TDMS Study 88032-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus OXYMETHOLONE DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 TIME: 07:29:33 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: 25022 Accidently Killed 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 NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus OXYMETHOLONE DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 TIME: 07:29:33 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 Cortex Vacuolization Cytoplasmic Bone Fibrous Osteodystrophy Heart Degeneration Chronic Kidney Cyst Mineralization Nephropathy Liver Basophilic Focus Clear Cell Focus Hyperplasia Inflammation Chronic Vacuolization Cytoplasmic Lung Mineralization Mammary Gland Dilatation Galactocele Hyperplasia Pancreas Atrophy Preputial Gland Inflammation Chronic Prostate Inflammation Chronic Spleen Fibrosis Testes Degeneration Hyperplasia Mineralization Thymus Atrophy Thyroid Gland Ultimobranchial Cyst ==================================================================================================== NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus OXYMETHOLONE DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 TIME: 07:29:33 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 ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Cortex Angiectasis Hypertrophy Vacuolization Cytoplasmic Adrenal Medulla Hyperplasia Clitoral Gland Inflammation Chronic Heart Degeneration Chronic Inflammation Chronic Intestine Large, Rectum Parasite Metazoan Kidney Mineralization Nephropathy Liver Clear Cell Focus Degeneration Cystic Hepatodiaphragmatic Nodule Hyperplasia Inflammation Chronic Mixed Cell Focus Lung Inflammation Chronic Mineralization Lymph Node, Mesenteric Ectasia Mammary Gland Dilatation Mesentery Inflammation Chronic Ovary DYSGENESIS Pituitary Gland Cyst Uterus Cyst ==================================================================================================== DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 1 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 Cortex | | Angiectasis | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | 21/50 (42%) 26/50 (52%) 15/50 (30%) 3/49 (6%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 77.6% 86.6% 50.0% 9.7% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/14 (0%) 0/20 (0%) | 19/25 (76%) 25/29 (86%) 15/30 (50%) 3/31 (10%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 684 705 728 (T) 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P<0.001N** P=0.424 P=0.018N* P<0.001N** | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P<0.001N** P=0.451 P=0.015N* P<0.001N** | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P<0.001N** P=0.385 P=0.024N* P<0.001N** | |COCHRAN-ARMITAGE | (e) | P<0.001N** | |FISHER EXACT | (e) (e) (e) | P=0.212 P=0.149N P<0.001N** | |=================================================================================================================================| | | |Adrenal Cortex | | Hemorrhage | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/51 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |ADJUSTED (b) | 0.0% 10.0% 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) | --- 692 --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.353N P=0.266 (e) (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.376N P=0.261 (e) (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.365N P=0.265 (e) (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.390N | (e) | |FISHER EXACT | P=0.243 (e) (e) | (e) (e) (e) | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 2 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 Cortex | | Hypertrophy | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | 0/50 (0%) 5/50 (10%) 0/50 (0%) 0/49 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 17.2% 0.0% 0.0% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/14 (0%) 0/20 (0%) | 0/25 (0%) 5/29 (17%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- 728 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.077N P=0.045 * (e) (e) | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.077N P=0.045 * (e) (e) | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.077N P=0.045 * (e) (e) | |COCHRAN-ARMITAGE | (e) | P=0.098N | |FISHER EXACT | (e) (e) (e) | P=0.028 * (e) (e) | |=================================================================================================================================| | | |Adrenal Cortex | | Pigmentation | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/49 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 4.3% 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) | --- --- --- --- | --- --- 478 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.703N (e) P=0.225 (e) | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.620N (e) P=0.142 (e) | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.644N (e) P=0.329 (e) | |COCHRAN-ARMITAGE | (e) | P=0.697N | |FISHER EXACT | (e) (e) (e) | (e) P=0.247 (e) | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 3 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 Cortex | | Vacuolization Cytoplasmic | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 22/51 (43%) 23/50 (46%) 40/50 (80%) 33/49 (67%) | 4/50 (8%) 5/50 (10%) 21/50 (42%) 36/49 (73%) | |ADJUSTED (b) | 59.9% 65.8% 94.8% 79.9% | 11.8% 11.5% 48.3% 85.4% | |TERMINAL (d) | 5/15 (33%) 5/15 (33%) 12/14 (86%) 12/20 (60%) | 0/25 (0%) 0/29 (0%) 8/30 (27%) 25/31 (81%) | |FIRST INCIDENCE (DAYS) | 316 408 353 116 | 533 523 118 490 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.311 P=0.543N P=0.021 * P=0.218 | P<0.001 ** P=0.570 P=0.002 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.004 ** P=0.377 P<0.001 ** P=0.002 ** | P<0.001 ** P=0.371 P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | P=0.002 ** P=0.461 P<0.001 ** P<0.001 ** | P<0.001 ** P=0.423 P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.023 * | P<0.001 ** | |FISHER EXACT | P=0.464 P<0.001 ** P=0.013 * | P=0.500 P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | |Adrenal Medulla | | Hyperplasia | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 15/51 (29%) 17/50 (34%) 20/50 (40%) 15/49 (31%) | 5/50 (10%) 1/50 (2%) 3/50 (6%) 13/49 (27%) | |ADJUSTED (b) | 53.7% 58.0% 66.4% 48.7% | 15.3% 3.4% 8.0% 39.0% | |TERMINAL (d) | 5/15 (33%) 5/15 (33%) 6/14 (43%) 6/20 (30%) | 2/25 (8%) 1/29 (3%) 1/30 (3%) 11/31 (35%) | |FIRST INCIDENCE (DAYS) | 464 408 353 629 | 478 728 (T) 638 659 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.213N P=0.526 P=0.322 P=0.350N | P<0.001 ** P=0.089N P=0.292N P=0.086 | |INCIDENTAL TUMOR | P=0.478N P=0.423 P=0.307 P=0.482 | P<0.001 ** P=0.095N P=0.357N P=0.078 | |LOGISTIC REGRESSION | P=0.453N P=0.435 P=0.257 P=0.575 | P<0.001 ** P=0.103N P=0.356N P=0.043 * | |COCHRAN-ARMITAGE | P=0.447N | P<0.001 ** | |FISHER EXACT | P=0.389 P=0.182 P=0.534 | P=0.102N P=0.357N P=0.030 * | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 4 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Blood Vessel | | Mineralization | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/51 (6%) 5/50 (10%) 6/50 (12%) 7/48 (15%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |ADJUSTED (b) | 9.7% 22.1% 31.6% 23.5% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 2/14 (14%) 1/20 (5%) | 0/25 (0%) 0/29 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 471 692 680 629 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.319 P=0.416 P=0.277 P=0.250 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.081 P=0.385 P=0.269 P=0.067 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.192 P=0.367 P=0.284 P=0.139 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.170 | (e) | |FISHER EXACT | P=0.346 P=0.234 P=0.135 | (e) (e) (e) | |=================================================================================================================================| | | |Bone | | Fibrous Osteodystrophy | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/51 (4%) 8/49 (16%) 13/50 (26%) 15/50 (30%) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |ADJUSTED (b) | 7.7% 33.8% 49.8% 46.7% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/15 (0%) 1/15 (7%) 3/14 (21%) 5/20 (25%) | 0/25 (0%) 0/29 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 611 692 605 577 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.033 * P=0.079 P=0.008 ** P=0.006 ** | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.001 ** P=0.064 P=0.006 ** P<0.001 ** | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.005 ** P=0.062 P=0.005 ** P<0.001 ** | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.005 ** | (e) | |FISHER EXACT | P=0.040 * P=0.002 ** P<0.001 ** | (e) (e) (e) | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 5 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Bone | | Osteosclerosis | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/51 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 2/50 (4%) 0/49 (0%) 0/50 (0%) | |ADJUSTED (b) | 3.4% 0.0% 0.0% 0.0% | 7.2% 6.7% 0.0% 0.0% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/14 (0%) 0/20 (0%) | 1/25 (4%) 1/29 (3%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 646 --- --- --- | 705 725 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.586N P=0.480N P=0.474N P=0.480N | P=0.110N P=0.643N P=0.213N P=0.206N | |INCIDENTAL TUMOR | P=0.646N P=0.461N P=0.439N P=0.531N | P=0.107N P=0.626N P=0.187N P=0.193N | |LOGISTIC REGRESSION | P=0.595N P=0.504N P=0.501N P=0.504N | P=0.109N P=0.653N P=0.209N P=0.205N | |COCHRAN-ARMITAGE | P=0.592N | P=0.125N | |FISHER EXACT | P=0.510N P=0.505N P=0.505N | P=0.691N P=0.253N P=0.247N | |=================================================================================================================================| | | |Bone Marrow | | Myelofibrosis | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/48 (2%) 2/49 (4%) 0/50 (0%) 0/49 (0%) | 0/50 (0%) 2/50 (4%) 2/49 (4%) 0/49 (0%) | |ADJUSTED (b) | 6.7% 9.7% 0.0% 0.0% | 0.0% 6.1% 6.7% 0.0% | |TERMINAL (d) | 1/15 (7%) 1/15 (7%) 0/14 (0%) 0/20 (0%) | 0/25 (0%) 1/29 (3%) 2/30 (7%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 728 (T) 675 --- --- | --- 665 728 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.210N P=0.540 P=0.514N P=0.443N | P=0.311N P=0.266 P=0.279 (e) | |INCIDENTAL TUMOR | P=0.225N P=0.523 P=0.514N P=0.443N | P=0.308N P=0.281 P=0.279 (e) | |LOGISTIC REGRESSION | P=0.230N P=0.550 P=0.514N P=0.443N | P=0.324N P=0.250 P=0.279 (e) | |COCHRAN-ARMITAGE | P=0.248N | P=0.350N | |FISHER EXACT | P=0.508 P=0.490N P=0.495N | P=0.247 P=0.242 (e) | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 6 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | | Hemorrhage | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION 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% 10.7% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 1/14 (7%) 0/20 (0%) | 0/25 (0%) 0/29 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 693 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.583N (e) P=0.255 (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.622N (e) P=0.265 (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.606N (e) P=0.271 (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.632N | (e) | |FISHER EXACT | (e) P=0.243 (e) | (e) (e) (e) | |=================================================================================================================================| | | |Brain | | Necrosis | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/51 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 7.0% 0.0% 0.0% 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) | 464 --- --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.353N P=0.229N P=0.240N P=0.229N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.545N P=0.271N P=0.295N P=0.464N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.340N P=0.240N P=0.269N P=0.232N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.359N | (e) | |FISHER EXACT | P=0.252N P=0.252N P=0.252N | (e) (e) (e) | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 7 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 Gland | | Cyst | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | 6/50 (12%) 6/48 (13%) 5/50 (10%) 2/50 (4%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 18.3% 20.7% 15.8% 5.4% | |TERMINAL (d) | 0/0 0/0 0/0 0/0 | 2/25 (8%) 6/29 (21%) 4/30 (13%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 562 728 (T) 693 511 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.063N P=0.529N P=0.408N P=0.107N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.080N P=0.607N P=0.516N P=0.202N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.075N P=0.608N P=0.480N P=0.136N | |COCHRAN-ARMITAGE | (e) | P=0.080N | |FISHER EXACT | (e) (e) (e) | P=0.591 P=0.500N P=0.134N | |=================================================================================================================================| | | |Clitoral Gland | | Inflammation Chronic | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | 7/50 (14%) 8/48 (17%) 11/50 (22%) 18/50 (36%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 22.3% 22.8% 31.8% 44.7% | |TERMINAL (d) | 0/0 0/0 0/0 0/0 | 4/25 (16%) 5/29 (17%) 8/30 (27%) 10/31 (32%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 548 556 229 177 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.010 ** P=0.602 P=0.318 P=0.040 * | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.002 ** P=0.415 P=0.299 P=0.015 * | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.003 ** P=0.464 P=0.217 P=0.010 ** | |COCHRAN-ARMITAGE | (e) | P=0.003 ** | |FISHER EXACT | (e) (e) (e) | P=0.465 P=0.218 P=0.010 ** | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 8 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Epididymis | | Atypia Cellular | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/51 (0%) 2/50 (4%) 1/50 (2%) 0/49 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |ADJUSTED (b) | 0.0% 4.5% 2.1% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/14 (0%) 0/20 (0%) | 0/0 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | --- 485 437 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.359N P=0.238 P=0.504 (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.848N P=0.128 P=0.318 (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.222N P=0.263 P=0.451 (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.355N | (e) | |FISHER EXACT | P=0.243 P=0.495 (e) | (e) (e) (e) | |=================================================================================================================================| | | |Eye: Lens | | Mineralization | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/1 (0%) 1/2 (50%) 0/2 (0%) 2/3 (67%) | 1/2 (50%) 1/1 (100%) 0/0 (0%) 0/0 (0%) | |ADJUSTED (b) | 0.0% 5.3% 0.0% 100.0% | 3.8% 100.0% 0.0% 0.0% | |TERMINAL (d) | 0/0 0/1 (0%) 0/0 2/2 (100%) | 0/0 1/1 (100%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | --- 709 --- 728 (T) | 708 728 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.546 P=0.511 (e) (e) | P=0.493N P=0.465N P=0.465N P=0.452N | |INCIDENTAL TUMOR | P=0.364 (e) (e) (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.466 (e) (e) (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.295 | P=1.000 | |FISHER EXACT | P=0.667 (e) P=0.500 | P=0.667 P=1.000N P=1.000N | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 9 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Eye: Retina | | Degeneration | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/1 (100%) 1/2 (50%) 0/2 (0%) 2/3 (67%) | 1/2 (50%) 1/1 (100%) 0/0 (0%) 0/0 (0%) | |ADJUSTED (b) | 2.0% 5.3% 0.0% 100.0% | 3.8% 100.0% 0.0% 0.0% | |TERMINAL (d) | 0/0 0/1 (0%) 0/0 2/2 (100%) | 0/0 1/1 (100%) 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 384 709 --- 728 (T) | 708 728 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.686 P=0.759N P=0.504N P=0.521N | P=0.493N P=0.465N P=0.465N P=0.452N | |INCIDENTAL TUMOR | P=0.364 (e) (e) (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.518 (e) (e) (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.563 | P=1.000 | |FISHER EXACT | P=0.667N P=0.333N P=0.750N | P=0.667 P=1.000N P=1.000N | |=================================================================================================================================| | | |Heart | | Mineralization | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/51 (6%) 5/49 (10%) 8/50 (16%) 5/47 (11%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |ADJUSTED (b) | 9.7% 22.1% 37.3% 17.3% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 2/14 (14%) 1/20 (5%) | 0/25 (0%) 0/29 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 471 692 680 629 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.530N P=0.416 P=0.135 P=0.448 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.307 P=0.376 P=0.130 P=0.192 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.512 P=0.356 P=0.131 P=0.316 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.473 | (e) | |FISHER EXACT | P=0.335 P=0.094 P=0.312 | (e) (e) (e) | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 10 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Heart | | Thrombosis | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/51 (0%) 1/49 (2%) 0/50 (0%) 2/47 (4%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | |ADJUSTED (b) | 0.0% 6.7% 0.0% 7.1% | 0.0% 0.0% 2.6% 0.0% | |TERMINAL (d) | 0/15 (0%) 1/15 (7%) 0/14 (0%) 1/20 (5%) | 0/25 (0%) 0/29 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | --- 728 (T) --- 145 | --- --- 670 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.201 P=0.500 (e) P=0.256 | P=0.774N (e) P=0.528 (e) | |INCIDENTAL TUMOR | P=0.301 P=0.500 (e) P=0.439 | P=0.792N (e) P=0.564 (e) | |LOGISTIC REGRESSION | P=0.186 P=0.500 (e) P=0.290 | P=0.789N (e) P=0.500 (e) | |COCHRAN-ARMITAGE | P=0.144 | P=0.789N | |FISHER EXACT | P=0.490 (e) P=0.227 | (e) P=0.500 (e) | |=================================================================================================================================| | | |Heart: Epicardium | | Inflammation Chronic | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/51 (0%) 0/49 (0%) 0/50 (0%) 0/47 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 4.2% | |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) | --- --- --- --- | --- --- --- 177 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.041 * (e) (e) P=0.235 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.064 (e) (e) P=0.500 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.051 (e) (e) P=0.573 | |COCHRAN-ARMITAGE | (e) | P=0.039 * | |FISHER EXACT | (e) (e) (e) | (e) (e) P=0.242 | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 11 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Heart: Myocardium | | Degeneration Chronic | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 43/51 (84%) 43/49 (88%) 48/50 (96%) 42/47 (89%) | 29/50 (58%) 34/50 (68%) 40/50 (80%) 45/49 (92%) | |ADJUSTED (b) | 97.5% 95.5% 100.0% 100.0% | 84.8% 84.5% 95.2% 100.0% | |TERMINAL (d) | 14/15 (93%) 13/15 (87%) 14/14 (100%) 20/20 (100%)| 20/25 (80%) 23/29 (79%) 28/30 (93%) 31/31 (100%)| |FIRST INCIDENCE (DAYS) | 316 146 281 114 | 548 523 229 387 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.104N P=0.401N P=0.475 P=0.138N | P=0.036 * P=0.521 P=0.196 P=0.057 | |INCIDENTAL TUMOR | P=0.537N P=0.527 P=0.105 P=0.633N | P<0.001 ** P=0.320 P=0.067 P<0.001 ** | |LOGISTIC REGRESSION | P=0.225 P=0.399 P=0.093 P=0.217 | P<0.001 ** P=0.331 P=0.040 * P<0.001 ** | |COCHRAN-ARMITAGE | P=0.441 | P<0.001 ** | |FISHER EXACT | P=0.419 P=0.049 * P=0.332 | P=0.204 P=0.015 * P<0.001 ** | |=================================================================================================================================| | | |Intestine Large, Colon | | Mineralization | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/48 (2%) 2/49 (4%) 0/46 (0%) 0/47 (0%) | 0/46 (0%) 0/46 (0%) 0/49 (0%) 0/48 (0%) | |ADJUSTED (b) | 4.8% 8.8% 0.0% 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) | 702 703 --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.227N P=0.558 P=0.482N P=0.465N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.295N P=0.569 P=0.461N P=0.531N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.234N P=0.548 P=0.482N P=0.474N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.255N | (e) | |FISHER EXACT | P=0.508 P=0.511N P=0.505N | (e) (e) (e) | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 12 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Intestine Large, Colon | | Parasite Metazoan | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/48 (6%) 0/49 (0%) 2/46 (4%) 3/47 (6%) | 1/46 (2%) 0/46 (0%) 3/49 (6%) 0/48 (0%) | |ADJUSTED (b) | 20.0% 0.0% 11.6% 15.0% | 4.0% 0.0% 10.0% 0.0% | |TERMINAL (d) | 3/15 (20%) 0/15 (0%) 1/14 (7%) 3/20 (15%) | 1/25 (4%) 0/29 (0%) 3/30 (10%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 728 (T) --- 705 728 (T) | 728 (T) --- 728 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.450 P=0.116N P=0.521N P=0.525N | P=0.416N P=0.470N P=0.371 P=0.457N | |INCIDENTAL TUMOR | P=0.428 P=0.116N P=0.508N P=0.525N | P=0.416N P=0.470N P=0.371 P=0.457N | |LOGISTIC REGRESSION | P=0.418 P=0.116N P=0.500N P=0.525N | P=0.416N P=0.470N P=0.371 P=0.457N | |COCHRAN-ARMITAGE | P=0.300 | P=0.447N | |FISHER EXACT | P=0.117N P=0.520N P=0.651 | P=0.500N P=0.333 P=0.489N | |=================================================================================================================================| | | |Intestine Large, Rectum | | Parasite Metazoan | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 3/47 (6%) 1/47 (2%) 1/46 (2%) | 2/44 (5%) 5/47 (11%) 5/46 (11%) 10/50 (20%) | |ADJUSTED (b) | 6.7% 17.1% 2.3% 5.0% | 8.0% 17.2% 16.7% 32.3% | |TERMINAL (d) | 1/15 (7%) 2/15 (13%) 0/14 (0%) 1/20 (5%) | 2/25 (8%) 5/29 (17%) 5/30 (17%) 10/31 (32%) | |FIRST INCIDENCE (DAYS) | 728 (T) 706 577 728 (T) | 728 (T) 728 (T) 728 (T) 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.343N P=0.316 P=0.752N P=0.698N | P=0.022 * P=0.275 P=0.292 P=0.032 * | |INCIDENTAL TUMOR | P=0.378N P=0.328 P=0.730 P=0.698N | P=0.022 * P=0.276 P=0.292 P=0.032 * | |LOGISTIC REGRESSION | P=0.416N P=0.348 P=0.762 P=0.698N | P=0.022 * P=0.276 P=0.292 P=0.032 * | |COCHRAN-ARMITAGE | P=0.448N | P=0.022 * | |FISHER EXACT | P=0.293 P=0.742 P=0.737 | P=0.245 P=0.236 P=0.024 * | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 13 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Intestine Small, Duodenum | | Mineralization | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/48 (4%) 1/49 (2%) 0/49 (0%) 0/47 (0%) | 0/47 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | |ADJUSTED (b) | 7.7% 4.0% 0.0% 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) | 611 703 --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.224N P=0.444N P=0.211N P=0.203N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.264N P=0.450N P=0.195N P=0.249N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.241N P=0.473N P=0.223N P=0.236N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.246N | (e) | |FISHER EXACT | P=0.492N P=0.242N P=0.253N | (e) (e) (e) | |=================================================================================================================================| | | |Kidney | | Cyst | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/51 (2%) 7/50 (14%) 4/50 (8%) 6/49 (12%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | |ADJUSTED (b) | 6.7% 31.6% 22.6% 24.0% | 0.0% 0.0% 0.0% 3.2% | |TERMINAL (d) | 1/15 (7%) 3/15 (20%) 2/14 (14%) 3/20 (15%) | 0/25 (0%) 0/29 (0%) 0/30 (0%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | 728 (T) 146 696 644 | --- --- --- 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.415 P=0.041 * P=0.182 P=0.111 | P=0.235 (e) (e) P=0.543 | |INCIDENTAL TUMOR | P=0.352 P=0.057 P=0.203 P=0.077 | P=0.235 (e) (e) P=0.543 | |LOGISTIC REGRESSION | P=0.403 P=0.074 P=0.211 P=0.077 | P=0.235 (e) (e) P=0.543 | |COCHRAN-ARMITAGE | P=0.244 | P=0.211 | |FISHER EXACT | P=0.028 * P=0.175 P=0.050 * | (e) (e) P=0.495 | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 14 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | | Mineralization | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 6/51 (12%) 6/50 (12%) 9/50 (18%) 25/49 (51%) | 27/50 (54%) 31/50 (62%) 35/50 (70%) 