TR 388 Rat Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus ETHYLENETHIOUREA DATE: 09/09/94 EXPERIMENT: 05076 TEST: 01 TIME: 21:03:12 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01ES82151 ROUTE: DOSED FEED NTP C#: 03372 PATHOLOGIST: J. TOFT S. EUSTIS CAS: 96-45-7 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus ETHYLENETHIOUREA DATE: 09/09/94 EXPERIMENT: 05076 TEST: 01 TIME: 21:03:12 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES82151 ROUTE: DOSED FEED NTP C#: 03372 PATHOLOGIST: J. TOFT S. EUSTIS CAS: 96-45-7 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 ETHYLENETHIOUREA DATE: 09/09/94 EXPERIMENT: 05076 TEST: 01 TIME: 21:03:12 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES82151 ROUTE: DOSED FEED NTP C#: 03372 PATHOLOGIST: J. TOFT S. EUSTIS CAS: 96-45-7 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF ETHYLENETHIOUREA ==================================================================================================== MALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma: Benign, Complex, Malignant, NOS Clitoral/Preputial Gland Adenoma Carcinoma or Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma Skin: Subcutaneous Tissue Neurofibrosarcoma, Fibrosarcoma, Sarcoma, Neurofibroma, or Fibroma Testes Adenoma Thymus Thymoma Benign Thyroid Gland: C-Cell Adenoma Carcinoma or Adenoma Thyroid Gland: Follicular Cell Adenoma Carcinoma Carcinoma or Adenoma Zymbal's Gland Carcinoma Carcinoma or Adenoma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus ETHYLENETHIOUREA DATE: 09/09/94 EXPERIMENT: 05076 TEST: 01 TIME: 21:03:12 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES82151 ROUTE: DOSED FEED NTP C#: 03372 PATHOLOGIST: J. TOFT S. EUSTIS CAS: 96-45-7 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF ETHYLENETHIOUREA ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Mammary Gland Carcinoma Fibroadenoma Pituitary Gland: Pars Distalis or Unspecified Site Carcinoma Carcinoma or Adenoma Thyroid Gland: Follicular Cell Adenoma Carcinoma Carcinoma or Adenoma Zymbal's Gland Carcinoma Carcinoma or Adenoma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/100 (1%) 0/49 (0%) 2/149 (1%) 1/100 (1%) | 3/99 (3%) 6/49 (12%) 2/147 (1%) 2/100 (2%) | |ADJUSTED (b) | 2.0% 0.0% 1.9% 3.6% | 5.6% 18.2% 2.2% 4.4% | |TERMINAL (d) | 0/37 (0%) 0/22 (0%) 0/52 (0%) 0/20 (0%) | 3/54 (6%) 6/33 (18%) 2/93 (2%) 1/34 (3%) | |FIRST INCIDENCE (DAYS) | 707 --- 453 719 | 740 (T) 740 (T) 740 (T) 637 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.521 P=0.634N P=0.619 P=0.668 | P=0.306N P=0.066 P=0.266N P=0.674N | |INCIDENTAL TUMOR | P=0.646 P=0.624N P=0.649 P=0.739N | P=0.244N P=0.066 P=0.266N P=0.573N | |LOGISTIC REGRESSION | P=0.623 P=0.626N P=0.636 P=0.694 | P=0.234N P=0.066 P=0.266N P=0.576N | |COCHRAN-ARMITAGE | P=0.616 | P=0.139N | |FISHER EXACT | P=0.671N P=0.646 P=0.751N | P=0.036 * P=0.320N P=0.495N | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 53/100 (53%) 24/49 (49%) 70/148 (47%) 46/100 (46%)| 10/99 (10%) 3/49 (6%) 18/148 (12%) 11/100 (11%)| |ADJUSTED (b) | 82.9% 75.7% 70.6% 78.3% | 16.9% 8.5% 17.1% 19.0% | |TERMINAL (d) | 27/37 (73%) 15/22 (68%) 26/52 (50%) 9/20 (45%) | 7/54 (13%) 2/33 (6%) 10/93 (11%) 2/34 (6%) | |FIRST INCIDENCE (DAYS) | 507 497 453 486 | 592 699 550 564 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.024 * P=0.147N P=0.366N P=0.086 | P=0.090 P=0.204N P=0.525 P=0.246 | |INCIDENTAL TUMOR | P=0.489N P=0.248N P=0.207N P=0.419N | P=0.531 P=0.262N P=0.439 P=0.545N | |LOGISTIC REGRESSION | P=0.493 P=0.260N P=0.232N P=0.519N | P=0.331 P=0.247N P=0.447 P=0.475 | |COCHRAN-ARMITAGE | P=0.220N | P=0.397 | |FISHER EXACT | P=0.387N P=0.226N P=0.198N | P=0.319N P=0.388 P=0.510 | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/100 (3%) 1/49 (2%) 6/148 (4%) 3/100 (3%) | 0/99 (0%) 0/49 (0%) 2/148 (1%) 0/100 (0%) | |ADJUSTED (b) | 5.8% 2.4% 8.6% 7.3% | 0.0% 0.0% 1.9% 0.0% | |TERMINAL (d) | 1/37 (3%) 0/22 (0%) 3/52 (6%) 0/20 (0%) | 0/54 (0%) 0/33 (0%) 1/93 (1%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 619 580 617 438 | --- --- 638 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.376 P=0.535N P=0.437 P=0.500 | P=0.743N (e) P=0.359 (e) | |INCIDENTAL TUMOR | P=0.593 P=0.646N P=0.464 P=0.645N | P=0.569N (e) P=0.377 (e) | |LOGISTIC REGRESSION | P=0.560 P=0.580N P=0.459 P=0.648 | P=0.662N (e) P=0.330 (e) | |COCHRAN-ARMITAGE | P=0.584 | P=0.660N | |FISHER EXACT | P=0.601N P=0.473 P=0.659N | (e) P=0.358 (e) | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 54/100 (54%) 25/49 (51%) 75/148 (51%) 47/100 (47%)| 10/99 (10%) 3/49 (6%) 20/148 (14%) 11/100 (11%)| |ADJUSTED (b) | 83.1% 76.3% 73.6% 78.5% | 16.9% 8.5% 18.8% 19.0% | |TERMINAL (d) | 27/37 (73%) 15/22 (68%) 28/52 (54%) 9/20 (45%) | 7/54 (13%) 2/33 (6%) 11/93 (12%) 2/34 (6%) | |FIRST INCIDENCE (DAYS) | 507 497 453 438 | 592 699 550 564 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.027 * P=0.175N P=0.488N P=0.087 | P=0.096 P=0.204N P=0.408 P=0.246 | |INCIDENTAL TUMOR | P=0.431N P=0.319N P=0.331N P=0.405N | P=0.543N P=0.262N P=0.332 P=0.545N | |LOGISTIC REGRESSION | P=0.527N P=0.316N P=0.365N P=0.490N | P=0.353 P=0.247N P=0.326 P=0.475 | |COCHRAN-ARMITAGE | P=0.194N | P=0.418 | |FISHER EXACT | P=0.433N P=0.350N P=0.198N | P=0.319N P=0.275 P=0.510 | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Bone | | Chondrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/100 (0%) 0/50 (0%) 0/150 (0%) 0/100 (0%) | 0/100 (0%) 2/50 (4%) 0/150 (0%) 0/100 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 5.7% 0.0% 0.0% | |TERMINAL (d) | 0/37 (0%) 0/22 (0%) 0/52 (0%) 0/20 (0%) | 0/54 (0%) 1/34 (3%) 0/93 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- 735 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.414N P=0.148 (e) (e) | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.329N P=0.099 (e) (e) | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.395N P=0.137 (e) (e) | |COCHRAN-ARMITAGE | (e) | P=0.326N | |FISHER EXACT | (e) (e) (e) | P=0.110 (e) (e) | |=================================================================================================================================| | | |Bone | | Osteosarcoma or Osteoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/100 (1%) 0/50 (0%) 2/150 (1%) 0/100 (0%) | 1/100 (1%) 0/50 (0%) 0/150 (0%) 0/100 (0%) | |ADJUSTED (b) | 1.0% 0.0% 1.4% 0.0% | 1.4% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/37 (0%) 0/22 (0%) 0/52 (0%) 0/20 (0%) | 0/54 (0%) 0/34 (0%) 0/93 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 416 --- 381 --- | 658 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.408N P=0.649N P=0.635 P=0.506N | P=0.475N P=0.618N P=0.405N P=0.535N | |INCIDENTAL TUMOR | P=0.360N P=0.638N P=0.643 P=0.469N | P=0.390N P=0.701N P=0.445N P=0.445N | |LOGISTIC REGRESSION | P=0.217N P=0.632N P=0.700 P=0.381N | P=0.440N P=0.660N P=0.432N P=0.499N | |COCHRAN-ARMITAGE | P=0.401N | P=0.444N | |FISHER EXACT | P=0.667N P=0.649 P=0.500N | P=0.667N P=0.400N