TDMS Study 05200-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest NITROMETHANE DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 TIME: 05:44:52 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-75189 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C61927 PATHOLOGIST: R. MILLER R. RENNE CAS: 75-52-5 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest NITROMETHANE DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 TIME: 05:44:52 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-75189 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C61927 PATHOLOGIST: R. MILLER R. RENNE CAS: 75-52-5 RATS(FISCHER344) ---------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED. ---------------- Adrenal Cortex Adrenal Medulla Bone Marrow Brain Clitoral Gland Clitoral/Preputial Gland Epididymis Heart Islets, Pancreatic Kidney Larynx 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 Northwest NITROMETHANE DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 TIME: 05:44:52 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-75189 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C61927 PATHOLOGIST: R. MILLER R. RENNE CAS: 75-52-5 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF NITROMETHANE ==================================================================================================== MALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Islets, Pancreatic Adenoma Carcinoma Skin Basal Cell Carcinoma Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma Fibrosarcoma Schwannoma Malignant Squamous Cell Papilloma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Benign Tumors ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Mammary Gland Carcinoma Carcinoma or Adenoma Fibroadenoma Fibroma, Fibroadenoma or Adenoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma Uterus Polyp Stromal Sarcoma Stromal or Polyp Stromal All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Benign Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROMETHANE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 94 PPM 188 PPM 375 PPM | CONTROL 94 PPM 188 PPM 375 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 16/50 (32%) 20/50 (40%) 21/50 (42%) 19/50 (38%) | 1/49 (2%) 1/50 (2%) 2/49 (4%) 4/50 (8%) | |ADJUSTED (b) | 71.6% 72.9% 77.2% 70.4% | 3.6% 5.3% 6.9% 13.5% | |TERMINAL (d) | 7/13 (54%) 9/16 (56%) 9/14 (64%) 2/8 (25%) | 1/28 (4%) 1/19 (5%) 2/29 (7%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | 611 574 499 544 | 733 (T) 733 (T) 733 (T) 651 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.098 P=0.338 P=0.239 P=0.101 | P=0.065 P=0.673 P=0.512 P=0.147 | |INCIDENTAL TUMOR | P=0.392 P=0.133 P=0.205 P=0.384 | P=0.075 P=0.673 P=0.512 P=0.205 | |LOGISTIC REGRESSION | P=0.302 P=0.141 P=0.167 P=0.260 | P=0.067 P=0.673 P=0.512 P=0.167 | |COCHRAN-ARMITAGE | P=0.346 | P=0.074 | |FISHER EXACT | P=0.266 P=0.204 P=0.338 | P=0.747N P=0.500 P=0.187 | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 2/50 (4%) | 0/49 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) | |ADJUSTED (b) | 7.7% 6.3% 10.5% 14.1% | 0.0% 0.0% 3.4% 0.0% | |TERMINAL (d) | 1/13 (8%) 1/16 (6%) 1/14 (7%) 0/8 (0%) | 0/28 (0%) 0/19 (0%) 1/29 (3%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | 733 (T) 733 (T) 643 698 | --- --- 733 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.216 P=0.717N P=0.509 P=0.362 | P=0.683 (e) P=0.507 (e) | |INCIDENTAL TUMOR | P=0.309 P=0.717N P=0.540 P=0.511 | P=0.683 (e) P=0.507 (e) | |LOGISTIC REGRESSION | P=0.287 P=0.717N P=0.487 P=0.427 | P=0.683 (e) P=0.507 (e) | |COCHRAN-ARMITAGE | P=0.337 | P=0.695 | |FISHER EXACT | P=0.753N P=0.500 P=0.500 | (e) P=0.500 (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROMETHANE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 94 PPM 188 PPM 375 PPM | CONTROL 94 PPM 188 PPM 375 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 17/50 (34%) 21/50 (42%) 22/50 (44%) 20/50 (40%) | 2/49 (4%) 1/50 (2%) 3/49 (6%) 4/50 (8%) | |ADJUSTED (b) | 76.3% 76.8% 78.0% 72.2% | 7.1% 5.3% 10.3% 13.5% | |TERMINAL (d) | 8/13 (62%) 10/16 (63%) 9/14 (64%) 2/8 (25%) | 2/28 (7%) 1/19 (5%) 3/29 (10%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | 611 574 499 544 | 733 (T) 733 (T) 733 (T) 651 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.093 P=0.352 P=0.243 P=0.094 | P=0.145 P=0.635N P=0.516 P=0.277 | |INCIDENTAL TUMOR | P=0.383 P=0.141 P=0.215 P=0.376 | P=0.162 P=0.635N P=0.516 P=0.356 | |LOGISTIC REGRESSION | P=0.301 P=0.129 P=0.168 P=0.254 | P=0.150 P=0.635N P=0.516 P=0.310 | |COCHRAN-ARMITAGE | P=0.348 | P=0.166 | |FISHER EXACT | P=0.268 P=0.206 P=0.339 | P=0.492N P=0.500 P=0.349 | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 3/50 (6%) 3/50 (6%) 3/50 (6%) | 7/47 (15%) 4/46 (9%) 6/47 (13%) 2/48 (4%) | |ADJUSTED (b) | 15.4% 11.6% 13.1% 24.1% | 25.0% 19.3% 17.3% 9.1% | |TERMINAL (d) | 0/13 (0%) 0/16 (0%) 1/14 (7%) 1/8 (13%) | 6/26 (23%) 3/18 (17%) 3/28 (11%) 2/22 (9%) | |FIRST INCIDENCE (DAYS) | 528 574 560 650 | 631 636 619 733 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.530N P=0.544N P=0.508N P=0.631N | P=0.096N P=0.474N P=0.449N P=0.117N | |INCIDENTAL TUMOR | P=0.347N P=0.606N P=0.509N P=0.443N | P=0.083N P=0.436N P=0.592N P=0.105N | |LOGISTIC REGRESSION | P=0.443N P=0.503N P=0.499N P=0.512N | P=0.087N P=0.386N P=0.505N P=0.102N | |COCHRAN-ARMITAGE | P=0.442N | P=0.082N | |FISHER EXACT | P=0.500N P=0.500N P=0.500N | P=0.274N P=0.500N P=0.074N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROMETHANE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 94 PPM 188 PPM 375 PPM | CONTROL 94 PPM 188 PPM 375 PPM | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | 0/47 (0%) 1/46 (2%) 3/47 (6%) 0/48 (0%) | |ADJUSTED (b) | 0.0% 4.3% 2.1% 4.2% | 0.0% 5.6% 10.7% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/16 (0%) 0/14 (0%) 0/8 (0%) | 0/26 (0%) 1/18 (6%) 3/28 (11%) 0/22 (0%) | |FIRST INCIDENCE (DAYS) | --- 665 492 664 | --- 733 (T) 733 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.372 P=0.483 P=0.508 P=0.477 | P=0.620 P=0.427 P=0.133 (e) | |INCIDENTAL TUMOR | P=0.453 P=0.419 P=0.469 P=0.557 | P=0.620 P=0.427 P=0.133 (e) | |LOGISTIC REGRESSION | P=0.375 P=0.493 P=0.414 P=0.497 | P=0.620 P=0.427 P=0.133 (e) | |COCHRAN-ARMITAGE | P=0.383 | P=0.626N | |FISHER EXACT | P=0.500 P=0.500 P=0.500 | P=0.495 P=0.121 (e) | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 4/50 (8%) 4/50 (8%) 4/50 (8%) | 7/47 (15%) 5/46 (11%) 9/47 (19%) 2/48 (4%) | |ADJUSTED (b) | 15.4% 15.4% 14.9% 27.2% | 25.0% 24.7% 27.2% 9.1% | |TERMINAL (d) | 0/13 (0%) 0/16 (0%) 1/14 (7%) 1/8 (13%) | 6/26 (23%) 4/18 (22%) 6/28 (21%) 2/22 (9%) | |FIRST INCIDENCE (DAYS) | 528 574 492 650 | 631 636 619 733 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.484 P=0.593 P=0.634 P=0.510 | P=0.116N P=0.625N P=0.451 P=0.117N | |INCIDENTAL TUMOR | P=0.448N P=0.519 P=0.624 P=0.572N | P=0.102N P=0.590N P=0.320 P=0.105N | |LOGISTIC REGRESSION | P=0.569N P=0.639 P=0.637 P=0.633 | P=0.106N P=0.534N P=0.387 P=0.102N | |COCHRAN-ARMITAGE | P=0.570 | P=0.099N | |FISHER EXACT | P=0.643N P=0.643N P=0.643N | P=0.395N P=0.392 P=0.074N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROMETHANE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 94 PPM 188 PPM 375 PPM | CONTROL 94 PPM 188 PPM 375 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 9/50 (18%) 4/50 (8%) 1/50 (2%) | 1/50 (2%) 1/50 (2%) 3/50 (6%) 1/50 (2%) | |ADJUSTED (b) | 26.9% 40.6% 20.0% 4.5% | 3.6% 2.6% 10.0% 4.3% | |TERMINAL (d) | 0/13 (0%) 5/16 (31%) 2/14 (14%) 0/8 (0%) | 1/28 (4%) 0/19 (0%) 3/30 (10%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | 552 601 590 681 | 733 (T) 580 733 (T) 733 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.014N* P=0.509 P=0.191N P=0.029N* | P=0.536 P=0.706 P=0.329 P=0.718 | |INCIDENTAL TUMOR | P=0.005N** P=0.448 P=0.161N P=0.007N** | P=0.540 P=0.763N P=0.329 P=0.718 | |LOGISTIC REGRESSION | P=0.006N** P=0.472 P=0.177N P=0.018N* | P=0.546 P=0.756N P=0.329 P=0.718 | |COCHRAN-ARMITAGE | P=0.006N** | P=0.555 | |FISHER EXACT | P=0.500 P=0.178N P=0.015N* | P=0.753N P=0.309 P=0.753N | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 3/50 (6%) 5/50 (10%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 7.7% 5.9% 14.2% 25.9% | 0.0% 2.1% 0.0% 0.0% | |TERMINAL (d) | 1/13 (8%) 0/16 (0%) 1/14 (7%) 1/8 (13%) | 0/28 (0%) 0/19 (0%) 0/30 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | 733 (T) 714 621 634 | --- 488 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.016 * P=0.750N P=0.318 P=0.068 | P=0.568N P=0.492 (e) (e) | |INCIDENTAL TUMOR | P=0.042 * P=0.741 P=0.324 P=0.101 | P=0.614N P=0.567 (e) (e) | |LOGISTIC REGRESSION | P=0.026 * P=0.747 P=0.297 P=0.089 | P=0.491N P=0.701 (e) (e) | |COCHRAN-ARMITAGE | P=0.031 * | P=0.567N | |FISHER EXACT | P=0.753N P=0.309 P=0.102 | P=0.500 (e) (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROMETHANE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 94 PPM 188 PPM 375 PPM | CONTROL 94 PPM 188 PPM 375 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 9/50 (18%) 10/50 (20%) 7/50 (14%) 6/50 (12%) | 1/50 (2%) 2/50 (4%) 3/50 (6%) 1/50 (2%) | |ADJUSTED (b) | 32.5% 44.1% 32.2% 29.3% | 3.6% 4.6% 10.0% 4.3% | |TERMINAL (d) | 1/13 (8%) 5/16 (31%) 3/14 (21%) 1/8 (13%) | 1/28 (4%) 0/19 (0%) 3/30 (10%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | 552 601 590 634 | 733 (T) 488 733 (T) 733 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.308N P=0.513 P=0.393N P=0.388N | P=0.596N P=0.440 P=0.329 P=0.718 | |INCIDENTAL TUMOR | P=0.148N P=0.440 P=0.361N P=0.209N | P=0.602 P=0.541 P=0.329 P=0.718 | |LOGISTIC REGRESSION | P=0.186N P=0.462 P=0.389N P=0.294N | P=0.579N P=0.604 P=0.329 P=0.718 | |COCHRAN-ARMITAGE | P=0.181N | P=0.578N | |FISHER EXACT | P=0.500 P=0.393N P=0.288N | P=0.500 P=0.309 P=0.753N | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 14.9% 14.3% 12.5% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 1/16 (6%) 2/14 (14%) 1/8 (13%) | 0/28 (0%) 0/19 (0%) 0/30 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | --- 636 733 (T) 733 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.399 P=0.125 P=0.252 P=0.403 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.470 P=0.111 P=0.252 P=0.403 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.487 P=0.107 P=0.252 P=0.403 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.555 | (e) | |FISHER EXACT | P=0.121 P=0.247 P=0.500 | (e) (e) (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROMETHANE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 94 PPM 188 PPM 375 PPM | CONTROL 94 PPM 188 PPM 375 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 2/50 (4%) 1/50 (2%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 14.9% 14.3% 12.5% | 2.9% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 1/16 (6%) 2/14 (14%) 1/8 (13%) | 0/28 (0%) 0/19 (0%) 0/30 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | --- 636 733 (T) 733 (T) | 691 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.399 P=0.125 P=0.252 P=0.403 | P=0.321N P=0.561N P=0.500N P=0.546N | |INCIDENTAL TUMOR | P=0.470 P=0.111 P=0.252 P=0.403 | P=0.280N P=0.443N P=0.479N P=0.443N | |LOGISTIC REGRESSION | P=0.487 P=0.107 P=0.252 P=0.403 | P=0.306N P=0.520N P=0.501N P=0.506N | |COCHRAN-ARMITAGE | P=0.555 | P=0.304N | |FISHER EXACT | P=0.121 P=0.247 P=0.500 | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 2.2% 4.0% 3.4% 14.5% | 2.8% 2.9% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/16 (0%) 0/14 (0%) 0/8 (0%) | 0/28 (0%) 0/19 (0%) 0/30 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | 504 650 639 656 | 658 621 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.326 P=0.743 P=0.757 P=0.447 | P=0.237N P=0.725 P=0.495N P=0.511N | |INCIDENTAL TUMOR | P=0.441 P=0.746 P=0.757N P=0.567 | P=0.222N P=0.681N P=0.479N P=0.443N | |LOGISTIC REGRESSION | P=0.350 P=0.753N P=0.740 P=0.500 | P=0.230N P=0.740N P=0.495N P=0.492N | |COCHRAN-ARMITAGE | P=0.351 | P=0.235N | |FISHER EXACT | P=0.753N P=0.753N P=0.500 | P=0.753N P=0.500N P=0.500N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROMETHANE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 94 PPM 188 PPM 375 PPM | CONTROL 94 PPM 188 PPM 375 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 5.8% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/16 (0%) 0/14 (0%) 0/8 (0%) | 0/28 (0%) 0/19 (0%) 0/30 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 509 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.597 (e) P=0.238 (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.623 (e) P=0.208 (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.576 (e) P=0.212 (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.593 | (e) | |FISHER EXACT | (e) P=0.247 (e) | (e) (e) (e) | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 3/50 (6%) 2/50 (4%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 2.2% 4.0% 9.0% 