TDMS Study 05217-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst T-BUTYLHYDROQUINONE DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 TIME: 07:15:00 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-85219 ROUTE: DOSED FEED NTP C#: C62157 PATHOLOGIST: J. E. HEATH CAS: 1948-33-0 ------------------------------------------------------------------------------------------------------------------------------------ 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: 03 TIME: 07:15:00 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-85219 ROUTE: DOSED FEED NTP C#: C62157 PATHOLOGIST: J. E. HEATH CAS: 1948-33-0 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: 03 TIME: 07:15:00 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-85219 ROUTE: DOSED FEED NTP C#: C62157 PATHOLOGIST: J. E. HEATH CAS: 1948-33-0 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF T-BUTYLHYDROQUINONE ==================================================================================================== MALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma: Benign, Complex, Malignant, NOS Clitoral/Preputial Gland Adenoma Carcinoma Carcinoma or Adenoma Liver Hepatocellular Carcinoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma Testes Adenoma Thyroid Gland: Follicular Cell Carcinoma Carcinoma or Adenoma Tongue Squamous Cell Papilloma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Mesothelioma: Benign, Malignant, NOS Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Mammary Gland Fibroadenoma Fibroma, Fibroadenoma or Adenoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) Squamous Cell Carcinoma Skin Squamous Cell Papilloma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated ==================================================================================================== DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/140 (1%) 0/70 (0%) 0/68 (0%) 1/70 (1%) | 4/140 (3%) 1/70 (1%) 0/68 (0%) 0/70 (0%) | |ADJUSTED (b) | 7.2% 0.0% 0.0% 4.8% | 9.3% 3.6% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/20 (5%) 0/7 (0%) 0/1 (0%) 0/14 (0%) | 1/32 (3%) 0/11 (0%) 0/16 (0%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | 786 --- --- 786 | 795 795 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.609N P=0.491N P=0.711N P=0.705N | P=0.058N P=0.527N P=0.178N P=0.161N | |INCIDENTAL TUMOR | P=0.636N P=0.438N P=0.613N P=0.722 | P=0.062N P=0.412N P=0.175N P=0.181N | |LOGISTIC REGRESSION | P=0.636N P=0.465N P=0.566N P=0.728 | P=0.058N P=0.476N P=0.176N P=0.158N | |COCHRAN-ARMITAGE | P=0.623N | P=0.067N | |FISHER EXACT | P=0.443N P=0.452N P=0.742N | P=0.459N P=0.202N P=0.195N | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 26/140 (19%) 20/69 (29%) 15/68 (22%) 12/70 (17%) | 4/140 (3%) 2/70 (3%) 1/68 (1%) 3/70 (4%) | |ADJUSTED (b) | 51.7% 85.5% 100.0% 49.8% | 10.1% 18.2% 3.1% 12.3% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 4/20 (20%) 5/7 (71%) 1/1 (100%) 5/14 (36%) | 2/32 (6%) 2/11 (18%) 0/16 (0%) 1/17 (6%) | |FIRST INCIDENCE (DAYS) | 617 655 473 487 | 817 898 (T) 789 750 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.445N P=0.012 * P=0.004 ** P=0.412N | P=0.494 P=0.539 P=0.430N P=0.516 | |INCIDENTAL TUMOR | P=0.528N P=0.044 * P=0.137 P=0.525N | P=0.442 P=0.595 P=0.418N P=0.464 | |LOGISTIC REGRESSION | P=0.497N P=0.021 * P=0.071 P=0.519N | P=0.487 P=0.602 P=0.422N P=0.510 | |COCHRAN-ARMITAGE | P=0.395N | P=0.412 | |FISHER EXACT | P=0.064 P=0.338 P=0.480N | P=0.682N P=0.472N P=0.429 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/140 (1%) 3/69 (4%) 1/68 (1%) 3/70 (4%) | 1/140 (1%) 0/70 (0%) 0/68 (0%) 1/70 (1%) | |ADJUSTED (b) | 6.3% 23.8% 5.0% 21.4% | 2.6% 0.0% 0.0% 5.3% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/20 (5%) 1/7 (14%) 0/1 (0%) 3/14 (21%) | 0/32 (0%) 0/11 (0%) 0/16 (0%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | 710 702 738 857 (T) | 865 --- --- 894 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.271 P=0.128 P=0.534 P=0.303 | P=0.515 P=0.685N P=0.609N P=0.647 | |INCIDENTAL TUMOR | P=0.248 P=0.173 P=0.593 P=0.291 | P=0.463 P=0.607N P=0.623N P=0.603 | |LOGISTIC REGRESSION | P=0.201 P=0.154 P=0.656 P=0.208 | P=0.506 P=0.667N P=0.630N P=0.641 | |COCHRAN-ARMITAGE | P=0.221 | P=0.461 | |FISHER EXACT | P=0.203 P=0.697 P=0.207 | P=0.667N P=0.673N P=0.557 | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 27/140 (19%) 21/69 (30%) 16/68 (24%) 13/70 (19%) | 5/140 (4%) 2/70 (3%) 1/68 (1%) 4/70 (6%) | |ADJUSTED (b) | 54.7% 85.9% 100.0% 55.4% | 12.4% 18.2% 3.1% 16.9% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 5/20 (25%) 5/7 (71%) 1/1 (100%) 6/14 (43%) | 2/32 (6%) 2/11 (18%) 0/16 (0%) 1/17 (6%) | |FIRST INCIDENCE (DAYS) | 617 655 473 487 | 817 898 (T) 789 750 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.482N P=0.009 ** P=0.002 ** P=0.437N | P=0.426 P=0.631 P=0.316N P=0.447 | |INCIDENTAL TUMOR | P=0.494 P=0.033 * P=0.089 P=0.551N | P=0.357 P=0.623N P=0.311N P=0.376 | |LOGISTIC REGRESSION | P=0.516 P=0.015 * P=0.048 * P=0.575N | P=0.414 P=0.642N P=0.314N P=0.434 | |COCHRAN-ARMITAGE | P=0.445N | P=0.330 | |FISHER EXACT | P=0.053 P=0.296 P=0.530N | P=0.571N P=0.361N P=0.348 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Brain | | Oligodendroglioma, Glioma, or Astrocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/140 (1%) 1/70 (1%) 0/68 (0%) 0/70 (0%) | 1/140 (1%) 0/70 (0%) 0/68 (0%) 0/70 (0%) | |ADJUSTED (b) | 2.3% 2.0% 0.0% 0.0% | 3.1% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/20 (0%) 0/7 (0%) 0/1 (0%) 0/14 (0%) | 1/32 (3%) 0/11 (0%) 0/16 (0%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | 556 564 --- --- | 898 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.215N P=0.707 P=0.461N P=0.413N | P=0.384N P=0.712N P=0.638N P=0.626N | |INCIDENTAL TUMOR | P=0.155N P=0.725 P=0.326N P=0.393N | P=0.384N P=0.712N P=0.638N P=0.626N | |LOGISTIC REGRESSION | P=0.198N P=0.729N P=0.411N P=0.401N | P=0.384N P=0.712N P=0.638N P=0.627N | |COCHRAN-ARMITAGE | P=0.199N | P=0.396N | |FISHER EXACT | P=0.742N P=0.452N P=0.443N | P=0.667N P=0.673N P=0.667N | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/140 (4%) 3/70 (4%) 6/68 (9%) 3/70 (4%) | 10/137 (7%) 6/69 (9%) 5/68 (7%) 7/70 (10%) | |ADJUSTED (b) | 13.4% 20.0% 100.0% 18.4% | 22.6% 23.5% 22.2% 27.0% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/20 (10%) 0/7 (0%) 1/1 (100%) 2/14 (14%) | 5/32 (16%) 0/10 (0%) 3/16 (19%) 2/17 (12%) | |FIRST INCIDENCE (DAYS) | 528 766 526 786 | 579 649 661 628 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.385 P=0.411 P=0.006 ** P=0.622 | P=0.432 P=0.296 P=0.609N P=0.424 | |INCIDENTAL TUMOR | P=0.400 P=0.534 P=0.061 P=0.625 | P=0.395 P=0.470 P=0.587N P=0.427 | |LOGISTIC REGRESSION | P=0.324 P=0.496 P=0.068 P=0.534 | P=0.406 P=0.413 P=0.578N P=0.426 | |COCHRAN-ARMITAGE | P=0.354 | P=0.322 | |FISHER EXACT | P=0.534 P=0.107 P=0.534 | P=0.459 P=0.596 P=0.337 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/140 (1%) 2/70 (3%) 2/68 (3%) 5/70 (7%) | 8/137 (6%) 4/69 (6%) 5/68 (7%) 8/70 (11%) | |ADJUSTED (b) | 1.8% 7.9% 6.0% 18.4% | 16.5% 16.0% 18.8% 29.0% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/20 (0%) 0/7 (0%) 0/1 (0%) 1/14 (7%) | 4/32 (13%) 1/10 (10%) 0/16 (0%) 2/17 (12%) | |FIRST INCIDENCE (DAYS) | 381 467 604 520 | 648 666 767 750 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.028 * P=0.383 P=0.346 P=0.044 * | P=0.149 P=0.490 P=0.487 P=0.173 | |INCIDENTAL TUMOR | P=0.039 * P=0.470 P=0.624 P=0.067 | P=0.103 P=0.590 P=0.519 P=0.141 | |LOGISTIC REGRESSION | P=0.024 * P=0.439 P=0.431 P=0.038 * | P=0.121 P=0.614 P=0.486 P=0.163 | |COCHRAN-ARMITAGE | P=0.025 * | P=0.089 | |FISHER EXACT | P=0.407 P=0.396 P=0.043 * | P=0.629N P=0.443 P=0.126 | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/140 (5%) 5/70 (7%) 7/68 (10%) 8/70 (11%) | 18/137 (13%) 10/69 (14%) 10/68 (15%) 14/70 (20%) | |ADJUSTED (b) | 15.0% 26.3% 100.0% 34.2% | 37.1% 35.8% 36.8% 47.4% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/20 (10%) 0/7 (0%) 1/1 (100%) 3/14 (21%) | 9/32 (28%) 1/10 (10%) 3/16 (19%) 4/17 (24%) | |FIRST INCIDENCE (DAYS) | 381 467 526 520 | 579 649 661 628 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.069 P=0.249 P=0.013 * P=0.108 | P=0.232 P=0.259 P=0.493 P=0.214 | |INCIDENTAL TUMOR | P=0.078 P=0.385 P=0.124 P=0.134 | P=0.166 P=0.449 P=0.535 P=0.189 | |LOGISTIC REGRESSION | P=0.044 * P=0.354 P=0.101 P=0.072 | P=0.184 P=0.433 P=0.517 P=0.202 | |COCHRAN-ARMITAGE | P=0.050 | P=0.121 | |FISHER EXACT | P=0.366 P=0.129 P=0.080 | P=0.472 P=0.457 P=0.139 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Intestine Small: Site Unspecified | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/140 (0%) 0/70 (0%) 1/68 (1%) 0/70 (0%) | 0/140 (0%) 0/70 (0%) 2/68 (3%) 0/70 (0%) | |ADJUSTED (b) | 0.0% 0.0% 2.2% 0.0% | 0.0% 0.0% 9.1% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/20 (0%) 0/7 (0%) 0/1 (0%) 0/14 (0%) | 0/32 (0%) 0/11 (0%) 1/16 (6%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 578 --- | --- --- 788 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.597 (e) P=0.328 (e) | P=0.492 (e) P=0.107 (e) | |INCIDENTAL TUMOR | P=0.668 (e) P=0.500 (e) | P=0.475 (e) P=0.112 (e) | |LOGISTIC REGRESSION | P=0.606 (e) P=0.362 (e) | P=0.488 (e) P=0.108 (e) | |COCHRAN-ARMITAGE | P=0.604 | P=0.461 | |FISHER EXACT | (e) P=0.327 (e) | (e) P=0.106 (e) | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/140 (5%) 2/69 (3%) 1/68 (1%) 3/70 (4%) | 3/140 (2%) 1/69 (1%) 3/67 (4%) 2/69 (3%) | |ADJUSTED (b) | 19.1% 7.6% 5.3% 15.9% | 7.0% 1.8% 14.4% 9.8% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/20 (10%) 0/7 (0%) 0/1 (0%) 1/14 (7%) | 1/32 (3%) 0/11 (0%) 1/16 (6%) 1/17 (6%) | |FIRST INCIDENCE (DAYS) | 667 697 744 708 | 661 537 816 869 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.424N P=0.502N P=0.534N P=0.489N | P=0.457 P=0.621N P=0.359 P=0.619 | |INCIDENTAL TUMOR | P=0.481N P=0.392N P=0.352N P=0.584N | P=0.333 P=0.579N P=0.353 P=0.577 | |LOGISTIC REGRESSION | P=0.455N P=0.434N P=0.320N P=0.567N | P=0.410 P=0.582N P=0.339 P=0.604 | |COCHRAN-ARMITAGE | P=0.413N | P=0.367 | |FISHER EXACT | P=0.381N P=0.200N P=0.559N | P=0.598N P=0.299 P=0.534 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/140 (6%) 2/69 (3%) 1/68 (1%) 3/70 (4%) | 3/140 (2%) 1/69 (1%) 4/67 (6%) 2/69 (3%) | |ADJUSTED (b) | 23.6% 7.6% 5.3% 15.9% | 7.0% 1.8% 20.1% 9.8% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 3/20 (15%) 0/7 (0%) 0/1 (0%) 1/14 (7%) | 1/32 (3%) 0/11 (0%) 2/16 (13%) 1/17 (6%) | |FIRST INCIDENCE (DAYS) | 667 697 744 708 | 661 537 816 869 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.330N P=0.428N P=0.515N P=0.386N | P=0.415 P=0.621N P=0.192 P=0.619 | |INCIDENTAL TUMOR | P=0.374N P=0.328N P=0.339N P=0.471N | P=0.300 P=0.579N P=0.186 P=0.577 | |LOGISTIC REGRESSION | P=0.364N P=0.363N P=0.277N P=0.476N | P=0.374 P=0.582N P=0.178 P=0.604 | |COCHRAN-ARMITAGE | P=0.320N | P=0.325 | |FISHER EXACT | P=0.301N P=0.146N P=0.470N | P=0.598N P=0.155 P=0.534 | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/140 (1%) 0/70 (0%) 1/68 (1%) 1/70 (1%) | 1/140 (1%) 0/70 (0%) 0/67 (0%) 0/70 (0%) | |ADJUSTED (b) | 2.6% 0.0% 9.1% 5.3% | 3.1% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/20 (0%) 0/7 (0%) 0/1 (0%) 0/14 (0%) | 1/32 (3%) 0/11 (0%) 0/16 (0%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | 694 --- 786 806 | 898 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.537 P=0.432N P=0.613 P=0.713 | P=0.384N P=0.712N P=0.638N P=0.626N | |INCIDENTAL TUMOR | P=0.505 P=0.392N P=0.702 P=0.671 | P=0.384N P=0.712N P=0.638N P=0.626N | |LOGISTIC REGRESSION | P=0.561 P=0.410N P=0.691 P=0.727 | P=0.383N P=0.712N P=0.638N P=0.627N | |COCHRAN-ARMITAGE | P=0.578 | P=0.396N | |FISHER EXACT | P=0.443N P=0.697 P=0.742N | P=0.667N P=0.676N P=0.667N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/140 (4%) 4/70 (6%) 0/68 (0%) 3/70 (4%) | 0/140 (0%) 1/70 (1%) 2/68 (3%) 2/70 (3%) | |ADJUSTED (b) | 11.3% 23.7% 0.0% 12.7% | 0.0% 2.4% 10.5% 7.5% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/20 (5%) 1/7 (14%) 0/1 (0%) 1/14 (7%) | 0/32 (0%) 0/11 (0%) 1/16 (6%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | 642 697 --- 708 | --- 697 883 831 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.522N P=0.245 P=0.287N P=0.572 | P=0.101 P=0.348 P=0.125 P=0.151 | |INCIDENTAL TUMOR | P=0.549N P=0.328 P=0.157N P=0.539 | P=0.068 P=0.393 P=0.112 P=0.107 | |LOGISTIC REGRESSION | P=0.550N P=0.303 P=0.175N P=0.536 | P=0.083 P=0.361 P=0.117 P=0.125 | |COCHRAN-ARMITAGE | P=0.519N | P=0.066 | |FISHER EXACT | P=0.348 P=0.135N P=0.534 | P=0.333 P=0.106 P=0.110 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/140 (0%) 0/70 (0%) 0/68 (0%) 2/70 (3%) | 0/140 (0%) 0/70 (0%) 0/68 (0%) 0/70 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 9.5% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/20 (0%) 0/7 (0%) 0/1 (0%) 0/14 (0%) | 0/32 (0%) 0/11 (0%) 0/16 (0%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 767 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.029 * (e) (e) P=0.101 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.013 * (e) (e) P=0.069 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.025 * (e) (e) P=0.099 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.023 * | (e) | |FISHER EXACT | (e) (e) P=0.110 | (e) (e) (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/140 (4%) 4/70 (6%) 0/68 (0%) 5/70 (7%) | 0/140 (0%) 1/70 (1%) 2/68 (3%) 2/70 (3%) | |ADJUSTED (b) | 11.3% 23.7% 0.0% 21.0% | 0.0% 2.4% 10.5% 7.5% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/20 (5%) 1/7 (14%) 0/1 (0%) 1/14 (7%) | 0/32 (0%) 0/11 (0%) 1/16 (6%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | 642 697 --- 708 | --- 697 883 831 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.272 P=0.245 P=0.287N P=0.228 | P=0.101 P=0.348 P=0.125 P=0.151 | |INCIDENTAL TUMOR | P=0.228 P=0.328 P=0.157N P=0.179 | P=0.068 P=0.393 P=0.112 P=0.107 | |LOGISTIC REGRESSION | P=0.239 P=0.303 P=0.175N P=0.196 | P=0.083 P=0.361 P=0.117 P=0.125 | |COCHRAN-ARMITAGE | P=0.265 | P=0.066 | |FISHER EXACT | P=0.348 P=0.135N P=0.208 | P=0.333 P=0.106 P=0.110 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/140 (4%) 4/70 (6%) 0/68 (0%) 5/70 (7%) | 0/140 (0%) 1/70 (1%) 2/68 (3%) 2/70 (3%) | |ADJUSTED (b) | 11.3% 23.7% 0.0% 21.0% | 0.0% 2.4% 10.5% 7.5% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/20 (5%) 1/7 (14%) 0/1 (0%) 1/14 (7%) | 0/32 (0%) 0/11 (0%) 1/16 (6%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | 642 697 --- 708 | --- 697 883 831 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.272 P=0.245 P=0.287N P=0.228 | P=0.101 P=0.348 P=0.125 P=0.151 | |INCIDENTAL TUMOR | P=0.228 P=0.328 P=0.157N P=0.179 | P=0.068 P=0.393 P=0.112 P=0.107 | |LOGISTIC REGRESSION | P=0.239 P=0.303 P=0.175N P=0.196 | P=0.083 P=0.361 P=0.117 P=0.125 | |COCHRAN-ARMITAGE | P=0.265 | P=0.066 | |FISHER EXACT | P=0.348 P=0.135N P=0.208 | P=0.333 P=0.106 P=0.110 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/140 (4%) 2/70 (3%) 1/68 (1%) 1/70 (1%) | 2/140 (1%) 2/70 (3%) 1/68 (1%) 1/70 (1%) | |ADJUSTED (b) | 10.4% 8.2% 2.4% 4.3% | 4.8% 18.2% 4.5% 5.9% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/20 (5%) 0/7 (0%) 0/1 (0%) 0/14 (0%) | 1/32 (3%) 2/11 (18%) 0/16 (0%) 1/17 (6%) | |FIRST INCIDENCE (DAYS) | 618 708 604 773 | 802 898 (T) 883 898 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.243N P=0.649N P=0.566N P=0.327N | P=0.509N P=0.312 P=0.711N P=0.701N | |INCIDENTAL TUMOR | P=0.221N P=0.569N P=0.332N P=0.350N | P=0.538N P=0.340 P=0.715N P=0.717N | |LOGISTIC REGRESSION | P=0.226N P=0.590N P=0.385N P=0.339N | P=0.489N P=0.365 P=0.720N P=0.689N | |COCHRAN-ARMITAGE | P=0.211N | P=0.568N | |FISHER EXACT | P=0.571N P=0.361N P=0.348N | P=0.407 P=0.697 P=0.742N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/140 (2%) 0/70 (0%) 0/68 (0%) 1/70 (1%) | 0/140 (0%) 1/70 (1%) 0/68 (0%) 0/70 (0%) | |ADJUSTED (b) | 12.6% 0.0% 0.0% 