TDMS Study 05142-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst T-BUTYL ALCOHOL DATE: 05/20/95 EXPERIMENT: 05142 TEST: 03 TIME: 07:57:17 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-55121 ROUTE: DOSED WATER NTP C#: 55367B PATHOLOGIST: DR J. HEATH S. EUSTIS CAS: 75-65-0 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst T-BUTYL ALCOHOL DATE: 05/20/95 EXPERIMENT: 05142 TEST: 03 TIME: 07:57:17 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-55121 ROUTE: DOSED WATER NTP C#: 55367B PATHOLOGIST: DR J. HEATH S. EUSTIS CAS: 75-65-0 RATS(FISCHER344) ---------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED. ---------------- Adrenal Cortex Adrenal Medulla Bone Marrow Brain Clitoral Gland Clitoral/Preputial Gland Epididymis Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst T-BUTYL ALCOHOL DATE: 05/20/95 EXPERIMENT: 05142 TEST: 03 TIME: 07:57:17 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-55121 ROUTE: DOSED WATER NTP C#: 55367B PATHOLOGIST: DR J. HEATH S. EUSTIS CAS: 75-65-0 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF T-BUTYL ALCOHOL ==================================================================================================== MALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma: Benign, Complex, Malignant, NOS Islets, Pancreatic Adenoma Carcinoma or Adenoma Kidney: Renal Tubule Adenoma Carcinoma or Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma Testes Adenoma Thymus Thymoma Benign Thymoma: Benign, Malignant, NOS Thyroid Gland: Follicular Cell Carcinoma or Adenoma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Benign Tumors Malignant and Benign Tumors ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Lung Alveolar/Bronchiolar Adenoma 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 Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 05/20/95 EXPERIMENT: 05142 TEST: 03 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.125% 0.25% 0.50% | VEHICLE 0.25% 0.50% 1.00% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 9/60 (15%) 7/60 (12%) 4/60 (7%) 4/60 (7%) | 3/60 (5%) 0/60 (0%) 1/60 (2%) 2/59 (3%) | |ADJUSTED (b) | 44.7% 35.0% 55.2% 14.2% | 9.4% 0.0% 4.5% 11.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/10 (20%) 0/6 (0%) 2/4 (50%) 0/1 (0%) | 2/28 (7%) 0/24 (0%) 1/22 (5%) 1/12 (8%) | |FIRST INCIDENCE (DAYS) | 588 584 637 506 | 591 --- 729 (T) 617 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.545N P=0.442N P=0.446N P=0.568N | P=0.484 P=0.146N P=0.384N P=0.641 | |INCIDENTAL TUMOR | P=0.106N P=0.284N P=0.240N P=0.143N | P=0.587 P=0.141N P=0.411N P=0.611N | |LOGISTIC REGRESSION | P=0.188N P=0.385N P=0.265N P=0.213N | P=0.598 P=0.131N P=0.333N P=0.586N | |COCHRAN-ARMITAGE | P=0.073N | P=0.562N | |FISHER EXACT | P=0.395N P=0.120N P=0.120N | P=0.122N P=0.309N P=0.508N | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/60 (7%) 1/60 (2%) 2/60 (3%) 0/60 (0%) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 1/59 (2%) | |ADJUSTED (b) | 24.9% 3.3% 26.7% 0.0% | 0.0% 4.2% 0.0% 1.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | |TERMINAL (d) | 2/10 (20%) 0/6 (0%) 1/4 (25%) 0/1 (0%) | 0/28 (0%) 1/24 (4%) 0/22 (0%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | 588 624 512 --- | --- 729 (T) --- 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.182N P=0.223N P=0.586N P=0.251N | P=0.324 P=0.469 (e) P=0.500 | |INCIDENTAL TUMOR | P=0.107N P=0.272N P=0.461N P=0.154N | P=0.324 P=0.469 (e) P=0.500 | |LOGISTIC REGRESSION | P=0.081N P=0.177N P=0.435N P=0.119N | P=0.407 P=0.469 (e) P=0.517 | |COCHRAN-ARMITAGE | P=0.053N | P=0.401 | |FISHER EXACT | P=0.182N P=0.340N P=0.059N | P=0.500 (e) P=0.496 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05142 TEST: 03 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.125% 0.25% 0.50% | VEHICLE 0.25% 0.50% 1.00% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/60 (20%) 7/60 (12%) 6/60 (10%) 4/60 (7%) | 3/60 (5%) 1/60 (2%) 2/60 (3%) 3/59 (5%) | |ADJUSTED (b) | 60.0% 35.0% 78.1% 14.2% | 9.4% 4.2% 6.9% 12.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | |TERMINAL (d) | 4/10 (40%) 0/6 (0%) 3/4 (75%) 0/1 (0%) | 2/28 (7%) 1/24 (4%) 1/22 (5%) 1/12 (8%) | |FIRST INCIDENCE (DAYS) | 588 584 512 506 | 591 729 (T) 565 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.436N P=0.231N P=0.496N P=0.431N | P=0.292 P=0.355N P=0.587N P=0.458 | |INCIDENTAL TUMOR | P=0.064N P=0.122N P=0.241N P=0.073N | P=0.411 P=0.348N P=0.638N P=0.575 | |LOGISTIC REGRESSION | P=0.087N P=0.142N P=0.250N P=0.084N | P=0.441 P=0.331N P=0.526N P=0.637 | |COCHRAN-ARMITAGE | P=0.024N* | P=0.469 | |FISHER EXACT | P=0.159N P=0.100N P=0.029N* | P=0.309N P=0.500N P=0.652 | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/60 (3%) 1/60 (2%) 1/60 (2%) 2/59 (3%) | 4/59 (7%) 6/60 (10%) 4/60 (7%) 2/60 (3%) | |ADJUSTED (b) | 13.9% 2.8% 3.1% 100.0% | 13.1% 19.4% 18.2% 7.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/10 (10%) 0/6 (0%) 0/4 (0%) 1/1 (100%) | 2/27 (7%) 3/24 (13%) 4/22 (18%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | 636 596 582 575 | 645 457 (I) 729 (T) 597 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.297 P=0.531N P=0.628N P=0.308 | P=0.450N P=0.313 P=0.550 P=0.571N | |INCIDENTAL TUMOR | P=0.423 P=0.589N P=0.602N P=0.397 | P=0.247N P=0.334 P=0.634 P=0.276N | |LOGISTIC REGRESSION | P=0.456 P=0.498N P=0.573N P=0.509 | P=0.241N P=0.353 P=0.610 P=0.403N | |COCHRAN-ARMITAGE | P=0.549 | P=0.185N | |FISHER EXACT | P=0.500N P=0.500N P=0.684 | P=0.382 P=0.632N P=0.332N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05142 TEST: 03 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.125% 0.25% 0.50% | VEHICLE 0.25% 0.50% 1.00% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 3/60 (5%) 3/60 (5%) 1/59 (2%) | 3/59 (5%) 2/60 (3%) 6/60 (10%) 4/60 (7%) | |ADJUSTED (b) | 2.2% 7.0% 13.0% 1.7% | 10.6% 6.6% 24.4% 21.