14.5% | 2.8% 2.9% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/16 (0%) 0/14 (0%) 0/8 (0%) | 0/28 (0%) 0/19 (0%) 0/30 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | 504 650 509 656 | 658 621 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.307 P=0.743 P=0.304 P=0.447 | P=0.237N P=0.725 P=0.495N P=0.511N | |INCIDENTAL TUMOR | P=0.418 P=0.746 P=0.282 P=0.567 | P=0.222N P=0.681N P=0.479N P=0.443N | |LOGISTIC REGRESSION | P=0.319 P=0.753N P=0.264 P=0.500 | P=0.230N P=0.740N P=0.495N P=0.492N | |COCHRAN-ARMITAGE | P=0.324 | P=0.235N | |FISHER EXACT | P=0.753N P=0.309 P=0.500 | P=0.753N P=0.500N P=0.500N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROMETHANE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 94 PPM 188 PPM 375 PPM | CONTROL 94 PPM 188 PPM 375 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 3/50 (6%) 2/50 (4%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 2.2% 4.0% 9.0% 14.5% | 2.8% 2.9% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/16 (0%) 0/14 (0%) 0/8 (0%) | 0/28 (0%) 0/19 (0%) 0/30 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | 504 650 509 656 | 658 621 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.307 P=0.743 P=0.304 P=0.447 | P=0.237N P=0.725 P=0.495N P=0.511N | |INCIDENTAL TUMOR | P=0.418 P=0.746 P=0.282 P=0.567 | P=0.222N P=0.681N P=0.479N P=0.443N | |LOGISTIC REGRESSION | P=0.319 P=0.753N P=0.264 P=0.500 | P=0.230N P=0.740N P=0.495N P=0.492N | |COCHRAN-ARMITAGE | P=0.324 | P=0.235N | |FISHER EXACT | P=0.753N P=0.309 P=0.500 | P=0.753N P=0.500N P=0.500N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 3/50 (6%) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | |ADJUSTED (b) | 7.7% 12.5% 0.0% 8.2% | 0.0% 3.1% 2.4% 3.3% | |TERMINAL (d) | 1/13 (8%) 2/16 (13%) 0/14 (0%) 0/8 (0%) | 0/28 (0%) 0/19 (0%) 0/30 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | 733 (T) 733 (T) --- 544 | --- 636 638 672 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.178 P=0.574 P=0.485N P=0.278 | P=0.386 P=0.471 P=0.520 P=0.469 | |INCIDENTAL TUMOR | P=0.167 P=0.574 P=0.485N P=0.276 | P=0.425 P=0.581 P=0.227 P=0.557 | |LOGISTIC REGRESSION | P=0.239 P=0.574 P=0.485N P=0.305 | P=0.387 P=0.528 P=0.512 P=0.502 | |COCHRAN-ARMITAGE | P=0.242 | P=0.383 | |FISHER EXACT | P=0.500 P=0.500N P=0.309 | P=0.500 P=0.500 P=0.500 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROMETHANE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 94 PPM 188 PPM 375 PPM | CONTROL 94 PPM 188 PPM 375 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 10.6% 0.0% | 3.2% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/16 (0%) 1/14 (7%) 0/8 (0%) | 0/28 (0%) 0/19 (0%) 0/30 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 650 --- | 714 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.550 (e) P=0.244 (e) | P=0.320N P=0.568N P=0.507N P=0.543N | |INCIDENTAL TUMOR | P=0.592 (e) P=0.232 (e) | P=0.280N P=0.443N P=0.479N P=0.443N | |LOGISTIC REGRESSION | P=0.581 (e) P=0.233 (e) | P=0.309N P=0.542N P=0.500N P=0.519N | |COCHRAN-ARMITAGE | P=0.593 | P=0.304N | |FISHER EXACT | (e) P=0.247 (e) | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 3/50 (6%) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | |ADJUSTED (b) | 7.7% 12.5% 10.6% 8.2% | 3.2% 3.1% 2.4% 3.3% | |TERMINAL (d) | 1/13 (8%) 2/16 (13%) 1/14 (7%) 0/8 (0%) | 0/28 (0%) 0/19 (0%) 0/30 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | 733 (T) 733 (T) 650 544 | 714 636 638 672 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.160 P=0.574 P=0.513 P=0.278 | P=0.626 P=0.706 P=0.753N P=0.719 | |INCIDENTAL TUMOR | P=0.169 P=0.574 P=0.501 P=0.276 | P=0.583N P=0.681N P=0.638 P=0.700N | |LOGISTIC REGRESSION | P=0.225 P=0.574 P=0.485 P=0.305 | P=0.632N P=0.760 P=0.762N P=0.755 | |COCHRAN-ARMITAGE | P=0.232 | P=0.633 | |FISHER EXACT | P=0.500 P=0.500 P=0.309 | P=0.753N P=0.753N P=0.753N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROMETHANE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 94 PPM 188 PPM 375 PPM | CONTROL 94 PPM 188 PPM 375 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 7.1% 0.0% 0.0% 8.7% | |TERMINAL (d) | 0/13 (0%) 0/16 (0%) 0/14 (0%) 0/8 (0%) | 2/28 (7%) 0/19 (0%) 0/30 (0%) 2/23 (9%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 733 (T) --- --- 733 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.479 P=0.327N P=0.223N P=0.624 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.479 P=0.327N P=0.223N P=0.624 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.479 P=0.327N P=0.223N P=0.624 | |COCHRAN-ARMITAGE | (e) | P=0.501 | |FISHER EXACT | (e) (e) (e) | P=0.247N P=0.247N P=0.691N | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 7/50 (14%) 1/50 (2%) 11/50 (22%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 6.0% 29.3% 2.0% 33.0% | |TERMINAL (d) | 0/13 (0%) 0/16 (0%) 0/14 (0%) 0/8 (0%) | 1/28 (4%) 4/19 (21%) 0/30 (0%) 5/23 (22%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 631 588 440 425 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.009 ** P=0.032 * P=0.489N P=0.006 ** | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.009 ** P=0.066 P=0.582N P=0.008 ** | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.009 ** P=0.052 P=0.447N P=0.011 * | |COCHRAN-ARMITAGE | (e) | P=0.009 ** | |FISHER EXACT | (e) (e) (e) | P=0.080 P=0.500N P=0.007 ** | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROMETHANE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 94 PPM 188 PPM 375 PPM | CONTROL 94 PPM 188 PPM 375 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 4/50 (8%) 7/50 (14%) 1/50 (2%) 13/50 (26%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 13.0% 29.3% 2.0% 40.5% | |TERMINAL (d) | 0/13 (0%) 0/16 (0%) 0/14 (0%) 0/8 (0%) | 3/28 (11%) 4/19 (21%) 0/30 (0%) 7/23 (30%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 631 588 440 425 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.009 ** P=0.116 P=0.169N P=0.009 ** | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.009 ** P=0.195 P=0.206N P=0.012 * | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.010 ** P=0.176 P=0.169N P=0.018 * | |COCHRAN-ARMITAGE | (e) | P=0.009 ** | |FISHER EXACT | (e) (e) (e) | P=0.262 P=0.181N P=0.016 * | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | 19/50 (38%) 21/50 (42%) 33/50 (66%) 36/50 (72%) | |ADJUSTED (b) | 7.7% 6.3% 3.7% 18.0% | 58.2% 68.5% 80.0% 92.1% | |TERMINAL (d) | 1/13 (8%) 1/16 (6%) 0/14 (0%) 1/8 (13%) | 15/28 (54%) 