TDMS Study 88032-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus OXYMETHOLONE DATE: 11/24/97 EXPERIMENT: 88032 TEST: 05 TIME: 11:27:30 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-05295 ROUTE: GAVAGE NTP C#: 88032B PATHOLOGIST: YARRINGTON, J. CAS: 434-07-01 ------------------------------------------------------------------------------------------------------------------------------------ CORE STUDY REASONS FOR REMOVAL: 25018 Dosing Accident 25019 Moribund Sacrifice 25020 Natural Death 25026 Other 25021 Terminal Sacrifice REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus OXYMETHOLONE DATE: 11/24/97 EXPERIMENT: 88032 TEST: 05 TIME: 11:27:30 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-05295 ROUTE: GAVAGE NTP C#: 88032B PATHOLOGIST: YARRINGTON, J. CAS: 434-07-01 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 Cortex Adrenal Medulla Bone Marrow Brain Clitoral Gland Clitoral/Preputial 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: Battelle Columbus OXYMETHOLONE DATE: 11/24/97 EXPERIMENT: 88032 TEST: 05 TIME: 11:27:30 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-05295 ROUTE: GAVAGE NTP C#: 88032B PATHOLOGIST: YARRINGTON, J. CAS: 434-07-01 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF OXYMETHOLONE ==================================================================================================== MALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma: Benign, Complex, Malignant, NOS Lung Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Skin Fibroma Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma Testes Adenoma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Liver Hepatocellular Adenoma Hepatocellular Carcinoma 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, Carcinoma, or Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Skin Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma Squamous Cell Carcinoma, Basal Cell Carcinoma, Basosquamous Tumor (malignant or NOS), or Carcinoma Squamous Cell Papilloma Uterus Polyp Stromal Sarcoma Stromal or Polyp Stromal All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Benign Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 11/24/97 EXPERIMENT: 88032 TEST: 05 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXYMETHOLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3 MG/KG 30 MG/KG 150 | 0 MG/KG 3 MG/KG 30 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 19/51 (37%) 25/50 (50%) 21/50 (42%) 29/49 (59%) | 7/50 (14%) 4/50 (8%) 2/50 (4%) 10/49 (20%) | |ADJUSTED (b) | 72.8% 77.3% 78.4% 93.2% | 22.1% 12.3% 4.8% 32.3% | |TERMINAL (d) | 9/15 (60%) 8/15 (53%) 9/14 (64%) 18/20 (90%) | 2/25 (8%) 2/29 (7%) 0/30 (0%) 10/31 (32%) | |FIRST INCIDENCE (DAYS) | 519 485 564 577 | 589 665 561 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.355 P=0.295 P=0.488 P=0.266 | P=0.111 P=0.214N P=0.064N P=0.460 | |INCIDENTAL TUMOR | P=0.031 * P=0.168 P=0.456 P=0.029 * | P=0.056 P=0.179N P=0.074N P=0.374 | |LOGISTIC REGRESSION | P=0.042 * P=0.206 P=0.554N P=0.043 * | P=0.071 P=0.155N P=0.058N P=0.383 | |COCHRAN-ARMITAGE | P=0.038 * | P=0.061 | |FISHER EXACT | P=0.138 P=0.388 P=0.023 * | P=0.262N P=0.080N P=0.282 | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 19/51 (37%) 25/50 (50%) 21/50 (42%) 29/49 (59%) | 7/50 (14%) 5/50 (10%) 2/50 (4%) 10/49 (20%) | |ADJUSTED (b) | 72.8% 77.3% 78.4% 93.2% | 22.1% 14.4% 4.8% 32.3% | |TERMINAL (d) | 9/15 (60%) 8/15 (53%) 9/14 (64%) 18/20 (90%) | 2/25 (8%) 2/29 (7%) 0/30 (0%) 10/31 (32%) | |FIRST INCIDENCE (DAYS) | 519 485 564 577 | 589 579 561 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.355 P=0.295 P=0.488 P=0.266 | P=0.151 P=0.312N P=0.064N P=0.460 | |INCIDENTAL TUMOR | P=0.031 * P=0.168 P=0.456 P=0.029 * | P=0.065 P=0.313N P=0.074N P=0.374 | |LOGISTIC REGRESSION | P=0.042 * P=0.206 P=0.554N P=0.043 * | P=0.097 P=0.263N P=0.058N P=0.383 | |COCHRAN-ARMITAGE | P=0.038 * | P=0.087 | |FISHER EXACT | P=0.138 P=0.388 P=0.023 * | P=0.380N P=0.080N P=0.282 | |=================================================================================================================================| DATE: 11/24/97 EXPERIMENT: 88032 TEST: 05 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXYMETHOLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3 MG/KG 30 MG/KG 150 | 0 MG/KG 3 MG/KG 30 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Brain | | Astrocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/51 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 14.3% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 2/14 (14%) 0/20 (0%) | 0/25 (0%) 0/29 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 728 (T) --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.551N (e) P=0.221 (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.551N (e) P=0.221 (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.551N (e) P=0.221 (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.632N | (e) | |FISHER EXACT | (e) P=0.243 (e) | (e) (e) (e) | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/51 (0%) 2/49 (4%) 2/50 (4%) 0/49 (0%) | 4/50 (8%) 4/48 (8%) 2/50 (4%) 2/50 (4%) | |ADJUSTED (b) | 0.0% 9.1% 14.3% 0.0% | 14.5% 13.8% 6.7% 6.5% | |TERMINAL (d) | 0/15 (0%) 1/15 (7%) 2/14 (14%) 0/20 (0%) | 3/25 (12%) 4/29 (14%) 2/30 (7%) 2/31 (6%) | |FIRST INCIDENCE (DAYS) | --- 597 728 (T) --- | 621 728 (T) 728 (T) 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.257N P=0.252 P=0.221 (e) | P=0.190N