TDMS Study 05217-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst T-BUTYLHYDROQUINONE DATE: 04/04/96 EXPERIMENT: 05217 TEST: 04 TIME: 08:26:28 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1ES85219 ROUTE: DOSED FEED NTP C#: C62157 PATHOLOGIST: J. E. HEATH CAS: 1948330 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst T-BUTYLHYDROQUINONE DATE: 04/04/96 EXPERIMENT: 05217 TEST: 04 TIME: 08:26:28 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1ES85219 ROUTE: DOSED FEED NTP C#: C62157 PATHOLOGIST: J. E. HEATH CAS: 1948330 RATS(FISCHER344) ---------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED. ---------------- Adrenal Cortex Adrenal Medulla Bone Marrow Brain Clitoral Gland Clitoral/Preputial Gland Epididymis Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst T-BUTYLHYDROQUINONE DATE: 04/04/96 EXPERIMENT: 05217 TEST: 04 TIME: 08:26:28 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1ES85219 ROUTE: DOSED FEED NTP C#: C62157 PATHOLOGIST: J. E. HEATH CAS: 1948330 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF T-BUTYLHYDROQUINONE ==================================================================================================== MALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma: Benign, Complex, Malignant, NOS Skin Fibroma Testes Adenoma Thyroid Gland: C-Cell Carcinoma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Clitoral/Preputial Gland Adenoma Carcinoma or Adenoma Mammary Gland Fibroadenoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma ==================================================================================================== DATE: 04/04/96 EXPERIMENT: 05217 TEST: 04 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE TERMINAL SACRIFICE AT 131 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.5% | UNTREATD 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/69 (17%) 12/70 (17%) | 4/67 (6%) 4/70 (6%) | |ADJUSTED (b) | 57.5% 42.5% | 17.1% 12.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 3/10 (30%) 7/22 (32%) | 2/18 (11%) 2/24 (8%) | |FIRST INCIDENCE (DAYS) | 707 732 | 677 499 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.066N | P=0.530N | |INCIDENTAL TUMOR | P=0.255N | P=0.503N | |LOGISTIC REGRESSION | P=0.163N | P=0.598N | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.573N | P=0.616N | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/69 (3%) 2/70 (3%) | 0/67 (0%) 1/70 (1%) | |ADJUSTED (b) | 12.0% 5.3% | 0.0% 2.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/10 (10%) 0/22 (0%) | 0/18 (0%) 0/24 (0%) | |FIRST INCIDENCE (DAYS) | 661 712 | --- 823 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.494N | P=0.538 | |INCIDENTAL TUMOR | P=0.626N | P=0.488 | |LOGISTIC REGRESSION | P=0.646N | P=0.517 | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.685N | P=0.511 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 04 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE TERMINAL SACRIFICE AT 131 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.5% | UNTREATD 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 15/69 (22%) 14/70 (20%) | 4/67 (6%) 5/70 (7%) | |ADJUSTED (b) | 65.0% 45.5% | 17.1% 15.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 4/10 (40%) 7/22 (32%) | 2/18 (11%) 2/24 (8%) | |FIRST INCIDENCE (DAYS) | 552 712 | 677 499 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.037N* | P=0.619 | |INCIDENTAL TUMOR | P=0.217N | P=0.630 | |LOGISTIC REGRESSION | P=0.157N | P=0.551 | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.483N | P=0.528 | |=================================================================================================================================| | | |Bone | | Osteosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 2/70 (3%) | 0/70 (0%) 0/70 (0%) | |ADJUSTED (b) | 0.0% 5.4% | 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 0/22 (0%) | 0/18 (0%) 0/24 (0%) | |FIRST INCIDENCE (DAYS) | --- 796 | --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.356 | (e) (e) | |INCIDENTAL TUMOR | P=0.232 | (e) (e) | |LOGISTIC REGRESSION | P=0.272 | (e) (e) | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.248 | (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 04 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE TERMINAL SACRIFICE AT 131 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.5% | UNTREATD 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/70 (1%) 1/69 (1%) | 3/69 (4%) 10/69 (14%) | |ADJUSTED (b) | 3.8% 2.0% | 13.4% 27.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 0/21 (0%) | 1/18 (6%) 3/23 (13%) | |FIRST INCIDENCE (DAYS) | 786 731 | 866 673 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.673N | P=0.093 | |INCIDENTAL TUMOR | P=0.756 | P=0.040 * | |LOGISTIC REGRESSION | P=0.750N | P=0.047 * | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.748 | P=0.039 * | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/70 (1%) 2/69 (3%) | 2/69 (3%) 5/69 (7%) | |ADJUSTED (b) | 3.8% 6.2% | 6.2% 21.