7.1% | 0.0% 4.5% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/20 (10%) 0/7 (0%) 0/1 (0%) 1/14 (7%) | 0/32 (0%) 0/11 (0%) 0/16 (0%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | 814 --- --- 857 (T) | --- 831 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.397N P=0.355N P=0.709N P=0.483N | P=0.609N P=0.340 (e) (e) | |INCIDENTAL TUMOR | P=0.394N P=0.320N P=0.571N P=0.493N | P=0.658N P=0.393 (e) (e) | |LOGISTIC REGRESSION | P=0.428N P=0.342N P=0.499N P=0.543N | P=0.639N P=0.346 (e) (e) | |COCHRAN-ARMITAGE | P=0.422N | P=0.656N | |FISHER EXACT | P=0.294N P=0.303N P=0.593N | P=0.333 (e) (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/140 (6%) 2/70 (3%) 1/68 (1%) 2/70 (3%) | 2/140 (1%) 3/70 (4%) 1/68 (1%) 1/70 (1%) | |ADJUSTED (b) | 22.2% 8.2% 2.4% 11.2% | 4.8% 21.9% 4.5% 5.9% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 3/20 (15%) 0/7 (0%) 0/1 (0%) 1/14 (7%) | 1/32 (3%) 2/11 (18%) 0/16 (0%) 1/17 (6%) | |FIRST INCIDENCE (DAYS) | 618 708 604 773 | 802 831 883 898 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.185N P=0.410N P=0.471N P=0.237N | P=0.454N P=0.128 P=0.711N P=0.701N | |INCIDENTAL TUMOR | P=0.167N P=0.325N P=0.234N P=0.256N | P=0.495N P=0.161 P=0.715N P=0.717N | |LOGISTIC REGRESSION | P=0.192N P=0.341N P=0.216N P=0.297N | P=0.447N P=0.161 P=0.720N P=0.689N | |COCHRAN-ARMITAGE | P=0.166N | P=0.523N | |FISHER EXACT | P=0.293N P=0.146N P=0.293N | P=0.207 P=0.697 P=0.742N | |=================================================================================================================================| | | |Mammary Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/140 (1%) 0/70 (0%) 1/68 (1%) 0/70 (0%) | 6/140 (4%) 0/70 (0%) 1/68 (1%) 2/70 (3%) | |ADJUSTED (b) | 4.4% 0.0% 25.0% 0.0% | 9.2% 0.0% 2.9% 8.6% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/20 (0%) 0/7 (0%) 0/1 (0%) 0/14 (0%) | 1/32 (3%) 0/11 (0%) 0/16 (0%) 1/17 (6%) | |FIRST INCIDENCE (DAYS) | 668 --- 852 --- | 613 --- 774 807 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.340N P=0.451N P=0.541 P=0.417N | P=0.315N P=0.112N P=0.246N P=0.397N | |INCIDENTAL TUMOR | P=0.376N P=0.392N P=0.702 P=0.462N | P=0.300N P=0.080N P=0.254N P=0.357N | |LOGISTIC REGRESSION | P=0.346N P=0.423N P=0.637 P=0.407N | P=0.344N P=0.095N P=0.254N P=0.429N | |COCHRAN-ARMITAGE | P=0.323N | P=0.362N | |FISHER EXACT | P=0.443N P=0.697 P=0.443N | P=0.085N P=0.271N P=0.466N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/140 (0%) 0/70 (0%) 0/68 (0%) 0/70 (0%) | 9/140 (6%) 6/70 (9%) 2/68 (3%) 4/70 (6%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 13.1% 35.4% 10.8% 10.5% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/20 (0%) 0/7 (0%) 0/1 (0%) 0/14 (0%) | 1/32 (3%) 3/11 (27%) 0/16 (0%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 540 640 890 690 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.284N P=0.279 P=0.217N P=0.466N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.344N P=0.401 P=0.235N P=0.555N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.323N P=0.369 P=0.224N P=0.516N | |COCHRAN-ARMITAGE | (e) | P=0.363N | |FISHER EXACT | (e) (e) (e) | P=0.379 P=0.241N P=0.552N | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/140 (1%) 0/70 (0%) 1/68 (1%) 0/70 (0%) | 14/140 (10%) 6/70 (9%) 3/68 (4%) 6/70 (9%) | |ADJUSTED (b) | 4.4% 0.0% 25.0% 0.0% | 20.3% 35.4% 13.4% 18.2% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/20 (0%) 0/7 (0%) 0/1 (0%) 0/14 (0%) | 2/32 (6%) 3/11 (27%) 0/16 (0%) 1/17 (6%) | |FIRST INCIDENCE (DAYS) | 668 --- 852 --- | 540 640 774 690 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.340N P=0.451N P=0.541 P=0.417N | P=0.240N P=0.596N P=0.125N P=0.379N | |INCIDENTAL TUMOR | P=0.376N P=0.392N P=0.702 P=0.462N | P=0.287N P=0.441N P=0.126N P=0.441N | |LOGISTIC REGRESSION | P=0.346N P=0.423N P=0.637 P=0.407N | P=0.281N P=0.485N P=0.124N P=0.471N | |COCHRAN-ARMITAGE | P=0.323N | P=0.325N | |FISHER EXACT | P=0.443N P=0.697 P=0.443N | P=0.476N P=0.132N P=0.476N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 16/140 (11%) 4/70 (6%) 4/68 (6%) 7/70 (10%) | 66/140 (47%) 33/70 (47%) 34/68 (50%) 27/70 (39%) | |ADJUSTED (b) | 51.9% 40.7% 24.8% 40.2% | 82.1% 96.6% 86.0% 74.4% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 8/20 (40%) 2/7 (29%) 0/1 (0%) 5/14 (36%) | 20/32 (63%) 10/11 (91%) 11/16 (69%) 9/17 (53%) | |FIRST INCIDENCE (DAYS) | 381 786 619 708 | 418 537 600 596 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.316N P=0.317N P=0.348 P=0.276N | P=0.061N P=0.196 P=0.541 P=0.082N | |INCIDENTAL TUMOR | P=0.345N P=0.199N P=0.514N P=0.342N | P=0.062N P=0.557N P=0.522 P=0.054N | |LOGISTIC REGRESSION | P=0.450N P=0.271N P=0.399N P=0.474N | P=0.050N* P=0.498 P=0.485 P=0.062N | |COCHRAN-ARMITAGE | P=0.387N | P=0.167N | |FISHER EXACT | P=0.139N P=0.153N P=0.477N | P=0.559N P=0.405 P=0.151N | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 18/140 (13%) 4/70 (6%) 5/68 (7%) 7/70 (10%) | 70/140 (50%) 33/70 (47%) 34/68 (50%) 27/70 (39%) | |ADJUSTED (b) | 54.0% 40.7% 43.6% 40.2% | 84.1% 96.6% 86.0% 74.4% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 8/20 (40%) 2/7 (29%) 0/1 (0%) 5/14 (36%) | 21/32 (66%) 10/11 (91%) 11/16 (69%) 9/17 (53%) | |FIRST INCIDENCE (DAYS) | 381 786 619 708 | 418 537 600 596 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.243N P=0.226N P=0.267 P=0.194N | P=0.031N* P=0.296 P=0.428N P=0.045N* | |INCIDENTAL TUMOR | P=0.274N P=0.124N P=0.531N P=0.254N | P=0.021N* P=0.378N P=0.444N P=0.016N* | |LOGISTIC REGRESSION | P=0.354N P=0.177N P=0.455N P=0.356N | P=0.018N* P=0.449N P=0.476N P=0.025N* | |COCHRAN-ARMITAGE | P=0.295N | P=0.087N | |FISHER EXACT | P=0.084N P=0.171N P=0.360N | P=0.404N P=0.559N P=0.078N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 18/140 (13%) 4/70 (6%) 5/68 (7%) 7/70 (10%) | 74/140 (53%) 34/70 (49%) 34/68 (50%) 30/70 (43%) | |ADJUSTED (b) | 54.0% 40.7% 43.6% 40.2% | 84.9% 96.6% 86.0% 76.3% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 8/20 (40%) 2/7 (29%) 0/1 (0%) 5/14 (36%) | 21/32 (66%) 10/11 (91%) 11/16 (69%) 9/17 (53%) | |FIRST INCIDENCE (DAYS) | 381 786 619 708 | 418 537 600 596 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.243N P=0.226N P=0.267 P=0.194N | P=0.042N* P=0.352 P=0.315N P=0.067N | |INCIDENTAL TUMOR | P=0.274N P=0.124N P=0.531N P=0.254N | P=0.030N* P=0.280N P=0.290N P=0.030N* | |LOGISTIC REGRESSION | P=0.354N P=0.177N P=0.455N P=0.356N | P=0.026N* P=0.352N P=0.308N P=0.040N* | |COCHRAN-ARMITAGE | P=0.295N | P=0.109N | |FISHER EXACT | P=0.084N P=0.171N P=0.360N | P=0.330N P=0.405N P=0.111N | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Papilloma Squamous or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/140 (0%) 1/70 (1%) 0/68 (0%) 2/70 (3%) | 1/140 (1%) 1/70 (1%) 1/68 (1%) 0/70 (0%) | |ADJUSTED (b) | 0.0% 4.8% 0.0% 9.3% | 3.1% 6.7% 6.3% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/20 (0%) 0/7 (0%) 0/1 (0%) 1/14 (7%) | 1/32 (3%) 0/11 (0%) 1/16 (6%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | --- 745 --- 647 | 898 (T) 873 898 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.089 P=0.295 (e) P=0.125 | P=0.430N P=0.528 P=0.600 P=0.626N | |INCIDENTAL TUMOR | P=0.072 P=0.369 (e) P=0.113 | P=0.451N P=0.576 P=0.600 P=0.626N | |LOGISTIC REGRESSION | P=0.069 P=0.344 (e) P=0.100 | P=0.410N P=0.552 P=0.600 P=0.627N | |COCHRAN-ARMITAGE | P=0.070 | P=0.471N | |FISHER EXACT | P=0.333 (e) P=0.110 | P=0.557 P=0.548 P=0.667N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/140 (2%) 1/70 (1%) 2/68 (3%) 0/70 (0%) | 0/140 (0%) 0/70 (0%) 2/68 (3%) 0/70 (0%) | |ADJUSTED (b) | 4.4% 1.7% 7.2% 0.0% | 0.0% 0.0% 3.6% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/20 (0%) 0/7 (0%) 0/1 (0%) 0/14 (0%) | 0/32 (0%) 0/11 (0%) 0/16 (0%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | 489 289 619 --- | --- --- 425 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.284N P=0.629N P=0.419 P=0.285N | P=0.474 (e) P=0.109 (e) | |INCIDENTAL TUMOR | P=0.258N P=0.246N