TDMS Study 05053-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Mason BROMOFORM DATE: 09/08/94 EXPERIMENT: 05053 TEST: 01 TIME: 01:16:50 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01ES2803301 ROUTE: GAVAGE NTP C#: 55130 PATHOLOGIST: K. MURTHY_____ CAS: 75-25-2 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Mason BROMOFORM DATE: 09/08/94 EXPERIMENT: 05053 TEST: 01 TIME: 01:16:50 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES2803301 ROUTE: GAVAGE NTP C#: 55130 PATHOLOGIST: K. MURTHY_____ CAS: 75-25-2 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: Mason BROMOFORM DATE: 09/08/94 EXPERIMENT: 05053 TEST: 01 TIME: 01:16:50 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES2803301 ROUTE: GAVAGE NTP C#: 55130 PATHOLOGIST: K. MURTHY_____ CAS: 75-25-2 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF BROMOFORM ==================================================================================================== MALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma Benign Clitoral/Preputial Gland Carcinoma Carcinoma or Adenoma Intestine Large Polyp Adenomatous Liver Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Mammary Gland Fibroadenoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Skin: Subcutaneous Tissue Neurofibrosarcoma, Fibrosarcoma, Sarcoma, Neurofibroma, or Fibroma Testes Adenoma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Mason BROMOFORM DATE: 09/08/94 EXPERIMENT: 05053 TEST: 01 TIME: 01:16:50 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES2803301 ROUTE: GAVAGE NTP C#: 55130 PATHOLOGIST: K. MURTHY_____ CAS: 75-25-2 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF BROMOFORM ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Clitoral/Preputial Gland Adenoma Intestine Large Polyp Adenomatous Liver Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Mammary Gland Fibroadenoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Uterus Polyp Stromal Sarcoma Stromal or Polyp Stromal All Organs Benign Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 09/08/94 EXPERIMENT: 05053 TEST: 01 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.1 G/KG 0.2 G/KG | VEHICLE 0.1 G/KG 0.2 G/KG | | | 46 VM 46 LM 46 HM | 46 VF 46 LF 46 HF | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 16/48 (33%) 11/50 (22%) 8/50 (16%) | 2/50 (4%) 0/18 (0%) 3/50 (6%) | |ADJUSTED (b) | 45.1% 30.0% 49.2% | 5.9% 0.0% 10.0% | |TERMINAL (d) | 13/32 (41%) 6/30 (20%) 4/11 (36%) | 2/34 (6%) 0/1 (0%) 2/28 (7%) | |FIRST INCIDENCE (DAYS) | 611 621 643 | 735 (T) --- 721 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.510 P=0.209N P=0.415 | P=0.332 P=0.972N P=0.422 | |INCIDENTAL TUMOR | P=0.093N P=0.082N P=0.281N | P=0.358 P=0.972N P=0.448 | |LOGISTIC REGRESSION | P=0.132N P=0.111N P=0.245N | P=0.367 P=0.972N P=0.458 | |COCHRAN-ARMITAGE | P=0.029N* | P=0.402 | |FISHER EXACT | P=0.152N P=0.039N* | P=0.538N P=0.500 | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/41 (10%) 3/38 (8%) 0/34 (0%) | 0/34 (0%) 1/9 (11%) 2/39 (5%) | |ADJUSTED (b) | 13.3% 11.6% 0.0% | 0.0% 100.0% 8.7% | |TERMINAL (d) | 4/30 (13%) 2/21 (10%) 0/10 (0%) | 0/24 (0%) 1/1 (100%) 2/23 (9%) | |FIRST INCIDENCE (DAYS) | 734 (T) 632 --- | --- 735 (T) 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.219N P=0.655N P=0.274N | P=0.176 P=0.009 ** P=0.228 | |INCIDENTAL TUMOR | P=0.187N P=0.647 P=0.274N | P=0.176 P=0.009 ** P=0.228 | |LOGISTIC REGRESSION | P=0.118N P=0.574N P=0.274N | P=0.176 P=0.009 ** P=0.228 | |COCHRAN-ARMITAGE | P=0.070N | P=0.205 | |FISHER EXACT | P=0.543N P=0.083N | P=0.209 P=0.282 | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05053 TEST: 01 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.1 G/KG 0.2 G/KG | VEHICLE 0.1 G/KG 0.2 G/KG | | | 46 VM 46 LM 46 HM | 46 VF 46 LF 46 HF | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/41 (15%) 2/38 (5%) 1/34 (3%) | 1/34 (3%) 1/9 (11%) 0/39 (0%) | |ADJUSTED (b) | 18.4% 7.5% 7.7% | 2.2% 2.9% 0.0% | |TERMINAL (d) | 5/30 (17%) 1/21 (5%) 0/10 (0%) | 0/24 (0%) 0/1 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | 377 680 716 | 630 638 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.181N P=0.235N P=0.336N | P=0.364N P=0.694 P=0.523N | |INCIDENTAL TUMOR | P=0.067N P=0.206N P=0.174N | P=0.217N P=0.565N P=0.398N | |LOGISTIC REGRESSION | P=0.043N* P=0.160N P=0.083N | P=0.272N P=0.757 P=0.420N | |COCHRAN-ARMITAGE | P=0.046N* | P=0.318N | |FISHER EXACT | P=0.158N P=0.088N | P=0.379 P=0.466N | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/41 (24%) 5/38 (13%) 1/34 (3%) | 1/34 (3%) 2/9 (22%) 2/39 (5%) | |ADJUSTED (b) | 31.4% 18.7% 7.7% | 2.2% 100.0% 8.7% | |TERMINAL (d) | 9/30 (30%) 3/21 (14%) 0/10 (0%) | 0/24 (0%) 1/1 (100%) 2/23 (9%) | |FIRST INCIDENCE (DAYS) | 377 632 716 | 630 638 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.077N P=0.288N P=0.134N | P=0.377 P=0.203 P=0.477 | |INCIDENTAL TUMOR | P=0.025N* P=0.271N P=0.061N | P=0.439 P=0.463 P=0.549 | |LOGISTIC REGRESSION | P=0.008N** P=0.163N P=0.014N* | P=0.462 P=0.143 P=0.553 | |COCHRAN-ARMITAGE | P=0.006N** | P=0.462 | |FISHER EXACT | P=0.163N P=0.008N** | P=0.106 P=0.552 | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05053 TEST: 01 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.1 G/KG 0.2 G/KG | VEHICLE 0.1 G/KG 0.2 G/KG | | | 46 VM 46 LM 46 HM | 46 VF 46 LF 46 HF | |=================================================================================================================================| | | |Intestine Large | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) | |ADJUSTED (b) | 0.0% 0.0% 8.3% | 0.0% 0.0% 7.1% | |TERMINAL (d) | 0/34 (0%) 0/30 (0%) 0/11 (0%) | 0/34 (0%) 0/28 (0%) 2/28 (7%) | |FIRST INCIDENCE (DAYS) | --- --- 723 | --- --- 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.137 (e) P=0.293 | P=0.080 (e) P=0.196 | |INCIDENTAL TUMOR | P=0.424 (e) P=0.788 | P=0.080 (e) P=0.196 | |LOGISTIC REGRESSION | P=0.174 (e) P=0.363 | P=0.080 (e) P=0.196 | |COCHRAN-ARMITAGE | P=0.269 | P=0.095 | |FISHER EXACT | (e) P=0.500 | (e) P=0.247 | |=================================================================================================================================| | | |Intestine Large | | Polyp Adenomatous | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) 6/50 (12%) | |ADJUSTED (b) | 0.0% 0.0% 11.4% | 0.0% 3.6% 17.6% | |TERMINAL (d) | 0/34 (0%) 0/30 (0%) 1/11 (9%) | 0/34 (0%) 1/28 (4%) 3/28 (11%) | |FIRST INCIDENCE (DAYS) | --- --- 527 | --- 735 (T) 637 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.042 * (e) P=0.118 | P=0.004 ** P=0.461 P=0.013 * | |INCIDENTAL TUMOR | P=0.045 * (e) P=0.095 | P=0.005 ** P=0.461 P=0.017 * | |LOGISTIC REGRESSION | P=0.101 (e) P=0.230 | P=0.004 ** P=0.461 P=0.015 * | |COCHRAN-ARMITAGE | P=0.095 | P=0.005 ** | |FISHER EXACT | (e) P=0.247 | P=0.500 P=0.013 * | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05053 TEST: 01 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.1 G/KG 0.2 G/KG | VEHICLE 0.1 G/KG 0.2 G/KG | | | 46 VM 46 LM 46 HM | 46 VF 46 LF 46 HF | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/48 (8%) 3/50 (6%) 1/50 (2%) | 2/48 (4%) 0/49 (0%) 0/50 (0%) | |ADJUSTED (b) | 12.5% 9.3% 5.3% | 6.1% 0.0% 0.0% | |TERMINAL (d) | 4/32 (13%) 2/30 (7%) 0/11 (0%) | 2/33 (6%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 734 (T) 679 670 | 735 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.428N P=0.530N P=0.554N | P=0.116N P=0.275N P=0.275N | |INCIDENTAL TUMOR | P=0.216N P=0.440N P=0.359N | P=0.116N P=0.275N P=0.275N | |LOGISTIC REGRESSION | P=0.251N P=0.464N P=0.373N | P=0.116N P=0.275N P=0.275N | |COCHRAN-ARMITAGE | P=0.122N | P=0.091N | |FISHER EXACT | P=0.477N P=0.168N | P=0.242N P=0.237N | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 