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 0/21 (0%) | 0/18 (0%) 5/23 (22%) | |FIRST INCIDENCE (DAYS) | 786 793 | 788 911 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.686 | P=0.310 | |INCIDENTAL TUMOR | P=0.490 | P=0.279 | |LOGISTIC REGRESSION | P=0.568 | P=0.279 | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.495 | P=0.220 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 04 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE TERMINAL SACRIFICE AT 131 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.5% | UNTREATD 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/70 (3%) 3/69 (4%) | 5/69 (7%) 15/69 (22%) | |ADJUSTED (b) | 7.7% 8.0% | 18.8% 45.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 0/21 (0%) | 1/18 (6%) 8/23 (35%) | |FIRST INCIDENCE (DAYS) | 786 731 | 788 673 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.647N | P=0.051 | |INCIDENTAL TUMOR | P=0.487 | P=0.019 * | |LOGISTIC REGRESSION | P=0.560 | P=0.019 * | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.493 | P=0.014 * | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/68 (3%) 6/70 (9%) | 1/70 (1%) 2/69 (3%) | |ADJUSTED (b) | 8.3% 20.6% | 1.9% 5.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 3/22 (14%) | 0/18 (0%) 0/24 (0%) | |FIRST INCIDENCE (DAYS) | 707 778 | 677 780 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.394 | P=0.538 | |INCIDENTAL TUMOR | P=0.241 | P=0.457 | |LOGISTIC REGRESSION | P=0.244 | P=0.501 | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.147 | P=0.495 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 04 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE TERMINAL SACRIFICE AT 131 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.5% | UNTREATD 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/70 (1%) 2/70 (3%) | 2/70 (3%) 2/70 (3%) | |ADJUSTED (b) | 10.0% 7.4% | 9.1% 5.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/10 (10%) 1/22 (5%) | 0/18 (0%) 0/24 (0%) | |FIRST INCIDENCE (DAYS) | 911 (T) 820 | 870 841 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.724N | P=0.593N | |INCIDENTAL TUMOR | P=0.674 | P=0.651 | |LOGISTIC REGRESSION | P=0.688 | P=0.662N | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.500 | P=0.690N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/70 (1%) 3/70 (4%) | 3/70 (4%) 2/70 (3%) | |ADJUSTED (b) | 10.0% 11.8% | 11.0% 5.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/10 (10%) 2/22 (9%) | 0/18 (0%) 0/24 (0%) | |FIRST INCIDENCE (DAYS) | 911 (T) 820 | 711 841 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.591 | P=0.402N | |INCIDENTAL TUMOR | P=0.524 | P=0.556N | |LOGISTIC REGRESSION | P=0.530 | P=0.478N | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.310 | P=0.500N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 04 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE TERMINAL SACRIFICE AT 131 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.5% | UNTREATD 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 4/70 (6%) 6/70 (9%) | 30/70 (43%) 17/70 (24%) | |ADJUSTED (b) | 19.9% 19.6% | 86.8% 56.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/10 (10%) 3/22 (14%) | 14/18 (78%) 12/24 (50%) | |FIRST INCIDENCE (DAYS) | 745 745 | 688 780 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.565N | P<0.001N** | |INCIDENTAL TUMOR | P=0.556 | P=0.002N** | |LOGISTIC REGRESSION | P=0.530 | P=0.002N** | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.372 | P=0.016N* | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 5/70 (7%) 7/70 (10%) | 31/70 (44%) 17/70 (24%) | |ADJUSTED (b) | 28.8% 23.0% | 87.5% 56.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/10 (20%) 3/22 (14%) | 14/18 (78%) 12/24 (50%) | |FIRST INCIDENCE (DAYS) | 745 745 | 688 780 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.463N | P<0.001N** | |INCIDENTAL TUMOR | P=0.596 | P=0.001N** | |LOGISTIC REGRESSION | P=0.602 | P<0.001N** | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.382 | P=0.010N* | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 04 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE TERMINAL SACRIFICE AT 131 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.5% | UNTREATD 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Papilloma Squamous or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 2/70 (3%) | 0/70 (0%) 0/70 (0%) | |ADJUSTED (b) | 0.0% 6.4% | 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 1/22 (5%) | 0/18 (0%) 0/24 (0%) | |FIRST INCIDENCE (DAYS) | --- 730 | --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.371 | (e) (e) | |INCIDENTAL TUMOR | P=0.320 | (e) (e) | |LOGISTIC REGRESSION | P=0.285 | (e) (e) | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.248 | (e) | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 1/70 (1%) 2/70 (3%) | 0/70 (0%) 0/70 (0%) | |ADJUSTED (b) | 4.3% 6.4% | 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 1/22 (5%) | 0/18 (0%) 0/24 (0%) | |FIRST INCIDENCE (DAYS) | 796 730 | --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.685 | (e) (e) | |INCIDENTAL TUMOR | P=0.582 | (e) (e) | |LOGISTIC REGRESSION | P=0.572 | (e) (e) | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.500 | (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 04 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE TERMINAL SACRIFICE AT 131 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.5% | UNTREATD 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Ovary | | Granulosa Cell Tumor Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 2/70 (3%) 1/70 (1%) | |ADJUSTED (b) | | 7.0% 4.2% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | | 0/18 (0%) 1/24 (4%) | |FIRST INCIDENCE (DAYS) | | 837 911 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.414N | |INCIDENTAL TUMOR | | P=0.495N | |LOGISTIC REGRESSION | | P=0.459N | |COCHRAN-ARMITAGE | | | |FISHER EXACT | | P=0.500N | |=================================================================================================================================| | | |Ovary | | Granulosa Cell Tumor: Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 3/70 (4%) 1/70 (1%) | |ADJUSTED (b) | | 9.7% 4.2% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | | 0/18 (0%) 1/24 (4%) | |FIRST INCIDENCE (DAYS) | | 820 911 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.234N | |INCIDENTAL TUMOR | | P=0.313N | |LOGISTIC REGRESSION | | P=0.274N | |COCHRAN-ARMITAGE | | | |FISHER EXACT | | P=0.310N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 04 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE TERMINAL SACRIFICE AT 131 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.5% | UNTREATD 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/67 (19%) 16/66 (24%) | 30/69 (43%) 18/70 (26%) | |ADJUSTED (b) | 46.6% 47.2% | 81.1% 50.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/10 (20%) 6/20 (30%) | 11/17 (65%) 9/24 (38%) | |FIRST INCIDENCE (DAYS) | 569 641 | 638 649 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.286N | P=0.004N** | |INCIDENTAL TUMOR | P=0.342 | P=0.009N** | |LOGISTIC REGRESSION | P=0.488 | P=0.007N** | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.321 | P=0.021N* | |=================================================================================================================================| | | |Skin | | Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign, | | malignant or NOS), or Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 1/70 (1%) 1/70 (1%) | 2/70 (3%) 0/70 (0%) | |ADJUSTED (b) | 10.0% 1.9% | 7.5% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/10 (10%) 0/22 (0%) | 0/18 (0%) 0/24 (0%) | |FIRST INCIDENCE (DAYS) | 911 (T) 712 | 777 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.633N | P=0.199N | |INCIDENTAL TUMOR | P=0.680N | P=0.265N | |LOGISTIC REGRESSION | P=0.722N | P=0.226N | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.752N | P=0.248N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 04 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE TERMINAL SACRIFICE AT 131 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.5% | UNTREATD 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Skin | | Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal | | Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 2/70 (3%) 2/70 (3%) | 2/70 (3%) 0/70 (0%) | |ADJUSTED (b) | 18.2% 4.9% | 7.5% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/10 (10%) 0/22 (0%) | 0/18 (0%) 0/24 (0%) | |FIRST INCIDENCE (DAYS) | 900 712 | 777 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.457N | P=0.199N | |INCIDENTAL TUMOR | P=0.634N | P=0.265N | |LOGISTIC REGRESSION | P=0.589N | P=0.226N | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.690N | P=0.248N | |=================================================================================================================================| | | |Skin | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 6/70 (9%) 3/70 (4%) | 1/70 (1%) 1/70 (1%) | |ADJUSTED (b) | 33.6% 12.5% | 3.7% 2.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/10 (10%) 2/22 (9%) | 0/18 (0%) 0/24 (0%) | |FIRST INCIDENCE (DAYS) | 730 866 | 856 837 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.043N* | P=0.708N | |INCIDENTAL TUMOR | P=0.141N | P=0.735 | |LOGISTIC REGRESSION | P=0.077N | P=0.748N | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.247N | P=0.752N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 04 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE TERMINAL SACRIFICE AT 131 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.5% | UNTREATD 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 6/70 (9%) 4/70 (6%) | 1/70 (1%) 1/70 (1%) | |ADJUSTED (b) | 33.6% 14.0% | 3.7% 2.