P=0.654 P=0.271N | P=0.389 (e) P=0.037 * (e) | |LOGISTIC REGRESSION | P=0.255N P=0.562N P=0.534 P=0.270N | P=0.452 (e) P=0.098 (e) | |COCHRAN-ARMITAGE | P=0.257N | P=0.461 | |FISHER EXACT | P=0.593N P=0.528 P=0.294N | (e) P=0.106 (e) | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/140 (2%) 2/70 (3%) 2/68 (3%) 2/70 (3%) | 1/140 (1%) 1/70 (1%) 3/68 (4%) 0/70 (0%) | |ADJUSTED (b) | 4.4% 6.3% 7.2% 9.3% | 3.1% 6.7% 9.6% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/20 (0%) 0/7 (0%) 0/1 (0%) 1/14 (7%) | 1/32 (3%) 0/11 (0%) 1/16 (6%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | 489 289 619 647 | 898 (T) 873 425 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.446 P=0.485 P=0.419 P=0.569 | P=0.576N P=0.528 P=0.109 P=0.626N | |INCIDENTAL TUMOR | P=0.419 P=0.538N P=0.654 P=0.569 | P=0.593 P=0.576 P=0.059 P=0.626N | |LOGISTIC REGRESSION | P=0.458 P=0.568 P=0.534 P=0.559 | P=0.610N P=0.552 P=0.101 P=0.627N | |COCHRAN-ARMITAGE | P=0.461 | P=0.616 | |FISHER EXACT | P=0.541 P=0.528 P=0.541 | P=0.557 P=0.103 P=0.667N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Oral Mucosa | | Squamous Cell Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/140 (1%) 1/70 (1%) 2/68 (3%) 0/70 (0%) | 0/140 (0%) 0/70 (0%) 1/68 (1%) 0/70 (0%) | |ADJUSTED (b) | 0.8% 1.7% 7.2% 0.0% | 0.0% 0.0% 1.8% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/20 (0%) 0/7 (0%) 0/1 (0%) 0/14 (0%) | 0/32 (0%) 0/11 (0%) 0/16 (0%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | 489 289 619 --- | --- --- 425 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.563N P=0.592 P=0.197 P=0.645N | P=0.612 (e) P=0.364 (e) | |INCIDENTAL TUMOR | P=0.569N P=0.594N P=0.409 P=0.557N | P=0.395 (e) P=0.186 (e) | |LOGISTIC REGRESSION | P=0.550N P=0.614 P=0.262 P=0.636N | P=0.597 (e) P=0.353 (e) | |COCHRAN-ARMITAGE | P=0.555N | P=0.604 | |FISHER EXACT | P=0.557 P=0.250 P=0.667N | (e) P=0.327 (e) | |=================================================================================================================================| | | |Ovary | | Granulosa Cell Tumor: Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 1/140 (1%) 2/70 (3%) 0/67 (0%) 1/70 (1%) | |ADJUSTED (b) | | 2.7% 6.1% 0.0% 5.9% | |INTERIM SACRIFICE 1 (c)| | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | | 0/32 (0%) 0/11 (0%) 0/16 (0%) 1/17 (6%) | |FIRST INCIDENCE (DAYS) | | 879 683 --- 898 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.619 P=0.227 P=0.604N P=0.632 | |INCIDENTAL TUMOR | | P=0.589 P=0.317 P=0.623N P=0.608 | |LOGISTIC REGRESSION | | P=0.602 P=0.259 P=0.626N P=0.647 | |COCHRAN-ARMITAGE | | P=0.577 | |FISHER EXACT | | P=0.258 P=0.676N P=0.557 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Pancreas | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/140 (2%) 0/69 (0%) 1/68 (1%) 0/70 (0%) | 0/140 (0%) 0/70 (0%) 0/67 (0%) 0/69 (0%) | |ADJUSTED (b) | 15.0% 0.0% 25.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 3/20 (15%) 0/7 (0%) 0/1 (0%) 0/14 (0%) | 0/32 (0%) 0/11 (0%) 0/16 (0%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | 857 (T) --- 852 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.181N P=0.352N P=0.349 P=0.187N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.193N P=0.352N P=0.465 P=0.187N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.183N P=0.352N P=0.484 P=0.187N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.193N | (e) | |FISHER EXACT | P=0.298N P=0.604N P=0.294N | (e) (e) (e) | |=================================================================================================================================| | | |Parathyroid Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/131 (0%) 0/64 (0%) 0/65 (0%) 0/66 (0%) | 3/126 (2%) 0/65 (0%) 0/63 (0%) 1/62 (2%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 6.6% 0.0% 0.0% 6.3% | |INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | |TERMINAL (d) | 0/19 (0%) 0/7 (0%) 0/1 (0%) 0/13 (0%) | 1/27 (4%) 0/9 (0%) 0/16 (0%) 1/16 (6%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 785 --- --- 898 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.367N P=0.314N P=0.259N P=0.510N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.387N P=0.267N P=0.251N P=0.538N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.378N P=0.284N P=0.253N P=0.523N | |COCHRAN-ARMITAGE | (e) | P=0.425N | |FISHER EXACT | (e) (e) (e) | P=0.285N P=0.294N P=0.599N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 38/139 (27%) 16/68 (24%) 17/66 (26%) 6/70 (9%) | 57/139 (41%) 27/70 (39%) 34/67 (51%) 28/70 (40%) | |ADJUSTED (b) | 68.0% 80.0% 100.0% 30.2% | 74.3% 75.2% 90.7% 69.8% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 9/20 (45%) 4/6 (67%) 1/1 (100%) 3/14 (21%) | 15/32 (47%) 5/11 (45%) 13/16 (81%) 7/17 (41%) | |FIRST INCIDENCE (DAYS) | 528 562 562 668 | 523 480 600 501 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.008N** P=0.431 P=0.034 * P=0.002N** | P=0.313N P=0.353 P=0.270 P=0.297N | |INCIDENTAL TUMOR | P=0.003N** P=0.426N P=0.421 P=0.001N** | P=0.504N P=0.342N P=0.161 P=0.372N | |LOGISTIC REGRESSION | P=0.003N** P=0.484N P=0.415 P=0.001N** | P=0.443N P=0.460N P=0.152 P=0.360N | |COCHRAN-ARMITAGE | P=0.002N** | P=0.449 | |FISHER EXACT | P=0.341N P=0.476N P<0.001N** | P=0.426N P=0.121 P=0.505N | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/139 (1%) 1/68 (1%) 1/66 (2%) 1/70 (1%) | 4/139 (3%) 1/70 (1%) 1/67 (1%) 3/70 (4%) | |ADJUSTED (b) | 4.3% 5.6% 4.2% 2.1% | 6.4% 9.1% 6.3% 10.1% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/20 (0%) 0/6 (0%) 0/1 (0%) 0/14 (0%) | 1/32 (3%) 1/11 (9%) 1/16 (6%) 1/17 (6%) | |FIRST INCIDENCE (DAYS) | 841 766 725 627 | 540 898 (T) 898 (T) 666 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.449 P=0.537 P=0.465 P=0.617 | P=0.417 P=0.515N P=0.431N P=0.476 | |INCIDENTAL TUMOR | P=0.421 P=0.612 P=0.572 P=0.608 | P=0.340 P=0.465N P=0.484N P=0.382 | |LOGISTIC REGRESSION | P=0.435 P=0.538 P=0.503 P=0.596 | P=0.403 P=0.440N P=0.441N P=0.467 | |COCHRAN-ARMITAGE | P=0.447 | P=0.376 | |FISHER EXACT | P=0.550 P=0.541 P=0.559 | P=0.456N P=0.476N P=0.433 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 39/139 (28%) 17/68 (25%) 18/66 (27%) 7/70 (10%) | 61/139 (44%) 28/70 (40%) 35/67 (52%) 31/70 (44%) | |ADJUSTED (b) | 69.4% 81.1% 100.0% 31.6% | 76.7% 79.3% 93.8% 74.0% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 9/20 (45%) 4/6 (67%) 1/1 (100%) 3/14 (21%) | 16/32 (50%) 6/11 (55%) 14/16 (88%) 8/17 (47%) | |FIRST INCIDENCE (DAYS) | 528 562 562 627 | 523 480 600 501 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.013N* P=0.378 P=0.024 * P=0.003N** | P=0.357N P=0.399 P=0.330 P=0.351N | |INCIDENTAL TUMOR | P=0.005N** P=0.470N P=0.368 P=0.002N** | P=0.471 P=0.276N P=0.207 P=0.479N | |LOGISTIC REGRESSION | P=0.005N** P=0.543N P=0.352 P=0.002N** | P=0.513N P=0.373N P=0.207 P=0.438N | |COCHRAN-ARMITAGE | P=0.004N** | P=0.382 | |FISHER EXACT | P=0.386N P=0.523N P=0.002N** | P=0.350N P=0.164 P=0.536 | |=================================================================================================================================| | | |Prostate | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/140 (4%) 2/70 (3%) 1/68 (1%) 1/70 (1%) | | |ADJUSTED (b) | 21.1% 16.0% 5.6% 7.1% | | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | | |TERMINAL (d) | 4/20 (20%) 1/7 (14%) 0/1 (0%) 1/14 (7%) | | |FIRST INCIDENCE (DAYS) | 712 619 757 857 (T) | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.190N P=0.646 P=0.603 P=0.219N | | |INCIDENTAL TUMOR | P=0.177N P=0.658 P=0.655 P=0.228N | | |LOGISTIC REGRESSION | P=0.246N P=0.661N P=0.595N P=0.318N | | |COCHRAN-ARMITAGE | P=0.211N | | |FISHER EXACT | P=0.571N P=0.361N P=0.348N | | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Skin | | Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign, | | malignant or NOS), or Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/140 (3%) 1/70 (1%) 0/68 (0%) 1/70 (1%) | 1/140 (1%) 1/70 (1%) 0/68 (0%) 0/70 (0%) | |ADJUSTED (b) | 11.0% 6.3% 0.0% 2.0% | 1.0% 4.2% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/20 (5%) 0/7 (0%) 0/1 (0%) 0/14 (0%) | 0/32 (0%) 0/11 (0%) 0/16 (0%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | 759 773 --- 626 | 640 807 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.279N P=0.570N P=0.388N P=0.414N | P=0.331N P=0.581 P=0.630N P=0.630N | |INCIDENTAL TUMOR | P=0.271N P=0.451N P=0.285N P=0.441N | P=0.305N P=0.639 P=0.682N P=0.521N | |LOGISTIC REGRESSION | P=0.280N P=0.508N P=0.287N P=0.448N | P=0.350N P=0.598 P=0.645N P=0.641N | |COCHRAN-ARMITAGE | P=0.257N | P=0.354N | |FISHER EXACT | P=0.459N P=0.202N P=0.459N | P=0.557 P=0.673N P=0.667N | |=================================================================================================================================| | | |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) | 11/140 (8%) 7/70 (10%) 4/68 (6%) 7/70 (10%) | 2/140 (1%) 1/70 (1%) 1/68 (1%) 2/70 (3%) | |ADJUSTED (b) | 32.4% 45.6% 44.8% 25.7% | 4.1% 4.2% 2.3% 9.4% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 5/20 (25%) 2/7 (29%) 0/1 (0%) 2/14 (14%) | 1/32 (3%) 0/11 (0%) 0/16 (0%) 1/17 (6%) | |FIRST INCIDENCE (DAYS) | 667 634 535 626 | 640 807 703 856 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.447 P=0.192 P=0.230 P=0.490 | P=0.376 P=0.689 P=0.728N P=0.465 | |INCIDENTAL TUMOR | P=0.413 P=0.302 P=0.499 P=0.412 | P=0.380 P=0.731 P=0.719 P=0.502 | |LOGISTIC REGRESSION | P=0.365 P=0.267 P=0.587 P=0.368 | P=0.354 P=0.726 P=0.728 P=0.460 | |COCHRAN-ARMITAGE | P=0.423 | P=0.328 | |FISHER EXACT | P=0.388 P=0.420N P=0.388 | P=0.742N P=0.697 P=0.407 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Skin | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 11/140 (8%) 8/70 (11%) 6/68 (9%) 6/70 (9%) | 5/140 (4%) 3/70 (4%) 1/68 (1%) 1/70 (1%) | |ADJUSTED (b) | 32.1% 61.8% 26.7% 26.7% | 9.3% 13.5% 3.6% 4.2% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 4/20 (20%) 4/7 (57%) 0/1 (0%) 2/14 (14%) | 2/32 (6%) 1/11 (9%) 0/16 (0%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | 577 619 619 642 | 540 498 816 869 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.533 P=0.110 P=0.065 P=0.591N | P=0.167N P=0.461 P=0.328N P=0.298N | |INCIDENTAL TUMOR | P=0.540N P=0.177 P=0.371 P=0.564 | P=0.261N P=0.513 P=0.365N P=0.393N | |LOGISTIC REGRESSION | P=0.456 P=0.165 P=0.329 P=0.508 | P=0.185N P=0.545 P=0.334N P=0.313N | |COCHRAN-ARMITAGE | P=0.515 | P=0.198N | |FISHER EXACT | P=0.271 P=0.502 P=0.525 | P=0.534 P=0.361N P=0.348N | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 14/140 (10%) 9/70 (13%) 7/68 (10%) 7/70 (10%) | 7/140 (5%) 3/70 (4%) 2/68 (3%) 3/70 (4%) | |ADJUSTED (b) | 40.3% 63.3% 28.2% 29.3% | 12.3% 13.5% 6.6% 15.4% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 5/20 (25%) 4/7 (57%) 0/1 (0%) 2/14 (14%) | 2/32 (6%) 1/11 (9%) 0/16 (0%) 2/17 (12%) | |FIRST INCIDENCE (DAYS) | 577 619 562 642 | 540 498 789 869 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.491N P=0.150 P=0.068 P=0.497N | P=0.363N P=0.636N P=0.351N P=0.492N | |INCIDENTAL TUMOR | P=0.480N P=0.239 P=0.416 P=0.589N | P=0.502N P=0.561N P=0.376N P=0.594N | |LOGISTIC REGRESSION | P=0.515 P=0.209 P=0.370 P=0.568 | P=0.402N P=0.553N P=0.363N P=0.511N | |COCHRAN-ARMITAGE | P=0.515N | P=0.434N | |FISHER EXACT | P=0.342 P=0.562 P=0.604N | P=0.559N P=0.389N P=0.559N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Skin | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/140 (3%) 1/70 (1%) 1/68 (1%) 1/70 (1%) | 1/140 (1%) 0/70 (0%) 1/68 (1%) 1/70 (1%) | |ADJUSTED (b) | 11.9% 3.8% 2.0% 3.6% | 2.3% 0.0% 3.1% 5.9% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/20 (5%) 0/7 (0%) 0/1 (0%) 0/14 (0%) | 0/32 (0%) 0/11 (0%) 0/16 (0%) 1/17 (6%) | |FIRST INCIDENCE (DAYS) | 673 730 562 745 | 856 --- 789 898 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.336N P=0.513N P=0.695N P=0.403N | P=0.427 P=0.678N P=0.609 P=0.631 | |INCIDENTAL TUMOR | P=0.352N P=0.451N P=0.514N P=0.487N | P=0.389 P=0.607N P=0.617 P=0.608 | |LOGISTIC REGRESSION | P=0.344N P=0.487N P=0.516N P=0.449N | P=0.413 P=0.663N P=0.603 P=0.640 | |COCHRAN-ARMITAGE | P=0.326N | P=0.377 | |FISHER EXACT | P=0.459N P=0.472N P=0.459N | P=0.667N P=0.548 P=0.557 | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/140 (3%) 1/70 (1%) 1/68 (1%) 1/70 (1%) | 2/140 (1%) 0/70 (0%) 1/68 (1%) 2/70 (3%) | |ADJUSTED (b) | 11.9% 3.8% 2.0% 3.6% | 3.3% 0.0% 3.1% 11.8% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/20 (5%) 0/7 (0%) 0/1 (0%) 0/14 (0%) | 0/32 (0%) 0/11 (0%) 0/16 (0%) 2/17 (12%) | |FIRST INCIDENCE (DAYS) | 673 730 562 745 | 648 --- 789 898 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.336N P=0.513N P=0.695N P=0.403N | P=0.320 P=0.424N P=0.716N P=0.464 | |INCIDENTAL TUMOR | P=0.352N P=0.451N P=0.514N P=0.487N | P=0.288 P=0.363N P=0.709N P=0.444 | |LOGISTIC REGRESSION | P=0.344N P=0.487N P=0.516N P=0.449N | P=0.300 P=0.404N P=0.730 P=0.461 | |COCHRAN-ARMITAGE | P=0.326N | P=0.272 | |FISHER EXACT | P=0.459N P=0.472N P=0.459N | P=0.443N P=0.697 P=0.407 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 22 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Skin | | Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/140 (1%) 0/70 (0%) 0/68 (0%) 0/70 (0%) | 0/140 (0%) 0/70 (0%) 0/68 (0%) 0/70 (0%) | |ADJUSTED (b) | 10.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/20 (10%) 0/7 (0%) 0/1 (0%) 0/14 (0%) | 0/32 (0%) 0/11 (0%) 0/16 (0%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | 857 (T) --- --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.201N P=0.488N P=0.916N P=0.318N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.201N P=0.488N P=0.916N P=0.318N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.201N P=0.488N P=0.916N P=0.318N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.198N | (e) | |FISHER EXACT | P=0.443N P=0.452N P=0.443N | (e) (e) (e) | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 6/140 (4%) 4/70 (6%) 4/68 (6%) 4/70 (6%) | 1/140 (1%) 0/70 (0%) 1/68 (1%) 0/70 (0%) | |ADJUSTED (b) | 18.2% 18.8% 44.8% 15.5% | 3.1% 0.0% 2.3% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 3/20 (15%) 0/7 (0%) 0/1 (0%) 1/14 (7%) | 1/32 (3%) 0/11 (0%) 0/16 (0%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | 667 634 535 647 | 898 (T) --- 703 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.386 P=0.315 P=0.061 P=0.520 | P=0.527N P=0.712N P=0.596 P=0.626N | |INCIDENTAL TUMOR | P=0.351 P=0.402 P=0.209 P=0.452 | P=0.525N P=0.712N P=0.608 P=0.626N | |LOGISTIC REGRESSION | P=0.346 P=0.387 P=0.271 P=0.435 | P=0.523N P=0.712N P=0.600 P=0.627N | |COCHRAN-ARMITAGE | P=0.382 | P=0.539N | |FISHER EXACT | P=0.441 P=0.423 P=0.441 | P=0.667N P=0.548 P=0.667N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 23 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/140 (2%) 2/70 (3%) 0/68 (0%) 2/70 (3%) | 0/140 (0%) 0/70 (0%) 0/68 (0%) 2/70 (3%) | |ADJUSTED (b) | 12.3% 28.6% 0.0% 9.7% | 0.0% 0.0% 0.0% 9.4% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/20 (10%) 2/7 (29%) 0/1 (0%) 1/14 (7%) | 0/32 (0%) 0/11 (0%) 0/16 (0%) 1/17 (6%) | |FIRST INCIDENCE (DAYS) | 795 857 (T) --- 702 | --- --- --- 856 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.555N P=0.407 P=0.675N P=0.640 | P=0.035 * (e) (e) P=0.128 | |INCIDENTAL TUMOR | P=0.569N P=0.449 P=0.571N P=0.612 | P=0.027 * (e) (e) P=0.112 | |LOGISTIC REGRESSION | P=0.550 P=0.430 P=0.475N P=0.557 | P=0.035 * (e) (e) P=0.131 | |COCHRAN-ARMITAGE | P=0.578 | P=0.023 * | |FISHER EXACT | P=0.541 P=0.303N P=0.541 | (e) (e) P=0.110 | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 8/140 (6%) 6/70 (9%) 4/68 (6%) 6/70 (9%) | 1/140 (1%) 0/70 (0%) 1/68 (1%) 2/70 (3%) | |ADJUSTED (b) | 25.0% 42.0% 44.8% 24.2% | 3.1% 0.0% 2.3% 9.4% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 4/20 (20%) 2/7 (29%) 0/1 (0%) 2/14 (14%) | 1/32 (3%) 0/11 (0%) 0/16 (0%) 1/17 (6%) | |FIRST INCIDENCE (DAYS) | 667 634 535 647 | 898 (T) --- 703 856 