TDMS Study 05044-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus 4-VINYL-1-CYCLOHEXENE DIEPOXIDE DATE: 09/06/94 EXPERIMENT: 05044 TEST: 01 TIME: 11:48:23 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-CP-95653 ROUTE: DERMAL,SOLUTION NTP C#: 60139A PATHOLOGIST: S. GRUMBEIN S. EUSTIS CAS: 106-87-6 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus 4-VINYL-1-CYCLOHEXENE DIEPOXIDE DATE: 09/06/94 EXPERIMENT: 05044 TEST: 01 TIME: 11:48:23 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-CP-95653 ROUTE: DERMAL,SOLUTION NTP C#: 60139A PATHOLOGIST: S. GRUMBEIN S. EUSTIS CAS: 106-87-6 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 Gland Bone Marrow Brain Clitoral Gland Epididymis Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus 4-VINYL-1-CYCLOHEXENE DIEPOXIDE DATE: 09/06/94 EXPERIMENT: 05044 TEST: 01 TIME: 11:48:23 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-CP-95653 ROUTE: DERMAL,SOLUTION NTP C#: 60139A PATHOLOGIST: S. GRUMBEIN S. EUSTIS CAS: 106-87-6 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF 4-VINYL-1-CYCLOHEXENE DIEPOXIDE ==================================================================================================== MALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma: Benign, Complex, Malignant, NOS Skin Basal Cell Adenoma Squamous Cell Carcinoma Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma Squamous Cell Papilloma Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma Thyroid Gland: C-Cell Carcinoma or Adenoma All Organs Benign Tumors Malignant Tumors ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Mammary Gland Fibroadenoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma Skin Basal Cell Carcinoma Squamous Cell Carcinoma Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma Thyroid Gland: C-Cell Adenoma Carcinoma or Adenoma Uterus Polyp Stromal Sarcoma Stromal or Polyp Stromal All Organs Malignant Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 09/06/94 EXPERIMENT: 05044 TEST: 01 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/ML 50 MG/ML 100 MG/ | 0 MG/ML 50 MG/ML 100 MG/ | | | ML | ML | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 15/50 (30%) 0/50 (0%) | 2/50 (4%) 3/48 (6%) 1/50 (2%) | |ADJUSTED (b) | 46.1% 64.7% 0.0% | 6.3% 13.0% 4.3% | |TERMINAL (d) | 1/7 (14%) 2/8 (25%) 0/4 (0%) | 1/27 (4%) 3/23 (13%) 0/15 (0%) | |FIRST INCIDENCE (DAYS) | 571 569 --- | 698 743 (T) 684 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.065N P=0.239 P=0.020N* | P=0.568 P=0.406 P=0.711N | |INCIDENTAL TUMOR | P=0.015N* P=0.104 P=0.005N** | P=0.513N P=0.374 P=0.519N | |LOGISTIC REGRESSION | P=0.021N* P=0.112 P=0.006N** | P=0.577N P=0.379 P=0.594N | |COCHRAN-ARMITAGE | P=0.019N* | P=0.400N | |FISHER EXACT | P=0.077 P=0.003N** | P=0.480 P=0.500N | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) | 1/50 (2%) 0/48 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 7.8% | 3.7% 0.0% 0.0% | |TERMINAL (d) | 0/7 (0%) 0/8 (0%) 0/4 (0%) | 1/27 (4%) 0/23 (0%) 0/15 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 350 | 743 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.079 (e) P=0.209 | P=0.343N P=0.532N P=0.617N | |INCIDENTAL TUMOR | P=0.175 (e) P=0.487 | P=0.343N P=0.532N P=0.617N | |LOGISTIC REGRESSION | P=0.098 (e) P=0.288 | P=0.343N P=0.532N P=0.617N | |COCHRAN-ARMITAGE | P=0.095 | P=0.271N | |FISHER EXACT | (e) P=0.247 | P=0.510N P=0.500N | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05044 TEST: 01 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/ML 50 MG/ML 100 MG/ | 0 MG/ML 50 MG/ML 100 MG/ | | | ML | ML | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 15/50 (30%) 2/50 (4%) | 3/50 (6%) 3/48 (6%) 1/50 (2%) | |ADJUSTED (b) | 46.1% 64.7% 7.8% | 9.9% 13.0% 4.3% | |TERMINAL (d) | 1/7 (14%) 2/8 (25%) 0/4 (0%) | 2/27 (7%) 3/23 (13%) 0/15 (0%) | |FIRST INCIDENCE (DAYS) | 571 569 350 | 698 743 (T) 684 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.187N P=0.239 P=0.126N | P=0.472N P=0.569 P=0.542N | |INCIDENTAL TUMOR | P=0.042N* P=0.104 P=0.018N* | P=0.362N P=0.540 P=0.371N | |LOGISTIC REGRESSION | P=0.080N P=0.112 P=0.052N | P=0.419N P=0.535 P=0.431N | |COCHRAN-ARMITAGE | P=0.070N | P=0.240N | |FISHER EXACT | P=0.077 