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 0/6 (0%) 0/4 (0%) 0/1 (0%) | 2/27 (7%) 1/24 (4%) 4/22 (18%) 1/12 (8%) | |FIRST INCIDENCE (DAYS) | 553 348 589 262 | 723 591 699 610 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.576N P=0.331 P=0.264 P=0.758N | P=0.073 P=0.548N P=0.162 P=0.192 | |INCIDENTAL TUMOR | P=0.409N P=0.270 P=0.303 P=0.736N | P=0.264 P=0.532N P=0.257 P=0.492 | |LOGISTIC REGRESSION | P=0.498N P=0.273 P=0.289 P=0.723 | P=0.181 P=0.523N P=0.197 P=0.342 | |COCHRAN-ARMITAGE | P=0.507N | P=0.317 | |FISHER EXACT | P=0.309 P=0.309 P=0.748 | P=0.492N P=0.254 P=0.509 | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/60 (5%) 3/60 (5%) 4/60 (7%) 3/59 (5%) | 7/59 (12%) 8/60 (13%) 10/60 (17%) 6/60 (10%) | |ADJUSTED (b) | 15.8% 7.0% 15.7% 100.0% | 22.8% 25.2% 41.2% 27.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/10 (10%) 0/6 (0%) 0/4 (0%) 1/1 (100%) | 4/27 (15%) 4/24 (17%) 8/22 (36%) 1/12 (8%) | |FIRST INCIDENCE (DAYS) | 553 348 582 262 | 645 457 (I) 699 597 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.338 P=0.647 P=0.379 P=0.355 | P=0.211 P=0.417 P=0.176 P=0.321 | |INCIDENTAL TUMOR | P=0.531 P=0.581 P=0.432 P=0.443 | P=0.534N P=0.448 P=0.297 P=0.463N | |LOGISTIC REGRESSION | P=0.557 P=0.657 P=0.445 P=0.656 | P=0.523 P=0.470 P=0.237 P=0.583 | |COCHRAN-ARMITAGE | P=0.548 | P=0.424N | |FISHER EXACT | P=0.660N P=0.500 P=0.652 | P=0.514 P=0.314 P=0.487N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05142 TEST: 03 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.125% 0.25% 0.50% | VEHICLE 0.25% 0.50% 1.00% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 15/60 (25%) 15/59 (25%) 7/59 (12%) 6/59 (10%) | 1/60 (2%) 1/60 (2%) 4/58 (7%) 1/60 (2%) | |ADJUSTED (b) | 68.0% 66.3% 51.4% 29.0% | 3.4% 4.0% 18.0% 4.2% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 4/10 (40%) 1/6 (17%) 1/4 (25%) 0/1 (0%) | 0/28 (0%) 0/24 (0%) 3/21 (14%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | 604 520 556 555 | 723 727 724 666 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.438N P=0.477 P=0.392N P=0.568N | P=0.261 P=0.735 P=0.114 P=0.637 | |INCIDENTAL TUMOR | P=0.012N* P=0.400N P=0.109N P=0.044N* | P=0.537 P=0.769 P=0.187 P=0.640N | |LOGISTIC REGRESSION | P=0.051N P=0.574N P=0.144N P=0.131N | P=0.351 P=0.742 P=0.120 P=0.710 | |COCHRAN-ARMITAGE | P=0.009N** | P=0.524 | |FISHER EXACT | P=0.563 P=0.053N P=0.029N* | P=0.752N P=0.172 P=0.752N | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/60 (3%) 0/59 (0%) 2/59 (3%) 0/59 (0%) | 1/60 (2%) 0/60 (0%) 0/58 (0%) 0/60 (0%) | |ADJUSTED (b) | 13.9% 0.0% 6.3% 0.0% | 3.6% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/10 (10%) 0/6 (0%) 0/4 (0%) 0/1 (0%) | 1/28 (4%) 0/24 (0%) 0/21 (0%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | 636 --- 542 --- | 729 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.407N P=0.285N P=0.582 P=0.499N | P=0.398N P=0.531N P=0.557N P=0.669N | |INCIDENTAL TUMOR | P=0.289N P=0.312N P=0.698N P=0.399N | P=0.398N P=0.531N P=0.557N P=0.669N | |LOGISTIC REGRESSION | P=0.288N P=0.240N P=0.649 P=0.392N | P=0.398N P=0.531N P=0.557N P=0.669N | |COCHRAN-ARMITAGE | P=0.251N | P=0.307N | |FISHER EXACT | P=0.252N P=0.684 P=0.252N | P=0.500N P=0.508N P=0.500N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05142 TEST: 03 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.125% 0.25% 0.50% | VEHICLE 0.25% 0.50% 1.00% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 17/60 (28%) 15/59 (25%) 9/59 (15%) 6/59 (10%) | 2/60 (3%) 1/60 (2%) 4/58 (7%) 1/60 (2%) | |ADJUSTED (b) | 74.5% 66.3% 54.5% 29.0% | 6.9% 4.0% 18.0% 4.2% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 5/10 (50%) 1/6 (17%) 1/4 (25%) 0/1 (0%) | 1/28 (4%) 0/24 (0%) 3/21 (14%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | 604 520 542 555 | 723 727 724 666 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.368N P=0.538N P=0.450N P=0.466N | P=0.404 P=0.543N P=0.226 P=0.714N | |INCIDENTAL TUMOR | P=0.007N** P=0.264N P=0.125N P=0.023N* | P=0.533N P=0.518N P=0.327 P=0.469N | |LOGISTIC REGRESSION | P=0.028N* P=0.387N P=0.167N P=0.066N | P=0.509 P=0.535N P=0.241 P=0.622N | |COCHRAN-ARMITAGE | P=0.004N** | P=0.502N | |FISHER EXACT | P=0.440N P=0.066N P=0.011N* | P=0.500N P=0.324 P=0.500N | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 3/60 (5%) 4/60 (7%) 3/60 (5%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 10.0% 40.0% 34.9% 24.3% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/10 (10%) 2/6 (33%) 0/4 (0%) 0/1 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 708 605 566 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.018 * P=0.160 P=0.061 P=0.091 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.131 P=0.206 P=0.127 P=0.206 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.094 P=0.188 P=0.093 P=0.215 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.283 | (e) | |FISHER EXACT | P=0.309 P=0.182 P=0.309 | (e) (e) (e) | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05142 TEST: 03 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.125% 0.25% 0.50% | VEHICLE 0.25% 0.50% 1.00% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 3/60 (5%) 4/60 (7%) 3/60 (5%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 10.0% 40.0% 34.9% 24.3% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/10 (10%) 2/6 (33%) 0/4 (0%) 0/1 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 708 605 566 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.018 * P=0.160 P=0.061 P=0.091 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.131 P=0.206 P=0.127 P=0.206 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.094 P=0.188 P=0.093 P=0.215 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.283 | (e) | |FISHER EXACT | P=0.309 P=0.182 P=0.309 | (e) (e) (e) | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 2/60 (3%) | |ADJUSTED (b) | 10.0% 0.0% 25.0% 0.0% | 0.0% 0.0% 4.5% 10.