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.344 P=0.151 P=0.104 P=0.395 | P=0.154 P=0.712N P=0.596 P=0.303 | |INCIDENTAL TUMOR | P=0.305 P=0.224 P=0.310 P=0.317 | P=0.139 P=0.712N P=0.608 P=0.283 | |LOGISTIC REGRESSION | P=0.265 P=0.209 P=0.393 P=0.287 | P=0.150 P=0.712N P=0.600 P=0.324 | |COCHRAN-ARMITAGE | P=0.312 | P=0.126 | |FISHER EXACT | P=0.305 P=0.593 P=0.305 | P=0.667N P=0.548 P=0.258 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 24 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 8/140 (6%) 6/70 (9%) 4/68 (6%) 6/70 (9%) | 1/140 (1%) 0/70 (0%) 1/68 (1%) 2/70 (3%) | |ADJUSTED (b) | 25.0% 42.0% 44.8% 24.2% | 3.1% 0.0% 2.3% 9.4% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 4/20 (20%) 2/7 (29%) 0/1 (0%) 2/14 (14%) | 1/32 (3%) 0/11 (0%) 0/16 (0%) 1/17 (6%) | |FIRST INCIDENCE (DAYS) | 667 634 535 647 | 898 (T) --- 703 856 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.344 P=0.151 P=0.104 P=0.395 | P=0.154 P=0.712N P=0.596 P=0.303 | |INCIDENTAL TUMOR | P=0.305 P=0.224 P=0.310 P=0.317 | P=0.139 P=0.712N P=0.608 P=0.283 | |LOGISTIC REGRESSION | P=0.265 P=0.209 P=0.393 P=0.287 | P=0.150 P=0.712N P=0.600 P=0.324 | |COCHRAN-ARMITAGE | P=0.312 | P=0.126 | |FISHER EXACT | P=0.305 P=0.593 P=0.305 | P=0.667N P=0.548 P=0.258 | |=================================================================================================================================| | | |Skin | | Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/140 (2%) 1/70 (1%) 0/68 (0%) 1/70 (1%) | 0/140 (0%) 0/70 (0%) 0/68 (0%) 0/70 (0%) | |ADJUSTED (b) | 9.2% 6.3% 0.0% 2.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/20 (5%) 0/7 (0%) 0/1 (0%) 0/14 (0%) | 0/32 (0%) 0/11 (0%) 0/16 (0%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | 759 773 --- 626 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.397N P=0.700N P=0.519N P=0.544N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.387N P=0.592N P=0.407N P=0.554N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.407N P=0.645N P=0.397N P=0.582N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.384N | (e) | |FISHER EXACT | P=0.593N P=0.303N P=0.593N | (e) (e) (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 25 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Spleen | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/140 (2%) 1/70 (1%) 0/68 (0%) 0/70 (0%) | 0/140 (0%) 0/70 (0%) 0/67 (0%) 0/70 (0%) | |ADJUSTED (b) | 9.9% 2.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/20 (5%) 0/7 (0%) 0/1 (0%) 0/14 (0%) | 0/32 (0%) 0/11 (0%) 0/16 (0%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | 795 564 --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.142N P=0.686N P=0.573N P=0.255N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.113N P=0.602N P=0.407N P=0.278N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.128N P=0.611N P=0.432N P=0.268N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.115N | (e) | |FISHER EXACT | P=0.593N P=0.303N P=0.294N | (e) (e) (e) | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/140 (1%) 0/70 (0%) 1/68 (1%) 1/70 (1%) | 0/140 (0%) 0/70 (0%) 1/68 (1%) 0/70 (0%) | |ADJUSTED (b) | 5.0% 0.0% 4.3% 2.3% | 0.0% 0.0% 3.6% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/20 (0%) 0/7 (0%) 0/1 (0%) 0/14 (0%) | 0/32 (0%) 0/11 (0%) 0/16 (0%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | 722 --- 729 647 | --- --- 816 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.552 P=0.455N P=0.597 P=0.724 | P=0.632 (e) P=0.369 (e) | |INCIDENTAL TUMOR | P=0.505 P=0.392N P=0.702 P=0.671 | P=0.608 (e) P=0.377 (e) | |LOGISTIC REGRESSION | P=0.564 P=0.435N P=0.665 P=0.727 | P=0.616 (e) P=0.364 (e) | |COCHRAN-ARMITAGE | P=0.578 | P=0.604 | |FISHER EXACT | P=0.443N P=0.697 P=0.742N | (e) P=0.327 (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 26 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) |113/140 (81%) 49/70 (70%) 56/67 (84%) 59/70 (84%) | | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | | |TERMINAL (d) | 20/20 (100%) 7/7 (100%) 1/1 (100%) 14/14 (100%)| | |FIRST INCIDENCE (DAYS) | 489 535 464 487 | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.270 P=0.359 P<0.001 ** P=0.510 | | |INCIDENTAL TUMOR | P=0.031 * P=0.025N* P=0.071 P=0.124 | | |LOGISTIC REGRESSION | P=0.018 * P=0.042N* P=0.047 * P=0.109 | | |COCHRAN-ARMITAGE | P=0.195 | | |FISHER EXACT | P=0.060N P=0.385 P=0.333 | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/140 (7%) 2/70 (3%) 2/68 (3%) 4/70 (6%) | 13/139 (9%) 7/70 (10%) 7/67 (10%) 6/70 (9%) | |ADJUSTED (b) | 25.1% 22.9% 10.9% 17.6% | 30.0% 28.1% 21.8% 24.2% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/20 (10%) 1/7 (14%) 0/1 (0%) 2/14 (14%) | 7/32 (22%) 0/11 (0%) 1/16 (6%) 3/17 (18%) | |FIRST INCIDENCE (DAYS) | 715 831 691 603 | 540 669 649 633 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.365N P=0.317N P=0.558N P=0.399N | P=0.364N P=0.354 P=0.572 P=0.448N | |INCIDENTAL TUMOR | P=0.383N P=0.192N P=0.322N P=0.455N | P=0.469N P=0.510 P=0.537 P=0.517N | |LOGISTIC REGRESSION | P=0.413N P=0.250N P=0.339N P=0.484N | P=0.414N P=0.476 P=0.542 P=0.451N | |COCHRAN-ARMITAGE | P=0.365N | P=0.492N | |FISHER EXACT | P=0.173N P=0.186N P=0.473N | P=0.530 P=0.491 P=0.537N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 27 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/140 (1%) 1/70 (1%) 0/68 (0%) 2/70 (3%) | 3/139 (2%) 0/70 (0%) 2/67 (3%) 1/70 (1%) | |ADJUSTED (b) | 5.0% 2.4% 0.0% 9.7% | 7.5% 0.0% 12.5% 4.5% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/20 (5%) 0/7 (0%) 0/1 (0%) 1/14 (7%) | 2/32 (6%) 0/11 (0%) 2/16 (13%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | 857 (T) 667 --- 702 | 744 --- 898 (T) 888 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.245 P=0.544 P=0.983N P=0.334 | P=0.512N P=0.339N P=0.570 P=0.525N | |INCIDENTAL TUMOR | P=0.229 P=0.562 P=0.983N P=0.314 | P=0.538N P=0.312N P=0.571 P=0.556N | |LOGISTIC REGRESSION | P=0.200 P=0.572 P=0.983N P=0.260 | P=0.499N P=0.291N P=0.584 P=0.523N | |COCHRAN-ARMITAGE | P=0.209 | P=0.566N | |FISHER EXACT | P=0.557 P=0.673N P=0.258 | P=0.292N P=0.524 P=0.590N | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/140 (8%) 3/70 (4%) 2/68 (3%) 6/70 (9%) | 15/139 (11%) 7/70 (10%) 9/67 (13%) 7/70 (10%) | |ADJUSTED (b) | 29.3% 24.7% 10.9% 26.5% | 33.6% 28.1% 32.2% 27.6% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 3/20 (15%) 1/7 (14%) 0/1 (0%) 3/14 (21%) | 8/32 (25%) 0/11 (0%) 3/16 (19%) 3/17 (18%) | |FIRST INCIDENCE (DAYS) | 715 667 691 603 | 540 669 649 633 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.549N P=0.429N P=0.543N P=0.584N | P=0.396N P=0.465 P=0.450 P=0.434N | |INCIDENTAL TUMOR | P=0.528 P=0.282N P=0.312N P=0.564 | P=0.508N P=0.563N P=0.413 P=0.512N | |LOGISTIC REGRESSION | P=0.488 P=0.347N P=0.300N P=0.509 | P=0.446N P=0.593N P=0.420 P=0.441N | |COCHRAN-ARMITAGE | P=0.542 | P=0.538N | |FISHER EXACT | P=0.253N P=0.141N P=0.525 | P=0.533N P=0.367 P=0.533N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 28 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/140 (0%) 0/70 (0%) 0/68 (0%) 3/70 (4%) | 2/139 (1%) 0/70 (0%) 1/67 (1%) 2/70 (3%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 18.8% | 6.3% 0.0% 6.3% 7.8% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/20 (0%) 0/7 (0%) 0/1 (0%) 1/14 (7%) | 2/32 (6%) 0/11 (0%) 1/16 (6%) 1/17 (6%) | |FIRST INCIDENCE (DAYS) | --- --- --- 810 | 898 (T) --- 898 (T) 673 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.011 * (e) (e) P=0.047 * | P=0.306 P=0.492N P=0.734 P=0.451 | |INCIDENTAL TUMOR | P=0.005 ** (e) (e) P=0.028 * | P=0.302 P=0.492N P=0.734 P=0.448 | |LOGISTIC REGRESSION | P=0.006 ** (e) (e) P=0.032 * | P=0.318 P=0.492N P=0.734 P=0.469 | |COCHRAN-ARMITAGE | P=0.004 ** | P=0.274 | |FISHER EXACT | (e) (e) P=0.036 * | P=0.441N P=0.695 P=0.410 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/140 (0%) 1/70 (1%) 1/68 (1%) 3/70 (4%) | 2/139 (1%) 0/70 (0%) 2/67 (3%) 2/70 (3%) | |ADJUSTED (b) | 0.0% 14.3% 12.5% 