P=0.500N | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/98 (7%) 1/49 (2%) 1/145 (1%) 3/99 (3%) | 4/98 (4%) 0/49 (0%) 3/141 (2%) 4/94 (4%) | |ADJUSTED (b) | 15.4% 3.6% 1.7% 4.6% | 7.5% 0.0% 3.4% 5.8% | |TERMINAL (d) | 4/36 (11%) 0/22 (0%) 0/49 (0%) 0/20 (0%) | 4/53 (8%) 0/34 (0%) 3/88 (3%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | 507 703 713 527 | 740 (T) --- 740 (T) 548 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.413N P=0.146N P=0.011N* P=0.330N | P=0.174 P=0.134N P=0.244N P=0.465 | |INCIDENTAL TUMOR | P=0.279N P=0.146N P=0.009N** P=0.218N | P=0.347 P=0.134N P=0.244N P=0.626N | |LOGISTIC REGRESSION | P=0.266N P=0.174N P=0.009N** P=0.179N | P=0.332 P=0.134N P=0.244N P=0.611 | |COCHRAN-ARMITAGE | P=0.243N | P=0.353 | |FISHER EXACT | P=0.187N P=0.008N** P=0.161N | P=0.193N P=0.307N P=0.616 | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/98 (2%) 1/49 (2%) 1/145 (1%) 1/99 (1%) | 1/98 (1%) 0/49 (0%) 2/141 (1%) 0/94 (0%) | |ADJUSTED (b) | 3.9% 2.1% 1.4% 2.0% | 1.4% 0.0% 2.3% 0.0% | |TERMINAL (d) | 1/36 (3%) 0/22 (0%) 0/49 (0%) 0/20 (0%) | 0/53 (0%) 0/34 (0%) 2/88 (2%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | 552 395 695 650 | 658 --- 740 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.515N P=0.712N P=0.386N P=0.602N | P=0.521N P=0.618N P=0.668 P=0.535N | |INCIDENTAL TUMOR | P=0.398N P=0.700 P=0.357N P=0.508N | P=0.461N P=0.727N P=0.643 P=0.452N | |LOGISTIC REGRESSION | P=0.376N P=0.730N P=0.366N P=0.502N | P=0.442N P=0.659N P=0.645 P=0.506N | |COCHRAN-ARMITAGE | P=0.416N | P=0.411N | |FISHER EXACT | P=0.742N P=0.356N P=0.496N | P=0.667N P=0.634 P=0.510N | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 9/98 (9%) 2/49 (4%) 2/145 (1%) 4/99 (4%) | 5/98 (5%) 0/49 (0%) 5/141 (4%) 4/94 (4%) | |ADJUSTED (b) | 19.0% 5.6% 3.0% 6.6% | 8.8% 0.0% 5.7% 5.8% | |TERMINAL (d) | 5/36 (14%) 0/22 (0%) 0/49 (0%) 0/20 (0%) | 4/53 (8%) 0/34 (0%) 5/88 (6%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | 507 395 695 527 | 658 --- 740 (T) 548 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.347N P=0.177N P=0.008N** P=0.292N | P=0.277 P=0.093N P=0.312N P=0.591 | |INCIDENTAL TUMOR | P=0.195N P=0.195N P=0.006N** P=0.167N | P=0.480 P=0.107N P=0.325N P=0.461N | |LOGISTIC REGRESSION | P=0.179N P=0.220N P=0.006N** P=0.136N | P=0.472 P=0.107N P=0.329N P=0.531N | |COCHRAN-ARMITAGE | P=0.178N | P=0.504 | |FISHER EXACT | P=0.224N P=0.005N** P=0.121N | P=0.127N P=0.391N P=0.526N | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/98 (4%) 0/50 (0%) 4/149 (3%) 2/100 (2%) | 0/99 (0%) 1/50 (2%) 1/150 (1%) 0/99 (0%) | |ADJUSTED (b) | 8.4% 0.0% 5.7% 3.9% | 0.0% 2.9% 1.1% 0.0% | |TERMINAL (d) | 1/37 (3%) 0/22 (0%) 1/51 (2%) 0/20 (0%) | 0/54 (0%) 1/34 (3%) 1/93 (1%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 628 --- 661 619 | --- 740 (T) 740 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.605 P=0.165N P=0.466N P=0.504N | P=0.612N P=0.408 P=0.608 (e) | |INCIDENTAL TUMOR | P=0.406N P=0.191N P=0.393N P=0.298N | P=0.612N P=0.408 P=0.608 (e) | |LOGISTIC REGRESSION | P=0.491N P=0.172N P=0.427N P=0.385N | P=0.612N P=0.408 P=0.608 (e) | |COCHRAN-ARMITAGE | P=0.423N | P=0.495N | |FISHER EXACT | P=0.188N P=0.397N P=0.332N | P=0.336 P=0.602 (e) | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/98 (2%) 2/50 (4%) 1/149 (1%) 2/100 (2%) | 0/99 (0%) 0/50 (0%) 1/150 (1%) 0/99 (0%) | |ADJUSTED (b) | 3.9% 9.1% 0.8% 2.9% | 0.0% 0.0% 1.1% 0.0% | |TERMINAL (d) | 0/37 (0%) 2/22 (9%) 0/51 (0%) 0/20 (0%) | 0/54 (0%) 0/34 (0%) 1/93 (1%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 692 733 (T) 585 596 | --- --- 740 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.571 P=0.477 P=0.389N P=0.594 | P=0.836 (e) P=0.608 (e) | |INCIDENTAL TUMOR | P=0.530N P=0.483 P=0.338N P=0.602N | P=0.836 (e) P=0.608 (e) | |LOGISTIC REGRESSION | P=0.588N P=0.470 P=0.359N P=0.685 | P=0.836 (e) P=0.608 (e) | |COCHRAN-ARMITAGE | P=0.557N | P=0.771N | |FISHER EXACT | P=0.415 P=0.347N P=0.682N | (e) P=0.602 (e) | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/98 (6%) 2/50 (4%) 5/149 (3%) 4/100 (4%) | 0/99 (0%) 1/50 (2%) 2/150 (1%) 0/99 (0%) | |ADJUSTED (b) | 12.0% 9.1% 6.5% 6.7% | 0.0% 2.9% 2.2% 0.0% | |TERMINAL (d) | 1/37 (3%) 2/22 (9%) 1/51 (2%) 0/20 (0%) | 0/54 (0%) 1/34 (3%) 2/93 (2%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 628 733 (T) 585 596 | --- 740 (T) 740 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.535 P=0.390N P=0.300N P=0.571N | P=0.602N P=0.408 P=0.365 (e) | |INCIDENTAL TUMOR | P=0.361N P=0.418N P=0.218N P=0.282N | P=0.602N P=0.408 P=0.365 (e) | |LOGISTIC REGRESSION | P=0.460N P=0.407N P=0.252N P=0.415N | P=0.602N P=0.408 P=0.365 (e) | |COCHRAN-ARMITAGE | P=0.391N | P=0.462N | |FISHER EXACT | P=0.454N P=0.235N P=0.361N | P=0.336 P=0.362 (e) | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/100 (1%) 1/49 (2%) 7/150 (5%) 3/100 (3%) | 0/99 (0%) 0/50 (0%) 2/150 (1%) 0/100 (0%) | |ADJUSTED (b) | 2.7% 2.7% 9.5% 7.5% | 0.0% 0.0% 2.2% 0.0% | |TERMINAL (d) | 1/37 (3%) 0/22 (0%) 2/52 (4%) 0/20 (0%) | 0/54 (0%) 0/34 (0%) 2/93 (2%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 733 (T) 646 632 631 | --- --- 740 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.170 P=0.635 P=0.093 P=0.185 | P=0.746 (e) P=0.365 (e) | |INCIDENTAL TUMOR | P=0.361 P=0.620 P=0.107 P=0.301 | P=0.746 (e) P=0.365 (e) | |LOGISTIC REGRESSION | P=0.355 P=0.600 P=0.100 P=0.247 | P=0.746 (e) P=0.365 (e) | |COCHRAN-ARMITAGE | P=0.367 | P=0.662N | |FISHER EXACT | P=0.551 P=0.103 P=0.311 | (e) P=0.362 (e) | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/100 (1%) 1/49 (2%) 8/150 (5%) 3/100 (3%) | 0/99 (0%) 0/50 (0%) 2/150 (1%) 0/100 (0%) | |ADJUSTED (b) | 2.7% 2.7% 11.0% 7.5% | 0.0% 0.0% 2.2% 0.0% | |TERMINAL (d) | 1/37 (3%) 0/22 (0%) 2/52 (4%) 0/20 (0%) | 0/54 (0%) 0/34 (0%) 2/93 (2%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 733 (T) 646 632 631 | --- --- 740 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.181 P=0.635 P=0.064 P=0.185 | P=0.746 (e) P=0.365 (e) | |INCIDENTAL TUMOR | P=0.386 P=0.620 P=0.074 P=0.301 | P=0.746 (e) P=0.365 (e) | |LOGISTIC REGRESSION | P=0.362 P=0.600 P=0.067 P=0.247 | P=0.746 (e) P=0.365 (e) | |COCHRAN-ARMITAGE | P=0.388 | P=0.662N | |FISHER EXACT | P=0.551 P=0.067 P=0.311 | (e) P=0.362 (e) | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/100 (1%) 0/50 (0%) 3/150 (2%) 2/100 (2%) | 2/100 (2%) 0/50 (0%) 2/150 (1%) 0/100 (0%) | |ADJUSTED (b) | 2.5% 0.0% 5.4% 4.5% | 3.7% 0.0% 1.8% 0.0% | |TERMINAL (d) | 0/37 (0%) 0/22 (0%) 2/52 (4%) 0/20 (0%) | 2/54 (4%) 0/34 (0%) 1/93 (1%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 720 --- 713 604 | 740 (T) --- 637 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.207 P=0.602N P=0.435 P=0.402 | P=0.317N P=0.345N P=0.491N P=0.345N | |INCIDENTAL TUMOR | P=0.328 P=0.624N P=0.455 P=0.565 | P=0.219N P=0.345N P=0.478N P=0.345N | |LOGISTIC REGRESSION | P=0.268 P=0.618N P=0.430 P=0.458 | P=0.253N P=0.345N P=0.517N P=0.345N | |COCHRAN-ARMITAGE | P=0.356 | P=0.232N | |FISHER EXACT | P=0.667N P=0.475 P=0.500 | P=0.443N P=0.525N P=0.249N | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/100 (1%) 0/50 (0%) 3/150 (2%) 3/100 (3%) | 2/100 (2%) 0/50 (0%) 2/150 (1%) 1/100 (1%) | |ADJUSTED (b) | 2.5% 0.0% 5.4% 6.4% | 3.7% 0.0% 1.8% 2.3% | |TERMINAL (d) | 0/37 (0%) 0/22 (0%) 2/52 (4%) 0/20 (0%) | 2/54 (4%) 0/34 (0%) 1/93 (1%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 720 --- 713 604 | 740 (T) --- 637 713 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.072 P=0.602N P=0.435 P=0.217 | P=0.665 P=0.345N P=0.491N P=0.645N | |INCIDENTAL TUMOR | P=0.151 P=0.624N P=0.455 P=0.366 | P=0.505N P=0.345N P=0.478N P=0.574N | |LOGISTIC REGRESSION | P=0.116 P=0.618N P=0.430 P=0.273 | P=0.575N P=0.345N P=0.517N P=0.599N | |COCHRAN-ARMITAGE | P=0.168 | P=0.530N | |FISHER EXACT | P=0.667N P=0.475 P=0.311 | P=0.443N P=0.525N P=0.500N | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/100 (1%) 0/50 (0%) 3/150 (2%) 3/100 (3%) | 2/100 (2%) 0/50 (0%) 2/150 (1%) 1/100 (1%) | |ADJUSTED (b) | 2.5% 0.0% 5.4% 6.4% | 3.7% 0.0% 1.8% 2.3% | |TERMINAL (d) | 0/37 (0%) 0/22 (0%) 2/52 (4%) 0/20 (0%) | 2/54 (4%) 0/34 (0%) 1/93 (1%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 720 --- 713 604 | 740 (T) --- 637 713 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.072 P=0.602N P=0.435 P=0.217 | P=0.665 P=0.345N P=0.491N P=0.645N | |INCIDENTAL TUMOR | P=0.151 P=0.624N P=0.455 P=0.366 | P=0.505N P=0.345N P=0.478N P=0.574N | |LOGISTIC REGRESSION | P=0.116 P=0.618N P=0.430 P=0.273 | P=0.575N P=0.345N P=0.517N P=0.599N | |COCHRAN-ARMITAGE | P=0.168 | P=0.530N | |FISHER EXACT | P=0.667N P=0.475 P=0.311 | P=0.443N P=0.525N P=0.500N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/100 (0%) 2/50 (4%) 2/150 (1%) 0/100 (0%) | 0/100 (0%) 0/50 (0%) 0/150 (0%) 0/100 (0%) | |ADJUSTED (b) | 0.0% 8.1% 3.8% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/37 (0%) 1/22 (5%) 2/52 (4%) 0/20 (0%) | 0/54 (0%) 0/34 (0%) 0/93 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | --- 705 733 (T) --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.481N P=0.128 P=0.316 (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.439N P=0.126 P=0.316 (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.438N P=0.120 P=0.316 (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.321N | (e) | |FISHER EXACT | P=0.110 P=0.359 (e) | (e) (e) (e) | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/100 (1%) 0/50 (0%) 2/150 (1%) 0/100 (0%) | 0/100 (0%) 0/50 (0%) 1/150 (1%) 0/100 (0%) | |ADJUSTED (b) | 2.7% 0.0% 3.8% 0.0% | 0.0% 0.0% 1.1% 0.0% | |TERMINAL (d) | 1/37 (3%) 0/22 (0%) 2/52 (4%) 0/20 (0%) | 0/54 (0%) 0/34 (0%) 1/93 (1%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 733 (T) --- 733 (T) --- | --- --- 740 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.566N P=0.604N P=0.618 P=0.623N | P=0.836 (e) P=0.608 (e) | |INCIDENTAL TUMOR | P=0.566N P=0.604N P=0.618 P=0.623N | P=0.836 (e) P=0.608 (e) | |LOGISTIC REGRESSION | P=0.566N P=0.604N P=0.618 P=0.623N | P=0.836 (e) P=0.608 (e) | |COCHRAN-ARMITAGE | P=0.401N | P=0.770N | |FISHER EXACT | P=0.667N P=0.649 P=0.500N | (e) P=0.600 (e) | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/100 (1%) 2/50 (4%) 4/150 (3%) 0/100 (0%) | 0/100 (0%) 0/50 (0%) 1/150 (1%) 0/100 (0%) | |ADJUSTED (b) | 2.7% 8.1% 7.7% 0.0% | 0.0% 0.0% 1.1% 0.0% | |TERMINAL (d) | 1/37 (3%) 1/22 (5%) 4/52 (8%) 0/20 (0%) | 0/54 (0%) 0/34 (0%) 1/93 (1%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 733 (T) 705 733 (T) --- | --- --- 740 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.376N P=0.315 P=0.295 P=0.623N | P=0.836 (e) P=0.608 (e) | |INCIDENTAL TUMOR | P=0.347N P=0.312 P=0.295 P=0.623N | P=0.836 (e) P=0.608 (e) | |LOGISTIC REGRESSION | P=0.330N P=0.303 P=0.295 P=0.623N | P=0.836 (e) P=0.608 (e) | |COCHRAN-ARMITAGE | P=0.196N | P=0.770N | |FISHER EXACT | P=0.258 P=0.335 P=0.500N | (e) P=0.600 (e) | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Mammary Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/100 (0%) 0/50 (0%) 1/150 (1%) 0/100 (0%) | 1/100 (1%) 1/50 (2%) 2/150 (1%) 0/100 (0%) | |ADJUSTED (b) | 0.0% 0.0% 1.9% 0.0% | 1.9% 2.9% 2.2% 0.0% | |TERMINAL (d) | 0/37 (0%) 0/22 (0%) 1/52 (2%) 0/20 (0%) | 1/54 (2%) 1/34 (3%) 2/93 (2%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 733 (T) --- | 740 (T) 740 (T) 740 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.823 (e) P=0.568 (e) | P=0.395N P=0.655 P=0.684 P=0.592N | |INCIDENTAL TUMOR | P=0.823 (e) P=0.568 (e) | P=0.395N P=0.655 P=0.684 P=0.592N | |LOGISTIC REGRESSION | P=0.823 (e) P=0.568 (e) | P=0.395N P=0.655 P=0.684 P=0.592N | |COCHRAN-ARMITAGE | P=0.770N | P=0.275N | |FISHER EXACT | (e) P=0.600 (e) | P=0.557 P=0.649 P=0.500N | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/100 (0%) 0/50 (0%) 1/150 (1%) 0/100 (0%) | 0/100 (0%) 1/50 (2%) 3/150 (2%) 4/100 (4%) | |ADJUSTED (b) | 0.0% 0.0% 1.9% 0.0% | 0.0% 2.6% 3.2% 8.1% | |TERMINAL (d) | 0/37 (0%) 0/22 (0%) 1/52 (2%) 0/20 (0%) | 0/54 (0%) 0/34 (0%) 3/93 (3%) 2/34 (6%) | |FIRST INCIDENCE (DAYS) | --- --- 733 (T) --- | --- 700 740 (T) 544 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.823 (e) P=0.568 (e) | P=0.016 * P=0.393 P=0.234 P=0.041 * | |INCIDENTAL TUMOR | P=0.823 (e) P=0.568 (e) | P=0.030 * P=0.299 P=0.234 P=0.034 * | |LOGISTIC REGRESSION | P=0.823 (e) P=0.568 (e) | P=0.053 P=0.369 P=0.234 P=0.065 | |COCHRAN-ARMITAGE | P=0.770N | P=0.058 | |FISHER EXACT | (e) P=0.600 (e) | P=0.333 P=0.214 P=0.061 | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/100 (0%) 0/50 (0%) 2/150 (1%) 0/100 (0%) | 1/100 (1%) 2/50 (4%) 5/150 (3%) 4/100 (4%) | |ADJUSTED (b) | 0.0% 0.0% 3.8% 0.0% | 1.9% 5.5% 5.4% 8.1% | |TERMINAL (d) | 0/37 (0%) 0/22 (0%) 2/52 (4%) 0/20 (0%) | 1/54 (2%) 1/34 (3%) 5/93 (5%) 2/34 (6%) | |FIRST INCIDENCE (DAYS) | --- --- 733 (T) --- | 740 (T) 700 740 (T) 544 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.723 (e) P=0.316 (e) | P=0.087 P=0.334 P=0.272 P=0.113 | |INCIDENTAL TUMOR | P=0.723 (e) P=0.316 (e) | P=0.125 P=0.286 P=0.272 P=0.105 | |LOGISTIC REGRESSION | P=0.723 (e) P=0.316 (e) | P=0.200 P=0.310 P=0.272 P=0.182 | |COCHRAN-ARMITAGE | P=0.663N | P=0.247 | |FISHER EXACT | (e) P=0.359 (e) | P=0.258 P=0.230 P=0.184 | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/100 (1%) 4/50 (8%) 4/150 (3%) 0/100 (0%) | 26/100 (26%) 8/50 (16%) 33/150 (22%) 17/100 (17%)| |ADJUSTED (b) | 1.9% 17.4% 7.7% 0.0% | 39.7% 22.7% 31.9% 34.8% | |TERMINAL (d) | 0/37 (0%) 3/22 (14%) 4/52 (8%) 0/20 (0%) | 18/54 (33%) 7/34 (21%) 25/93 (27%) 8/34 (24%) | |FIRST INCIDENCE (DAYS) | 698 728 733 (T) --- | 431 700 622 565 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.243N P=0.061 P=0.290 P=0.594N | P=0.407 P=0.042N* P=0.137N P=0.426N | |INCIDENTAL TUMOR | P=0.200N P=0.056 P=0.305 P=0.480N | P=0.295N P=0.079N P=0.229N P=0.190N | |LOGISTIC REGRESSION | P=0.201N P=0.052 P=0.292 P=0.542N | P=0.204N P=0.094N P=0.214N P=0.098N | |COCHRAN-ARMITAGE | P=0.102N | P=0.133N | |FISHER EXACT | P=0.043 * P=0.335 P=0.500N | P=0.119N P=0.281N P=0.084N | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/100 (1%) 4/50 (8%) 5/150 (3%) 0/100 (0%) | 27/100 (27%) 9/50 (18%) 35/150 (23%) 17/100 (17%)| |ADJUSTED (b) | 1.9% 17.4% 9.6% 0.0% | 41.4% 25.5% 33.9% 34.8% | |TERMINAL (d) | 0/37 (0%) 3/22 (14%) 5/52 (10%) 0/20 (0%) | 19/54 (35%) 8/34 (24%) 27/93 (29%) 8/34 (24%) | |FIRST INCIDENCE (DAYS) | 698 728 733 (T) --- | 431 700 622 565 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.263N P=0.061 P=0.196 P=0.594N | P=0.478 P=0.053N P=0.147N P=0.375N | |INCIDENTAL TUMOR | P=0.219N P=0.056 P=0.207 P=0.480N | P=0.240N P=0.098N P=0.241N P=0.155N | |LOGISTIC REGRESSION | P=0.217N P=0.052 P=0.195 P=0.542N | P=0.152N P=0.118N P=0.227N P=0.075N | |COCHRAN-ARMITAGE | P=0.105N | P=0.090N | |FISHER EXACT | P=0.043 * P=0.230 P=0.500N | P=0.155N P=0.304N P=0.062N | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/100 (1%) 4/50 (8%) 6/150 (4%) 0/100 (0%) | 27/100 (27%) 9/50 (18%) 37/150 (25%) 21/100 (21%)| |ADJUSTED (b) | 1.9% 17.4% 11.5% 0.0% | 41.4% 25.5% 35.9% 41.3% | |TERMINAL (d) | 0/37 (0%) 3/22 (14%) 6/52 (12%) 0/20 (0%) | 19/54 (35%) 8/34 (24%) 29/93 (31%) 10/34 (29%) | |FIRST INCIDENCE (DAYS) | 698 728 733 (T) --- | 431 700 622 544 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.282N P=0.061 P=0.130 P=0.594N | P=0.171 P=0.053N P=0.205N P=0.464 | |INCIDENTAL TUMOR | P=0.237N P=0.056 P=0.138 P=0.480N | P=0.525 P=0.098N P=0.318N P=0.416N | |LOGISTIC REGRESSION | P=0.231N P=0.052 P=0.129 P=0.542N | P=0.398N P=0.118N P=0.302N P=0.228N | |COCHRAN-ARMITAGE | P=0.108N | P=0.281N | |FISHER EXACT | P=0.043 * P=0.155 P=0.500N | P=0.155N P=0.393N P=0.204N | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) | | Papilloma Squamous or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/100 (1%) 0/50 (0%) 2/150 (1%) 1/100 (1%) | 1/100 (1%) 0/50 (0%) 3/150 (2%) 1/100 (1%) | |ADJUSTED (b) | 1.4% 0.0% 3.3% 5.0% | 1.3% 0.0% 2.7% 2.9% | |TERMINAL (d) | 0/37 (0%) 0/22 (0%) 1/52 (2%) 1/20 (5%) | 0/54 (0%) 0/34 (0%) 1/93 (1%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 633 --- 696 733 (T) | 654 --- 494 734 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.471 P=0.619N P=0.613 P=0.671 | P=0.524 P=0.623N P=0.494 P=0.690 | |INCIDENTAL TUMOR | P=0.573 P=0.748N P=0.641 P=0.739 | P=0.626 P=0.701N P=0.360 P=0.700N | |LOGISTIC REGRESSION | P=0.555 P=0.639N P=0.632 P=0.733 | P=0.635 P=0.662N P=0.426 P=0.754 | |COCHRAN-ARMITAGE | P=0.614 | P=0.627 | |FISHER EXACT | P=0.667N P=0.649 P=0.751N | P=0.667N P=0.475 P=0.751N | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/100 (1%) 1/50 (2%) 2/150 (1%) 1/100 (1%) | 1/100 (1%) 1/50 (2%) 3/150 (2%) 1/100 (1%) | |ADJUSTED (b) | 1.4% 2.7% 3.3% 5.0% | 1.3% 2.4% 2.7% 2.9% | |TERMINAL (d) | 0/37 (0%) 0/22 (0%) 1/52 (2%) 1/20 (5%) | 0/54 (0%) 0/34 (0%) 1/93 (1%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 633 646 696 733 (T) | 654 652 494 734 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.601 P=0.626 P=0.613 P=0.671 | P=0.639 P=0.620 P=0.494 P=0.690 | |INCIDENTAL TUMOR | P=0.614N P=0.545 P=0.641 P=0.739 | P=0.520N P=0.522 P=0.360 P=0.700N | |LOGISTIC REGRESSION | P=0.631N P=0.599 P=0.632 P=0.733 | P=0.535N P=0.574 P=0.426 P=0.754 | |COCHRAN-ARMITAGE | P=0.577N | P=0.547N | |FISHER EXACT | P=0.557 P=0.649 P=0.751N | P=0.557 P=0.475 P=0.751N | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Parathyroid Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/90 (2%) 2/48 (4%) 2/137 (1%) 1/54 (2%) | 1/93 (1%) 2/48 (4%) 2/139 (1%) 0/79 (0%) | |ADJUSTED (b) | 4.8% 7.6% 4.2% 4.5% | 2.0% 5.9% 2.4% 0.0% | |TERMINAL (d) | 1/34 (3%) 1/22 (5%) 2/48 (4%) 0/12 (0%) | 1/50 (2%) 2/34 (6%) 2/84 (2%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | 701 692 733 (T) 728 | 740 (T) 740 (T) 740 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.599N P=0.499 P=0.571N P=0.722N | P=0.319N P=0.367 P=0.676 P=0.609N | |INCIDENTAL TUMOR | P=0.593N P=0.502 P=0.548N P=0.714N | P=0.319N P=0.367 P=0.676 P=0.609N | |LOGISTIC REGRESSION | P=0.643N P=0.483 P=0.568N P=0.682 | P=0.319N P=0.367 P=0.676 P=0.609N | |COCHRAN-ARMITAGE | P=0.490N | P=0.225N | |FISHER EXACT | P=0.433 P=0.519N P=0.685N | P=0.267 P=0.647 P=0.541N | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 34/100 (34%) 10/48 (21%) 35/145 (24%) 22/99 (22%) | 47/100 (47%) 27/49 (55%) 71/147 (48%) 42/100 (42%)| |ADJUSTED (b) | 48.9% 39.9% 42.7% 52.2% | 63.9% 65.6% 63.0% 64.3% | |TERMINAL (d) | 9/37 (24%) 8/22 (36%) 13/52 (25%) 6/20 (30%) | 29/54 (54%) 20/34 (59%) 52/92 (57%) 15/34 (44%) | |FIRST INCIDENCE (DAYS) | 435 382 276 555 | 466 610 372 462 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.414 P=0.042N* P=0.100N P=0.411N | P=0.073 P=0.436N P=0.271N P=0.188 | |INCIDENTAL TUMOR | P=0.137N P=0.084N P=0.061N P=0.047N* | P=0.283N P=0.366 P=0.485N P=0.366N | |LOGISTIC REGRESSION | P=0.157N P=0.073N P=0.062N P=0.076N | P=0.225N P=0.361 P=0.513N P=0.315N | |COCHRAN-ARMITAGE | P=0.101N | P=0.146N | |FISHER EXACT | P=0.072N P=0.062N P=0.045N* | P=0.225 P=0.472 P=0.285N | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/100 (1%) 0/48 (0%) 1/145 (1%) 0/99 (0%) | 0/100 (0%) 1/49 (2%) 2/147 (1%) 5/100 (5%) | |ADJUSTED (b) | 1.7% 0.0% 0.9% 0.0% | 0.0% 2.9% 1.8% 10.4% | |TERMINAL (d) | 0/37 (0%) 0/22 (0%) 0/52 (0%) 0/20 (0%) | 0/54 (0%) 1/34 (3%) 1/92 (1%) 1/34 (3%) | |FIRST INCIDENCE (DAYS) | 678 --- 603 --- | --- 740 (T) 603 576 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.479N P=0.619N P=0.673N P=0.584N | P=0.003 ** P=0.408 P=0.360 P=0.017 * | |INCIDENTAL TUMOR | P=0.360N P=0.638N P=0.666N P=0.486N | P=0.034 * P=0.408 P=0.376 P=0.060 | |LOGISTIC REGRESSION | P=0.416N P=0.644N P=0.676N P=0.527N | P=0.014 * P=0.408 P=0.315 P=0.033 * | |COCHRAN-ARMITAGE | P=0.419N | P=0.014 * | |FISHER EXACT | P=0.676N P=0.651N P=0.503N | P=0.329 P=0.353 P=0.030 * | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 35/100 (35%) 10/48 (21%) 36/145 (25%) 22/99 (22%) | 47/100 (47%) 28/49 (57%) 73/147 (50%) 47/100 (47%)| |ADJUSTED (b) | 49.8% 39.9% 43.1% 52.2% | 63.9% 68.0% 64.2% 68.8% | |TERMINAL (d) | 9/37 (24%) 8/22 (36%) 13/52 (25%) 6/20 (30%) | 29/54 (54%) 21/34 (62%) 53/92 (58%) 16/34 (47%) | |FIRST INCIDENCE (DAYS) | 435 382 276 555 | 466 610 372 462 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.457 P=0.034N* P=0.095N P=0.369N | P=0.014 * P=0.509N P=0.335N P=0.062 | |INCIDENTAL TUMOR | P=0.105N P=0.067N P=0.055N P=0.033N* | P=0.525N P=0.287 P=0.545 P=0.500 | |LOGISTIC REGRESSION | P=0.128N P=0.058N P=0.057N P=0.058N | P=0.484N P=0.281 P=0.505 P=0.519 | |COCHRAN-ARMITAGE | P=0.081N | P=0.364N | |FISHER EXACT | P=0.057N P=0.057N P=0.033N* | P=0.161 P=0.390 P=0.556N | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Skin | | Basosquamous Tumor Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/100 (1%) 2/50 (4%) 1/150 (1%) 0/100 (0%) | 0/100 (0%) 0/50 (0%) 0/150 (0%) 0/100 (0%) | |ADJUSTED (b) | 1.4% 7.4% 1.9% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/37 (0%) 1/22 (5%) 1/52 (2%) 0/20 (0%) | 0/54 (0%) 0/34 (0%) 0/93 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 628 674 733 (T) --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.269N P=0.303 P=0.679N P=0.536N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.204N P=0.242 P=0.670N P=0.429N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.210N P=0.272 P=0.672N P=0.497N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.182N | (e) | |FISHER EXACT | P=0.258 P=0.641N P=0.500N | (e) (e) (e) | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/100 (3%) 0/50 (0%) 2/150 (1%) 2/100 (2%) | 1/100 (1%) 1/50 (2%) 0/150 (0%) 0/100 (0%) | |ADJUSTED (b) | 6.8% 0.0% 1.7% 5.1% | 1.4% 2.9% 0.0% 0.0% | |TERMINAL (d) | 2/37 (5%) 0/22 (0%) 0/52 (0%) 0/20 (0%) | 0/54 (0%) 1/34 (3%) 0/93 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 640 --- 585 654 | 658 740 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.520 P=0.230N P=0.332N P=0.676N | P=0.310N P=0.639 P=0.405N P=0.535N | |INCIDENTAL TUMOR | P=0.585N P=0.278N P=0.321N P=0.558N | P=0.263N P=0.592 P=0.445N P=0.445N | |LOGISTIC REGRESSION | P=0.624 P=0.255N P=0.324N P=0.586N | P=0.265N P=0.610 P=0.432N P=0.499N | |COCHRAN-ARMITAGE | P=0.615N | P=0.262N | |FISHER EXACT | P=0.293N P=0.316N P=0.500N | P=0.557 P=0.400N P=0.500N | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Skin | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/100 (1%) 0/50 (0%) 2/150 (1%) 0/100 (0%) | 0/100 (0%) 0/50 (0%) 1/150 (1%) 0/100 (0%) | |ADJUSTED (b) | 1.9% 0.0% 2.6% 0.0% | 0.0% 0.0% 1.1% 0.0% | |TERMINAL (d) | 0/37 (0%) 0/22 (0%) 0/52 (0%) 0/20 (0%) | 0/54 (0%) 0/34 (0%) 1/93 (1%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 698 --- 634 --- | --- --- 740 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.490N P=0.627N P=0.607 P=0.594N | P=0.836 (e) P=0.608 (e) | |INCIDENTAL TUMOR | P=0.348N P=0.624N P=0.654 P=0.480N | P=0.836 (e) P=0.608 (e) | |LOGISTIC REGRESSION | P=0.430N P=0.630N P=0.634 P=0.542N | P=0.836 (e) P=0.608 (e) | |COCHRAN-ARMITAGE | P=0.401N | P=0.770N | |FISHER EXACT | P=0.667N P=0.649 P=0.500N | (e) P=0.600 (e) | |=================================================================================================================================| | | |Skin | | Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/100 (0%) 0/50 (0%) 2/150 (1%) 0/100 (0%) | 2/100 (2%) 0/50 (0%) 0/150 (0%) 0/100 (0%) | |ADJUSTED (b) | 0.0% 0.0% 2.6% 0.0% | 3.1% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/37 (0%) 0/22 (0%) 1/52 (2%) 0/20 (0%) | 0/54 (0%) 0/34 (0%) 0/93 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 503 --- | 694 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.735N (e) P=0.323 (e) | P=0.243N P=0.360N P=0.138N P=0.313N | |INCIDENTAL TUMOR | P=0.712N (e) P=0.325 (e) | P=0.163N P=0.478N P=0.179N P=0.179N | |LOGISTIC REGRESSION | P=0.648N (e) P=0.336 (e) | P=0.208N P=0.387N P=0.148N P=0.253N | |COCHRAN-ARMITAGE | P=0.663N | P=0.205N | |FISHER EXACT | (e) P=0.359 (e) | P=0.443N P=0.159N P=0.249N | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Skin | | Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, | | Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/100 (4%) 0/50 (0%) 6/150 (4%) 2/100 (2%) | 3/100 (3%) 1/50 (2%) 1/150 (1%) 0/100 (0%) | |ADJUSTED (b) | 8.6% 0.0% 6.7% 5.1% | 4.4% 2.9% 1.1% 0.0% | |TERMINAL (d) | 2/37 (5%) 0/22 (0%) 1/52 (2%) 0/20 (0%) | 0/54 (0%) 1/34 (3%) 1/93 (1%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 640 --- 503 654 | 658 740 (T) 740 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.582N P=0.158N P=0.599 P=0.537N | P=0.118N P=0.505N P=0.152N P=0.176N | |INCIDENTAL TUMOR | P=0.368N P=0.189N P=0.624N P=0.379N | P=0.073N P=0.638N P=0.193N P=0.076N | |LOGISTIC REGRESSION | P=0.431N P=0.173N P=0.627 P=0.428N | P=0.087N P=0.553N P=0.168N P=0.126N | |COCHRAN-ARMITAGE | P=0.403N | P=0.082N | |FISHER EXACT | P=0.194N P=0.621N P=0.341N | P=0.593N P=0.177N P=0.123N | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/100 (2%) 3/50 (6%) 10/150 (7%) 1/100 (1%) | 0/100 (0%) 0/50 (0%) 2/150 (1%) 1/100 (1%) | |ADJUSTED (b) | 4.2% 13.6% 13.0% 3.8% | 0.0% 0.0% 2.0% 1.2% | |TERMINAL (d) | 1/37 (3%) 3/22 (14%) 2/52 (4%) 0/20 (0%) | 0/54 (0%) 0/34 (0%) 1/93 (1%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 640 733 (T) 594 723 | --- --- 713 600 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.430N P=0.272 P=0.077 P=0.635N | P=0.311 (e) P=0.362 P=0.505 | |INCIDENTAL TUMOR | P=0.224N P=0.223 P=0.087 P=0.517N | P=0.514 (e) P=0.333 P=0.731 | |LOGISTIC REGRESSION | P=0.279N P=0.239 P=0.078 P=0.574N | P=0.399 (e) P=0.354 P=0.476 | |COCHRAN-ARMITAGE | P=0.202N | P=0.398 | |FISHER EXACT | P=0.207 P=0.078 P=0.500N | (e) P=0.359 P=0.500 | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/100 (2%) 2/50 (4%) 6/150 (4%) 1/100 (1%) | 1/100 (1%) 0/50 (0%) 1/150 (1%) 1/100 (1%) | |ADJUSTED (b) | 4.7% 6.6% 7.1% 1.7% | 1.9% 0.0% 1.1% 2.6% | |TERMINAL (d) | 0/37 (0%) 0/22 (0%) 1/52 (2%) 0/20 (0%) | 1/54 (2%) 0/34 (0%) 1/93 (1%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 712 642 503 634 | 740 (T) --- 740 (T) 726 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.418N P=0.487 P=0.285 P=0.600N | P=0.477 P=0.592N P=0.635N P=0.668 | |INCIDENTAL TUMOR | P=0.231N P=0.399 P=0.313 P=0.435N | P=0.555 P=0.592N P=0.635N P=0.744 | |LOGISTIC REGRESSION | P=0.293N P=0.446 P=0.303 P=0.556N | P=0.506 P=0.592N P=0.635N P=0.693 | |COCHRAN-ARMITAGE | P=0.277N | P=0.599 | |FISHER EXACT | P=0.407 P=0.312 P=0.500N | P=0.667N P=0.641N P=0.751N | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, Sarcoma, | | Neurofibroma, or Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/100 (4%) 6/50 (12%) 17/150 (11%) 2/100 (2%) | 1/100 (1%) 0/50 (0%) 3/150 (2%) 2/100 (2%) | |ADJUSTED (b) | 8.6% 23.6% 20.9% 5.5% | 1.9% 0.0% 3.1% 3.8% | |TERMINAL (d) | 1/37 (3%) 4/22 (18%) 4/52 (8%) 0/20 (0%) | 1/54 (2%) 0/34 (0%) 2/93 (2%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 640 642 503 634 | 740 (T) --- 713 600 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.296N P=0.115 P=0.033 * P=0.503N | P=0.211 P=0.592N P=0.510 P=0.411 | |INCIDENTAL TUMOR | P=0.095N P=0.068 P=0.037 * P=0.307N | P=0.402 P=0.592N P=0.486 P=0.605 | |LOGISTIC REGRESSION | P=0.132N P=0.082 P=0.033 * P=0.425N | P=0.317 P=0.592N P=0.502 P=0.492 | |COCHRAN-ARMITAGE | P=0.089N | P=0.356 | |FISHER EXACT | P=0.070 P=0.031 * P=0.341N | P=0.667N P=0.475 P=0.500 | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, or Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/100 (2%) 3/50 (6%) 7/150 (5%) 1/100 (1%) | 1/100 (1%) 0/50 (0%) 1/150 (1%) 1/100 (1%) | |ADJUSTED (b) | 4.7% 10.9% 8.9% 1.7% | 1.9% 0.0% 1.1% 2.6% | |TERMINAL (d) | 0/37 (0%) 1/22 (5%) 2/52 (4%) 0/20 (0%) | 1/54 (2%) 0/34 (0%) 1/93 (1%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 712 642 503 634 | 740 (T) --- 740 (T) 726 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.371N P=0.270 P=0.207 P=0.600N | P=0.477 P=0.592N