TDMS Study 05092-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst O-NITROANISOLE DATE: 09/12/94 EXPERIMENT: 05092 TEST: 01 TIME: 16:30:04 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-45038 ROUTE: DOSED FEED NTP C#: C60388 PATHOLOGIST: R. THOMPSON S. EUSTIS CAS: 0091-23-6 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst O-NITROANISOLE DATE: 09/12/94 EXPERIMENT: 05092 TEST: 01 TIME: 16:30:04 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-45038 ROUTE: DOSED FEED NTP C#: C60388 PATHOLOGIST: R. THOMPSON S. EUSTIS CAS: 0091-23-6 RATS(FISCHER344) ---------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED. ---------------- Adrenal Gland Bone Marrow Brain Clitoral Gland Epididymis Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst O-NITROANISOLE DATE: 09/12/94 EXPERIMENT: 05092 TEST: 01 TIME: 16:30:04 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-45038 ROUTE: DOSED FEED NTP C#: C60388 PATHOLOGIST: R. THOMPSON S. EUSTIS CAS: 0091-23-6 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF O-NITROANISOLE ==================================================================================================== MALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma Malignant Pheochromocytoma: Benign, Complex, Malignant, NOS Clitoral/Preputial Gland Carcinoma Carcinoma or Adenoma Kidney: Renal Tubule Carcinoma Carcinoma or Adenoma Lung Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Pancreas Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma Stomach, Forestomach Squamous Cell Carcinoma or Papilloma Squamous Testes Adenoma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst O-NITROANISOLE DATE: 09/12/94 EXPERIMENT: 05092 TEST: 01 TIME: 16:30:04 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-45038 ROUTE: DOSED FEED NTP C#: C60388 PATHOLOGIST: R. THOMPSON S. EUSTIS CAS: 0091-23-6 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF O-NITROANISOLE ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Liver Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Mammary Gland Fibroadenoma Fibroma, Fibroadenoma or Adenoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma Pancreas Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Malignant Tumors ==================================================================================================== DATE: 09/12/94 EXPERIMENT: 05092 TEST: 01 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-NITROANISOLE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.0222% 0.0666% 0.200% | 0.0% 0.0222% 0.0666% 0.200% | | | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/58 (3%) 0/60 (0%) 1/60 (2%) 0/59 (0%) | 1/60 (2%) 5/60 (8%) 0/60 (0%) 2/60 (3%) | |ADJUSTED (b) | 6.7% 0.0% 4.2% 0.0% | 2.5% 12.2% 0.0% 6.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 2/30 (7%) 0/34 (0%) 1/24 (4%) 0/9 (0%) | 0/33 (0%) 5/41 (12%) 0/26 (0%) 2/33 (6%) | |FIRST INCIDENCE (DAYS) | 728 (T) --- 728 (T) --- | 687 728 (T) --- 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.520N P=0.211N P=0.578N P=0.526N | P=0.541N P=0.156 P=0.557N P=0.491 | |INCIDENTAL TUMOR | P=0.520N P=0.211N P=0.578N P=0.526N | P=0.543N P=0.118 P=0.545N P=0.459 | |LOGISTIC REGRESSION | P=0.520N P=0.211N P=0.578N P=0.526N | P=0.539N P=0.129 P=0.519N P=0.489 | |COCHRAN-ARMITAGE | P=0.265N | P=0.500N | |FISHER EXACT | P=0.239N P=0.487N P=0.244N | P=0.103 P=0.500N P=0.500 | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/59 (12%) 7/60 (12%) 8/60 (13%) 10/59 (17%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 1/59 (2%) | |ADJUSTED (b) | 18.9% 20.6% 25.8% 73.0% | 3.0% 0.0% 0.0% 3.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 3/31 (10%) 7/34 (21%) 3/24 (13%) 6/9 (67%) | 1/33 (3%) 0/41 (0%) 0/26 (0%) 1/32 (3%) | |FIRST INCIDENCE (DAYS) | 669 728 (T) 604 613 | 728 (T) --- --- 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.563N P=0.352 P=0.003 ** | P=0.513 P=0.457N P=0.548N P=0.755 | |INCIDENTAL TUMOR | P=0.054 P=0.587 P=0.571N P=0.090 | P=0.513 P=0.457N P=0.548N P=0.755 | |LOGISTIC REGRESSION | P=0.017 * P=0.597N P=0.473 P=0.042 * | P=0.513 P=0.457N P=0.548N P=0.755 | |COCHRAN-ARMITAGE | P=0.217 | P=0.537 | |FISHER EXACT | P=0.598N P=0.514 P=0.301 | P=0.500N P=0.500N P=0.748 | |=================================================================================================================================| DATE: 09/12/94 EXPERIMENT: 05092 TEST: 01 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-NITROANISOLE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.0222% 0.0666% 0.200% | 0.0% 0.0222% 0.0666% 0.200% | | | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/59 (10%) 3/60 (5%) 2/60 (3%) 0/59 (0%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 1/59 (2%) | |ADJUSTED (b) | 18.2% 8.4% 7.7% 0.0% | 0.0% 0.0% 2.6% 3.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 5/31 (16%) 2/34 (6%) 1/24 (4%) 0/9 (0%) | 0/33 (0%) 0/41 (0%) 0/26 (0%) 1/32 (3%) | |FIRST INCIDENCE (DAYS) | 669 682 718 --- | --- --- 613 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.119N P=0.213N P=0.224N P=0.173N | P=0.289 (e) P=0.467 P=0.494 | |INCIDENTAL TUMOR | P=0.044N* P=0.245N P=0.151N P=0.107N | P=0.364 (e) P=0.739 P=0.494 | |LOGISTIC REGRESSION | P=0.058N P=0.227N P=0.165N P=0.094N | P=0.298 (e) P=0.511 P=0.494 | |COCHRAN-ARMITAGE | P=0.018N* | P=0.302 | |FISHER EXACT | P=0.237N P=0.131N P=0.014N* | (e) P=0.500 P=0.496 | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/59 (20%) 10/60 (17%) 10/60 (17%) 10/59 (17%) | 1/60 (2%) 0/60 (0%) 1/60 (2%) 2/59 (3%) | |ADJUSTED (b) | 32.2% 28.5% 31.9% 73.0% | 3.0% 0.0% 2.6% 6.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 7/31 (23%) 9/34 (26%) 4/24 (17%) 6/9 (67%) | 1/33 (3%) 0/41 (0%) 0/26 (0%) 2/32 (6%) | |FIRST INCIDENCE (DAYS) | 669 682 604 613 | 728 (T) --- 613 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.007 ** P=0.346N P=0.568 P=0.030 * | P=0.211 P=0.457N P=0.715 P=0.489 | |INCIDENTAL TUMOR | P=0.308 P=0.433N P=0.285N P=0.350 | P=0.256 P=0.457N P=0.672N P=0.489 | |LOGISTIC REGRESSION | P=0.157 P=0.379N P=0.449N P=0.252 | P=0.217 P=0.457N P=0.751 P=0.489 | |COCHRAN-ARMITAGE | P=0.441N | P=0.230 | |FISHER EXACT | P=0.390N P=0.390N P=0.407N | P=0.500N P=0.752N P=0.494 | |=================================================================================================================================| DATE: 09/12/94 EXPERIMENT: 05092 TEST: 01 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-NITROANISOLE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.0222% 0.0666% 0.200% | 0.0% 0.0222% 0.0666% 0.200% | | | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | |=================================================================================================================================| | | |Bone | | Chondroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 5.1% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/32 (0%) 1/34 (3%) 0/24 (0%) 0/9 (0%) | 0/33 (0%) 0/41 (0%) 0/26 (0%) 0/33 (0%) | |FIRST INCIDENCE (DAYS) | --- 638 --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.540N P=0.252 (e) (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.342N P=0.246 (e) (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.427N P=0.235 (e) (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.380N | (e) | |FISHER EXACT | P=0.248 (e) (e) | (e) (e) (e) | |=================================================================================================================================| | | |Brain | | Oligodendroglioma, Glioma, or Astrocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/60 (3%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 4.8% 0.0% 0.0% 2.