18.8% | 6.3% 0.0% 10.9% 7.8% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/20 (0%) 1/7 (14%) 0/1 (0%) 1/14 (7%) | 2/32 (6%) 0/11 (0%) 1/16 (6%) 1/17 (6%) | |FIRST INCIDENCE (DAYS) | --- 857 (T) 806 810 | 898 (T) --- 888 673 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.036 * P=0.291 P=0.190 P=0.047 * | P=0.283 P=0.492N P=0.445 P=0.451 | |INCIDENTAL TUMOR | P=0.021 * P=0.291 P=0.337 P=0.028 * | P=0.262 P=0.492N P=0.436 P=0.448 | |LOGISTIC REGRESSION | P=0.021 * P=0.291 P=0.250 P=0.032 * | P=0.287 P=0.492N P=0.471 P=0.469 | |COCHRAN-ARMITAGE | P=0.018 * | P=0.237 | |FISHER EXACT | P=0.333 P=0.327 P=0.036 * | P=0.441N P=0.393 P=0.410 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 29 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Tongue | | Squamous Cell Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/140 (1%) 0/70 (0%) 0/68 (0%) 0/70 (0%) | 0/140 (0%) 0/70 (0%) 1/68 (1%) 0/70 (0%) | |ADJUSTED (b) | 3.5% 0.0% 0.0% 0.0% | 0.0% 0.0% 1.9% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/20 (0%) 0/7 (0%) 0/1 (0%) 0/14 (0%) | 0/32 (0%) 0/11 (0%) 0/16 (0%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | 719 --- --- --- | --- --- 613 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.229N P=0.471N P=0.526N P=0.420N | P=0.614 (e) P=0.368 (e) | |INCIDENTAL TUMOR | P=0.225N P=0.392N P=0.431N P=0.462N | P=0.669 (e) P=0.318 (e) | |LOGISTIC REGRESSION | P=0.211N P=0.422N P=0.457N P=0.407N | P=0.602 (e) P=0.354 (e) | |COCHRAN-ARMITAGE | P=0.198N | P=0.604 | |FISHER EXACT | P=0.443N P=0.452N P=0.443N | (e) P=0.327 (e) | |=================================================================================================================================| | | |Tongue | | Squamous Cell Carcinoma or Papilloma Squamous | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/140 (1%) 0/70 (0%) 0/68 (0%) 2/70 (3%) | 1/140 (1%) 1/70 (1%) 2/68 (3%) 0/70 (0%) | |ADJUSTED (b) | 3.5% 0.0% 0.0% 9.3% | 3.1% 6.7% 8.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/20 (0%) 0/7 (0%) 0/1 (0%) 1/14 (7%) | 1/32 (3%) 0/11 (0%) 1/16 (6%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | 719 --- --- 647 | 898 (T) 873 613 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.321 P=0.471N P=0.526N P=0.439 | P=0.511N P=0.528 P=0.272 P=0.626N | |INCIDENTAL TUMOR | P=0.291 P=0.392N P=0.431N P=0.393 | P=0.494N P=0.576 P=0.247 P=0.626N | |LOGISTIC REGRESSION | P=0.306 P=0.422N P=0.457N P=0.419 | P=0.527N P=0.552 P=0.270 P=0.627N | |COCHRAN-ARMITAGE | P=0.318 | P=0.555N | |FISHER EXACT | P=0.443N P=0.452N P=0.407 | P=0.557 P=0.250 P=0.667N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 30 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Tongue | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/140 (0%) 0/70 (0%) 0/68 (0%) 2/70 (3%) | 1/140 (1%) 1/70 (1%) 1/68 (1%) 0/70 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 9.3% | 3.1% 6.7% 6.3% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/20 (0%) 0/7 (0%) 0/1 (0%) 1/14 (7%) | 1/32 (3%) 0/11 (0%) 1/16 (6%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 647 | 898 (T) 873 898 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.038 * (e) (e) P=0.125 | P=0.430N P=0.528 P=0.600 P=0.626N | |INCIDENTAL TUMOR | P=0.033 * (e) (e) P=0.113 | P=0.451N P=0.576 P=0.600 P=0.626N | |LOGISTIC REGRESSION | P=0.024 * (e) (e) P=0.100 | P=0.410N P=0.552 P=0.600 P=0.627N | |COCHRAN-ARMITAGE | P=0.023 * | P=0.471N | |FISHER EXACT | (e) (e) P=0.110 | P=0.557 P=0.548 P=0.667N | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 16/140 (11%) 12/70 (17%) 5/68 (7%) 9/70 (13%) | |ADJUSTED (b) | | 27.7% 38.8% 19.2% 24.8% | |INTERIM SACRIFICE 1 (c)| | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | | 4/32 (13%) 1/11 (9%) 0/16 (0%) 2/17 (12%) | |FIRST INCIDENCE (DAYS) | | 633 576 425 591 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.386N P=0.105 P=0.221N P=0.556 | |INCIDENTAL TUMOR | | P=0.402N P=0.228 P=0.224N P=0.584N | |LOGISTIC REGRESSION | | P=0.506N P=0.160 P=0.231N P=0.514 | |COCHRAN-ARMITAGE | | P=0.515N | |FISHER EXACT | | P=0.175 P=0.256N P=0.462 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 31 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 3/140 (2%) 1/70 (1%) 1/68 (1%) 0/70 (0%) | |ADJUSTED (b) | | 4.1% 2.3% 6.3% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | | 0/32 (0%) 0/11 (0%) 1/16 (6%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | | 302 669 898 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.172N P=0.592N P=0.564N P=0.250N | |INCIDENTAL TUMOR | | P=0.218N P=0.679N P=0.620N P=0.326N | |LOGISTIC REGRESSION | | P=0.185N P=0.570N P=0.582N P=0.274N | |COCHRAN-ARMITAGE | | P=0.185N | |FISHER EXACT | | P=0.593N P=0.604N P=0.294N | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 18/140 (13%) 13/70 (19%) 6/68 (9%) 9/70 (13%) | |ADJUSTED (b) | | 29.9% 40.2% 24.2% 24.8% | |INTERIM SACRIFICE 1 (c)| | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | | 4/32 (13%) 1/11 (9%) 1/16 (6%) 2/17 (12%) | |FIRST INCIDENCE (DAYS) | | 302 576 425 591 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.291N P=0.114 P=0.233N P=0.492N | |INCIDENTAL TUMOR | | P=0.334N P=0.201 P=0.248N P=0.524N | |LOGISTIC REGRESSION | | P=0.403N P=0.173 P=0.247N P=0.549N | |COCHRAN-ARMITAGE | | P=0.407N | |FISHER EXACT | | P=0.185 P=0.271N P=0.593N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 32 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/140 (2%) 1/70 (1%) 3/68 (4%) 3/70 (4%) | 0/140 (0%) 0/70 (0%) 1/68 (1%) 0/70 (0%) | |ADJUSTED (b) | 8.2% 1.9% 16.3% 7.8% | 0.0% 0.0% 6.3% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/20 (5%) 0/7 (0%) 0/1 (0%) 0/14 (0%) | 0/32 (0%) 0/11 (0%) 1/16 (6%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | 500 554 642 487 | --- --- 898 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.184 P=0.648N P=0.096 P=0.334 | P=0.616 (e) P=0.362 (e) | |INCIDENTAL TUMOR | P=0.222 P=0.583N P=0.311 P=0.366 | P=0.616 (e) P=0.362 (e) | |LOGISTIC REGRESSION | P=0.190 P=0.581N P=0.265 P=0.327 | P=0.616 (e) P=0.362 (e) | |COCHRAN-ARMITAGE | P=0.194 | P=0.604 | |FISHER EXACT | P=0.593N P=0.305 P=0.318 | (e) P=0.327 (e) | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/140 (2%) 1/70 (1%) 3/68 (4%) 4/70 (6%) | 0/140 (0%) 0/70 (0%) 1/68 (1%) 0/70 (0%) | |ADJUSTED (b) | 8.2% 1.9% 16.3% 10.4% | 0.0% 0.0% 6.3% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/20 (5%) 0/7 (0%) 0/1 (0%) 0/14 (0%) | 0/32 (0%) 0/11 (0%) 1/16 (6%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | 500 554 642 487 | --- --- 898 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.085 P=0.648N P=0.096 P=0.173 | P=0.616 (e) P=0.362 (e) | |INCIDENTAL TUMOR | P=0.097 P=0.583N P=0.311 P=0.181 | P=0.616 (e) P=0.362 (e) | |LOGISTIC REGRESSION | P=0.085 P=0.581N P=0.265 P=0.168 | P=0.616 (e) P=0.362 (e) | |COCHRAN-ARMITAGE | P=0.088 | P=0.604 | |FISHER EXACT | P=0.593N P=0.305 P=0.170 | (e) P=0.327 (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 33 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |All Organs | | Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/140 (1%) 0/70 (0%) 0/68 (0%) 1/70 (1%) | 0/140 (0%) 0/70 (0%) 0/68 (0%) 0/70 (0%) | |ADJUSTED (b) | 10.0% 0.0% 0.0% 7.1% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/20 (10%) 0/7 (0%) 0/1 (0%) 1/14 (7%) | 0/32 (0%) 0/11 (0%) 0/16 (0%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | 857 (T) --- --- 857 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.547N P=0.488N P=0.916N P=0.626N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.547N P=0.488N P=0.916N P=0.626N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.547N P=0.488N P=0.916N P=0.626N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.623N | (e) | |FISHER EXACT | P=0.443N P=0.452N P=0.742N | (e) (e) (e) | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/140 (1%) 0/70 (0%) 0/68 (0%) 0/70 (0%) | 1/140 (1%) 0/70 (0%) 0/68 (0%) 1/70 (1%) | |ADJUSTED (b) | 3.0% 0.0% 0.0% 0.0% | 