553 506 563 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.220 P=0.448 P=0.322N P=0.341 | P=0.542 P=0.082N P=0.376N P=0.293N | |INCIDENTAL TUMOR | P=0.176 P=0.421 P=0.299N P=0.270 | P=0.204 P=0.212N P=0.344N P=0.459 | |LOGISTIC REGRESSION | P=0.167 P=0.484 P=0.311N P=0.269 | P=0.213 P=0.221N P=0.328N P=0.478 | |COCHRAN-ARMITAGE | P=0.144 | P=0.300 | |FISHER EXACT | P=0.500 P=0.273N P=0.266 | P=0.365N P=0.226N P=0.558 | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 89006 TEST: 08 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 9 INTERFERON A/INTERFERON AD MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 500 U 5000 U 5000 U A | VEHICLE 500 U 5000 U 5000 U A | | | CONTROL A/D A/D | CONTROL A/D A/D | |=================================================================================================================================| | | |Liver | | Hepatocholangiocarcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 3.3% 0.0% 2.0% 6.1% | 4.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/28 (0%) 0/28 (0%) 1/27 (4%) | 1/25 (4%) 0/32 (0%) 0/25 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 700 --- 435 609 | 729 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.288 P=0.507N P=0.757 P=0.507 | P=0.679N P=0.451N P=0.500N P=0.457N | |INCIDENTAL TUMOR | P=0.287 P=0.621N P=0.711 P=0.481 | P=0.679N P=0.451N P=0.500N P=0.457N | |LOGISTIC REGRESSION | P=0.231 P=0.510N P=0.713N P=0.499 | P=0.679N P=0.451N P=0.500N P=0.457N | |COCHRAN-ARMITAGE | P=0.274 | P=0.703N | |FISHER EXACT | P=0.500N P=0.753N P=0.500 | P=0.495N P=0.495N P=0.495N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 9/50 (18%) 11/50 (22%) 9/50 (18%) 6/50 (12%) | 0/50 (0%) 5/50 (10%) 4/50 (8%) 3/50 (6%) | |ADJUSTED (b) | 30.1% 31.6% 29.6% 20.5% | 0.0% 14.4% 14.0% 7.8% | |TERMINAL (d) | 7/27 (26%) 6/28 (21%) 7/28 (25%) 5/27 (19%) | 0/25 (0%) 3/32 (9%) 3/25 (12%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | 603 540 656 591 | --- 698 581 601 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.166N P=0.391 P=0.590N P=0.287N | P=0.593N P=0.061 P=0.062 P=0.128 | |INCIDENTAL TUMOR | P=0.157N P=0.392 P=0.573 P=0.305N | P=0.565N P=0.035 * P=0.081 P=0.241 | |LOGISTIC REGRESSION | P=0.135N P=0.364 P=0.577 P=0.270N | P=0.619 P=0.047 * P=0.057 P=0.127 | |COCHRAN-ARMITAGE | P=0.164N | P=0.624 | |FISHER EXACT | P=0.402 P=0.602N P=0.288N | P=0.028 * P=0.059 P=0.121 | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 89006 TEST: 08 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 9 INTERFERON A/INTERFERON AD MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 500 U 5000 U 5000 U A | VEHICLE 500 U 5000 U 5000 U A | | | CONTROL A/D A/D | CONTROL A/D A/D | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 4/50 (8%) 3/50 (6%) 3/50 (6%) | 2/50 (4%) 4/50 (8%) 0/50 (0%) 7/50 (14%) | |ADJUSTED (b) | 15.4% 12.5% 10.0% 9.5% | 7.3% 10.3% 0.0% 19.2% | |TERMINAL (d) | 3/27 (11%) 2/28 (7%) 2/28 (7%) 2/27 (7%) | 1/25 (4%) 2/32 (6%) 0/25 (0%) 3/31 (10%) | |FIRST INCIDENCE (DAYS) | 469 622 689 567 | 708 483 --- 612 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.423N P=0.517N P=0.348N P=0.358N | P=0.029 * P=0.437 P=0.248N P=0.133 | |INCIDENTAL TUMOR | P=0.409N P=0.520N P=0.406N P=0.350N | P=0.009 ** P=0.294 P=0.267N P=0.027 * | |LOGISTIC REGRESSION | P=0.420N P=0.501N P=0.366N P=0.363N | P=0.016 * P=0.302 P=0.253N P=0.078 | |COCHRAN-ARMITAGE | P=0.430N | P=0.017 * | |FISHER EXACT | P=0.500N P=0.357N P=0.357N | P=0.339 P=0.247N P=0.080 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/50 (26%) 12/50 (24%) 11/50 (22%) 9/50 (18%) | 2/50 (4%) 9/50 (18%) 4/50 (8%) 9/50 (18%) | |ADJUSTED (b) | 40.1% 34.7% 35.0% 29.3% | 7.3% 23.8% 14.0% 23.9% | |TERMINAL (d) | 9/27 (33%) 7/28 (25%) 8/28 (29%) 7/27 (26%) | 1/25 (4%) 5/32 (16%) 3/25 (12%) 4/31 (13%) | |FIRST INCIDENCE (DAYS) | 469 540 656 567 | 708 483 581 601 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.245N P=0.516N P=0.393N P=0.237N | P=0.159 P=0.069 P=0.330 P=0.054 | |INCIDENTAL TUMOR | P=0.224N P=0.508N P=0.472N P=0.244N | P=0.096 P=0.023 * P=0.360 P=0.012 * | |LOGISTIC REGRESSION | P=0.206N P=0.532N P=0.445N P=0.226N | P=0.100 P=0.028 * P=0.311 P=0.026 * | |COCHRAN-ARMITAGE | P=0.243N | P=0.105 | |FISHER EXACT | P=0.500N P=0.408N P=0.235N | P=0.026 * P=0.339 P=0.026 * | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 89006 TEST: 08 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 9 INTERFERON A/INTERFERON AD MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 500 U 5000 U 5000 U A | VEHICLE 500 U 5000 U 5000 U A | | | CONTROL A/D A/D | CONTROL A/D A/D | |=================================================================================================================================| | | |Ovary | | Cystadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 4/46 (9%) 2/48 (4%) 0/49 (0%) 1/48 (2%) | |ADJUSTED (b) | | 16.1% 4.8% 0.0% 3.4% | |TERMINAL (d) | | 3/22 (14%) 0/32 (0%) 0/25 (0%) 1/29 (3%) | |FIRST INCIDENCE (DAYS) | | 675 685 --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.361N P=0.213N P=0.055N P=0.117N | |INCIDENTAL TUMOR | | P=0.497N P=0.360N P=0.061N P=0.165N | |LOGISTIC REGRESSION | | P=0.397N P=0.290N P=0.060N P=0.153N | |COCHRAN-ARMITAGE | | P=0.387N | |FISHER EXACT | | P=0.318N P=0.051N P=0.168N | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/45 (0%) 0/47 (0%) 0/47 (0%) 0/41 (0%) | 11/46 (24%) 8/47 (17%) 7/44 (16%) 5/43 (12%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 38.9% 23.9% 31.8% 16.7% | |TERMINAL (d) | 0/25 (0%) 0/28 (0%) 0/27 (0%) 0/20 (0%) | 9/25 (36%) 5/29 (17%) 7/22 (32%) 4/27 (15%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 638 687 729 (T) 563 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.118N P=0.193N P=0.300N P=0.069N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.157N P=0.239N P=0.270N P=0.053N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.207N P=0.226N P=0.338N P=0.131N | |COCHRAN-ARMITAGE | (e) | P=0.183N | |FISHER EXACT | (e) (e) (e) | P=0.286N P=0.247N P=0.108N | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 89006 TEST: 08 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 9 INTERFERON A/INTERFERON AD MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 500 U 5000 U 5000 U A | VEHICLE 500 U 5000 U 5000 U A | | | CONTROL A/D A/D | CONTROL A/D A/D | |=================================================================================================================================| | | |Skin | | Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal | | Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 