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/32 (0%) 0/34 (0%) 0/24 (0%) 0/9 (0%) | 0/33 (0%) 0/41 (0%) 0/26 (0%) 0/33 (0%) | |FIRST INCIDENCE (DAYS) | 458 (I) --- --- 481 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.673 P=0.237N P=0.261N P=0.617N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.456N P=0.279N P=0.183N P=0.319N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.584N P=0.210N P=0.228N P=0.395N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.646N | (e) | |FISHER EXACT | P=0.248N P=0.248N P=0.500N | (e) (e) (e) | |=================================================================================================================================| DATE: 09/12/94 EXPERIMENT: 05092 TEST: 01 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-NITROANISOLE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.0222% 0.0666% 0.200% | 0.0% 0.0222% 0.0666% 0.200% | | | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/60 (7%) 0/60 (0%) 1/60 (2%) 1/59 (2%) | 3/55 (5%) 5/57 (9%) 4/60 (7%) 3/58 (5%) | |ADJUSTED (b) | 11.3% 0.0% 4.2% 5.6% | 10.0% 13.2% 11.6% 9.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/9 (0%) | |TERMINAL (d) | 3/32 (9%) 0/34 (0%) 1/24 (4%) 0/9 (0%) | 3/30 (10%) 5/38 (13%) 1/26 (4%) 3/31 (10%) | |FIRST INCIDENCE (DAYS) | 603 --- 728 (T) 686 | 728 (T) 728 (T) 456 (I) 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.620N P=0.060N P=0.257N P=0.523N | P=0.492N P=0.491 P=0.421 P=0.650N | |INCIDENTAL TUMOR | P=0.413N P=0.059N P=0.244N P=0.296N | P=0.482N P=0.491 P=0.456 P=0.650N | |LOGISTIC REGRESSION | P=0.442N P=0.065N P=0.199N P=0.332N | P=0.454N P=0.491 P=0.515 P=0.650N | |COCHRAN-ARMITAGE | P=0.303N | P=0.424N | |FISHER EXACT | P=0.059N P=0.182N P=0.187N | P=0.378 P=0.549 P=0.635N | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/60 (12%) 5/60 (8%) 4/60 (7%) 9/59 (15%) | 4/55 (7%) 1/57 (2%) 3/60 (5%) 2/58 (3%) | |ADJUSTED (b) | 19.4% 13.5% 10.5% 46.1% | 11.9% 2.6% 9.4% 6.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 1/10 (10%) 1/9 (11%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 5/32 (16%) 4/34 (12%) 1/24 (4%) 3/9 (33%) | 3/30 (10%) 1/38 (3%) 1/26 (4%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | 599 458 (I) 458 (I) 457 (I) | 518 728 (T) 641 722 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.005 ** P=0.358N P=0.383N P=0.023 * | P=0.483N P=0.128N P=0.579N P=0.329N | |INCIDENTAL TUMOR | P=0.096 P=0.370N P=0.283N P=0.194 | P=0.404N P=0.161N P=0.443N P=0.322N | |LOGISTIC REGRESSION | P=0.137 P=0.390N P=0.272N P=0.235 | P=0.443N P=0.159N P=0.483N P=0.319N | |COCHRAN-ARMITAGE | P=0.191 | P=0.426N | |FISHER EXACT | P=0.381N P=0.264N P=0.381 | P=0.171N P=0.451N P=0.314N | |=================================================================================================================================| DATE: 09/12/94 EXPERIMENT: 05092 TEST: 01 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-NITROANISOLE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.0222% 0.0666% 0.200% | 0.0% 0.0222% 0.0666% 0.200% | | | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/60 (18%) 5/60 (8%) 5/60 (8%) 10/59 (17%) | 7/55 (13%) 6/57 (11%) 6/60 (10%) 5/58 (9%) | |ADJUSTED (b) | 29.9% 13.5% 14.4% 49.1% | 21.7% 15.8% 17.6% 15.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 1/10 (10%) 1/9 (11%) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/9 (0%) | |TERMINAL (d) | 8/32 (25%) 4/34 (12%) 2/24 (8%) 3/9 (33%) | 6/30 (20%) 6/38 (16%) 2/26 (8%) 4/31 (13%) | |FIRST INCIDENCE (DAYS) | 599 458 (I) 458 (I) 457 (I) | 518 728 (T) 456 (I) 722 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.010 * P=0.079N P=0.185N P=0.060 | P=0.410N P=0.333N P=0.603N P=0.360N | |INCIDENTAL TUMOR | P=0.179 P=0.081N P=0.120N P=0.410 | P=0.356N P=0.371N P=0.491N P=0.354N | |LOGISTIC REGRESSION | P=0.232 P=0.092N P=0.098N P=0.447 | P=0.359N P=0.406N P=0.479N P=0.354N | |COCHRAN-ARMITAGE | P=0.349 | P=0.328N | |FISHER EXACT | P=0.089N P=0.089N P=0.517N | P=0.472N P=0.433N P=0.344N | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Squamous Cell Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/60 (3%) 0/60 (0%) 0/60 (0%) 0/59 (0%) | 0/55 (0%) 0/57 (0%) 0/60 (0%) 0/58 (0%) | |ADJUSTED (b) | 5.5% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/32 (0%) 0/34 (0%) 0/24 (0%) 0/9 (0%) | 0/30 (0%) 0/38 (0%) 0/26 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 676 --- --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.350N P=0.237N P=0.274N P=0.431N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.155N P=0.316N P=0.128N P=0.139N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.272N P=0.241N P=0.245N P=0.314N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.241N | (e) | |FISHER EXACT | P=0.248N P=0.248N P=0.252N | (e) (e) (e) | |=================================================================================================================================| DATE: 09/12/94 EXPERIMENT: 05092 TEST: 01 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-NITROANISOLE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.0222% 0.0666% 0.200% | 0.0% 0.0222% 0.0666% 0.200% | | | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/59 (2%) 4/59 (7%) 4/60 (7%) 2/58 (3%) | 2/60 (3%) 1/60 (2%) 2/59 (3%) 0/60 (0%) | |ADJUSTED (b) | 3.1% 11.8% 11.9% 5.9% | 5.4% 2.2% 5.8% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/32 (3%) 4/34 (12%) 1/24 (4%) 0/9 (0%) | 1/33 (3%) 0/41 (0%) 0/26 (0%) 0/33 (0%) | |FIRST INCIDENCE (DAYS) | 728 (T) 728 (T) 596 518 | 673 672 633 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.257 P=0.197 P=0.140 P=0.307 | P=0.242N P=0.456N P=0.608 P=0.251N | |INCIDENTAL TUMOR | P=0.606N P=0.197 P=0.230 P=0.564 | P=0.190N P=0.635N P=0.671N P=0.279N | |LOGISTIC REGRESSION | P=0.550 P=0.197 P=0.176 P=0.492 | P=0.211N P=0.489N P=0.663 P=0.243N | |COCHRAN-ARMITAGE | P=0.554N | P=0.209N | |FISHER EXACT | P=0.182 P=0.187 P=0.494 | P=0.500N P=0.684 P=0.248N | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/59 (2%) 4/59 (7%) 4/60 (7%) 2/58 (3%) | 2/60 (3%) 1/60 (2%) 3/59 (5%) 0/60 (0%) | |ADJUSTED (b) | 3.1% 11.8% 11.9% 5.9% | 5.4% 2.2% 8.2% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/32 (3%) 4/34 (12%) 1/24 (4%) 0/9 (0%) | 1/33 (3%) 0/41 (0%) 0/26 (0%) 0/33 (0%) | |FIRST INCIDENCE (DAYS) | 728 (T) 728 (T) 596 518 | 673 672 610 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.257 P=0.197 P=0.140 P=0.307 | P=0.255N P=0.456N P=0.407 P=0.251N | |INCIDENTAL TUMOR | P=0.606N P=0.197 P=0.230 P=0.564 | P=0.166N P=0.635N P=0.626 P=0.279N | |LOGISTIC REGRESSION | P=0.550 P=0.197 P=0.176 P=0.492 | P=0.153N P=0.489N P=0.472 P=0.243N | |COCHRAN-ARMITAGE | P=0.554N | P=0.221N | |FISHER EXACT | P=0.182 P=0.187 P=0.494 | P=0.500N P=0.492 P=0.248N | |=================================================================================================================================| DATE: 09/12/94 EXPERIMENT: 05092 TEST: 01 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-NITROANISOLE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.0222% 0.0666% 0.200% | 0.0% 0.0222% 0.0666% 0.200% | | | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | |=================================================================================================================================| | | |Islets, Pancreatic | | Mixed Tumor Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/59 (0%) 0/59 (0%) 2/60 (3%) 1/58 (2%) | 0/60 (0%) 0/60 (0%) 0/59 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 5.4% 11.1% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/32 (0%) 0/34 (0%) 0/24 (0%) 1/9 (11%) | 0/33 (0%) 0/41 (0%) 0/26 (0%) 0/33 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 667 728 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.138 (e) P=0.211 P=0.249 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.393 (e) P=0.385 P=0.249 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.269 (e) P=0.239 P=0.249 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.349 | (e) | |FISHER EXACT | (e) P=0.252 P=0.496 | (e) (e) (e) | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/59 (0%) 0/60 (0%) 0/60 (0%) 2/59 (3%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 17.9% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/32 (0%) 0/34 (0%) 0/24 (0%) 1/9 (11%) | 0/33 (0%) 0/41 (0%) 0/26 (0%) 0/33 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 697 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.002 ** (e) (e) P=0.051 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.021 * (e) (e) P=0.153 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.007 ** (e) (e) P=0.088 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.041 * | (e) | |FISHER EXACT | (e) (e) P=0.248 | (e) (e) (e) | |=================================================================================================================================| DATE: 09/12/94 EXPERIMENT: 05092 TEST: 01 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-NITROANISOLE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.0222% 0.0666% 0.200% | 0.0% 0.0222% 0.0666% 0.200% | | | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/59 (0%) 1/60 (2%) 1/60 (2%) 3/59 (5%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 2.9% 4.2% 21.9% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/32 (0%) 1/34 (3%) 1/24 (4%) 1/9 (11%) | 0/33 (0%) 0/41 (0%) 0/26 (0%) 0/33 (0%) | |FIRST INCIDENCE (DAYS) | --- 728 (T) 728 (T) 663 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.001 ** P=0.512 P=0.443 P=0.016 * | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.017 * P=0.512 P=0.443 P=0.097 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.010 * P=0.512 P=0.443 P=0.046 * | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.063 | (e) | |FISHER EXACT | P=0.504 P=0.504 P=0.122 | (e) (e) (e) | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 3/60 (5%) 1/60 (2%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 3/60 (5%) | |ADJUSTED (b) | 0.0% 8.8% 4.2% 12.4% | 0.0% 0.0% 0.0% 9.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/32 (0%) 3/34 (9%) 1/24 (4%) 0/9 (0%) | 0/33 (0%) 0/41 (0%) 0/26 (0%) 3/33 (9%) | |FIRST INCIDENCE (DAYS) | --- 728 (T) 728 (T) 604 | --- --- --- 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.096 P=0.131 P=0.443 P=0.106 | P=0.008 ** (e) (e) P=0.120 | |INCIDENTAL TUMOR | P=0.277 P=0.131 P=0.443 P=0.420 | P=0.008 ** (e) (e) P=0.120 | |LOGISTIC REGRESSION | P=0.238 P=0.131 P=0.443 P=0.196 | P=0.008 ** (e) (e) P=0.120 | |COCHRAN-ARMITAGE | P=0.430 | P=0.009 ** | |FISHER EXACT | P=0.122 P=0.500 P=0.248 | (e) (e) P=0.122 | |=================================================================================================================================| DATE: 09/12/94 EXPERIMENT: 05092 TEST: 01 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-NITROANISOLE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.0222% 0.0666% 0.200% | 0.0% 0.0222% 0.0666% 0.200% | | | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 4/60 (7%) 1/60 (2%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 3/60 (5%) | |ADJUSTED (b) | 0.0% 11.8% 4.2% 12.4% | 0.0% 0.0% 0.0% 9.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/32 (0%) 4/34 (12%) 1/24 (4%) 0/9 (0%) | 0/33 (0%) 0/41 (0%) 0/26 (0%) 3/33 (9%) | |FIRST INCIDENCE (DAYS) | --- 728 (T) 728 (T) 604 | --- --- --- 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.137 P=0.070 P=0.443 P=0.106 | P=0.008 ** (e) (e) P=0.120 | |INCIDENTAL TUMOR | P=0.328 P=0.070 P=0.443 P=0.420 | P=0.008 ** (e) (e) P=0.120 | |LOGISTIC REGRESSION | P=0.303 P=0.070 P=0.443 P=0.196 | P=0.008 ** (e) (e) P=0.120 | |COCHRAN-ARMITAGE | P=0.533 | P=0.009 ** | |FISHER EXACT | P=0.059 P=0.500 P=0.248 | (e) (e) P=0.122 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 4/60 (7%) 1/60 (2%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 3/60 (5%) | |ADJUSTED (b) | 0.0% 11.8% 4.2% 12.4% | 0.0% 0.0% 0.0% 9.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/32 (0%) 4/34 (12%) 1/24 (4%) 0/9 (0%) | 0/33 (0%) 0/41 (0%) 0/26 (0%) 3/33 (9%) | |FIRST INCIDENCE (DAYS) | --- 728 (T) 728 (T) 604 | --- --- --- 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.137 P=0.070 P=0.443 P=0.106 | P=0.008 ** (e) (e) P=0.120 | |INCIDENTAL TUMOR | P=0.328 P=0.070 P=0.443 P=0.420 | P=0.008 ** (e) (e) P=0.120 | |LOGISTIC REGRESSION | P=0.303 P=0.070 P=0.443 P=0.196 | P=0.008 ** (e) (e) P=0.120 | |COCHRAN-ARMITAGE | P=0.533 | P=0.009 ** | |FISHER EXACT | P=0.059 P=0.500 P=0.248 | (e) (e) P=0.122 | |=================================================================================================================================| DATE: 09/12/94 EXPERIMENT: 05092 TEST: 01 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-NITROANISOLE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.0222% 0.0666% 0.200% | 0.0% 0.0222% 0.0666% 0.200% | | | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/60 (5%) 3/60 (5%) 2/60 (3%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 3/60 (5%) 3/60 (5%) | |ADJUSTED (b) | 6.9% 7.3% 8.3% 0.0% | 0.0% 0.0% 9.4% 7.8% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 1/10 (10%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/9 (0%) | |TERMINAL (d) | 1/32 (3%) 1/34 (3%) 2/24 (8%) 0/9 (0%) | 0/33 (0%) 0/41 (0%) 2/26 (8%) 1/33 (3%) | |FIRST INCIDENCE (DAYS) | 458 (I) 457 (I) 728 (T) --- | --- --- 456 (I) 604 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.185N P=0.648N P=0.577N P=0.200N | P=0.050 * (e) P=0.096 P=0.126 | |INCIDENTAL TUMOR | P=0.096N P=0.643 P=0.577N P=0.104N | P=0.059 (e) P=0.096 P=0.138 | |LOGISTIC REGRESSION | P=0.067N P=0.630N P=0.493N P=0.075N | P=0.054 (e) P=0.121 P=0.118 | |COCHRAN-ARMITAGE | P=0.075N | P=0.055 | |FISHER EXACT | P=0.660N P=0.500N P=0.122N | (e) P=0.122 P=0.122 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/60 (7%) 4/60 (7%) 3/60 (5%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 3/60 (5%) 3/60 (5%) | |ADJUSTED (b) | 9.9% 10.1% 12.5% 0.0% | 0.0% 0.0% 9.4% 7.8% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 1/10 (10%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/9 (0%) | |TERMINAL (d) | 2/32 (6%) 2/34 (6%) 3/24 (13%) 0/9 (0%) | 0/33 (0%) 0/41 (0%) 2/26 (8%) 1/33 (3%) | |FIRST INCIDENCE (DAYS) | 458 (I) 457 (I) 728 (T) --- | --- --- 456 (I) 604 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.163N P=0.622N P=0.610N P=0.160N | P=0.050 * (e) P=0.096 P=0.126 | |INCIDENTAL TUMOR | P=0.088N P=0.633 P=0.610N P=0.086N | P=0.059 (e) P=0.096 P=0.138 | |LOGISTIC REGRESSION | P=0.044N* P=0.630N P=0.502N P=0.047N* | P=0.054 (e) P=0.121 P=0.118 | |COCHRAN-ARMITAGE | P=0.040N* | P=0.055 | |FISHER EXACT | P=0.641N P=0.500N P=0.059N | (e) P=0.122 P=0.122 | |=================================================================================================================================| DATE: 09/12/94 EXPERIMENT: 05092 TEST: 01 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-NITROANISOLE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.0222% 0.0666% 0.200% | 0.0% 0.0222% 0.0666% 0.200% | | | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 2/60 (3%) 0/60 (0%) 2/60 (3%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 6.1% 0.0% 5.2% 2.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/32 (0%) 0/34 (0%) 0/24 (0%) 0/9 (0%) | 2/33 (6%) 0/41 (0%) 0/26 (0%) 0/33 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 728 (T) --- 536 476 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.610N P=0.192N P=0.623 P=0.500N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.547N P=0.192N P=0.650 P=0.474N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.584N P=0.192N P=0.681 P=0.499N | |COCHRAN-ARMITAGE | (e) | P=0.590N | |FISHER EXACT | (e) (e) (e) | P=0.248N P=0.691N P=0.500N | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) | 3/60 (5%) 0/60 (0%) 2/60 (3%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 2.9% 0.0% 0.0% | 9.1% 0.0% 5.2% 2.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/32 (0%) 1/34 (3%) 0/24 (0%) 0/9 (0%) | 3/33 (9%) 0/41 (0%) 0/26 (0%) 0/33 (0%) | |FIRST INCIDENCE (DAYS) | --- 728 (T) --- --- | 728 (T) --- 536 476 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.800N P=0.512 (e) (e) | P=0.456N P=0.086N P=0.590N P=0.306N | |INCIDENTAL TUMOR | P=0.800N P=0.512 (e) (e) | P=0.399N P=0.086N P=0.564N P=0.287N | |LOGISTIC REGRESSION | P=0.800N P=0.512 (e) (e) | P=0.428N P=0.086N P=0.531N P=0.308N | |COCHRAN-ARMITAGE | P=0.585N | P=0.430N | |FISHER EXACT | P=0.500 (e) (e) | P=0.122N P=0.500N P=0.309N | |=================================================================================================================================| DATE: 09/12/94 EXPERIMENT: 05092 TEST: 01 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-NITROANISOLE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.0222% 0.0666% 0.200% | 0.0% 0.0222% 0.0666% 0.200% | | | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 1/60 (2%) 2/60 (3%) 1/60 (2%) | 17/60 (28%) 18/60 (30%) 15/60 (25%) 9/60 (15%) | |ADJUSTED (b) | 9.1% 2.9% 6.3% 7.7% | 44.3% 40.5% 49.3% 25.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 2/32 (6%) 1/34 (3%) 1/24 (4%) 0/9 (0%) | 13/33 (39%) 15/41 (37%) 12/26 (46%) 7/33 (21%) | |FIRST INCIDENCE (DAYS) | 716 728 (T) 632 697 | 438 436 416 634 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.586 P=0.285N P=0.590N P=0.698 | P=0.049N* P=0.396N P=0.480 P=0.064N | |INCIDENTAL TUMOR | P=0.410N P=0.321N P=0.517N P=0.411N | P=0.024N* P=0.545 P=0.590N P=0.043N* | |LOGISTIC REGRESSION | P=0.548N P=0.292N P=0.534N P=0.627N | P=0.034N* P=0.561 P=0.522N P=0.065N | |COCHRAN-ARMITAGE | P=0.340N | P=0.027N* | |FISHER EXACT | P=0.309N P=0.500N P=0.309N | P=0.500 P=0.418N P=0.060N | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 2/60 (3%) 2/60 (3%) 1/60 (2%) | 17/60 (28%) 18/60 (30%) 15/60 (25%) 9/60 (15%) | |ADJUSTED (b) | 9.1% 5.9% 6.3% 7.7% | 44.3% 40.5% 49.3% 25.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 2/32 (6%) 2/34 (6%) 1/24 (4%) 0/9 (0%) | 13/33 (39%) 15/41 (37%) 12/26 (46%) 7/33 (21%) | |FIRST INCIDENCE (DAYS) | 716 728 (T) 632 697 | 438 436 416 634 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.627 P=0.473N P=0.590N P=0.698 | P=0.049N* P=0.396N P=0.480 P=0.064N | |INCIDENTAL TUMOR | P=0.374N P=0.510N P=0.517N P=0.411N | P=0.024N* P=0.545 P=0.590N P=0.043N* | |LOGISTIC REGRESSION | P=0.488N P=0.484N P=0.534N P=0.627N | P=0.034N* P=0.561 P=0.522N P=0.065N | |COCHRAN-ARMITAGE | P=0.268N | P=0.027N* | |FISHER EXACT | P=0.500N P=0.500N P=0.309N | P=0.500 P=0.418N P=0.060N | |=================================================================================================================================| DATE: 09/12/94 EXPERIMENT: 05092 TEST: 01 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-NITROANISOLE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.0222% 0.0666% 0.200% | 0.0% 0.0222% 0.0666% 0.200% | | | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 2/60 (3%) 2/60 (3%) 1/60 (2%) | 18/60 (30%) 18/60 (30%) 17/60 (28%) 10/60 (17%) | |ADJUSTED (b) | 9.1% 5.9% 6.3% 7.7% | 47.1% 40.5% 51.9% 26.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 2/32 (6%) 2/34 (6%) 1/24 (4%) 0/9 (0%) | 14/33 (42%) 15/41 (37%) 12/26 (46%) 7/33 (21%) | |FIRST INCIDENCE (DAYS) | 716 728 (T) 632 697 | 438 436 416 476 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.627 P=0.473N P=0.590N P=0.698 | P=0.067N P=0.314N P=0.379 P=0.071N | |INCIDENTAL TUMOR | P=0.374N P=0.510N P=0.517N P=0.411N | P=0.029N* P=0.531N P=0.491 P=0.044N* | |LOGISTIC REGRESSION | P=0.488N P=0.484N P=0.534N P=0.627N | P=0.044N* P=0.518N P=0.562 P=0.070N | |COCHRAN-ARMITAGE | P=0.268N | P=0.036N* | |FISHER EXACT | P=0.500N P=0.500N P=0.309N | P=0.579N P=0.500N P=0.065N | |=================================================================================================================================| | | |Pancreas | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/59 (8%) 3/59 (5%) 0/60 (0%) 5/58 (9%) | 0/60 (0%) 0/60 (0%) 0/59 (0%) 2/60 (3%) | |ADJUSTED (b) | 15.6% 8.8% 0.0% 33.4% | 0.0% 0.0% 0.0% 6.