3.1% 0.0% 0.0% 3.4% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/20 (0%) 0/7 (0%) 0/1 (0%) 0/14 (0%) | 1/32 (3%) 0/11 (0%) 0/16 (0%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | 626 --- --- --- | 898 (T) --- --- 841 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.214N P=0.436N P=0.497N P=0.399N | P=0.500 P=0.712N P=0.638N P=0.632 | |INCIDENTAL TUMOR | P=0.177N P=0.405N P=0.326N P=0.393N | P=0.475 P=0.712N P=0.638N P=0.608 | |LOGISTIC REGRESSION | P=0.204N P=0.410N P=0.427N P=0.404N | P=0.500 P=0.712N P=0.638N P=0.636 | |COCHRAN-ARMITAGE | P=0.198N | P=0.461 | |FISHER EXACT | P=0.443N P=0.452N P=0.443N | P=0.667N P=0.673N P=0.557 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 34 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/140 (3%) 0/70 (0%) 0/68 (0%) 1/70 (1%) | 1/140 (1%) 0/70 (0%) 0/68 (0%) 1/70 (1%) | |ADJUSTED (b) | 12.7% 0.0% 0.0% 7.1% | 3.1% 0.0% 0.0% 3.4% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/20 (10%) 0/7 (0%) 0/1 (0%) 1/14 (7%) | 1/32 (3%) 0/11 (0%) 0/16 (0%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | 626 --- --- 857 (T) | 898 (T) --- --- 841 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.261N P=0.242N P=0.442N P=0.351N | P=0.500 P=0.712N P=0.638N P=0.632 | |INCIDENTAL TUMOR | P=0.243N P=0.226N P=0.294N P=0.348N | P=0.475 P=0.712N P=0.638N P=0.608 | |LOGISTIC REGRESSION | P=0.305N P=0.215N P=0.263N P=0.449N | P=0.500 P=0.712N P=0.638N P=0.636 | |COCHRAN-ARMITAGE | P=0.276N | P=0.461 | |FISHER EXACT | P=0.195N P=0.202N P=0.459N | P=0.667N P=0.673N P=0.557 | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 84/140 (60%) 47/70 (67%) 40/68 (59%) 32/70 (46%) | 52/140 (37%) 33/70 (47%) 22/68 (32%) 27/70 (39%) | |ADJUSTED (b) | 87.8% 97.2% 100.0% 75.2% | 66.4% 79.3% 51.6% 63.2% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 11/20 (55%) 6/7 (86%) 1/1 (100%) 6/14 (43%) | 12/32 (38%) 4/11 (36%) 2/16 (13%) 5/17 (29%) | |FIRST INCIDENCE (DAYS) | 375 394 464 423 | 421 481 197 501 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.156N P=0.043 * P=0.006 ** P=0.090N | P=0.249N P=0.045 * P=0.257N P=0.420N | |INCIDENTAL TUMOR | P=0.032N* P=0.121 P=0.533 P=0.052N | P=0.491N P=0.158 P=0.267N P=0.465 | |LOGISTIC REGRESSION | P=0.013N* P=0.091 P=0.529N P=0.026N* | P=0.425N P=0.142 P=0.292N P=0.553 | |COCHRAN-ARMITAGE | P=0.023N* | P=0.467N | |FISHER EXACT | P=0.196 P=0.494N P=0.035N* | P=0.107 P=0.302N P=0.478 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 35 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/140 (1%) 0/70 (0%) 1/68 (1%) 3/70 (4%) | 1/140 (1%) 0/70 (0%) 0/68 (0%) 0/70 (0%) | |ADJUSTED (b) | 5.0% 0.0% 6.3% 7.2% | 0.9% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/20 (5%) 0/7 (0%) 0/1 (0%) 0/14 (0%) | 0/32 (0%) 0/11 (0%) 0/16 (0%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | 857 (T) --- 761 626 | 380 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.046 * P=0.709N P=0.330 P=0.121 | P=0.393N P=0.633N P=0.643N P=0.633N | |INCIDENTAL TUMOR | P=0.037 * P=0.709N P=0.387 P=0.115 | P=0.605N P=0.638N P=0.814N P=0.923N | |LOGISTIC REGRESSION | P=0.034 * P=0.709N P=0.460 P=0.102 | P=0.403N P=0.642N P=0.647N P=0.652N | |COCHRAN-ARMITAGE | P=0.035 * | P=0.396N | |FISHER EXACT | P=0.667N P=0.548 P=0.109 | P=0.667N P=0.673N P=0.667N | |=================================================================================================================================| | | |All Organs | | Osteosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/140 (0%) 0/70 (0%) 2/68 (3%) 0/70 (0%) | 0/140 (0%) 0/70 (0%) 1/68 (1%) 0/70 (0%) | |ADJUSTED (b) | 0.0% 0.0% 4.2% 0.0% | 0.0% 0.0% 3.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/20 (0%) 0/7 (0%) 0/1 (0%) 0/14 (0%) | 0/32 (0%) 0/11 (0%) 0/16 (0%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 501 --- | --- --- 788 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.453 (e) P=0.082 (e) | P=0.625 (e) P=0.365 (e) | |INCIDENTAL TUMOR | P=0.559 (e) P=0.240 (e) | P=0.608 (e) P=0.377 (e) | |LOGISTIC REGRESSION | P=0.464 (e) P=0.106 (e) | P=0.612 (e) P=0.361 (e) | |COCHRAN-ARMITAGE | P=0.461 | P=0.604 | |FISHER EXACT | (e) P=0.106 (e) | (e) P=0.327 (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 36 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |All Organs | | Osteosarcoma or Osteoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/140 (0%) 0/70 (0%) 2/68 (3%) 0/70 (0%) | 0/140 (0%) 0/70 (0%) 1/68 (1%) 0/70 (0%) | |ADJUSTED (b) | 0.0% 0.0% 4.2% 0.0% | 0.0% 0.0% 3.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/20 (0%) 0/7 (0%) 0/1 (0%) 0/14 (0%) | 0/32 (0%) 0/11 (0%) 0/16 (0%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 501 --- | --- --- 788 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.453 (e) P=0.082 (e) | P=0.625 (e) P=0.365 (e) | |INCIDENTAL TUMOR | P=0.559 (e) P=0.240 (e) | P=0.608 (e) P=0.377 (e) | |LOGISTIC REGRESSION | P=0.464 (e) P=0.106 (e) | P=0.612 (e) P=0.361 (e) | |COCHRAN-ARMITAGE | P=0.461 | P=0.604 | |FISHER EXACT | (e) P=0.106 (e) | (e) P=0.327 (e) | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) |119/140 (85%) 56/70 (80%) 56/68 (82%) 59/70 (84%) | 97/140 (69%) 51/70 (73%) 49/68 (72%) 50/70 (71%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 94.9% 100.0% 96.0% 95.8% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 20/20 (100%) 7/7 (100%) 1/1 (100%) 14/14 (100%)| 27/32 (84%) 11/11 (100%) 14/16 (88%) 15/17 (88%) | |FIRST INCIDENCE (DAYS) | 381 535 464 487 | 418 480 425 501 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.434 P=0.187 P<0.001 ** P=0.424N | P=0.245N P=0.097 P=0.495N P=0.336N | |INCIDENTAL TUMOR | P=0.583 P=0.127N P=0.407N P=0.702N | P=0.426N P=0.432 P=0.567 P=0.382N | |LOGISTIC REGRESSION | P=0.479N P=0.144N P=0.395N P=0.433N | P=0.443N P=0.329 P=0.505 P=0.497N | |COCHRAN-ARMITAGE | P=0.500N | P=0.405 | |FISHER EXACT | P=0.234N P=0.381N P=0.521N | P=0.357 P=0.405 P=0.439 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 37 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) |102/140 (73%) 53/70 (76%) 50/68 (74%) 47/70 (67%) | 73/140 (52%) 39/70 (56%) 38/68 (56%) 39/70 (56%) | |ADJUSTED (b) | 94.7% 97.8% 100.0% 91.2% | 80.8% 84.9% 82.2% 82.8% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 15/20 (75%) 6/7 (86%) 1/1 (100%) 10/14 (71%) | 18/32 (56%) 5/11 (45%) 9/16 (56%) 10/17 (59%) | |FIRST INCIDENCE (DAYS) | 375 289 464 423 | 302 481 197 501 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.434N P=0.083 P=0.001 ** P=0.289N | P=0.373N P=0.152 P=0.509 P=0.461N | |INCIDENTAL TUMOR | P=0.175N P=0.390 P=0.527N P=0.223N | P=0.261 P=0.449 P=0.322 P=0.267 | |LOGISTIC REGRESSION | P=0.130N P=0.320 P=0.499N P=0.186N | P=0.372 P=0.473 P=0.334 P=0.423 | |COCHRAN-ARMITAGE | P=0.214N | P=0.332 | |FISHER EXACT | P=0.394 P=0.529 P=0.241N | P=0.366 P=0.360 P=0.366 | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) |120/140 (86%) 59/70 (84%) 57/68 (84%) 60/70 (86%) |113/140 (81%) 59/70 (84%) 56/68 (82%) 59/70 (84%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 96.6% 100.0% 98.2% 98.3% | |INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 20/20 (100%) 7/7 (100%) 1/1 (100%) 14/14 (100%)| 28/32 (88%) 11/11 (100%) 15/16 (94%) 16/17 (94%) | |FIRST INCIDENCE (DAYS) | 375 289 464 423 | 302 480 197 501 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.424 P=0.119 P<0.001 ** P=0.448N | P=0.267N P=0.105 P=0.445N P=0.370N | |INCIDENTAL TUMOR | P=0.629 P=0.406N P=0.500N (e) | P=0.213 P=0.417 P=0.463 P=0.379 | |LOGISTIC REGRESSION | P=0.536N P=0.745N P=0.281N (e) | P=0.171 P=0.436 P=0.309 P=0.325 | |COCHRAN-ARMITAGE | P=0.525N | P=0.313 | |FISHER EXACT | P=0.466N P=0.433N P=0.576N | P=0.333 P=0.468 P=0.333 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 03 PAGE 38 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 123 WEEKS FEMALE TERMINAL SACRIFICE AT 129 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): 93 (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).