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).