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 5/32 (16%) 3/34 (9%) 0/24 (0%) 1/9 (11%) | 0/33 (0%) 0/41 (0%) 0/26 (0%) 2/33 (6%) | |FIRST INCIDENCE (DAYS) | 728 (T) 728 (T) --- 613 | --- --- --- 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.021 * P=0.321N P=0.062N P=0.070 | P=0.039 * (e) (e) P=0.238 | |INCIDENTAL TUMOR | P=0.158 P=0.321N P=0.062N P=0.353 | P=0.039 * (e) (e) P=0.238 | |LOGISTIC REGRESSION | P=0.106 P=0.321N P=0.062N P=0.231 | P=0.039 * (e) (e) P=0.238 | |COCHRAN-ARMITAGE | P=0.400 | P=0.042 * | |FISHER EXACT | P=0.358N P=0.027N* P=0.618 | (e) (e) P=0.248 | |=================================================================================================================================| DATE: 09/12/94 EXPERIMENT: 05092 TEST: 01 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-NITROANISOLE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.0222% 0.0666% 0.200% | 0.0% 0.0222% 0.0666% 0.200% | | | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 17/60 (28%) 12/60 (20%) 9/59 (15%) 4/59 (7%) | 28/60 (47%) 30/60 (50%) 28/60 (47%) 20/60 (33%) | |ADJUSTED (b) | 41.5% 31.1% 30.0% 17.0% | 66.3% 62.2% 67.0% 48.8% | |INTERIM SACRIFICE 1 (c)| 3/10 (30%) 1/10 (10%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 2/10 (20%) 1/10 (10%) 1/9 (11%) | |TERMINAL (d) | 10/32 (31%) 9/34 (26%) 5/23 (22%) 0/9 (0%) | 19/33 (58%) 23/41 (56%) 13/26 (50%) 13/33 (39%) | |FIRST INCIDENCE (DAYS) | 457 (I) 456 (I) 557 518 | 613 456 (I) 457 (I) 386 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.186N P=0.169N P=0.192N P=0.160N | P=0.119N P=0.335N P=0.216 P=0.124N | |INCIDENTAL TUMOR | P=0.008N** P=0.195N P=0.080N P=0.007N** | P=0.028N* P=0.385 P=0.576 P=0.093N | |LOGISTIC REGRESSION | P=0.007N** P=0.207N P=0.074N P=0.005N** | P=0.036N* P=0.526 P=0.574 P=0.102N | |COCHRAN-ARMITAGE | P=0.003N** | P=0.038N* | |FISHER EXACT | P=0.197N P=0.066N P=0.002N** | P=0.428 P=0.573N P=0.096N | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 18/60 (30%) 12/60 (20%) 10/59 (17%) 4/59 (7%) | 29/60 (48%) 30/60 (50%) 28/60 (47%) 20/60 (33%) | |ADJUSTED (b) | 44.2% 31.1% 32.5% 17.0% | 68.7% 62.2% 67.0% 48.8% | |INTERIM SACRIFICE 1 (c)| 3/10 (30%) 1/10 (10%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 2/10 (20%) 1/10 (10%) 1/9 (11%) | |TERMINAL (d) | 11/32 (34%) 9/34 (26%) 5/23 (22%) 0/9 (0%) | 20/33 (61%) 23/41 (56%) 13/26 (50%) 13/33 (39%) | |FIRST INCIDENCE (DAYS) | 457 (I) 456 (I) 557 518 | 613 456 (I) 457 (I) 386 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.177N P=0.123N P=0.214N P=0.136N | P=0.100N P=0.268N P=0.260 P=0.092N | |INCIDENTAL TUMOR | P=0.006N** P=0.142N P=0.082N P=0.006N** | P=0.021N* P=0.472 P=0.515N P=0.064N | |LOGISTIC REGRESSION | P=0.005N** P=0.154N P=0.082N P=0.003N** | P=0.036N* P=0.552N P=0.522N P=0.071N | |COCHRAN-ARMITAGE | P=0.002N** | P=0.030N* | |FISHER EXACT | P=0.146N P=0.071N P<0.001N** | P=0.500 P=0.500N P=0.068N | |=================================================================================================================================| DATE: 09/12/94 EXPERIMENT: 05092 TEST: 01 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-NITROANISOLE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.0222% 0.0666% 0.200% | 0.0% 0.0222% 0.0666% 0.200% | | | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 1/60 (2%) 0/60 (0%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 8.9% 2.9% 0.0% 10.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 2/32 (6%) 1/34 (3%) 0/24 (0%) 0/9 (0%) | 0/33 (0%) 0/41 (0%) 0/26 (0%) 0/33 (0%) | |FIRST INCIDENCE (DAYS) | 695 728 (T) --- 632 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.324 P=0.290N P=0.171N P=0.478 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.649 P=0.321N P=0.121N P=0.525N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.511 P=0.301N P=0.140N P=0.675 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.617N | (e) | |FISHER EXACT | P=0.309N P=0.122N P=0.500N | (e) (e) (e) | |=================================================================================================================================| | | |Skin | | Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 5.2% 0.0% 0.0% 11.1% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/32 (3%) 0/34 (0%) 0/24 (0%) 1/9 (11%) | 0/33 (0%) 0/41 (0%) 0/26 (0%) 0/33 (0%) | |FIRST INCIDENCE (DAYS) | 603 --- --- 728 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.561 P=0.238N P=0.274N P=0.693 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.701 P=0.233N P=0.253N P=0.671N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.685 P=0.240N P=0.240N P=0.627N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.646N | (e) | |FISHER EXACT | P=0.248N P=0.248N P=0.500N | (e) (e) (e) | |=================================================================================================================================| DATE: 09/12/94 EXPERIMENT: 05092 TEST: 01 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-NITROANISOLE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.0222% 0.0666% 0.200% | 0.0% 0.0222% 0.0666% 0.200% | | | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | |=================================================================================================================================| | | |Skin | | Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, | | Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 6/60 (10%) 2/60 (3%) 1/60 (2%) 3/60 (5%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 16.8% 5.9% 3.8% 20.0% | 3.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 4/32 (13%) 2/34 (6%) 0/24 (0%) 1/9 (11%) | 1/33 (3%) 0/41 (0%) 0/26 (0%) 0/33 (0%) | |FIRST INCIDENCE (DAYS) | 603 728 (T) 722 632 | 728 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.347 P=0.125N P=0.106N P=0.515 | P=0.486N P=0.457N P=0.548N P=0.500N | |INCIDENTAL TUMOR | P=0.476N P=0.136N P=0.057N P=0.395N | P=0.486N P=0.457N P=0.548N P=0.500N | |LOGISTIC REGRESSION | P=0.614 P=0.136N P=0.069N P=0.495N | P=0.486N P=0.457N P=0.548N P=0.500N | |COCHRAN-ARMITAGE | P=0.367N | P=0.472N | |FISHER EXACT | P=0.136N P=0.057N P=0.245N | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 3/60 (5%) 2/60 (3%) 1/60 (2%) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 3.1% 8.0% 6.3% 7.1% | 0.0% 4.9% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/32 (3%) 2/34 (6%) 1/24 (4%) 0/9 (0%) | 0/33 (0%) 2/41 (5%) 0/26 (0%) 0/33 (0%) | |FIRST INCIDENCE (DAYS) | 728 (T) 638 632 695 | --- 728 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.519 P=0.327 P=0.436 P=0.503 | P=0.400N P=0.287 (e) (e) | |INCIDENTAL TUMOR | P=0.466N P=0.323 P=0.451 P=0.708 | P=0.400N P=0.287 (e) (e) | |LOGISTIC REGRESSION | P=0.582N P=0.302 P=0.482 P=0.608 | P=0.400N P=0.287 (e) (e) | |COCHRAN-ARMITAGE | P=0.424N | P=0.380N | |FISHER EXACT | P=0.309 P=0.500 P=0.752N | P=0.248 (e) (e) | |=================================================================================================================================| DATE: 