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/10 (10%) 0/6 (0%) 1/4 (25%) 0/1 (0%) | 0/28 (0%) 0/24 (0%) 1/22 (5%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- 729 (T) --- | --- --- 729 (T) 605 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.691 P=0.602N P=0.546 P=0.923N | P=0.029 * (e) P=0.452 P=0.159 | |INCIDENTAL TUMOR | P=0.691 P=0.602N P=0.546 P=0.923N | P=0.094 (e) P=0.452 P=0.377 | |LOGISTIC REGRESSION | P=0.691 P=0.602N P=0.546 P=0.923N | P=0.052 (e) P=0.452 P=0.211 | |COCHRAN-ARMITAGE | P=0.405N | P=0.070 | |FISHER EXACT | P=0.500N P=0.752N P=0.500N | (e) P=0.500 P=0.248 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05142 TEST: 03 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.125% 0.25% 0.50% | VEHICLE 0.25% 0.50% 1.00% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/60 (0%) 1/60 (2%) 1/60 (2%) | 0/60 (0%) 1/60 (2%) 2/60 (3%) 2/60 (3%) | |ADJUSTED (b) | 10.0% 0.0% 25.0% 12.5% | 0.0% 4.2% 6.3% 10.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | |TERMINAL (d) | 1/10 (10%) 0/6 (0%) 1/4 (25%) 0/1 (0%) | 0/28 (0%) 1/24 (4%) 1/22 (5%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- 729 (T) 669 | --- 729 (T) 457 (I) 605 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.154 P=0.602N P=0.546 P=0.426 | P=0.076 P=0.469 P=0.213 P=0.159 | |INCIDENTAL TUMOR | P=0.223 P=0.602N P=0.546 P=0.591 | P=0.155 P=0.469 P=0.213 P=0.377 | |LOGISTIC REGRESSION | P=0.199 P=0.602N P=0.546 P=0.528 | P=0.149 P=0.469 P=0.246 P=0.211 | |COCHRAN-ARMITAGE | P=0.539 | P=0.160 | |FISHER EXACT | P=0.500N P=0.752N P=0.752N | P=0.500 P=0.248 P=0.248 | |=================================================================================================================================| | | |Mammary Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 2/60 (3%) 1/60 (2%) 2/60 (3%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 7.1% 4.2% 6.8% 3.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 0/6 (0%) 0/4 (0%) 0/1 (0%) | 2/28 (7%) 1/24 (4%) 0/22 (0%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 729 (T) 729 (T) 694 631 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.578 P=0.554N P=0.646 P=0.720N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.456N P=0.554N P=0.645N P=0.620N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.538N P=0.554N P=0.663 P=0.594N | |COCHRAN-ARMITAGE | (e) | P=0.444N | |FISHER EXACT | (e) (e) (e) | P=0.500N P=0.691N P=0.500N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05142 TEST: 03 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.125% 0.25% 0.50% | VEHICLE 0.25% 0.50% 1.00% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 6/60 (10%) 5/60 (8%) 1/60 (2%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 18.9% 18.4% 4.2% 3.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 0/6 (0%) 0/4 (0%) 0/1 (0%) | 3/28 (11%) 3/24 (13%) 0/22 (0%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 625 646 708 636 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.083N P=0.588N P=0.098N P=0.226N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.015N* P=0.560N P=0.046N* P=0.052N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.034N* P=0.559N P=0.072N P=0.102N | |COCHRAN-ARMITAGE | (e) | P=0.019N* | |FISHER EXACT | (e) (e) (e) | P=0.500N P=0.057N P=0.057N | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 8/60 (13%) 5/60 (8%) 3/60 (5%) 2/60 (3%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 25.4% 18.4% 10.7% 7.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 0/6 (0%) 0/4 (0%) 0/1 (0%) | 5/28 (18%) 3/24 (13%) 0/22 (0%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 625 646 694 631 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.145N P=0.371N P=0.169N P=0.255N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.020N* P=0.338N P=0.067N P=0.058N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.013N* P=0.330N P=0.126N P=0.096N | |COCHRAN-ARMITAGE | (e) | P=0.028N* | |FISHER EXACT | (e) (e) (e) | P=0.279N P=0.102N P=0.047N* | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05142 TEST: 03 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.125% 0.25% 0.50% | VEHICLE 0.25% 0.50% 1.00% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 2/60 (3%) 1/60 (2%) 0/60 (0%) | 14/60 (23%) 15/60 (25%) 11/60 (18%) 8/60 (13%) | |ADJUSTED (b) | 8.3% 25.0% 2.3% 0.0% | 34.5% 47.5% 40.8% 32.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 2/10 (20%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 1/6 (17%) 0/4 (0%) 0/1 (0%) | 4/28 (14%) 9/24 (38%) 7/22 (32%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | 720 708 525 --- | 457 (I) 457 (I) 652 610 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.613N P=0.375 P=0.635 P=0.944N | P=0.432N P=0.375 P=0.477N P=0.447N | |INCIDENTAL TUMOR | P=0.326N P=0.556 P=0.647N P=0.467N | P=0.045N* P=0.451 P=0.321N P=0.019N* | |LOGISTIC REGRESSION | P=0.377N P=0.424 P=0.743 P=0.856N | P=0.106N P=0.450 P=0.390N P=0.151N | |COCHRAN-ARMITAGE | P=0.248N | P=0.063N | |FISHER EXACT | P=0.500 P=0.752N P=0.500N | P=0.500 P=0.327N P=0.119N | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 2/60 (3%) 1/60 (2%) 0/60 (0%) | 16/60 (27%) 15/60 (25%) 11/60 (18%) 9/60 (15%) | |ADJUSTED (b) | 8.3% 25.0% 2.3% 0.0% | 40.0% 47.5% 40.8% 35.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 2/10 (20%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 1/6 (17%) 0/4 (0%) 0/1 (0%) | 6/28 (21%) 9/24 (38%) 7/22 (32%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | 720 708 525 --- | 457 (I) 457 (I) 652 610 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.613N P=0.375 P=0.635 P=0.944N | P=0.420N P=0.518 P=0.338N P=0.445N | |INCIDENTAL TUMOR | P=0.326N P=0.556 P=0.647N P=0.467N | P=0.040N* P=0.560N P=0.197N P=0.019N* | |LOGISTIC REGRESSION | P=0.377N P=0.424 P=0.743 P=0.856N | P=0.091N P=0.559N P=0.242N P=0.123N | |COCHRAN-ARMITAGE | P=0.248N | P=0.052N | |FISHER EXACT | P=0.500 P=0.752N P=0.500N | P=0.500N P=0.191N P=0.088N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05142 TEST: 03 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.125% 0.25% 0.50% | VEHICLE 0.25% 0.50% 1.00% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 2/60 (3%) 1/60 (2%) 0/60 (0%) | 19/60 (32%) 17/60 (28%) 12/60 (20%) 10/60 (17%) | |ADJUSTED (b) | 8.3% 25.0% 2.3% 0.0% | 48.2% 52.6% 43.3% 37.