4/49 (8%) 2/50 (4%) | |ADJUSTED (b) | 11.0% 5.8% 0.0% | 0.0% 13.8% 7.1% | |TERMINAL (d) | 3/34 (9%) 1/30 (3%) 0/11 (0%) | 0/34 (0%) 3/28 (11%) 2/28 (7%) | |FIRST INCIDENCE (DAYS) | 610 659 --- | --- 722 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.122N P=0.362N P=0.220N | P=0.173 P=0.043 * P=0.196 | |INCIDENTAL TUMOR | P=0.048N* P=0.275N P=0.144N | P=0.192 P=0.033 * P=0.196 | |LOGISTIC REGRESSION | P=0.054N P=0.320N P=0.109N | P=0.197 P=0.038 * P=0.196 | |COCHRAN-ARMITAGE | P=0.037N* | P=0.223 | |FISHER EXACT | P=0.339N P=0.059N | P=0.056 P=0.247 | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05053 TEST: 01 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.1 G/KG 0.2 G/KG | VEHICLE 0.1 G/KG 0.2 G/KG | | | 46 VM 46 LM 46 HM | 46 VF 46 LF 46 HF | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 4/49 (8%) 2/50 (4%) | |ADJUSTED (b) | 13.5% 5.8% 3.1% | 0.0% 13.8% 7.1% | |TERMINAL (d) | 3/34 (9%) 1/30 (3%) 0/11 (0%) | 0/34 (0%) 3/28 (11%) 2/28 (7%) | |FIRST INCIDENCE (DAYS) | 610 659 636 | --- 722 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.194N P=0.239N P=0.343N | P=0.173 P=0.043 * P=0.196 | |INCIDENTAL TUMOR | P=0.039N* P=0.113N P=0.088N | P=0.192 P=0.033 * P=0.196 | |LOGISTIC REGRESSION | P=0.082N P=0.204N P=0.161N | P=0.197 P=0.038 * P=0.196 | |COCHRAN-ARMITAGE | P=0.060N | P=0.223 | |FISHER EXACT | P=0.218N P=0.102N | P=0.056 P=0.247 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 4/49 (8%) 2/50 (4%) | |ADJUSTED (b) | 13.5% 5.8% 3.1% | 0.0% 13.8% 7.1% | |TERMINAL (d) | 3/34 (9%) 1/30 (3%) 0/11 (0%) | 0/34 (0%) 3/28 (11%) 2/28 (7%) | |FIRST INCIDENCE (DAYS) | 610 659 636 | --- 722 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.194N P=0.239N P=0.343N | P=0.173 P=0.043 * P=0.196 | |INCIDENTAL TUMOR | P=0.039N* P=0.113N P=0.088N | P=0.192 P=0.033 * P=0.196 | |LOGISTIC REGRESSION | P=0.082N P=0.204N P=0.161N | P=0.197 P=0.038 * P=0.196 | |COCHRAN-ARMITAGE | P=0.060N | P=0.223 | |FISHER EXACT | P=0.218N P=0.102N | P=0.056 P=0.247 | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05053 TEST: 01 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.1 G/KG 0.2 G/KG | VEHICLE 0.1 G/KG 0.2 G/KG | | | 46 VM 46 LM 46 HM | 46 VF 46 LF 46 HF | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) | 2/50 (4%) 1/32 (3%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 2.1% 9.1% | 5.6% 2.8% 3.6% | |TERMINAL (d) | 0/34 (0%) 0/30 (0%) 1/11 (9%) | 1/34 (3%) 0/15 (0%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | --- 600 734 (T) | 691 625 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.212 P=0.531 P=0.276 | P=0.436N P=0.651N P=0.548N | |INCIDENTAL TUMOR | P=0.309 P=0.531 P=0.276 | P=0.401N P=0.739N P=0.522N | |LOGISTIC REGRESSION | P=0.310 P=0.448 P=0.276 | P=0.403N P=0.691N P=0.529N | |COCHRAN-ARMITAGE | P=0.331 | P=0.385N | |FISHER EXACT | P=0.500 P=0.500 | P=0.664N P=0.500N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) | 2/50 (4%) 1/32 (3%) 2/50 (4%) | |ADJUSTED (b) | 0.0% 2.1% 11.5% | 5.6% 2.8% 7.1% | |TERMINAL (d) | 0/34 (0%) 0/30 (0%) 1/11 (9%) | 1/34 (3%) 0/15 (0%) 2/28 (7%) | |FIRST INCIDENCE (DAYS) | --- 600 591 | 691 625 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.077 P=0.531 P=0.118 | P=0.541 P=0.651N P=0.638 | |INCIDENTAL TUMOR | P=0.170 P=0.531 P=0.183 | P=0.573 P=0.739N P=0.660 | |LOGISTIC REGRESSION | P=0.144 P=0.448 P=0.202 | P=0.577 P=0.691N P=0.665 | |COCHRAN-ARMITAGE | P=0.142 | P=0.603 | |FISHER EXACT | P=0.500 P=0.247 | P=0.664N P=0.691N | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05053 TEST: 01 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.1 G/KG 0.2 G/KG | VEHICLE 0.1 G/KG 0.2 G/KG | | | 46 VM 46 LM 46 HM | 46 VF 46 LF 46 HF | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 1/50 (2%) 0/50 (0%) | 22/50 (44%) 17/50 (34%) 6/50 (12%) | |ADJUSTED (b) | 14.7% 3.3% 