P=0.562N P=0.257N P=0.245N | |INCIDENTAL TUMOR | P=0.258N P=0.205 P=0.221 (e) | P=0.230N P=0.615N P=0.350N P=0.354N | |LOGISTIC REGRESSION | P=0.308N P=0.236 P=0.221 (e) | P=0.200N P=0.604N P=0.289N P=0.285N | |COCHRAN-ARMITAGE | P=0.325N | P=0.240N | |FISHER EXACT | P=0.238 P=0.243 (e) | P=0.619 P=0.339N P=0.339N | |=================================================================================================================================| DATE: 11/24/97 EXPERIMENT: 88032 TEST: 05 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXYMETHOLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3 MG/KG 30 MG/KG 150 | 0 MG/KG 3 MG/KG 30 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/51 (6%) 2/49 (4%) 0/50 (0%) 1/49 (2%) | 1/50 (2%) 3/48 (6%) 1/50 (2%) 3/50 (6%) | |ADJUSTED (b) | 15.3% 7.0% 0.0% 2.7% | 4.0% 9.8% 2.1% 8.7% | |TERMINAL (d) | 2/15 (13%) 0/15 (0%) 0/14 (0%) 0/20 (0%) | 1/25 (4%) 2/29 (7%) 0/30 (0%) 2/31 (6%) | |FIRST INCIDENCE (DAYS) | 479 321 --- 629 | 728 (T) 705 478 659 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.301N P=0.494N P=0.127N P=0.244N | P=0.418 P=0.352 P=0.747N P=0.386 | |INCIDENTAL TUMOR | P=0.310N P=0.436N P=0.182N P=0.408N | P=0.443 P=0.357 P=0.738 P=0.386 | |LOGISTIC REGRESSION | P=0.332N P=0.519N P=0.119N P=0.321N | P=0.379 P=0.337 P=0.749N P=0.345 | |COCHRAN-ARMITAGE | P=0.354N | P=0.375 | |FISHER EXACT | P=0.519N P=0.125N P=0.324N | P=0.293 P=0.753N P=0.309 | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/51 (6%) 4/49 (8%) 2/50 (4%) 1/49 (2%) | 5/50 (10%) 7/48 (15%) 3/50 (6%) 5/50 (10%) | |ADJUSTED (b) | 15.3% 15.5% 14.3% 2.7% | 18.4% 23.2% 8.7% 15.0% | |TERMINAL (d) | 2/15 (13%) 1/15 (7%) 2/14 (14%) 0/20 (0%) | 4/25 (16%) 6/29 (21%) 2/30 (7%) 4/31 (13%) | |FIRST INCIDENCE (DAYS) | 479 321 728 (T) 629 | 621 705 478 659 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.129N P=0.513 P=0.522N P=0.244N | P=0.363N P=0.480 P=0.277N P=0.493N | |INCIDENTAL TUMOR | P=0.130N P=0.530 P=0.607N P=0.408N | P=0.393N P=0.438 P=0.385N P=0.599N | |LOGISTIC REGRESSION | P=0.185N P=0.476 P=0.458N P=0.321N | P=0.408N P=0.436 P=0.346N P=0.559N | |COCHRAN-ARMITAGE | P=0.183N | P=0.442N | |FISHER EXACT | P=0.477 P=0.509N P=0.324N | P=0.351 P=0.357N P=0.630N | |=================================================================================================================================| DATE: 11/24/97 EXPERIMENT: 88032 TEST: 05 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXYMETHOLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3 MG/KG 30 MG/KG 150 | 0 MG/KG 3 MG/KG 30 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | 2/50 (4%) 0/48 (0%) 1/50 (2%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 5.9% 0.0% 3.3% 0.0% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/14 (0%) 0/20 (0%) | 1/25 (4%) 0/29 (0%) 1/30 (3%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 478 --- 728 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.291N P=0.226N P=0.465N P=0.223N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.269N P=0.295N P=0.504N P=0.216N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.301N P=0.251N P=0.497N P=0.220N | |COCHRAN-ARMITAGE | (e) | P=0.304N | |FISHER EXACT | (e) (e) (e) | P=0.258N P=0.500N P=0.247N | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/49 (8%) 2/48 (4%) 2/50 (4%) 1/48 (2%) | 0/49 (0%) 1/49 (2%) 0/49 (0%) 1/49 (2%) | |ADJUSTED (b) | 18.0% 9.1% 6.2% 5.0% | 0.0% 3.4% 0.0% 2.9% | |TERMINAL (d) | 1/15 (7%) 1/15 (7%) 0/14 (0%) 1/20 (5%) | 0/25 (0%) 1/29 (3%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 591 597 564 728 (T) | --- 728 (T) --- 704 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.181N P=0.310N P=0.288N P=0.126N | P=0.516 P=0.530 (e) P=0.525 | |INCIDENTAL TUMOR | P=0.205N P=0.331N P=0.246N P=0.157N | P=0.505 P=0.530 (e) P=0.523 | |LOGISTIC REGRESSION | P=0.227N P=0.315N P=0.301N P=0.154N | P=0.506 P=0.530 (e) P=0.515 | |COCHRAN-ARMITAGE | P=0.230N | P=0.489 | |FISHER EXACT | P=0.349N P=0.329N P=0.187N | P=0.500 (e) P=0.500 | |=================================================================================================================================| DATE: 11/24/97 EXPERIMENT: 88032 TEST: 05 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXYMETHOLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3 MG/KG 30 MG/KG 150 | 0 MG/KG 3 MG/KG 30 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/48 (0%) 2/50 (4%) 0/48 (0%) | 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | |ADJUSTED (b) | 0.0% 0.0% 7.1% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/14 (0%) 0/20 (0%) | 0/25 (0%) 0/29 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 669 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.619N (e) P=0.299 (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.698N (e) P=0.324 (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.628N (e) P=0.267 (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.634N | (e) | |FISHER EXACT | (e) P=0.253 (e) | (e) (e) (e) | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/49 (8%) 2/48 (4%) 4/50 (8%) 1/48 (2%) | 0/49 (0%) 1/49 (2%) 0/49 (0%) 1/49 (2%) | |ADJUSTED (b) | 18.0% 9.1% 12.8% 5.0% | 0.0% 3.4% 0.0% 2.9% | |TERMINAL (d) | 1/15 (7%) 1/15 (7%) 0/14 (0%) 1/20 (5%) | 0/25 (0%) 1/29 (3%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 591 597 564 728 (T) | --- 728 (T) --- 704 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.161N P=0.310N P=0.553N P=0.126N | P=0.516 P=0.530 (e) P=0.525 | |INCIDENTAL TUMOR | P=0.195N P=0.331N P=0.500N P=0.157N | P=0.505 P=0.530 (e) P=0.523 | |LOGISTIC REGRESSION | P=0.200N P=0.315N P=0.594N P=0.154N | P=0.506 P=0.530 (e) P=0.515 | |COCHRAN-ARMITAGE | P=0.203N | P=0.489 | |FISHER EXACT | P=0.349N P=0.631N P=0.187N | P=0.500 (e) P=0.500 | |=================================================================================================================================| DATE: 11/24/97 EXPERIMENT: 88032 TEST: 05 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXYMETHOLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3 MG/KG 30 MG/KG 150 | 0 MG/KG 3 MG/KG 30 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/51 (0%) 1/50 (2%) 0/50 (0%) 2/49 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | |ADJUSTED (b) | 0.0% 2.4% 0.0% 10.0% | 0.0% 0.0% 0.0% 3.2% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/14 (0%) 2/20 (10%) | 0/25 (0%) 0/29 (0%) 0/30 (0%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | --- 561 --- 728 (T) | --- --- --- 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.214 P=0.520 (e) P=0.302 | P=0.235 (e) (e) P=0.543 | |INCIDENTAL TUMOR | P=0.209 P=0.460 (e) P=0.302 | P=0.235 (e) (e) P=0.543 | |LOGISTIC REGRESSION | P=0.150 P=0.502 (e) P=0.302 | P=0.235 (e) (e) P=0.543 | |COCHRAN-ARMITAGE | P=0.151 | P=0.211 | |FISHER EXACT | P=0.495 (e) P=0.238 | (e) (e) P=0.495 | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/51 (2%) 1/50 (2%) 1/50 (2%) 0/49 (0%) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 8/49 (16%) | |ADJUSTED (b) | 6.7% 2.2% 7.1% 0.0% | 4.0% 3.4% 3.3% 24.5% | |TERMINAL (d) | 1/15 (7%) 0/15 (0%) 1/14 (7%) 0/20 (0%) | 1/25 (4%) 1/29 (3%) 1/30 (3%) 7/31 (23%) | |FIRST INCIDENCE (DAYS) | 728 (T) 424 728 (T) --- | 728 (T) 728 (T) 728 (T) 659 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.295N P=0.756 P=0.749 P=0.443N | P<0.001 ** P=0.729N P=0.721N P=0.037 * | |INCIDENTAL TUMOR | P=0.383N P=0.705 P=0.749 P=0.443N | P<0.001 ** P=0.729N P=0.721N P=0.035 * | |LOGISTIC REGRESSION | P=0.343N P=0.762 P=0.749 P=0.443N | P<0.001 ** P=0.729N P=0.721N P=0.028 * | |COCHRAN-ARMITAGE | P=0.344N | P<0.001 ** | |FISHER EXACT | P=0.748 P=0.748 P=0.510N | P=0.753N P=0.753N P=0.014 * | |=================================================================================================================================| DATE: 11/24/97 EXPERIMENT: 88032 TEST: 05 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXYMETHOLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3 MG/KG 30 MG/KG 150 | 0 MG/KG 3 MG/KG 30 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/51 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) | |ADJUSTED (b) | 0.0% 4.8% 0.0% 0.0% | 0.0% 0.0% 0.0% 6.5% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/14 (0%) 0/20 (0%) | 0/25 (0%) 0/29 (0%) 0/30 (0%) 2/31 (6%) | |FIRST INCIDENCE (DAYS) | --- 707 --- --- | --- --- --- 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.574N P=0.520 (e) (e) | P=0.051 (e) (e) P=0.286 | |INCIDENTAL TUMOR | P=0.666N P=0.539 (e) (e) | P=0.051 (e) (e) P=0.286 | |LOGISTIC REGRESSION | P=0.599N P=0.525 (e) (e) | P=0.051 (e) (e) P=0.286 | |COCHRAN-ARMITAGE | P=0.616N | P=0.039 * | |FISHER EXACT | P=0.495 (e) (e) | (e) (e) P=0.242 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/51 (2%) 2/50 (4%) 1/50 (2%) 0/49 (0%) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 10/49 (20%) | |ADJUSTED (b) | 6.7% 6.8% 7.1% 0.0% | 4.0% 3.4% 3.3% 30.8% | |TERMINAL (d) | 1/15 (7%) 0/15 (0%) 1/14 (7%) 0/20 (0%) | 1/25 (4%) 1/29 (3%) 1/30 (3%) 9/31 (29%) | |FIRST INCIDENCE (DAYS) | 728 (T) 424 728 (T) --- | 728 (T) 728 (T) 728 (T) 659 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.200N P=0.507 P=0.749 P=0.443N | P<0.001 ** P=0.729N P=0.721N P=0.012 * | |INCIDENTAL TUMOR | P=0.281N P=0.464 P=0.749 P=0.443N | P<0.001 ** P=0.729N P=0.721N P=0.012 * | |LOGISTIC REGRESSION | P=0.246N P=0.492 P=0.749 P=0.443N | P<0.001 ** P=0.729N P=0.721N P=0.009 ** | |COCHRAN-ARMITAGE | P=0.243N | P<0.001 ** | |FISHER EXACT | P=0.492 P=0.748 P=0.510N | P=0.753N P=0.753N P=0.003 ** | |=================================================================================================================================| DATE: 11/24/97 EXPERIMENT: 88032 TEST: 05 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXYMETHOLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3 MG/KG 30 MG/KG 150 | 0 MG/KG 3 MG/KG 30 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/51 (2%) 2/50 (4%) 1/50 (2%) 0/49 (0%) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 10/49 (20%) | |ADJUSTED (b) | 6.7% 6.8% 7.1% 0.0% | 4.0% 3.4% 3.3% 30.8% | |TERMINAL (d) | 1/15 (7%) 0/15 (0%) 1/14 (7%) 0/20 (0%) | 1/25 (4%) 1/29 (3%) 1/30 (3%) 9/31 (29%) | |FIRST INCIDENCE (DAYS) | 728 (T) 424 728 (T) --- | 728 (T) 728 (T) 728 (T) 659 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.200N P=0.507 P=0.749 P=0.443N | P<0.001 ** P=0.729N P=0.721N P=0.012 * | |INCIDENTAL TUMOR | P=0.281N P=0.464 P=0.749 P=0.443N | P<0.001 ** P=0.729N P=0.721N P=0.012 * | |LOGISTIC REGRESSION | P=0.246N P=0.492 P=0.749 P=0.443N | P<0.001 ** P=0.729N P=0.721N P=0.009 ** | |COCHRAN-ARMITAGE | P=0.243N | P<0.001 ** | |FISHER EXACT | P=0.492 P=0.748 P=0.510N | P=0.753N P=0.753N P=0.003 ** | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/51 (8%) 1/50 (2%) 0/50 (0%) 3/47 (6%) | 0/50 (0%) 0/50 (0%) 6/50 (12%) 1/49 (2%) | |ADJUSTED (b) | 18.3% 6.3% 0.0% 15.0% | 