2.9% 0.0% | 5.1% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/28 (0%) 0/28 (0%) 0/27 (0%) | 0/25 (0%) 0/32 (0%) 0/25 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 656 --- | 655 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.705N (e) P=0.483 (e) | P=0.490N P=0.218N P=0.271N P=0.248N | |INCIDENTAL TUMOR | P=0.645N (e) P=0.410 (e) | P=0.701N P=0.311N P=0.293N P=0.500N | |LOGISTIC REGRESSION | P=0.733N (e) P=0.506 (e) | P=0.480N P=0.261N P=0.233N P=0.232N | |COCHRAN-ARMITAGE | P=0.725N | P=0.482N | |FISHER EXACT | (e) P=0.500 (e) | P=0.247N P=0.247N P=0.247N | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |ADJUSTED (b) | 0.0% 0.0% 3.6% 0.0% | 6.1% 0.0% 0.0% 6.3% | |TERMINAL (d) | 0/27 (0%) 0/28 (0%) 1/28 (4%) 0/27 (0%) | 0/25 (0%) 0/32 (0%) 0/25 (0%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | --- --- 728 (T) --- | 675 --- --- 720 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.729N (e) P=0.507 (e) | P=0.320 P=0.198N P=0.265N P=0.635N | |INCIDENTAL TUMOR | P=0.729N (e) P=0.507 (e) | P=0.111 P=0.311N P=0.293N P=0.411 | |LOGISTIC REGRESSION | P=0.729N (e) P=0.507 (e) | P=0.279 P=0.241N P=0.245N P=0.693 | |COCHRAN-ARMITAGE | P=0.725N | P=0.284 | |FISHER EXACT | (e) P=0.500 (e) | P=0.247N P=0.247N P=0.691N | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 89006 TEST: 08 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 9 INTERFERON A/INTERFERON AD MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 500 U 5000 U 5000 U A | VEHICLE 500 U 5000 U 5000 U A | | | CONTROL A/D A/D | CONTROL A/D A/D | |=================================================================================================================================| | | |Skin | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 6.1% 0.0% 0.0% 3.2% | |TERMINAL (d) | 0/27 (0%) 0/28 (0%) 0/28 (0%) 0/27 (0%) | 0/25 (0%) 0/32 (0%) 0/25 (0%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 675 --- --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.659 P=0.198N P=0.265N P=0.448N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.512 P=0.311N P=0.293N P=0.717N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.634 P=0.241N P=0.245N P=0.504N | |COCHRAN-ARMITAGE | (e) | P=0.637 | |FISHER EXACT | (e) (e) (e) | P=0.247N P=0.247N P=0.500N | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 0.0% 3.6% 0.0% | 6.1% 0.0% 0.0% 3.2% | |TERMINAL (d) | 0/27 (0%) 0/28 (0%) 1/28 (4%) 0/27 (0%) | 0/25 (0%) 0/32 (0%) 0/25 (0%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | --- --- 728 (T) --- | 675 --- --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.729N (e) P=0.507 (e) | P=0.659 P=0.198N P=0.265N P=0.448N | |INCIDENTAL TUMOR | P=0.729N (e) P=0.507 (e) | P=0.512 P=0.311N P=0.293N P=0.717N | |LOGISTIC REGRESSION | P=0.729N (e) P=0.507 (e) | P=0.634 P=0.241N P=0.245N P=0.504N | |COCHRAN-ARMITAGE | P=0.725N | P=0.637 | |FISHER EXACT | (e) P=0.500 (e) | P=0.247N P=0.247N P=0.500N | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 89006 TEST: 08 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 9 INTERFERON A/INTERFERON AD MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 500 U 5000 U 5000 U A | VEHICLE 500 U 5000 U 5000 U A | | | CONTROL A/D A/D | CONTROL A/D A/D | |=================================================================================================================================| | | |Skin | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 2/50 (4%) 0/50 (0%) 2/50 (4%) | |ADJUSTED (b) | 0.0% 2.7% 0.0% 0.0% | 6.5% 6.3% 0.0% 5.6% | |TERMINAL (d) | 0/27 (0%) 0/28 (0%) 0/28 (0%) 0/27 (0%) | 1/25 (4%) 2/32 (6%) 0/25 (0%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | --- 615 --- --- | 671 729 (T) --- 612 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.699N P=0.480 (e) (e) | P=0.539 P=0.619N P=0.261N P=0.665N | |INCIDENTAL TUMOR | P=0.780N P=0.540 (e) (e) | P=0.543 P=0.657N P=0.267N P=0.684N | |LOGISTIC REGRESSION | P=0.734N P=0.522 (e) (e) | P=0.504 P=0.658N P=0.249N P=0.693 | |COCHRAN-ARMITAGE | P=0.706N | P=0.510 | |FISHER EXACT | P=0.500 (e) (e) | P=0.691N P=0.247N P=0.691N | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 5/49 (10%) 2/49 (4%) 0/50 (0%) | 1/47 (2%) 1/50 (2%) 0/50 (0%) 2/49 (4%) | |ADJUSTED (b) | 0.0% 15.5% 6.0% 0.0% | 4.0% 2.7% 0.0% 5.6% | |TERMINAL (d) | 0/27 (0%) 3/28 (11%) 1/28 (4%) 0/27 (0%) | 1/25 (4%) 0/32 (0%) 0/25 (0%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | --- 615 587 --- | 729 (T) 701 --- 612 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.133N P=0.033 * P=0.233 (e) | P=0.314 P=0.705N P=0.500N P=0.542 | |INCIDENTAL TUMOR | P=0.162N P=0.039 * P=0.266 (e) | P=0.304 P=0.750N P=0.500N P=0.640 | |LOGISTIC REGRESSION | P=0.127N P=0.031 * P=0.242 (e) | P=0.282 P=0.727N P=0.500N P=0.513 | |COCHRAN-ARMITAGE | P=0.128N | P=0.283 | |FISHER EXACT | P=0.028 * P=0.247 (e) | P=0.737N P=0.485N P=0.516 | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 89006 TEST: 08 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 9 INTERFERON A/INTERFERON AD MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 500 U 5000 U 5000 U A | VEHICLE 500 U 5000 U 5000 U A | | | CONTROL A/D A/D | CONTROL A/D A/D | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 3.0% 0.0% 0.0% | 0.0% 6.3% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/28 (0%) 0/28 (0%) 0/27 (0%) | 0/25 (0%) 2/32 (6%) 0/25 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | --- 654 --- --- | --- 729 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.683N P=0.477 (e) (e) | P=0.455N P=0.294 (e) (e) | |INCIDENTAL TUMOR | P=0.626N P=0.379 (e) (e) | P=0.455N P=0.294 (e) (e) | |LOGISTIC REGRESSION | P=0.715N P=0.508 (e) (e) | P=0.455N P=0.294 (e) (e) | |COCHRAN-ARMITAGE | P=0.706N | P=0.485N | |FISHER EXACT | P=0.500 (e) (e) | P=0.247 (e) (e) | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/49 (0%) 1/50 (2%) 0/50 (0%) | 5/50 (10%) 3/50 (6%) 2/49 (4%) 4/50 (8%) | |ADJUSTED (b) | 3.4% 0.0% 3.6% 0.0% | 18.0% 9.4% 8.0% 12.9% | |TERMINAL (d) | 0/27 (0%) 0/28 (0%) 1/28 (4%) 0/27 (0%) | 4/25 (16%) 3/32 (9%) 2/25 (8%) 4/31 (13%) | |FIRST INCIDENCE (DAYS) | 707 --- 728 (T) --- | 654 729 (T) 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.494N P=0.500N P=0.756N P=0.487N | P=0.580 P=0.239N P=0.220N P=0.387N | |INCIDENTAL TUMOR | P=0.451N P=0.621N P=0.716 P=0.483N | P=0.553 P=0.262N P=0.233N P=0.449N | |LOGISTIC REGRESSION | P=0.484N P=0.513N P=0.759 P=0.496N | P=0.542 P=0.278N P=0.247N P=0.463N | |COCHRAN-ARMITAGE | P=0.497N | P=0.511 | |FISHER EXACT | P=0.505N P=0.753N