0.0% | 50.9% 51.0% 18.2% | |TERMINAL (d) | 5/34 (15%) 1/30 (3%) 0/11 (0%) | 14/34 (41%) 12/28 (43%) 4/28 (14%) | |FIRST INCIDENCE (DAYS) | 734 (T) 734 (T) --- | 537 618 543 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.057N P=0.132N P=0.215N | P=0.004N** P=0.509N P=0.004N** | |INCIDENTAL TUMOR | P=0.057N P=0.132N P=0.215N | P<0.001N** P=0.329N P<0.001N** | |LOGISTIC REGRESSION | P=0.057N P=0.132N P=0.215N | P<0.001N** P=0.369N P<0.001N** | |COCHRAN-ARMITAGE | P=0.011N* | P<0.001N** | |FISHER EXACT | P=0.102N P=0.028N* | P=0.206N P<0.001N** | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 1/50 (2%) 0/50 (0%) | 23/50 (46%) 17/50 (34%) 6/50 (12%) | |ADJUSTED (b) | 14.7% 3.3% 0.0% | 53.3% 51.0% 18.2% | |TERMINAL (d) | 5/34 (15%) 1/30 (3%) 0/11 (0%) | 15/34 (44%) 12/28 (43%) 4/28 (14%) | |FIRST INCIDENCE (DAYS) | 734 (T) 734 (T) --- | 537 618 543 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.057N P=0.132N P=0.215N | P=0.003N** P=0.441N P=0.002N** | |INCIDENTAL TUMOR | P=0.057N P=0.132N P=0.215N | P<0.001N** P=0.265N P<0.001N** | |LOGISTIC REGRESSION | P=0.057N P=0.132N P=0.215N | P<0.001N** P=0.303N P<0.001N** | |COCHRAN-ARMITAGE | P=0.011N* | P<0.001N** | |FISHER EXACT | P=0.102N P=0.028N* | P=0.154N P<0.001N** | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05053 TEST: 01 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.1 G/KG 0.2 G/KG | VEHICLE 0.1 G/KG 0.2 G/KG | | | 46 VM 46 LM 46 HM | 46 VF 46 LF 46 HF | |=================================================================================================================================| | | |Pancreas | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 1/50 (2%) | 1/48 (2%) 0/49 (0%) 3/50 (6%) | |ADJUSTED (b) | 2.9% 10.0% 5.0% | 3.0% 0.0% 9.7% | |TERMINAL (d) | 1/34 (3%) 3/30 (10%) 0/11 (0%) | 1/33 (3%) 0/28 (0%) 2/28 (7%) | |FIRST INCIDENCE (DAYS) | 734 (T) 734 (T) 666 | 735 (T) --- 665 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.285 P=0.261 P=0.563 | P=0.151 P=0.533N P=0.257 | |INCIDENTAL TUMOR | P=0.409 P=0.261 P=0.777N | P=0.177 P=0.533N P=0.290 | |LOGISTIC REGRESSION | P=0.417 P=0.261 P=0.691 | P=0.173 P=0.533N P=0.293 | |COCHRAN-ARMITAGE | P=0.610N | P=0.185 | |FISHER EXACT | P=0.309 P=0.753N | P=0.495N P=0.324 | |=================================================================================================================================| | | |Pancreas | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 1/50 (2%) | 1/48 (2%) 1/49 (2%) 3/50 (6%) | |ADJUSTED (b) | 2.9% 10.0% 5.0% | 3.0% 3.6% 9.7% | |TERMINAL (d) | 1/34 (3%) 3/30 (10%) 0/11 (0%) | 1/33 (3%) 1/28 (4%) 2/28 (7%) | |FIRST INCIDENCE (DAYS) | 734 (T) 734 (T) 666 | 735 (T) 735 (T) 665 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.285 P=0.261 P=0.563 | P=0.169 P=0.725 P=0.257 | |INCIDENTAL TUMOR | P=0.409 P=0.261 P=0.777N | P=0.193 P=0.725 P=0.290 | |LOGISTIC REGRESSION | P=0.417 P=0.261 P=0.691 | P=0.197 P=0.725 P=0.293 | |COCHRAN-ARMITAGE | P=0.610N | P=0.212 | |FISHER EXACT | P=0.309 P=0.753N | P=0.747N P=0.324 | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05053 TEST: 01 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.1 G/KG 0.2 G/KG | VEHICLE 0.1 G/KG 0.2 G/KG | | | 46 VM 46 LM 46 HM | 46 VF 46 LF 46 HF | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/50 (24%) 12/48 (25%) 2/45 (4%) | 29/48 (60%) 12/46 (26%) 16/48 (33%) | |ADJUSTED (b) | 31.8% 31.9% 11.8% | 66.6% 38.1% 46.9% | |TERMINAL (d) | 9/34 (26%) 6/28 (21%) 1/11 (9%) | 19/33 (58%) 8/26 (31%) 10/27 (37%) | |FIRST INCIDENCE (DAYS) | 586 537 616 | 610 538 582 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.149N P=0.508 P=0.130N | P=0.043N* P=0.019N* P=0.067N | |INCIDENTAL TUMOR | P=0.034N* P=0.543 P=0.044N* | P=0.008N** P=0.003N** P=0.013N* | |LOGISTIC REGRESSION | P=0.024N* P=0.567 P=0.028N* | P=0.008N** P=0.003N** P=0.012N* | |COCHRAN-ARMITAGE | P=0.011N* | P=0.005N** | |FISHER EXACT | P=0.547 P=0.007N** | P<0.001N** P=0.007N** | |=================================================================================================================================| | | |Skin | | Basosquamous Tumor Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 5.9% 0.0% 0.0% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/34 (6%) 0/30 (0%) 0/11 (0%) | 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 734 (T) --- --- | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.187N P=0.266N P=0.507N | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.187N P=0.266N P=0.507N | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.187N P=0.266N P=0.507N | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.095N | (e) | |FISHER EXACT | P=0.247N P=0.247N | (e) (e) | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05053 TEST: 01 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.1 G/KG 0.2 G/KG | VEHICLE 0.1 G/KG 0.2 G/KG | | | 46 VM 46 LM 46 HM | 46 VF 46 LF 46 HF | |=================================================================================================================================| | | |Skin | | Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, | | Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 5.4% 3.3% 0.0% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/34 (3%) 1/30 (3%) 0/11 (0%) | 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 611 734 (T) --- | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.257N P=0.513N P=0.383N | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.185N P=0.511N P=0.249N | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.167N P=0.493N P=0.269N | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.142N | (e) | |FISHER EXACT | P=0.500N P=0.247N | (e) (e) | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 4/50 (8%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 10.8% 13.3% 0.0% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 3/34 (9%) 4/30 (13%) 0/11 (0%) | 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 514 734 (T) --- | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.253N P=0.589 P=0.214N | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.282N P=0.477 P=0.235N | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.103N P=0.620N P=0.084N | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.060N | (e) | |FISHER EXACT | P=0.643N P=0.059N | (e) (e) | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05053 TEST: 01 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.1 G/KG 0.2 G/KG | VEHICLE 0.1 G/KG 0.2 G/KG | | | 46 VM 46 LM 46 HM | 46 VF 46 LF 46 HF | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, Sarcoma, | | Neurofibroma, or Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 5/50 (10%) 0/50 (0%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) | |ADJUSTED (b) | 13.4% 15.6% 0.0% | 2.9% 3.2% 0.0% | |TERMINAL (d) | 3/34 (9%) 4/30 (13%) 0/11 (0%) | 1/34 (3%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 514 659 --- | 735 (T) 687 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.195N P=0.582 P=0.158N | P=0.359N P=0.719 P=0.539N | |INCIDENTAL TUMOR | P=0.097N P=0.637 P=0.066N | P=0.336N P=0.673 P=0.539N | |LOGISTIC REGRESSION | P=0.061N P=0.609N P=0.049N* | P=0.350N P=0.729 P=0.539N | |COCHRAN-ARMITAGE | P=0.036N* | P=0.331N | |FISHER EXACT | P=0.630N P=0.028N* | P=0.753N P=0.500N | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 46/50 (92%) 45/50 (90%) 37/50 (74%) | | |ADJUSTED (b) | 100.0% 97.8% 100.0% | | |TERMINAL (d) | 34/34 (100%) 29/30 (97%) 11/11 (100%) | | |FIRST INCIDENCE (DAYS) | 429 537 499 | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.432 P<0.001 ** | | |INCIDENTAL TUMOR | P=0.529N P=0.379N P=0.555N | | |LOGISTIC REGRESSION | P=0.234N P=0.134N P=0.251N | | |COCHRAN-ARMITAGE | P=0.008N** | | |FISHER