0.0% 0.0% 18.4% 3.2% | |TERMINAL (d) | 2/15 (13%) 0/15 (0%) 0/14 (0%) 3/20 (15%) | 0/25 (0%) 0/29 (0%) 5/30 (17%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | 549 720 --- 728 (T) | --- --- 441 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.560 P=0.179N P=0.060N P=0.369N | P=0.502 (e) P=0.027 * P=0.543 | |INCIDENTAL TUMOR | P=0.513 P=0.193N P=0.067N P=0.402N | P=0.525 (e) P=0.022 * P=0.543 | |LOGISTIC REGRESSION | P=0.436 P=0.168N P=0.057N P=0.481N | P=0.449 (e) P=0.018 * P=0.543 | |COCHRAN-ARMITAGE | P=0.402 | P=0.444 | |FISHER EXACT | P=0.187N P=0.061N P=0.546N | (e) P=0.013 * P=0.495 | |=================================================================================================================================| DATE: 11/24/97 EXPERIMENT: 88032 TEST: 05 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXYMETHOLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3 MG/KG 30 MG/KG 150 | 0 MG/KG 3 MG/KG 30 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/51 (10%) 1/50 (2%) 0/50 (0%) 3/47 (6%) | 0/50 (0%) 0/50 (0%) 7/50 (14%) 1/49 (2%) | |ADJUSTED (b) | 22.0% 6.3% 0.0% 15.0% | 0.0% 0.0% 21.7% 3.2% | |TERMINAL (d) | 2/15 (13%) 0/15 (0%) 0/14 (0%) 3/20 (15%) | 0/25 (0%) 0/29 (0%) 6/30 (20%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | 549 720 --- 728 (T) | --- --- 441 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.599N P=0.097N P=0.030N* P=0.240N | P=0.522 (e) P=0.015 * P=0.543 | |INCIDENTAL TUMOR | P=0.593 P=0.105N P=0.031N* P=0.288N | P=0.542 (e) P=0.012 * P=0.543 | |LOGISTIC REGRESSION | P=0.543 P=0.093N P=0.028N* P=0.333N | P=0.467 (e) P=0.010 ** P=0.543 | |COCHRAN-ARMITAGE | P=0.506 | P=0.458 | |FISHER EXACT | P=0.107N P=0.030N* P=0.404N | (e) P=0.006 ** P=0.495 | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/51 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 2.0% 0.0% | 12.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/14 (0%) 0/20 (0%) | 3/25 (12%) 0/29 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 353 --- | 728 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.783N (e) P=0.496 (e) | P=0.154N P=0.095N P=0.090N P=0.085N | |INCIDENTAL TUMOR | P=0.553N (e) P=0.638 (e) | P=0.154N P=0.095N P=0.090N P=0.085N | |LOGISTIC REGRESSION | P=0.601N (e) P=0.505 (e) | P=0.154N P=0.095N P=0.090N P=0.085N | |COCHRAN-ARMITAGE | P=0.767N | P=0.175N | |FISHER EXACT | (e) P=0.495 (e) | P=0.121N P=0.121N P=0.121N | |=================================================================================================================================| DATE: 11/24/97 EXPERIMENT: 88032 TEST: 05 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXYMETHOLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3 MG/KG 30 MG/KG 150 | 0 MG/KG 3 MG/KG 30 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/51 (8%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | 21/50 (42%) 11/50 (22%) 1/50 (2%) 4/50 (8%) | |ADJUSTED (b) | 16.2% 5.0% 5.0% 4.8% | 60.0% 34.0% 2.9% 9.5% | |TERMINAL (d) | 1/15 (7%) 0/15 (0%) 0/14 (0%) 0/20 (0%) | 12/25 (48%) 8/29 (28%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 471 709 706 561 | 506 652 693 387 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.502N P=0.170N P=0.178N P=0.279N | P<0.001N** P=0.013N* P<0.001N** P<0.001N** | |INCIDENTAL TUMOR | P=0.636 P=0.201N P=0.198N P=0.456N | P<0.001N** P=0.016N* P<0.001N** P<0.001N** | |LOGISTIC REGRESSION | P=0.569N P=0.181N P=0.179N P=0.342N | P<0.001N** P=0.016N* P<0.001N** P<0.001N** | |COCHRAN-ARMITAGE | P=0.567N | P<0.001N** | |FISHER EXACT | P=0.187N P=0.187N P=0.348N | P=0.026N* P<0.001N** P<0.001N** | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/51 (8%) 1/50 (2%) 2/50 (4%) 2/50 (4%) | 23/50 (46%) 11/50 (22%) 1/50 (2%) 4/50 (8%) | |ADJUSTED (b) | 16.2% 5.0% 6.9% 4.8% | 66.1% 34.0% 2.9% 9.5% | |TERMINAL (d) | 1/15 (7%) 0/15 (0%) 0/14 (0%) 0/20 (0%) | 14/25 (56%) 8/29 (28%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 471 709 353 561 | 506 652 693 387 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.473N P=0.170N P=0.334N P=0.279N | P<0.001N** P=0.004N** P<0.001N** P<0.001N** | |INCIDENTAL TUMOR | P=0.532N P=0.201N P=0.310N P=0.456N | P<0.001N** P=0.005N** P<0.001N** P<0.001N** | |LOGISTIC REGRESSION | P=0.504N P=0.181N P=0.397N P=0.342N | P<0.001N** P=0.005N** P<0.001N** P<0.001N** | |COCHRAN-ARMITAGE | P=0.530N | P<0.001N** | |FISHER EXACT | P=0.187N P=0.348N P=0.348N | P=0.010N** P<0.001N** P<0.001N** | |=================================================================================================================================| DATE: 11/24/97 EXPERIMENT: 88032 TEST: 05 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXYMETHOLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3 MG/KG 30 MG/KG 150 | 0 MG/KG 3 MG/KG 30 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Papilloma Squamous or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/51 (6%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 10.4% 6.7% 0.0% 5.0% | 0.0% 3.4% 0.0% 0.0% | |TERMINAL (d) | 0/15 (0%) 1/15 (7%) 0/14 (0%) 1/20 (5%) | 0/25 (0%) 1/29 (3%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 591 728 (T) --- 728 (T) | --- 728 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.401N P=0.264N P=0.088N P=0.248N | P=0.524N P=0.530 (e) (e) | |INCIDENTAL TUMOR | P=0.438N P=0.290N P=0.088N P=0.308N | P=0.524N P=0.530 (e) (e) | |LOGISTIC REGRESSION | P=0.456N P=0.300N P=0.123N P=0.307N | P=0.524N P=0.530 (e) (e) | |COCHRAN-ARMITAGE | P=0.457N | P=0.547N | |FISHER EXACT | P=0.316N P=0.125N P=0.316N | P=0.500 (e) (e) | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/51 (6%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 10.4% 6.7% 0.0% 5.0% | 0.0% 6.9% 0.0% 0.0% | |TERMINAL (d) | 0/15 (0%) 1/15 (7%) 0/14 (0%) 1/20 (5%) | 0/25 (0%) 2/29 (7%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 591 728 (T) --- 728 (T) | --- 728 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.401N P=0.264N P=0.088N P=0.248N | P=0.301N P=0.271 (e) (e) | |INCIDENTAL TUMOR | P=0.438N P=0.290N P=0.088N P=0.308N | P=0.301N P=0.271 (e) (e) | |LOGISTIC REGRESSION | P=0.456N P=0.300N P=0.123N P=0.307N | P=0.301N P=0.271 (e) (e) | |COCHRAN-ARMITAGE | P=0.457N | P=0.326N | |FISHER EXACT | P=0.316N P=0.125N P=0.316N | P=0.247 (e) (e) | |=================================================================================================================================| DATE: 11/24/97 EXPERIMENT: 88032 TEST: 05 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXYMETHOLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3 MG/KG 30 MG/KG 150 | 0 MG/KG 3 MG/KG 30 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Oral Mucosa | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/51 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 7.0% 6.7% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/15 (0%) 1/15 (7%) 0/14 (0%) 0/20 (0%) | 0/25 (0%) 0/29 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 591 728 (T) --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.219N P=0.460N P=0.188N P=0.209N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.231N P=0.501N P=0.206N P=0.257N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.243N P=0.495N P=0.247N P=0.243N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.242N | (e) | |FISHER EXACT | P=0.508N P=0.252N P=0.252N | (e) (e) (e) | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 30/51 (59%) 32/50 (64%) 30/50 (60%) 19/49 (39%) | 27/50 (54%) 26/50 (52%) 18/49 (37%) 14/50 (28%) | |ADJUSTED (b) | 76.4% 83.0% 89.4% 57.7% | 69.2% 65.7% 44.9% 43.6% | |TERMINAL (d) | 8/15 (53%) 9/15 (60%) 11/14 (79%) 7/20 (35%) | 14/25 (56%) 16/29 (55%) 9/30 (30%) 13/31 (42%) | |FIRST INCIDENCE (DAYS) | 316 408 437 434 | 478 537 478 695 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.004N** P=0.551N P=0.428N P=0.015N* | P=0.002N** P=0.291N P=0.033N* P=0.002N** | |INCIDENTAL TUMOR | P=0.019N* P=0.307 P=0.523 P=0.159N | P=0.003N** P=0.500N P=0.106N P=0.008N** | |LOGISTIC REGRESSION | P=0.007N** P=0.376 P=0.563 P=0.165N | P=0.003N** P=0.471N P=0.063N P=0.005N** | |COCHRAN-ARMITAGE | P=0.006N** | P=0.003N** | |FISHER EXACT | P=0.371 P=0.533 P=0.035N* | P=0.500N P=0.064N P=0.007N** | |=================================================================================================================================| DATE: 11/24/97 EXPERIMENT: 88032 TEST: 05 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXYMETHOLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3 MG/KG 30 MG/KG 150 | 0 MG/KG 3 MG/KG 30 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Skin | | Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal | | Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/51 (8%) 2/50 (4%) 2/50 (4%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 4/50 (8%) 5/50 (10%) | |ADJUSTED (b) | 22.5% 7.6% 7.6% 10.0% | 0.0% 0.0% 13.3% 15.6% | |TERMINAL (d) | 3/15 (20%) 0/15 (0%) 0/14 (0%) 2/20 (10%) | 0/25 (0%) 0/29 (0%) 4/30 (13%) 4/31 (13%) | |FIRST INCIDENCE (DAYS) | 611 600 680 728 (T) | --- --- 728 (T) 725 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.332N P=0.320N P=0.310N P=0.217N | P=0.013 * (e) P=0.087 P=0.056 | |INCIDENTAL TUMOR | P=0.382N P=0.353N P=0.307N P=0.229N | P=0.013 * (e) P=0.087 P=0.056 | |LOGISTIC REGRESSION | P=0.411N P=0.307N P=0.272N P=0.261N | P=0.013 * (e) P=0.087 P=0.052 | |COCHRAN-ARMITAGE | P=0.438N | P=0.008 ** | |FISHER EXACT | P=0.348N P=0.348N P=0.348N | (e) P=0.059 P=0.028 * | |=================================================================================================================================| | | |Skin | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/51 (0%) 5/50 (10%) 2/50 (4%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 22.7% 12.0% 6.0% | 0.0% 0.0% 3.3% 3.2% | |TERMINAL (d) | 0/15 (0%) 2/15 (13%) 1/14 (7%) 0/20 (0%) | 0/25 (0%) 0/29 (0%) 1/30 (3%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | --- 479 707 434 | --- --- 728 (T) 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.471N P=0.042 * P=0.232 P=0.251 | P=0.339 (e) P=0.536 P=0.543 | |INCIDENTAL TUMOR | P=0.576 P=0.032 * P=0.265 P=0.050 * | P=0.339 (e) P=0.536 P=0.543 | |LOGISTIC REGRESSION | P=0.564N P=0.035 * P=0.266 P=0.245 | P=0.339 (e) P=0.536 P=0.543 | |COCHRAN-ARMITAGE | P=0.556N | P=0.307 | |FISHER EXACT | P=0.027 * P=0.243 P=0.243 | (e) P=0.500 P=0.500 | |=================================================================================================================================| DATE: 11/24/97 EXPERIMENT: 88032 TEST: 05 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXYMETHOLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3 MG/KG 30 MG/KG 150 | 0 MG/KG 3 MG/KG 30 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/51 (0%) 7/50 (14%) 2/50 (4%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 26.9% 12.0% 6.0% | 0.0% 2.2% 3.3% 3.2% | |TERMINAL (d) | 0/15 (0%) 2/15 (13%) 1/14 (7%) 0/20 (0%) | 0/25 (0%) 0/29 (0%) 1/30 (3%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | --- 479 707 434 | --- 562 728 (T) 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.316N P=0.015 * P=0.232 P=0.251 | P=0.536 P=0.519 P=0.536 P=0.543 | |INCIDENTAL TUMOR | P=0.596N P=0.007 ** P=0.265 P=0.050 * | P=0.417 P=0.410 P=0.536 P=0.543 | |LOGISTIC REGRESSION | P=0.387N P=0.009 ** P=0.266 P=0.245 | P=0.510 P=0.513 P=0.536 P=0.543 | |COCHRAN-ARMITAGE | P=0.381N | P=0.510 | |FISHER EXACT | P=0.006 ** P=0.243 P=0.243 | P=0.500 P=0.500 P=0.500 | |=================================================================================================================================| | | |Skin | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/51 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 5.4% 0.0% 0.0% | 0.0% 2.2% 0.0% 0.0% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/14 (0%) 0/20 (0%) | 0/25 (0%) 0/29 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | --- 485 --- --- | --- 562 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.382N P=0.277 (e) (e) | P=0.546N P=0.519 (e) (e) | |INCIDENTAL TUMOR | P=0.581N P=0.203 (e) (e) | P=0.806N P=0.410 (e) (e) | |LOGISTIC REGRESSION | P=0.362N P=0.235 (e) (e) | P=0.528N P=0.513 (e) (e) | |COCHRAN-ARMITAGE | P=0.386N | P=0.547N | |FISHER EXACT | P=0.243 (e) (e) | P=0.500 (e) (e) | |=================================================================================================================================| DATE: 11/24/97 EXPERIMENT: 88032 TEST: 05 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXYMETHOLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3 MG/KG 30 MG/KG 150 | 0 MG/KG 3 MG/KG 30 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/51 (8%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 4/50 (8%) 0/50 (0%) | |ADJUSTED (b) | 22.5% 5.0% 4.3% 5.0% | 0.0% 0.0% 13.3% 0.0% | |TERMINAL (d) | 3/15 (20%) 0/15 (0%) 0/14 (0%) 1/20 (5%) | 0/25 (0%) 0/29 (0%) 4/30 (13%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 611 709 703 728 (T) | --- --- 728 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.234N P=0.169N P=0.174N P=0.107N | P=0.563N (e) P=0.087 (e) | |INCIDENTAL TUMOR | P=0.270N P=0.180N P=0.174N P=0.115N | P=0.563N (e) P=0.087 (e) | |LOGISTIC REGRESSION | P=0.284N P=0.146N P=0.136N P=0.135N | P=0.563N (e) P=0.087 (e) | |COCHRAN-ARMITAGE | P=0.317N | P=0.609N | |FISHER EXACT | P=0.187N P=0.187N P=0.187N | (e) P=0.059 (e) | |=================================================================================================================================| | | |Skin | | Squamous Cell Carcinoma, Basal Cell Carcinoma, Basosquamous Tumor | | (malignant or NOS), or Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/51 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |ADJUSTED (b) | 0.0% 2.8% 3.4% 0.0% | 0.0% 0.0% 0.0% 6.5% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/14 (0%) 0/20 (0%) | 0/25 (0%) 0/29 (0%) 0/30 (0%) 2/31 (6%) | |FIRST INCIDENCE (DAYS) | --- 600 680 --- | --- --- --- 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.498N P=0.511 P=0.555 (e) | P=0.051 (e) (e) P=0.286 | |INCIDENTAL TUMOR | P=0.529N P=0.460 P=0.561 (e) | P=0.051 (e) (e) P=0.286 | |LOGISTIC REGRESSION | P=0.511N P=0.496 P=0.520 (e) | P=0.051 (e) (e) P=0.286 | |COCHRAN-ARMITAGE | P=0.509N | P=0.041 * | |FISHER EXACT | P=0.495 P=0.495 (e) | (e) (e) P=0.247 | |=================================================================================================================================| DATE: 11/24/97 EXPERIMENT: 88032 TEST: 05 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXYMETHOLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3 MG/KG 30 MG/KG 150 | 0 MG/KG 3 MG/KG 30 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/51 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 5.0% | 0.0% 0.0% 0.0% 6.3% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/14 (0%) 1/20 (5%) | 0/25 (0%) 0/29 (0%) 0/30 (0%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | --- --- --- 728 (T) | --- --- --- 725 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.292 (e) (e) P=0.557 | P=0.053 (e) (e) P=0.292 | |INCIDENTAL TUMOR | P=0.292 (e) (e) P=0.557 | P=0.049 * (e) (e) P=0.289 | |LOGISTIC REGRESSION | P=0.292 (e) (e) P=0.557 | P=0.050 (e) (e) P=0.282 | |COCHRAN-ARMITAGE | P=0.233 | P=0.041 * | |FISHER EXACT | (e) (e) P=0.495 | (e) (e) P=0.247 | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/51 (8%) 1/50 (2%) 2/50 (4%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 4/50 (8%) 3/50 (6%) | |ADJUSTED (b) | 22.5% 5.0% 7.6% 10.0% | 0.0% 0.0% 13.3% 9.4% | |TERMINAL (d) | 3/15 (20%) 0/15 (0%) 0/14 (0%) 2/20 (10%) | 0/25 (0%) 0/29 (0%) 4/30 (13%) 2/31 (6%) | |FIRST INCIDENCE (DAYS) | 611 709 680 728 (T) | --- --- 728 (T) 725 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.411N P=0.169N P=0.310N P=0.217N | P=0.100 (e) P=0.087 P=0.166 | |INCIDENTAL TUMOR | P=0.472N P=0.180N P=0.307N P=0.229N | P=0.098 (e) P=0.087 P=0.164 | |LOGISTIC REGRESSION | P=0.486N P=0.146N P=0.272N P=0.261N | P=0.098 (e) P=0.087 P=0.158 | |COCHRAN-ARMITAGE | P=0.530N | P=0.073 | |FISHER EXACT | P=0.187N P=0.348N P=0.348N | (e) P=0.059 P=0.121 | |=================================================================================================================================| DATE: 11/24/97 EXPERIMENT: 88032 TEST: 05 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXYMETHOLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3 