P=0.635N P=0.668 | |INCIDENTAL TUMOR | P=0.207N P=0.202 P=0.227 P=0.435N | P=0.555 P=0.592N P=0.635N P=0.744 | |LOGISTIC REGRESSION | P=0.240N P=0.231 P=0.220 P=0.556N | P=0.506 P=0.592N P=0.635N P=0.693 | |COCHRAN-ARMITAGE | P=0.212N | P=0.599 | |FISHER EXACT | P=0.207 P=0.227 P=0.500N | P=0.667N P=0.641N P=0.751N | |=================================================================================================================================| | | |Spleen | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/100 (1%) 0/50 (0%) 1/150 (1%) 0/100 (0%) | 0/100 (0%) 0/50 (0%) 2/150 (1%) 0/100 (0%) | |ADJUSTED (b) | 2.7% 0.0% 0.9% 0.0% | 0.0% 0.0% 2.0% 0.0% | |TERMINAL (d) | 1/37 (3%) 0/22 (0%) 0/52 (0%) 0/20 (0%) | 0/54 (0%) 0/34 (0%) 1/93 (1%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 733 (T) --- 619 --- | --- --- 694 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.504N P=0.604N P=0.679N P=0.623N | P=0.754 (e) P=0.360 (e) | |INCIDENTAL TUMOR | P=0.426N P=0.604N P=0.670N P=0.623N | P=0.672N (e) P=0.333 (e) | |LOGISTIC REGRESSION | P=0.440N P=0.604N P=0.671N P=0.623N | P=0.700N (e) P=0.348 (e) | |COCHRAN-ARMITAGE | P=0.420N | P=0.663N | |FISHER EXACT | P=0.667N P=0.641N P=0.500N | (e) P=0.359 (e) | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 22 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 87/100 (87%) 44/50 (88%) 133/150 (89%) 85/100 (85%)| | |ADJUSTED (b) | 98.8% 97.8% 100.0% 100.0% | | |TERMINAL (d) | 36/37 (97%) 21/22 (95%) 52/52 (100%) 20/20 (100%)| | |FIRST INCIDENCE (DAYS) | 372 444 381 438 | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.264N P=0.280 P=0.006 ** | | |INCIDENTAL TUMOR | P=0.254 P=0.596N P=0.384 P=0.299 | | |LOGISTIC REGRESSION | P=0.384 P=0.497 P=0.354 P=0.393 | | |COCHRAN-ARMITAGE | P=0.321N | | |FISHER EXACT | P=0.543 P=0.418 P=0.419N | | |=================================================================================================================================| | | |Thymus | | Thymoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/79 (0%) 0/45 (0%) 0/120 (0%) 2/87 (2%) | 0/89 (0%) 0/44 (0%) 0/131 (0%) 0/85 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 6.7% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/19 (0%) 0/44 (0%) 1/19 (5%) | 0/51 (0%) 0/31 (0%) 0/80 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 604 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.024 * (e) (e) P=0.175 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.043 * (e) (e) P=0.214 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.045 * (e) (e) P=0.237 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.053 | (e) | |FISHER EXACT | (e) (e) P=0.273 | (e) (e) (e) | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 23 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 21/98 (21%) 10/46 (22%) 41/143 (29%) 12/100 (12%)| 21/98 (21%) 17/49 (35%) 26/137 (19%) 18/99 (18%) | |ADJUSTED (b) | 41.3% 33.9% 49.3% 32.6% | 31.9% 44.2% 26.7% 34.3% | |TERMINAL (d) | 12/37 (32%) 4/21 (19%) 15/51 (29%) 3/20 (15%) | 13/54 (24%) 13/34 (38%) 22/92 (24%) 8/34 (24%) | |FIRST INCIDENCE (DAYS) | 507 642 486 538 | 424 581 558 564 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.458N P=0.406N P=0.117 P=0.413N | P=0.375 P=0.218 P=0.159N P=0.378 | |INCIDENTAL TUMOR | P=0.053N P=0.552N P=0.151 P=0.131N | P=0.241N P=0.084 P=0.312N P=0.410N | |LOGISTIC REGRESSION | P=0.078N P=0.548N P=0.128 P=0.118N | P=0.206N P=0.088 P=0.291N P=0.367N | |COCHRAN-ARMITAGE | P=0.025N* | P=0.141N | |FISHER EXACT | P=0.564 P=0.132 P=0.056N | P=0.064 P=0.381N P=0.347N | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/98 (3%) 1/46 (2%) 0/143 (0%) 0/100 (0%) | 4/98 (4%) 1/49 (2%) 3/137 (2%) 1/99 (1%) | |ADJUSTED (b) | 8.1% 4.8% 0.0% 0.0% | 6.3% 2.9% 3.3% 2.9% | |TERMINAL (d) | 3/37 (8%) 1/21 (5%) 0/51 (0%) 0/20 (0%) | 1/54 (2%) 1/34 (3%) 3/92 (3%) 1/34 (3%) | |FIRST INCIDENCE (DAYS) | 733 (T) 733 (T) --- --- | 674 740 (T) 740 (T) 740 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.117N P=0.522N P=0.071N P=0.248N | P=0.307N P=0.365N P=0.242N P=0.303N | |INCIDENTAL TUMOR | P=0.117N P=0.522N P=0.071N P=0.248N | P=0.208N P=0.491N P=0.313N P=0.175N | |LOGISTIC REGRESSION | P=0.117N P=0.522N P=0.071N P=0.248N | P=0.226N P=0.402N P=0.277N P=0.218N | |COCHRAN-ARMITAGE | P=0.067N | P=0.171N | |FISHER EXACT | P=0.618N P=0.066N P=0.119N | P=0.459N P=0.321N P=0.181N | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 24 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 23/98 (23%) 11/46 (24%) 41/143 (29%) 12/100 (12%)| 23/98 (23%) 18/49 (37%) 28/137 (20%) 18/99 (18%) | |ADJUSTED (b) | 46.0% 37.8% 49.3% 32.6% | 34.1% 46.9% 28.8% 34.3% | |TERMINAL (d) | 14/37 (38%) 5/21 (24%) 15/51 (29%) 3/20 (15%) | 13/54 (24%) 14/34 (41%) 24/92 (26%) 8/34 (24%) | |FIRST INCIDENCE (DAYS) | 507 642 486 538 | 424 581 558 564 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.355N P=0.395N P=0.193 P=0.316N | P=0.496 P=0.240 P=0.130N P=0.491 | |INCIDENTAL TUMOR | P=0.030N* P=0.537N P=0.251 P=0.084N | P=0.143N P=0.082 P=0.280N P=0.259N | |LOGISTIC REGRESSION | P=0.043N* P=0.540N P=0.221 P=0.068N | P=0.124N P=0.097 P=0.249N P=0.249N | |COCHRAN-ARMITAGE | P=0.011N* | P=0.076N | |FISHER EXACT | P=0.555 P=0.227 P=0.026N* | P=0.069 P=0.345N P=0.230N | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/98 (1%) 1/46 (2%) 27/143 (19%) 57/100 (57%)| 1/98 (1%) 0/49 (0%) 18/137 (13%) 57/99 (58%) | |ADJUSTED (b) | 2.7% 4.8% 35.3% 87.4% | 1.9% 0.0% 18.8% 86.6% | |TERMINAL (d) | 1/37 (3%) 1/21 (5%) 11/51 (22%) 14/20 (70%) | 1/54 (2%) 0/34 (0%) 16/92 (17%) 26/34 (76%) | |FIRST INCIDENCE (DAYS) | 733 (T) 733 (T) 466 391 | 740 (T) --- 597 469 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.630 P<0.001 ** P<0.001 ** | P<0.001 ** P=0.592N P=0.003 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P=0.630 P<0.001 ** P<0.001 ** | P<0.001 ** P=0.592N P=0.002 ** P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P=0.630 P<0.001 ** P<0.001 ** | P<0.001 ** P=0.592N P=0.002 ** P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** | |FISHER EXACT | P=0.538 P<0.001 ** P<0.001 ** | P=0.667N P<0.001 ** P<0.001 ** | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 25 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/98 (4%) 2/46 (4%) 13/143 (9%) 70/100 (70%)| 2/98 (2%) 1/49 (2%) 4/137 (3%) 25/99 (25%) | |ADJUSTED (b) | 6.7% 5.1% 17.6% 96.8% | 3.7% 2.9% 4.2% 48.2% | |TERMINAL (d) | 1/37 (3%) 0/21 (0%) 6/51 (12%) 18/20 (90%) | 2/54 (4%) 1/34 (3%) 3/92 (3%) 12/34 (35%) | |FIRST INCIDENCE (DAYS) | 512 497 552 391 | 740 (T) 740 (T) 721 462 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.641N P=0.103 P<0.001 ** | P<0.001 ** P=0.659N P=0.595 P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P=0.620 P=0.110 P<0.001 ** | P<0.001 ** P=0.659N P=0.562 P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P=0.640 P=0.109 P<0.001 ** | P<0.001 ** P=0.659N P=0.584 P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** | |FISHER EXACT | P=0.625 P=0.106 P<0.001 ** | P=0.742N P=0.509 P<0.001 ** | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/98 (5%) 3/46 (7%) 39/143 (27%) 85/100 (85%)| 3/98 (3%) 1/49 (2%) 22/137 (16%) 67/99 (68%) | |ADJUSTED (b) | 9.3% 9.6% 47.1% 100.0% | 5.6% 2.9% 22.8% 89.7% | |TERMINAL (d) | 2/37 (5%) 1/21 (5%) 16/51 (31%) 20/20 (100%)| 3/54 (6%) 1/34 (3%) 19/92 (21%) 27/34 (79%) | |FIRST INCIDENCE (DAYS) | 512 497 466 391 | 740 (T) 740 (T) 597 462 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.590 P<0.001 ** P<0.001 ** | P<0.001 ** P=0.481N P=0.005 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P=0.520 P<0.001 ** P<0.001 ** | P<0.001 ** P=0.481N P=0.004 ** P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P=0.514 P<0.001 ** P<0.001 ** | P<0.001 ** P=0.481N P=0.004 ** P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** | |FISHER EXACT | P=0.499 P<0.001 ** P<0.001 ** | P=0.593N P<0.001 ** P<0.001 ** | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 26 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Tongue | | Squamous Cell Carcinoma or Papilloma Squamous | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/100 (1%) 0/50 (0%) 1/150 (1%) 1/100 (1%) | 1/100 (1%) 1/50 (2%) 3/150 (2%) 1/100 (1%) | |ADJUSTED (b) | 1.4% 0.0% 1.4% 5.0% | 1.3% 2.4% 2.7% 2.9% | |TERMINAL (d) | 0/37 (0%) 0/22 (0%) 0/52 (0%) 1/20 (5%) | 0/54 (0%) 0/34 (0%) 1/93 (1%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 633 --- 696 733 (T) | 654 652 494 734 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.487 P=0.619N P=0.687N P=0.671 | P=0.639 P=0.620 P=0.494 P=0.690 | |INCIDENTAL TUMOR | P=0.601 P=0.748N P=0.656N P=0.739 | P=0.520N P=0.522 P=0.360 P=0.700N | |LOGISTIC REGRESSION | P=0.563 P=0.639N P=0.670N P=0.733 | P=0.535N P=0.574 P=0.426 P=0.754 | |COCHRAN-ARMITAGE | P=0.599 | P=0.547N | |FISHER EXACT | P=0.667N P=0.641N P=0.751N | P=0.557 P=0.475 P=0.751N | |=================================================================================================================================| | | |Tongue | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/100 (1%) 0/50 (0%) 1/150 (1%) 1/100 (1%) | 1/100 (1%) 0/50 (0%) 3/150 (2%) 1/100 (1%) | |ADJUSTED (b) | 1.4% 0.0% 1.4% 5.0% | 1.3% 0.0% 2.7% 2.9% | |TERMINAL (d) | 0/37 (0%) 0/22 (0%) 0/52 (0%) 1/20 (5%) | 0/54 (0%) 0/34 (0%) 1/93 (1%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 633 --- 696 733 (T) | 654 --- 494 734 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.487 P=0.619N P=0.687N P=0.671 | P=0.524 P=0.623N P=0.494 P=0.690 | |INCIDENTAL TUMOR | P=0.601 P=0.748N P=0.656N P=0.739 | P=0.626 P=0.701N P=0.360 P=0.700N | |LOGISTIC REGRESSION | P=0.563 P=0.639N P=0.670N P=0.733 | P=0.635 P=0.662N P=0.426 P=0.754 | |COCHRAN-ARMITAGE | P=0.599 | P=0.627 | |FISHER EXACT | P=0.667N P=0.641N P=0.751N | P=0.667N P=0.475 P=0.751N | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 27 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 15/100 (15%) 13/50 (26%) 28/150 (19%) 10/100 (10%)| |ADJUSTED (b) | | 24.4% 34.1% 26.6% 21.6% | |TERMINAL (d) | | 11/54 (20%) 9/34 (26%) 20/93 (22%) 5/34 (15%) | |FIRST INCIDENCE (DAYS) | | 494 679 312 570 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.373N P=0.216 P=0.438 P=0.518N | |INCIDENTAL TUMOR | | P=0.140N P=0.112 P=0.310 P=0.327N | |LOGISTIC REGRESSION | | P=0.135N P=0.124 P=0.312 P=0.233N | |COCHRAN-ARMITAGE | | P=0.050N | |FISHER EXACT | | P=0.081 P=0.282 P=0.196N | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 16/100 (16%) 13/50 (26%) 29/150 (19%) 11/100 (11%)| |ADJUSTED (b) | | 25.1% 34.1% 27.3% 22.5% | |TERMINAL (d) | | 11/54 (20%) 9/34 (26%) 20/93 (22%) 5/34 (15%) | |FIRST INCIDENCE (DAYS) | | 480 679 312 570 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.409N P=0.265 P=0.469 P=0.515N | |INCIDENTAL TUMOR | | P=0.148N P=0.132 P=0.307 P=0.326N | |LOGISTIC REGRESSION | | P=0.076N P=0.145 P=0.325 P=0.217N | |COCHRAN-ARMITAGE | | P=0.060N | |FISHER EXACT | | P=0.108 P=0.309 P=0.204N | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 28 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Zymbal's Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/100 (0%) 0/50 (0%) 0/150 (0%) 1/100 (1%) | 0/100 (0%) 0/50 (0%) 2/150 (1%) 0/100 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 3.7% | 0.0% 0.0% 2.1% 0.0% | |TERMINAL (d) | 0/37 (0%) 0/22 (0%) 0/52 (0%) 0/20 (0%) | 0/54 (0%) 0/34 (0%) 1/93 (1%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 722 | --- --- 720 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.169 (e) (e) P=0.432 | P=0.749 (e) P=0.365 (e) | |INCIDENTAL TUMOR | P=0.242 (e) (e) P=0.520 | P=0.672N (e) P=0.333 (e) | |LOGISTIC REGRESSION | P=0.169 (e) (e) P=0.423 | P=0.733N (e) P=0.356 (e) | |COCHRAN-ARMITAGE | P=0.230 | P=0.663N | |FISHER EXACT | (e) (e) P=0.500 | (e) P=0.359 (e) | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/100 (2%) 1/50 (2%) 6/150 (4%) 7/100 (7%) | 1/100 (1%) 0/50 (0%) 1/150 (1%) 6/100 (6%) | |ADJUSTED (b) | 3.6% 3.3% 5.8% 15.6% | 1.9% 0.0% 0.7% 9.8% | |TERMINAL (d) | 0/37 (0%) 0/22 (0%) 1/52 (2%) 0/20 (0%) | 1/54 (2%) 0/34 (0%) 0/93 (0%) 1/34 (3%) | |FIRST INCIDENCE (DAYS) | 628 696 395 640 | 740 (T) --- 494 565 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.012 * P=0.706N P=0.292 P=0.035 * | P=0.001 ** P=0.592N P=0.648N P=0.040 * | |INCIDENTAL TUMOR | P=0.073 P=0.704 P=0.310 P=0.125 | P=0.012 * P=0.592N P=0.761N P=0.141 | |LOGISTIC REGRESSION | P=0.048 * P=0.728N P=0.320 P=0.135 | P=0.004 ** P=0.592N P=0.708N P=0.062 | |COCHRAN-ARMITAGE | P=0.042 * | P=0.003 ** | |FISHER EXACT | P=0.742N P=0.312 P=0.085 | P=0.667N P=0.641N P=0.059 | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 29 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/100 (2%) 1/50 (2%) 6/150 (4%) 8/100 (8%) | 1/100 (1%) 0/50 (0%) 3/150 (2%) 6/100 (6%) | |ADJUSTED (b) | 3.6% 3.3% 5.8% 18.7% | 1.9% 0.0% 2.7% 9.8% | |TERMINAL (d) | 0/37 (0%) 0/22 (0%) 1/52 (2%) 0/20 (0%) | 1/54 (2%) 0/34 (0%) 1/93 (1%) 1/34 (3%) | |FIRST INCIDENCE (DAYS) | 628 696 395 640 | 740 (T) --- 494 565 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.004 ** P=0.706N P=0.292 P=0.018 * | P=0.003 ** P=0.592N P=0.502 P=0.040 * | |INCIDENTAL TUMOR | P=0.036 * P=0.704 P=0.310 P=0.078 | P=0.026 * P=0.592N P=0.385 P=0.141 | |LOGISTIC REGRESSION | P=0.020 * P=0.728N P=0.320 P=0.068 | P=0.011 * P=0.592N P=0.445 P=0.062 | |COCHRAN-ARMITAGE | P=0.019 * | P=0.009 ** | |FISHER EXACT | P=0.742N P=0.312 P=0.050 | P=0.667N P=0.475 P=0.059 | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/100 (2%) 0/50 (0%) 0/150 (0%) 1/100 (1%) | 0/100 (0%) 0/50 (0%) 1/150 (1%) 0/100 (0%) | |ADJUSTED (b) | 4.7% 0.0% 0.0% 5.0% | 0.0% 0.0% 0.8% 0.0% | |TERMINAL (d) | 0/37 (0%) 0/22 (0%) 0/52 (0%) 1/20 (5%) | 0/54 (0%) 0/34 (0%) 0/93 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 712 --- --- 733 (T) | --- --- 665 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.692 P=0.371N P=0.174N P=0.652N | P=0.807N (e) P=0.599 (e) | |INCIDENTAL TUMOR | P=0.645N P=0.383N P=0.146N