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/10 (10%) 2/22 (9%) | 0/18 (0%) 0/24 (0%) | |FIRST INCIDENCE (DAYS) | 730 671 | 856 837 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.093N | P=0.708N | |INCIDENTAL TUMOR | P=0.247N | P=0.735 | |LOGISTIC REGRESSION | P=0.185N | P=0.748N | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.372N | P=0.752N | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 3/70 (4%) | 0/70 (0%) 2/70 (3%) | |ADJUSTED (b) | 0.0% 9.7% | 0.0% 7.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 1/22 (5%) | 0/18 (0%) 1/24 (4%) | |FIRST INCIDENCE (DAYS) | --- 743 | --- 855 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.235 | P=0.295 | |INCIDENTAL TUMOR | P=0.163 | P=0.257 | |LOGISTIC REGRESSION | P=0.167 | P=0.274 | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.122 | P=0.248 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 04 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE TERMINAL SACRIFICE AT 131 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.5% | UNTREATD 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 59/70 (84%) 60/70 (86%) | | |ADJUSTED (b) | 100.0% 100.0% | | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | | |TERMINAL (d) | 10/10 (100%) 22/22 (100%) | | |FIRST INCIDENCE (DAYS) | 484 600 | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.002N** | | |INCIDENTAL TUMOR | P=0.506 | | |LOGISTIC REGRESSION | P=0.758 | | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.500 | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/70 (10%) 6/69 (9%) | 3/70 (4%) 6/69 (9%) | |ADJUSTED (b) | 30.0% 17.9% | 11.4% 16.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/10 (10%) 2/22 (9%) | 1/18 (6%) 1/24 (4%) | |FIRST INCIDENCE (DAYS) | 604 730 | 677 499 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.191N | P=0.348 | |INCIDENTAL TUMOR | P=0.616N | P=0.273 | |LOGISTIC REGRESSION | P=0.409N | P=0.254 | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.511N | P=0.239 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 04 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE TERMINAL SACRIFICE AT 131 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.5% | UNTREATD 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/70 (0%) 5/69 (7%) | 0/70 (0%) 1/69 (1%) | |ADJUSTED (b) | 0.0% 12.1% | 0.0% 4.2% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 0/22 (0%) | 0/18 (0%) 1/24 (4%) | |FIRST INCIDENCE (DAYS) | --- 641 | --- 911 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.082 | P=0.557 | |INCIDENTAL TUMOR | P=0.012 * | P=0.557 | |LOGISTIC REGRESSION | P=0.038 * | P=0.557 | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.028 * | P=0.496 | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/70 (10%) 11/69 (16%) | 3/70 (4%) 7/69 (10%) | |ADJUSTED (b) | 30.0% 27.8% | 11.4% 20.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/10 (10%) 2/22 (9%) | 1/18 (6%) 2/24 (8%) | |FIRST INCIDENCE (DAYS) | 604 641 | 677 499 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.595 | P=0.259 | |INCIDENTAL TUMOR | P=0.103 | P=0.196 | |LOGISTIC REGRESSION | P=0.293 | P=0.172 | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.215 | P=0.157 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 04 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE TERMINAL SACRIFICE AT 131 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.5% | UNTREATD 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/70 (3%) 0/69 (0%) | 0/70 (0%) 0/69 (0%) | |ADJUSTED (b) | 12.6% 0.0% | 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/10 (10%) 0/22 (0%) | 0/18 (0%) 0/24 (0%) | |FIRST INCIDENCE (DAYS) | 732 --- | --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.127N | (e) (e) | |INCIDENTAL TUMOR | P=0.162N | (e) (e) | |LOGISTIC REGRESSION | P=0.184N | (e) (e) | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.252N | (e) | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # | |----------- | | | |OVERALL (a) | | 8/70 (11%) 6/70 (9%) | |ADJUSTED (b) | | 21.2% 18.5% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | | 1/18 (6%) 2/24 (8%) | |FIRST INCIDENCE (DAYS) | | 562 672 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.281N | |INCIDENTAL TUMOR | | P=0.463N | |LOGISTIC REGRESSION | | P=0.369N | |COCHRAN-ARMITAGE | | | |FISHER EXACT | | P=0.390N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 04 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE TERMINAL SACRIFICE AT 131 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.5% | UNTREATD 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # | |----------- | | | |OVERALL (a) | | 8/70 (11%) 7/70 (10%) | |ADJUSTED (b) | | 21.2% 22.2% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | | 1/18 (6%) 3/24 (13%) | |FIRST INCIDENCE (DAYS) | | 562 672 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.368N | |INCIDENTAL TUMOR | | P=0.559N | |LOGISTIC REGRESSION | | P=0.476N | |COCHRAN-ARMITAGE | | | |FISHER EXACT | | P=0.500N | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 46/70 (66%) 39/70 (56%) | 37/70 (53%) 34/70 (49%) | |ADJUSTED (b) | 86.9% 78.2% | 74.3% 64.