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: 07:20:57 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 ------------------------------------------------------------------------------------------------------------------------------------ 27 WEEK SSAC REASONS FOR REMOVAL: 25017 Scheduled Sacrifice REMOVAL DATE RANGE: 102193 102293 TREATMENT GROUPS: INCLUDE 001 0 MG/KG INCLUDE 002 0 MG/KG INCLUDE 003 3 MG/KG INCLUDE 004 3 MG/KG INCLUDE 005 30 MG/KG INCLUDE 006 30 MG/KG INCLUDE 007 150 MG/KG INCLUDE 008 100 MG/KG NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus OXYMETHOLONE DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 TIME: 07:20:57 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 Kidney Mineralization Lung Inflammation Chronic Mineralization Mammary Gland Dilatation ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Clitoral Gland Inflammation Chronic Heart Degeneration Chronic Kidney Nephropathy Lung Inflammation Chronic Mineralization Mammary Gland Hyperplasia Ovary DYSGENESIS ==================================================================================================== DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 1 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE TERMINAL SACRIFICE AT . 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 | | Accessory Adrenal Cortical Nodule | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/10 (0%) 1/10 (10%) 1/10 (10%) 1/10 (10%) | 3/10 (30%) 2/10 (20%) 1/10 (10%) 0/10 (0%) | |ADJUSTED (b) | 0.0% 10.0% 10.0% 10.0% | 30.0% 20.0% 10.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 1/10 (10%) 1/10 (10%) | 3/10 (30%) 2/10 (20%) 1/10 (10%) 0/10 (0%) | |TERMINAL (d) | 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | --- 184 (I) 184 (I) 184 (I) | 184 (I) 184 (I) 184 (I) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.555 P=0.500 P=0.500 P=0.500 | P=0.081N P=0.500N P=0.293N P=0.111N | |INCIDENTAL TUMOR | P=0.555 P=0.500 P=0.500 P=0.500 | P=0.081N P=0.500N P=0.293N P=0.111N | |LOGISTIC REGRESSION | P=0.555 P=0.500 P=0.500 P=0.500 | P=0.081N P=0.500N P=0.293N P=0.111N | |COCHRAN-ARMITAGE | P=0.555 | P=0.079N | |FISHER EXACT | P=0.500 P=0.500 P=0.500 | P=0.500N P=0.291N P=0.105N | |=================================================================================================================================| | | |Adrenal Cortex | | Vacuolization Cytoplasmic | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 10/10 (100%) 8/10 (80%) 0/10 (0%) 8/10 (80%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |ADJUSTED (b) | 100.0% 80.0% 0.0% 80.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 10/10 (100%) 8/10 (80%) 0/10 (0%) 8/10 (80%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 184 (I) 184 (I) --- 184 (I) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.554 P=0.234N P<0.001N** P=0.234N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.554 P=0.234N P<0.001N** P=0.234N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.554 P=0.234N P<0.001N** P=0.234N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.555 | (e) | |FISHER EXACT | P=0.237N P<0.001N** P=0.237N | (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 . 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 | | Inflammation Chronic | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | 6/10 (60%) 7/10 (70%) 10/10 (100%) 8/10 (80%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 60.0% 70.0% 100.0% 80.0% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 6/10 (60%) 7/10 (70%) 10/10 (100%) 8/10 (80%) | |TERMINAL (d) | 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 184 (I) 184 (I) 184 (I) 184 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.304 P=0.500 P=0.051 P=0.317 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.304 P=0.500 P=0.051 P=0.317 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.304 P=0.500 P=0.051 P=0.317 | |COCHRAN-ARMITAGE | (e) | P=0.302 | |FISHER EXACT | (e) (e) (e) | P=0.500 P=0.043 * P=0.314 | |=================================================================================================================================| | | |Heart: Myocardium | | Degeneration Chronic | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 10/10 (100%) 10/10 (100%) 9/10 (90%) 10/10 (100%)| 5/10 (50%) 5/10 (50%) 7/10 (70%) 10/10 (100%)| |ADJUSTED (b) | 100.0% 100.0% 90.0% 100.0% | 50.0% 50.0% 70.0% 100.0% | |INTERIM SACRIFICE 1 (c)| 10/10 (100%) 10/10 (100%) 9/10 (90%) 10/10 (100%)| 5/10 (50%) 5/10 (50%) 7/10 (70%) 10/10 (100%)| |TERMINAL (d) | 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 184 (I) 184 (I) 184 (I) 184 (I) | 184 (I) 184 (I) 184 (I) 184 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.765 (e) P=0.500N (e) | P=0.008 ** P=0.669 P=0.328 P=0.022 * | |INCIDENTAL TUMOR | P=0.765 (e) P=0.500N (e) | P=0.008 ** P=0.669 P=0.328 P=0.022 * | |LOGISTIC REGRESSION | P=0.765 (e) P=0.500N (e) | P=0.008 ** P=0.669 P=0.328 P=0.022 * | |COCHRAN-ARMITAGE | P=0.768 | P=0.007 ** | |FISHER EXACT | P=1.000N P=0.500N P=1.000N | P=0.672N P=0.325 P=0.016 * | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 3 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE TERMINAL SACRIFICE AT . 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) | 2/10 (20%) 0/10 (0%) 1/10 (10%) 9/10 (90%) | 10/10 (100%) 10/10 (100%) 10/10 (100%) 9/10 (90%) | |ADJUSTED (b) | 20.0% 0.0% 10.0% 90.0% | 100.0% 100.0% 100.0% 90.0% | |INTERIM SACRIFICE 1 (c)| 2/10 (20%) 0/10 (0%) 1/10 (10%) 9/10 (90%) | 10/10 (100%) 10/10 (100%) 10/10 (100%) 9/10 (90%) | |TERMINAL (d) | 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 184 (I) --- 184 (I) 184 (I) | 184 (I) 184 (I) 184 (I) 184 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.234N P=0.500N P=0.004 ** | P=0.215N (e) (e) P=0.500N | |INCIDENTAL TUMOR | P<0.001 ** P=0.234N P=0.500N P=0.004 ** | P=0.215N (e) (e) P=0.500N | |LOGISTIC REGRESSION | P<0.001 ** P=0.234N P=0.500N P=0.004 ** | P=0.215N (e) (e) P=0.500N | |COCHRAN-ARMITAGE | P<0.001 ** | P=0.212N | |FISHER EXACT | P=0.237N P=0.500N P=0.003 ** | P=1.000N P=1.000N P=0.500N | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 8/10 (80%) 7/10 (70%) 9/10 (90%) 10/10 (100%)| 0/10 (0%) 1/10 (10%) 2/10 (20%) 7/10 (70%) | |ADJUSTED (b) | 80.0% 70.0% 90.0% 100.0% | 0.0% 10.0% 20.0% 70.0% | |INTERIM SACRIFICE 1 (c)| 8/10 (80%) 7/10 (70%) 9/10 (90%) 10/10 (100%)| 0/10 (0%) 1/10 (10%) 2/10 (20%) 7/10 (70%) | |TERMINAL (d) | 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 184 (I) 184 (I) 184 (I) 184 (I) | --- 184 (I) 184 (I) 184 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.105 P=0.500N P=0.500 P=0.234 | P<0.001 ** P=0.500 P=0.234 P=0.003 ** | |INCIDENTAL TUMOR | P=0.105 P=0.500N P=0.500 P=0.234 | P<0.001 ** P=0.500 P=0.234 P=0.003 ** | |LOGISTIC REGRESSION | P=0.105 P=0.500N P=0.500 P=0.234 | P<0.001 ** P=0.500 P=0.234 P=0.003 ** | |COCHRAN-ARMITAGE | P=0.102 | P<0.001 ** | |FISHER EXACT | P=0.500N P=0.500 P=0.237 | P=0.500 P=0.237 P=0.002 ** | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 4 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE TERMINAL SACRIFICE AT . 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 | | Hepatodiaphragmatic Nodule | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/10 (10%) 1/10 (10%) 1/10 (10%) 1/10 (10%) | 1/10 (10%) 5/10 (50%) 1/10 (10%) 2/10 (20%) | |ADJUSTED (b) | 10.0% 10.0% 10.0% 10.0% | 10.0% 50.0% 10.0% 20.0% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 1/10 (10%) 1/10 (10%) 1/10 (10%) | 1/10 (10%) 5/10 (50%) 1/10 (10%) 2/10 (20%) | |TERMINAL (d) | 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 184 (I) 184 (I) 184 (I) 184 (I) | 184 (I) 184 (I) 184 (I) 184 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.695 P=0.766 P=0.766 P=0.766 | P=0.429N P=0.077 P=0.766 P=0.500 | |INCIDENTAL TUMOR | P=0.695 P=0.766 P=0.766 P=0.766 | P=0.429N P=0.077 P=0.766 P=0.500 | |LOGISTIC REGRESSION | P=0.695 P=0.766 P=0.766 P=0.766 | P=0.429N P=0.077 P=0.766 P=0.500 | |COCHRAN-ARMITAGE | P=0.697 | P=0.428N | |FISHER EXACT | P=0.763N P=0.763N P=0.763N | P=0.070 P=0.763N P=0.500 | |=================================================================================================================================| | | |Liver | | Inflammation Chronic | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/10 (30%) 1/10 (10%) 3/10 (30%) 1/10 (10%) | 2/10 (20%) 5/10 (50%) 