P=0.546N | P=0.704N (e) P=0.555 (e) | |LOGISTIC REGRESSION | P=0.709 P=0.378N P=0.166N P=0.631N | P=0.764N (e) P=0.571 (e) | |COCHRAN-ARMITAGE | P=0.605N | P=0.770N | |FISHER EXACT | P=0.443N P=0.159N P=0.500N | (e) P=0.600 (e) | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 30 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/100 (2%) 0/50 (0%) 0/150 (0%) 1/100 (1%) | 1/100 (1%) 0/50 (0%) 1/150 (1%) 0/100 (0%) | |ADJUSTED (b) | 4.7% 0.0% 0.0% 5.0% | 1.9% 0.0% 0.8% 0.0% | |TERMINAL (d) | 0/37 (0%) 0/22 (0%) 0/52 (0%) 1/20 (5%) | 1/54 (2%) 0/34 (0%) 0/93 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 712 --- --- 733 (T) | 740 (T) --- 665 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.692 P=0.371N P=0.174N P=0.652N | P=0.493N P=0.592N P=0.641N P=0.592N | |INCIDENTAL TUMOR | P=0.645N P=0.383N P=0.146N P=0.546N | P=0.424N P=0.592N P=0.667N P=0.592N | |LOGISTIC REGRESSION | P=0.709 P=0.378N P=0.166N P=0.631N | P=0.430N P=0.592N P=0.661N P=0.592N | |COCHRAN-ARMITAGE | P=0.605N | P=0.420N | |FISHER EXACT | P=0.443N P=0.159N P=0.500N | P=0.667N P=0.641N P=0.500N | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, | | or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 54/100 (54%) 29/50 (58%) 91/150 (61%) 55/100 (55%)| 36/100 (36%) 19/50 (38%) 74/150 (49%) 52/100 (52%)| |ADJUSTED (b) | 71.5% 70.9% 80.7% 84.2% | 46.7% 45.0% 55.9% 69.9% | |TERMINAL (d) | 18/37 (49%) 11/22 (50%) 33/52 (63%) 12/20 (60%) | 15/54 (28%) 12/34 (35%) 36/93 (39%) 15/34 (44%) | |FIRST INCIDENCE (DAYS) | 372 444 371 486 | 523 523 312 469 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.009 ** P=0.480N P=0.163 P=0.026 * | P<0.001 ** P=0.369N P=0.168 P=0.001 ** | |INCIDENTAL TUMOR | P=0.536N P=0.345 P=0.182 P=0.452 | P=0.146 P=0.455 P=0.026 * P=0.104 | |LOGISTIC REGRESSION | P=0.487N P=0.262 P=0.175 P=0.456 | P=0.086 P=0.475 P=0.023 * P=0.111 | |COCHRAN-ARMITAGE | P=0.481N | P=0.016 * | |FISHER EXACT | P=0.387 P=0.180 P=0.500 | P=0.474 P=0.025 * P=0.016 * | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 31 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |All Organs | | Mesothelioma Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/100 (2%) 2/50 (4%) 4/150 (3%) 3/100 (3%) | 1/100 (1%) 0/50 (0%) 0/150 (0%) 0/100 (0%) | |ADJUSTED (b) | 3.7% 7.1% 5.3% 4.1% | 1.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/37 (0%) 1/22 (5%) 1/52 (2%) 0/20 (0%) | 0/54 (0%) 0/34 (0%) 0/93 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 650 646 605 506 | 424 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.355 P=0.476 P=0.500 P=0.419 | P=0.443N P=0.636N P=0.420N P=0.498N | |INCIDENTAL TUMOR | P=0.564 P=0.466 P=0.547 P=0.595 | P=0.566N P=0.788N P=0.597N P=0.690N | |LOGISTIC REGRESSION | P=0.507 P=0.437 P=0.527 P=0.518 | P=0.603N P=0.863N P=0.544N P=0.742N | |COCHRAN-ARMITAGE | P=0.520 | P=0.444N | |FISHER EXACT | P=0.407 P=0.544 P=0.500 | P=0.667N P=0.400N P=0.500N | |=================================================================================================================================| | | |All Organs | | Osteosarcoma or Osteoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/100 (1%) 0/50 (0%) 2/150 (1%) 0/100 (0%) | 1/100 (1%) 0/50 (0%) 0/150 (0%) 0/100 (0%) | |ADJUSTED (b) | 1.0% 0.0% 1.4% 0.0% | 1.4% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/37 (0%) 0/22 (0%) 0/52 (0%) 0/20 (0%) | 0/54 (0%) 0/34 (0%) 0/93 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 416 --- 381 --- | 658 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.408N P=0.649N P=0.635 P=0.506N | P=0.475N P=0.618N P=0.405N P=0.535N | |INCIDENTAL TUMOR | P=0.360N P=0.638N P=0.643 P=0.469N | P=0.390N P=0.701N P=0.445N P=0.445N | |LOGISTIC REGRESSION | P=0.217N P=0.632N P=0.700 P=0.381N | P=0.440N P=0.660N P=0.432N P=0.499N | |COCHRAN-ARMITAGE | P=0.401N | P=0.444N | |FISHER EXACT | P=0.667N P=0.649 P=0.500N | P=0.667N P=0.400N P=0.500N | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 32 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 98/100 (98%) 46/50 (92%) 146/150 (97%) 94/100 (94%)| 78/100 (78%) 39/50 (78%) 117/150 (78%) 86/100 (86%)| |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 91.5% 88.6% 88.4% 96.5% | |TERMINAL (d) | 37/37 (100%) 22/22 (100%) 52/52 (100%) 20/20 (100%)| 47/54 (87%) 29/34 (85%) 78/93 (84%) 31/34 (91%) | |FIRST INCIDENCE (DAYS) | 372 382 276 391 | 424 581 312 462 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.120N P=0.370 P=0.009 ** | P<0.001 ** P=0.087N P=0.137N P<0.001 ** | |INCIDENTAL TUMOR | P=0.520 P=0.025N* P=0.547N P=0.531N | P=0.018 * P=0.409N P=0.482N P=0.027 * | |LOGISTIC REGRESSION | P=0.597 P=0.115N P=0.678N P=0.483N | P=0.043 * P=0.414N P=0.456N P=0.093 | |COCHRAN-ARMITAGE | P=0.209N | P=0.065 | |FISHER EXACT | P=0.096N P=0.544N P=0.140N | P=0.578N P=0.564N P=0.099 | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 66/100 (66%) 36/50 (72%) 116/150 (77%) 91/100 (91%)| 49/100 (49%) 24/50 (48%) 93/150 (62%) 76/100 (76%)| |ADJUSTED (b) | 80.3% 79.2% 89.1% 98.9% | 58.9% 53.7% 67.5% 88.6% | |TERMINAL (d) | 22/37 (59%) 13/22 (59%) 39/52 (75%) 19/20 (95%) | 21/54 (39%) 14/34 (41%) 49/93 (53%) 25/34 (74%) | |FIRST INCIDENCE (DAYS) | 372 368 371 391 | 424 447 312 462 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.507N P=0.075 P<0.001 ** | P<0.001 ** P=0.227N P=0.247 P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P=0.260 P=0.033 * P<0.001 ** | P<0.001 ** P=0.541 P=0.025 * P=0.002 ** | |LOGISTIC REGRESSION | P<0.001 ** P=0.193 P=0.031 * P<0.001 ** | P<0.001 ** P=0.545N P=0.022 * P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** | |FISHER EXACT | P=0.291 P=0.034 * P<0.001 ** | P=0.523N P=0.029 * P<0.001 ** | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05076 TEST: 01 PAGE 33 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLENETHIOUREA MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 25 PPM 83 PPM 250 PPM | 0 PPM 25 PPM 83 PPM 250 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 98/100 (98%) 49/50 (98%) 148/150 (99%) 95/100 (95%)| 94/100 (94%) 46/50 (92%) 139/150 (93%) 99/100 (99%)| |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 94.9% 95.8% 93.9% 100.0% | |TERMINAL (d) | 37/37 (100%) 22/22 (100%) 52/52 (100%) 20/20 (100%)| 49/54 (91%) 32/34 (94%) 84/93 (90%) 34/34 (100%)| |FIRST INCIDENCE (DAYS) | 372 368 276 391 | 424 447 312 462 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.241N P=0.322 P=0.008 ** | P<0.001 ** P=0.060N P=0.098N P=0.003 ** | |INCIDENTAL TUMOR | P=0.604N (e) P=0.581 (e) | P=0.093 P=0.421N P=0.460N P=0.149 | |LOGISTIC REGRESSION | P=0.723 (e) P=0.349 (e) | P=0.072 P=0.385N P=0.430N P=0.062 | |COCHRAN-ARMITAGE | P=0.093N | P=0.035 * | |FISHER EXACT | P=0.707N P=0.525 P=0.222N | P=0.441N P=0.445N P=0.059 | |=================================================================================================================================| (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 229860-229860/229860 --multipart-boundary--