36/49 (73%) | |ADJUSTED (b) | 20.5% 23.8% 40.9% 69.7% | 76.1% 74.4% 84.9% 81.4% | |TERMINAL (d) | 1/15 (7%) 0/15 (0%) 3/14 (21%) 11/20 (55%) | 17/25 (68%) 19/29 (66%) 24/30 (80%) 23/31 (74%) | |FIRST INCIDENCE (DAYS) | 464 600 437 34 | 478 299 118 177 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.566N P=0.335 P=0.001 ** | P=0.290 P=0.546 P=0.329 P=0.333 | |INCIDENTAL TUMOR | P<0.001 ** P=0.596 P=0.249 P<0.001 ** | P=0.083 P=0.383 P=0.206 P=0.085 | |LOGISTIC REGRESSION | P<0.001 ** P=0.613 P=0.295 P<0.001 ** | P=0.044 * P=0.304 P=0.268 P=0.038 * | |COCHRAN-ARMITAGE | P<0.001 ** | P=0.044 * | |FISHER EXACT | P=0.606 P=0.274 P<0.001 ** | P=0.272 P=0.074 P=0.035 * | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 43/51 (84%) 47/50 (94%) 50/50 (100%) 48/49 (98%) | 32/50 (64%) 26/50 (52%) 38/50 (76%) 41/49 (84%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 83.8% 75.8% 94.9% 97.5% | |TERMINAL (d) | 15/15 (100%) 15/15 (100%) 14/14 (100%) 20/20 (100%)| 19/25 (76%) 21/29 (72%) 28/30 (93%) 30/31 (97%) | |FIRST INCIDENCE (DAYS) | 316 321 281 80 | 533 556 478 394 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.256N P=0.483 P=0.361 P=0.390N | P=0.060 P=0.049N* P=0.530 P=0.382 | |INCIDENTAL TUMOR | P=0.043 * P=0.077 P=0.010 ** P=0.051 | P=0.003 ** P=0.060N P=0.235 P=0.076 | |LOGISTIC REGRESSION | P=0.007 ** P=0.072 P=0.009 ** P=0.007 ** | P<0.001 ** P=0.061N P=0.186 P=0.024 * | |COCHRAN-ARMITAGE | P=0.058 | P=0.002 ** | |FISHER EXACT | P=0.106 P=0.003 ** P=0.018 * | P=0.156N P=0.138 P=0.022 * | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 15 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | | Pigmentation Hemosiderin | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/51 (8%) 4/50 (8%) 2/50 (4%) 4/49 (8%) | 5/50 (10%) 7/50 (14%) 4/50 (8%) 3/49 (6%) | |ADJUSTED (b) | 16.9% 15.1% 5.3% 10.8% | 15.1% 17.8% 10.5% 7.6% | |TERMINAL (d) | 1/15 (7%) 1/15 (7%) 0/14 (0%) 0/20 (0%) | 2/25 (8%) 2/29 (7%) 1/30 (3%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | 600 563 577 551 | 533 537 561 490 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.597N P=0.574N P=0.298N P=0.546N | P=0.149N P=0.463 P=0.434N P=0.295N | |INCIDENTAL TUMOR | P=0.504 P=0.618N P=0.275N P=0.607 | P=0.254N P=0.299 P=0.585N P=0.389N | |LOGISTIC REGRESSION | P=0.484 P=0.632N P=0.329N P=0.619 | P=0.376N P=0.351 P=0.499N P=0.367N | |COCHRAN-ARMITAGE | P=0.533 | P=0.184N | |FISHER EXACT | P=0.631 P=0.348N P=0.620 | P=0.380 P=0.500N P=0.369N | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Accumulation, Hyaline Droplet | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/51 (4%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |ADJUSTED (b) | 8.8% 0.0% 0.0% 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) | 646 --- --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.334N P=0.229N P=0.226N P=0.208N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.408N P=0.194N P=0.172N P=0.270N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.359N P=0.225N P=0.215N P=0.230N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.363N | (e) | |FISHER EXACT | P=0.252N P=0.252N P=0.258N | (e) (e) (e) | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 16 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | | Hyperplasia | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/51 (6%) 2/50 (4%) 3/50 (6%) 1/49 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |ADJUSTED (b) | 20.0% 10.4% 12.4% 4.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 3/15 (20%) 1/15 (7%) 1/14 (7%) 0/20 (0%) | 0/25 (0%) 0/29 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 728 (T) 703 644 703 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.203N P=0.479N P=0.657N P=0.213N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.233N P=0.482N P=0.644 P=0.243N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.251N P=0.448N P=0.595N P=0.227N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.290N | (e) | |FISHER EXACT | P=0.509N P=0.652 P=0.324N | (e) (e) (e) | |=================================================================================================================================| | | |Liver | | Angiectasis | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/51 (2%) 2/50 (4%) 0/50 (0%) 0/49 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |ADJUSTED (b) | 6.7% 8.9% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/15 (7%) 0/15 (0%) 0/14 (0%) 0/20 (0%) | 0/25 (0%) 0/29 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 728 (T) 706 --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.214N P=0.528 P=0.514N P=0.443N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.258N P=0.545 P=0.514N P=0.443N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.228N P=0.549 P=0.514N P=0.443N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.255N | (e) | |FISHER EXACT | P=0.492 P=0.505N P=0.510N | (e) (e) (e) | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 17 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | | Basophilic Focus | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 23/51 (45%) 29/50 (58%) 41/50 (82%) 38/49 (78%) | 37/50 (74%) 40/50 (80%) 37/50 (74%) 41/49 (84%) | |ADJUSTED (b) | 95.4% 86.4% 97.5% 100.0% | 92.0% 97.5% 92.4% 97.6% | |TERMINAL (d) | 14/15 (93%) 11/15 (73%) 13/14 (93%) 20/20 (100%)| 22/25 (88%) 28/29 (97%) 27/30 (90%) 30/31 (97%) | |FIRST INCIDENCE (DAYS) | 553 321 517 434 | 478 556 478 510 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.296 P=0.263 P=0.007 ** P=0.100 | P=0.388N P=0.424N P=0.213N P=0.366N | |INCIDENTAL TUMOR | P=0.003 ** P=0.169 P<0.001 ** P<0.001 ** | P=0.148 P=0.362 P=0.597N P=0.143 | |LOGISTIC REGRESSION | P=0.001 ** P=0.195 P<0.001 ** P<0.001 ** | P=0.189 P=0.415 P=0.565N P=0.197 | |COCHRAN-ARMITAGE | P=0.005 ** | P=0.205 | |FISHER EXACT | P=0.136 P<0.001 ** P<0.001 ** | P=0.318 P=0.590N P=0.176 | |=================================================================================================================================| | | |Liver | | Clear Cell Focus | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/51 (4%) 2/50 (4%) 6/50 (12%) 12/49 (24%) | 5/50 (10%) 11/50 (22%) 6/50 (12%) 14/49 (29%) | |ADJUSTED (b) | 13.3% 13.3% 32.5% 56.1% | 20.0% 36.0% 20.0% 45.2% | |TERMINAL (d) | 2/15 (13%) 2/15 (13%) 4/14 (29%) 11/20 (55%) | 5/25 (20%) 10/29 (34%) 6/30 (20%) 14/31 (45%) | |FIRST INCIDENCE (DAYS) | 728 (T) 728 (T) 517 561 | 728 (T) 579 728 (T) 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.002 ** P=0.701 P=0.126 P=0.010 ** | P=0.073 P=0.136 P=0.631 P=0.047 * | |INCIDENTAL TUMOR | P<0.001 ** P=0.701 P=0.089 P=0.009 ** | P=0.058 P=0.117 P=0.631 P=0.047 * | |LOGISTIC REGRESSION | P<0.001 ** P=0.701 P=0.180 P=0.009 ** | P=0.066 P=0.123 P=0.631 P=0.047 * | |COCHRAN-ARMITAGE | P<0.001 ** | P=0.035 * | |FISHER EXACT | P=0.684 P=0.128 P=0.003 ** | P=0.086 P=0.500 P=0.017 * | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 18 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | | Degeneration Cystic | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/51 (0%) 4/50 (8%) 0/50 (0%) 0/49 (0%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 3/49 (6%) | |ADJUSTED (b) | 0.0% 19.0% 0.0% 0.0% | 0.0% 0.0% 3.3% 9.7% | |TERMINAL (d) | 0/15 (0%) 1/15 (7%) 0/14 (0%) 0/20 (0%) | 0/25 (0%) 0/29 (0%) 1/30 (3%) 3/31 (10%) | |FIRST INCIDENCE (DAYS) | --- 692 --- --- | --- --- 728 (T) 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.154N P=0.082 (e) (e) | P=0.029 * (e) P=0.536 P=0.160 | |INCIDENTAL TUMOR | P=0.195N P=0.082 (e) (e) | P=0.029 * (e) P=0.536 P=0.160 | |LOGISTIC REGRESSION | P=0.162N P=0.078 (e) (e) | P=0.029 * (e) P=0.536 P=0.160 | |COCHRAN-ARMITAGE | P=0.185N | P=0.020 * | |FISHER EXACT | P=0.056 (e) (e) | (e) P=0.500 P=0.117 | |=================================================================================================================================| | | |Liver | | Eosinophilic Focus | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 6/51 (12%) 4/50 (8%) 4/50 (8%) 2/49 (4%) | 8/50 (16%) 6/50 (12%) 3/50 (6%) 3/49 (6%) | |ADJUSTED (b) | 36.8% 19.8% 18.0% 7.3% | 26.6% 19.0% 10.0% 8.5% | |TERMINAL (d) | 5/15 (33%) 2/15 (13%) 1/14 (7%) 1/20 (5%) | 5/25 (20%) 4/29 (14%) 3/30 (10%) 2/31 (6%) | |FIRST INCIDENCE (DAYS) | 707 692 609 561 | 562 702 728 (T) 511 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.087N P=0.330N P=0.373N P=0.063N | P=0.070N P=0.297N P=0.062N P=0.064N | |INCIDENTAL TUMOR | P=0.116N P=0.327N P=0.336N P=0.079N | P=0.097N P=0.327N P=0.108N P=0.128N | |LOGISTIC REGRESSION | P=0.129N P=0.275N P=0.268N P=0.091N | P=0.093N P=0.334N P=0.084N P=0.103N | |COCHRAN-ARMITAGE | P=0.165N | P=0.103N | |FISHER EXACT | P=0.383N P=0.383N P=0.148N | P=0.387N P=0.100N P=0.106N | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 19 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | | Hematopoietic Cell Proliferation | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/51 (0%) 2/50 (4%) 2/50 (4%) 0/49 (0%) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | |ADJUSTED (b) | 0.0% 10.3% 4.0% 0.0% | 8.0% 3.4% 0.0% 0.0% | |TERMINAL (d) | 0/15 (0%) 1/15 (7%) 0/14 (0%) 0/20 (0%) | 2/25 (8%) 1/29 (3%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | --- 693 281 --- | 728 (T) 728 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.310N P=0.263 P=0.235 (e) | P=0.164N P=0.448N P=0.198N P=0.192N | |INCIDENTAL TUMOR | P=0.157N P=0.261 P=0.362 (e) | P=0.164N P=0.448N P=0.198N P=0.192N | |LOGISTIC REGRESSION | P=0.232N P=0.265 P=0.187 (e) | P=0.164N P=0.448N P=0.198N P=0.192N | |COCHRAN-ARMITAGE | P=0.327N | P=0.189N | |FISHER EXACT | P=0.243 P=0.243 (e) | P=0.500N P=0.247N P=0.253N | |=================================================================================================================================| | | |Liver | | Hepatodiaphragmatic Nodule | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 7/51 (14%) 3/50 (6%) 2/50 (4%) 6/49 (12%) | 12/50 (24%) 6/50 (12%) 4/50 (8%) 9/49 (18%) | |ADJUSTED (b) | 29.4% 17.1% 5.8% 23.3% | 32.5% 17.3% 11.7% 25.5% | |TERMINAL (d) | 3/15 (20%) 2/15 (13%) 0/14 (0%) 3/20 (15%) | 4/25 (16%) 4/29 (14%) 2/30 (7%) 6/31 (19%) | |FIRST INCIDENCE (DAYS) | 429 706 644 563 | 478 501 665 659 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.510 P=0.147N P=0.071N P=0.346N | P=0.489N P=0.075N P=0.022N* P=0.203N | |INCIDENTAL TUMOR | P=0.373 P=0.181N P=0.094N P=0.537N | P=0.510 P=0.170N P=0.060N P=0.440N | |LOGISTIC REGRESSION | P=0.341 P=0.147N P=0.080N P=0.519N | P=0.534 P=0.112N P=0.028N* P=0.331N | |COCHRAN-ARMITAGE | P=0.344 | P=0.534 | |FISHER EXACT | P=0.167N P=0.085N P=0.531N | P=0.096N P=0.027N* P=0.331N | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 20 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | | Inflammation Chronic | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 9/51 (18%) 4/50 (8%) 3/50 (6%) 1/49 (2%) | 17/50 (34%) 13/50 (26%) 10/50 (20%) 5/49 (10%) | |ADJUSTED (b) | 33.4% 24.4% 13.9% 5.0% | 46.2% 39.6% 30.5% 15.3% | |TERMINAL (d) | 3/15 (20%) 3/15 (20%) 1/14 (7%) 1/20 (5%) | 8/25 (32%) 10/29 (34%) 8/30 (27%) 4/31 (13%) | |FIRST INCIDENCE (DAYS) | 316 714 527 728 (T) | 478 582 478 680 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.016N* P=0.121N P=0.066N P=0.006N** | P=0.002N** P=0.165N P=0.054N P=0.002N** | |INCIDENTAL TUMOR | P=0.022N* P=0.108N P=0.077N P=0.005N** | P=0.006N** P=0.272N P=0.150N P=0.011N* | |LOGISTIC REGRESSION | P=0.031N* P=0.122N P=0.080N P=0.012N* | P=0.005N** P=0.249N P=0.088N P=0.005N** | |COCHRAN-ARMITAGE | P=0.030N* | P=0.005N** | |FISHER EXACT | P=0.125N P=0.065N P=0.009N** | P=0.257N P=0.088N P=0.004N** | |=================================================================================================================================| | | |Liver | | Mixed Cell Focus | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/51 (4%) 1/50 (2%) 4/50 (8%) 4/49 (8%) | 2/50 (4%) 7/50 (14%) 9/50 (18%) 7/49 (14%) | |ADJUSTED (b) | 13.3% 6.7% 20.0% 18.5% | 8.0% 22.7% 30.0% 22.6% | |TERMINAL (d) | 2/15 (13%) 1/15 (7%) 2/14 (14%) 3/20 (15%) | 2/25 (8%) 6/29 (21%) 9/30 (30%) 7/31 (23%) | |FIRST INCIDENCE (DAYS) | 728 (T) 728 (T) 666 708 | 728 (T) 639 728 (T) 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.340 