P=0.046N* | P=0.641 P=0.309N | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 3/49 (6%) 1/50 (2%) | 2/45 (4%) 7/50 (14%) 3/49 (6%) | |ADJUSTED (b) | 0.0% 14.0% 2.6% | 8.0% 25.7% 12.2% | |TERMINAL (d) | 0/6 (0%) 0/8 (0%) 0/4 (0%) | 2/25 (8%) 4/23 (17%) 0/14 (0%) | |FIRST INCIDENCE (DAYS) | --- 538 568 | 743 (T) 534 675 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.349 P=0.158 P=0.511 | P=0.174 P=0.061 P=0.283 | |INCIDENTAL TUMOR | P=0.393 P=0.104 P=0.569 | P=0.426 P=0.055 P=0.475 | |LOGISTIC REGRESSION | P=0.385 P=0.121 P=0.519 | P=0.305 P=0.059 P=0.411 | |COCHRAN-ARMITAGE | P=0.385 | P=0.475 | |FISHER EXACT | P=0.121 P=0.505 | P=0.107 P=0.541 | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05044 TEST: 01 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/ML 50 MG/ML 100 MG/ | 0 MG/ML 50 MG/ML 100 MG/ | | | ML | ML | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 3/49 (6%) 1/50 (2%) | 3/45 (7%) 7/50 (14%) 3/49 (6%) | |ADJUSTED (b) | 0.0% 14.0% 2.6% | 10.6% 25.7% 12.2% | |TERMINAL (d) | 0/6 (0%) 0/8 (0%) 0/4 (0%) | 2/25 (8%) 4/23 (17%) 0/14 (0%) | |FIRST INCIDENCE (DAYS) | --- 538 568 | 698 534 675 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.349 P=0.158 P=0.511 | P=0.263 P=0.116 P=0.395 | |INCIDENTAL TUMOR | P=0.393 P=0.104 P=0.569 | P=0.555N P=0.095 P=0.667N | |LOGISTIC REGRESSION | P=0.385 P=0.121 P=0.519 | P=0.447 P=0.127 P=0.586 | |COCHRAN-ARMITAGE | P=0.385 | P=0.520N | |FISHER EXACT | P=0.121 P=0.505 | P=0.205 P=0.620N | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 2/49 (4%) 0/50 (0%) | 0/45 (0%) 0/50 (0%) 0/49 (0%) | |ADJUSTED (b) | 0.0% 8.9% 0.0% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/6 (0%) 0/8 (0%) 0/4 (0%) | 0/25 (0%) 0/23 (0%) 0/14 (0%) | |FIRST INCIDENCE (DAYS) | --- 609 --- | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.650 P=0.306 (e) | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.627N P=0.204 (e) | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.669 P=0.245 (e) | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.664N | (e) | |FISHER EXACT | P=0.247 (e) | (e) (e) | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05044 TEST: 01 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/ML 50 MG/ML 100 MG/ | 0 MG/ML 50 MG/ML 100 MG/ | | | ML | ML | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 3/46 (7%) | 0/48 (0%) 1/48 (2%) 1/48 (2%) | |ADJUSTED (b) | 2.5% 7.2% 16.7% | 0.0% 4.3% 6.7% | |TERMINAL (d) | 0/7 (0%) 0/8 (0%) 0/4 (0%) | 0/27 (0%) 1/23 (4%) 1/15 (7%) | |FIRST INCIDENCE (DAYS) | 548 642 591 | --- 743 (T) 743 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.188 P=0.572 P=0.287 | P=0.214 P=0.468 P=0.383 | |INCIDENTAL TUMOR | P=0.286 P=0.425 P=0.370 | P=0.214 P=0.468 P=0.383 | |LOGISTIC REGRESSION | P=0.196 P=0.500 P=0.276 | P=0.214 P=0.468 P=0.383 | |COCHRAN-ARMITAGE | P=0.196 | P=0.331 | |FISHER EXACT | P=0.500 P=0.278 | P=0.500 P=0.500 | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/46 (0%) | 0/48 (0%) 0/48 (0%) 0/48 (0%) | |ADJUSTED (b) | 0.0% 20.5% 0.0% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/7 (0%) 1/8 (13%) 0/4 (0%) | 0/27 (0%) 0/23 (0%) 0/15 (0%) | |FIRST INCIDENCE (DAYS) | --- 730 --- | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.569 P=0.277 (e) | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.618 P=0.280 (e) | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.605 P=0.284 (e) | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.652 | (e) | |FISHER EXACT | P=0.247 (e) | (e) (e) | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05044 TEST: 01 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/ML 50 MG/ML 100 MG/ | 0 MG/ML 50 MG/ML 100 MG/ | | | ML | ML | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 4/50 (8%) 3/46 (7%) | 0/48 (0%) 1/48 (2%) 1/48 (2%) | |ADJUSTED (b) | 2.5% 26.2% 16.7% | 0.0% 4.3% 6.7% | |TERMINAL (d) | 0/7 (0%) 1/8 (13%) 0/4 (0%) | 0/27 (0%) 1/23 (4%) 1/15 (7%) | |FIRST INCIDENCE (DAYS) | 548 642 591 | --- 743 (T) 743 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.178 P=0.246 P=0.287 | P=0.214 P=0.468 P=0.383 | |INCIDENTAL TUMOR | P=0.282 P=0.163 P=0.370 | P=0.214 P=0.468 P=0.383 | |LOGISTIC REGRESSION | P=0.216 P=0.195 P=0.276 | P=0.214 P=0.468 