EXACT | P=0.500N P=0.016N* | | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05053 TEST: 01 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.1 G/KG 0.2 G/KG | VEHICLE 0.1 G/KG 0.2 G/KG | | | 46 VM 46 LM 46 HM | 46 VF 46 LF 46 HF | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 1/49 (2%) 3/47 (6%) | 4/50 (8%) 3/47 (6%) 2/49 (4%) | |ADJUSTED (b) | 5.7% 3.3% 13.2% | 11.8% 8.3% 7.1% | |TERMINAL (d) | 1/34 (3%) 1/30 (3%) 0/9 (0%) | 4/34 (12%) 1/27 (4%) 2/28 (7%) | |FIRST INCIDENCE (DAYS) | 688 734 (T) 603 | 735 (T) 577 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.152 P=0.532N P=0.209 | P=0.348N P=0.613N P=0.429N | |INCIDENTAL TUMOR | P=0.548 P=0.392N P=0.576N | P=0.331N P=0.512N P=0.429N | |LOGISTIC REGRESSION | P=0.303 P=0.488N P=0.383 | P=0.292N P=0.553N P=0.429N | |COCHRAN-ARMITAGE | P=0.383 | P=0.274N | |FISHER EXACT | P=0.500N P=0.480 | P=0.535N P=0.349N | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 1/49 (2%) 4/47 (9%) | 5/50 (10%) 3/47 (6%) 2/49 (4%) | |ADJUSTED (b) | 5.7% 3.3% 16.5% | 14.7% 8.3% 7.1% | |TERMINAL (d) | 1/34 (3%) 1/30 (3%) 0/9 (0%) | 5/34 (15%) 1/27 (4%) 2/28 (7%) | |FIRST INCIDENCE (DAYS) | 688 734 (T) 603 | 735 (T) 577 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.065 P=0.532N P=0.107 | P=0.230N P=0.479N P=0.298N | |INCIDENTAL TUMOR | P=0.392 P=0.392N P=0.689N | P=0.214N P=0.381N P=0.298N | |LOGISTIC REGRESSION | P=0.166 P=0.488N P=0.233 | P=0.185N P=0.421N P=0.298N | |COCHRAN-ARMITAGE | P=0.224 | P=0.167N | |FISHER EXACT | P=0.500N P=0.319 | P=0.393N P=0.226N | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05053 TEST: 01 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.1 G/KG 0.2 G/KG | VEHICLE 0.1 G/KG 0.2 G/KG | | | 46 VM 46 LM 46 HM | 46 VF 46 LF 46 HF | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/49 (0%) 0/47 (0%) | 1/50 (2%) 1/47 (2%) 2/49 (4%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% | 2.9% 3.7% 6.3% | |TERMINAL (d) | 0/34 (0%) 0/30 (0%) 0/9 (0%) | 1/34 (3%) 1/27 (4%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | --- --- --- | 735 (T) 735 (T) 713 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.338 P=0.710 P=0.458 | |INCIDENTAL TUMOR | (e) (e) (e) | P=0.356 P=0.710 P=0.478 | |LOGISTIC REGRESSION | (e) (e) (e) | P=0.354 P=0.710 P=0.470 | |COCHRAN-ARMITAGE | (e) | P=0.373 | |FISHER EXACT | (e) (e) | P=0.737 P=0.492 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 3/49 (6%) 2/47 (4%) | 1/50 (2%) 1/47 (2%) 1/49 (2%) | |ADJUSTED (b) | 0.0% 9.7% 6.5% | 2.9% 3.7% 2.8% | |TERMINAL (d) | 0/34 (0%) 2/30 (7%) 0/9 (0%) | 1/34 (3%) 1/27 (4%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | --- 721 600 | 735 (T) 735 (T) 713 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.054 P=0.103 P=0.188 | P=0.603 P=0.710 P=0.742 | |INCIDENTAL TUMOR | P=0.222 P=0.169 P=0.418 | P=0.619 P=0.710 P=0.761N | |LOGISTIC REGRESSION | P=0.134 P=0.114 P=0.229 | P=0.612 P=0.710 P=0.744 | |COCHRAN-ARMITAGE | P=0.190 | P=0.633 | |FISHER EXACT | P=0.121 P=0.237 | P=0.737 P=0.747 | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05053 TEST: 01 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.1 G/KG 0.2 G/KG | VEHICLE 0.1 G/KG 0.2 G/KG | | | 46 VM 46 LM 46 HM | 46 VF 46 LF 46 HF | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 3/49 (6%) 2/47 (4%) | 2/50 (4%) 2/47 (4%) 3/49 (6%) | |ADJUSTED (b) | 0.0% 9.7% 6.5% | 5.9% 7.4% 8.9% | |TERMINAL (d) | 0/34 (0%) 2/30 (7%) 0/9 (0%) | 2/34 (6%) 2/27 (7%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | --- 721 600 | 735 (T) 735 (T) 713 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.054 P=0.103 P=0.188 | P=0.353 P=0.610 P=0.453 | |INCIDENTAL TUMOR | P=0.222 P=0.169 P=0.418 | P=0.379 P=0.610 P=0.483 | |LOGISTIC REGRESSION | P=0.134 P=0.114 P=0.229 | P=0.371 P=0.610 P=0.461 | |COCHRAN-ARMITAGE | P=0.190 | P=0.398 | |FISHER EXACT | P=0.121 