P=0.500N P=0.355 P=0.475 | P=0.356 P=0.119 P=0.047 * P=0.135 | |INCIDENTAL TUMOR | P=0.286 P=0.500N P=0.360 P=0.438 | P=0.310 P=0.098 P=0.047 * P=0.135 | |LOGISTIC REGRESSION | P=0.261 P=0.500N P=0.408 P=0.446 | P=0.335 P=0.107 P=0.047 * P=0.135 | |COCHRAN-ARMITAGE | P=0.196 | P=0.239 | |FISHER EXACT | P=0.508N P=0.329 P=0.320 | P=0.080 P=0.026 * P=0.075 | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 21 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | | Necrosis | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/51 (6%) 1/50 (2%) 1/50 (2%) 1/49 (2%) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/49 (2%) | |ADJUSTED (b) | 9.0% 2.7% 7.1% 4.2% | 4.0% 5.5% 0.0% 2.9% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 1/14 (7%) 0/20 (0%) | 1/25 (4%) 0/29 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 479 598 728 (T) 708 | 728 (T) 639 --- 695 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.370N P=0.281N P=0.280N P=0.260N | P=0.503N P=0.550 P=0.464N P=0.719N | |INCIDENTAL TUMOR | P=0.519N P=0.370N P=0.362N P=0.504N | P=0.636N P=0.491 P=0.464N P=0.723N | |LOGISTIC REGRESSION | P=0.428N P=0.311N P=0.326N P=0.320N | P=0.541N P=0.515 P=0.464N P=0.742N | |COCHRAN-ARMITAGE | P=0.427N | P=0.547N | |FISHER EXACT | P=0.316N P=0.316N P=0.324N | P=0.500 P=0.500N P=0.747 | |=================================================================================================================================| | | |Liver | | Regeneration | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/49 (4%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 3.3% 0.0% 5.8% | |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) | --- --- --- --- | --- 725 --- 695 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.196 P=0.536 (e) P=0.288 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.149 P=0.545 (e) P=0.259 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.171 P=0.526 (e) P=0.251 | |COCHRAN-ARMITAGE | (e) | P=0.157 | |FISHER EXACT | (e) (e) (e) | P=0.500 (e) P=0.242 | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 22 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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: Bile Duct | | Hyperplasia | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 29/51 (57%) 27/50 (54%) 24/50 (48%) 0/49 (0%) | 1/50 (2%) 3/50 (6%) 6/50 (12%) 0/49 (0%) | |ADJUSTED (b) | 86.2% 76.2% 75.0% 0.0% | 4.0% 9.5% 16.6% 0.0% | |TERMINAL (d) | 11/15 (73%) 8/15 (53%) 8/14 (57%) 0/20 (0%) | 1/25 (4%) 2/29 (7%) 3/30 (10%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 316 479 517 --- | 728 (T) 665 561 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001N** P=0.324N P=0.179N P<0.001N** | P=0.159N P=0.354 P=0.092 P=0.457N | |INCIDENTAL TUMOR | P<0.001N** P=0.444N P=0.178N P<0.001N** | P=0.243N P=0.367 P=0.029 * P=0.457N | |LOGISTIC REGRESSION | P<0.001N** P=0.423N P=0.154N P<0.001N** | P=0.190N P=0.340 P=0.061 P=0.457N | |COCHRAN-ARMITAGE | P<0.001N** | P=0.197N | |FISHER EXACT | P=0.464N P=0.244N P<0.001N** | P=0.309 P=0.056 P=0.505N | |=================================================================================================================================| | | |Liver: Centrilobular | | Necrosis | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/51 (2%) 3/50 (6%) 1/50 (2%) 1/49 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | |ADJUSTED (b) | 2.9% 8.1% 2.7% 2.7% | 0.0% 0.0% 0.0% 2.4% | |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) | 600 588 629 629 | --- --- --- 659 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.399N P=0.334 P=0.716N P=0.724N | P=0.240 (e) (e) P=0.543 | |INCIDENTAL TUMOR | P=0.435N P=0.222 P=0.766 P=0.744 | P=0.208 (e) (e) P=0.523 | |LOGISTIC REGRESSION | P=0.431N P=0.297 P=0.746 P=0.754 | P=0.211 (e) (e) P=0.495 | |COCHRAN-ARMITAGE | P=0.443N | P=0.211 | |FISHER EXACT | P=0.301 P=0.748 P=0.742 | (e) (e) P=0.495 | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 23 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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: Centrilobular | | Vacuolization Cytoplasmic | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 9/51 (18%) 6/50 (12%) 10/50 (20%) 2/49 (4%) | 7/50 (14%) 8/50 (16%) 6/50 (12%) 3/49 (6%) | |ADJUSTED (b) | 27.2% 17.6% 33.3% 7.4% | 21.1% 18.6% 14.0% 9.7% | |TERMINAL (d) | 1/15 (7%) 1/15 (7%) 2/14 (14%) 1/20 (5%) | 2/25 (8%) 1/29 (3%) 1/30 (3%) 3/31 (10%) | |FIRST INCIDENCE (DAYS) | 479 321 605 577 | 533 523 118 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.026N* P=0.264N P=0.559N P=0.021N* | P=0.071N P=0.586 P=0.429N P=0.110N | |INCIDENTAL TUMOR | P=0.038N* P=0.340N P=0.495 P=0.075N | P=0.123N P=0.373 P=0.433N P=0.153N | |LOGISTIC REGRESSION | P=0.084N P=0.299N P=0.481 P=0.031N* | P=0.076N P=0.456 P=0.463N P=0.155N | |COCHRAN-ARMITAGE | P=0.034N* | P=0.087N | |FISHER EXACT | P=0.303N P=0.481 P=0.030N* | P=0.500 P=0.500N P=0.167N | |=================================================================================================================================| | | |Lung | | Inflammation Chronic | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 12/51 (24%) 13/50 (26%) 11/50 (22%) 14/47 (30%) | 8/50 (16%) 12/50 (24%) 7/50 (14%) 17/49 (35%) | |ADJUSTED (b) | 46.2% 43.3% 41.5% 41.4% | 28.2% 35.3% 22.5% 44.7% | |TERMINAL (d) | 4/15 (27%) 3/15 (20%) 3/14 (21%) 5/20 (25%) | 6/25 (24%) 8/29 (28%) 6/30 (20%) 11/31 (35%) | |FIRST INCIDENCE (DAYS) | 429 146 353 114 | 506 299 708 177 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.549 P=0.573 P=0.422N P=0.565N | P=0.069 P=0.330 P=0.365N P=0.098 | |INCIDENTAL TUMOR | P=0.460 P=0.586N P=0.375N P=0.526 | P=0.065 P=0.412 P=0.365N P=0.121 | |LOGISTIC REGRESSION | P=0.303 P=0.477 P=0.458N P=0.327 | P=0.045 * P=0.258 P=0.412N P=0.031 * | |COCHRAN-ARMITAGE | P=0.283 | P=0.024 * | |FISHER EXACT | P=0.477 P=0.522N P=0.318 | P=0.227 P=0.500N P=0.028 * | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 24 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | | Mineralization | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 19/51 (37%) 25/50 (50%) 27/50 (54%) 28/47 (60%) | 15/50 (30%) 23/50 (46%) 33/50 (66%) 33/49 (67%) | |ADJUSTED (b) | 63.3% 78.9% 80.8% 83.7% | 52.0% 66.8% 86.4% 86.6% | |TERMINAL (d) | 6/15 (40%) 9/15 (60%) 9/14 (64%) 15/20 (75%) | 12/25 (48%) 18/29 (62%) 25/30 (83%) 26/31 (84%) | |FIRST INCIDENCE (DAYS) | 366 146 353 145 | 540 562 229 490 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.471 P=0.288 P=0.197 P=0.292 | P=0.010 ** P=0.176 P=0.003 ** P=0.004 ** | |INCIDENTAL TUMOR | P=0.100 P=0.189 P=0.092 P=0.028 * | P<0.001 ** P=0.103 P=0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | P=0.046 * P=0.162 P=0.093 P=0.022 * | P=0.001 ** P=0.118 P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.056 | P<0.001 ** | |FISHER EXACT | P=0.138 P=0.068 P=0.022 * | P=0.074 P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | |Lung | | Pigmentation | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/47 (0%) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 0/49 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 6.3% 3.4% 3.3% 0.0% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/14 (0%) 0/20 (0%) | 1/25 (4%) 1/29 (3%) 1/30 (3%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 561 728 (T) 728 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.188N P=0.458N P=0.455N P=0.214N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.245N P=0.517N P=0.595N P=0.368N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.209N P=0.499N P=0.499N P=0.242N | |COCHRAN-ARMITAGE | (e) | P=0.211N | |FISHER EXACT | (e) (e) (e) | P=0.500N P=0.500N P=0.253N | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 25 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | | Vacuolization Cytoplasmic | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 6/51 (12%) 7/50 (14%) 7/50 (14%) 4/47 (9%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |ADJUSTED (b) | 36.2% 28.8% 25.9% 14.8% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 5/15 (33%) 2/15 (13%) 1/14 (7%) 2/20 (10%) | 0/25 (0%) 0/29 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 666 561 564 577 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.144N P=0.566 P=0.571 P=0.223N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.229N P=0.546 P=0.584 P=0.271N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.235N P=0.585 P=0.609 P=0.317N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.278N | (e) | |FISHER EXACT | P=0.485 P=0.485 P=0.424N | (e) (e) (e) | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/51 (2%) 1/50 (2%) 3/50 (6%) 2/47 (4%) | 4/50 (8%) 10/50 (20%) 4/50 (8%) 9/49 (18%) | |ADJUSTED (b) | 6.7% 2.8% 14.8% 7.3% | 16.0% 31.1% 12.0% 26.8% | |TERMINAL (d) | 1/15 (7%) 0/15 (0%) 1/14 (7%) 1/20 (5%) | 4/25 (16%) 8/29 (28%) 3/30 (10%) 7/31 (23%) | |FIRST INCIDENCE (DAYS) | 728 (T) 600 666 563 | 728 (T) 562 560 659 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.551 P=0.754N P=0.323 P=0.578 | P=0.382 P=0.119 P=0.551N P=0.217 | |INCIDENTAL TUMOR | P=0.486 P=0.738 P=0.348 P=0.556 | P=0.287 P=0.106 P=0.640N P=0.205 | |LOGISTIC REGRESSION | P=0.445 P=0.759N P=0.360 P=0.491 | P=0.305 P=0.101 P=0.595N P=0.179 | |COCHRAN-ARMITAGE | P=0.436 | P=0.257 | |FISHER EXACT | P=0.748 P=0.301 P=0.469 | P=0.074 P=0.643N P=0.109 | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 26 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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: Interstitium | | Fibrosis | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/51 (2%) 2/50 (4%) 0/50 (0%) 0/47 (0%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |ADJUSTED (b) | 2.0% 8.4% 0.0% 0.0% | 2.1% 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) | 384 692 --- --- | 533 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.243N P=0.535 P=0.504N P=0.521N | P=0.528N P=0.500N P=0.513N P=0.513N | |INCIDENTAL TUMOR | P=0.395N P=0.487 P=0.682N P=0.923N | P=0.469N P=0.638N P=0.581N P=0.500N | |LOGISTIC REGRESSION | P=0.251N P=0.493 P=0.527N P=0.383N | P=0.492N P=0.466N P=0.439N P=0.444N | |COCHRAN-ARMITAGE | P=0.263N | P=0.521N | |FISHER EXACT | P=0.492 P=0.505N P=0.520N | P=0.500N P=0.500N P=0.505N | |=================================================================================================================================| | | |Lymph Node | | Ectasia | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/4 (25%) 2/4 (50%) 0/0 (0%) 0/2 (0%) | 1/4 (25%) 0/1 (0%) 0/1 (0%) 0/1 (0%) | |ADJUSTED (b) | 3.2% 100.0% 0.0% 0.0% | 100.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/1 (0%) 2/2 (100%) 0/0 0/0 | 1/1 (100%) 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 611 728 (T) --- --- | 728 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.588N P=0.702 P=0.459N P=0.465N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.644N P=0.599 (e) P=0.638N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.644N P=0.599 (e) P=0.638N | P=0.251N P=0.493 (e) P=0.383N | |COCHRAN-ARMITAGE | P=0.374N | P=0.691N | |FISHER EXACT | P=0.500 P=1.000N P=0.667N | P=0.800N P=0.800N P=0.800N | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 27 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Congestion | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/51 (0%) 0/47 (0%) 0/50 (0%) 0/49 (0%) | 2/49 (4%) 0/48 (0%) 0/48 (0%) 0/48 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 8.