4/10 (40%) 2/10 (20%) | |ADJUSTED (b) | 30.0% 10.0% 30.0% 10.0% | 20.0% 50.0% 40.0% 20.0% | |INTERIM SACRIFICE 1 (c)| 3/10 (30%) 1/10 (10%) 3/10 (30%) 1/10 (10%) | 2/10 (20%) 5/10 (50%) 4/10 (40%) 2/10 (20%) | |TERMINAL (d) | 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 184 (I) 184 (I) 184 (I) 184 (I) | 184 (I) 184 (I) 184 (I) 184 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.344N P=0.293N P=0.683 P=0.293N | P=0.303N P=0.180 P=0.317 P=0.707 | |INCIDENTAL TUMOR | P=0.344N P=0.293N P=0.683 P=0.293N | P=0.303N P=0.180 P=0.317 P=0.707 | |LOGISTIC REGRESSION | P=0.344N P=0.293N P=0.683 P=0.293N | P=0.303N P=0.180 P=0.317 P=0.707 | |COCHRAN-ARMITAGE | P=0.342N | P=0.301N | |FISHER EXACT | P=0.291N P=0.686N P=0.291N | P=0.175 P=0.314 P=0.709N | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 5 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE TERMINAL SACRIFICE AT . 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) | 3/10 (30%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |ADJUSTED (b) | 30.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 3/10 (30%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 184 (I) --- --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.228N P=0.111N P=0.111N P=0.111N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.228N P=0.111N P=0.111N P=0.111N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.228N P=0.111N P=0.111N P=0.111N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.225N | (e) | |FISHER EXACT | P=0.105N P=0.105N P=0.105N | (e) (e) (e) | |=================================================================================================================================| | | |Lung | | Inflammation Chronic | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/10 (20%) 3/10 (30%) 8/10 (80%) 3/10 (30%) | 2/10 (20%) 4/10 (40%) 7/10 (70%) 2/10 (20%) | |ADJUSTED (b) | 20.0% 30.0% 80.0% 30.0% | 20.0% 40.0% 70.0% 20.0% | |INTERIM SACRIFICE 1 (c)| 2/10 (20%) 3/10 (30%) 8/10 (80%) 3/10 (30%) | 2/10 (20%) 4/10 (40%) 7/10 (70%) 2/10 (20%) | |TERMINAL (d) | 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 184 (I) 184 (I) 184 (I) 184 (I) | 184 (I) 184 (I) 184 (I) 184 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.556N P=0.500 P=0.015 * P=0.500 | P=0.369N P=0.317 P=0.040 * P=0.707 | |INCIDENTAL TUMOR | P=0.556N P=0.500 P=0.015 * P=0.500 | P=0.369N P=0.317 P=0.040 * P=0.707 | |LOGISTIC REGRESSION | P=0.556N P=0.500 P=0.015 * P=0.500 | P=0.369N P=0.317 P=0.040 * P=0.707 | |COCHRAN-ARMITAGE | P=0.557N | P=0.367N | |FISHER EXACT | P=0.500 P=0.012 * P=0.500 | P=0.314 P=0.035 * P=0.709N | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 6 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE TERMINAL SACRIFICE AT . 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 | | Inflammation Granulomatous | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/10 (10%) 2/10 (20%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |ADJUSTED (b) | 10.0% 20.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 2/10 (20%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 184 (I) 184 (I) --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.245N P=0.500 P=0.500N P=0.500N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.245N P=0.500 P=0.500N P=0.500N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.245N P=0.500 P=0.500N P=0.500N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.243N | (e) | |FISHER EXACT | P=0.500 P=0.500N P=0.500N | (e) (e) (e) | |=================================================================================================================================| | | |Lung | | Mineralization | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/10 (0%) 4/10 (40%) 4/10 (40%) 1/10 (10%) | 0/10 (0%) 2/10 (20%) 4/10 (40%) 1/10 (10%) | |ADJUSTED (b) | 0.0% 40.0% 40.0% 10.0% | 0.0% 20.0% 40.0% 10.