P=0.237 | P=0.668 P=0.490 | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # | |----------- | | | |OVERALL (a) | | 10/50 (20%) 9/50 (18%) 2/50 (4%) | |ADJUSTED (b) | | 26.4% 26.1% 6.2% | |TERMINAL (d) | | 7/34 (21%) 5/28 (18%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | | 630 538 665 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.040N* P=0.519 P=0.033N* | |INCIDENTAL TUMOR | | P=0.020N* P=0.594N P=0.023N* | |LOGISTIC REGRESSION | | P=0.020N* P=0.591N P=0.020N* | |COCHRAN-ARMITAGE | | P=0.015N* | |FISHER EXACT | | P=0.500N P=0.014N* | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05053 TEST: 01 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.1 G/KG 0.2 G/KG | VEHICLE 0.1 G/KG 0.2 G/KG | | | 46 VM 46 LM 46 HM | 46 VF 46 LF 46 HF | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # | |----------- | | | |OVERALL (a) | | 11/50 (22%) 9/50 (18%) 2/50 (4%) | |ADJUSTED (b) | | 27.9% 26.1% 6.2% | |TERMINAL (d) | | 7/34 (21%) 5/28 (18%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | | 537 538 665 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.024N* P=0.582N P=0.021N* | |INCIDENTAL TUMOR | | P=0.008N** P=0.460N P=0.009N** | |LOGISTIC REGRESSION | | P=0.010N** P=0.458N P=0.009N** | |COCHRAN-ARMITAGE | | P=0.008N** | |FISHER EXACT | | P=0.402N P=0.007N** | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 2.9% 5.7% 2.6% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/34 (3%) 1/30 (3%) 0/11 (0%) | 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 734 (T) 649 527 | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.428 P=0.483 P=0.631 | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.520 P=0.608 P=0.588 | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.614 P=0.515 P=0.770N | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.622N | (e) | |FISHER EXACT | P=0.500 P=0.753N | (e) (e) | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05053 TEST: 01 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.1 G/KG 0.2 G/KG | VEHICLE 0.1 G/KG 0.2 G/KG | | | 46 VM 46 LM 46 HM | 46 VF 46 LF 46 HF | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, | | or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 14/50 (28%) 9/50 (18%) 5/50 (10%) | 9/50 (18%) 13/50 (26%) 6/50 (12%) | |ADJUSTED (b) | 34.8% 20.4% 27.8% | 22.8% 32.3% 17.5% | |TERMINAL (d) | 9/34 (26%) 1/30 (3%) 2/11 (18%) | 5/34 (15%) 3/28 (11%) 3/28 (11%) | |FIRST INCIDENCE (DAYS) | 483 600 600 | 642 576 483 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.190N P=0.193N P=0.364N | P=0.386N P=0.122 P=0.390N | |INCIDENTAL TUMOR | P=0.007N** P=0.108N P=0.087N | P=0.237N P=0.179 P=0.266N | |LOGISTIC REGRESSION | P=0.004N** P=0.086N P=0.048N* | P=0.257N P=0.172 P=0.293N | |COCHRAN-ARMITAGE | P=0.015N* | P=0.261N | |FISHER EXACT | P=0.171N P=0.020N* | P=0.235 P=0.288N | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma And Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 2.4% | 5.9% 0.0% 0.0% | |TERMINAL (d) | 0/34 (0%) 0/30 (0%) 0/11 (0%) | 2/34 (6%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 393 | 735 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.246 (e) P=0.469 | P=0.120N P=0.282N P=0.282N | |INCIDENTAL TUMOR | P=0.233 (e) P=0.419 | P=0.120N P=0.282N P=0.282N | |LOGISTIC REGRESSION | P=0.430 (e) P=0.666 | P=0.120N P=0.282N P=0.282N | |COCHRAN-ARMITAGE | P=0.269 | P=0.095N | |FISHER EXACT | (e) P=0.500 | P=0.247N P=0.247N | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05053 TEST: 01 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.1 G/KG 0.2 G/KG | VEHICLE 0.1 G/KG 0.2 G/KG | | | 46 VM 46 LM 46 HM | 46 VF 46 LF 46 HF | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 2.4% | 5.9% 0.0% 0.0% | |TERMINAL (d) | 0/34 (0%) 0/30 (0%) 0/11 (0%) | 2/34 (6%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 393 | 735 