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/14 (0%) 0/20 (0%) | 2/24 (8%) 0/29 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 728 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.262N P=0.197N P=0.190N P=0.183N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.262N P=0.197N P=0.190N P=0.183N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.262N P=0.197N P=0.190N P=0.183N | |COCHRAN-ARMITAGE | (e) | P=0.291N | |FISHER EXACT | (e) (e) (e) | P=0.253N P=0.253N P=0.253N | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Ectasia | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/51 (4%) 2/47 (4%) 2/50 (4%) 1/49 (2%) | 0/49 (0%) 1/48 (2%) 1/48 (2%) 2/48 (4%) | |ADJUSTED (b) | 13.3% 10.3% 5.1% 5.0% | 0.0% 3.4% 3.3% 6.5% | |TERMINAL (d) | 2/15 (13%) 1/15 (7%) 0/14 (0%) 1/20 (5%) | 0/24 (0%) 1/29 (3%) 1/30 (3%) 2/31 (6%) | |FIRST INCIDENCE (DAYS) | 728 (T) 693 517 728 (T) | --- 728 (T) 728 (T) 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.314N P=0.677N P=0.678N P=0.398N | P=0.249 P=0.538 P=0.545 P=0.296 | |INCIDENTAL TUMOR | P=0.415N P=0.679N P=0.633 P=0.398N | P=0.249 P=0.538 P=0.545 P=0.296 | |LOGISTIC REGRESSION | P=0.389N P=0.649N P=0.687N P=0.398N | P=0.249 P=0.538 P=0.545 P=0.296 | |COCHRAN-ARMITAGE | P=0.392N | P=0.205 | |FISHER EXACT | P=0.660 P=0.684 P=0.515N | P=0.495 P=0.495 P=0.242 | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 28 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Ectasia | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 5/49 (10%) 3/49 (6%) 5/48 (10%) | 0/50 (0%) 1/48 (2%) 3/49 (6%) 4/49 (8%) | |ADJUSTED (b) | 15.7% 29.6% 16.4% 25.0% | 0.0% 3.4% 9.5% 12.9% | |TERMINAL (d) | 2/15 (13%) 4/15 (27%) 2/14 (14%) 5/20 (25%) | 0/25 (0%) 1/29 (3%) 2/30 (7%) 4/31 (13%) | |FIRST INCIDENCE (DAYS) | 589 703 605 728 (T) | --- 728 (T) 698 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.585 P=0.370 P=0.661N P=0.502 | P=0.061 P=0.530 P=0.151 P=0.092 | |INCIDENTAL TUMOR | P=0.563 P=0.357 P=0.644 P=0.493 | P=0.059 P=0.530 P=0.166 P=0.092 | |LOGISTIC REGRESSION | P=0.438 P=0.432 P=0.616N P=0.435 | P=0.058 P=0.530 P=0.143 P=0.092 | |COCHRAN-ARMITAGE | P=0.374 | P=0.043 * | |FISHER EXACT | P=0.346 P=0.651 P=0.335 | P=0.490 P=0.117 P=0.056 | |=================================================================================================================================| | | |Mammary Gland | | Dilatation | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 31/51 (61%) 24/48 (50%) 23/49 (47%) 23/50 (46%) | 27/50 (54%) 34/50 (68%) 13/49 (27%) 17/50 (34%) | |ADJUSTED (b) | 80.9% 73.7% 66.5% 61.8% | 70.0% 75.1% 33.7% 48.8% | |TERMINAL (d) | 9/15 (60%) 8/15 (53%) 6/14 (43%) 8/20 (40%) | 14/25 (56%) 18/29 (62%) 6/30 (20%) 14/31 (45%) | |FIRST INCIDENCE (DAYS) | 316 424 281 80 | 478 501 497 177 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.108N P=0.122N P=0.084N P=0.047N* | P=0.002N** P=0.375 P=0.003N** P=0.010N** | |INCIDENTAL TUMOR | P=0.138N P=0.238N P=0.109N P=0.053N | P=0.003N** P=0.111 P=0.006N** P=0.023N* | |LOGISTIC REGRESSION | P=0.181N P=0.181N P=0.137N P=0.088N | P=0.002N** P=0.123 P=0.004N** P=0.032N* | |COCHRAN-ARMITAGE | P=0.192N | P=0.002N** | |FISHER EXACT | P=0.190N P=0.117N P=0.098N | P=0.109 P=0.005N** P=0.035N* | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 29 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | | Galactocele | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/51 (2%) 4/48 (8%) 1/49 (2%) 7/50 (14%) | 2/50 (4%) 1/50 (2%) 3/49 (6%) 2/50 (4%) | |ADJUSTED (b) | 6.7% 23.5% 7.1% 27.5% | 8.0% 3.4% 9.5% 5.6% | |TERMINAL (d) | 1/15 (7%) 3/15 (20%) 1/14 (7%) 4/20 (20%) | 2/25 (8%) 1/29 (3%) 2/30 (7%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | 728 (T) 706 728 (T) 563 | 728 (T) 728 (T) 698 659 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.060 P=0.184 P=0.749 P=0.068 | P=0.590 P=0.448N P=0.575 P=0.614N | |INCIDENTAL TUMOR | P=0.046 * P=0.183 P=0.749 P=0.052 | P=0.588 P=0.448N P=0.595 P=0.614N | |LOGISTIC REGRESSION | P=0.027 * P=0.202 P=0.753 P=0.037 * | P=0.567 P=0.448N P=0.566 P=0.655N | |COCHRAN-ARMITAGE | P=0.022 * | P=0.529 | |FISHER EXACT | P=0.163 P=0.742 P=0.028 * | P=0.500N P=0.490 P=0.691N | |=================================================================================================================================| | | |Mammary Gland | | Hyperplasia Focal | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/51 (0%) 0/48 (0%) 1/49 (2%) 1/50 (2%) | 3/50 (6%) 0/50 (0%) 1/49 (2%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 0.0% 7.1% 5.0% | 12.0% 0.0% 2.7% 3.2% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 1/14 (7%) 1/20 (5%) | 3/25 (12%) 0/29 (0%) 0/30 (0%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | --- --- 728 (T) 728 (T) | 728 (T) --- 671 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.449 (e) P=0.486 P=0.557 | P=0.447N P=0.095N P=0.249N P=0.230N | |INCIDENTAL TUMOR | P=0.449 (e) P=0.486 P=0.557 | P=0.447N P=0.095N P=0.233N P=0.230N | |LOGISTIC REGRESSION | P=0.449 (e) P=0.486 P=0.557 | P=0.463N P=0.095N P=0.266N P=0.230N | |COCHRAN-ARMITAGE | P=0.373 | P=0.494N | |FISHER EXACT | (e) P=0.490 P=0.495 | P=0.121N P=0.316N P=0.309N | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 30 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | | Mineralization | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/51 (4%) 4/48 (8%) 3/49 (6%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |ADJUSTED (b) | 5.2% 17.3% 19.6% 5.8% | 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) | 471 692 720 629 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.336N P=0.390 P=0.505 P=0.640N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.507N P=0.313 P=0.432 P=0.523 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.413N P=0.317 P=0.497 P=0.695N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.412N | (e) | |FISHER EXACT | P=0.310 P=0.481 P=0.684 | (e) (e) (e) | |=================================================================================================================================| | | |Mammary Gland: Lobular | | Hyperplasia | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/51 (0%) 0/48 (0%) 4/49 (8%) 35/50 (70%) | 0/50 (0%) 1/50 (2%) 0/49 (0%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 0.0% 16.3% 87.3% | 0.0% 3.4% 0.0% 2.6% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 1/14 (7%) 15/20 (75%) | 0/25 (0%) 1/29 (3%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 597 115 | --- 728 (T) --- 663 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** (e) P=0.083 P<0.001 ** | P=0.516 P=0.530 (e) P=0.528 | |INCIDENTAL TUMOR | P<0.001 ** (e) P=0.079 P<0.001 ** | P=0.517 P=0.530 (e) P=0.545 | |LOGISTIC REGRESSION | P<0.001 ** (e) P=0.071 P<0.001 ** | P=0.495 P=0.530 (e) P=0.499 | |COCHRAN-ARMITAGE | P<0.001 ** | P=0.490 | |FISHER EXACT | (e) P=0.054 P<0.001 ** | P=0.500 (e) P=0.500 | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 31 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Mesentery: Fat | | Inflammation Chronic | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 10/14 (71%) 4/6 (67%) 5/5 (100%) 3/3 (100%) | 2/5 (40%) 3/3 (100%) 10/12 (83%) 10/10 (100%)| |ADJUSTED (b) | 75.5% 100.0% 100.0% 9.0% | 100.0% 100.0% 85.5% 100.0% | |TERMINAL (d) | 2/3 (67%) 2/2 (100%) 2/2 (100%) 0/0 | 1/1 (100%) 2/2 (100%) 5/6 (83%) 5/5 (100%) | |FIRST INCIDENCE (DAYS) | 479 479 538 563 | 574 299 229 177 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.277N P=0.084N P=0.130N P=0.075N | P=0.065 P=0.741N P=0.184 P=0.144 | |INCIDENTAL TUMOR | P=0.194 P=0.563N P=0.244 P=0.262 | P=0.101 (e) P=0.246 P=0.122 | |LOGISTIC REGRESSION | P=0.258 P=0.628N P=0.238 P=0.385 | P=0.051 P=0.184 P=0.112 P=0.020 * | |COCHRAN-ARMITAGE | P=0.251 | P=0.052 | |FISHER EXACT | P=0.613N P=0.258 P=0.421 | P=0.179 P=0.117 P=0.022 * | |=================================================================================================================================| | | |Mesentery: Fat | | Mineralization | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/14 (36%) 2/6 (33%) 3/5 (60%) 0/3 (0%) | 1/5 (20%) 0/3 (0%) 3/12 (25%) 5/10 (50%) | |ADJUSTED (b) | 42.0% 51.7% 52.7% 0.0% | 3.2% 0.0% 35.0% 62.2% | |TERMINAL (d) | 1/3 (33%) 1/2 (50%) 1/2 (50%) 0/0 | 0/1 (0%) 0/2 (0%) 2/6 (33%) 3/5 (60%) | |FIRST INCIDENCE (DAYS) | 486 675 538 --- | 693 --- 659 659 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.111N P=0.219N P=0.339N P=0.053N | P=0.063 P=0.488N P=0.633 P=0.359 | |INCIDENTAL TUMOR | P=0.458N P=0.633N P=0.362 P=0.390N | P=0.088 (e) P=0.686N P=0.399 | |LOGISTIC REGRESSION | P=0.294N P=0.659N P=0.329 P=0.293N | P=0.076 P=0.611N P=0.745 P=0.397 | |COCHRAN-ARMITAGE | P=0.288N | P=0.076 | |FISHER EXACT | P=0.664N P=0.336 P=0.324N | P=0.625N P=0.670 P=0.294 | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 32 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Mesentery: Fat | | Necrosis | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/14 (14%) 2/6 (33%) 1/5 (20%) 0/3 (0%) | 2/5 (40%) 0/3 (0%) 2/12 (17%) 1/10 (10%) | |ADJUSTED (b) | 7.1% 51.7% 3.3% 0.0% | 6.5% 0.0% 19.3% 2.5% | |TERMINAL (d) | 0/3 (0%) 1/2 (50%) 0/2 (0%) 0/0 | 0/1 (0%) 0/2 (0%) 1/6 (17%) 0/5 (0%) | |FIRST INCIDENCE (DAYS) | 605 675 669 --- | 693 --- 708 659 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.207N P=0.673N P=0.412N P=0.204N | P=0.523N P=0.229N P=0.518N P=0.453N | |INCIDENTAL TUMOR | P=0.430N P=0.343 P=0.523 P=0.472N | P=0.321N (e) P=0.246N P=0.309N | |LOGISTIC REGRESSION | P=0.459N P=0.359 P=0.661 P=0.611N | P=0.325N P=0.303N P=0.212N P=0.226N | |COCHRAN-ARMITAGE | P=0.438N | P=0.343N | |FISHER EXACT | P=0.343 P=0.624 P=0.669N | P=0.357N P=0.330N P=0.242N | |=================================================================================================================================| | | |Nose | | Inflammation | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 6/49 (12%) 3/50 (6%) 2/50 (4%) | 1/49 (2%) 3/50 (6%) 0/49 (0%) 0/50 (0%) | |ADJUSTED (b) | 15.2% 30.4% 12.5% 6.9% | 4.0% 8.7% 0.0% 0.0% | |TERMINAL (d) | 1/15 (7%) 3/15 (20%) 0/14 (0%) 0/20 (0%) | 1/25 (4%) 1/29 (3%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 519 588 644 666 | 728 (T) 652 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.122N P=0.396 P=0.443N P=0.262N | P=0.116N P=0.352 P=0.464N P=0.457N | |INCIDENTAL TUMOR | P=0.203N P=0.363 P=0.486N P=0.475N | P=0.110N P=0.399 P=0.464N P=0.457N | |LOGISTIC REGRESSION | P=0.165N P=0.399 P=0.474N P=0.338N | P=0.127N P=0.332 P=0.464N P=0.457N | |COCHRAN-ARMITAGE | P=0.166N | P=0.131N | |FISHER EXACT | P=0.357 P=0.500N P=0.339N | P=0.316 P=0.500N P=0.495N | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 33 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Nose | | Inflammation Chronic | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/49 (0%) 2/50 (4%) 1/50 (2%) | 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |ADJUSTED (b) | 11.1% 0.0% 9.1% 4.5% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/15 (7%) 0/15 (0%) 1/14 (7%) 0/20 (0%) | 0/25 (0%) 0/29 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 464 --- 517 715 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.431N P=0.125N P=0.491N P=0.267N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.637N P=0.161N P=0.662N P=0.435N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.478N P=0.130N P=0.541N P=0.306N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.484N | (e) | |FISHER EXACT | P=0.125N P=0.500N P=0.309N | (e) (e) (e) | |=================================================================================================================================| | | |Ovary | | DYSGENESIS | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | | 0/50 (0%) 1/49 (2%) 43/50 (86%) 49/49 (100%)| |ADJUSTED (b) | | 0.0% 3.0% 97.7% 100.0% | |TERMINAL (d) | | 0/25 (0%) 0/29 (0%) 29/30 (97%) 31/31 (100%)| |FIRST INCIDENCE (DAYS) | | --- 702 441 177 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P<0.001 ** P=0.519 P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | | P<0.001 ** P=0.523 P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | | P<0.001 ** P=0.512 P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | | P<0.001 ** | |FISHER EXACT | | P=0.495 P<0.001 ** P<0.001 ** | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 34 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Ovary: Follicle | | Cyst | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | | 0/50 (0%) 2/49 (4%) 1/50 (2%) 1/49 (2%) | |ADJUSTED (b) | | 0.0% 6.9% 3.3% 3.2% | |TERMINAL (d) | | 0/25 (0%) 2/29 (7%) 1/30 (3%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | | --- 728 (T) 728 (T) 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.640N P=0.271 P=0.536 P=0.543 | |INCIDENTAL TUMOR | | P=0.640N P=0.271 P=0.536 P=0.543 | |LOGISTIC REGRESSION | | P=0.640N P=0.271 P=0.536 P=0.543 | |COCHRAN-ARMITAGE | | P=0.653 | |FISHER EXACT | | P=0.242 P=0.500 P=0.495 | |=================================================================================================================================| | | |Ovary: Periovarian Tissue | | Cyst | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | | 4/50 (8%) 0/49 (0%) 4/50 (8%) 2/49 (4%) | |ADJUSTED (b) | | 12.0% 0.0% 10.1% 6.1% | |TERMINAL (d) | | 0/25 (0%) 0/29 (0%) 1/30 (3%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | | 562 --- 478 704 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.536N P=0.051N P=0.593N P=0.275N | |INCIDENTAL TUMOR | | P=0.586 P=0.081N P=0.503 P=0.519N | |LOGISTIC REGRESSION | | P=0.570N P=0.070N P=0.622N P=0.347N | |COCHRAN-ARMITAGE | | P=0.578N | |FISHER EXACT | | P=0.061N P=0.643N P=0.349N | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 35 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Pancreas | | Inflammation Chronic | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 0/48 (0%) 0/50 (0%) 0/48 (0%) | 0/50 (0%) 0/49 (0%) 2/49 (4%) 0/49 (0%) | |ADJUSTED (b) | 8.7% 0.0% 0.0% 0.0% | 0.0% 0.0% 6.7% 0.0% | |TERMINAL (d) | 1/15 (7%) 0/15 (0%) 0/14 (0%) 0/20 (0%) | 0/25 (0%) 0/29 (0%) 2/30 (7%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 464 --- --- --- | --- --- 728 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.334N P=0.245N P=0.247N P=0.217N | P=0.661N (e) P=0.279 (e) | |INCIDENTAL TUMOR | P=0.457N P=0.295N P=0.345N P=0.388N | P=0.661N (e) P=0.279 (e) | |LOGISTIC REGRESSION | P=0.346N P=0.248N P=0.255N P=0.238N | P=0.661N (e) P=0.279 (e) | |COCHRAN-ARMITAGE | P=0.360N | P=0.695N | |FISHER EXACT | P=0.253N P=0.242N P=0.253N | (e) P=0.242 (e) | |=================================================================================================================================| | | |Pancreas: Acinus | | Atrophy | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 11/49 (22%) 7/48 (15%) 11/50 (22%) 4/48 (8%) | 8/50 (16%) 7/49 (14%) 5/49 (10%) 3/49 (6%) | |ADJUSTED (b) | 42.4% 21.8% 45.3% 18.5% | 26.9% 19.9% 16.0% 9.7% | |TERMINAL (d) | 4/15 (27%) 1/15 (7%) 5/14 (36%) 3/20 (15%) | 5/25 (20%) 3/29 (10%) 4/30 (13%) 3/31 (10%) | |FIRST INCIDENCE (DAYS) | 429 479 538 708 | 506 576 698 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.032N* P=0.200N P=0.520N P=0.021N* | P=0.052N P=0.390N P=0.187N P=0.054N | |INCIDENTAL TUMOR | P=0.097N P=0.315N P=0.496 P=0.092N | P=0.075N P=0.471N P=0.239N P=0.084N | |LOGISTIC REGRESSION | P=0.066N P=0.238N P=0.542N P=0.044N* | P=0.072N P=0.484N P=0.237N P=0.087N | |COCHRAN-ARMITAGE | P=0.064N | P=0.080N | |FISHER EXACT | P=0.232N P=0.574N P=0.049N* | P=0.517N P=0.290N P=0.106N | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 36 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Parathyroid Gland | | Hyperplasia | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 10/46 (22%) 14/44 (32%) 17/48 (35%) 15/43 (35%) | 0/47 (0%) 0/46 (0%) 2/42 (5%) 0/38 (0%) | |ADJUSTED (b) | 50.2% 57.1% 58.6% 48.9% | 0.0% 0.0% 7.1% 0.0% | |TERMINAL (d) | 5/13 (38%) 5/14 (36%) 4/14 (29%) 5/18 (28%) | 0/23 (0%) 0/27 (0%) 2/28 (7%) 0/25 (0%) | |FIRST INCIDENCE (DAYS) | 471 588 605 629 | --- --- 728 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.539N P=0.347 P=0.189 P=0.414 | P=0.696N (e) P=0.282 (e) | |INCIDENTAL TUMOR | P=0.284 P=0.291 P=0.169 P=0.163 | P=0.696N (e) P=0.282 (e) | |LOGISTIC REGRESSION | P=0.357 P=0.328 P=0.213 P=0.214 | P=0.696N (e) P=0.282 (e) | |COCHRAN-ARMITAGE | P=0.244 | P=0.738N | |FISHER EXACT | P=0.200 P=0.108 P=0.127 | (e) P=0.220 (e) | |=================================================================================================================================| | | |Pituitary Gland | | Cyst | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/51 (4%) 2/50 (4%) 3/50 (6%) 3/49 (6%) | 10/50 (20%) 9/50 (18%) 4/49 (8%) 1/50 (2%) | |ADJUSTED (b) | 8.7% 7.4% 11.1% 15.0% | 34.4% 29.1% 12.5% 3.2% | |TERMINAL (d) | 1/15 (7%) 0/15 (0%) 1/14 (7%) 3/20 (15%) | 7/25 (28%) 8/29 (28%) 3/30 (10%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | 479 692 517 728 (T) | 548 523 674 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.533 P=0.650N P=0.512 P=0.601 | P=0.001N** P=0.376N P=0.042N* P=0.002N** | |INCIDENTAL TUMOR | P=0.287 P=0.685 P=0.249 P=0.450 | P=0.001N** P=0.420N P=0.044N* P=0.003N** | |LOGISTIC REGRESSION | P=0.416 P=0.695 P=0.442 P=0.507 | P=0.002N** P=0.418N P=0.049N* P=0.003N** | |COCHRAN-ARMITAGE | P=0.424 | P=0.003N** | |FISHER EXACT | P=0.684 P=0.491 P=0.481 | P=0.500N P=0.080N P=0.004N** | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 37 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Pituitary Gland | | Hemorrhage | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/51 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | 1/50 (2%) 0/50 (0%) 2/49 (4%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 3.0% 0.0% 6.1% 0.0% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/14 (0%) 0/20 (0%) | 0/25 (0%) 0/29 (0%) 1/30 (3%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 678 --- 693 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.445N P=0.494N P=0.542 P=0.483N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.441N P=0.455N P=0.595 P=0.455N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.464N P=0.497N P=0.518 P=0.498N | |COCHRAN-ARMITAGE | (e) | P=0.472N | |FISHER EXACT | (e) (e) (e) | P=0.500N P=0.492 P=0.500N | |=================================================================================================================================| | | |Pituitary Gland | | Hyperplasia | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/51 (4%) 2/50 (4%) 0/50 (0%) 1/49 (2%) | 3/50 (6%) 2/50 (4%) 2/49 (4%) 1/50 (2%) | |ADJUSTED (b) | 8.5% 10.7% 0.0% 3.1% | 9.2% 4.9% 6.7% 3.0% | |TERMINAL (d) | 1/15 (7%) 0/15 (0%) 0/14 (0%) 0/20 (0%) | 1/25 (4%) 0/29 (0%) 2/30 (7%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 366 707 --- 646 | 533 562 728 (T) 713 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.409N P=0.688N P=0.252N P=0.470N | P=0.253N P=0.465N P=0.451N P=0.264N | |INCIDENTAL TUMOR | P=0.602N P=0.685 P=0.345N P=0.690N | P=0.286N P=0.548N P=0.482N P=0.249N | |LOGISTIC REGRESSION | P=0.475N P=0.688 P=0.283N P=0.500N | P=0.280N P=0.518N P=0.499N P=0.304N | |COCHRAN-ARMITAGE | P=0.473N | P=0.280N | |FISHER EXACT | P=0.684 P=0.252N P=0.515N | P=0.500N P=0.510N P=0.309N | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 38 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Pituitary Gland | | Mineralization | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/51 (4%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | 0/50 (0%) 0/50 (0%) 1/49 (2%) 1/50 (2%) | |ADJUSTED (b) | 6.4% 5.6% 0.0% 0.0% | 0.0% 0.0% 3.3% 2.9% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/14 (0%) 0/20 (0%) | 0/25 (0%) 0/29 (0%) 1/30 (3%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 611 714 --- --- | --- --- 728 (T) 695 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.215N P=0.482N P=0.202N P=0.202N | P=0.336 (e) P=0.536 P=0.531 | |INCIDENTAL TUMOR | P=0.256N P=0.524N P=0.234N P=0.256N | P=0.334 (e) P=0.536 P=0.545 | |LOGISTIC REGRESSION | P=0.248N P=0.500N P=0.250N P=0.247N | P=0.322 (e) P=0.536 P=0.511 | |COCHRAN-ARMITAGE | P=0.246N | P=0.308 | |FISHER EXACT | P=0.508N P=0.252N P=0.258N | (e) P=0.495 P=0.500 | |=================================================================================================================================| | | |Pituitary Gland | | Necrosis | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/51 (4%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |ADJUSTED (b) | 8.6% 0.0% 0.0% 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) | 657 --- --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.342N P=0.195N P=0.203N P=0.198N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.408N P=0.194N P=0.172N P=0.270N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.359N P=0.225N P=0.215N P=0.231N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.363N | (e) | |FISHER EXACT | P=0.252N P=0.252N P=0.258N | (e) (e) (e) | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 39 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hyperplasia | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/51 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | 1/50 (2%) 2/50 (4%) 2/49 (4%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 5.0% | 4.0% 5.9% 6.7% 0.0% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/14 (0%) 1/20 (5%) | 1/25 (4%) 1/29 (3%) 2/30 (7%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 728 (T) | 728 (T) 646 728 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.292 (e) (e) P=0.557 | P=0.198N P=0.554 P=0.564 P=0.457N | |INCIDENTAL TUMOR | P=0.292 (e) (e) P=0.557 | P=0.199N P=0.560 P=0.564 P=0.457N | |LOGISTIC REGRESSION | P=0.292 (e) (e) P=0.557 | P=0.214N P=0.525 P=0.564 P=0.457N | |COCHRAN-ARMITAGE | P=0.230 | P=0.232N | |FISHER EXACT | (e) (e) P=0.490 | P=0.500 P=0.492 P=0.500N | |=================================================================================================================================| | | |Preputial Gland | | Cyst | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/51 (6%) 2/49 (4%) 0/50 (0%) 0/49 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |ADJUSTED (b) | 11.2% 5.5% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/15 (7%) 0/15 (0%) 0/14 (0%) 0/20 (0%) | 0/0 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 429 408 --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.111N P=0.476N P=0.117N P=0.107N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.189N P=0.602N P=0.180N P=0.200N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.094N P=0.511N P=0.146N P=0.119N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.117N | (e) | |FISHER EXACT | P=0.519N P=0.125N P=0.129N | (e) (e) (e) | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 40 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Preputial Gland | | Inflammation Chronic | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 45/51 (88%) 37/49 (76%) 42/50 (84%) 36/49 (73%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |ADJUSTED (b) | 93.4% 89.8% 93.0% 91.6% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 12/15 (80%) 11/15 (73%) 11/14 (79%) 17/20 (85%) | 0/0 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 316 146 353 80 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.051N P=0.111N P=0.257N P=0.024N* | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.194N P=0.084N P=0.309N P=0.108N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.188N P=0.077N P=0.352N P=0.068N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.119N | (e) | |FISHER EXACT | P=0.081N P=0.372N P=0.051N | (e) (e) (e) | |=================================================================================================================================| | | |Preputial Gland | | Mineralization | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/51 (0%) 2/49 (4%) 0/50 (0%) 0/49 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |ADJUSTED (b) | 0.0% 10.