10/19 (53%) 22/30 (73%) 20/23 (87%) | |FIRST INCIDENCE (DAYS) | 733 (T) 733 (T) 650 698 | 454 435 468 552 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.244 P=0.717N P=0.756N P=0.362 | P<0.001 ** P=0.076 P=0.015 * P<0.001 ** | |INCIDENTAL TUMOR | P=0.314 P=0.717N P=0.753 P=0.421 | P<0.001 ** P=0.229 P=0.005 ** P<0.001 ** | |LOGISTIC REGRESSION | P=0.300 P=0.717N P=0.759 P=0.387 | P<0.001 ** P=0.219 P=0.003 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.351 | P<0.001 ** | |FISHER EXACT | P=0.753N P=0.753N P=0.500 | P=0.419 P=0.004 ** P<0.001 ** | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROMETHANE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 94 PPM 188 PPM 375 PPM | CONTROL 94 PPM 188 PPM 375 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | 20/50 (40%) 21/50 (42%) 33/50 (66%) 36/50 (72%) | |ADJUSTED (b) | 7.7% 6.3% 3.7% 18.0% | 61.4% 68.5% 80.0% 92.1% | |TERMINAL (d) | 1/13 (8%) 1/16 (6%) 0/14 (0%) 1/8 (13%) | 16/28 (57%) 10/19 (53%) 22/30 (73%) 20/23 (87%) | |FIRST INCIDENCE (DAYS) | 733 (T) 733 (T) 650 698 | 454 435 468 552 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.244 P=0.717N P=0.756N P=0.362 | P<0.001 ** P=0.101 P=0.024 * P<0.001 ** | |INCIDENTAL TUMOR | P=0.314 P=0.717N P=0.753 P=0.421 | P<0.001 ** P=0.285 P=0.009 ** P<0.001 ** | |LOGISTIC REGRESSION | P=0.300 P=0.717N P=0.759 P=0.387 | P<0.001 ** P=0.278 P=0.006 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.351 | P<0.001 ** | |FISHER EXACT | P=0.753N P=0.753N P=0.500 | P=0.500 P=0.008 ** P=0.001 ** | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | 21/50 (42%) 25/50 (50%) 34/50 (68%) 41/50 (82%) | |ADJUSTED (b) | 7.7% 6.3% 3.7% 18.0% | 62.4% 74.9% 80.4% 95.2% | |TERMINAL (d) | 1/13 (8%) 1/16 (6%) 0/14 (0%) 1/8 (13%) | 16/28 (57%) 11/19 (58%) 22/30 (73%) 21/23 (91%) | |FIRST INCIDENCE (DAYS) | 733 (T) 733 (T) 650 698 | 454 435 440 425 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.244 P=0.717N P=0.756N P=0.362 | P<0.001 ** P=0.032 * P=0.028 * P<0.001 ** | |INCIDENTAL TUMOR | P=0.314 P=0.717N P=0.753 P=0.421 | P<0.001 ** P=0.138 P=0.008 ** P<0.001 ** | |LOGISTIC REGRESSION | P=0.300 P=0.717N P=0.759 P=0.387 | P<0.001 ** P=0.112 P=0.006 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.351 | P<0.001 ** | |FISHER EXACT | P=0.753N P=0.753N P=0.500 | P=0.274 P=0.008 ** P<0.001 ** | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROMETHANE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 94 PPM 188 PPM 375 PPM | CONTROL 94 PPM 188 PPM 375 PPM | | | | | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 8.3% 7.1% 4.3% | 3.1% 0.0% 5.2% 4.3% | |TERMINAL (d) | 0/13 (0%) 1/16 (6%) 1/14 (7%) 0/8 (0%) | 0/28 (0%) 0/19 (0%) 0/30 (0%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | --- 490 733 (T) 675 | 713 --- 545 733 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.427 P=0.258 P=0.515 P=0.500 | P=0.475 P=0.575N P=0.487 P=0.710 | |INCIDENTAL TUMOR | P=0.453 P=0.291 P=0.515 P=0.557 | P=0.507 P=0.443N P=0.579 P=0.752N | |LOGISTIC REGRESSION | P=0.499 P=0.242 P=0.515 P=0.493 | P=0.499 P=0.541N P=0.513 P=0.734 | |COCHRAN-ARMITAGE | P=0.499 | P=0.499 | |FISHER EXACT | P=0.247 P=0.500 P=0.500 | P=0.500N P=0.500 P=0.753N | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 38/50 (76%) 36/47 (77%) 32/50 (64%) 39/49 (80%) | 33/50 (66%) 36/50 (72%) 39/50 (78%) 40/50 (80%) | |ADJUSTED (b) | 100.0% 97.1% 84.6% 97.1% | 74.2% 91.8% 88.5% 88.5% | |TERMINAL (d) | 13/13 (100%) 15/16 (94%) 9/14 (64%) 7/8 (88%) | 17/28 (61%) 16/19 (84%) 25/30 (83%) 18/23 (78%) | |FIRST INCIDENCE (DAYS) | 242 490 499 444 | 454 488 468 425 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.160 P=0.380N P=0.228N P=0.162 | P=0.104 P=0.044 * P=0.286 P=0.062 | |INCIDENTAL TUMOR | P=0.421 P=0.555N P=0.141N P=0.308 | P=0.070 P=0.317 P=0.098 P=0.107 | |LOGISTIC REGRESSION | P=0.464 P=0.511 P=0.132N P=0.424 | P=0.056 P=0.262 P=0.126 P=0.094 | |COCHRAN-ARMITAGE | P=0.446 | P=0.063 | |FISHER EXACT | P=0.568 P=0.138N P=0.426 | P=0.333 P=0.133 P=0.088 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROMETHANE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 94 PPM 188 PPM 375 PPM | CONTROL 94 PPM 188 PPM 375 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 38/50 (76%) 36/47 (77%) 32/50 (64%) 39/49 (80%) | 33/50 (66%) 36/50 (72%) 40/50 (80%) 40/50 (80%) | |ADJUSTED (b) | 100.0% 97.1% 84.6% 97.1% | 74.2% 91.8% 90.8% 88.5% | |TERMINAL (d) | 13/13 (100%) 15/16 (94%) 9/14 (64%) 7/8 (88%) | 17/28 (61%) 16/19 (84%) 26/30 (87%) 18/23 (78%) | |FIRST INCIDENCE (DAYS) | 242 490 499 444 | 454 488 468 425 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.160 P=0.380N P=0.228N P=0.162 | P=0.100 P=0.044 * P=0.236 P=0.062 | |INCIDENTAL TUMOR | P=0.421 P=0.555N P=0.141N P=0.308 | P=0.065 P=0.317 P=0.064 P=0.107 | |LOGISTIC REGRESSION | P=0.464 P=0.511 P=0.132N P=0.424 | P=0.051 P=0.262 P=0.082 P=0.094 | |COCHRAN-ARMITAGE | P=0.446 | P=0.059 | |FISHER EXACT | P=0.568 P=0.138N P=0.426 | P=0.333 P=0.088 P=0.088 | |=================================================================================================================================| | | |Pituitary Gland: Pars Intermedia | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/47 (0%) 1/50 (2%) 2/49 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 7.1% 8.1% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/16 (0%) 1/14 (7%) 0/8 (0%) | 0/28 (0%) 0/19 (0%) 0/30 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 733 (T) 636 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.053 (e) P=0.515 P=0.233 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.072 (e) P=0.515 P=0.274 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.065 (e) P=0.515 P=0.230 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.070 | (e) | |FISHER EXACT | (e) P=0.500 P=0.242 | (e) (e) (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROMETHANE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 94 PPM 188 PPM 375 PPM | CONTROL 94 PPM 188 PPM 375 PPM | | | | | |=================================================================================================================================| | | |Skin | | Basal Cell Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 9.1% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/16 (0%) 0/14 (0%) 0/8 (0%) | 0/28 (0%) 0/19 (0%) 0/30 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 480 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.037 * (e) (e) P=0.199 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.064 (e) (e) P=0.271 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.042 * (e) (e) P=0.228 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.046 * | (e) | |FISHER EXACT | (e) (e) P=0.247 | (e) (e) (e) | |=================================================================================================================================| | | |Skin | | Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal | | Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 7/50 (14%) 4/50 (8%) 3/50 (6%) 7/50 (14%) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | |ADJUSTED (b) | 44.7% 22.0% 12.8% 40.9% | 2.3% 5.3% 3.3% 4.3% | |TERMINAL (d) | 5/13 (38%) 3/16 (19%) 1/14 (7%) 2/8 (25%) | 0/28 (0%) 1/19 (5%) 1/30 (3%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | 673 650 608 480 | 573 733 (T) 733 (T) 733 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.277 P=0.185N P=0.143N P=0.352 | P=0.619 P=0.710 P=0.758N P=0.739 | |INCIDENTAL TUMOR | P=0.416 P=0.223N P=0.133N P=0.523 | P=0.624 P=0.763N P=0.633 P=0.749N | |LOGISTIC REGRESSION | P=0.438 P=0.305N P=0.167N P=0.543 | P=0.630 P=0.752N P=0.756N P=0.753N | |COCHRAN-ARMITAGE | P=0.485 | P=0.633 | |FISHER EXACT | P=0.262N P=0.159N P=0.613N | P=0.753N P=0.753N P=0.753N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROMETHANE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 94 PPM 188 PPM 375 PPM | CONTROL 94 PPM 188 PPM 375 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 13.9% 0.0% 4.5% 0.0% | 2.9% 5.3% 0.0% 0.0% | |TERMINAL (d) | 1/13 (8%) 0/16 (0%) 0/14 (0%) 0/8 (0%) | 0/28 (0%) 1/19 (5%) 0/30 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | 623 --- 678 --- | 691 733 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.098N P=0.126N P=0.311N P=0.158N | P=0.251N P=0.681 P=0.500N P=0.546N | |INCIDENTAL TUMOR | P=0.075N P=0.134N P=0.308N P=0.128N | P=0.225N P=0.753 P=0.479N P=0.443N | |LOGISTIC REGRESSION | P=0.087N P=0.128N P=0.305N P=0.125N | P=0.240N P=0.720 P=0.501N P=0.506N | |COCHRAN-ARMITAGE | P=0.086N | P=0.235N | |FISHER EXACT | P=0.121N P=0.309N P=0.121N | P=0.753N P=0.500N P=0.500N | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 6/50 (12%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | 1/50 (2%) 3/50 (6%) 0/50 (0%) 3/50 (6%) | |ADJUSTED (b) | 30.6% 0.0% 10.9% 0.0% | 2.9% 11.5% 0.0% 10.0% | |TERMINAL (d) | 3/13 (23%) 0/16 (0%) 0/14 (0%) 0/8 (0%) | 0/28 (0%) 1/19 (5%) 0/30 (0%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | 623 --- 678 --- | 691 579 --- 387 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.022N* P=0.016N* P=0.137N P=0.037N* | P=0.306 P=0.221 P=0.500N P=0.256 | |INCIDENTAL TUMOR | P=0.013N* P=0.016N* P=0.129N P=0.027N* | P=0.344 P=0.358 P=0.479N P=0.319 | |LOGISTIC REGRESSION | P=0.015N* P=0.020N* P=0.137N P=0.020N* | P=0.329 P=0.292 P=0.501N P=0.339 | |COCHRAN-ARMITAGE | P=0.014N* | P=0.325 | |FISHER EXACT | P=0.013N* P=0.134N P=0.013N* | P=0.309 P=0.500N P=0.309 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROMETHANE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 94 PPM 188 PPM 375 PPM | CONTROL 94 PPM 188 PPM 375 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 18.2% 0.0% 0.0% 0.0% | 0.0% 2.5% 0.0% 4.0% | |TERMINAL (d) | 2/13 (15%) 0/16 (0%) 0/14 (0%) 0/8 (0%) | 0/28 (0%) 0/19 (0%) 0/30 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | 644 --- --- --- | --- 579 --- 720 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.058N P=0.105N P=0.118N P=0.186N | P=0.401 P=0.486 (e) P=0.464 | |INCIDENTAL TUMOR | P=0.052N P=0.098N P=0.102N P=0.175N | P=0.442 P=0.581 (e) P=0.557 | |LOGISTIC REGRESSION | P=0.051N P=0.133N P=0.125N P=0.142N | P=0.407 P=0.580 (e) P=0.476 | |COCHRAN-ARMITAGE | P=0.047N* | P=0.405 | |FISHER EXACT | P=0.121N P=0.121N P=0.121N | P=0.500 (e) P=0.500 | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 3/50 (6%) | |ADJUSTED (b) | 18.2% 0.0% 10.9% 0.0% | 0.0% 6.6% 0.0% 10.0% | |TERMINAL (d) | 2/13 (15%) 0/16 (0%) 0/14 (0%) 0/8 (0%) | 0/28 (0%) 0/19 (0%) 0/30 (0%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | 644 --- 678 --- | --- 579 --- 387 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.168N P=0.105N P=0.494N P=0.186N | P=0.094 P=0.201 (e) P=0.102 | |INCIDENTAL TUMOR | P=0.122N P=0.098N P=0.495N P=0.175N | P=0.104 P=0.319 (e) P=0.115 | |LOGISTIC REGRESSION | P=0.141N P=0.133N P=0.517N P=0.142N | P=0.099 P=0.261 (e) P=0.143 | |COCHRAN-ARMITAGE | P=0.125N | P=0.097 | |FISHER EXACT | P=0.121N P=0.500N P=0.121N | P=0.247 (e) P=0.121 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROMETHANE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 94 PPM 188 PPM 375 PPM | CONTROL 94 PPM 188 PPM 375 PPM | | | | | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 6/50 (12%) 2/50 (4%) 2/50 (4%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 41.0% 10.0% 10.5% 16.3% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 5/13 (38%) 1/16 (6%) 1/14 (7%) 1/8 (13%) | 0/28 (0%) 0/19 (0%) 0/30 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | 673 650 643 675 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.191N P=0.092N P=0.113N P=0.268N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.153N P=0.107N P=0.107N P=0.227N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.143N P=0.155N P=0.146N P=0.220N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.113N | (e) | |FISHER EXACT | P=0.134N P=0.134N P=0.134N | (e) (e) (e) | |=================================================================================================================================| | | |Skin | | Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | |ADJUSTED (b) | 0.0% 0.0% 10.9% 0.0% | 0.0% 4.2% 0.0% 6.3% | |TERMINAL (d) | 0/13 (0%) 0/16 (0%) 0/14 (0%) 0/8 (0%) | 0/28 (0%) 0/19 (0%) 0/30 (0%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | --- --- 678 --- | --- 698 --- 387 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.553 (e) P=0.242 (e) | P=0.133 P=0.443 (e) P=0.218 | |INCIDENTAL TUMOR | P=0.670 (e) P=0.205 (e) | P=0.126 P=0.557 (e) P=0.195 | |LOGISTIC REGRESSION | P=0.571 (e) P=0.228 (e) | P=0.144 P=0.474 (e) P=0.303 | |COCHRAN-ARMITAGE | P=0.593 | P=0.140 | |FISHER EXACT | (e) P=0.247 (e) | P=0.500 (e) P=0.247 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROMETHANE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 94 PPM 188 PPM 375 PPM | CONTROL 94 PPM 188 PPM 375 PPM | | | | | |=================================================================================================================================| | | |Skin | | Schwannoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 14.5% | 0.0% 0.0% 3.