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 2/10 (20%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 1/6 (17%) 0/4 (0%) 0/1 (0%) | 9/28 (32%) 10/24 (42%) 7/22 (32%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | 720 708 525 --- | 457 (I) 457 (I) 652 610 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.613N P=0.375 P=0.635 P=0.944N | P=0.346N P=0.564 P=0.241N P=0.398N | |INCIDENTAL TUMOR | P=0.326N P=0.556 P=0.647N P=0.467N | P=0.018N* P=0.503N P=0.107N P=0.013N* | |LOGISTIC REGRESSION | P=0.377N P=0.424 P=0.743 P=0.856N | P=0.048N* P=0.494N P=0.142N P=0.072N | |COCHRAN-ARMITAGE | P=0.248N | P=0.023N* | |FISHER EXACT | P=0.500 P=0.752N P=0.500N | P=0.421N P=0.105N P=0.043N* | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Papilloma Squamous or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 2/60 (3%) | |ADJUSTED (b) | 10.0% 0.0% 0.0% 3.3% | 0.0% 4.0% 0.0% 5.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/10 (10%) 0/6 (0%) 0/4 (0%) 0/1 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- --- 594 | --- 727 --- 597 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.394 P=0.602N P=0.682N P=0.541 | P=0.098 P=0.477 (e) P=0.216 | |INCIDENTAL TUMOR | P=0.455 P=0.602N P=0.682N P=0.606 | P=0.285 P=0.500 (e) P=0.389 | |LOGISTIC REGRESSION | P=0.505 P=0.602N P=0.682N P=0.674 | P=0.132 P=0.480 (e) P=0.241 | |COCHRAN-ARMITAGE | P=0.595 | P=0.140 | |FISHER EXACT | P=0.500N P=0.500N P=0.752N | P=0.500 (e) P=0.248 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05142 TEST: 03 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.125% 0.25% 0.50% | VEHICLE 0.25% 0.50% 1.00% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | 0/60 (0%) 2/60 (3%) 1/60 (2%) 2/60 (3%) | |ADJUSTED (b) | 10.0% 0.0% 0.0% 3.3% | 0.0% 7.4% 3.0% 5.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/10 (10%) 0/6 (0%) 0/4 (0%) 0/1 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- --- 594 | --- 703 651 597 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.394 P=0.602N P=0.682N P=0.541 | P=0.163 P=0.224 P=0.506 P=0.216 | |INCIDENTAL TUMOR | P=0.455 P=0.602N P=0.682N P=0.606 | P=0.453 P=0.231 P=0.607 P=0.389 | |LOGISTIC REGRESSION | P=0.505 P=0.602N P=0.682N P=0.674 | P=0.224 P=0.217 P=0.493 P=0.241 | |COCHRAN-ARMITAGE | P=0.595 | P=0.246 | |FISHER EXACT | P=0.500N P=0.500N P=0.752N | P=0.248 P=0.500 P=0.248 | |=================================================================================================================================| | | |Pancreas | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/60 (5%) 6/59 (10%) 1/60 (2%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 0/59 (0%) 0/60 (0%) | |ADJUSTED (b) | 22.9% 63.3% 16.7% 2.6% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/10 (10%) 3/6 (50%) 0/4 (0%) 0/1 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | 694 693 685 575 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.456 P=0.111 P=0.667N P=0.683 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.253N P=0.250 P=0.381N P=0.395N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.434N P=0.156 P=0.571N P=0.524N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.095N | (e) | |FISHER EXACT | P=0.237 P=0.309N P=0.309N | (e) (e) (e) | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05142 TEST: 03 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.125% 0.25% 0.50% | VEHICLE 0.25% 0.50% 1.00% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Pancreas | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/60 (5%) 7/59 (12%) 2/60 (3%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 0/59 (0%) 0/60 (0%) | |ADJUSTED (b) | 22.9% 64.8% 18.9% 2.6% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/10 (10%) 3/6 (50%) 0/4 (0%) 0/1 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | 694 639 551 575 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.488 P=0.073 P=0.527 P=0.683 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.219N P=0.156 P=0.580N P=0.395N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.330N P=0.108 P=0.652N P=0.524N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.096N | (e) | |FISHER EXACT | P=0.154 P=0.500N P=0.309N | (e) (e) (e) | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 39/59 (66%) 38/60 (63%) 35/59 (59%) 27/58 (47%) | 33/60 (55%) 32/60 (53%) 28/59 (47%) 30/59 (51%) | |ADJUSTED (b) | 93.2% 96.3% 100.0% 93.5% | 79.3% 80.6% 74.2% 92.2% | |INTERIM SACRIFICE 1 (c)| 6/10 (60%) 5/10 (50%) 4/10 (40%) 4/9 (44%) | 3/10 (30%) 3/10 (30%) 2/10 (20%) 3/10 (30%) | |TERMINAL (d) | 7/9 (78%) 5/6 (83%) 4/4 (100%) 0/1 (0%) | 20/28 (71%) 17/24 (71%) 13/22 (59%) 10/12 (83%) | |FIRST INCIDENCE (DAYS) | 456 (I) 395 398 456 (I) | 457 (I) 424 377 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.174 P=0.520 P=0.190 P=0.337 | P=0.035 * P=0.385 P=0.559N P=0.031 * | |INCIDENTAL TUMOR | P=0.027N* P=0.436N P=0.367N P=0.033N* | P=0.513 P=0.534 P=0.305N P=0.437 | |LOGISTIC REGRESSION | P=0.021N* P=0.416N P=0.353N P=0.033N* | P=0.439N P=0.547 P=0.350N P=0.538N | |COCHRAN-ARMITAGE | P=0.014N* | P=0.332N | |FISHER EXACT | P=0.451N P=0.284N P=0.026N* | P=0.500N P=0.261N P=0.394N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05142 TEST: 03 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.125% 0.25% 0.50% | VEHICLE 0.25% 0.50% 1.00% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/59 (2%) 0/60 (0%) 0/59 (0%) 0/58 (0%) | 2/60 (3%) 1/60 (2%) 1/59 (2%) 1/59 (2%) | |ADJUSTED (b) | 4.8% 0.0% 0.0% 0.0% | 5.0% 3.0% 3.8% 2.2% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/9 (0%) 0/6 (0%) 0/4 (0%) 0/1 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | 645 --- --- --- | 457 (I) 624 703 555 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.364N P=0.473N P=0.567N P=0.581N | P=0.480N P=0.524N P=0.520N P=0.562N | |INCIDENTAL TUMOR | P=0.305N P=0.402N P=0.500N P=0.467N | P=0.254N P=0.500N P=0.376N P=0.366N | |LOGISTIC REGRESSION | P=0.335N P=0.493N P=0.536N P=0.554N | P=0.411N P=0.488N P=0.504N P=0.489N | |COCHRAN-ARMITAGE | P=0.308N | P=0.416N | |FISHER EXACT | P=0.496N P=0.500N P=0.504N | P=0.500N P=0.506N P=0.506N | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 39/59 (66%) 38/60 (63%) 35/59 (59%) 27/58 (47%) | 35/60 (58%) 33/60 (55%) 29/59 (49%) 31/59 (53%) | |ADJUSTED (b) | 93.2% 96.3% 100.0% 93.5% | 80.4% 81.2% 75.2% 92.4% | |INTERIM SACRIFICE 1 (c)| 6/10 (60%) 5/10 (50%) 4/10 (40%) 4/9 (44%) | 4/10 (40%) 3/10 (30%) 2/10 (20%) 3/10 (30%) | |TERMINAL (d) | 7/9 (78%) 5/6 (83%) 4/4 (100%) 0/1 (0%) | 20/28 (71%) 17/24 (71%) 13/22 (59%) 10/12 (83%) | |FIRST INCIDENCE (DAYS) | 456 (I) 395 398 456 (I) | 457 (I) 424 377 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.174 P=0.520 P=0.190 P=0.337 | P=0.047 * P=0.444 P=0.501N P=0.045 * | |INCIDENTAL TUMOR | P=0.027N* P=0.436N P=0.367N P=0.033N* | P=0.439N P=0.543N P=0.208N P=0.565 | |LOGISTIC REGRESSION | P=0.021N* P=0.416N P=0.353N P=0.033N* | P=0.371N P=0.527N P=0.283N P=0.443N | |COCHRAN-ARMITAGE | P=0.014N* | P=0.279N | |FISHER EXACT | P=0.451N P=0.284N P=0.026N* | P=0.427N P=0.206N P=0.326N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05142 TEST: 03 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.125% 0.25% 0.50% | VEHICLE 0.25% 0.50% 1.00% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Skin | | Basal Cell Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 0.0% 7.0% 0.0% | 0.0% 0.0% 0.0% 2.2% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 0/6 (0%) 0/4 (0%) 0/1 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 556 --- | --- --- --- 576 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.559 (e) P=0.221 (e) | P=0.207 (e) (e) P=0.500 | |INCIDENTAL TUMOR | P=0.653 (e) P=0.237 (e) | P=0.310 (e) (e) P=0.630 | |LOGISTIC REGRESSION | P=0.592 (e) P=0.234 (e) | P=0.201 (e) (e) P=0.510 | |COCHRAN-ARMITAGE | P=0.595 | P=0.199 | |FISHER EXACT | (e) P=0.248 (e) | (e) (e) P=0.500 | |=================================================================================================================================| | | |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) | 3/60 (5%) 5/60 (8%) 6/60 (10%) 3/60 (5%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 2/60 (3%) | |ADJUSTED (b) | 14.1% 32.0% 43.4% 18.4% | 0.0% 0.0% 2.9% 6.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 1/6 (17%) 1/4 (25%) 0/1 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | 588 591 456 (I) 555 | --- --- 645 576 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.224 P=0.328 P=0.109 P=0.414 | P=0.051 (e) P=0.494 P=0.199 | |INCIDENTAL TUMOR | P=0.520N P=0.342 P=0.200 P=0.554N | P=0.157 (e) P=0.607 P=0.377 | |LOGISTIC REGRESSION | P=0.511 P=0.359 P=0.195 P=0.607 | P=0.069 (e) P=0.494 P=0.237 | |COCHRAN-ARMITAGE | P=0.517N | P=0.070 | |FISHER EXACT | P=0.359 P=0.245 P=0.660N | (e) P=0.500 P=0.248 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05142 TEST: 03 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.125% 0.25% 0.50% | VEHICLE 0.25% 0.50% 1.00% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Skin | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 3/60 (5%) 1/60 (2%) 1/60 (2%) | 0/60 (0%) 1/60 (2%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 6.7% 17.3% 2.2% 20.0% | 0.0% 4.2% 2.4% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 0/6 (0%) 0/4 (0%) 0/1 (0%) | 0/28 (0%) 1/24 (4%) 0/22 (0%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | 692 584 484 679 | --- 729 (T) 562 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.477 P=0.277 P=0.641 P=0.403 | P=0.672N P=0.469 P=0.486 (e) | |INCIDENTAL TUMOR | P=0.398N P=0.369 P=0.647N P=0.727N | P=0.588N P=0.469 P=0.419 (e) | |LOGISTIC REGRESSION | P=0.505N P=0.307 P=0.761 P=0.597 | P=0.604N P=0.469 P=0.518 (e) | |COCHRAN-ARMITAGE | P=0.444N | P=0.595N | |FISHER EXACT | P=0.309 P=0.752N P=0.752N | P=0.500 P=0.500 (e) | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 4/60 (7%) 2/60 (3%) 2/60 (3%) | 2/60 (3%) 4/60 (7%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 15.3% 19.2% 6.3% 22.0% | 7.1% 14.9% 2.4% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 0/6 (0%) 0/4 (0%) 0/1 (0%) | 2/28 (7%) 3/24 (13%) 0/22 (0%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | 553 562 484 566 | 729 (T) 610 562 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.546 P=0.466 P=0.662 P=0.502 | P=0.181N P=0.277 P=0.564N P=0.438N | |INCIDENTAL TUMOR | P=0.242N P=0.572 P=0.408N P=0.408N | P=0.132N P=0.279 P=0.602N P=0.438N | |LOGISTIC REGRESSION | P=0.363N P=0.504 P=0.526N P=0.601N | P=0.111N P=0.296 P=0.521N P=0.438N | |COCHRAN-ARMITAGE | P=0.319N | P=0.087N | |FISHER EXACT | P=0.500 P=0.500N P=0.500N | P=0.340 P=0.500N P=0.248N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05142 TEST: 03 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.125% 0.25% 0.50% | VEHICLE 0.25% 0.50% 1.00% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Skin | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 1/60 (2%) 1/60 (2%) 1/60 (2%) | 2/60 (3%) 3/60 (5%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 9.2% 2.3% 4.2% 2.4% | 7.1% 10.8% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 0/6 (0%) 0/4 (0%) 0/1 (0%) | 2/28 (7%) 2/24 (8%) 0/22 (0%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | 553 562 623 566 | 729 (T) 610 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.539N P=0.512N P=0.639N P=0.679N | P=0.146N P=0.441 P=0.292N P=0.438N | |INCIDENTAL TUMOR | P=0.333N P=0.475N P=0.500N P=0.422N | P=0.121N P=0.444 P=0.292N P=0.438N | |LOGISTIC REGRESSION | P=0.423N P=0.499N P=0.536N P=0.520N | P=0.100N P=0.462 P=0.292N P=0.438N | |COCHRAN-ARMITAGE | P=0.409N | P=0.073N | |FISHER EXACT | P=0.500N P=0.500N P=0.500N | P=0.500 P=0.248N P=0.248N | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 2/60 (3%) 2/60 (3%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 19.6% 29.2% 2.3% | 0.0% 0.0% 2.9% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 1/6 (17%) 1/4 (25%) 0/1 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | --- 626 638 555 | --- --- 645 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.192 P=0.199 P=0.132 P=0.514 | P=0.658 (e) P=0.494 (e) | |INCIDENTAL TUMOR | P=0.310 P=0.172 P=0.145 P=0.551 | P=0.734N (e) P=0.607 (e) | |LOGISTIC REGRESSION | P=0.338 P=0.234 P=0.143 P=0.504 | P=0.690 (e) P=0.494 (e) | |COCHRAN-ARMITAGE | P=0.470 | P=0.694 | |FISHER EXACT | P=0.248 P=0.248 P=0.500 | (e) P=0.500 (e) | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05142 TEST: 03 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.125% 0.25% 0.50% | VEHICLE 0.25% 0.50% 1.00% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 3/60 (5%) 2/60 (3%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 14.1% 15.4% 14.1% 2.6% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 0/6 (0%) 0/4 (0%) 0/1 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | 588 591 456 (I) 575 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.426N P=0.648 P=0.676N P=0.524N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.150N P=0.631N P=0.500N P=0.227N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.227N P=0.660N P=0.529N P=0.355N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.194N | (e) | |FISHER EXACT | P=0.660N P=0.500N P=0.309N | (e) (e) (e) | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 5/60 (8%) 4/60 (7%) 3/60 (5%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 1/60 (2%) | |ADJUSTED (b) | 14.1% 32.0% 39.1% 18.4% | 0.0% 0.0% 2.9% 4.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 1/6 (17%) 1/4 (25%) 0/1 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | 588 591 456 (I) 555 | --- --- 645 667 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.249 P=0.328 P=0.278 P=0.414 | P=0.175 (e) P=0.494 P=0.425 | |INCIDENTAL TUMOR | P=0.511N P=0.342 P=0.434 P=0.554N | P=0.341 (e) P=0.607 P=0.607 | |LOGISTIC REGRESSION | P=0.544 P=0.359 P=0.427 P=0.607 | P=0.224 (e) P=0.494 P=0.477 | |COCHRAN-ARMITAGE | P=0.482N | P=0.236 | |FISHER EXACT | P=0.359 P=0.500 P=0.660N | (e) P=0.500 P=0.500 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05142 TEST: 03 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.125% 0.25% 0.50% | VEHICLE 0.25% 0.50% 1.00% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 5/60 (8%) 4/60 (7%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 14.1% 32.0% 39.1% 4.8% | 0.0% 0.0% 2.9% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 1/6 (17%) 1/4 (25%) 0/1 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | 588 591 456 (I) 555 | --- --- 645 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.442 P=0.328 P=0.278 P=0.674 | P=0.658 (e) P=0.494 (e) | |INCIDENTAL TUMOR | P=0.345N P=0.342 P=0.434 P=0.392N | P=0.734N (e) P=0.607 (e) | |LOGISTIC REGRESSION | P=0.418N P=0.359 P=0.427 P=0.537N | P=0.690 (e) P=0.494 (e) | |COCHRAN-ARMITAGE | P=0.321N | P=0.694 | |FISHER EXACT | P=0.359 P=0.500 P=0.500N | (e) P=0.500 (e) | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 38/60 (63%) 34/60 (57%) 39/60 (65%) 40/60 (67%) | | |ADJUSTED (b) | 96.7% 100.0% 96.7% 100.0% | | |INTERIM SACRIFICE 1 (c)| 4/10 (40%) 3/10 (30%) 8/10 (80%) 7/10 (70%) | | |TERMINAL (d) | 9/10 (90%) 6/6 (100%) 3/4 (75%) 1/1 (100%) | | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 456 (I) 456 (I) | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.492N P=0.048 * P=0.004 ** | | |INCIDENTAL TUMOR | P=0.120 P=0.323N P=0.333 P=0.257 | | |LOGISTIC REGRESSION | P=0.154 P=0.252N P=0.379 P=0.319 | | |COCHRAN-ARMITAGE | P=0.271 | | |FISHER EXACT | P=0.288N P=0.500 P=0.424 | | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05142 TEST: 03 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.125% 0.25% 0.50% | VEHICLE 0.25% 0.50% 1.00% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Thymus | | Thymoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/54 (2%) 0/59 (0%) 0/57 (0%) 2/56 (4%) | 0/58 (0%) 0/57 (0%) 0/59 (0%) 0/58 (0%) | |ADJUSTED (b) | 11.1% 0.0% 0.0% 100.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 0/9 (0%) 1/9 (11%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/9 (11%) 0/5 (0%) 0/4 (0%) 1/1 (100%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- --- 456 (I) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.047 * P=0.617N P=0.662N P=0.106 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.047 * P=0.617N P=0.662N P=0.106 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.199 P=0.617N P=0.662N P=0.444 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.246 | (e) | |FISHER EXACT | P=0.478N P=0.486N P=0.514 | (e) (e) (e) | |=================================================================================================================================| | | |Thymus | | Thymoma: Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/54 (2%) 1/59 (2%) 0/57 (0%) 3/56 (5%) | 0/58 (0%) 0/57 (0%) 0/59 (0%) 0/58 (0%) | |ADJUSTED (b) | 11.1% 5.9% 0.0% 100.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 0/9 (0%) 1/9 (11%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/9 (11%) 0/5 (0%) 0/4 (0%) 1/1 (100%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 673 --- 274 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.024 * P=0.705 P=0.662N P=0.055 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.048 * P=0.761N P=0.662N P=0.055 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.164 P=0.762 P=0.662N P=0.321 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.160 | (e) | |FISHER EXACT | P=0.730N P=0.486N P=0.323 | (e) (e) (e) | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05142 TEST: 03 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.125% 0.25% 0.50% | VEHICLE 0.25% 0.50% 1.00% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/60 (8%) 5/59 (8%) 1/60 (2%) 5/60 (8%) | 8/59 (14%) 4/60 (7%) 6/60 (10%) 9/60 (15%) | |ADJUSTED (b) | 34.2% 38.0% 4.8% 22.6% | 24.8% 12.0% 20.1% 38.2% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 1/10 (10%) 0/10 (0%) 1/10 (10%) | 1/9 (11%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 3/10 (30%) 2/6 (33%) 0/4 (0%) 0/1 (0%) | 6/28 (21%) 2/24 (8%) 2/22 (9%) 1/12 (8%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 637 456 (I) | 457 (I) 430 575 610 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.223 P=0.485 P=0.232N P=0.206 | P=0.069 P=0.242N P=0.510N P=0.125 | |INCIDENTAL TUMOR | P=0.410 P=0.438 P=0.222N P=0.376 | P=0.341 P=0.189N P=0.445N P=0.486 | |LOGISTIC REGRESSION | P=0.561 P=0.628N P=0.155N P=0.551 | P=0.239 P=0.191N P=0.434N P=0.375 | |COCHRAN-ARMITAGE | P=0.497N | P=0.312 | |FISHER EXACT | P=0.618 P=0.103N P=0.628N | P=0.173N P=0.376N P=0.515 | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 2/59 (3%) 0/60 (0%) 1/60 (2%) | 1/59 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 3.2% 7.4% 0.0% 2.3% | 3.6% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 0/6 (0%) 0/4 (0%) 0/1 (0%) | 1/28 (4%) 0/24 (0%) 0/22 (0%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | 603 629 --- 555 | 729 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.591N P=0.533 P=0.528N P=0.731 | P=0.395N P=0.531N P=0.548N P=0.669N | |INCIDENTAL TUMOR | P=0.407N P=0.453 P=0.500N P=0.704N | P=0.395N P=0.531N P=0.548N P=0.669N | |LOGISTIC REGRESSION | P=0.516N P=0.500 P=0.508N P=0.762N | P=0.395N P=0.531N P=0.548N P=0.669N | |COCHRAN-ARMITAGE | P=0.498N | P=0.304N | |FISHER EXACT | P=0.494 P=0.500N P=0.752N | P=0.496N P=0.496N P=0.496N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05142 TEST: 03 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.125% 0.25% 0.50% | VEHICLE 0.25% 0.50% 1.00% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/60 (10%) 7/59 (12%) 1/60 (2%) 6/60 (10%) | 9/59 (15%) 4/60 (7%) 6/60 (10%) 9/60 (15%) | |ADJUSTED (b) | 36.3% 42.6% 4.8% 24.4% | 28.3% 12.0% 20.1% 38.2% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 1/10 (10%) 0/10 (0%) 1/10 (10%) | 1/9 (11%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 3/10 (30%) 2/6 (33%) 0/4 (0%) 0/1 (0%) | 7/28 (25%) 2/24 (8%) 2/22 (9%) 1/12 (8%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 637 456 (I) | 457 (I) 430 575 610 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.271 P=0.387 P=0.148N P=0.219 | P=0.101 P=0.171N P=0.414N P=0.165 | |INCIDENTAL TUMOR | P=0.533 P=0.306 P=0.133N P=0.420 | P=0.414 P=0.130N P=0.351N P=0.551 | |LOGISTIC REGRESSION | P=0.515N P=0.502 P=0.089N P=0.556 | P=0.317 P=0.130N P=0.335N P=0.462 | |COCHRAN-ARMITAGE | P=0.433N | P=0.403 | |FISHER EXACT | P=0.487 P=0.057N P=0.619N | P=0.113N P=0.279N P=0.585N | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/60 (3%) 0/59 (0%) 0/60 (0%) 0/60 (0%) | 1/59 (2%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 5.9% 0.0% 0.0% 0.0% | 3.6% 0.0% 4.5% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 0/6 (0%) 0/4 (0%) 0/1 (0%) | 1/28 (4%) 0/24 (0%) 1/22 (5%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | 573 --- --- --- | 729 (T) --- 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.132N P=0.224N P=0.268N P=0.274N | P=0.565N P=0.531N P=0.708 P=0.669N | |INCIDENTAL TUMOR | P=0.095N P=0.267N P=0.237N P=0.183N | P=0.565N P=0.531N P=0.708 P=0.669N | |LOGISTIC REGRESSION | P=0.115N P=0.243N P=0.239N P=0.239N | P=0.565N P=0.531N P=0.708 P=0.669N | |COCHRAN-ARMITAGE | P=0.115N | P=0.402N | |FISHER EXACT | P=0.252N P=0.248N P=0.248N | P=0.496N P=0.748N P=0.496N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05142 TEST: 03 PAGE 22 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.125% 0.25% 0.50% | VEHICLE 0.25% 0.50% 1.00% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/60 (3%) 0/59 (0%) 0/60 (0%) 0/60 (0%) | 1/59 (2%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 8.4% 0.0% 0.0% 0.0% | 3.0% 0.0% 4.5% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 0/6 (0%) 0/4 (0%) 0/1 (0%) | 0/28 (0%) 0/24 (0%) 1/22 (5%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | 623 --- --- --- | 650 --- 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.141N P=0.206N P=0.249N P=0.321N | P=0.510N P=0.526N P=0.734 P=0.564N | |INCIDENTAL TUMOR | P=0.095N P=0.267N P=0.237N P=0.183N | P=0.414N P=0.500N P=0.732N P=0.393N | |LOGISTIC REGRESSION | P=0.127N P=0.237N P=0.263N P=0.271N | P=0.440N P=0.503N P=0.747 P=0.509N | |COCHRAN-ARMITAGE | P=0.115N | P=0.402N | |FISHER EXACT | P=0.252N P=0.248N P=0.248N | P=0.496N P=0.748N P=0.496N | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/60 (7%) 0/59 (0%) 0/60 (0%) 0/60 (0%) | 2/59 (3%) 0/60 (0%) 2/60 (3%) 0/60 (0%) | |ADJUSTED (b) | 13.7% 0.0% 0.0% 0.0% | 6.5% 0.0% 9.1% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 0/6 (0%) 0/4 (0%) 0/1 (0%) | 1/28 (4%) 0/24 (0%) 2/22 (9%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | 573 --- --- --- | 650 --- 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.028N* P=0.053N P=0.078N P=0.104N | P=0.403N P=0.271N P=0.628 P=0.371N | |INCIDENTAL TUMOR | P=0.014N* P=0.078N P=0.061N P=0.034N* | P=0.337N P=0.257N P=0.679 P=0.258N | |LOGISTIC REGRESSION | P=0.022N* P=0.064N P=0.069N P=0.070N | P=0.317N P=0.251N P=0.664 P=0.282N | |COCHRAN-ARMITAGE | P=0.020N* | P=0.244N | |FISHER EXACT | P=0.061N P=0.059N P=0.059N | P=0.244N P=0.684N P=0.244N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05142 TEST: 03 PAGE 23 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.125% 0.25% 0.50% | VEHICLE 0.25% 0.50% 1.00% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 14/60 (23%) 6/60 (10%) 9/60 (15%) 7/60 (12%) | |ADJUSTED (b) | | 39.1% 19.7% 26.3% 22.8% | |INTERIM SACRIFICE 1 (c)| | 3/10 (30%) 1/10 (10%) 2/10 (20%) 1/10 (10%) | |TERMINAL (d) | | 9/28 (32%) 3/24 (13%) 3/22 (14%) 1/12 (8%) | |FIRST INCIDENCE (DAYS) | | 457 (I) 457 (I) 457 (I) 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.385N P=0.075N P=0.302N P=0.350N | |INCIDENTAL TUMOR | | P=0.156N P=0.066N P=0.214N P=0.149N | |LOGISTIC REGRESSION | | P=0.122N P=0.050N* P=0.190N P=0.085N | |COCHRAN-ARMITAGE | | P=0.111N | |FISHER EXACT | | P=0.042N* P=0.177N P=0.074N | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 14/60 (23%) 6/60 (10%) 9/60 (15%) 7/60 (12%) | |ADJUSTED (b) | | 39.1% 19.7% 26.3% 22.8% | |INTERIM SACRIFICE 1 (c)| | 3/10 (30%) 1/10 (10%) 2/10 (20%) 1/10 (10%) | |TERMINAL (d) | | 9/28 (32%) 3/24 (13%) 3/22 (14%) 1/12 (8%) | |FIRST INCIDENCE (DAYS) | | 457 (I) 457 (I) 457 (I) 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.385N P=0.075N P=0.302N P=0.350N | |INCIDENTAL TUMOR | | P=0.156N P=0.066N P=0.214N P=0.149N | |LOGISTIC REGRESSION | | P=0.122N P=0.050N* P=0.190N P=0.085N | |COCHRAN-ARMITAGE | | P=0.111N | |FISHER EXACT | | P=0.042N* P=0.177N P=0.074N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05142 TEST: 03 PAGE 24 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.125% 0.25% 0.50% | VEHICLE 0.25% 0.50% 1.00% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 1/60 (2%) | 2/60 (3%) 1/60 (2%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 0.0% 4.2% 2.2% | 5.2% 2.5% 0.0% 2.