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.246 (e) P=0.469 | P=0.120N P=0.282N P=0.282N | |INCIDENTAL TUMOR | P=0.233 (e) P=0.419 | P=0.120N P=0.282N P=0.282N | |LOGISTIC REGRESSION | P=0.430 (e) P=0.666 | P=0.120N P=0.282N P=0.282N | |COCHRAN-ARMITAGE | P=0.269 | P=0.095N | |FISHER EXACT | (e) P=0.500 | P=0.247N P=0.247N | |=================================================================================================================================| | | |All Organs | | Mesothelioma Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 4/50 (8%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 5.9% 3.3% 14.4% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/34 (6%) 1/30 (3%) 0/11 (0%) | 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 734 (T) 734 (T) 356 | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.076 P=0.544N P=0.121 | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.339 P=0.544N P=0.528 | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.247 P=0.544N P=0.337 | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.238 | (e) | |FISHER EXACT | P=0.500N P=0.339 | (e) (e) | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05053 TEST: 01 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.1 G/KG 0.2 G/KG | VEHICLE 0.1 G/KG 0.2 G/KG | | | 46 VM 46 LM 46 HM | 46 VF 46 LF 46 HF | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 46/50 (92%) 47/50 (94%) 38/50 (76%) | 41/50 (82%) 28/50 (56%) 33/50 (66%) | |ADJUSTED (b) | 100.0% 97.9% 100.0% | 87.1% 72.8% 80.0% | |TERMINAL (d) | 34/34 (100%) 29/30 (97%) 11/11 (100%) | 28/34 (82%) 18/28 (64%) 20/28 (71%) | |FIRST INCIDENCE (DAYS) | 429 537 499 | 537 538 543 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.304 P<0.001 ** | P=0.372N P=0.199N P=0.413N | |INCIDENTAL TUMOR | P=0.549 P=0.636N P=0.592 | P=0.104N P=0.032N* P=0.122N | |LOGISTIC REGRESSION | P=0.341N P=0.417N P=0.420N | P=0.113N P=0.032N* P=0.131N | |COCHRAN-ARMITAGE | P=0.012N* | P=0.054N | |FISHER EXACT | P=0.500 P=0.027N* | P=0.004N** P=0.055N | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 25/50 (50%) 21/50 (42%) 14/50 (28%) | 17/50 (34%) 18/50 (36%) 10/50 (20%) | |ADJUSTED (b) | 55.3% 46.2% 52.1% | 40.4% 44.1% 27.4% | |TERMINAL (d) | 14/34 (41%) 7/30 (23%) 2/11 (18%) | 10/34 (29%) 6/28 (21%) 5/28 (18%) | |FIRST INCIDENCE (DAYS) | 377 337 356 | 537 576 319 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.515 P=0.339N P=0.478 | P=0.202N P=0.255 P=0.193N | |INCIDENTAL TUMOR | P<0.001N** P=0.072N P=0.009N** | P=0.064N P=0.411 P=0.052N | |LOGISTIC REGRESSION | P=0.005N** P=0.241N P=0.013N* | P=0.069N P=0.459 P=0.062N | |COCHRAN-ARMITAGE | P=0.016N* | P=0.078N | |FISHER EXACT | P=0.274N P=0.020N* | P=0.500 P=0.088N | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05053 TEST: 01 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BROMOFORM TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.1 G/KG 0.2 G/KG | VEHICLE 0.1 G/KG 0.2 G/KG | | | 46 VM 46 LM 46 HM | 46 VF 46 LF 46 HF | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 49/50 (98%) 49/50 (98%) 42/50 (84%) | 47/50 (94%) 37/50 (74%) 38/50 (76%) | |ADJUSTED (b) | 100.0% 98.0% 100.0% | 94.0% 86.0% 86.0% | |TERMINAL (d) | 34/34 (100%) 29/30 (97%) 11/11 (100%) | 31/34 (91%) 22/28 (79%) 22/28 (79%) | |FIRST INCIDENCE (DAYS) | 377 337 356 | 537 538 319 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.389 P<0.001 ** | P=0.376N P=0.479N P=0.401N | |INCIDENTAL TUMOR | P=0.405N P=0.747N P=0.909 | P=0.026N* P=0.083N P=0.020N* | |LOGISTIC REGRESSION | P=0.196N P=0.612N P=0.926N | P=0.031N* P=0.073N P=0.023N* | |COCHRAN-ARMITAGE | P=0.005N** | P=0.015N* | |FISHER EXACT | P=0.753N P=0.015N* | P=0.006N** P=0.011N* | |=================================================================================================================================| (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).