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/16 (0%) 0/14 (0%) 1/8 (13%) | 0/28 (0%) 0/19 (0%) 0/30 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 544 | --- --- 698 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.030 * (e) (e) P=0.192 | P=0.683 (e) P=0.506 (e) | |INCIDENTAL TUMOR | P=0.026 * (e) (e) P=0.187 | P=0.717 (e) P=0.521 (e) | |LOGISTIC REGRESSION | P=0.046 * (e) (e) P=0.238 | P=0.691 (e) P=0.499 (e) | |COCHRAN-ARMITAGE | P=0.046 * | P=0.693 | |FISHER EXACT | (e) (e) P=0.247 | (e) P=0.500 (e) | |=================================================================================================================================| | | |Skin | | Squamous Cell Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |ADJUSTED (b) | 6.3% 12.5% 2.6% 12.5% | 0.0% 0.0% 3.3% 0.0% | |TERMINAL (d) | 0/13 (0%) 2/16 (13%) 0/14 (0%) 1/8 (13%) | 0/28 (0%) 0/19 (0%) 1/30 (3%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | 725 733 (T) 608 733 (T) | --- --- 733 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.596 P=0.548 P=0.758N P=0.638 | P=0.685 (e) P=0.514 (e) | |INCIDENTAL TUMOR | P=0.593N P=0.502 P=0.755N P=0.743 | P=0.685 (e) P=0.514 (e) | |LOGISTIC REGRESSION | P=0.575N P=0.486 P=0.762N P=0.661 | P=0.685 (e) P=0.514 (e) | |COCHRAN-ARMITAGE | P=0.530N | P=0.693 | |FISHER EXACT | P=0.500 P=0.753N P=0.753N | (e) P=0.500 (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROMETHANE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 94 PPM 188 PPM 375 PPM | CONTROL 94 PPM 188 PPM 375 PPM | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Carcinoma, Basal Cell Carcinoma, Basosquamous Tumor | | (malignant or NOS), or Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |ADJUSTED (b) | 6.3% 12.5% 2.6% 20.5% | 0.0% 0.0% 3.3% 0.0% | |TERMINAL (d) | 0/13 (0%) 2/16 (13%) 0/14 (0%) 1/8 (13%) | 0/28 (0%) 0/19 (0%) 1/30 (3%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | 725 733 (T) 608 480 | --- --- 733 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.138 P=0.548 P=0.758N P=0.192 | P=0.685 (e) P=0.514 (e) | |INCIDENTAL TUMOR | P=0.210 P=0.502 P=0.755N P=0.314 | P=0.685 (e) P=0.514 (e) | |LOGISTIC REGRESSION | P=0.231 P=0.486 P=0.762N P=0.300 | P=0.685 (e) P=0.514 (e) | |COCHRAN-ARMITAGE | P=0.237 | P=0.693 | |FISHER EXACT | P=0.500 P=0.753N P=0.309 | (e) P=0.500 (e) | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 13.3% | 2.3% 5.3% 0.0% 4.3% | |TERMINAL (d) | 0/13 (0%) 0/16 (0%) 0/14 (0%) 0/8 (0%) | 0/28 (0%) 1/19 (5%) 0/30 (0%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | --- --- --- 660 | 573 733 (T) --- 733 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.012 * (e) (e) P=0.109 | P=0.625N P=0.710 P=0.509N P=0.739 | |INCIDENTAL TUMOR | P=0.034 * (e) (e) P=0.172 | P=0.613N P=0.763N P=0.773N P=0.749N | |LOGISTIC REGRESSION | P=0.011 * (e) (e) P=0.113 | P=0.616N P=0.752N P=0.448N P=0.753N | |COCHRAN-ARMITAGE | P=0.012 * | P=0.615N | |FISHER EXACT | (e) (e) P=0.121 | P=0.753N P=0.500N P=0.753N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROMETHANE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 94 PPM 188 PPM 375 PPM | CONTROL 94 PPM 188 PPM 375 PPM | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 7/50 (14%) 4/50 (8%) 3/50 (6%) 5/50 (10%) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | |ADJUSTED (b) | 44.7% 22.0% 12.8% 35.0% | 2.3% 5.3% 3.3% 4.3% | |TERMINAL (d) | 5/13 (38%) 3/16 (19%) 1/14 (7%) 2/8 (25%) | 0/28 (0%) 1/19 (5%) 1/30 (3%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | 673 650 608 660 | 573 733 (T) 733 (T) 733 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.563N P=0.185N P=0.143N P=0.614 | P=0.619 P=0.710 P=0.758N P=0.739 | |INCIDENTAL TUMOR | P=0.431N P=0.223N P=0.133N P=0.494N | P=0.624 P=0.763N P=0.633 P=0.749N | |LOGISTIC REGRESSION | P=0.427N P=0.305N P=0.167N P=0.529N | P=0.630 P=0.752N P=0.756N P=0.753N | |COCHRAN-ARMITAGE | P=0.356N | P=0.633 | |FISHER EXACT | P=0.262N P=0.159N P=0.380N | P=0.753N P=0.753N P=0.753N | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 6/50 (12%) 2/50 (4%) 2/50 (4%) 4/50 (8%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 41.0% 10.0% 10.5% 24.1% | 2.3% 5.3% 0.0% 4.3% | |TERMINAL (d) | 5/13 (38%) 1/16 (6%) 1/14 (7%) 1/8 (13%) | 0/28 (0%) 1/19 (5%) 0/30 (0%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | 673 650 643 660 | 573 733 (T) --- 733 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.550N P=0.092N P=0.113N P=0.581N | P=0.625N P=0.710 P=0.509N P=0.739 | |INCIDENTAL TUMOR | P=0.442N P=0.107N P=0.107N P=0.480N | P=0.613N P=0.763N P=0.773N P=0.749N | |LOGISTIC REGRESSION | P=0.450N P=0.155N P=0.146N P=0.484N | P=0.616N P=0.752N P=0.448N P=0.753N | |COCHRAN-ARMITAGE | P=0.388N | P=0.615N | |FISHER EXACT | P=0.134N P=0.134N P=0.370N | P=0.753N P=0.500N P=0.753N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 PAGE 22 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROMETHANE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 94 PPM 188 PPM 375 PPM | CONTROL 94 PPM 188 PPM 375 PPM | | | | | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 38/50 (76%) 34/50 (68%) 40/50 (80%) 31/50 (62%) | | |ADJUSTED (b) | 100.0% 91.1% 100.0% 100.0% | | |TERMINAL (d) | 13/13 (100%) 13/16 (81%) 14/14 (100%) 8/8 (100%) | | |FIRST INCIDENCE (DAYS) | 490 427 395 480 | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.418 P=0.293N P=0.458 P=0.455 | | |INCIDENTAL TUMOR | P=0.096N P=0.283N P=0.467 P=0.091N | | |LOGISTIC REGRESSION | P=0.080N P=0.325N P=0.454 P=0.073N | | |COCHRAN-ARMITAGE | P=0.117N | | |FISHER EXACT | P=0.252N P=0.405 P=0.097N | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 5/50 (10%) 8/50 (16%) 8/50 (16%) | 8/50 (16%) 9/50 (18%) 8/50 (16%) 10/49 (20%) | |ADJUSTED (b) | 30.6% 24.7% 42.6% 50.9% | 25.3% 33.8% 24.5% 34.2% | |TERMINAL (d) | 1/13 (8%) 3/16 (19%) 5/14 (36%) 3/8 (38%) | 6/28 (21%) 4/19 (21%) 6/30 (20%) 5/22 (23%) | |FIRST INCIDENCE (DAYS) | 504 574 560 617 | 600 561 657 634 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.237 P=0.280N P=0.598N P=0.404 | P=0.304 P=0.252 P=0.557N P=0.260 | |INCIDENTAL TUMOR | P=0.399 P=0.304N P=0.570N P=0.588N | P=0.365 P=0.426 P=0.536 P=0.369 | |LOGISTIC REGRESSION | P=0.407 P=0.300N P=0.608 P=0.586 | P=0.322 P=0.399 P=0.608 P=0.320 | |COCHRAN-ARMITAGE | P=0.433 | P=0.346 | |FISHER EXACT | P=0.277N P=0.607N P=0.607N | P=0.500 P=0.607N P=0.379 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 PAGE 23 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROMETHANE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 94 PPM 188 PPM 375 PPM | CONTROL 94 PPM 188 PPM 375 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 3/50 (6%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 3/49 (6%) | |ADJUSTED (b) | 0.0% 10.0% 6.7% 14.2% | 7.1% 0.0% 0.0% 11.8% | |TERMINAL (d) | 0/13 (0%) 1/16 (6%) 0/14 (0%) 0/8 (0%) | 2/28 (7%) 0/19 (0%) 0/30 (0%) 2/22 (9%) | |FIRST INCIDENCE (DAYS) | --- 650 728 607 | 733 (T) --- --- 660 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.071 P=0.249 P=0.514 P=0.101 | P=0.220 P=0.327N P=0.223N P=0.410 | |INCIDENTAL TUMOR | P=0.157 P=0.216 P=0.471 P=0.162 | P=0.230 P=0.327N P=0.223N P=0.438 | |LOGISTIC REGRESSION | P=0.096 P=0.222 P=0.482 P=0.117 | P=0.225 P=0.327N P=0.223N P=0.434 | |COCHRAN-ARMITAGE | P=0.104 | P=0.240 | |FISHER EXACT | P=0.247 P=0.500 P=0.121 | P=0.247N P=0.247N P=0.490 | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 7/50 (14%) 9/50 (18%) 11/50 (22%) | 10/50 (20%) 9/50 (18%) 8/50 (16%) 12/49 (24%) | |ADJUSTED (b) | 30.6% 33.3% 46.4% 57.8% | 32.1% 33.8% 24.5% 42.0% | |TERMINAL (d) | 1/13 (8%) 4/16 (25%) 5/14 (36%) 3/8 (38%) | 8/28 (29%) 4/19 (21%) 6/30 (20%) 7/22 (32%) | |FIRST INCIDENCE (DAYS) | 504 574 560 607 | 600 561 657 634 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.079 P=0.488N P=0.508 P=0.164 | P=0.260 P=0.406 P=0.345N P=0.235 | |INCIDENTAL TUMOR | P=0.200 P=0.540N P=0.529 P=0.351 | P=0.314 P=0.596 P=0.458N P=0.333 | |LOGISTIC REGRESSION | P=0.174 P=0.536N P=0.498 P=0.282 | P=0.278 P=0.581 P=0.394N P=0.301 | |COCHRAN-ARMITAGE | P=0.198 | P=0.306 | |FISHER EXACT | P=0.500N P=0.500 P=0.306 | P=0.500N P=0.398N P=0.384 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 PAGE 24 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROMETHANE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 94 PPM 188 PPM 375 PPM | CONTROL 94 PPM 188 PPM 375 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |ADJUSTED (b) | 2.6% 2.4% 12.9% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/16 (0%) 1/14 (7%) 0/8 (0%) | 0/28 (0%) 0/19 (0%) 0/30 (0%) 0/22 (0%) | |FIRST INCIDENCE (DAYS) | 590 523 720 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.437N P=0.749 P=0.498 P=0.495N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.369N P=0.733N P=0.514 P=0.486N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.367N P=0.752N P=0.498 P=0.508N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.367N | (e) | |FISHER EXACT | P=0.753N P=0.500 P=0.500N | (e) (e) (e) | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | |ADJUSTED (b) | 2.6% 8.5% 12.9% 0.0% | 0.0% 3.4% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 1/16 (6%) 1/14 (7%) 0/8 (0%) | 0/28 (0%) 0/19 (0%) 0/30 (0%) 0/22 (0%) | |FIRST INCIDENCE (DAYS) | 590 523 720 --- | --- 665 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.381N P=0.512 P=0.498 P=0.495N | P=0.566N P=0.462 (e) (e) | |INCIDENTAL TUMOR | P=0.323N P=0.553 P=0.514 P=0.486N | P=0.537N P=0.557 (e) (e) | |LOGISTIC REGRESSION | P=0.297N P=0.507 P=0.498 P=0.508N | P=0.569N P=0.503 (e) (e) | |COCHRAN-ARMITAGE | P=0.296N | P=0.570N | |FISHER EXACT | P=0.500 P=0.500 P=0.500N | P=0.500 (e) (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 PAGE 25 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROMETHANE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 94 PPM 188 PPM 375 PPM | CONTROL 94 PPM 188 PPM 375 PPM | | | | | |=================================================================================================================================| | | |Urinary Bladder | | Carcinoma or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 2/49 (4%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 3.1% 0.0% 0.0% | 0.0% 0.0% 6.7% 3.4% | |TERMINAL (d) | 0/13 (0%) 0/16 (0%) 0/14 (0%) 0/8 (0%) | 0/28 (0%) 0/19 (0%) 2/30 (7%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | --- 607 --- --- | --- --- 733 (T) 676 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.552N P=0.482 (e) (e) | P=0.228 (e) P=0.253 P=0.462 | |INCIDENTAL TUMOR | P=0.554N P=0.500 (e) (e) | P=0.248 (e) P=0.253 P=0.557 | |LOGISTIC REGRESSION | P=0.572N P=0.506 (e) (e) | P=0.238 (e) P=0.253 P=0.500 | |COCHRAN-ARMITAGE | P=0.567N | P=0.245 | |FISHER EXACT | P=0.500 (e) (e) | (e) P=0.242 P=0.500 | |=================================================================================================================================| | | |Urinary Bladder | | Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 2/49 (4%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 3.1% 0.0% 0.0% | 0.0% 0.0% 6.7% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/16 (0%) 0/14 (0%) 0/8 (0%) | 0/28 (0%) 0/19 (0%) 2/30 (7%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | --- 607 --- --- | --- --- 733 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.552N P=0.482 (e) (e) | P=0.579 (e) P=0.253 (e) | |INCIDENTAL TUMOR | P=0.554N P=0.500 (e) (e) | P=0.579 (e) P=0.253 (e) | |LOGISTIC REGRESSION | P=0.572N P=0.506 (e) (e) | P=0.579 (e) P=0.253 (e) | |COCHRAN-ARMITAGE | P=0.567N | P=0.593 | |FISHER EXACT | P=0.500 (e) (e) | (e) P=0.242 (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 PAGE 26 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROMETHANE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 94 PPM 188 PPM 375 PPM | CONTROL 94 PPM 188 PPM 375 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 6/50 (12%) 11/50 (22%) 6/50 (12%) 6/50 (12%) | |ADJUSTED (b) | | 19.8% 37.6% 18.3% 22.7% | |TERMINAL (d) | | 4/28 (14%) 4/19 (21%) 5/30 (17%) 4/23 (17%) | |FIRST INCIDENCE (DAYS) | | 713 428 432 651 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.409N P=0.049 * P=0.585N P=0.485 | |INCIDENTAL TUMOR | | P=0.357N P=0.131 P=0.543N P=0.598 | |LOGISTIC REGRESSION | | P=0.362N P=0.112 P=0.619 P=0.530 | |COCHRAN-ARMITAGE | | P=0.354N | |FISHER EXACT | | P=0.143 P=0.620N P=0.620N | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 6/50 (12%) 12/50 (24%) 6/50 (12%) 6/50 (12%) | |ADJUSTED (b) | | 19.8% 38.9% 18.3% 22.7% | |TERMINAL (d) | | 4/28 (14%) 4/19 (21%) 5/30 (17%) 4/23 (17%) | |FIRST INCIDENCE (DAYS) | | 713 428 432 651 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.374N