TDMS Study 05058-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst ROXARSONE DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 TIME: 07:46:37 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NOI-ES-28024 ROUTE: DOSED FEED NTP C#: C56508 PATHOLOGIST: H. GILES CAS: 121-19-7 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst ROXARSONE DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 TIME: 07:46:37 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NOI-ES-28024 ROUTE: DOSED FEED NTP C#: C56508 PATHOLOGIST: H. GILES CAS: 121-19-7 RATS(FISCHER344) ---------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED. ---------------- Adrenal Gland Bone Marrow Brain Clitoral Gland Epididymis Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst ROXARSONE DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 TIME: 07:46:37 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NOI-ES-28024 ROUTE: DOSED FEED NTP C#: C56508 PATHOLOGIST: H. GILES CAS: 121-19-7 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF ROXARSONE ==================================================================================================== MALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Bone Osteosarcoma Islets, Pancreatic Adenoma Pancreas Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma All Organs Osteosarcoma Osteosarcoma or Osteoma Benign Tumors ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Clitoral/Preputial Gland Adenoma Mammary Gland Carcinoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma ==================================================================================================== DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 15/50 (30%) 14/49 (29%) 16/50 (32%) | 0/49 (0%) 1/48 (2%) 2/50 (4%) | |ADJUSTED (b) | 43.5% 47.6% 61.1% | 0.0% 2.9% 4.7% | |TERMINAL (d) | 7/24 (29%) 5/18 (28%) 9/18 (50%) | 0/26 (0%) 1/34 (3%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 616 629 637 | --- 729 (T) 677 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.274 P=0.449 P=0.295 | P=0.173 P=0.554 P=0.280 | |INCIDENTAL TUMOR | P=0.469 P=0.550N P=0.488 | P=0.183 P=0.554 P=0.253 | |LOGISTIC REGRESSION | P=0.449 P=0.546N P=0.491 | P=0.151 P=0.554 P=0.239 | |COCHRAN-ARMITAGE | P=0.457 | P=0.146 | |FISHER EXACT | P=0.526N P=0.500 | P=0.495 P=0.253 | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 4/49 (8%) 4/50 (8%) | 0/49 (0%) 0/48 (0%) 0/50 (0%) | |ADJUSTED (b) | 17.1% 18.9% 14.0% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/24 (8%) 3/18 (17%) 0/18 (0%) | 0/26 (0%) 0/34 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 675 637 671 | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.530N P=0.628N P=0.586N | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.379N P=0.565N P=0.363N | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.441N P=0.545N P=0.508N | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.430N | (e) | |FISHER EXACT | P=0.513N P=0.500N | (e) (e) | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 19/50 (38%) 16/49 (33%) 17/50 (34%) | 0/49 (0%) 1/48 (2%) 2/50 (4%) | |ADJUSTED (b) | 51.9% 55.7% 62.7% | 0.0% 2.9% 4.7% | |TERMINAL (d) | 8/24 (33%) 7/18 (39%) 9/18 (50%) | 0/26 (0%) 1/34 (3%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 616 629 637 | --- 729 (T) 677 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.461 P=0.553 P=0.494 | P=0.173 P=0.554 P=0.280 | |INCIDENTAL TUMOR | P=0.347N P=0.407N P=0.379N | P=0.183 P=0.554 P=0.253 | |LOGISTIC REGRESSION | P=0.385N P=0.393N P=0.426N | P=0.151 P=0.554 P=0.239 | |COCHRAN-ARMITAGE | P=0.376N | P=0.146 | |FISHER EXACT | P=0.365N P=0.418N | P=0.495 P=0.253 | |=================================================================================================================================| | | |Bone | | Osteosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) | |ADJUSTED (b) | 7.5% 0.0% 0.0% | 0.0% 0.0% 5.8% | |TERMINAL (d) | 0/24 (0%) 0/18 (0%) 0/18 (0%) | 0/27 (0%) 0/35 (0%) 1/32 (3%) | |FIRST INCIDENCE (DAYS) | 283 --- --- | --- --- 724 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.041N* P=0.133N P=0.130N | P=0.112 (e) P=0.287 | |INCIDENTAL TUMOR | P=0.065N P=0.223N P=0.161N | P=0.121 (e) P=0.268 | |LOGISTIC REGRESSION | P=0.061N P=0.146N P=0.196N | P=0.112 (e) P=0.280 | |COCHRAN-ARMITAGE | P=0.037N* | P=0.095 | |FISHER EXACT | P=0.121N P=0.121N | (e) P=0.247 | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/49 (14%) 3/48 (6%) 2/48 (4%) | 1/44 (2%) 3/47 (6%) 6/48 (13%) | |ADJUSTED (b) | 23.0% 11.1% 8.0% | 4.2% 8.9% 16.8% | |TERMINAL (d) | 4/24 (17%) 1/17 (6%) 1/17 (6%) | 1/24 (4%) 2/32 (6%) 3/30 (10%) | |FIRST INCIDENCE (DAYS) | 581 637 630 | 729 (T) 728 530 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.089N P=0.261N P=0.141N | P=0.057 P=0.410 P=0.100 | |INCIDENTAL TUMOR | P=0.068N P=0.178N P=0.121N | P=0.070 P=0.311 P=0.116 | |LOGISTIC REGRESSION | P=0.051N P=0.166N P=0.085N | P=0.049 * P=0.393 P=0.074 | |COCHRAN-ARMITAGE | P=0.052N | P=0.045 * | |FISHER EXACT | P=0.167N P=0.084N | P=0.334 P=0.070 | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 4/48 (8%) 0/48 (0%) | 1/44 (2%) 1/47 (2%) 1/48 (2%) | |ADJUSTED (b) | 0.0% 13.7% 0.0% | 3.0% 2.0% 3.3% | |TERMINAL (d) | 0/24 (0%) 1/17 (6%) 0/17 (0%) | 0/24 (0%) 0/32 (0%) 1/30 (3%) | |FIRST INCIDENCE (DAYS) | --- 581 --- | 701 486 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.580 P=0.052 (e) | P=0.606N P=0.745N P=0.716N | |INCIDENTAL TUMOR | P=0.597N P=0.065 (e) | P=0.556N P=0.755N P=0.716N | |LOGISTIC REGRESSION | P=0.623N P=0.067 (e) | P=0.605N P=0.687N P=0.730N | |COCHRAN-ARMITAGE | P=0.615 | P=0.617N | |FISHER EXACT | P=0.056 (e) | P=0.736N P=0.731N | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/49 (14%) 7/48 (15%) 2/48 (4%) | 2/44 (5%) 4/47 (9%) 7/48 (15%) | |ADJUSTED (b) | 23.0% 23.6% 8.0% | 7.1% 10.7% 19.9% | |TERMINAL (d) | 4/24 (17%) 2/17 (12%) 1/17 (6%) | 1/24 (4%) 2/32 (6%) 4/30 (13%) | |FIRST INCIDENCE (DAYS) | 581 581 630 | 701 486 530 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.132N P=0.469 P=0.141N | P=0.091 P=0.438 P=0.142 | |INCIDENTAL TUMOR | P=0.090N P=0.589 P=0.121N | P=0.112 P=0.359 P=0.158 | |LOGISTIC REGRESSION | P=0.075N P=0.613 P=0.085N | P=0.070 P=0.370 P=0.106 | |COCHRAN-ARMITAGE | P=0.077N | P=0.070 | |FISHER EXACT | P=0.597 P=0.084N | P=0.371 P=0.101 | |=================================================================================================================================| | | |Intestine Small: Jejunum | | Leiomyosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 8.6% 0.0% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/24 (0%) 1/18 (6%) 0/18 (0%) | 0/27 (0%) 0/35 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | --- 681 --- | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.631 P=0.205 (e) | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.658N P=0.214 (e) | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.663 P=0.224 (e) | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.669 | (e) | |FISHER EXACT | P=0.247 (e) | (e) (e) | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 4/50 (8%) | 1/50 (2%) 2/50 (4%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 11.6% 12.0% | 2.9% 5.7% 0.0% | |TERMINAL (d) | 0/24 (0%) 1/18 (6%) 0/18 (0%) | 0/27 (0%) 2/35 (6%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | --- 681 638 | 687 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.046 * P=0.102 P=0.063 | P=0.318N P=0.569 P=0.473N | |INCIDENTAL TUMOR | P=0.078 P=0.111 P=0.102 | P=0.328N P=0.463 P=0.484N | |LOGISTIC REGRESSION | P=0.049 * P=0.114 P=0.060 | P=0.335N P=0.518 P=0.502N | |COCHRAN-ARMITAGE | P=0.049 * | P=0.360N | |FISHER EXACT | P=0.121 P=0.059 | P=0.500 P=0.500N | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 7.3% 5.0% 0.0% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/24 (4%) 0/18 (0%) 0/18 (0%) | 0/27 (0%) 0/35 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 695 723 --- | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.184N P=0.579N P=0.292N | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.123N P=0.519N P=0.229N | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.154N P=0.535N P=0.246N | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.142N | (e) | |FISHER EXACT | P=0.500N P=0.247N | (e) (e) | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 4/50 (8%) 4/50 (8%) | 1/50 (2%) 2/50 (4%) 0/50 (0%) | |ADJUSTED (b) | 7.3% 16.1% 12.0% | 2.9% 5.7% 0.0% | |TERMINAL (d) | 1/24 (4%) 1/18 (6%) 0/18 (0%) | 0/27 (0%) 2/35 (6%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 695 681 638 | 687 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.233 P=0.264 P=0.299 | P=0.318N P=0.569 P=0.473N | |INCIDENTAL TUMOR | P=0.370 P=0.310 P=0.428 | P=0.328N P=0.463 P=0.484N | |LOGISTIC REGRESSION | P=0.274 P=0.307 P=0.337 | P=0.335N P=0.518 