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 4/10 (40%) 12/22 (55%) | 8/18 (44%) 7/24 (29%) | |FIRST INCIDENCE (DAYS) | 484 641 | 504 540 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.002N** | P=0.178N | |INCIDENTAL TUMOR | P=0.277N | P=0.528 | |LOGISTIC REGRESSION | P=0.036N* | P=0.552 | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.150N | P=0.368N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 04 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE TERMINAL SACRIFICE AT 131 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.5% | UNTREATD 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 3/70 (4%) 4/70 (6%) | 0/70 (0%) 0/70 (0%) | |ADJUSTED (b) | 6.0% 18.2% | 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 4/22 (18%) | 0/18 (0%) 0/24 (0%) | |FIRST INCIDENCE (DAYS) | 552 911 (T) | --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.545N | (e) (e) | |INCIDENTAL TUMOR | P=0.541 | (e) (e) | |LOGISTIC REGRESSION | P=0.575 | (e) (e) | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.500 | (e) | |=================================================================================================================================| | | |All Organs | | Osteosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 2/70 (3%) | 0/70 (0%) 0/70 (0%) | |ADJUSTED (b) | 0.0% 5.4% | 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 0/22 (0%) | 0/18 (0%) 0/24 (0%) | |FIRST INCIDENCE (DAYS) | --- 796 | --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.356 | (e) (e) | |INCIDENTAL TUMOR | P=0.232 | (e) (e) | |LOGISTIC REGRESSION | P=0.272 | (e) (e) | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.248 | (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 04 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE TERMINAL SACRIFICE AT 131 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.5% | UNTREATD 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Osteosarcoma or Osteoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 2/70 (3%) | 0/70 (0%) 0/70 (0%) | |ADJUSTED (b) | 0.0% 5.4% | 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 0/22 (0%) | 0/18 (0%) 0/24 (0%) | |FIRST INCIDENCE (DAYS) | --- 796 | --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.356 | (e) (e) | |INCIDENTAL TUMOR | P=0.232 | (e) (e) | |LOGISTIC REGRESSION | P=0.272 | (e) (e) | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.248 | (e) | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 59/70 (84%) 60/70 (86%) | 46/70 (66%) 42/70 (60%) | |ADJUSTED (b) | 100.0% 100.0% | 95.6% 86.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 10/10 (100%) 22/22 (100%) | 16/18 (89%) 18/24 (75%) | |FIRST INCIDENCE (DAYS) | 484 600 | 562 499 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.002N** | P=0.061N | |INCIDENTAL TUMOR | P=0.506 | P=0.172N | |LOGISTIC REGRESSION | P=0.758 | P=0.179N | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.500 | P=0.300N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 04 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE TERMINAL SACRIFICE AT 131 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.5% | UNTREATD 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 52/70 (74%) 49/70 (70%) | 40/70 (57%) 41/70 (59%) | |ADJUSTED (b) | 94.0% 86.8% | 76.7% 77.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 7/10 (70%) 15/22 (68%) | 8/18 (44%) 13/24 (54%) | |FIRST INCIDENCE (DAYS) | 484 600 | 504 540 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.003N** | P=0.293N | |INCIDENTAL TUMOR | P=0.604 | P=0.267 | |LOGISTIC REGRESSION | P=0.583N | P=0.271 | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.353N | P=0.500 | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 59/70 (84%) 60/70 (86%) | 59/70 (84%) 57/70 (81%) | |ADJUSTED (b) | 100.0% 100.0% | 98.3% 96.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 10/10 (100%) 22/22 (100%) | 17/18 (94%) 22/24 (92%) | |FIRST INCIDENCE (DAYS) | 484 600 | 504 499 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.002N** | P=0.098N | |INCIDENTAL TUMOR | P=0.506 | P=0.485N | |LOGISTIC REGRESSION | P=0.758 | P=0.353N | |COCHRAN-ARMITAGE | | | |FISHER EXACT | P=0.500 | P=0.411N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 04 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE TERMINAL SACRIFICE AT 131 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. (c) Observed incidence at interim kill. Male interim sacrifices(days): 92 Female interim sacrifices(days): 92 (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).