09/12/94 EXPERIMENT: 05092 TEST: 01 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-NITROANISOLE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.0222% 0.0666% 0.200% | 0.0% 0.0222% 0.0666% 0.200% | | | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 4.3% 0.0% 0.0% | 0.0% 2.4% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/32 (0%) 0/34 (0%) 0/24 (0%) 0/9 (0%) | 0/33 (0%) 1/41 (2%) 0/26 (0%) 0/33 (0%) | |FIRST INCIDENCE (DAYS) | --- 456 (I) --- --- | --- 728 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.457N P=0.246 (e) (e) | P=0.598N P=0.543 (e) (e) | |INCIDENTAL TUMOR | P=0.326N P=0.201 (e) (e) | P=0.598N P=0.543 (e) (e) | |LOGISTIC REGRESSION | P=0.345N P=0.261 (e) (e) | P=0.598N P=0.543 (e) (e) | |COCHRAN-ARMITAGE | P=0.380N | P=0.585N | |FISHER EXACT | P=0.248 (e) (e) | P=0.500 (e) (e) | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, Sarcoma, | | Neurofibroma, or Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 5/60 (8%) 2/60 (3%) 1/60 (2%) | 0/60 (0%) 3/60 (5%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 3.1% 12.0% 6.3% 7.1% | 0.0% 7.3% 2.2% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/32 (3%) 2/34 (6%) 1/24 (4%) 0/9 (0%) | 0/33 (0%) 3/41 (7%) 0/26 (0%) 0/33 (0%) | |FIRST INCIDENCE (DAYS) | 728 (T) 456 (I) 632 695 | --- 728 (T) 533 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.600N P=0.120 P=0.436 P=0.503 | P=0.302N P=0.162 P=0.500 (e) | |INCIDENTAL TUMOR | P=0.267N P=0.101 P=0.451 P=0.708 | P=0.273N P=0.162 P=0.545 (e) | |LOGISTIC REGRESSION | P=0.324N P=0.103 P=0.482 P=0.608 | P=0.289N P=0.162 P=0.541 (e) | |COCHRAN-ARMITAGE | P=0.271N | P=0.282N | |FISHER EXACT | P=0.103 P=0.500 P=0.752N | P=0.122 P=0.500 (e) | |=================================================================================================================================| DATE: 09/12/94 EXPERIMENT: 05092 TEST: 01 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-NITROANISOLE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.0222% 0.0666% 0.200% | 0.0% 0.0222% 0.0666% 0.200% | | | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, or Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 1/60 (2%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 4.3% 0.0% 0.0% | 0.0% 2.4% 2.2% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/32 (0%) 0/34 (0%) 0/24 (0%) 0/9 (0%) | 0/33 (0%) 1/41 (2%) 0/26 (0%) 0/33 (0%) | |FIRST INCIDENCE (DAYS) | --- 456 (I) --- --- | --- 728 (T) 533 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.457N P=0.246 (e) (e) | P=0.552N P=0.543 P=0.500 (e) | |INCIDENTAL TUMOR | P=0.326N P=0.201 (e) (e) | P=0.500N P=0.543 P=0.545 (e) | |LOGISTIC REGRESSION | P=0.345N P=0.261 (e) (e) | P=0.538N P=0.543 P=0.541 (e) | |COCHRAN-ARMITAGE | P=0.380N | P=0.540N | |FISHER EXACT | P=0.248 (e) (e) | P=0.500 P=0.500 (e) | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/59 (0%) 0/60 (0%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 3.1% 0.0% 0.0% 9.7% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/32 (3%) 0/34 (0%) 0/24 (0%) 0/9 (0%) | 0/33 (0%) 0/41 (0%) 0/26 (0%) 0/33 (0%) | |FIRST INCIDENCE (DAYS) | 728 (T) --- --- 518 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.064 P=0.488N P=0.557N P=0.260 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.275 P=0.488N P=0.557N P=0.566 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.179 P=0.488N P=0.557N P=0.468 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.193 | (e) | |FISHER EXACT | P=0.504N P=0.500N P=0.500 | (e) (e) (e) | |=================================================================================================================================| DATE: 09/12/94 EXPERIMENT: 05092 TEST: 01 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-NITROANISOLE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.0222% 0.0666% 0.200% | 0.0% 0.0222% 0.0666% 0.200% | | | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma or Papilloma Squamous | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 2/60 (3%) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 2/60 (3%) | |ADJUSTED (b) | 0.0% 0.0% 8.3% 15.3% | 0.0% 2.3% 0.0% 6.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/32 (0%) 0/34 (0%) 2/24 (8%) 1/9 (11%) | 0/33 (0%) 0/41 (0%) 0/26 (0%) 2/33 (6%) | |FIRST INCIDENCE (DAYS) | --- --- 728 (T) 663 | --- 727 --- 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.007 ** (e) P=0.177 P=0.066 | P=0.137 P=0.553 (e) P=0.238 | |INCIDENTAL TUMOR | P=0.023 * (e) P=0.177 P=0.153 | P=0.135 P=0.362 (e) P=0.238 | |LOGISTIC REGRESSION | P=0.029 * (e) P=0.177 P=0.133 | P=0.136 P=0.543 (e) P=0.238 | |COCHRAN-ARMITAGE | P=0.124 | P=0.149 | |FISHER EXACT | (e) P=0.248 P=0.248 | P=0.500 (e) P=0.248 | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 53/60 (88%) 51/60 (85%) 54/60 (90%) 52/60 (87%) | | |ADJUSTED (b) | 96.3% 98.0% 100.0% 100.0% | | |INTERIM SACRIFICE 1 (c)| 5/10 (50%) 6/10 (60%) 9/10 (90%) 7/9 (78%) | | |TERMINAL (d) | 30/32 (94%) 33/34 (97%) 24/24 (100%) 9/9 (100%) | | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 456 (I) 456 (I) | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.332N P=0.078 P<0.001 ** | | |INCIDENTAL TUMOR | P=0.173 P=0.511N P=0.439 P=0.493 | | |LOGISTIC REGRESSION | P=0.316 P=0.512N P=0.465 P=0.421 | | |COCHRAN-ARMITAGE | P=0.533N | | |FISHER EXACT | P=0.395N P=0.500 P=0.500N | | |=================================================================================================================================| DATE: 09/12/94 EXPERIMENT: 05092 TEST: 01 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-NITROANISOLE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.0222% 0.0666% 0.200% | 0.0% 0.0222% 0.0666% 0.200% | | | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/59 (2%) 2/60 (3%) 2/60 (3%) 0/60 (0%) | 5/60 (8%) 4/60 (7%) 2/60 (3%) 4/60 (7%) | |ADJUSTED (b) | 3.1% 5.9% 6.1% 0.0% | 15.2% 9.8% 7.7% 10.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/9 (11%) | |TERMINAL (d) | 1/32 (3%) 2/34 (6%) 0/24 (0%) 0/9 (0%) | 5/33 (15%) 4/41 (10%) 2/26 (8%) 2/33 (6%) | |FIRST INCIDENCE (DAYS) | 728 (T) 728 (T) 637 --- | 728 (T) 728 (T) 728 (T) 458 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.548N P=0.521 P=0.446 P=0.751N | P=0.564N P=0.365N P=0.319N P=0.512N | |INCIDENTAL TUMOR | P=0.289N P=0.521 P=0.545 P=0.751N | P=0.530N P=0.365N P=0.319N P=0.461N | |LOGISTIC REGRESSION | P=0.388N P=0.521 P=0.484 P=0.751N | P=0.541N P=0.365N P=0.319N P=0.512N | |COCHRAN-ARMITAGE | P=0.246N | P=0.508N | |FISHER EXACT | P=0.506 P=0.506 P=0.496N | P=0.500N P=0.219N P=0.500N | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/59 (2%) 2/60 (3%) 0/60 (0%) 1/60 (2%) | 2/60 (3%) 2/60 (3%) 2/60 (3%) 2/60 (3%) | |ADJUSTED (b) | 3.1% 5.4% 0.0% 2.5% | 5.3% 4.9% 5.7% 3.