P=0.502N | |COCHRAN-ARMITAGE | P=0.274 | P=0.360N | |FISHER EXACT | P=0.339 P=0.339 | P=0.500 P=0.500N | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 3.1% 11.1% 5.6% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/24 (0%) 2/18 (11%) 1/18 (6%) | 0/27 (0%) 0/35 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 693 729 (T) 729 (T) | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.532 P=0.414 P=0.704 | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.579 P=0.440 P=0.755N | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.592 P=0.463 P=0.755 | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.622N | (e) | |FISHER EXACT | P=0.500 P=0.753N | (e) (e) | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 7.2% 11.1% 5.6% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/24 (4%) 2/18 (11%) 1/18 (6%) | 0/27 (0%) 0/35 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 693 729 (T) 729 (T) | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.494N P=0.599 P=0.590N | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.451N P=0.621 P=0.525N | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.429N P=0.654 P=0.525N | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.390N | (e) | |FISHER EXACT | P=0.691N P=0.500N | (e) (e) | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 4.6% 0.0% | 0.0% 2.9% 0.0% | |TERMINAL (d) | 0/24 (0%) 0/18 (0%) 0/18 (0%) | 0/27 (0%) 1/35 (3%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | --- 580 --- | --- 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.657N P=0.234 (e) | P=0.714N P=0.552 (e) | |INCIDENTAL TUMOR | P=0.683 P=0.328 (e) | P=0.714N P=0.552 (e) | |LOGISTIC REGRESSION | P=0.604 P=0.204 (e) | P=0.714N P=0.552 (e) | |COCHRAN-ARMITAGE | P=0.669 | P=0.731 | |FISHER EXACT | P=0.247 (e) | P=0.500 (e) | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 6.1% 0.0% 4.5% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/24 (0%) 0/18 (0%) 0/18 (0%) | 0/27 (0%) 0/35 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 671 --- 723 | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.393N P=0.266N P=0.536N | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.266N P=0.223N P=0.373N | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.363N P=0.239N P=0.502N | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.360N | (e) | |FISHER EXACT | P=0.247N P=0.500N | (e) (e) | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) | |ADJUSTED (b) | 6.1% 4.6% 4.5% | 0.0% 2.9% 0.0% | |TERMINAL (d) | 0/24 (0%) 0/18 (0%) 0/18 (0%) | 0/27 (0%) 1/35 (3%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 671 580 723 | --- 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.410N P=0.666 P=0.536N | P=0.714N P=0.552 (e) | |INCIDENTAL TUMOR | P=0.309N P=0.610N P=0.373N | P=0.714N P=0.552 (e) | |LOGISTIC REGRESSION | P=0.406N P=0.691 P=0.502N | P=0.714N P=0.552 (e) | |COCHRAN-ARMITAGE | P=0.390N | P=0.731 | |FISHER EXACT | P=0.691N P=0.500N | P=0.500 (e) | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) | |ADJUSTED (b) | 6.1% 4.6% 4.5% | 0.0% 2.9% 0.0% | |TERMINAL (d) | 0/24 (0%) 0/18 (0%) 0/18 (0%) | 0/27 (0%) 1/35 (3%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 671 580 723 | --- 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.410N P=0.666 P=0.536N | P=0.714N P=0.552 (e) | |INCIDENTAL TUMOR | P=0.309N P=0.610N P=0.373N | P=0.714N P=0.552 (e) | |LOGISTIC REGRESSION | P=0.406N P=0.691 P=0.502N | P=0.714N P=0.552 (e) | |COCHRAN-ARMITAGE | P=0.390N | P=0.731 | |FISHER EXACT | P=0.691N P=0.500N | P=0.500 (e) | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 8.3% 8.0% 0.0% | 0.0% 0.0% 3.1% | |TERMINAL (d) | 2/24 (8%) 1/18 (6%) 0/18 (0%) | 0/27 (0%) 0/35 (0%) 1/32 (3%) | |FIRST INCIDENCE (DAYS) | 729 (T) 633 --- | --- --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.229N P=0.608 P=0.303N | P=0.286 (e) P=0.534 | |INCIDENTAL TUMOR | P=0.227N P=0.655 P=0.303N | P=0.286 (e) P=0.534 | |LOGISTIC REGRESSION | P=0.182N P=0.675 P=0.303N | P=0.286 (e) P=0.534 | |COCHRAN-ARMITAGE | P=0.176N | P=0.269 | |FISHER EXACT | P=0.691N P=0.247N | (e) P=0.500 | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 4/50 (8%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% | 9.9% 0.0% 2.3% | |TERMINAL (d) | 0/24 (0%) 0/18 (0%) 0/18 (0%) | 1/27 (4%) 0/35 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- | 404 --- 678 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.072N