TDMS Study 05128-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst D & C YELLOW NO. 11 DATE: 04/03/96 EXPERIMENT: 05128 TEST: 06 TIME: 23:51:52 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-95271 ROUTE: DOSED FEED NTP C#: 61789B PATHOLOGIST: J. E. HEATH CAS: 8003-22-3 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst D & C YELLOW NO. 11 DATE: 04/03/96 EXPERIMENT: 05128 TEST: 06 TIME: 23:51:52 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-95271 ROUTE: DOSED FEED NTP C#: 61789B PATHOLOGIST: J. E. HEATH CAS: 8003-22-3 RATS(FISCHER344) ---------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED. ---------------- Adrenal Cortex Adrenal Medulla Bone Marrow Brain Clitoral Gland Clitoral/Preputial Gland Epididymis Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst D & C YELLOW NO. 11 DATE: 04/03/96 EXPERIMENT: 05128 TEST: 06 TIME: 23:51:52 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-95271 ROUTE: DOSED FEED NTP C#: 61789B PATHOLOGIST: J. E. HEATH CAS: 8003-22-3 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF D & C YELLOW NO. 11 ==================================================================================================== MALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma: Benign, Complex, Malignant, NOS Clitoral/Preputial Gland Adenoma Carcinoma or Adenoma Intestine Small: Site Unspecified Carcinoma Islets, Pancreatic Adenoma Carcinoma or Adenoma Kidney: Renal Tubule Adenoma Carcinoma or Adenoma Liver Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) Papilloma Squamous or Papilloma Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma Pancreas Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma Skin Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma Keratoacanthoma Squamous Cell Papilloma Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma Squamous Cell Papilloma, Papilloma, or Keratoacanthoma Testes Adenoma Tongue Squamous Cell Papilloma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Mesothelioma: Benign, Malignant, NOS Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst D & C YELLOW NO. 11 DATE: 04/03/96 EXPERIMENT: 05128 TEST: 06 TIME: 23:51:52 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-95271 ROUTE: DOSED FEED NTP C#: 61789B PATHOLOGIST: J. E. HEATH CAS: 8003-22-3 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF D & C YELLOW NO. 11 ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Clitoral/Preputial Gland Adenoma Carcinoma or Adenoma Liver Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Alveolar/Bronchiolar Carcinoma Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) Squamous Cell Carcinoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma Carcinoma or Adenoma Uterus Polyp Stromal All Organs Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.05% 0.17% 0.5% | UNTREATD 0.05% 0.17% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/60 (12%) 8/59 (14%) 12/60 (20%) 8/60 (13%) | 2/58 (3%) 1/60 (2%) 2/59 (3%) 1/59 (2%) | |ADJUSTED (b) | 25.9% 25.8% 49.3% 55.7% | 7.7% 2.4% 4.9% 4.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | |TERMINAL (d) | 3/19 (16%) 1/19 (5%) 1/8 (13%) 0/2 (0%) | 1/22 (5%) 0/26 (0%) 1/37 (3%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | 615 560 499 498 | 719 631 658 740 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.025 * P=0.483 P=0.028 * P=0.032 * | P=0.473N P=0.486N P=0.553N P=0.479N | |INCIDENTAL TUMOR | P=0.503N P=0.419 P=0.224 P=0.419 | P=0.502N P=0.480N P=0.642 P=0.477N | |LOGISTIC REGRESSION | P=0.271 P=0.449 P=0.101 P=0.222 | P=0.473N P=0.486N P=0.646N P=0.472N | |COCHRAN-ARMITAGE | P=0.516 | P=0.478N | |FISHER EXACT | P=0.486 P=0.159 P=0.500 | P=0.487N P=0.684N P=0.494N | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/60 (7%) 1/59 (2%) 2/60 (3%) 0/60 (0%) | 0/58 (0%) 0/60 (0%) 1/59 (2%) 1/59 (2%) | |ADJUSTED (b) | 18.5% 5.3% 19.8% 0.0% | 0.0% 0.0% 2.4% 3.