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 1/9 (11%) | |TERMINAL (d) | 1/32 (3%) 1/34 (3%) 0/24 (0%) 0/9 (0%) | 1/33 (3%) 2/41 (5%) 1/26 (4%) 0/33 (0%) | |FIRST INCIDENCE (DAYS) | 728 (T) 655 --- 589 | 669 728 (T) 457 (I) 458 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.596 P=0.505 P=0.557N P=0.609 | P=0.582 P=0.628N P=0.624 P=0.671 | |INCIDENTAL TUMOR | P=0.568N P=0.473 P=0.557N P=0.776 | P=0.607 P=0.695 P=0.629 P=0.671 | |LOGISTIC REGRESSION | P=0.620N P=0.498 P=0.557N P=0.741 | P=0.614N P=0.667N P=0.694 P=0.681N | |COCHRAN-ARMITAGE | P=0.555N | P=0.621 | |FISHER EXACT | P=0.506 P=0.496N P=0.748N | P=0.691N P=0.691N P=0.691N | |=================================================================================================================================| DATE: 09/12/94 EXPERIMENT: 05092 TEST: 01 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-NITROANISOLE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.0222% 0.0666% 0.200% | 0.0% 0.0222% 0.0666% 0.200% | | | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/59 (3%) 4/60 (7%) 2/60 (3%) 1/60 (2%) | 7/60 (12%) 6/60 (10%) 4/60 (7%) 6/60 (10%) | |ADJUSTED (b) | 6.3% 11.2% 6.1% 2.5% | 20.1% 14.6% 13.3% 13.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 2/9 (22%) | |TERMINAL (d) | 2/32 (6%) 3/34 (9%) 0/24 (0%) 0/9 (0%) | 6/33 (18%) 6/41 (15%) 3/26 (12%) 2/33 (6%) | |FIRST INCIDENCE (DAYS) | 728 (T) 655 637 589 | 669 728 (T) 457 (I) 458 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.611N P=0.355 P=0.624 P=0.699 | P=0.572 P=0.344N P=0.399N P=0.523N | |INCIDENTAL TUMOR | P=0.268N P=0.333 P=0.686N P=0.671N | P=0.533N P=0.385N P=0.396N P=0.481N | |LOGISTIC REGRESSION | P=0.361N P=0.337 P=0.673 P=0.609N | P=0.523N P=0.398N P=0.334N P=0.502N | |COCHRAN-ARMITAGE | P=0.237N | P=0.506N | |FISHER EXACT | P=0.348 P=0.684N P=0.494N | P=0.500N P=0.264N P=0.500N | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/59 (2%) 1/60 (2%) 2/60 (3%) 0/60 (0%) | 0/60 (0%) 2/60 (3%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 3.1% 2.2% 6.6% 0.0% | 0.0% 4.7% 3.8% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/32 (3%) 0/34 (0%) 1/24 (4%) 0/9 (0%) | 0/33 (0%) 1/41 (2%) 1/26 (4%) 0/33 (0%) | |FIRST INCIDENCE (DAYS) | 728 (T) 559 647 --- | --- 727 728 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.539N P=0.758N P=0.425 P=0.751N | P=0.412N P=0.294 P=0.452 (e) | |INCIDENTAL TUMOR | P=0.324N P=0.754N P=0.494 P=0.751N | P=0.413N P=0.186 P=0.452 (e) | |LOGISTIC REGRESSION | P=0.362N P=0.757N P=0.480 P=0.751N | P=0.409N P=0.289 P=0.452 (e) | |COCHRAN-ARMITAGE | P=0.330N | P=0.385N | |FISHER EXACT | P=0.748N P=0.506 P=0.496N | P=0.248 P=0.500 (e) | |=================================================================================================================================| DATE: 09/12/94 EXPERIMENT: 05092 TEST: 01 PAGE 22 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-NITROANISOLE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.0222% 0.0666% 0.200% | 0.0% 0.0222% 0.0666% 0.200% | | | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/59 (3%) 1/60 (2%) 2/60 (3%) 1/60 (2%) | 0/60 (0%) 2/60 (3%) 2/60 (3%) 0/60 (0%) | |ADJUSTED (b) | 6.3% 2.2% 6.6% 2.0% | 0.0% 4.7% 6.4% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 2/32 (6%) 0/34 (0%) 1/24 (4%) 0/9 (0%) | 0/33 (0%) 1/41 (2%) 1/26 (4%) 0/33 (0%) | |FIRST INCIDENCE (DAYS) | 728 (T) 559 647 491 | --- 727 630 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.587 P=0.491N P=0.608 P=0.717 | P=0.414N P=0.294 P=0.199 (e) | |INCIDENTAL TUMOR | P=0.413N P=0.486N P=0.666 P=0.610N | P=0.354N P=0.186 P=0.328 (e) | |LOGISTIC REGRESSION | P=0.487N P=0.500N P=0.669 P=0.528N | P=0.402N P=0.289 P=0.220 (e) | |COCHRAN-ARMITAGE | P=0.473N | P=0.386N | |FISHER EXACT | P=0.494N P=0.684N P=0.494N | P=0.248 P=0.248 (e) | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 12/60 (20%) 13/60 (22%) 8/60 (13%) 11/60 (18%) | |ADJUSTED (b) | | 28.2% 30.8% 25.6% 27.8% | |INTERIM SACRIFICE 1 (c)| | 3/10 (30%) 0/10 (0%) 0/10 (0%) 2/9 (22%) | |TERMINAL (d) | | 7/33 (21%) 12/41 (29%) 5/26 (19%) 7/33 (21%) | |FIRST INCIDENCE (DAYS) | | 438 646 533 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.522N P=0.495N P=0.369N P=0.535N | |INCIDENTAL TUMOR | | P=0.447N P=0.586N P=0.281N P=0.489N | |LOGISTIC REGRESSION | | P=0.444N P=0.510 P=0.232N P=0.492N | |COCHRAN-ARMITAGE | | P=0.424N | |FISHER EXACT | | P=0.500 P=0.232N P=0.500N | |=================================================================================================================================| DATE: 09/12/94 EXPERIMENT: 05092 TEST: 01 PAGE 23 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-NITROANISOLE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.0222% 0.0666% 0.200% | 0.0% 0.0222% 0.0666% 0.200% | | | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 0/60 (0%) 0/60 (0%) 3/60 (5%) 1/60 (2%) | |ADJUSTED (b) | | 0.0% 0.0% 8.5% 2.5% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | | 0/33 (0%) 0/41 (0%) 0/26 (0%) 0/33 (0%) | |FIRST INCIDENCE (DAYS) | | --- --- 459 647 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.370 (e) P=0.097 P=0.486 | |INCIDENTAL TUMOR | | P=0.390 (e) P=0.105 P=0.429 | |LOGISTIC REGRESSION | | P=0.393 (e) P=0.131 P=0.501 | |COCHRAN-ARMITAGE | | P=0.387 | |FISHER EXACT | | (e) P=0.122 P=0.500 | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 12/60 (20%) 13/60 (22%) 11/60 (18%) 12/60 (20%) | |ADJUSTED (b) | | 28.2% 30.8% 31.9% 29.6% | |INTERIM SACRIFICE 1 (c)| | 3/10 (30%) 0/10 (0%) 0/10 (0%) 2/9 (22%) | |TERMINAL (d) | | 7/33 (21%) 12/41 (29%) 5/26 (19%) 7/33 (21%) | |FIRST INCIDENCE (DAYS) | | 438 646 459 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.491 P=0.495N P=0.513 P=0.551 | |INCIDENTAL TUMOR | | P=0.539N P=0.586N P=0.572N P=0.584 | |LOGISTIC REGRESSION | | P=0.535N P=0.510 P=0.493N P=0.583N | |COCHRAN-ARMITAGE | | P=0.518N | |FISHER EXACT | | P=0.500 P=0.500N P=0.590N | |=================================================================================================================================| DATE: 09/12/94 EXPERIMENT: 05092 TEST: 01 PAGE 24 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-NITROANISOLE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.0222% 0.0666% 0.200% | 0.0% 0.0222% 0.0666% 0.200% | | | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 2/60 (3%) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 3.1% 0.0% 0.0% 9.7% | 0.0% 2.4% 0.0% 3.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/32 (3%) 0/34 (0%) 0/24 (0%) 0/9 (0%) | 0/33 (0%) 1/41 (2%) 0/26 (0%) 1/33 (3%) | |FIRST INCIDENCE (DAYS) | 728 (T) --- --- 518 | --- 728 (T) --- 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.064 P=0.488N P=0.557N P=0.260 | P=0.440 P=0.543 (e) P=0.500 | |INCIDENTAL TUMOR | P=0.275 P=0.488N P=0.557N P=0.566 | P=0.440 P=0.543 (e) P=0.500 | |LOGISTIC REGRESSION | P=0.177 P=0.488N P=0.557N P=0.468 | P=0.440 P=0.543 (e) P=0.500 | |COCHRAN-ARMITAGE | P=0.191 | P=0.460 | |FISHER EXACT | P=0.500N P=0.500N P=0.500 | P=0.500 (e) P=0.500 | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 0/60 (0%) 0/60 (0%) 2/60 (3%) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 6.3% 0.0% 0.0% 9.7% | 3.0% 2.4% 0.0% 3.