P=0.383 | |COCHRAN-ARMITAGE | P=0.220 | P=0.331 | |FISHER EXACT | P=0.181 P=0.278 | P=0.500 P=0.500 | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) | 2/50 (4%) 3/50 (6%) 1/50 (2%) | |ADJUSTED (b) | 14.3% 25.0% 0.0% | 7.4% 11.5% 3.2% | |TERMINAL (d) | 1/7 (14%) 2/8 (25%) 0/4 (0%) | 2/27 (7%) 2/23 (9%) 0/15 (0%) | |FIRST INCIDENCE (DAYS) | 743 (T) 743 (T) --- | 743 (T) 625 648 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.491N P=0.550 P=0.612N | P=0.583N P=0.417 P=0.660N | |INCIDENTAL TUMOR | P=0.491N P=0.550 P=0.612N | P=0.518N P=0.508 P=0.610N | |LOGISTIC REGRESSION | P=0.491N P=0.550 P=0.612N | P=0.506N P=0.414 P=0.604N | |COCHRAN-ARMITAGE | P=0.360N | P=0.399N | |FISHER EXACT | P=0.500 P=0.500N | P=0.500 P=0.500N | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05044 TEST: 01 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/ML 50 MG/ML 100 MG/ | 0 MG/ML 50 MG/ML 100 MG/ | | | ML | ML | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) | 20/50 (40%) 11/50 (22%) 8/50 (16%) | |ADJUSTED (b) | 5.9% 8.3% 7.7% | 54.4% 37.6% 40.2% | |TERMINAL (d) | 0/7 (0%) 0/8 (0%) 0/4 (0%) | 12/27 (44%) 7/23 (30%) 4/15 (27%) | |FIRST INCIDENCE (DAYS) | 682 722 684 | 425 542 675 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.587 P=0.710N P=0.722 | P=0.117N P=0.140N P=0.191N | |INCIDENTAL TUMOR | P=0.631 P=0.713N P=0.750 | P=0.014N* P=0.025N* P=0.026N* | |LOGISTIC REGRESSION | P=0.610 P=0.726N P=0.738 | P=0.014N* P=0.057N P=0.023N* | |COCHRAN-ARMITAGE | P=0.640 | P=0.004N** | |FISHER EXACT | P=0.753N P=0.753N | P=0.041N* P=0.007N** | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 3/50 (6%) 1/50 (2%) | 21/50 (42%) 14/50 (28%) 9/50 (18%) | |ADJUSTED (b) | 19.3% 31.2% 7.7% | 57.5% 47.1% 42.1% | |TERMINAL (d) | 1/7 (14%) 2/8 (25%) 0/4 (0%) | 13/27 (48%) 9/23 (39%) 4/15 (27%) | |FIRST INCIDENCE (DAYS) | 682 722 684 | 425 542 648 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.541N P=0.579 P=0.603N | P=0.162N P=0.283N P=0.223N | |INCIDENTAL TUMOR | P=0.507N P=0.579 P=0.579N | P=0.021N* P=0.065N P=0.032N* | |LOGISTIC REGRESSION | P=0.495N P=0.616 P=0.571N | P=0.021N* P=0.147N P=0.027N* | |COCHRAN-ARMITAGE | P=0.399N | P=0.006N** | |FISHER EXACT | P=0.500 P=0.500N | P=0.104N P=0.008N** | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05044 TEST: 01 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/ML 50 MG/ML 100 MG/ | 0 MG/ML 50 MG/ML 100 MG/ | | | ML | ML | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) | 1/50 (2%) 2/50 (4%) 1/50 (2%) | |ADJUSTED (b) | 2.9% 4.5% 0.0% | 2.1% 6.3% 3.0% | |TERMINAL (d) | 0/7 (0%) 0/8 (0%) 0/4 (0%) | 0/27 (0%) 1/23 (4%) 0/15 (0%) | |FIRST INCIDENCE (DAYS) | 584 676 --- | 586 471 635 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.349N P=0.729N P=0.494N | P=0.538 P=0.468 P=0.712 | |INCIDENTAL TUMOR | P=0.300N P=0.740 P=0.431N | P=0.523N P=0.668 P=0.710N | |LOGISTIC REGRESSION | P=0.333N P=0.762N P=0.490N | P=0.576N P=0.549 P=0.729N | |COCHRAN-ARMITAGE | P=0.331N | P=0.622N | |FISHER EXACT | P=0.753N P=0.500N | P=0.500 P=0.753N | |=================================================================================================================================| | | |Parathyroid Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 2/45 (4%) 1/45 (2%) | 1/47 (2%) 1/43 (2%) 0/48 (0%) | |ADJUSTED (b) | 0.0% 19.6% 25.0% | 2.6% 4.2% 0.0% | |TERMINAL (d) | 0/7 (0%) 1/7 (14%) 1/4 (25%) | 0/26 (0%) 0/21 (0%) 0/14 (0%) | |FIRST INCIDENCE (DAYS) | --- 695 743 (T) | 662 739 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.222 P=0.271 P=0.388 | P=0.434N P=0.706 P=0.573N | |INCIDENTAL TUMOR | P=0.251 P=0.264 P=0.388 | P=0.312N P=0.582 P=0.471N | |LOGISTIC REGRESSION | P=0.247 P=0.270 P=0.388 | P=0.372N P=0.731 P=0.492N | |COCHRAN-ARMITAGE | P=0.339 | P=0.329N | |FISHER EXACT | P=0.226 P=0.479 | P=0.730 P=0.495N | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05044 TEST: 01 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/ML 50 MG/ML 100 MG/ | 0 MG/ML 50 MG/ML 100 MG/ | | | ML | ML | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 24/50 (48%) 26/50 (52%) 27/48 (56%) | 19/47 (40%) 14/49 (29%) 17/48 (35%) | |ADJUSTED (b) | 74.8% 89.8% 90.4% | 55.9% 43.0% 67.6% | |TERMINAL (d) | 3/7 (43%) 6/8 (75%) 2/4 (50%) | 12/26 (46%) 7/23 (30%) 8/15 (53%) | |FIRST INCIDENCE (DAYS) | 458 389 394 | 586 534 519 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.167 P=0.453N P=0.223 | P=0.153 P=0.382N P=0.116 | |INCIDENTAL TUMOR | P=0.155 P=0.357 P=0.229 | P=0.486N P=0.174N P=0.571 | |LOGISTIC REGRESSION | P=0.226 P=0.422 P=0.261 | P=0.514 P=0.230N P=0.471 | |COCHRAN-ARMITAGE | P=0.237 | P=0.345N | |FISHER EXACT | P=0.421 P=0.269 | P=0.157N P=0.385N | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/48 (0%) | 14/47 (30%) 15/49 (31%) 11/48 (23%) | |ADJUSTED (b) | 28.6% 2.8% 0.0% | 40.4% 46.9% 34.6% | |TERMINAL (d) | 2/7 (29%) 0/8 (0%) 0/4 (0%) | 7/26 (27%) 7/23 (30%) 2/15 (13%) | |FIRST INCIDENCE (DAYS) | 743 (T) 596 --- | 626 584 396 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.183N P=0.455N P=0.362N | P=0.323 P=0.275 P=0.375 | |INCIDENTAL TUMOR | P=0.167N P=0.519N P=0.362N | P=0.230N P=0.285 P=0.200N | |LOGISTIC REGRESSION | P=0.151N P=0.448N P=0.362N | P=0.317N P=0.304 P=0.302N | |COCHRAN-ARMITAGE | P=0.148N | P=0.262N | |FISHER EXACT | P=0.500N P=0.258N | P=0.554 P=0.299N | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05044 TEST: 01 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/ML 50 MG/ML 100 MG/ | 0 MG/ML 50 MG/ML 100 MG/ | | | ML | ML | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 26/50 (52%) 27/50 (54%) 27/48 (56%) | 33/47 (70%) 29/49 (59%) 28/48 (58%) | |ADJUSTED (b) | 87.4% 90.1% 90.4% | 82.0% 75.5% 82.6% | |TERMINAL (d) | 5/7 (71%) 6/8 (75%) 2/4 (50%) | 19/26 (73%) 14/23 (61%) 10/15 (67%) | |FIRST INCIDENCE (DAYS) | 458 389 394 | 586 534 396 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.240 P=0.383N P=0.290 | P=0.107 P=0.471 P=0.086 | |INCIDENTAL TUMOR | P=0.258 P=0.426 P=0.328 | P=0.194N P=0.423N P=0.226N | |LOGISTIC REGRESSION | P=0.358 P=0.502 P=0.397 | P=0.320N P=0.341N P=0.360N | |COCHRAN-ARMITAGE | P=0.374 | P=0.139N | |FISHER EXACT | P=0.500 P=0.413 | P=0.180N P=0.160N | |=================================================================================================================================| | | |Skin | | Basal Cell Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 4/50 (8%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) | |ADJUSTED (b) | 4.2% 0.0% 42.5% | 3.7% 4.3% 0.0% | |TERMINAL (d) | 0/7 (0%) 0/8 (0%) 1/4 (25%) | 1/27 (4%) 1/23 (4%) 0/15 (0%) | |FIRST INCIDENCE (DAYS) | 620 --- 668 | 743 (T) 743 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.044 * P=0.443N P=0.118 | P=0.453N P=0.726 P=0.617N | |INCIDENTAL TUMOR | P=0.070 P=0.587N P=0.155 | P=0.453N P=0.726 P=0.617N | |LOGISTIC REGRESSION | P=0.063 P=0.500N P=0.143 | P=0.453N P=0.726 P=0.617N | |COCHRAN-ARMITAGE | P=0.082 | P=0.331N | |FISHER EXACT | P=0.500N P=0.181 | P=0.753N P=0.500N | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05044 TEST: 01 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/ML 50 MG/ML 100 MG/ | 0 MG/ML 50 MG/ML 100 MG/ | | | ML | ML | |=================================================================================================================================| | | |Skin | | Basal Cell Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 3/50 (6%) | 0/50 (0%) 3/50 (6%) 4/50 (8%) | |ADJUSTED (b) | 3.8% 8.4% 20.1% | 0.0% 12.5% 20.0% | |TERMINAL (d) | 0/7 (0%) 0/8 (0%) 0/4 (0%) | 0/27 (0%) 2/23 (9%) 2/15 (13%) | |FIRST INCIDENCE (DAYS) | 619 642 595 | --- 739 654 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.170 P=0.597 P=0.266 | P=0.012 * P=0.098 P=0.020 * | |INCIDENTAL TUMOR | P=0.281 P=0.425 P=0.356 | P=0.032 * P=0.066 P=0.040 * | |LOGISTIC REGRESSION | P=0.208 P=0.508 P=0.291 | P=0.015 * P=0.081 P=0.032 * | |COCHRAN-ARMITAGE | P=0.222 | P=0.049 * | |FISHER EXACT | P=0.500 P=0.309 | P=0.121 P=0.059 | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 8.6% 29.4% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/7 (0%) 0/8 (0%) 1/4 (25%) | 0/27 (0%) 0/23 (0%) 0/15 (0%) | |FIRST INCIDENCE (DAYS) | --- 647 558 | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.055 P=0.305 P=0.101 | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.089 P=0.287 P=0.125 | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.075 P=0.250 P=0.116 | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.082 | (e) | |FISHER EXACT | P=0.247 P=0.121 | (e) (e) | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05044 TEST: 01 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/ML 50 MG/ML 100 MG/ | 0 MG/ML 50 MG/ML 100 MG/ | | | ML | ML | |=================================================================================================================================| | | |Skin | | Squamous Cell Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 33/50 (66%) 36/50 (72%) | 0/50 (0%) 16/50 (32%) 34/50 (68%) | |ADJUSTED (b) | 0.0% 100.0% 100.0% | 0.0% 63.6% 100.0% | |TERMINAL (d) | 0/7 (0%) 8/8 (100%) 4/4 (100%) | 0/27 (0%) 14/23 (61%) 15/15 (100%) | |FIRST INCIDENCE (DAYS) | --- 596 543 | --- 625 601 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** | |FISHER EXACT | P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | |Skin | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 33/50 (66%) 36/50 (72%) | 0/50 (0%) 16/50 (32%) 34/50 (68%) | |ADJUSTED (b) | 0.0% 100.0% 100.0% | 0.0% 63.6% 100.0% | |TERMINAL (d) | 0/7 (0%) 8/8 (100%) 4/4 (100%) | 0/27 (0%) 14/23 (61%) 15/15 (100%) | |FIRST INCIDENCE (DAYS) | --- 596 543 | --- 625 601 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** | |FISHER EXACT | P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05044 TEST: 01 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/ML 50 MG/ML 100 MG/ | 0 MG/ML 50 MG/ML 100 MG/ | | | ML | ML | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 6/50 (12%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 25.2% 39.3% | 0.0% 0.0% 4.5% | |TERMINAL (d) | 0/7 (0%) 1/8 (13%) 0/4 (0%) | 0/27 (0%) 0/23 (0%) 0/15 (0%) | |FIRST INCIDENCE (DAYS) | --- 688 595 | --- --- 689 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.004 ** P=0.174 P=0.014 * | P=0.204 (e) P=0.396 | |INCIDENTAL TUMOR | P=0.012 * P=0.158 P=0.026 * | P=0.324 (e) P=0.541 | |LOGISTIC REGRESSION | P=0.006 ** P=0.159 P=0.015 * | P=0.248 (e) P=0.476 | |COCHRAN-ARMITAGE | P=0.010 * | P=0.269 | |FISHER EXACT | P=0.121 P=0.013 * | (e) P=0.500 | |=================================================================================================================================| | | |Skin | | Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 7/50 (14%) | 1/50 (2%) 4/50 (8%) 4/50 (8%) | |ADJUSTED (b) | 7.9% 8.4% 51.2% | 3.7% 16.7% 20.0% | |TERMINAL (d) | 0/7 (0%) 0/8 (0%) 1/4 (25%) | 1/27 (4%) 3/23 (13%) 2/15 (13%) | |FIRST INCIDENCE (DAYS) | 619 642 595 | 743 (T) 739 654 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.022 * P=0.587N P=0.055 | P=0.040 * P=0.137 P=0.064 | |INCIDENTAL TUMOR | P=0.060 P=0.597 P=0.096 | P=0.080 P=0.105 P=0.106 | |LOGISTIC REGRESSION | P=0.034 * P=0.691N P=0.066 | P=0.047 * P=0.119 P=0.091 | |COCHRAN-ARMITAGE | P=0.042 * | P=0.146 | |FISHER EXACT | P=0.691N P=0.080 | P=0.181 P=0.181 | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05044 TEST: 01 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/ML 50 MG/ML 100 MG/ | 0 MG/ML 50 MG/ML 100 MG/ | | | ML | ML | |=================================================================================================================================| | | |Skin | | Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, | | Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 33/50 (66%) 37/50 (74%) | 1/50 (2%) 17/50 (34%) 34/50 (68%) | |ADJUSTED (b) | 7.9% 100.0% 100.0% | 3.7% 65.1% 100.0% | |TERMINAL (d) | 0/7 (0%) 8/8 (100%) 4/4 (100%) | 1/27 (4%) 14/23 (61%) 15/15 (100%) | |FIRST INCIDENCE (DAYS) | 619 596 543 | 743 (T) 625 601 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** | |FISHER EXACT | P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 14.3% 15.4% 0.0% | 6.1% 0.0% 0.0% | |TERMINAL (d) | 1/7 (14%) 1/8 (13%) 0/4 (0%) | 1/27 (4%) 0/23 (0%) 0/15 (0%) | |FIRST INCIDENCE (DAYS) | 743 (T) 642 --- | 635 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.455N P=0.563 P=0.612N | P=0.140N P=0.289N P=0.330N | |INCIDENTAL TUMOR | P=0.407N P=0.481 P=0.612N | P=0.097N P=0.173N P=0.271N | |LOGISTIC REGRESSION | P=0.404N P=0.571 P=0.612N | P=0.104N P=0.245N P=0.256N | |COCHRAN-ARMITAGE | P=0.360N | P=0.095N | |FISHER EXACT | P=0.500 P=0.500N | P=0.247N P=0.247N | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05044 TEST: 01 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/ML 50 MG/ML 100 MG/ | 0 MG/ML 50 MG/ML 100 MG/ | | | ML | ML | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, Sarcoma, | | Neurofibroma, or Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 16.4% 15.4% 25.0% | 6.1% 0.0% 0.0% | |TERMINAL (d) | 1/7 (14%) 1/8 (13%) 1/4 (25%) | 1/27 (4%) 0/23 (0%) 0/15 (0%) | |FIRST INCIDENCE (DAYS) | 548 642 743 (T) | 635 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.498N P=0.649N P=0.622N | P=0.140N P=0.289N P=0.330N | |INCIDENTAL TUMOR | P=0.432N P=0.643 P=0.591N | P=0.097N P=0.173N P=0.271N | |LOGISTIC REGRESSION | P=0.420N P=0.674N P=0.536N | P=0.104N P=0.245N P=0.256N | |COCHRAN-ARMITAGE | P=0.390N | P=0.095N | |FISHER EXACT | P=0.691N P=0.500N | P=0.247N P=0.247N | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 44/50 (88%) 40/50 (80%) 39/50 (78%) | | |ADJUSTED (b) | 100.0% 100.0% 100.0% | | |TERMINAL (d) | 7/7 (100%) 8/8 (100%) 4/4 (100%) | | |FIRST INCIDENCE (DAYS) | 379 387 543 | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.430 P=0.116N P=0.449 | | |INCIDENTAL TUMOR | P=0.149N P=0.211N P=0.162N | | |LOGISTIC REGRESSION | P=0.139N P=0.248N P=0.143N | | |COCHRAN-ARMITAGE | P=0.121N | | |FISHER EXACT | P=0.207N P=0.143N | | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05044 TEST: 01 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/ML 50 MG/ML 100 MG/ | 0 MG/ML 50 MG/ML 100 MG/ | | | ML | ML | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/48 (15%) 6/50 (12%) 2/43 (5%) | 6/46 (13%) 14/48 (29%) 9/49 (18%) | |ADJUSTED (b) | 39.0% 22.4% 27.3% | 21.4% 45.8% 39.0% | |TERMINAL (d) | 1/7 (14%) 0/8 (0%) 1/4 (25%) | 5/27 (19%) 8/23 (35%) 4/15 (27%) | |FIRST INCIDENCE (DAYS) | 379 538 595 | 736 471 404 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.122N P=0.388N P=0.174N | P=0.040 * P=0.018 * P=0.053 | |INCIDENTAL TUMOR | P=0.121N P=0.373N P=0.199N | P=0.224 P=0.022 * P=0.202 | |LOGISTIC REGRESSION | P=0.089N P=0.468N P=0.108N | P=0.208 P=0.027 * P=0.223 | |COCHRAN-ARMITAGE | P=0.088N | P=0.315 | |FISHER EXACT | P=0.468N P=0.108N | P=0.048 * P=0.335 | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/48 (4%) 0/50 (0%) 0/43 (0%) | 0/46 (0%) 3/48 (6%) 1/49 (2%) | |ADJUSTED (b) | 9.1% 0.0% 0.0% | 0.0% 8.7% 6.7% | |TERMINAL (d) | 0/7 (0%) 0/8 (0%) 0/4 (0%) | 0/27 (0%) 1/23 (4%) 1/15 (7%) | |FIRST INCIDENCE (DAYS) | 607 --- --- | --- 542 743 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.096N P=0.202N P=0.261N | P=0.268 P=0.106 P=0.383 | |INCIDENTAL TUMOR | P=0.096N P=0.260N P=0.236N | P=0.414 P=0.216 P=0.383 | |LOGISTIC REGRESSION | P=0.102N P=0.227N P=0.263N | P=0.411 P=0.144 P=0.383 | |COCHRAN-ARMITAGE | P=0.102N | P=0.398 | |FISHER EXACT | P=0.237N P=0.275N | P=0.129 P=0.516 | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05044 TEST: 01 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/ML 50 MG/ML 100 MG/ | 0 MG/ML 50 MG/ML 100 MG/ | | | ML | ML | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 9/48 (19%) 6/50 (12%) 2/43 (5%) | 6/46 (13%) 15/48 (31%) 10/49 (20%) | |ADJUSTED (b) | 44.6% 22.4% 27.3% | 21.4% 49.4% 44.5% | |TERMINAL (d) | 1/7 (14%) 0/8 (0%) 1/4 (25%) | 5/27 (19%) 9/23 (39%) 5/15 (33%) | |FIRST INCIDENCE (DAYS) | 379 538 595 | 736 471 404 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.044N* P=0.203N P=0.076N | P=0.020 * P=0.010 ** P=0.026 * | |INCIDENTAL TUMOR | P=0.039N* P=0.199N P=0.077N | P=0.136 P=0.012 * P=0.118 | |LOGISTIC REGRESSION | P=0.029N* P=0.259N P=0.041N* | P=0.131 P=0.015 * P=0.137 | |COCHRAN-ARMITAGE | P=0.029N* | P=0.239 | |FISHER EXACT | P=0.259N P=0.038N* | P=0.030 * P=0.248 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/48 (2%) 3/50 (6%) 3/43 (7%) | 2/46 (4%) 0/48 (0%) 1/49 (2%) | |ADJUSTED (b) | 4.5% 19.2% 29.7% | 7.4% 0.0% 3.7% | |TERMINAL (d) | 0/7 (0%) 1/8 (13%) 1/4 (25%) | 2/27 (7%) 0/23 (0%) 0/15 (0%) | |FIRST INCIDENCE (DAYS) | 667 569 503 | 743 (T) --- 670 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.161 P=0.374 P=0.236 | P=0.497N P=0.274N P=0.672N | |INCIDENTAL TUMOR | P=0.171 P=0.319 P=0.207 | P=0.411N P=0.274N P=0.582N | |LOGISTIC REGRESSION | P=0.197 