MG/KG 30 MG/KG 150 | 0 MG/KG 3 MG/KG 30 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/51 (8%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 4/50 (8%) 2/50 (4%) | |ADJUSTED (b) | 22.5% 5.0% 4.3% 10.0% | 0.0% 0.0% 13.3% 6.3% | |TERMINAL (d) | 3/15 (20%) 0/15 (0%) 0/14 (0%) 2/20 (10%) | 0/25 (0%) 0/29 (0%) 4/30 (13%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | 611 709 703 728 (T) | --- --- 728 (T) 725 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.442N P=0.169N P=0.174N P=0.217N | P=0.234 (e) P=0.087 P=0.292 | |INCIDENTAL TUMOR | P=0.492N P=0.180N P=0.174N P=0.229N | P=0.231 (e) P=0.087 P=0.289 | |LOGISTIC REGRESSION | P=0.522N P=0.146N P=0.136N P=0.261N | P=0.232 (e) P=0.087 P=0.282 | |COCHRAN-ARMITAGE | P=0.567N | P=0.189 | |FISHER EXACT | P=0.187N P=0.187N P=0.348N | (e) P=0.059 P=0.247 | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 33/51 (65%) 20/50 (40%) 0/50 (0%) 0/49 (0%) | | |ADJUSTED (b) | 96.9% 72.3% 0.0% 0.0% | | |TERMINAL (d) | 14/15 (93%) 8/15 (53%) 0/14 (0%) 0/20 (0%) | | |FIRST INCIDENCE (DAYS) | 479 485 --- --- | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001N** P=0.012N* P<0.001N** P<0.001N** | | |INCIDENTAL TUMOR | P<0.001N** P=0.002N** P<0.001N** P<0.001N** | | |LOGISTIC REGRESSION | P<0.001N** P<0.001N** P<0.001N** P<0.001N** | | |COCHRAN-ARMITAGE | P<0.001N** | | |FISHER EXACT | P=0.011N* P<0.001N** P<0.001N** | | |=================================================================================================================================| DATE: 11/24/97 EXPERIMENT: 88032 TEST: 05 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXYMETHOLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3 MG/KG 30 MG/KG 150 | 0 MG/KG 3 MG/KG 30 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/51 (10%) 4/48 (8%) 5/50 (10%) 4/49 (8%) | 5/50 (10%) 8/49 (16%) 7/50 (14%) 4/49 (8%) | |ADJUSTED (b) | 18.1% 18.3% 25.9% 16.4% | 17.2% 25.2% 21.1% 11.1% | |TERMINAL (d) | 1/15 (7%) 2/15 (13%) 3/14 (21%) 2/20 (10%) | 2/25 (8%) 6/29 (21%) 5/30 (17%) 2/31 (6%) | |FIRST INCIDENCE (DAYS) | 486 588 538 675 | 684 652 665 490 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.386N P=0.447N P=0.580N P=0.387N | P=0.181N P=0.369 P=0.495 P=0.407N | |INCIDENTAL TUMOR | P=0.557N P=0.538N P=0.561 P=0.607N | P=0.181N P=0.397 P=0.554 P=0.407N | |LOGISTIC REGRESSION | P=0.517N P=0.524N P=0.623N P=0.520N | P=0.222N P=0.343 P=0.459 P=0.490N | |COCHRAN-ARMITAGE | P=0.507N | P=0.250N | |FISHER EXACT | P=0.539N P=0.617 P=0.526N | P=0.264 P=0.380 P=0.513N | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/51 (10%) 4/48 (8%) 6/50 (12%) 4/49 (8%) | 5/50 (10%) 8/49 (16%) 7/50 (14%) 4/49 (8%) | |ADJUSTED (b) | 18.1% 18.3% 27.8% 16.4% | 17.2% 25.2% 21.1% 11.1% | |TERMINAL (d) | 1/15 (7%) 2/15 (13%) 3/14 (21%) 2/20 (10%) | 2/25 (8%) 6/29 (21%) 5/30 (17%) 2/31 (6%) | |FIRST INCIDENCE (DAYS) | 486 588 538 675 | 684 652 665 490 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.363N P=0.447N P=0.559 P=0.387N | P=0.181N P=0.369 P=0.495 P=0.407N | |INCIDENTAL TUMOR | P=0.529N P=0.538N P=0.431 P=0.607N | P=0.181N P=0.397 P=0.554 P=0.407N | |LOGISTIC REGRESSION | P=0.494N P=0.524N P=0.502 P=0.520N | P=0.222N P=0.343 P=0.459 P=0.490N | |COCHRAN-ARMITAGE | P=0.483N | P=0.250N | |FISHER EXACT | P=0.539N P=0.486 P=0.526N | P=0.264 P=0.380 P=0.513N | |=================================================================================================================================| DATE: 11/24/97 EXPERIMENT: 88032 TEST: 05 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXYMETHOLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3 MG/KG 30 MG/KG 150 | 0 MG/KG 3 MG/KG 30 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 4/50 (8%) 8/50 (16%) 2/50 (4%) 0/50 (0%) | |ADJUSTED (b) | | 13.4% 24.4% 6.1% 0.0% | |TERMINAL (d) | | 2/25 (8%) 6/29 (21%) 1/30 (3%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | | 533 576 693 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.006N** P=0.258 P=0.281N P=0.048N* | |INCIDENTAL TUMOR | | P=0.009N** P=0.172 P=0.280N P=0.047N* | |LOGISTIC REGRESSION | | P=0.008N** P=0.193 P=0.326N P=0.062N | |COCHRAN-ARMITAGE | | P=0.009N** | |FISHER EXACT | | P=0.178 P=0.339N P=0.059N | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 5/50 (10%) 9/50 (18%) 2/50 (4%) 0/50 (0%) | |ADJUSTED (b) | | 17.2% 26.3% 6.1% 0.0% | |TERMINAL (d) | | 3/25 (12%) 6/29 (21%) 1/30 (3%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | | 533 576 693 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.003N** P=0.288 P=0.168N P=0.023N* | |INCIDENTAL TUMOR | | P=0.004N** P=0.203 P=0.166N P=0.022N* | |LOGISTIC REGRESSION | | P=0.004N** P=0.211 P=0.200N P=0.031N* | |COCHRAN-ARMITAGE | | P=0.004N** | |FISHER EXACT | | P=0.194 P=0.218N P=0.028N* | |=================================================================================================================================| DATE: 11/24/97 EXPERIMENT: 88032 TEST: 05 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXYMETHOLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3 MG/KG 30 MG/KG 150 | 0 MG/KG 3 MG/KG 30 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 21/51 (41%) 15/50 (30%) 7/50 (14%) 4/50 (8%) | 12/50 (24%) 11/50 (22%) 11/50 (22%) 5/50 (10%) | |ADJUSTED (b) | 71.7% 51.3% 25.8% 11.5% | 36.1% 27.8% 27.9% 13.4% | |TERMINAL (d) | 8/15 (53%) 5/15 (33%) 2/14 (14%) 0/20 (0%) | 6/25 (24%) 4/29 (14%) 4/30 (13%) 2/31 (6%) | |FIRST INCIDENCE (DAYS) | 486 408 577 551 | 533 523 441 539 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001N** P=0.121N P=0.002N** P<0.001N** | P=0.031N* P=0.379N P=0.371N P=0.032N* | |INCIDENTAL TUMOR | P<0.001N** P=0.164N P=0.002N** P<0.001N** | P=0.049N* P=0.577N P=0.565N P=0.076N | |LOGISTIC REGRESSION | P<0.001N** P=0.134N P=0.001N** P<0.001N** | P=0.084N P=0.512N P=0.498N P=0.053N | |COCHRAN-ARMITAGE | P<0.001N** | P=0.039N* | |FISHER EXACT | P=0.167N P=0.002N** P<0.001N** | P=0.500N P=0.500N P=0.054N | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated | | Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 4.9% 0.0% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/14 (0%) 0/20 (0%) | 0/25 (0%) 0/29 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- 638 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.673N (e) P=0.286 (e) | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.683 (e) P=0.135 (e) | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.692N (e) P=0.238 (e) | |COCHRAN-ARMITAGE | (e) | P=0.693N | |FISHER EXACT | (e) (e) (e) | (e) P=0.247 (e) | |=================================================================================================================================| DATE: 11/24/97 EXPERIMENT: 88032 TEST: 05 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXYMETHOLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3 MG/KG 30 MG/KG 150 | 0 MG/KG 3 MG/KG 30 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/51 (4%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |ADJUSTED (b) | 9.4% 8.3% 0.0% 5.0% | 0.0% 0.0% 3.3% 0.0% | |TERMINAL (d) | 1/15 (7%) 0/15 (0%) 0/14 (0%) 1/20 (5%) | 0/25 (0%) 0/29 (0%) 1/30 (3%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 600 622 --- 728 (T) | --- --- 728 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.390N P=0.675N P=0.226N P=0.421N | P=0.765N (e) P=0.536 (e) | |INCIDENTAL TUMOR | P=0.423N P=0.676 P=0.247N P=0.433N | P=0.765N (e) P=0.536 (e) | |LOGISTIC REGRESSION | P=0.462N P=0.688N P=0.225N P=0.479N | P=0.765N (e) P=0.536 (e) | |COCHRAN-ARMITAGE | P=0.466N | P=0.785N | |FISHER EXACT | P=0.684 P=0.252N P=0.508N | (e) P=0.500 (e) | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 50/51 (98%) 45/50 (90%) 40/50 (80%) 39/50 (78%) | 44/50 (88%) 40/50 (80%) 29/50 (58%) 33/50 (66%) | |ADJUSTED (b) | 100.0% 97.8% 97.3% 95.1% | 97.7% 92.9% 69.9% 82.2% | |TERMINAL (d) | 15/15 (100%) 14/15 (93%) 13/14 (93%) 18/20 (90%) | 24/25 (96%) 26/29 (90%) 18/30 (60%) 24/31 (77%) | |FIRST INCIDENCE (DAYS) | 316 146 437 434 | 478 537 441 387 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.016N* P=0.194N P=0.061N P=0.008N** | P=0.011N* P=0.089N P=0.001N** P=0.003N** | |INCIDENTAL TUMOR | P=0.040N* P=0.116N P=0.003N** P=0.012N* | P=0.009N** P=0.132N P<0.001N** P=0.002N** | |LOGISTIC REGRESSION | P=0.038N* P=0.123N P<0.001N** P=0.005N** | P=0.014N* P=0.117N P<0.001N** P=0.005N** | |COCHRAN-ARMITAGE | P=0.011N* | P=0.018N* | |FISHER EXACT | P=0.098N P=0.004N** P=0.002N** | P=0.207N P<0.001N** P=0.008N** | |=================================================================================================================================| DATE: 11/24/97 EXPERIMENT: 88032 TEST: 05 PAGE 22 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXYMETHOLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 3 MG/KG 30 MG/KG 150 | 0 MG/KG 3 MG/KG 30 MG/KG 100 | | | MG/KG | MG/KG | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 28/51 (55%) 22/50 (44%) 16/50 (32%) 7/50 (14%) | 17/50 (34%) 18/50 (36%) 16/50 (32%) 12/50 (24%) | |ADJUSTED (b) | 82.7% 61.3% 49.7% 22.5% | 50.6% 41.7% 38.1% 31.9% | |TERMINAL (d) | 10/15 (67%) 5/15 (33%) 4/14 (29%) 2/20 (10%) | 10/25 (40%) 6/29 (21%) 6/30 (20%) 7/31 (23%) | |FIRST INCIDENCE (DAYS) | 366 321 281 551 | 533 523 441 539 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001N** P=0.147N P=0.019N* P<0.001N** | P=0.079N P=0.485N P=0.339N P=0.093N | |INCIDENTAL TUMOR | P<0.001N** P=0.192N P=0.010N** P<0.001N** | P=0.157N P=0.405 P=0.581N P=0.161N | |LOGISTIC REGRESSION | P<0.001N** P=0.174N P=0.016N* P<0.001N** | P=0.234N P=0.500 P=0.498N P=0.166N | |COCHRAN-ARMITAGE | P<0.001N** | P=0.109N | |FISHER EXACT | P=0.185N P=0.017N* P<0.001N** | P=0.500 P=0.500N P=0.189N | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 51/51 (100%) 48/50 (96%) 44/50 (88%) 40/50 (80%) | 45/50 (90%) 45/50 (90%) 37/50 (74%) 37/50 (74%) | |ADJUSTED (b) | 100.0% 98.0% 97.5% 95.2% | 97.8% 93.8% 78.7% 85.8% | |TERMINAL (d) | 15/15 (100%) 14/15 (93%) 13/14 (93%) 18/20 (90%) | 24/25 (96%) 26/29 (90%) 20/30 (67%) 25/31 (81%) | |FIRST INCIDENCE (DAYS) | 316 146 281 434 | 478 523 441 387 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.012N* P=0.275N P=0.126N P=0.009N** | P=0.021N* P=0.239N P=0.033N* P=0.014N* | |INCIDENTAL TUMOR | P=0.004N** P=0.353N P=0.009N** P=0.016N* | P=0.011N* P=0.635N P=0.030N* P=0.014N* | |LOGISTIC REGRESSION | P=0.050N P=0.273N P=0.017N* P=0.003N** | P=0.014N* P=0.572N P=0.035N* P=0.026N* | |COCHRAN-ARMITAGE | P<0.001N** | P=0.015N* | |FISHER EXACT | P=0.243N P=0.013N* P<0.001N** | P=0.630N P=0.033N* P=0.033N* | |=================================================================================================================================| DATE: 11/24/97 EXPERIMENT: 88032 TEST: 05 PAGE 23 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXYMETHOLONE 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).