TR 351 Mouse Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus PARA-CHLOROANILINE DATE: 09/03/94 EXPERIMENT: 05020 TEST: 02 TIME: 20:08:05 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1CP9565302 ROUTE: GAVAGE NTP C#: 02039B PATHOLOGIST: R. PERSING CAS: 106-47-8 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus PARA-CHLOROANILINE DATE: 09/03/94 EXPERIMENT: 05020 TEST: 02 TIME: 20:08:05 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1CP9565302 ROUTE: GAVAGE NTP C#: 02039B PATHOLOGIST: R. PERSING CAS: 106-47-8 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 Gland Bone Marrow Brain 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: Battelle Columbus PARA-CHLOROANILINE DATE: 09/03/94 EXPERIMENT: 05020 TEST: 02 TIME: 20:08:05 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1CP9565302 ROUTE: GAVAGE NTP C#: 02039B PATHOLOGIST: R. PERSING CAS: 106-47-8 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF PARA-CHLOROANILINE ==================================================================================================== MALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Liver Hemangiosarcoma Hepatocellular Adenoma Hepatocellular Carcinoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Skin: Subcutaneous Tissue Neurofibrosarcoma, Fibrosarcoma, Sarcoma, Neurofibroma, or Fibroma All Organs Hemangiosarcoma Hemangiosarcoma or Hemangioma Malignant Lymphoma And Histiocytic Sarcoma Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type Malignant Tumors Malignant and Benign Tumors ==================================================================================================== FEMALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Liver Hepatocellular Carcinoma Lung Alveolar/Bronchiolar Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma All Organs Malignant Lymphoma And Histiocytic Sarcoma Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 09/03/94 EXPERIMENT: 05020 TEST: 02 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG | VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Adrenal Gland: Non-medullary, Non-cortical | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/5 (0%) 0/7 (0%) 2/50 (4%) | 2/50 (4%) 0/5 (0%) 0/4 (0%) 0/49 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 5.7% | 5.1% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/42 (0%) 0/0 0/0 2/35 (6%) | 2/39 (5%) 0/0 0/1 (0%) 0/41 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 728 (T) | 728 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.139 (e) (e) P=0.199 | P=0.163N (e) P=0.981N P=0.227N | |INCIDENTAL TUMOR | P=0.139 (e) (e) P=0.199 | P=0.163N (e) P=0.981N P=0.227N | |LOGISTIC REGRESSION | P=0.139 (e) (e) P=0.199 | P=0.163N (e) P=0.981N P=0.227N | |COCHRAN-ARMITAGE | P=0.145 | P=0.186N | |FISHER EXACT | (e) (e) P=0.253 | P=0.825N P=0.856N P=0.253N | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/4 (0%) 0/7 (0%) 0/50 (0%) | 2/50 (4%) 0/5 (0%) 0/4 (0%) 0/49 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 5.1% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/42 (0%) 0/0 0/0 0/35 (0%) | 2/39 (5%) 0/0 0/1 (0%) 0/41 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 728 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.163N (e) P=0.981N P=0.227N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.163N (e) P=0.981N P=0.227N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.163N (e) P=0.981N P=0.227N | |COCHRAN-ARMITAGE | (e) | P=0.186N | |FISHER EXACT | (e) (e) (e) | P=0.825N P=0.856N P=0.253N | |=================================================================================================================================| DATE: 09/03/94 EXPERIMENT: 