P=0.032 * P=0.585N P=0.485 | |INCIDENTAL TUMOR | | P=0.328N P=0.094 P=0.543N P=0.598 | |LOGISTIC REGRESSION | | P=0.298N P=0.090 P=0.619 P=0.530 | |COCHRAN-ARMITAGE | | P=0.320N | |FISHER EXACT | | P=0.096 P=0.620N P=0.620N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 PAGE 27 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROMETHANE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 94 PPM 188 PPM 375 PPM | CONTROL 94 PPM 188 PPM 375 PPM | | | | | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 4.1% 0.0% 2.6% | 3.6% 5.3% 0.0% 4.3% | |TERMINAL (d) | 0/13 (0%) 0/16 (0%) 0/14 (0%) 0/8 (0%) | 1/28 (4%) 1/19 (5%) 0/30 (0%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | --- 397 --- 595 | 733 (T) 733 (T) --- 733 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.548 P=0.240 (e) P=0.511 | P=0.635N P=0.673 P=0.486N P=0.718 | |INCIDENTAL TUMOR | P=0.528 P=0.290 (e) P=0.514 | P=0.635N P=0.673 P=0.486N P=0.718 | |LOGISTIC REGRESSION | P=0.409 P=0.214 (e) P=0.494 | P=0.635N P=0.673 P=0.486N P=0.718 | |COCHRAN-ARMITAGE | P=0.539 | P=0.615N | |FISHER EXACT | P=0.247 (e) P=0.500 | P=0.753N P=0.500N P=0.753N | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 35/50 (70%) 27/50 (54%) 33/50 (66%) 25/50 (50%) | 22/50 (44%) 13/50 (26%) 14/50 (28%) 9/50 (18%) | |ADJUSTED (b) | 88.2% 92.1% 80.3% 90.0% | 52.5% 38.1% 37.6% 27.2% | |TERMINAL (d) | 9/13 (69%) 14/16 (88%) 7/14 (50%) 6/8 (75%) | 9/28 (32%) 3/19 (16%) 8/30 (27%) 3/23 (13%) | |FIRST INCIDENCE (DAYS) | 411 427 499 405 | 519 428 512 597 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.388N P=0.119N P=0.441N P=0.357N | P=0.020N* P=0.268N P=0.089N P=0.030N* | |INCIDENTAL TUMOR | P=0.044N* P=0.071N P=0.370N P=0.029N* | P=0.004N** P=0.017N* P=0.130N P=0.002N** | |LOGISTIC REGRESSION | P=0.053N P=0.091N P=0.410N P=0.033N* | P=0.005N** P=0.033N* P=0.124N P=0.001N** | |COCHRAN-ARMITAGE | P=0.059N | P=0.007N** | |FISHER EXACT | P=0.074N P=0.415N P=0.033N* | P=0.046N* P=0.072N P=0.004N** | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 PAGE 28 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROMETHANE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 94 PPM 188 PPM 375 PPM | CONTROL 94 PPM 188 PPM 375 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 2.1% 8.1% 0.0% 9.1% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/16 (0%) 0/14 (0%) 0/8 (0%) | 0/28 (0%) 0/19 (0%) 0/30 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | 490 439 --- 709 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.435N P=0.297 P=0.500N P=0.696 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.383N P=0.350 P=0.531N P=0.729N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.441N P=0.324 P=0.588N P=0.759 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.409N | (e) | |FISHER EXACT | P=0.309 P=0.500N P=0.753N | (e) (e) (e) | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 50/50 (100%) 45/50 (90%) 50/50 (100%) 47/50 (94%) | 44/50 (88%) 47/50 (94%) 48/50 (96%) 49/50 (98%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 97.7% 100.0% 100.0% 100.0% | |TERMINAL (d) | 13/13 (100%) 16/16 (100%) 14/14 (100%) 8/8 (100%) | 27/28 (96%) 19/19 (100%) 30/30 (100%) 23/23 (100%)| |FIRST INCIDENCE (DAYS) | 242 427 395 444 | 454 428 432 425 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.229 P=0.293N P=0.530N P=0.278 | P=0.162 P=0.015 * P=0.425 P=0.058 | |INCIDENTAL TUMOR | P=0.145N P=0.043N* (e) P=0.105N | P=0.029 * P=0.134 P=0.102 P=0.045 * | |LOGISTIC REGRESSION | P=0.139N P=0.023N* (e) P=0.045N* | P=0.021 * P=0.161 P=0.094 P=0.036 * | |COCHRAN-ARMITAGE | P=0.313N | P=0.035 * | |FISHER EXACT | P=0.028N* P=1.000N P=0.121N | P=0.243 P=0.134 P=0.056 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 PAGE 29 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROMETHANE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 94 PPM 188 PPM 375 PPM | CONTROL 94 PPM 188 PPM 375 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 40/50 (80%) 35/50 (70%) 39/50 (78%) 33/50 (66%) | 28/50 (56%) 21/50 (42%) 20/50 (40%) 27/50 (54%) | |ADJUSTED (b) | 92.4% 96.9% 89.6% 96.2% | 63.0% 56.5% 49.8% 65.0% | |TERMINAL (d) | 10/13 (77%) 15/16 (94%) 10/14 (71%) 7/8 (88%) | 12/28 (43%) 6/19 (32%) 11/30 (37%) 10/23 (43%) | |FIRST INCIDENCE (DAYS) | 411 292 395 405 | 519 428 432 387 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.475 P=0.258N P=0.489N P=0.529 | P=0.435 P=0.518N P=0.108N P=0.412 | |INCIDENTAL TUMOR | P=0.110N P=0.181N P=0.434N P=0.065N | P=0.537N P=0.054N P=0.124N P=0.380N | |LOGISTIC REGRESSION | P=0.107N P=0.197N P=0.499N P=0.087N | P=0.513 P=0.086N P=0.078N P=0.455N | |COCHRAN-ARMITAGE | P=0.112N | P=0.501 | |FISHER EXACT | P=0.178N P=0.500N P=0.088N | P=0.115N P=0.080N P=0.500N | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 50/50 (100%) 49/50 (98%) 50/50 (100%) 49/50 (98%) | 49/50 (98%) 50/50 (100%) 50/50 (100%) 50/50 (100%)| |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 98.0% 100.0% 100.0% 100.0% | |TERMINAL (d) | 13/13 (100%) 16/16 (100%) 14/14 (100%) 8/8 (100%) | 27/28 (96%) 19/19 (100%) 30/30 (100%) 23/23 (100%)| |FIRST INCIDENCE (DAYS) | 242 292 395 405 | 454 428 432 387 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.210 P=0.481N P=0.530N P=0.210 | P=0.347 P=0.034 * P=0.513N P=0.170 | |INCIDENTAL TUMOR | P=0.380N P=0.550N (e) P=0.500N | P=0.313 P=0.577 P=0.486 P=0.539 | |LOGISTIC REGRESSION | P=0.340N P=0.510N (e) P=0.455N | P=0.313 P=0.577 P=0.486 P=0.539 | |COCHRAN-ARMITAGE | P=0.405N | P=0.304 | |FISHER EXACT | P=0.500N P=1.000N P=0.500N | P=0.500 P=0.500 P=0.500 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05200 TEST: 05 PAGE 30 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NITROMETHANE TERMINAL SACRIFICE AT 105 WEEKS (a) Number of tumor-bearing animals / number of animals examined at site. (b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for intercurrent mortality. (d) Observed incidence at terminal kill. (f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between the controls and that dosed group. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. The incidental tumor test regards these lesions as non-fatal. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fisher's exact tests compare directly the overall incidence rates. For all tests, a negative trend is indicated by "N". (e) Value of Statistic cannot be computed. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01).