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 2/32 (6%) 0/34 (0%) 0/24 (0%) 0/9 (0%) | 1/33 (3%) 1/41 (2%) 0/26 (0%) 1/33 (3%) | |FIRST INCIDENCE (DAYS) | 728 (T) --- --- 518 | 728 (T) 728 (T) --- 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.150 P=0.225N P=0.303N P=0.372 | P=0.653 P=0.713N P=0.548N P=0.762 | |INCIDENTAL TUMOR | P=0.400 P=0.225N P=0.303N P=0.656 | P=0.653 P=0.713N P=0.548N P=0.762 | |LOGISTIC REGRESSION | P=0.336 P=0.225N P=0.303N P=0.624 | P=0.653 P=0.713N P=0.548N P=0.762 | |COCHRAN-ARMITAGE | P=0.386 | P=0.676 | |FISHER EXACT | P=0.248N P=0.248N P=0.691N | P=0.752N P=0.500N P=0.752N | |=================================================================================================================================| DATE: 09/12/94 EXPERIMENT: 05092 TEST: 01 PAGE 25 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-NITROANISOLE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.0222% 0.0666% 0.200% | 0.0% 0.0222% 0.0666% 0.200% | | | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, | | or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 26/60 (43%) 26/60 (43%) 42/60 (70%) 36/60 (60%) | 14/60 (23%) 11/60 (18%) 15/60 (25%) 27/60 (45%) | |ADJUSTED (b) | 60.9% 60.7% 91.1% 89.4% | 32.7% 24.6% 38.3% 59.2% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 2/9 (22%) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/9 (0%) | |TERMINAL (d) | 16/32 (50%) 18/34 (53%) 20/24 (83%) 6/9 (67%) | 6/33 (18%) 8/41 (20%) 5/26 (19%) 15/33 (45%) | |FIRST INCIDENCE (DAYS) | 496 423 437 456 (I) | 494 533 302 407 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.514N P<0.001 ** P<0.001 ** | P<0.001 ** P=0.204N P=0.285 P=0.017 * | |INCIDENTAL TUMOR | P=0.034 * P=0.534 P=0.001 ** P=0.080 | P<0.001 ** P=0.531N P=0.557N P=0.007 ** | |LOGISTIC REGRESSION | P=0.024 * P=0.543 P=0.001 ** P=0.104 | P<0.001 ** P=0.596 P=0.460 P=0.008 ** | |COCHRAN-ARMITAGE | P=0.031 * | P<0.001 ** | |FISHER EXACT | P=0.573N P=0.003 ** P=0.050 * | P=0.327N P=0.500 P=0.010 * | |=================================================================================================================================| | | |All Organs | | Mesothelioma Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 0/60 (0%) 1/60 (2%) 3/60 (5%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 3.6% 0.0% 4.2% 8.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/32 (0%) 0/34 (0%) 1/24 (4%) 0/9 (0%) | 0/33 (0%) 0/41 (0%) 0/26 (0%) 0/33 (0%) | |FIRST INCIDENCE (DAYS) | 456 (I) --- 728 (T) 502 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.112 P=0.244N P=0.535N P=0.438 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.450 P=0.240N P=0.533N P=0.497N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.248 P=0.142N P=0.484N P=0.656 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.187 | (e) | |FISHER EXACT | P=0.248N P=0.500N P=0.500 | (e) (e) (e) | |=================================================================================================================================| DATE: 09/12/94 EXPERIMENT: 05092 TEST: 01 PAGE 26 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-NITROANISOLE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.0222% 0.0666% 0.200% | 0.0% 0.0222% 0.0666% 0.200% | | | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 58/60 (97%) 54/60 (90%) 56/60 (93%) 55/60 (92%) | 43/60 (72%) 46/60 (77%) 41/60 (68%) 37/60 (62%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 89.3% 91.9% 88.6% 83.7% | |INTERIM SACRIFICE 1 (c)| 8/10 (80%) 6/10 (60%) 9/10 (90%) 7/9 (78%) | 3/10 (30%) 2/10 (20%) 3/10 (30%) 2/9 (22%) | |TERMINAL (d) | 32/32 (100%) 34/34 (100%) 24/24 (100%) 9/9 (100%) | 28/33 (85%) 37/41 (90%) 21/26 (81%) 26/33 (79%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 456 (I) 456 (I) | 438 436 416 386 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.213N P=0.146 P<0.001 ** | P=0.271N P=0.234N P=0.210 P=0.238N | |INCIDENTAL TUMOR | P=0.424 P=0.195N P=0.370N P=0.454N | P=0.051N P=0.341 P=0.575N P=0.169N | |LOGISTIC REGRESSION | P=0.580N P=0.195N P=0.354N P=0.415N | P=0.070N P=0.388 P=0.572 P=0.177N | |COCHRAN-ARMITAGE | P=0.366N | P=0.065N | |FISHER EXACT | P=0.136N P=0.340N P=0.219N | P=0.339 P=0.421N P=0.166N | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 37/60 (62%) 35/60 (58%) 46/60 (77%) 47/60 (78%) | 21/60 (35%) 18/60 (30%) 30/60 (50%) 34/60 (57%) | |ADJUSTED (b) | 75.2% 74.0% 91.9% 97.4% | 47.5% 39.0% 62.1% 71.7% | |INTERIM SACRIFICE 1 (c)| 2/10 (20%) 2/10 (20%) 1/10 (10%) 3/9 (33%) | 0/10 (0%) 0/10 (0%) 3/10 (30%) 1/9 (11%) | |TERMINAL (d) | 20/32 (63%) 22/34 (65%) 20/24 (83%) 8/9 (89%) | 11/33 (33%) 13/41 (32%) 9/26 (35%) 20/33 (61%) | |FIRST INCIDENCE (DAYS) | 456 (I) 423 437 456 (I) | 494 533 302 407 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.376N P=0.016 * P<0.001 ** | P=0.003 ** P=0.173N P=0.028 * P=0.024 * | |INCIDENTAL TUMOR | P=0.038 * P=0.530N P=0.069 P=0.121 | P=0.003 ** P=0.563N P=0.167 P=0.013 * | |LOGISTIC REGRESSION | P=0.023 * P=0.471N P=0.048 * P=0.111 | P=0.003 ** P=0.566 P=0.108 P=0.010 ** | |COCHRAN-ARMITAGE | P=0.012 * | P=0.002 ** | |FISHER EXACT | P=0.426N P=0.057 P=0.036 * | P=0.348N P=0.070 P=0.014 * | |=================================================================================================================================| DATE: 09/12/94 EXPERIMENT: 05092 TEST: 01 PAGE 27 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- O-NITROANISOLE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.0222% 0.0666% 0.200% | 0.0% 0.0222% 0.0666% 0.200% | | | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC 15 SSAC | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 58/60 (97%) 56/60 (93%) 59/60 (98%) 58/60 (97%) | 49/60 (82%) 48/60 (80%) 51/60 (85%) 50/60 (83%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 92.4% 96.0% 92.7% 94.3% | |INTERIM SACRIFICE 1 (c)| 8/10 (80%) 7/10 (70%) 9/10 (90%) 8/9 (89%) | 3/10 (30%) 2/10 (20%) 5/10 (50%) 3/9 (33%) | |TERMINAL (d) | 32/32 (100%) 34/34 (100%) 24/24 (100%) 9/9 (100%) | 29/33 (88%) 39/41 (95%) 22/26 (85%) 30/33 (91%) | |FIRST INCIDENCE (DAYS) | 456 (I) 423 437 456 (I) | 438 436 302 386 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.323N P=0.070 P<0.001 ** | P=0.202 P=0.070N P=0.079 P=0.442 | |INCIDENTAL TUMOR | P=0.327 P=0.500N P=0.500 P=0.539 | P=0.533 P=0.605 P=0.494 P=0.600 | |LOGISTIC REGRESSION | P=0.321 P=0.568N P=0.456 P=0.539 | P=0.335 P=0.438N P=0.274 P=0.445 | |COCHRAN-ARMITAGE | P=0.452 | P=0.413 | |FISHER EXACT | P=0.340N P=0.500 P=0.691N | P=0.500N P=0.404 P=0.500 | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for intercurrent mortality. (c) Observed incidence at interim kill. Male interim sacrifices(days): 456 Female interim sacrifices(days): 456 (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).