05020 TEST: 02 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG | VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/4 (0%) 0/7 (0%) 0/50 (0%) | 2/50 (4%) 0/5 (0%) 1/4 (25%) 0/49 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 5.1% 0.0% 100.0% 0.0% | |TERMINAL (d) | 0/42 (0%) 0/0 0/0 0/35 (0%) | 2/39 (5%) 0/0 1/1 (100%) 0/41 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 728 (T) --- 728 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.155N (e) P=0.053 P=0.227N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.155N (e) P=0.053 P=0.227N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.155N (e) P=0.051 P=0.227N | |COCHRAN-ARMITAGE | (e) | P=0.185N | |FISHER EXACT | (e) (e) (e) | P=0.825N P=0.210 P=0.253N | |=================================================================================================================================| | | |Bone Marrow | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/3 (0%) 0/7 (0%) 2/50 (4%) | 0/48 (0%) 0/5 (0%) 0/3 (0%) 0/49 (0%) | |ADJUSTED (b) | 2.3% 0.0% 0.0% 5.5% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/43 (2%) 0/0 0/0 1/35 (3%) | 0/38 (0%) 0/0 0/0 0/41 (0%) | |FIRST INCIDENCE (DAYS) | 728 (T) --- --- 722 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.300 (e) (e) P=0.435 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.491 (e) (e) P=0.571 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.383 (e) (e) P=0.461 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.390 | (e) | |FISHER EXACT | P=0.943N P=0.877N P=0.500 | (e) (e) (e) | |=================================================================================================================================| DATE: 09/03/94 EXPERIMENT: 05020 TEST: 02 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG | VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 2/49 (4%) 1/50 (2%) 5/50 (10%) | 3/50 (6%) 1/50 (2%) 1/50 (2%) 4/50 (8%) | |ADJUSTED (b) | 11.6% 5.6% 3.4% 13.8% | 7.7% 2.4% 2.3% 9.8% | |TERMINAL (d) | 5/43 (12%) 2/36 (6%) 1/29 (3%) 4/35 (11%) | 3/39 (8%) 1/42 (2%) 1/44 (2%) 4/41 (10%) | |FIRST INCIDENCE (DAYS) | 728 (T) 728 (T) 728 (T) 690 | 728 (T) 728 (T) 728 (T) 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.279 P=0.293N P=0.214N P=0.502 | P=0.225 P=0.279N P=0.263N P=0.527 | |INCIDENTAL TUMOR | P=0.298 P=0.293N P=0.214N P=0.577 | P=0.225 P=0.279N P=0.263N P=0.527 | |LOGISTIC REGRESSION | P=0.310 P=0.293N P=0.214N P=0.576 | P=0.225 P=0.279N P=0.263N P=0.527 | |COCHRAN-ARMITAGE | P=0.350 | P=0.222 | |FISHER EXACT | P=0.226N P=0.102N P=0.630N | P=0.309N P=0.309N P=0.500 | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/49 (4%) 1/50 (2%) 6/50 (12%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 4.7% 4.9% 3.4% 14.9% | 2.6% 0.0% 0.0% 2.4% | |TERMINAL (d) | 2/43 (5%) 1/36 (3%) 1/29 (3%) 3/35 (9%) | 1/39 (3%) 0/42 (0%) 0/44 (0%) 1/41 (2%) | |FIRST INCIDENCE (DAYS) | 728 (T) 479 728 (T) 399 | 728 (T) --- --- 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.031 * P=0.637 P=0.636N P=0.097 | P=0.540 P=0.485N P=0.476N P=0.751N | |INCIDENTAL TUMOR | P=0.039 * P=0.645 P=0.636N P=0.186 | P=0.540 P=0.485N P=0.476N P=0.751N | |LOGISTIC REGRESSION | P=0.036 * P=0.667N P=0.636N P=0.153 | P=0.540 P=0.485N P=0.476N P=0.751N | |COCHRAN-ARMITAGE | P=0.037 * | P=0.536 | |FISHER EXACT | P=0.684 P=0.500N P=0.134 | P=0.500N P=0.500N P=0.753N | |=================================================================================================================================| DATE: 09/03/94 EXPERIMENT: 05020 TEST: 02 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG | VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 9/50 (18%) 15/49 (31%) 10/50 (20%) 4/50 (8%) | 5/50 (10%) 7/50 (14%) 8/50 (16%) 8/50 (16%) | |ADJUSTED (b) | 20.9% 36.0% 29.1% 11.4% | 12.3% 16.7% 18.2% 19.0% | |TERMINAL (d) | 9/43 (21%) 10/36 (28%) 7/29 (24%) 4/35 (11%) | 4/39 (10%) 7/42 (17%) 8/44 (18%) 7/41 (17%) | |FIRST INCIDENCE (DAYS) | 728 (T) 432 443 728 (T) | 672 728 (T) 728 (T) 722 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.044N* P=0.060 P=0.205 P=0.209N | P=0.310 P=0.428 P=0.354 P=0.308 | |INCIDENTAL TUMOR | P=0.024N* P=0.124 P=0.317 P=0.209N | P=0.293 P=0.379 P=0.308 P=0.249 | |LOGISTIC REGRESSION | P=0.020N* P=0.097 P=0.478 P=0.209N | P=0.305 P=0.374 P=0.302 P=0.287 | |COCHRAN-ARMITAGE | P=0.019N* | P=0.301 | |FISHER EXACT | P=0.109 P=0.500 P=0.117N | P=0.380 P=0.277 P=0.277 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 7/49 (14%) 11/50 (22%) 17/50 (34%) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 5/50 (10%) | |ADJUSTED (b) | 7.0% 16.3% 25.9% 37.9% | 2.1% 4.8% 0.0% 11.7% | |TERMINAL (d) | 3/43 (7%) 2/36 (6%) 1/29 (3%) 8/35 (23%) | 0/39 (0%) 2/42 (5%) 0/44 (0%) 4/41 (10%) | |FIRST INCIDENCE (DAYS) | 728 (T) 637 514 490 | 480 728 (T) --- 616 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.127 P=0.011 * P<0.001 ** | P=0.034 * P=0.512 P=0.492N P=0.117 | |INCIDENTAL TUMOR | P=0.001 ** P=0.282 P=0.245 P=0.002 ** | P=0.062 P=0.517 P=0.500N P=0.152 | |LOGISTIC REGRESSION | P<0.001 ** P=0.149 P=0.069 P<0.001 ** | P=0.028 * P=0.509 P=0.656N P=0.082 | |COCHRAN-ARMITAGE | P<0.001 ** | P=0.032 * | |FISHER EXACT | P=0.151 P=0.020 * P<0.001 ** | P=0.500 P=0.500N P=0.102 | |=================================================================================================================================| DATE: 09/03/94 EXPERIMENT: 05020 TEST: 02 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG | VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/50 (22%) 21/49 (43%) 20/50 (40%) 21/50 (42%) | 6/50 (12%) 9/50 (18%) 8/50 (16%) 11/50 (22%) | |ADJUSTED (b) | 25.6% 46.4% 47.0% 47.1% | 14.1% 21.4% 18.2% 25.4% | |TERMINAL (d) | 11/43 (26%) 12/36 (33%) 8/29 (28%) 12/35 (34%) | 4/39 (10%) 9/42 (21%) 8/44 (18%) 9/41 (22%) | |FIRST INCIDENCE (DAYS) | 728 (T) 432 443 490 | 480 728 (T) 728 (T) 616 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.081 P=0.012 * P=0.007 ** P=0.010 * | P=0.171 P=0.335 P=0.472 P=0.174 | |INCIDENTAL TUMOR | P=0.201 P=0.042 * P=0.127 P=0.043 * | P=0.208 P=0.296 P=0.423 P=0.167 | |LOGISTIC REGRESSION | P=0.158 P=0.019 * P=0.045 * P=0.027 * | P=0.180 P=0.278 P=0.395 P=0.146 | |COCHRAN-ARMITAGE | P=0.115 | P=0.161 | |FISHER EXACT | P=0.022 * P=0.041 * P=0.026 * | P=0.288 P=0.387 P=0.143 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/50 (22%) 21/49 (43%) 20/50 (40%) 21/50 (42%) | 6/50 (12%) 9/50 (18%) 8/50 (16%) 11/50 (22%) | |ADJUSTED (b) | 25.6% 46.4% 47.0% 47.1% | 14.1% 21.4% 18.2% 25.4% | |TERMINAL (d) | 11/43 (26%) 12/36 (33%) 8/29 (28%) 12/35 (34%) | 4/39 (10%) 9/42 (21%) 8/44 (18%) 9/41 (22%) | |FIRST INCIDENCE (DAYS) | 728 (T) 432 443 490 | 480 728 (T) 728 (T) 616 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.081 P=0.012 * P=0.007 ** P=0.010 * | P=0.171 P=0.335 P=0.472 P=0.174 | |INCIDENTAL TUMOR | P=0.201 P=0.042 * P=0.127 P=0.043 * | P=0.208 P=0.296 P=0.423 P=0.167 | |LOGISTIC REGRESSION | P=0.158 P=0.019 * P=0.045 * P=0.027 * | P=0.180 P=0.278 P=0.395 P=0.146 | |COCHRAN-ARMITAGE | P=0.115 | P=0.161 | |FISHER EXACT | P=0.022 * P=0.041 * P=0.026 * | P=0.288 P=0.387 P=0.143 | |=================================================================================================================================| DATE: 09/03/94 EXPERIMENT: 05020 TEST: 02 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG | VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 4/10 (40%) 5/14 (36%) 4/50 (8%) | 5/50 (10%) 2/8 (25%) 1/7 (14%) 2/50 (4%) | |ADJUSTED (b) | 11.6% 80.0% 69.2% 10.5% | 12.2% 66.7% 33.3% 4.9% | |TERMINAL (d) | 5/43 (12%) 4/5 (80%) 2/3 (67%) 2/35 (6%) | 4/39 (10%) 2/3 (67%) 1/3 (33%) 2/41 (5%) | |FIRST INCIDENCE (DAYS) | 728 (T) 728 (T) 443 682 | 666 728 (T) 728 (T) 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.316N P=0.001 ** P=0.006 ** P=0.611N | P=0.093N P=0.228 P=0.688 P=0.203N | |INCIDENTAL TUMOR | P=0.124N P=0.001 ** P=0.013 * P=0.460N | P=0.096N P=0.035 * P=0.489 P=0.231N | |LOGISTIC REGRESSION | P=0.169N P=0.001 ** P=0.007 ** P=0.546N | P=0.089N P=0.054 P=0.548 P=0.206N | |COCHRAN-ARMITAGE | P=0.178N | P=0.112N | |FISHER EXACT | P=0.034 * P=0.033 * P=0.500N | P=0.245 P=0.562 P=0.218N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/10 (10%) 3/14 (21%) 3/50 (6%) | 1/50 (2%) 1/8 (13%) 0/7 (0%) 2/50 (4%) | |ADJUSTED (b) | 7.0% 20.0% 37.1% 8.3% | 2.6% 33.3% 0.0% 4.9% | |TERMINAL (d) | 3/43 (7%) 1/5 (20%) 1/3 (33%) 2/35 (6%) | 1/39 (3%) 1/3 (33%) 0/3 (0%) 2/41 (5%) | |FIRST INCIDENCE (DAYS) | 728 (T) 728 (T) 666 725 | 728 (T) 728 (T) --- 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.569 P=0.444 P=0.056 P=0.566 | P=0.583 P=0.160 P=0.952N P=0.517 | |INCIDENTAL TUMOR | P=0.367N P=0.444 P=0.085 P=0.664 | P=0.583 P=0.160 P=0.952N P=0.517 | |LOGISTIC REGRESSION | P=0.478N P=0.444 P=0.011 * P=0.594 | P=0.583 P=0.160 P=0.952N P=0.517 | |COCHRAN-ARMITAGE | P=0.484N | P=0.535 | |FISHER EXACT | P=0.528 P=0.113 P=0.661N | P=0.259 P=0.877N P=0.500 | |=================================================================================================================================| DATE: 09/03/94 EXPERIMENT: 05020 TEST: 02 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG | VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 5/10 (50%) 7/14 (50%) 6/50 (12%) | 6/50 (12%) 2/8 (25%) 1/7 (14%) 4/50 (8%) | |ADJUSTED (b) | 18.6% 100.0% 100.0% 15.9% | 14.7% 66.7% 33.3% 9.8% | |TERMINAL (d) | 8/43 (19%) 5/5 (100%) 3/3 (100%) 4/35 (11%) | 5/39 (13%) 2/3 (67%) 1/3 (33%) 4/41 (10%) | |FIRST INCIDENCE (DAYS) | 728 (T) 728 (T) 443 682 | 666 728 (T) 728 (T) 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.251N P<0.001 ** P<0.001 ** P=0.538N | P=0.196N P=0.265 P=0.712 P=0.344N | |INCIDENTAL TUMOR | P=0.079N P<0.001 ** P=0.001 ** P=0.410N | P=0.198N P=0.056 P=0.532 P=0.376N | |LOGISTIC REGRESSION | P=0.106N P<0.001 ** P<0.001 ** P=0.456N | P=0.192N P=0.076 P=0.587 P=0.356N | |COCHRAN-ARMITAGE | P=0.117N | P=0.241N | |FISHER EXACT | P=0.031 * P=0.014 * P=0.387N | P=0.303 P=0.622 P=0.370N | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 4.8% 0.0% 0.0% | |TERMINAL (d) | 0/43 (0%) 0/36 (0%) 0/29 (0%) 0/35 (0%) | 0/39 (0%) 2/42 (5%) 0/44 (0%) 0/41 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- 728 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.365N P=0.255 (e) (e) | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.365N P=0.255 (e) (e) | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.365N P=0.255 (e) (e) | |COCHRAN-ARMITAGE | (e) | P=0.369N | |FISHER EXACT | (e) (e) (e) | P=0.247 (e) (e) | |=================================================================================================================================| DATE: 09/03/94 EXPERIMENT: 05020 TEST: 02 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG | VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 4.8% 0.0% 0.0% | |TERMINAL (d) | 0/43 (0%) 0/36 (0%) 0/29 (0%) 0/35 (0%) | 0/39 (0%) 2/42 (5%) 0/44 (0%) 0/41 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- 728 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.365N