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 0/6 (0%) 0/4 (0%) 0/1 (0%) | 1/28 (4%) 0/24 (0%) 0/22 (0%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 623 526 | 428 590 --- 591 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.199 (e) P=0.492 P=0.496 | P=0.412N P=0.527N P=0.274N P=0.591N | |INCIDENTAL TUMOR | P=0.265 (e) P=0.500 P=0.500 | P=0.321N P=0.417N P=0.165N P=0.521N | |LOGISTIC REGRESSION | P=0.238 (e) P=0.480 P=0.501 | P=0.357N P=0.484N P=0.222N P=0.484N | |COCHRAN-ARMITAGE | P=0.236 | P=0.367N | |FISHER EXACT | (e) P=0.500 P=0.500 | P=0.500N P=0.248N P=0.500N | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 4.6% 0.0% | 0.0% 0.0% 4.3% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/10 (0%) 0/6 (0%) 0/4 (0%) 0/1 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) 0/12 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 355 --- | --- --- 724 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.587 (e) P=0.232 (e) | P=0.614 (e) P=0.461 (e) | |INCIDENTAL TUMOR | P=0.624 (e) P=0.240 (e) | P=0.734N (e) P=0.607 (e) | |LOGISTIC REGRESSION | P=0.569 (e) P=0.203 (e) | P=0.637 (e) P=0.475 (e) | |COCHRAN-ARMITAGE | P=0.595 | P=0.694 | |FISHER EXACT | (e) P=0.248 (e) | (e) P=0.500 (e) | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05142 TEST: 03 PAGE 25 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.125% 0.25% 0.50% | VEHICLE 0.25% 0.50% 1.00% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 30/60 (50%) 28/60 (47%) 24/60 (40%) 25/60 (42%) | 22/60 (37%) 20/60 (33%) 19/60 (32%) 14/60 (23%) | |ADJUSTED (b) | 85.0% 85.1% 100.0% 78.4% | 54.4% 49.5% 53.5% 43.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 1/10 (10%) | |TERMINAL (d) | 6/10 (60%) 3/6 (50%) 4/4 (100%) 0/1 (0%) | 11/28 (39%) 5/24 (21%) 8/22 (36%) 2/12 (17%) | |FIRST INCIDENCE (DAYS) | 288 553 510 456 (I) | 524 232 457 (I) 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.046 * P=0.524N P=0.299 P=0.132 | P=0.463N P=0.548 P=0.562 P=0.502N | |INCIDENTAL TUMOR | P=0.215N P=0.401N P=0.255N P=0.225N | P=0.015N* P=0.420N P=0.498N P=0.046N* | |LOGISTIC REGRESSION | P=0.373N P=0.400N P=0.325N P=0.329N | P=0.039N* P=0.468N P=0.496N P=0.026N* | |COCHRAN-ARMITAGE | P=0.184N | P=0.063N | |FISHER EXACT | P=0.428N P=0.179N P=0.232N | P=0.424N P=0.350N P=0.081N | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 57/60 (95%) 55/60 (92%) 58/60 (97%) 56/60 (93%) | 48/60 (80%) 45/60 (75%) 40/60 (67%) 39/60 (65%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 97.9% 95.5% 92.8% 94.7% | |INTERIM SACRIFICE 1 (c)| 10/10 (100%) 8/10 (80%) 9/10 (90%) 9/10 (90%) | 5/10 (50%) 4/10 (40%) 2/10 (20%) 3/10 (30%) | |TERMINAL (d) | 10/10 (100%) 6/6 (100%) 4/4 (100%) 1/1 (100%) | 27/28 (96%) 22/24 (92%) 19/22 (86%) 10/12 (83%) | |FIRST INCIDENCE (DAYS) | 456 (I) 395 343 456 (I) | 457 (I) 424 377 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.509 P=0.034 * P=0.006 ** | P=0.077 P=0.421 P=0.494N P=0.074 | |INCIDENTAL TUMOR | P=0.581N P=0.282N P=0.500 P=0.549N | P=0.052N P=0.463N P=0.113N P=0.104N | |LOGISTIC REGRESSION | P=0.568N P=0.279N P=0.612 P=0.493N | P=0.035N* P=0.471N P=0.148N P=0.062N | |COCHRAN-ARMITAGE | P=0.537N | P=0.033N* | |FISHER EXACT | P=0.359N P=0.500 P=0.500N | P=0.331N P=0.074N P=0.051N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05142 TEST: 03 PAGE 26 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.125% 0.25% 0.50% | VEHICLE 0.25% 0.50% 1.00% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 38/60 (63%) 33/60 (55%) 32/60 (53%) 30/60 (50%) | 33/60 (55%) 31/60 (52%) 29/60 (48%) 22/60 (37%) | |ADJUSTED (b) | 93.9% 87.1% 100.0% 83.4% | 70.8% 72.8% 70.4% 61.2% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) | 1/10 (10%) 0/10 (0%) 3/10 (30%) 2/10 (20%) | |TERMINAL (d) | 8/10 (80%) 3/6 (50%) 4/4 (100%) 0/1 (0%) | 15/28 (54%) 13/24 (54%) 11/22 (50%) 3/12 (25%) | |FIRST INCIDENCE (DAYS) | 288 348 355 262 | 226 232 377 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.067 P=0.377N P=0.245 P=0.160 | P=0.528 P=0.469 P=0.531 P=0.545N | |INCIDENTAL TUMOR | P=0.087N P=0.222N P=0.197N P=0.103N | P=0.004N** P=0.405N P=0.299N P=0.011N* | |LOGISTIC REGRESSION | P=0.174N P=0.193N P=0.294N P=0.136N | P=0.029N* P=0.483N P=0.354N P=0.042N* | |COCHRAN-ARMITAGE | P=0.098N | P=0.021N* | |FISHER EXACT | P=0.229N P=0.177N P=0.099N | P=0.427N P=0.292N P=0.033N* | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 59/60 (98%) 57/60 (95%) 59/60 (98%) 59/60 (98%) | 54/60 (90%) 51/60 (85%) 48/60 (80%) 50/60 (83%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 100.0% 96.1% 97.9% 100.0% | |INTERIM SACRIFICE 1 (c)| 10/10 (100%) 8/10 (80%) 9/10 (90%) 9/10 (90%) | 6/10 (60%) 4/10 (40%) 5/10 (50%) 5/10 (50%) | |TERMINAL (d) | 10/10 (100%) 6/6 (100%) 4/4 (100%) 1/1 (100%) | 28/28 (100%) 22/24 (92%) 21/22 (95%) 12/12 (100%)| |FIRST INCIDENCE (DAYS) | 288 348 343 262 | 226 232 377 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.513 P=0.045 * P=0.005 ** | P=0.011 * P=0.410 P=0.476 P=0.013 * | |INCIDENTAL TUMOR | P=0.442 P=0.289N P=0.760 P=0.760 | P=0.180N P=0.292N P=0.154N P=0.335N | |LOGISTIC REGRESSION | P=0.512 P=0.134N P=0.557N P=0.642N | P=0.211N P=0.375N P=0.223N P=0.230N | |COCHRAN-ARMITAGE | P=0.444 | P=0.190N | |FISHER EXACT | P=0.309N P=0.752N P=0.752N | P=0.291N P=0.100N P=0.211N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05142 TEST: 03 PAGE 27 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL 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. (c) Observed incidence at interim kill. Male interim sacrifices(days): 456 Female interim sacrifices(days): 457 (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).