P=0.333 P=0.265 | P=0.440N P=0.274N P=0.605N | |COCHRAN-ARMITAGE | P=0.199 | P=0.343N | |FISHER EXACT | P=0.324 P=0.268 | P=0.237N P=0.476N | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05044 TEST: 01 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/ML 50 MG/ML 100 MG/ | 0 MG/ML 50 MG/ML 100 MG/ | | | ML | ML | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/48 (4%) 4/50 (8%) 3/43 (7%) | 2/46 (4%) 0/48 (0%) 1/49 (2%) | |ADJUSTED (b) | 7.1% 27.3% 29.7% | 7.4% 0.0% 3.7% | |TERMINAL (d) | 0/7 (0%) 1/8 (13%) 1/4 (25%) | 2/27 (7%) 0/23 (0%) 0/15 (0%) | |FIRST INCIDENCE (DAYS) | 571 569 503 | 743 (T) --- 670 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.312 P=0.417 P=0.425 | P=0.497N P=0.274N P=0.672N | |INCIDENTAL TUMOR | P=0.346 P=0.332 P=0.407 | P=0.411N P=0.274N P=0.582N | |LOGISTIC REGRESSION | P=0.359 P=0.369 P=0.450 | P=0.440N P=0.274N P=0.605N | |COCHRAN-ARMITAGE | P=0.363 | P=0.343N | |FISHER EXACT | P=0.359 P=0.447 | P=0.237N P=0.476N | |=================================================================================================================================| | | |Urinary Bladder | | Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/49 (0%) | 0/50 (0%) 2/50 (4%) 0/48 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% | 0.0% 8.0% 0.0% | |TERMINAL (d) | 0/6 (0%) 0/8 (0%) 0/4 (0%) | 0/27 (0%) 1/23 (4%) 0/14 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- | --- 676 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.553 P=0.183 (e) | |INCIDENTAL TUMOR | (e) (e) (e) | P=0.626 P=0.144 (e) | |LOGISTIC REGRESSION | (e) (e) (e) | P=0.602 P=0.205 (e) | |COCHRAN-ARMITAGE | (e) | P=0.661 | |FISHER EXACT | (e) (e) | P=0.247 (e) | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05044 TEST: 01 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/ML 50 MG/ML 100 MG/ | 0 MG/ML 50 MG/ML 100 MG/ | | | ML | ML | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # | |----------- | | | |OVERALL (a) | | 3/50 (6%) 8/50 (16%) 6/50 (12%) | |ADJUSTED (b) | | 7.8% 30.8% 26.2% | |TERMINAL (d) | | 0/27 (0%) 6/23 (26%) 2/15 (13%) | |FIRST INCIDENCE (DAYS) | | 626 600 404 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.044 * P=0.053 P=0.070 | |INCIDENTAL TUMOR | | P=0.215 P=0.056 P=0.398 | |LOGISTIC REGRESSION | | P=0.163 P=0.060 P=0.272 | |COCHRAN-ARMITAGE | | P=0.215 | |FISHER EXACT | | P=0.100 P=0.243 | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # | |----------- | | | |OVERALL (a) | | 3/50 (6%) 9/50 (18%) 6/50 (12%) | |ADJUSTED (b) | | 7.8% 32.3% 26.2% | |TERMINAL (d) | | 0/27 (0%) 6/23 (26%) 2/15 (13%) | |FIRST INCIDENCE (DAYS) | | 626 534 404 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.048 * P=0.032 * P=0.070 | |INCIDENTAL TUMOR | | P=0.265 P=0.044 * P=0.398 | |LOGISTIC REGRESSION | | P=0.189 P=0.045 * P=0.272 | |COCHRAN-ARMITAGE | | P=0.221 | |FISHER EXACT | | P=0.061 P=0.243 | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05044 TEST: 01 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/ML 50 MG/ML 100 MG/ | 0 MG/ML 50 MG/ML 100 MG/ | | | ML | ML | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 6.2% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/7 (0%) 0/8 (0%) 0/4 (0%) | 0/27 (0%) 0/23 (0%) 0/15 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 591 | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.100 (e) P=0.258 | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.158 (e) P=0.316 | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.097 (e) P=0.242 | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.095 | (e) | |FISHER EXACT | (e) P=0.247 | (e) (e) | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, | | or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 16/50 (32%) 15/50 (30%) 15/50 (30%) | 12/50 (24%) 17/50 (34%) 13/50 (26%) | |ADJUSTED (b) | 60.3% 65.7% 70.3% | 31.1% 58.7% 50.9% | |TERMINAL (d) | 2/7 (29%) 3/8 (38%) 1/4 (25%) | 2/27 (7%) 12/23 (52%) 5/15 (33%) | |FIRST INCIDENCE (DAYS) | 379 404 543 | 586 571 601 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.428 P=0.322N P=0.488 | P=0.064 P=0.081 P=0.089 | |INCIDENTAL TUMOR | P=0.500N P=0.495N P=0.525N | P=0.304 P=0.073 P=0.497 | |LOGISTIC REGRESSION | P=0.483N P=0.495N