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 4/10 (40%) 4/10 (40%) 1/10 (10%) | 0/10 (0%) 2/10 (20%) 4/10 (40%) 1/10 (10%) | |TERMINAL (d) | 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | --- 184 (I) 184 (I) 184 (I) | --- 184 (I) 184 (I) 184 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.335N P=0.051 P=0.051 P=0.500 | P=0.613N P=0.234 P=0.051 P=0.500 | |INCIDENTAL TUMOR | P=0.335N P=0.051 P=0.051 P=0.500 | P=0.613N P=0.234 P=0.051 P=0.500 | |LOGISTIC REGRESSION | P=0.335N P=0.051 P=0.051 P=0.500 | P=0.613N P=0.234 P=0.051 P=0.500 | |COCHRAN-ARMITAGE | P=0.333N | P=0.615N | |FISHER EXACT | P=0.043 * P=0.043 * P=0.500 | P=0.237 P=0.043 * P=0.500 | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 7 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE TERMINAL SACRIFICE AT . 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 | | Dilatation | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 9/10 (90%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 90.0% | 0.0% 0.0% 0.0% 10.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 9/10 (90%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | |TERMINAL (d) | 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | --- --- --- 184 (I) | --- --- --- 184 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** (e) (e) P<0.001 ** | P=0.215 (e) (e) P=0.500 | |INCIDENTAL TUMOR | P<0.001 ** (e) (e) P<0.001 ** | P=0.215 (e) (e) P=0.500 | |LOGISTIC REGRESSION | P<0.001 ** (e) (e) P<0.001 ** | P=0.215 (e) (e) P=0.500 | |COCHRAN-ARMITAGE | P<0.001 ** | P=0.212 | |FISHER EXACT | (e) (e) P<0.001 ** | (e) (e) P=0.500 | |=================================================================================================================================| | | |Mammary Gland: Lobular | | Hyperplasia | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%)| |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 100.0% 100.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%)| |TERMINAL (d) | 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- 184 (I) 184 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P<0.001 ** (e) P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P<0.001 ** (e) P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P<0.001 ** (e) P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | (e) | P<0.001 ** | |FISHER EXACT | (e) (e) (e) | (e) P<0.001 ** P<0.001 ** | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 8 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE TERMINAL SACRIFICE AT . 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) | 1/10 (10%) 0/10 (0%) 2/10 (20%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |ADJUSTED (b) | 10.0% 0.0% 20.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 2/10 (20%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 184 (I) --- 184 (I) --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.434N P=0.500N P=0.500 P=0.500N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.434N P=0.500N P=0.500 P=0.500N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.434N P=0.500N P=0.500 P=0.500N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.433N | (e) | |FISHER EXACT | P=0.500N P=0.500 P=0.500N | (e) (e) (e) | |=================================================================================================================================| | | |Ovary | | DYSGENESIS | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | | 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%)| |ADJUSTED (b) | | 0.0% 0.0% 100.0% 100.0% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%)| |TERMINAL (d) | | 0/0 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | | --- --- 184 (I) 184 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P<0.001 ** (e) P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | | P<0.001 ** (e) P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | | P<0.001 ** (e) P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | | P<0.001 ** | |FISHER EXACT | | (e) P<0.001 ** P<0.001 ** | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 9 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE TERMINAL SACRIFICE AT . 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: Acinus | | Atrophy | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/10 (0%) 2/10 (20%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | |ADJUSTED (b) | 0.0% 20.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 10.