P=0.255 (e) (e) | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.365N P=0.255 (e) (e) | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.365N P=0.255 (e) (e) | |COCHRAN-ARMITAGE | (e) | P=0.369N | |FISHER EXACT | (e) (e) (e) | P=0.247 (e) (e) | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/40 (0%) 0/4 (0%) 0/4 (0%) 0/41 (0%) | 3/46 (7%) 1/5 (20%) 2/6 (33%) 3/42 (7%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 8.1% 100.0% 66.7% 8.8% | |TERMINAL (d) | 0/35 (0%) 0/0 0/0 0/28 (0%) | 3/37 (8%) 1/1 (100%) 2/3 (67%) 3/34 (9%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 728 (T) 728 (T) 728 (T) 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.468N P=0.099 P=0.022 * P=0.624 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.468N P=0.099 P=0.022 * P=0.624 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.468N P=0.099 P=0.022 * P=0.624 | |COCHRAN-ARMITAGE | (e) | P=0.516N | |FISHER EXACT | (e) (e) (e) | P=0.347 P=0.096 P=0.617 | |=================================================================================================================================| DATE: 09/03/94 EXPERIMENT: 05020 TEST: 02 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG | VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 4/49 (8%) 5/50 (10%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 7.0% 10.4% 16.2% 2.9% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 3/43 (7%) 3/36 (8%) 4/29 (14%) 1/35 (3%) | 0/39 (0%) 0/42 (0%) 0/44 (0%) 0/41 (0%) | |FIRST INCIDENCE (DAYS) | 728 (T) 667 674 728 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.228N P=0.416 P=0.180 P=0.381N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.196N P=0.488 P=0.255 P=0.381N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.191N P=0.465 P=0.255 P=0.381N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.174N | (e) | |FISHER EXACT | P=0.489 P=0.357 P=0.309N | (e) (e) (e) | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 6/50 (12%) 3/49 (6%) 9/50 (18%) 4/50 (8%) | 1/50 (2%) 0/50 (0%) 3/50 (6%) 3/50 (6%) | |ADJUSTED (b) | 12.8% 8.3% 21.8% 10.2% | 2.1% 0.0% 6.6% 7.0% | |TERMINAL (d) | 3/43 (7%) 3/36 (8%) 2/29 (7%) 1/35 (3%) | 0/39 (0%) 0/42 (0%) 2/44 (5%) 2/41 (5%) | |FIRST INCIDENCE (DAYS) | 502 728 (T) 389 682 | 527 --- 667 667 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.496N P=0.317N P=0.180 P=0.450N | P=0.131 P=0.504N P=0.337 P=0.321 | |INCIDENTAL TUMOR | P=0.294N P=0.253N P=0.511N P=0.137N | P=0.090 P=0.500N P=0.256 P=0.212 | |LOGISTIC REGRESSION | P=0.428N P=0.221N P=0.496 P=0.321N | P=0.117 P=0.474N P=0.260 P=0.268 | |COCHRAN-ARMITAGE | P=0.436N | P=0.126 | |FISHER EXACT | P=0.254N P=0.288 P=0.370N | P=0.500N P=0.309 P=0.309 | |=================================================================================================================================| DATE: 09/03/94 EXPERIMENT: 05020 TEST: 02 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG | VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, Sarcoma, | | Neurofibroma, or Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 8/50 (16%) 7/49 (14%) 14/50 (28%) 5/50 (10%) | 1/50 (2%) 0/50 (0%) 3/50 (6%) 3/50 (6%) | |ADJUSTED (b) | 17.2% 18.6% 34.1% 12.9% | 2.1% 0.0% 6.6% 7.0% | |TERMINAL (d) | 5/43 (12%) 6/36 (17%) 5/29 (17%) 2/35 (6%) | 0/39 (0%) 0/42 (0%) 2/44 (5%) 2/41 (5%) | |FIRST INCIDENCE (DAYS) | 502 667 389 682 | 527 --- 667 667 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.316N P=0.601 P=0.046 * P=0.379N | P=0.131 P=0.504N P=0.337 P=0.321 | |INCIDENTAL TUMOR | P=0.143N P=0.507N P=0.419 P=0.122N | P=0.090 P=0.500N P=0.256 P=0.212 | |LOGISTIC REGRESSION | P=0.225N P=0.507N P=0.204 P=0.249N | P=0.117 P=0.474N P=0.260 