P=0.500N | P=0.357N P=0.226N P=0.500N | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 89006 TEST: 08 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 9 INTERFERON A/INTERFERON AD MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 500 U 5000 U 5000 U A | VEHICLE 500 U 5000 U 5000 U A | | | CONTROL A/D A/D | CONTROL A/D A/D | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | |ADJUSTED (b) | | 2.5% 0.0% 2.4% 6.5% | |TERMINAL (d) | | 0/25 (0%) 0/32 (0%) 0/25 (0%) 2/31 (6%) | |FIRST INCIDENCE (DAYS) | | 655 --- 624 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.282 P=0.486N P=0.741 P=0.541 | |INCIDENTAL TUMOR | | P=0.290 P=0.565N P=0.731N P=0.431 | |LOGISTIC REGRESSION | | P=0.273 P=0.535N P=0.752N P=0.497 | |COCHRAN-ARMITAGE | | P=0.274 | |FISHER EXACT | | P=0.500N P=0.753N P=0.500 | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 2/50 (4%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | |ADJUSTED (b) | | 5.5% 0.0% 2.4% 6.5% | |TERMINAL (d) | | 0/25 (0%) 0/32 (0%) 0/25 (0%) 2/31 (6%) | |FIRST INCIDENCE (DAYS) | | 655 --- 624 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.405 P=0.203N P=0.532N P=0.650N | |INCIDENTAL TUMOR | | P=0.352 P=0.311N P=0.495N P=0.546 | |LOGISTIC REGRESSION | | P=0.393 P=0.255N P=0.489N P=0.691 | |COCHRAN-ARMITAGE | | P=0.395 | |FISHER EXACT | | P=0.247N P=0.500N P=0.691N | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 89006 TEST: 08 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 9 INTERFERON A/INTERFERON AD MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 500 U 5000 U 5000 U A | VEHICLE 500 U 5000 U 5000 U A | | | CONTROL A/D A/D | CONTROL A/D A/D | |=================================================================================================================================| | | |All Organs | | Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 3.6% 3.6% 5.8% | 4.0% 0.0% 4.0% 3.2% | |TERMINAL (d) | 0/27 (0%) 1/28 (4%) 1/28 (4%) 1/27 (4%) | 1/25 (4%) 0/32 (0%) 1/25 (4%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | --- 728 (T) 728 (T) 566 | 729 (T) --- 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.269 P=0.507 P=0.507 P=0.235 | P=0.655 P=0.451N P=0.763 P=0.714N | |INCIDENTAL TUMOR | P=0.237 P=0.507 P=0.507 P=0.212 | P=0.655 P=0.451N P=0.763 P=0.714N | |LOGISTIC REGRESSION | P=0.281 P=0.507 P=0.507 P=0.226 | P=0.655 P=0.451N P=0.763 P=0.714N | |COCHRAN-ARMITAGE | P=0.273 | P=0.624 | |FISHER EXACT | P=0.500 P=0.500 P=0.247 | P=0.500N P=0.753N P=0.753N | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 6/50 (12%) 4/50 (8%) 4/50 (8%) | 2/50 (4%) 3/50 (6%) 1/50 (2%) 5/50 (10%) | |ADJUSTED (b) | 11.5% 18.2% 11.5% 11.7% | 6.5% 8.8% 3.0% 15.0% | |TERMINAL (d) | 1/27 (4%) 3/28 (11%) 2/28 (7%) 2/27 (7%) | 1/25 (4%) 2/32 (6%) 0/25 (0%) 4/31 (13%) | |FIRST INCIDENCE (DAYS) | 503 615 571 532 | 671 701 667 612 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.483N P=0.352 P=0.630 P=0.629N | P=0.139 P=0.595 P=0.542N P=0.276 | |INCIDENTAL TUMOR | P=0.480N P=0.325 P=0.616 P=0.586N | P=0.088 P=0.508 P=0.558N P=0.263 | |LOGISTIC REGRESSION | P=0.508N P=0.373 P=0.625N P=0.630 | P=0.102 P=0.540 P=0.514N P=0.212 | |COCHRAN-ARMITAGE | P=0.495N | P=0.107 | |FISHER EXACT | P=0.370 P=0.643N P=0.643N | P=0.500 P=0.500N P=0.218 | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 89006 TEST: 08 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 9 INTERFERON A/INTERFERON AD MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 500 U 5000 U 5000 U A | VEHICLE 500 U 5000 U 5000 U A | | | CONTROL A/D A/D | CONTROL A/D A/D | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 7/50 (14%) 5/50 (10%) 5/50 (10%) | 3/50 (6%) 3/50 (6%) 2/50 (4%) 6/50 (12%) | |ADJUSTED (b) | 11.5% 21.5% 14.9% 13.6% | 10.4% 8.8% 6.9% 18.2% | |TERMINAL (d) | 1/27 (4%) 4/28 (14%) 3/28 (11%) 2/27 (7%) | 2/25 (8%) 2/32 (6%) 1/25 (4%) 5/31 (16%) | |FIRST INCIDENCE (DAYS) | 503 615 571 532 | 671 701 667 612 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.538N P=0.253 P=0.494 P=0.507 | P=0.139 P=0.558N P=0.533N P=0.323 | |INCIDENTAL TUMOR | P=0.552N P=0.228 P=0.476 P=0.540 | P=0.094 P=0.637N P=0.546N P=0.312 | |LOGISTIC REGRESSION | P=0.563N P=0.258 P=0.512 P=0.475 | P=0.096 P=0.615N P=0.528N P=0.240 | |COCHRAN-ARMITAGE | P=0.550N | P=0.101 | |FISHER EXACT | P=0.262 P=0.500 P=0.500 | P=0.661N P=0.500N P=0.243 | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 0.0% 2.2% 6.5% | 4.7% 2.1% 6.1% 2.0% | |TERMINAL (d) | 0/27 (0%) 0/28 (0%) 0/28 (0%) 1/27 (4%) | 0/25 (0%) 0/32 (0%) 1/25 (4%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 563 685 | 649 577 564 426 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.157 (e) P=0.491 P=0.250 | P=0.516N P=0.484N P=0.672 P=0.527N | |INCIDENTAL TUMOR | P=0.154 (e) P=0.540 P=0.249 | P=0.428N P=0.575N P=0.691N P=0.697N | |LOGISTIC REGRESSION | P=0.141 (e) P=0.560 P=0.242 | P=0.491N P=0.608N P=0.682N P=0.425N | |COCHRAN-ARMITAGE | P=0.149 | P=0.499N | |FISHER EXACT | (e) P=0.500 P=0.247 | P=0.500N P=0.691N P=0.500N | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 89006 TEST: 08 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 9 INTERFERON A/INTERFERON AD MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 500 U 5000 U 5000 U A | VEHICLE 500 U 5000 U 5000 U A | | | CONTROL A/D A/D | CONTROL A/D A/D | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated | | Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 2/50 (4%) 5/50 (10%) 2/50 (4%) | 11/50 (22%) 13/50 (26%) 11/50 (22%) 6/50 (12%) | |ADJUSTED (b) | 11.8% 7.1% 16.3% 7.1% | 32.8% 33.3% 33.9% 15.5% | |TERMINAL (d) | 2/27 (7%) 2/28 (7%) 3/28 (11%) 1/27 (4%) | 5/25 (20%) 8/32 (25%) 6/25 (24%) 3/31 (10%) | |FIRST INCIDENCE (DAYS) | 603 728 (T) 656 725 | 597 623 567 449 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.313N P=0.351N P=0.494 P=0.343N | P=0.056N P=0.552N P=0.547 P=0.108N | |INCIDENTAL TUMOR | P=0.297N P=0.296N P=0.479 P=0.370N | P=0.055N P=0.435 P=0.576N P=0.101N | |LOGISTIC REGRESSION | P=0.289N P=0.353N P=0.482 P=0.334N | P=0.065N P=0.428 P=0.555 P=0.138N | |COCHRAN-ARMITAGE | P=0.315N | P=0.064N | |FISHER EXACT | P=0.339N P=0.500 P=0.339N | P=0.408 P=0.595N P=0.143N | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 22/50 (44%) 26/50 (52%) 28/50 (56%) 29/50 (58%) | 34/50 (68%) 32/50 (64%) 33/50 (66%) 31/50 (62%) | |ADJUSTED (b) | 63.7% 73.8% 76.8% 79.5% | 94.1% 77.7% 88.5% 73.7% | |TERMINAL (d) | 15/27 (56%) 19/28 (68%) 20/28 (71%) 20/27 (74%) | 23/25 (92%) 23/32 (72%) 21/25 (84%) 20/31 (65%) | |FIRST INCIDENCE (DAYS) | 503 540 556 547 | 597 553 