P=0.519N | P=0.226 P=0.103 P=0.324 | |COCHRAN-ARMITAGE | P=0.457N | P=0.456 | |FISHER EXACT | P=0.500N P=0.500N | P=0.189 P=0.500 | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05044 TEST: 01 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/ML 50 MG/ML 100 MG/ | 0 MG/ML 50 MG/ML 100 MG/ | | | ML | ML | |=================================================================================================================================| | | |All Organs | | Mesothelioma Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 2.1% 8.2% 2.4% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/7 (0%) 0/8 (0%) 0/4 (0%) | 0/27 (0%) 0/23 (0%) 0/15 (0%) | |FIRST INCIDENCE (DAYS) | 470 626 550 | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.610 P=0.571 P=0.752N | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.608N P=0.476 P=0.730 | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.611N P=0.507 P=0.714N | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.622N | (e) | |FISHER EXACT | P=0.500 P=0.753N | (e) (e) | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 50/50 (100%) 45/50 (90%) 46/50 (92%) | 39/50 (78%) 40/50 (80%) 32/50 (64%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% | 88.2% 95.1% 88.4% | |TERMINAL (d) | 7/7 (100%) 8/8 (100%) 4/4 (100%) | 22/27 (81%) 21/23 (91%) 11/15 (73%) | |FIRST INCIDENCE (DAYS) | 379 387 394 | 425 471 404 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.378 P=0.101N P=0.411 | P=0.078 P=0.130 P=0.083 | |INCIDENTAL TUMOR | P=0.191N P=0.038N* P=0.197N | P=0.180N P=0.388 P=0.231N | |LOGISTIC REGRESSION | P=0.093N P=0.072N P=0.116N | P=0.227N P=0.332 P=0.274N | |COCHRAN-ARMITAGE | P=0.070N | P=0.069N | |FISHER EXACT | P=0.028N* P=0.059N | P=0.500 P=0.093N | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05044 TEST: 01 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/ML 50 MG/ML 100 MG/ | 0 MG/ML 50 MG/ML 100 MG/ | | | ML | ML | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 24/50 (48%) 40/50 (80%) 41/50 (82%) | 25/50 (50%) 38/50 (76%) 39/50 (78%) | |ADJUSTED (b) | 75.9% 100.0% 100.0% | 61.8% 97.4% 100.0% | |TERMINAL (d) | 3/7 (43%) 8/8 (100%) 4/4 (100%) | 12/27 (44%) 22/23 (96%) 15/15 (100%) | |FIRST INCIDENCE (DAYS) | 379 373 242 | 586 534 396 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.001 ** P=0.105 P=0.004 ** | P<0.001 ** P=0.002 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P=0.002 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P=0.002 ** | |FISHER EXACT | P<0.001 ** P<0.001 ** | P=0.006 ** P=0.003 ** | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 50/50 (100%) 49/50 (98%) 49/50 (98%) | 43/50 (86%) 47/50 (94%) 44/50 (88%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% | 89.6% 100.0% 100.0% | |TERMINAL (d) | 7/7 (100%) 8/8 (100%) 4/4 (100%) | 22/27 (81%) 23/23 (100%) 15/15 (100%) | |FIRST INCIDENCE (DAYS) | 379 373 242 | 425 471 396 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.261 P=0.210N P=0.295 | P=0.003 ** P=0.050 P=0.003 ** | |INCIDENTAL TUMOR | P=0.485N (e) P=0.362N | P=0.207 P=0.059 P=0.339 | |LOGISTIC REGRESSION | P=0.437N (e) P=0.626N | P=0.159 P=0.203 P=0.233 | |COCHRAN-ARMITAGE | P=0.331N | P=0.436 | |FISHER EXACT | P=0.500N P=0.500N | P=0.159 P=0.500 | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05044 TEST: 01 PAGE 22 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4-VINYL-1-CYCLOHEXENE DIEPOXIDE TERMINAL SACRIFICE AT 107 WEEKS (a) Number of tumor-bearing animals / number of animals examined at site. (b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for intercurrent mortality. (d) Observed incidence at terminal kill. (f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between the controls and that dosed group. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. The incidental tumor test regards these lesions as non-fatal. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fisher's exact tests compare directly the overall incidence rates. For all tests, a negative trend is indicated by "N". (e) Value of Statistic cannot be computed. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01). --multipart-boundary Content-type: text/plain Range: bytes 149862-149862/149862 --multipart-boundary--