P=0.268 | |COCHRAN-ARMITAGE | P=0.231N | P=0.126 | |FISHER EXACT | P=0.517N P=0.114 P=0.277N | P=0.500N P=0.309 P=0.309 | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, or Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 6/50 (12%) 3/49 (6%) 10/50 (20%) 4/50 (8%) | 1/50 (2%) 0/50 (0%) 3/50 (6%) 3/50 (6%) | |ADJUSTED (b) | 12.8% 8.3% 23.8% 10.2% | 2.1% 0.0% 6.6% 7.0% | |TERMINAL (d) | 3/43 (7%) 3/36 (8%) 2/29 (7%) 1/35 (3%) | 0/39 (0%) 0/42 (0%) 2/44 (5%) 2/41 (5%) | |FIRST INCIDENCE (DAYS) | 502 728 (T) 389 682 | 527 --- 667 667 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.491N P=0.317N P=0.125 P=0.450N | P=0.131 P=0.504N P=0.337 P=0.321 | |INCIDENTAL TUMOR | P=0.277N P=0.253N P=0.555N P=0.137N | P=0.090 P=0.500N P=0.256 P=0.212 | |LOGISTIC REGRESSION | P=0.423N P=0.221N P=0.389 P=0.321N | P=0.117 P=0.474N P=0.260 P=0.268 | |COCHRAN-ARMITAGE | P=0.431N | P=0.126 | |FISHER EXACT | P=0.254N P=0.207 P=0.370N | P=0.500N P=0.309 P=0.309 | |=================================================================================================================================| DATE: 09/03/94 EXPERIMENT: 05020 TEST: 02 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG | VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/47 (4%) 0/49 (0%) 5/49 (10%) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/49 (0%) | |ADJUSTED (b) | 7.0% 5.0% 0.0% 12.4% | 2.6% 2.4% 2.3% 0.0% | |TERMINAL (d) | 3/43 (7%) 1/36 (3%) 0/29 (0%) 2/35 (6%) | 1/39 (3%) 1/42 (2%) 1/44 (2%) 0/41 (0%) | |FIRST INCIDENCE (DAYS) | 728 (T) 667 --- 628 | 728 (T) 728 (T) 728 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.125 P=0.566N P=0.199N P=0.281 | P=0.318N P=0.745N P=0.735N P=0.490N | |INCIDENTAL TUMOR | P=0.219 P=0.492N P=0.199N P=0.473 | P=0.318N P=0.745N P=0.735N P=0.490N | |LOGISTIC REGRESSION | P=0.146 P=0.543N P=0.199N P=0.341 | P=0.318N P=0.745N P=0.736N P=0.490N | |COCHRAN-ARMITAGE | P=0.145 | P=0.327N | |FISHER EXACT | P=0.530N P=0.125N P=0.346 | P=0.753N P=0.753N P=0.505N | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 4.7% 0.0% 0.0% 0.0% | 2.6% 2.1% 0.0% 0.0% | |TERMINAL (d) | 2/43 (5%) 0/36 (0%) 0/29 (0%) 0/35 (0%) | 1/39 (3%) 0/42 (0%) 0/44 (0%) 0/41 (0%) | |FIRST INCIDENCE (DAYS) | 728 (T) --- --- --- | 728 (T) 439 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.270N P=0.278N P=0.329N P=0.285N | P=0.297N P=0.754N P=0.476N P=0.490N | |INCIDENTAL TUMOR | P=0.270N P=0.278N P=0.329N P=0.285N | P=0.351N P=0.752N P=0.476N P=0.490N | |LOGISTIC REGRESSION | P=0.270N P=0.278N P=0.329N P=0.285N | P=0.349N P=0.748N P=0.476N P=0.490N | |COCHRAN-ARMITAGE | P=0.241N | P=0.303N | |FISHER EXACT | P=0.253N P=0.247N P=0.247N | P=0.753N P=0.500N P=0.500N | |=================================================================================================================================| DATE: 09/03/94 EXPERIMENT: 05020 TEST: 02 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG | VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 0/5 (0%) 0/7 (0%) 3/48 (6%) | 3/49 (6%) 0/4 (0%) 0/3 (0%) 2/49 (4%) | |ADJUSTED (b) | 9.3% 0.0% 0.0% 8.6% | 7.7% 0.0% 0.0% 4.9% | |TERMINAL (d) | 4/43 (9%) 0/0 0/0 3/35 (9%) | 3/39 (8%) 0/0 0/0 2/41 (5%) | |FIRST INCIDENCE (DAYS) | 728 (T) --- --- 728 (T) | 728 (T) --- --- 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.560N (e) (e) P=0.612N | P=0.417N (e) (e) P=0.477N | |INCIDENTAL TUMOR | P=0.560N (e) (e) P=0.612N | P=0.417N (e) (e) P=0.477N | |LOGISTIC REGRESSION | P=0.560N (e) (e) P=0.612N | P=0.417N (e) (e) P=0.477N | |COCHRAN-ARMITAGE | P=0.532N | P=0.475N | |FISHER EXACT | P=0.675N P=0.583N P=0.523N | P=0.786N P=0.834N P=0.500N | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 