P=0.058N P=0.159N | |INCIDENTAL TUMOR | (e) (e) (e) | P=0.074N P=0.048N* P=0.157N | |LOGISTIC REGRESSION | (e) (e) (e) | P=0.078N P=0.054N P=0.183N | |COCHRAN-ARMITAGE | (e) | P=0.082N | |FISHER EXACT | (e) (e) | P=0.059N P=0.181N | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 3/50 (6%) | 21/50 (42%) 17/50 (34%) 21/50 (42%) | |ADJUSTED (b) | 6.1% 0.0% 13.1% | 58.5% 42.5% 56.2% | |TERMINAL (d) | 1/24 (4%) 0/18 (0%) 1/18 (6%) | 13/27 (48%) 12/35 (34%) 16/32 (50%) | |FIRST INCIDENCE (DAYS) | 538 --- 695 | 526 685 685 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.332 P=0.276N P=0.422 | P=0.311N P=0.097N P=0.326N | |INCIDENTAL TUMOR | P=0.399 P=0.151N P=0.513 | P=0.362N P=0.314N P=0.409N | |LOGISTIC REGRESSION | P=0.390 P=0.244N P=0.498 | P=0.406N P=0.230N P=0.463N | |COCHRAN-ARMITAGE | P=0.390 | P=0.541 | |FISHER EXACT | P=0.247N P=0.500 | P=0.268N P=0.580N | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 3/50 (6%) | 24/50 (48%) 17/50 (34%) 22/50 (44%) | |ADJUSTED (b) | 6.1% 0.0% 13.1% | 61.2% 42.5% 57.2% | |TERMINAL (d) | 1/24 (4%) 0/18 (0%) 1/18 (6%) | 13/27 (48%) 12/35 (34%) 16/32 (50%) | |FIRST INCIDENCE (DAYS) | 538 --- 695 | 404 685 678 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.332 P=0.276N P=0.422 | P=0.195N P=0.038N* P=0.212N | |INCIDENTAL TUMOR | P=0.399 P=0.151N P=0.513 | P=0.218N P=0.132N P=0.258N | |LOGISTIC REGRESSION | P=0.390 P=0.244N P=0.498 | P=0.320N P=0.105N P=0.392N | |COCHRAN-ARMITAGE | P=0.390 | P=0.381N | |FISHER EXACT | P=0.247N P=0.500 | P=0.111N P=0.421N | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) | | Papilloma Squamous or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) | 1/50 (2%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 7.2% 0.0% 2.8% | 2.9% 0.0% 2.7% | |TERMINAL (d) | 0/24 (0%) 0/18 (0%) 0/18 (0%) | 0/27 (0%) 0/35 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 703 --- 671 | 700 --- 723 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.395N P=0.270N P=0.541N | P=0.626N P=0.478N P=0.714N | |INCIDENTAL TUMOR | P=0.266N P=0.223N P=0.373N | P=0.634N P=0.674N P=0.747N | |LOGISTIC REGRESSION | P=0.362N P=0.253N P=0.501N | P=0.653N P=0.497N P=0.747N | |COCHRAN-ARMITAGE | P=0.360N | P=0.669N | |FISHER EXACT | P=0.247N P=0.500N | P=0.500N P=0.753N | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) | 1/50 (2%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 7.2% 0.0% 2.8% | 2.9% 0.0% 2.7% | |TERMINAL (d) | 0/24 (0%) 0/18 (0%) 0/18 (0%) | 0/27 (0%) 0/35 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 703 --- 671 | 700 --- 723 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.395N P=0.270N P=0.541N | P=0.626N P=0.478N P=0.714N | |INCIDENTAL TUMOR | P=0.266N P=0.223N P=0.373N | P=0.634N P=0.674N P=0.747N | |LOGISTIC REGRESSION | P=0.362N P=0.253N P=0.501N | P=0.653N P=0.497N P=0.747N | |COCHRAN-ARMITAGE | P=0.360N | P=0.669N | |FISHER EXACT | P=0.247N P=0.500N | P=0.500N P=0.753N | |=================================================================================================================================| | | |Pancreas | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 5/50 (10%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 4.2% 5.6% 18.8% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/24 (4%) 1/18 (6%) 1/18 (6%) | 0/27 (0%) 0/35 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 664 | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.035 * P=0.697 P=0.075 | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.061 P=0.697 P=0.136 | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.046 * P=0.697 P=0.099 | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.049 * | (e) | |FISHER EXACT | P=0.753N P=0.102 | (e) (e) | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Pharynx | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 7.2% 0.0% 2.8% | 2.9% 0.0% 0.0% | |TERMINAL (d) | 0/24 (0%) 0/18 (0%) 0/18 (0%) | 0/27 (0%) 0/35 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 703 --- 671 | 700 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.395N P=0.270N P=0.541N | P=0.250N P=0.478N P=0.473N | |INCIDENTAL TUMOR | P=0.266N P=0.223N P=0.373N | P=0.279N P=0.674N P=0.484N | |LOGISTIC REGRESSION | P=0.362N P=0.253N P=0.501N | P=0.265N P=0.497N P=0.495N | |COCHRAN-ARMITAGE | P=0.360N | P=0.269N | |FISHER EXACT | P=0.247N P=0.500N | P=0.500N P=0.500N | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 