293 563 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.233 P=0.273 P=0.184 P=0.136 | P=0.183N P=0.064N P=0.572N P=0.111N | |INCIDENTAL TUMOR | P=0.211 P=0.181 P=0.138 P=0.098 | P=0.370N P=0.184N P=0.507N P=0.333N | |LOGISTIC REGRESSION | P=0.300 P=0.166 P=0.110 P=0.119 | P=0.437N P=0.211N P=0.530 P=0.394N | |COCHRAN-ARMITAGE | P=0.223 | P=0.365N | |FISHER EXACT | P=0.274 P=0.159 P=0.115 | P=0.417N P=0.500N P=0.338N | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 89006 TEST: 08 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 9 INTERFERON A/INTERFERON AD MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 500 U 5000 U 5000 U A | VEHICLE 500 U 5000 U 5000 U A | | | CONTROL A/D A/D | CONTROL A/D A/D | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 32/50 (64%) 30/50 (60%) 25/50 (50%) 30/50 (60%) | 35/50 (70%) 33/50 (66%) 28/50 (56%) 30/50 (60%) | |ADJUSTED (b) | 69.1% 69.2% 62.7% 65.8% | 73.6% 71.2% 72.1% 66.0% | |TERMINAL (d) | 13/27 (48%) 15/28 (54%) 14/28 (50%) 12/27 (44%) | 13/25 (52%) 19/32 (59%) 15/25 (60%) 16/31 (52%) | |FIRST INCIDENCE (DAYS) | 469 405 435 524 | 409 483 506 426 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.528 P=0.514N P=0.199N P=0.420N | P=0.275N P=0.153N P=0.260N P=0.155N | |INCIDENTAL TUMOR | P=0.534N P=0.555N P=0.168N P=0.384N | P=0.320N P=0.524N P=0.158N P=0.279N | |LOGISTIC REGRESSION | P=0.461 P=0.391N P=0.114N P=0.390N | P=0.396N P=0.546N P=0.133N P=0.299N | |COCHRAN-ARMITAGE | P=0.480 | P=0.353N | |FISHER EXACT | P=0.418N P=0.113N P=0.418N | P=0.415N P=0.107N P=0.201N | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 42/50 (84%) 40/50 (80%) 41/50 (82%) 47/50 (94%) | 48/50 (96%) 48/50 (96%) 44/50 (88%) 44/50 (88%) | |ADJUSTED (b) | 89.3% 90.7% 93.0% 95.9% | 98.0% 96.0% 97.7% 93.6% | |TERMINAL (d) | 22/27 (81%) 24/28 (86%) 25/28 (89%) 25/27 (93%) | 24/25 (96%) 30/32 (94%) 24/25 (96%) 28/31 (90%) | |FIRST INCIDENCE (DAYS) | 469 405 435 524 | 409 483 293 426 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.183 P=0.497N P=0.509N P=0.304 | P=0.152N P=0.101N P=0.433N P=0.086N | |INCIDENTAL TUMOR | P=0.050 * P=0.539N P=0.608 P=0.107 | P=0.133N P=0.586N P=0.211N P=0.200N | |LOGISTIC REGRESSION | P=0.045 * P=0.456N P=0.588N P=0.103 | P=0.196N P=0.610N P=0.296N P=0.185N | |COCHRAN-ARMITAGE | P=0.034 * | P=0.172N | |FISHER EXACT | P=0.398N P=0.500N P=0.100 | P=0.691N P=0.134N P=0.134N | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 89006 TEST: 08 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 9 INTERFERON A/INTERFERON AD MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS (a) Number of tumor-bearing animals / number of animals examined at site. (b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for intercurrent mortality. (d) Observed incidence at terminal kill. (f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between the controls and that dosed group. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. The incidental tumor test regards these lesions as non-fatal. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fisher's exact tests compare directly the overall incidence rates. For all tests, a negative trend is indicated by "N". (e) Value of Statistic cannot be computed. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01).