4/49 (8%) 1/50 (2%) 10/50 (20%) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | |ADJUSTED (b) | 9.3% 9.7% 3.4% 23.9% | 5.1% 2.4% 2.3% 2.4% | |TERMINAL (d) | 4/43 (9%) 2/36 (6%) 1/29 (3%) 5/35 (14%) | 2/39 (5%) 1/42 (2%) 1/44 (2%) 1/41 (2%) | |FIRST INCIDENCE (DAYS) | 728 (T) 479 728 (T) 399 | 728 (T) 728 (T) 728 (T) 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.011 * P=0.560 P=0.315N P=0.047 * | P=0.483N P=0.474N P=0.458N P=0.483N | |INCIDENTAL TUMOR | P=0.019 * P=0.633 P=0.315N P=0.124 | P=0.483N P=0.474N P=0.458N P=0.483N | |LOGISTIC REGRESSION | P=0.014 * P=0.639N P=0.315N P=0.084 | P=0.483N P=0.474N P=0.458N P=0.483N | |COCHRAN-ARMITAGE | P=0.014 * | P=0.488N | |FISHER EXACT | P=0.631 P=0.181N P=0.074 | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| DATE: 09/03/94 EXPERIMENT: 05020 TEST: 02 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG | VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 4/49 (8%) 1/50 (2%) 10/50 (20%) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | |ADJUSTED (b) | 9.3% 9.7% 3.4% 23.9% | 5.1% 2.4% 2.3% 2.4% | |TERMINAL (d) | 4/43 (9%) 2/36 (6%) 1/29 (3%) 5/35 (14%) | 2/39 (5%) 1/42 (2%) 1/44 (2%) 1/41 (2%) | |FIRST INCIDENCE (DAYS) | 728 (T) 479 728 (T) 399 | 728 (T) 728 (T) 728 (T) 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.011 * P=0.560 P=0.315N P=0.047 * | P=0.483N P=0.474N P=0.458N P=0.483N | |INCIDENTAL TUMOR | P=0.019 * P=0.633 P=0.315N P=0.124 | P=0.483N P=0.474N P=0.458N P=0.483N | |LOGISTIC REGRESSION | P=0.014 * P=0.639N P=0.315N P=0.084 | P=0.483N P=0.474N P=0.458N P=0.483N | |COCHRAN-ARMITAGE | P=0.014 * | P=0.488N | |FISHER EXACT | P=0.631 P=0.181N P=0.074 | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma And Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 10/50 (20%) 3/49 (6%) 9/50 (18%) 3/50 (6%) | 19/50 (38%) 12/50 (24%) 5/50 (10%) 10/50 (20%) | |ADJUSTED (b) | 21.6% 7.7% 23.9% 8.0% | 41.3% 27.8% 10.3% 23.0% | |TERMINAL (d) | 7/43 (16%) 1/36 (3%) 4/29 (14%) 2/35 (6%) | 12/39 (31%) 11/42 (26%) 2/44 (5%) 8/41 (20%) | |FIRST INCIDENCE (DAYS) | 496 674 423 682 | 666 528 521 609 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.149N P=0.072N P=0.443 P=0.074N | P=0.082N P=0.083N P=0.001N** P=0.041N* | |INCIDENTAL TUMOR | P=0.066N P=0.014N* P=0.283N P=0.020N* | P=0.048N* P=0.180N P<0.001N** P=0.040N* | |LOGISTIC REGRESSION | P=0.095N P=0.037N* P=0.397N P=0.034N* | P=0.031N* P=0.165N P<0.001N** P=0.032N* | |COCHRAN-ARMITAGE | P=0.098N | P=0.078N | |FISHER EXACT | P=0.039N* P=0.500N P=0.036N* | P=0.097N P<0.001N** P=0.038N* | |=================================================================================================================================| DATE: 09/03/94 EXPERIMENT: 05020 TEST: 02 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG | VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 10/50 (20%) 3/49 (6%) 9/50 (18%) 3/50 (6%) | 19/50 (38%) 12/50 (24%) 5/50 (10%) 10/50 (20%) | |ADJUSTED (b) | 21.6% 7.7% 23.9% 8.0% | 41.3% 27.8% 10.3% 23.0% | |TERMINAL (d) | 7/43 (16%) 1/36 (3%) 4/29 (14%) 2/35 (6%) | 12/39 (31%) 11/42 (26%) 2/44 (5%) 8/41 (20%) | |FIRST INCIDENCE (DAYS) | 496 674 423 682 | 666 528 521 609 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.149N P=0.072N P=0.443 P=0.074N | P=0.082N P=0.083N P=0.001N** P=0.041N* | |INCIDENTAL TUMOR | P=0.066N P=0.014N* P=0.283N P=0.020N* | P=0.048N* P=0.180N P<0.001N** P=0.040N* | |LOGISTIC REGRESSION | P=0.095N P=0.037N* P=0.397N P=0.034N* | P=0.031N* P=0.165N P<0.001N** P=0.032N* | |COCHRAN-ARMITAGE | P=0.098N | P=0.078N | |FISHER EXACT | P=0.039N* P=0.500N P=0.036N* | P=0.097N P<0.001N** P=0.038N* | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 