13/48 (27%) 8/48 (17%) | 27/50 (54%) 28/49 (57%) 18/48 (38%) | |ADJUSTED (b) | 21.4% 49.3% 34.4% | 69.5% 67.7% 46.5% | |TERMINAL (d) | 4/24 (17%) 7/18 (39%) 4/17 (24%) | 16/27 (59%) 21/34 (62%) 11/31 (35%) | |FIRST INCIDENCE (DAYS) | 616 495 671 | 485 486 678 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.188 P=0.026 * P=0.224 | P=0.019N* P=0.320N P=0.025N* | |INCIDENTAL TUMOR | P=0.266 P=0.044 * P=0.323 | P=0.031N* P=0.576 P=0.043N* | |LOGISTIC REGRESSION | P=0.307 P=0.049 * P=0.325 | P=0.049N* P=0.463 P=0.060N | |COCHRAN-ARMITAGE | P=0.313 | P=0.065N | |FISHER EXACT | P=0.051 P=0.355 | P=0.455 P=0.075N | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 13/48 (27%) 8/48 (17%) | 28/50 (56%) 28/49 (57%) 18/48 (38%) | |ADJUSTED (b) | 21.4% 49.3% 34.4% | 70.4% 67.7% 46.5% | |TERMINAL (d) | 4/24 (17%) 7/18 (39%) 4/17 (24%) | 16/27 (59%) 21/34 (62%) 11/31 (35%) | |FIRST INCIDENCE (DAYS) | 616 495 671 | 485 486 678 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.188 P=0.026 * P=0.224 | P=0.013N* P=0.260N P=0.017N* | |INCIDENTAL TUMOR | P=0.266 P=0.044 * P=0.323 | P=0.019N* P=0.541N P=0.027N* | |LOGISTIC REGRESSION | P=0.307 P=0.049 * P=0.325 | P=0.032N* P=0.544 P=0.039N* | |COCHRAN-ARMITAGE | P=0.313 | P=0.043N* | |FISHER EXACT | P=0.051 P=0.355 | P=0.535 P=0.051N | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 4/50 (8%) 4/50 (8%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 13.3% 13.7% 13.7% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/24 (8%) 1/18 (6%) 1/18 (6%) | 0/27 (0%) 0/35 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 651 633 651 | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.504 P=0.558 P=0.572 | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.504N P=0.629 P=0.579N | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.571N P=0.637 P=0.642N | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.573 | (e) | |FISHER EXACT | P=0.643N P=0.643N | (e) (e) | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Skin | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 2.1% 0.0% 11.1% | 0.0% 0.0% 3.1% | |TERMINAL (d) | 0/24 (0%) 0/18 (0%) 2/18 (11%) | 0/27 (0%) 0/35 (0%) 1/32 (3%) | |FIRST INCIDENCE (DAYS) | 564 --- 729 (T) | --- --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.312 P=0.504N P=0.434 | P=0.286 (e) P=0.534 | |INCIDENTAL TUMOR | P=0.307 P=0.419N P=0.434 | P=0.286 (e) P=0.534 | |LOGISTIC REGRESSION | P=0.357 P=0.559N P=0.494 | P=0.286 (e) P=0.534 | |COCHRAN-ARMITAGE | P=0.360 | P=0.269 | |FISHER EXACT | P=0.500N P=0.500 | (e) P=0.500 | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 0.0% 11.1% | 0.0% 0.0% 3.1% | |TERMINAL (d) | 0/24 (0%) 0/18 (0%) 2/18 (11%) | 0/27 (0%) 0/35 (0%) 1/32 (3%) | |FIRST INCIDENCE (DAYS) | --- --- 729 (T) | --- --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.072 (e) P=0.176 | P=0.286 (e) P=0.534 | |INCIDENTAL TUMOR | P=0.072 (e) P=0.176 | P=0.286 (e) P=0.534 | |LOGISTIC REGRESSION | P=0.072 (e) P=0.176 | P=0.286 (e) P=0.534 | |COCHRAN-ARMITAGE | P=0.095 | P=0.269 | |FISHER EXACT | (e) P=0.247 | (e) P=0.500 | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Skin | | Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, | | Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 5/50 (10%) 6/50 (12%) | 0/50 (0%) 1/50 (2%) 2/50 (4%) | |ADJUSTED (b) | 15.1% 18.8% 23.8% | 0.0% 2.9% 6.3% | |TERMINAL (d) | 2/24 (8%) 2/18 (11%) 3/18 (17%) | 0/27 (0%) 1/35 (3%) 2/32 (6%) | |FIRST INCIDENCE (DAYS) | 564 633 651 | --- 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.347 P=0.532 P=0.404 | P=0.161 P=0.552 P=0.276 | |INCIDENTAL TUMOR | P=0.458 P=0.624 P=0.523 | P=0.161 P=0.552 P=0.276 | |LOGISTIC REGRESSION | P=0.438 P=0.631 P=0.501 | P=0.161 P=0.552 P=0.276 | |COCHRAN-ARMITAGE | P=0.436 | P=0.142 | |FISHER EXACT | P=0.630N P=0.500 | P=0.500 P=0.247 | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 3/50 (6%) | 1/50 (2%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 3.1% 5.6% 12.1% | 3.7% 0.0% 3.1% | |TERMINAL (d) | 0/24 (0%) 1/18 (6%) 1/18 (6%) | 1/27 (4%) 0/35 (0%) 1/32 (3%) | |FIRST INCIDENCE (DAYS) | 693 729 (T) 581 | 729 (T) --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.159 P=0.709 P=0.249 | P=0.638N P=0.448N P=0.724N | |INCIDENTAL TUMOR | P=0.211 P=0.736 P=0.345 | P=0.638N P=0.448N P=0.724N | |LOGISTIC REGRESSION | P=0.203 P=0.746 P=0.304 | P=0.638N P=0.448N P=0.724N | |COCHRAN-ARMITAGE | P=0.202 | P=0.669N | |FISHER EXACT | P=0.753N P=0.309 | P=0.500N P=0.753N | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) | |ADJUSTED (b) | 8.3% 5.6% 2.2% | 2.0% 2.3% 0.0% | |TERMINAL (d) | 2/24 (8%) 1/18 (6%) 0/18 (0%) | 0/27 (0%) 0/35 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 630 | 404 581 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.446N P=0.601N P=0.559N | P=0.335N P=0.753 P=0.504N | |INCIDENTAL TUMOR | P=0.450N P=0.601N P=0.566N | P=0.500N P=0.750 P=0.500N | |LOGISTIC REGRESSION | P=0.385N P=0.601N P=0.500N | P=0.268N P=0.745 P=0.323N | |COCHRAN-ARMITAGE | P=0.378N | P=0.331N | |FISHER EXACT | P=0.500N P=0.500N | P=0.753N P=0.500N | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, Sarcoma, | | Neurofibroma, or Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 4/50 (8%) | 3/50 (6%) 1/50 (2%) 1/50 (2%) | |ADJUSTED (b) | 11.2% 11.1% 14.1% | 9.3% 2.3% 3.1% | |TERMINAL (d) | 2/24 (8%) 2/18 (11%) 1/18 (6%) | 2/27 (7%) 0/35 (0%) 1/32 (3%) | |FIRST INCIDENCE (DAYS) | 693 729 (T) 581 | 404 581 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.323 P=0.620N P=0.409 | P=0.177N P=0.269N P=0.264N | |INCIDENTAL TUMOR | P=0.376 P=0.599N P=0.489 | P=0.245N P=0.272N P=0.262N | |LOGISTIC REGRESSION | P=0.415 P=0.558N P=0.501 | P=0.215N P=0.311N P=0.324N | |COCHRAN-ARMITAGE | P=0.417 | P=0.202N | |FISHER EXACT | P=0.500N P=0.500 | P=0.309N P=0.309N | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, or Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) | 2/50 (4%) 1/50 (2%) 0/50 (0%) | |ADJUSTED (b) | 8.3% 5.6% 2.2% | 5.6% 2.3% 0.0% | |TERMINAL (d) | 2/24 (8%) 1/18 (6%) 0/18 (0%) | 1/27 (4%) 0/35 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 630 | 404 581 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.446N P=0.601N P=0.559N | P=0.135N P=0.478N P=0.223N | |INCIDENTAL TUMOR | P=0.450N P=0.601N P=0.566N | P=0.203N P=0.487N P=0.221N | |LOGISTIC REGRESSION | P=0.385N P=0.601N P=0.500N | P=0.134N P=0.518N P=0.231N | |COCHRAN-ARMITAGE | P=0.378N | P=0.142N | |FISHER EXACT | P=0.500N P=0.500N | P=0.500N P=0.247N | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 46/50 (92%) 48/50 (96%) 43/50 (86%) | | |ADJUSTED (b) | 100.0% 100.0% 93.0% | | |TERMINAL (d) | 24/24 (100%) 18/18 (100%) 15/18 (83%) | | |FIRST INCIDENCE (DAYS) | 538 495 534 | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.322 P=0.099 P=0.352 | | |INCIDENTAL TUMOR | P=0.118N P=0.343 P=0.199N | | |LOGISTIC REGRESSION | P=0.138N P=0.332 P=0.212N | | |COCHRAN-ARMITAGE | P=0.187N | | |FISHER EXACT | P=0.339 P=0.262N | | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 2/50 (4%) 3/50 (6%) | 8/50 (16%) 6/50 (12%) 9/50 (18%) | |ADJUSTED (b) | 15.7% 7.8% 11.6% | 25.4% 16.4% 28.1% | |TERMINAL (d) | 3/24 (13%) 0/18 (0%) 1/18 (6%) | 5/27 (19%) 5/35 (14%) 9/32 (28%) | |FIRST INCIDENCE (DAYS) | 710 637 678 | 630 685 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.506N P=0.441N P=0.606N | P=0.538N P=0.241N P=0.569N | |INCIDENTAL TUMOR | P=0.401N P=0.364N P=0.505N | P=0.513 P=0.409N P=0.557 | |LOGISTIC REGRESSION | P=0.429N P=0.372N P=0.525N | P=0.553N P=0.344N P=0.587N | |COCHRAN-ARMITAGE | P=0.417N | P=0.445 | |FISHER EXACT | P=0.339N P=0.500N | P=0.387N P=0.500 | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) | 2/50 (4%) 4/50 (8%) 1/50 (2%) | |ADJUSTED (b) | 4.2% 7.8% 5.1% | 5.4% 11.4% 3.1% | |TERMINAL (d) | 1/24 (4%) 1/18 (6%) 0/18 (0%) | 0/27 (0%) 4/35 (11%) 1/32 (3%) | |FIRST INCIDENCE (DAYS) | 729 (T) 625 647 | 582 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.357 P=0.434 P=0.470 | P=0.344N P=0.427 P=0.456N | |INCIDENTAL TUMOR | P=0.402 P=0.480 P=0.551 | P=0.442N P=0.309 P=0.656N | |LOGISTIC REGRESSION | P=0.389 P=0.491 P=0.499 | P=0.383N P=0.346 P=0.510N | |COCHRAN-ARMITAGE | P=0.390 | P=0.406N | |FISHER EXACT | P=0.500 P=0.500 | P=0.339 P=0.500N | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 4/50 (8%) 5/50 (10%) | 10/50 (20%) 10/50 (20%) 10/50 (20%) | |ADJUSTED (b) | 19.8% 15.0% 16.1% | 29.5% 27.6% 31.3% | |TERMINAL (d) | 4/24 (17%) 1/18 (6%) 1/18 (6%) | 5/27 (19%) 9/35 (26%) 10/32 (31%) | |FIRST INCIDENCE (DAYS) | 710 625 647 | 582 685 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.472 P=0.626N P=0.523 | P=0.399N P=0.400N P=0.446N | |INCIDENTAL TUMOR | P=0.547N P=0.535N P=0.609N | P=0.509N P=0.563 P=0.592 | |LOGISTIC REGRESSION | P=0.566 P=0.536N P=0.623 | P=0.439N P=0.563N P=0.509N | |COCHRAN-ARMITAGE | P=0.568 | P=0.550 | |FISHER EXACT | P=0.500N P=0.630N | P=0.598N P=0.598N | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) | 1/50 (2%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 0.0% 7.7% | 2.8% 0.0% 3.1% | |TERMINAL (d) | 0/24 (0%) 0/18 (0%) 1/18 (6%) | 0/27 (0%) 0/35 (0%) 1/32 (3%) | |FIRST INCIDENCE (DAYS) | --- --- 634 | 686 --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.090 (e) P=0.213 | P=0.639N P=0.484N P=0.727N | |INCIDENTAL TUMOR | P=0.077 (e) P=0.208 | P=0.634N P=0.674N P=0.732N | |LOGISTIC REGRESSION | P=0.095 (e) P=0.237 | P=0.657N P=0.500N P=0.752N | |COCHRAN-ARMITAGE | P=0.095 | P=0.669N | |FISHER EXACT | (e) P=0.247 | P=0.500N P=0.753N | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Uterus | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # | |----------- | | | |OVERALL (a) | | 1/50 (2%) 2/50 (4%) 1/50 (2%) | |ADJUSTED (b) | | 2.8% 5.7% 2.9% | |TERMINAL (d) | | 0/27 (0%) 2/35 (6%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | | 686 729 (T) 727 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.572N P=0.569 P=0.724N | |INCIDENTAL TUMOR | | P=0.577N P=0.463 P=0.747N | |LOGISTIC REGRESSION | | P=0.587N P=0.518 P=0.753N | |COCHRAN-ARMITAGE | | P=0.622N | |FISHER EXACT | | P=0.500 P=0.753N | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # | |----------- | | | |OVERALL (a) | | 10/50 (20%) 18/50 (36%) 13/50 (26%) | |ADJUSTED (b) | | 28.3% 44.0% 34.4% | |TERMINAL (d) | | 5/27 (19%) 13/35 (37%) 9/32 (28%) | |FIRST INCIDENCE (DAYS) | | 404 481 517 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.440 P=0.170 P=0.471 | |INCIDENTAL TUMOR | | P=0.212 P=0.077 P=0.235 | |LOGISTIC REGRESSION | | P=0.266 P=0.057 P=0.291 | |COCHRAN-ARMITAGE | | P=0.287 | |FISHER EXACT | | P=0.059 P=0.318 | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 22 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # | |----------- | | | |OVERALL (a) | | 10/50 (20%) 18/50 (36%) 14/50 (28%) | |ADJUSTED (b) | | 28.3% 44.0% 36.1% | |TERMINAL (d) | | 5/27 (19%) 13/35 (37%) 9/32 (28%) | |FIRST INCIDENCE (DAYS) | | 404 481 517 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.365 P=0.170 P=0.396 | |INCIDENTAL TUMOR | | P=0.157 P=0.077 P=0.174 | |LOGISTIC REGRESSION | | P=0.200 P=0.057 P=0.219 | |COCHRAN-ARMITAGE | | P=0.218 | |FISHER EXACT | | P=0.059 P=0.241 | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 1/50 (2%) 1/50 (2%) | |ADJUSTED (b) | 4.6% 3.2% 2.3% | 0.0% 2.4% 2.0% | |TERMINAL (d) | 0/24 (0%) 0/18 (0%) 0/18 (0%) | 0/27 (0%) 0/35 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 581 681 637 | --- 608 407 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.374N P=0.521N P=0.486N | P=0.341 P=0.490 P=0.500 | |INCIDENTAL TUMOR | P=0.315N P=0.439N P=0.458N | P=0.157 P=0.388 P=0.500 | |LOGISTIC REGRESSION | P=0.423N P=0.512N P=0.568N | P=0.361 P=0.492 P=0.663 | |COCHRAN-ARMITAGE | P=0.378N | P=0.331 | |FISHER EXACT | P=0.500N P=0.500N | P=0.500 P=0.500 | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 23 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, | | or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 27/50 (54%) 28/50 (56%) 25/50 (50%) | 14/50 (28%) 12/50 (24%) 11/50 (22%) | |ADJUSTED (b) | 64.1% 71.1% 68.7% | 34.1% 26.7% 26.0% | |TERMINAL (d) | 10/24 (42%) 8/18 (44%) 9/18 (50%) | 3/27 (11%) 4/35 (11%) 4/32 (13%) | |FIRST INCIDENCE (DAYS) | 538 535 534 | 582 481 517 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.445 P=0.274 P=0.478 | P=0.201N P=0.325N P=0.221N | |INCIDENTAL TUMOR | P=0.285N P=0.525N P=0.338N | P=0.548N P=0.386 P=0.551 | |LOGISTIC REGRESSION | P=0.387N P=0.558 P=0.428N | P=0.444 P=0.565 P=0.490 | |COCHRAN-ARMITAGE | P=0.382N | P=0.281N | |FISHER EXACT | P=0.500 P=0.421N | P=0.410N P=0.322N | |=================================================================================================================================| | | |All Organs | | Mesothelioma Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 4.2% 4.2% 5.6% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/24 (4%) 0/18 (0%) 0/18 (0%) | 0/27 (0%) 0/35 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 710 651 | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.349 P=0.715 P=0.466 | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.445 P=0.736 P=0.551 | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.379 P=0.738 P=0.501 | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.378 | (e) | |FISHER EXACT | P=0.753N P=0.500 | (e) (e) | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 24 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Osteosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) | |ADJUSTED (b) | 7.5% 0.0% 0.0% | 0.0% 0.0% 5.8% | |TERMINAL (d) | 0/24 (0%) 0/18 (0%) 0/18 (0%) | 0/27 (0%) 0/35 (0%) 1/32 (3%) | |FIRST INCIDENCE (DAYS) | 283 --- --- | --- --- 724 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.041N* P=0.133N P=0.130N | P=0.112 (e) P=0.287 | |INCIDENTAL TUMOR | P=0.065N P=0.223N P=0.161N | P=0.121 (e) P=0.268 | |LOGISTIC REGRESSION | P=0.061N P=0.146N P=0.196N | P=0.112 (e) P=0.280 | |COCHRAN-ARMITAGE | P=0.037N* | P=0.095 | |FISHER EXACT | P=0.121N P=0.121N | (e) P=0.247 | |=================================================================================================================================| | | |All Organs | | Osteosarcoma or Osteoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) | |ADJUSTED (b) | 7.5% 0.0% 0.0% | 0.0% 0.0% 5.8% | |TERMINAL (d) | 0/24 (0%) 0/18 (0%) 0/18 (0%) | 0/27 (0%) 0/35 (0%) 1/32 (3%) | |FIRST INCIDENCE (DAYS) | 283 --- --- | --- --- 724 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.041N* P=0.133N P=0.130N | P=0.112 (e) P=0.287 | |INCIDENTAL TUMOR | P=0.065N P=0.223N P=0.161N | P=0.121 (e) P=0.268 | |LOGISTIC REGRESSION | P=0.061N P=0.146N P=0.196N | P=0.112 (e) P=0.280 | |COCHRAN-ARMITAGE | P=0.037N* | P=0.095 | |FISHER EXACT | P=0.121N P=0.121N | (e) P=0.247 | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 25 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 47/50 (94%) 50/50 (100%) 50/50 (100%) | 44/50 (88%) 44/50 (88%) 42/50 (84%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% | 91.6% 93.6% 91.2% | |TERMINAL (d) | 24/24 (100%) 18/18 (100%) 18/18 (100%) | 23/27 (85%) 32/35 (91%) 28/32 (88%) | |FIRST INCIDENCE (DAYS) | 538 495 534 | 404 481 517 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.099 P=0.082 P=0.101 | P=0.104N P=0.134N P=0.119N | |INCIDENTAL TUMOR | P=0.073 P=0.190 P=0.200 | P=0.189N P=0.608N P=0.303N | |LOGISTIC REGRESSION | P=0.066 P=0.138 P=0.214 | P=0.286N P=0.615N P=0.340N | |COCHRAN-ARMITAGE | P=0.037 * | P=0.330N | |FISHER EXACT | P=0.121 P=0.121 | P=0.620N P=0.387N | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 36/50 (72%) 35/50 (70%) 33/50 (66%) | 21/50 (42%) 20/50 (40%) 20/50 (40%) | |ADJUSTED (b) | 77.6% 78.7% 75.7% | 47.7% 42.6% 44.3% | |TERMINAL (d) | 14/24 (58%) 9/18 (50%) 9/18 (50%) | 6/27 (22%) 9/35 (26%) 8/32 (25%) | |FIRST INCIDENCE (DAYS) | 283 496 534 | 404 481 407 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.463 P=0.335 P=0.491 | P=0.305N P=0.352N P=0.317N | |INCIDENTAL TUMOR | P=0.197N P=0.385N P=0.244N | P=0.356 P=0.336 P=0.440 | |LOGISTIC REGRESSION | P=0.278N P=0.459N P=0.294N | P=0.317 P=0.549N P=0.377 | |COCHRAN-ARMITAGE | P=0.294N | P=0.459N | |FISHER EXACT | P=0.500N P=0.333N | P=0.500N P=0.500N | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 26 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 50/50 (100%) 50/50 (100%) 50/50 (100%) | 48/50 (96%) 47/50 (94%) 46/50 (92%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% | 96.0% 94.0% 93.9% | |TERMINAL (d) | 24/24 (100%) 18/18 (100%) 18/18 (100%) | 25/27 (93%) 32/35 (91%) 29/32 (91%) | |FIRST INCIDENCE (DAYS) | 283 495 534 | 404 481 407 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.189 P=0.166 P=0.199 | P=0.103N P=0.106N P=0.109N | |INCIDENTAL TUMOR | (e) (e) (e) | P=0.319N P=0.618N P=0.404N | |LOGISTIC REGRESSION | (e) (e) (e) | P=0.265N P=0.618N P=0.320N | |COCHRAN-ARMITAGE | (e) | P=0.264N | |FISHER EXACT | P=1.000N P=1.000N | P=0.500N P=0.339N | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for intercurrent mortality. (d) Observed incidence at terminal kill. (f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between the controls and that dosed group. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. The incidental tumor test regards these lesions as non-fatal. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fisher's exact tests compare directly the overall incidence rates. For all tests, a negative trend is indicated by "N". (e) Value of Statistic cannot be computed. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01). --multipart-boundary Content-type: text/plain Range: bytes 177944-177944/177944 --multipart-boundary--