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 2/10 (20%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | |TERMINAL (d) | 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | --- 184 (I) --- --- | --- --- --- 184 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.383N P=0.234 (e) (e) | P=0.215 (e) (e) P=0.500 | |INCIDENTAL TUMOR | P=0.383N P=0.234 (e) (e) | P=0.215 (e) (e) P=0.500 | |LOGISTIC REGRESSION | P=0.383N P=0.234 (e) (e) | P=0.215 (e) (e) P=0.500 | |COCHRAN-ARMITAGE | P=0.381N | P=0.212 | |FISHER EXACT | P=0.237 (e) (e) | (e) (e) P=0.500 | |=================================================================================================================================| | | |Preputial Gland | | Inflammation Chronic | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 7/10 (70%) 10/10 (100%) 9/10 (90%) 8/10 (80%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |ADJUSTED (b) | 70.0% 100.0% 90.0% 80.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 7/10 (70%) 10/10 (100%) 9/10 (90%) 8/10 (80%) | 0/0 0/0 0/0 0/0 | |TERMINAL (d) | 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 184 (I) 184 (I) 184 (I) 184 (I) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.513N P=0.111 P=0.293 P=0.500 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.513N P=0.111 P=0.293 P=0.500 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.513N P=0.111 P=0.293 P=0.500 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.513N | (e) | |FISHER EXACT | P=0.105 P=0.291 P=0.500 | (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 . 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) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 1/10 (10%) 1/10 (10%) 2/10 (20%) | |ADJUSTED (b) | 10.0% 0.0% 0.0% 0.0% | 0.0% 10.0% 10.0% 20.0% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 1/10 (10%) 1/10 (10%) 2/10 (20%) | |TERMINAL (d) | 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 184 (I) --- --- --- | --- 184 (I) 184 (I) 184 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.592N P=0.500N P=0.500N P=0.500N | P=0.200 P=0.500 P=0.500 P=0.234 | |INCIDENTAL TUMOR | P=0.592N P=0.500N P=0.500N P=0.500N | P=0.200 P=0.500 P=0.500 P=0.234 | |LOGISTIC REGRESSION | P=0.592N P=0.500N P=0.500N P=0.500N | P=0.200 P=0.500 P=0.500 P=0.234 | |COCHRAN-ARMITAGE | P=0.593N | P=0.197 | |FISHER EXACT | P=0.500N P=0.500N P=0.500N | P=0.500 P=0.500 P=0.237 | |=================================================================================================================================| | | |Thyroid Gland: Follicle | | Cyst | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |ADJUSTED (b) | 20.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 184 (I) --- --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.356N P=0.234N P=0.234N P=0.234N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.356N P=0.234N P=0.234N P=0.234N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.356N P=0.234N P=0.234N P=0.234N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.355N | (e) | |FISHER EXACT | P=0.237N P=0.237N P=0.237N | (e) (e) (e) | |=================================================================================================================================| DATE: 11/25/97 EXPERIMENT: 88032 TEST: 05 PAGE 11 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE TERMINAL SACRIFICE AT . 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 | | Hydrometra | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | | 2/10 (20%) 3/10 (30%) 4/10 (40%) 1/10 (10%) | |ADJUSTED (b) | | 20.0% 30.0% 40.0% 10.0% | |INTERIM SACRIFICE 1 (c)| | 2/10 (20%) 3/10 (30%) 4/10 (40%) 1/10 (10%) | |TERMINAL (d) | | 0/0 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | | 184 (I) 184 (I) 184 (I) 184 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.270N P=0.500 P=0.317 P=0.500N | |INCIDENTAL TUMOR | | P=0.270N P=0.500 P=0.317 P=0.500N | |LOGISTIC REGRESSION | | P=0.270N P=0.500 P=0.317 P=0.500N | |COCHRAN-ARMITAGE | | P=0.267N | |FISHER EXACT | | P=0.500 P=0.314 P=0.500N | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for intercurrent mortality. (c) Observed incidence at interim kill. Male interim sacrifices(days): 184 Female interim sacrifices(days): 184 (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).