23/50 (46%) 20/49 (41%) 17/50 (34%) 18/50 (36%) | 20/50 (40%) 15/50 (30%) 12/50 (24%) 17/50 (34%) | |ADJUSTED (b) | 53.5% 47.0% 46.7% 47.2% | 48.5% 34.8% 27.3% 40.5% | |TERMINAL (d) | 23/43 (53%) 14/36 (39%) 11/29 (38%) 15/35 (43%) | 18/39 (46%) 14/42 (33%) 12/44 (27%) 16/41 (39%) | |FIRST INCIDENCE (DAYS) | 728 (T) 432 443 682 | 666 439 728 (T) 722 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.420N P=0.540 P=0.502 P=0.505N | P=0.461N P=0.139N P=0.028N* P=0.275N | |INCIDENTAL TUMOR | P=0.283N P=0.456N P=0.360N P=0.364N | P=0.499N P=0.175N P=0.040N* P=0.332N | |LOGISTIC REGRESSION | P=0.240N P=0.422N P=0.247N P=0.341N | P=0.442N P=0.214N P=0.048N* P=0.316N | |COCHRAN-ARMITAGE | P=0.223N | P=0.484N | |FISHER EXACT | P=0.376N P=0.154N P=0.208N | P=0.201N P=0.066N P=0.339N | |=================================================================================================================================| DATE: 09/03/94 EXPERIMENT: 05020 TEST: 02 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG | VEHICLE 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 25/50 (50%) 16/49 (33%) 28/50 (56%) 27/50 (54%) | 24/50 (48%) 16/50 (32%) 10/50 (20%) 21/50 (42%) | |ADJUSTED (b) | 51.0% 36.7% 56.7% 57.2% | 50.0% 37.1% 20.5% 46.4% | |TERMINAL (d) | 19/43 (44%) 9/36 (25%) 8/29 (28%) 15/35 (43%) | 15/39 (38%) 15/42 (36%) 6/44 (14%) 17/41 (41%) | |FIRST INCIDENCE (DAYS) | 496 479 389 399 | 480 528 521 609 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.103 P=0.179N P=0.088 P=0.210 | P=0.502 P=0.066N P=0.003N** P=0.307N | |INCIDENTAL TUMOR | P=0.300 P=0.025N* P=0.187N P=0.481N | P=0.516N P=0.129N P=0.002N** P=0.360N | |LOGISTIC REGRESSION | P=0.227 P=0.068N P=0.338N P=0.503 | P=0.435N P=0.083N P=0.004N** P=0.320N | |COCHRAN-ARMITAGE | P=0.132 | P=0.476 | |FISHER EXACT | P=0.061N P=0.344 P=0.421 | P=0.076N P=0.003N** P=0.344N | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 40/50 (80%) 30/49 (61%) 35/50 (70%) 36/50 (72%) | 36/50 (72%) 26/50 (52%) 21/50 (42%) 31/50 (62%) | |ADJUSTED (b) | 81.6% 65.1% 71.1% 76.5% | 75.0% 59.0% 43.5% 67.3% | |TERMINAL (d) | 34/43 (79%) 20/36 (56%) 15/29 (52%) 24/35 (69%) | 27/39 (69%) 24/42 (57%) 17/44 (39%) 26/41 (63%) | |FIRST INCIDENCE (DAYS) | 496 432 389 399 | 480 439 521 609 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.296 P=0.258N P=0.215 P=0.405 | P=0.474N P=0.024N* P=0.002N** P=0.169N | |INCIDENTAL TUMOR | P=0.386N P=0.024N* P=0.034N* P=0.187N | P=0.411N P=0.039N* P=0.001N** P=0.189N | |LOGISTIC REGRESSION | P=0.436N P=0.038N* P=0.078N P=0.229N | P=0.443N P=0.036N* P=0.002N** P=0.143N | |COCHRAN-ARMITAGE | P=0.546N | P=0.512N | |FISHER EXACT | P=0.033N* P=0.178N P=0.241N | P=0.032N* P=0.002N** P=0.198N | |=================================================================================================================================| DATE: 09/03/94 EXPERIMENT: 05020 TEST: 02 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PARA-CHLOROANILINE TERMINAL SACRIFICE AT 104 WEEKS (a) Number of tumor-bearing animals / number of animals examined at site. (b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for intercurrent mortality. (d) Observed incidence at terminal kill. (f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between the controls and that dosed group. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. The incidental tumor test regards these lesions as non-fatal. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fisher's exact tests compare directly the overall incidence rates. For all tests, a negative trend is indicated by "N". (e) Value of Statistic cannot be computed. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01).