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/14 (0%) 0/20 (0%) | 0/0 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | --- 703 --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.345N P=0.264 (e) (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.439N P=0.280 (e) (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.364N P=0.265 (e) (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.388N | (e) | |FISHER EXACT | P=0.238 (e) (e) | (e) (e) (e) | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 41 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Prostate | | Inflammation Chronic | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 10/51 (20%) 5/50 (10%) 0/50 (0%) 0/49 (0%) | | |ADJUSTED (b) | 33.0% 20.2% 0.0% 0.0% | | |TERMINAL (d) | 3/15 (20%) 0/15 (0%) 0/14 (0%) 0/20 (0%) | | |FIRST INCIDENCE (DAYS) | 316 703 --- --- | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.003N** P=0.124N P=0.002N** P=0.001N** | | |INCIDENTAL TUMOR | P=0.007N** P=0.144N P=0.004N** P=0.003N** | | |LOGISTIC REGRESSION | P=0.004N** P=0.142N P=0.003N** P=0.001N** | | |COCHRAN-ARMITAGE | P=0.004N** | | |FISHER EXACT | P=0.141N P<0.001N** P<0.001N** | | |=================================================================================================================================| | | |Prostate | | Mineralization | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/51 (0%) 1/50 (2%) 0/50 (0%) 2/49 (4%) | | |ADJUSTED (b) | 0.0% 4.0% 0.0% 7.6% | | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/14 (0%) 1/20 (5%) | | |FIRST INCIDENCE (DAYS) | --- 703 --- 629 | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.204 P=0.545 (e) P=0.296 | | |INCIDENTAL TUMOR | P=0.160 P=0.539 (e) P=0.260 | | |LOGISTIC REGRESSION | P=0.156 P=0.523 (e) P=0.239 | | |COCHRAN-ARMITAGE | P=0.151 | | |FISHER EXACT | P=0.495 (e) P=0.238 | | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 42 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Salivary Glands | | Atrophy | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/51 (0%) 2/49 (4%) 0/50 (0%) 0/49 (0%) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | |ADJUSTED (b) | 0.0% 6.4% 0.0% 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) | --- 598 --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.374N P=0.273 (e) (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.407N P=0.225 (e) (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.390N P=0.231 (e) (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.388N | (e) | |FISHER EXACT | P=0.238 (e) (e) | (e) (e) (e) | |=================================================================================================================================| | | |Skin: Epidermis | | Cyst | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/51 (4%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | |ADJUSTED (b) | 5.3% 3.8% 0.0% 0.0% | 0.0% 0.0% 2.3% 3.2% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/14 (0%) 0/20 (0%) | 0/25 (0%) 0/29 (0%) 0/30 (0%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | 429 693 --- --- | --- --- 560 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.233N P=0.475N P=0.220N P=0.229N | P=0.322 (e) P=0.509 P=0.543 | |INCIDENTAL TUMOR | P=0.337N P=0.559N P=0.336N P=0.437N | P=0.178 (e) P=0.243 P=0.543 | |LOGISTIC REGRESSION | P=0.223N P=0.505N P=0.290N P=0.204N | P=0.309 (e) P=0.542 P=0.543 | |COCHRAN-ARMITAGE | P=0.242N | P=0.307 | |FISHER EXACT | P=0.508N P=0.258N P=0.252N | (e) P=0.500 P=0.500 | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 43 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Spleen | | Congestion | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/51 (0%) 2/50 (4%) 0/50 (0%) 0/48 (0%) | 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/49 (0%) | |ADJUSTED (b) | 0.0% 9.5% 0.0% 0.0% | 0.0% 3.3% 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) | --- 629 --- --- | --- 725 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.339N P=0.250 (e) (e) | P=0.521N P=0.536 (e) (e) | |INCIDENTAL TUMOR | P=0.354N P=0.218 (e) (e) | P=0.549N P=0.545 (e) (e) | |LOGISTIC REGRESSION | P=0.387N P=0.247 (e) (e) | P=0.528N P=0.526 (e) (e) | |COCHRAN-ARMITAGE | P=0.394N | P=0.549N | |FISHER EXACT | P=0.243 (e) (e) | P=0.495 (e) (e) | |=================================================================================================================================| | | |Spleen | | Fibrosis | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 7/51 (14%) 3/50 (6%) 2/50 (4%) 0/48 (0%) | 1/50 (2%) 1/49 (2%) 3/50 (6%) 0/49 (0%) | |ADJUSTED (b) | 37.3% 20.0% 14.3% 0.0% | 4.0% 2.8% 9.1% 0.0% | |TERMINAL (d) | 5/15 (33%) 3/15 (20%) 2/14 (14%) 0/20 (0%) | 1/25 (4%) 0/29 (0%) 1/30 (3%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 600 728 (T) 728 (T) --- | 728 (T) 665 693 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.008N** P=0.140N P=0.075N P=0.003N** | P=0.297N P=0.734N P=0.371 P=0.457N | |INCIDENTAL TUMOR | P=0.008N** P=0.160N P=0.084N P=0.004N** | P=0.313N P=0.719N P=0.398 P=0.457N | |LOGISTIC REGRESSION | P=0.015N* P=0.109N P=0.047N* P=0.006N** | P=0.323N P=0.752N P=0.349 P=0.457N | |COCHRAN-ARMITAGE | P=0.023N* | P=0.337N | |FISHER EXACT | P=0.167N P=0.085N P=0.008N** | P=0.747 P=0.309 P=0.505N | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 44 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Spleen | | Hematopoietic Cell Proliferation | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/51 (6%) 3/50 (6%) 2/50 (4%) 3/48 (6%) | 2/50 (4%) 6/49 (12%) 0/50 (0%) 3/49 (6%) | |ADJUSTED (b) | 16.3% 8.8% 9.0% 15.0% | 6.1% 15.4% 0.0% 7.6% | |TERMINAL (d) | 2/15 (13%) 0/15 (0%) 1/14 (7%) 3/20 (15%) | 1/25 (4%) 2/29 (7%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 646 321 353 728 (T) | 540 537 --- 659 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.546N P=0.629N P=0.509N P=0.541N | P=0.414N P=0.182 P=0.224N P=0.566 | |INCIDENTAL TUMOR | P=0.465N P=0.568N P=0.430N P=0.562N | P=0.532N P=0.080 P=0.262N P=0.553 | |LOGISTIC REGRESSION | P=0.560 P=0.653 P=0.514N P=0.581N | P=0.559 P=0.083 P=0.232N P=0.489 | |COCHRAN-ARMITAGE | P=0.561 | P=0.467N | |FISHER EXACT | P=0.652 P=0.509N P=0.632 | P=0.128 P=0.247N P=0.490 | |=================================================================================================================================| | | |Spleen: Lymphoid Follicle | | Depletion Cellular | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/51 (2%) 1/50 (2%) 1/50 (2%) 2/48 (4%) | 1/50 (2%) 1/49 (2%) 1/50 (2%) 2/49 (4%) | |ADJUSTED (b) | 2.1% 2.2% 4.8% 4.3% | 3.0% 2.9% 2.0% 5.3% | |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) | 429 424 705 115 | 678 691 118 511 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.359 P=0.748 P=0.755N P=0.466 | P=0.380 P=0.747N P=0.754N P=0.533 | |INCIDENTAL TUMOR | P=0.312 P=0.647 P=0.705 P=0.680 | P=0.468 P=0.716N P=0.436N P=0.528 | |LOGISTIC REGRESSION | P=0.658N P=0.705N P=0.724 P=0.608N | P=0.431 P=0.761N P=0.582N P=0.494 | |COCHRAN-ARMITAGE | P=0.353 | P=0.356 | |FISHER EXACT | P=0.748 P=0.748 P=0.477 | P=0.747 P=0.753N P=0.492 | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 45 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Stomach, Forestomach | | Edema | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/51 (4%) 0/50 (0%) 0/49 (0%) 0/48 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 4.8% 0.0% 0.0% 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) | 519 --- --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.351N P=0.240N P=0.220N P=0.229N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.506N P=0.320N P=0.336N P=0.454N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.321N P=0.223N P=0.289N P=0.217N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.367N | (e) | |FISHER EXACT | P=0.252N P=0.258N P=0.263N | (e) (e) (e) | |=================================================================================================================================| | | |Stomach, Forestomach | | Hyperkeratosis | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/51 (2%) 0/50 (0%) 0/49 (0%) 2/48 (4%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 2.4% 0.0% 0.0% 6.8% | 2.1% 0.0% 0.0% 2.3% | |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) | 519 --- --- 577 | 533 --- --- 539 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.188 P=0.505N P=0.482N P=0.537 | P=0.498 P=0.500N P=0.513N P=0.748 | |INCIDENTAL TUMOR | P=0.055 P=0.602N P=0.682N P=0.268 | P=0.578 P=0.638N P=0.581N P=0.771 | |LOGISTIC REGRESSION | P=0.162 P=0.483N P=0.551N P=0.483 | P=0.550 P=0.466N P=0.439N P=0.718N | |COCHRAN-ARMITAGE | P=0.154 | P=0.511 | |FISHER EXACT | P=0.505N P=0.510N P=0.477 | P=0.500N P=0.500N P=0.753N | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 46 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Stomach, Forestomach | | Inflammation Chronic | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/51 (6%) 3/50 (6%) 9/49 (18%) 4/48 (8%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 15.5% 11.7% 30.2% 12.1% | 3.8% 2.6% 0.0% 0.0% | |TERMINAL (d) | 2/15 (13%) 1/15 (7%) 1/14 (7%) 0/20 (0%) | 0/25 (0%) 0/29 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 549 598 644 639 | 708 652 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.519N P=0.648N P=0.110 P=0.606 | P=0.282N P=0.725N P=0.459N P=0.452N | |INCIDENTAL TUMOR | P=0.546 P=0.618 P=0.089 P=0.498 | P=0.285N P=0.716N P=0.436N P=0.455N | |LOGISTIC REGRESSION | P=0.544 P=0.662N P=0.076 P=0.480 | P=0.307N P=0.759N P=0.481N P=0.480N | |COCHRAN-ARMITAGE | P=0.543 | P=0.307N | |FISHER EXACT | P=0.652 P=0.052 P=0.466 | P=0.753N P=0.500N P=0.500N | |=================================================================================================================================| | | |Stomach, Forestomach | | Mineralization | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/51 (2%) 2/50 (4%) 2/49 (4%) 2/48 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 3.1% 9.1% 9.5% 6.4% | 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) | 611 629 680 629 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.597 P=0.521 P=0.551 P=0.563 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.465 P=0.476 P=0.558 P=0.460 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.520 P=0.501 P=0.517 P=0.480 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.515 | (e) | |FISHER EXACT | P=0.492 P=0.485 P=0.477 | (e) (e) (e) | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 47 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Stomach, Forestomach | | Perforation | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/51 (0%) 0/50 (0%) 2/49 (4%) 0/48 (0%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 10.0% 0.0% | 3.8% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 1/14 (7%) 0/20 (0%) | 0/25 (0%) 0/29 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 666 --- | 708 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.583N (e) P=0.268 (e) | P=0.493N P=0.465N P=0.459N P=0.452N | |INCIDENTAL TUMOR | P=0.621N (e) P=0.259 (e) | P=0.501N P=0.455N P=0.436N P=0.455N | |LOGISTIC REGRESSION | P=0.621N (e) P=0.262 (e) | P=0.508N P=0.482N P=0.481N P=0.480N | |COCHRAN-ARMITAGE | P=0.641N | P=0.517N | |FISHER EXACT | (e) P=0.238 (e) | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | |Stomach, Forestomach | | Ulcer | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 6/51 (12%) 2/50 (4%) 4/49 (8%) 5/48 (10%) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | |ADJUSTED (b) | 21.6% 8.9% 17.9% 18.0% | 6.0% 5.5% 2.0% 0.0% | |TERMINAL (d) | 2/15 (13%) 1/15 (7%) 1/14 (7%) 1/20 (5%) | 1/25 (4%) 0/29 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 384 561 681 639 | 533 652 118 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.543 P=0.136N P=0.335N P=0.382N | P=0.134N P=0.657N P=0.487N P=0.223N | |INCIDENTAL TUMOR | P=0.330 P=0.206N P=0.445N P=0.556 | P=0.102N P=0.691 P=0.262N P=0.216N | |LOGISTIC REGRESSION | P=0.400 P=0.141N P=0.406N P=0.543N | P=0.106N P=0.685 P=0.297N P=0.234N | |COCHRAN-ARMITAGE | P=0.403 | P=0.142N | |FISHER EXACT | P=0.141N P=0.396N P=0.543N | P=0.691N P=0.500N P=0.247N | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 48 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Stomach, Forestomach: Epithelium | | Hyperplasia | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/51 (0%) 0/50 (0%) 2/49 (4%) 2/48 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 0.0% 14.3% 9.1% | 0.0% 0.0% 0.0% 3.2% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 2/14 (14%) 1/20 (5%) | 0/25 (0%) 0/29 (0%) 0/30 (0%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | --- --- 728 (T) 712 | --- --- --- 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.255 (e) P=0.221 P=0.300 | P=0.235 (e) (e) P=0.543 | |INCIDENTAL TUMOR | P=0.216 (e) P=0.221 P=0.253 | P=0.235 (e) (e) P=0.543 | |LOGISTIC REGRESSION | P=0.218 (e) P=0.221 P=0.282 | P=0.235 (e) (e) P=0.543 | |COCHRAN-ARMITAGE | P=0.156 | P=0.215 | |FISHER EXACT | (e) P=0.238 P=0.233 | (e) (e) P=0.500 | |=================================================================================================================================| | | |Stomach, Glandular | | Erosion | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/51 (4%) 0/50 (0%) 1/49 (2%) 0/48 (0%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 8.8% 0.0% 2.7% 0.0% | 0.0% 2.1% 0.0% 0.0% | |TERMINAL (d) | 1/15 (7%) 0/15 (0%) 0/14 (0%) 0/20 (0%) | 0/25 (0%) 0/29 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 486 --- 629 --- | --- 537 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.295N P=0.245N P=0.476N P=0.211N | P=0.556N P=0.504 (e) (e) | |INCIDENTAL TUMOR | P=0.404N P=0.295N P=0.609N P=0.388N | P=0.497N P=0.362 (e) (e) | |LOGISTIC REGRESSION | P=0.333N P=0.243N P=0.536N P=0.249N | P=0.521N P=0.531 (e) (e) | |COCHRAN-ARMITAGE | P=0.338N | P=0.547N | |FISHER EXACT | P=0.252N P=0.515N P=0.263N | P=0.500 (e) (e) | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 49 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Stomach, Glandular | | Mineralization | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 6/51 (12%) 6/50 (12%) 7/49 (14%) 7/48 (15%) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | |ADJUSTED (b) | 21.2% 25.8% 34.1% 23.5% | 0.0% 3.4% 3.3% 0.0% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 2/14 (14%) 1/20 (5%) | 0/25 (0%) 1/29 (3%) 1/30 (3%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 471 692 680 629 | --- 728 (T) 728 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.555N P=0.546N P=0.562 P=0.591N | P=0.479N P=0.530 P=0.536 (e) | |INCIDENTAL TUMOR | P=0.265 P=0.575N P=0.561 P=0.323 | P=0.479N P=0.530 P=0.536 (e) | |LOGISTIC REGRESSION | P=0.455 P=0.605N P=0.543 P=0.466 | P=0.479N P=0.530 P=0.536 (e) | |COCHRAN-ARMITAGE | P=0.418 | P=0.511N | |FISHER EXACT | P=0.606 P=0.469 P=0.453 | P=0.500 P=0.500 (e) | |=================================================================================================================================| | | |Stomach, Glandular | | Ulcer | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/51 (0%) 0/50 (0%) 0/49 (0%) 1/48 (2%) | 0/50 (0%) 0/50 (0%) 3/50 (6%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 5.0% | 0.0% 0.0% 6.6% 0.0% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/14 (0%) 1/20 (5%) | 0/25 (0%) 0/29 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 728 (T) | --- --- 118 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.292 (e) (e) P=0.557 | P=0.639N (e) P=0.130 (e) | |INCIDENTAL TUMOR | P=0.292 (e) (e) P=0.557 | P=0.563N (e) P=0.227 (e) | |LOGISTIC REGRESSION | P=0.292 (e) (e) P=0.557 | P=0.525N (e) P=0.239 (e) | |COCHRAN-ARMITAGE | P=0.227 | P=0.642N | |FISHER EXACT | (e) (e) P=0.485 | (e) P=0.121 (e) | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 50 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Testes | | Degeneration | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 9/51 (18%) 9/50 (18%) 37/50 (74%) 28/49 (57%) | | |ADJUSTED (b) | 29.4% 38.2% 97.3% 86.5% | | |TERMINAL (d) | 1/15 (7%) 3/15 (20%) 13/14 (93%) 16/20 (80%) | | |FIRST INCIDENCE (DAYS) | 486 675 353 551 | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.017 * P=0.503N P<0.001 ** P=0.004 ** | | |INCIDENTAL TUMOR | P<0.001 ** P=0.562N P<0.001 ** P<0.001 ** | | |LOGISTIC REGRESSION | P<0.001 ** P=0.582N P<0.001 ** P<0.001 ** | | |COCHRAN-ARMITAGE | P<0.001 ** | | |FISHER EXACT | P=0.584 P<0.001 ** P<0.001 ** | | |=================================================================================================================================| | | |Testes | | Mineralization | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 17/51 (33%) 10/50 (20%) 33/50 (66%) 19/49 (39%) | | |ADJUSTED (b) | 54.6% 40.5% 87.6% 63.2% | | |TERMINAL (d) | 4/15 (27%) 3/15 (20%) 10/14 (71%) 10/20 (50%) | | |FIRST INCIDENCE (DAYS) | 549 485 437 563 | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.478N P=0.079N P=0.026 * P=0.446N | | |INCIDENTAL TUMOR | P=0.216 P=0.076N P=0.002 ** P=0.467 | | |LOGISTIC REGRESSION | P=0.258 P=0.073N P=0.002 ** P=0.418 | | |COCHRAN-ARMITAGE | P=0.273 | | |FISHER EXACT | P=0.098N P<0.001 ** P=0.360 | | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 51 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Testes: Interstitial Cell | | Hyperplasia | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 16/51 (31%) 22/50 (44%) 0/50 (0%) 0/49 (0%) | | |ADJUSTED (b) | 40.2% 61.2% 0.0% 0.0% | | |TERMINAL (d) | 2/15 (13%) 5/15 (33%) 0/14 (0%) 0/20 (0%) | | |FIRST INCIDENCE (DAYS) | 366 424 --- --- | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001N** P=0.266 P<0.001N** P<0.001N** | | |INCIDENTAL TUMOR | P<0.001N** P=0.039 * P<0.001N** P=0.002N** | | |LOGISTIC REGRESSION | P<0.001N** P=0.031 * P<0.001N** P<0.001N** | | |COCHRAN-ARMITAGE | P<0.001N** | | |FISHER EXACT | P=0.135 P<0.001N** P<0.001N** | | |=================================================================================================================================| | | |Thymus | | Atrophy | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 6/42 (14%) 3/42 (7%) 7/38 (18%) 7/39 (18%) | 3/45 (7%) 2/47 (4%) 7/44 (16%) 6/42 (14%) | |ADJUSTED (b) | 13.4% 8.5% 25.4% 21.0% | 7.9% 4.3% 17.1% 12.8% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 0/12 (0%) 0/16 (0%) | 0/23 (0%) 0/27 (0%) 1/27 (4%) 0/26 (0%) | |FIRST INCIDENCE (DAYS) | 384 485 527 434 | 533 501 118 387 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.356 P=0.236N P=0.570 P=0.566 | P=0.148 P=0.465N P=0.194 P=0.258 | |INCIDENTAL TUMOR | P=0.029 * P=0.328N P=0.247 P=0.069 | P=0.214 P=0.647 P=0.189 P=0.263 | |LOGISTIC REGRESSION | P=0.083 P=0.384N P=0.276 P=0.101 | P=0.091 P=0.499N P=0.170 P=0.102 | |COCHRAN-ARMITAGE | P=0.238 | P=0.096 | |FISHER EXACT | P=0.241N P=0.421 P=0.441 | P=0.479N P=0.148 P=0.208 | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 52 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | | Ultimobranchial Cyst | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/51 (2%) 6/48 (13%) 3/50 (6%) 0/49 (0%) | 2/50 (4%) 1/49 (2%) 0/50 (0%) 2/49 (4%) | |ADJUSTED (b) | 6.7% 21.2% 11.4% 0.0% | 4.3% 3.4% 0.0% 4.7% | |TERMINAL (d) | 1/15 (7%) 2/15 (13%) 0/14 (0%) 0/20 (0%) | 0/25 (0%) 1/29 (3%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 728 (T) 321 622 --- | 533 728 (T) --- 394 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.052N P=0.063 P=0.335 P=0.443N | P=0.498 P=0.483N P=0.252N P=0.686 | |INCIDENTAL TUMOR | P=0.060N P=0.044 * P=0.355 P=0.443N | P=0.569 P=0.645N P=0.323N P=0.694N | |LOGISTIC REGRESSION | P=0.057N P=0.044 * P=0.349 P=0.443N | P=0.545 P=0.621N P=0.165N P=0.627N | |COCHRAN-ARMITAGE | P=0.064N | P=0.488 | |FISHER EXACT | P=0.047 * P=0.301 P=0.510N | P=0.508N P=0.247N P=0.684 | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Hyperplasia | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/51 (2%) 0/48 (0%) 0/50 (0%) 0/49 (0%) | 0/50 (0%) 0/49 (0%) 2/50 (4%) 0/49 (0%) | |ADJUSTED (b) | 3.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 6.7% 0.0% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/14 (0%) 0/20 (0%) | 0/25 (0%) 0/29 (0%) 2/30 (7%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 605 --- --- --- | --- --- 728 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.577N P=0.488N P=0.462N P=0.472N | P=0.661N (e) P=0.279 (e) | |INCIDENTAL TUMOR | P=0.588N P=0.564N P=0.500N P=0.519N | P=0.661N (e) P=0.279 (e) | |LOGISTIC REGRESSION | P=0.585N P=0.516N P=0.522N P=0.506N | P=0.661N (e) P=0.279 (e) | |COCHRAN-ARMITAGE | P=0.594N | P=0.695N | |FISHER EXACT | P=0.515N P=0.505N P=0.510N | (e) P=0.247 (e) | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 53 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | |=================================================================================================================================| | | |Urinary Bladder | | Inflammation Chronic | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/51 (2%) 1/50 (2%) 0/50 (0%) 2/49 (4%) | 0/50 (0%) 3/50 (6%) 1/49 (2%) 0/50 (0%) | |ADJUSTED (b) | 4.2% 2.1% 0.0% 7.1% | 0.0% 10.3% 3.2% 0.0% | |TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/14 (0%) 1/20 (5%) | 0/25 (0%) 3/29 (10%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 660 408 --- 145 | --- 728 (T) 713 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.329 P=0.735N P=0.443N P=0.544 | P=0.198N P=0.147 P=0.543 (e) | |INCIDENTAL TUMOR | P=0.316 P=0.729 P=0.439N P=0.690 | P=0.202N P=0.147 P=0.545 (e) | |LOGISTIC REGRESSION | P=0.444 P=0.755N P=0.492N P=0.552 | P=0.203N P=0.147 P=0.520 (e) | |COCHRAN-ARMITAGE | P=0.301 | P=0.230N | |FISHER EXACT | P=0.748 P=0.505N P=0.485 | P=0.121 P=0.495 (e) | |=================================================================================================================================| | | |Urinary Bladder: Transitional Epithelium | | Hyperplasia | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/51 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | 0/50 (0%) 0/50 (0%) 2/49 (4%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 2.7% | 0.0% 0.0% 5.3% 2.8% | |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) | --- --- --- 629 | --- --- 638 680 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.257 (e) (e) P=0.542 | P=0.385 (e) P=0.277 P=0.523 | |INCIDENTAL TUMOR | P=0.231 (e) (e) P=0.481 | P=0.256 (e) P=0.129 P=0.545 | |LOGISTIC REGRESSION | P=0.229 (e) (e) P=0.491 | P=0.358 (e) P=0.233 P=0.503 | |COCHRAN-ARMITAGE | P=0.230 | P=0.358 | |FISHER EXACT | (e) (e) P=0.490 | (e) P=0.242 P=0.500 | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 54 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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 | | Hemorrhage | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | | 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | |ADJUSTED (b) | | 4.0% 3.3% 4.8% 0.0% | |TERMINAL (d) | | 1/25 (4%) 0/29 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | | 728 (T) 725 560 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.307N P=0.723N P=0.543 P=0.457N | |INCIDENTAL TUMOR | | P=0.391N P=0.719N P=0.421 P=0.457N | |LOGISTIC REGRESSION | | P=0.330N P=0.732N P=0.501 P=0.457N | |COCHRAN-ARMITAGE | | P=0.330N | |FISHER EXACT | | P=0.753N P=0.500 P=0.500N | |=================================================================================================================================| | | |Uterus | | Hydrometra | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | | 3/50 (6%) 4/50 (8%) 5/50 (10%) 6/50 (12%) | |ADJUSTED (b) | | 10.4% 13.8% 15.7% 19.4% | |TERMINAL (d) | | 2/25 (8%) 4/29 (14%) 4/30 (13%) 6/31 (19%) | |FIRST INCIDENCE (DAYS) | | 573 728 (T) 671 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.290 P=0.579 P=0.447 P=0.347 | |INCIDENTAL TUMOR | | P=0.246 P=0.535 P=0.372 P=0.250 | |LOGISTIC REGRESSION | | P=0.262 P=0.546 P=0.392 P=0.298 | |COCHRAN-ARMITAGE | | P=0.215 | |FISHER EXACT | | P=0.500 P=0.357 P=0.243 | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 55 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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: Endometrium | | Cyst | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | | 1/50 (2%) 1/50 (2%) 9/50 (18%) 3/50 (6%) | |ADJUSTED (b) | | 4.0% 2.4% 27.5% 9.3% | |TERMINAL (d) | | 1/25 (4%) 0/29 (0%) 7/30 (23%) 2/31 (6%) | |FIRST INCIDENCE (DAYS) | | 728 (T) 582 671 713 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.388 P=0.726N P=0.020 * P=0.391 | |INCIDENTAL TUMOR | | P=0.327 P=0.729 P=0.022 * P=0.386 | |LOGISTIC REGRESSION | | P=0.344 P=0.758 P=0.016 * P=0.370 | |COCHRAN-ARMITAGE | | P=0.309 | |FISHER EXACT | | P=0.753N P=0.008 ** P=0.309 | |=================================================================================================================================| | | |Uterus: Endometrium | | Hyperplasia Cystic | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | | 1/50 (2%) 0/50 (0%) 4/50 (8%) 3/50 (6%) | |ADJUSTED (b) | | 3.3% 0.0% 11.9% 8.5% | |TERMINAL (d) | | 0/25 (0%) 0/29 (0%) 3/30 (10%) 2/31 (6%) | |FIRST INCIDENCE (DAYS) | | 705 --- 441 511 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.171 P=0.487N P=0.218 P=0.351 | |INCIDENTAL TUMOR | | P=0.202 P=0.455N P=0.210 P=0.367 | |LOGISTIC REGRESSION | | P=0.143 P=0.484N P=0.179 P=0.305 | |COCHRAN-ARMITAGE | | P=0.143 | |FISHER EXACT | | P=0.500N P=0.181 P=0.309 | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 56 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS 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).