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | |TERMINAL (d) | 3/19 (16%) 1/19 (5%) 1/8 (13%) 0/2 (0%) | 0/22 (0%) 0/26 (0%) 0/37 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | 677 733 (T) 712 --- | --- --- 671 723 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.454N P=0.182N P=0.663 P=0.404N | P=0.312 (e) P=0.531 P=0.527 | |INCIDENTAL TUMOR | P=0.294N P=0.190N P=0.522N P=0.311N | P=0.380 (e) P=0.323 P=0.522 | |LOGISTIC REGRESSION | P=0.255N P=0.186N P=0.574N P=0.211N | P=0.299 (e) P=0.510 P=0.512 | |COCHRAN-ARMITAGE | P=0.082N | P=0.299 | |FISHER EXACT | P=0.187N P=0.340N P=0.059N | (e) P=0.504 P=0.504 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.05% 0.17% 0.5% | UNTREATD 0.05% 0.17% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/60 (17%) 9/59 (15%) 14/60 (23%) 8/60 (13%) | 3/58 (5%) 1/60 (2%) 3/59 (5%) 2/59 (3%) | |ADJUSTED (b) | 39.8% 29.9% 60.2% 55.7% | 10.7% 2.4% 7.2% 7.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/8 (0%) | |TERMINAL (d) | 6/19 (32%) 2/19 (11%) 2/8 (25%) 0/2 (0%) | 1/22 (5%) 0/26 (0%) 1/37 (3%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | 615 560 499 498 | 712 631 658 723 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.033 * P=0.516N P=0.024 * P=0.051 | P=0.557N P=0.300N P=0.510N P=0.463N | |INCIDENTAL TUMOR | P=0.442N P=0.573N P=0.214 P=0.489 | P=0.538N P=0.320N P=0.471 P=0.462N | |LOGISTIC REGRESSION | P=0.433 P=0.567N P=0.134 P=0.426 | P=0.567N P=0.291N P=0.610N P=0.470N | |COCHRAN-ARMITAGE | P=0.360N | P=0.571N | |FISHER EXACT | P=0.516N P=0.247 P=0.399N | P=0.297N P=0.652N P=0.492N | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/59 (8%) 2/59 (3%) 1/60 (2%) 0/60 (0%) | 11/59 (19%) 4/59 (7%) 5/59 (8%) 4/60 (7%) | |ADJUSTED (b) | 21.3% 9.3% 4.5% 0.0% | 40.2% 16.0% 13.5% 13.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 3/19 (16%) 1/20 (5%) 0/8 (0%) 0/2 (0%) | 7/22 (32%) 4/25 (16%) 5/37 (14%) 2/23 (9%) | |FIRST INCIDENCE (DAYS) | 638 726 686 --- | 629 740 (T) 740 (T) 656 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.200N P=0.203N P=0.287N P=0.302N | P=0.100N P=0.029N* P=0.009N** P=0.043N* | |INCIDENTAL TUMOR | P=0.070N P=0.234N P=0.173N P=0.145N | P=0.097N P=0.036N* P=0.034N* P=0.045N* | |LOGISTIC REGRESSION | P=0.084N P=0.228N P=0.169N P=0.108N | P=0.086N P=0.043N* P=0.035N* P=0.036N* | |COCHRAN-ARMITAGE | P=0.031N* | P=0.105N | |FISHER EXACT | P=0.219N P=0.100N P=0.027N* | P=0.047N* P=0.089N P=0.044N* | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.05% 0.17% 0.5% | UNTREATD 0.05% 0.17% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/59 (8%) 4/59 (7%) 1/60 (2%) 2/60 (3%) | 6/59 (10%) 3/59 (5%) 6/59 (10%) 3/60 (5%) | |ADJUSTED (b) | 23.7% 13.4% 3.3% 35.7% | 23.3% 7.0% 15.2% 9.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 1/9 (11%) 0/10 (0%) 1/9 (11%) | |TERMINAL (d) | 4/19 (21%) 1/20 (5%) 0/8 (0%) 0/2 (0%) | 4/22 (18%) 0/25 (0%) 5/37 (14%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | 688 510 650 716 | 660 358 (I) 456 358 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.548 P=0.496N P=0.318N P=0.355 | P=0.313N P=0.231N P=0.317N P=0.241N | |INCIDENTAL TUMOR | P=0.283N P=0.507N P=0.195N P=0.675N | P=0.269N P=0.268N P=0.442N P=0.221N | |LOGISTIC REGRESSION | P=0.342N P=0.528N P=0.192N P=0.645 | P=0.297N P=0.244N P=0.552N P=0.235N | |COCHRAN-ARMITAGE | P=0.165N | P=0.295N | |FISHER EXACT | P=0.500N P=0.100N P=0.213N | P=0.245N P=0.619N P=0.237N | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/59 (17%) 6/59 (10%) 2/60 (3%) 2/60 (3%) | 17/59 (29%) 7/59 (12%) 11/59 (19%) 7/60 (12%) | |ADJUSTED (b) | 42.9% 21.7% 7.7% 35.7% | 58.9% 21.8% 28.5% 21.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 1/9 (11%) 0/10 (0%) 1/9 (11%) | |TERMINAL (d) | 7/19 (37%) 2/20 (10%) 0/8 (0%) 0/2 (0%) | 11/22 (50%) 4/25 (16%) 10/37 (27%) 3/23 (13%) | |FIRST INCIDENCE (DAYS) | 638 510 650 716 | 629 358 (I) 456 358 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.365N P=0.199N P=0.138N P=0.638N | P=0.069N P=0.012N* P=0.007N** P=0.018N* | |INCIDENTAL TUMOR | P=0.049N* P=0.220N P=0.047N* P=0.225N | P=0.054N P=0.016N* P=0.033N* P=0.015N* | |LOGISTIC REGRESSION | P=0.071N P=0.234N P=0.045N* P=0.184N | P=0.061N P=0.017N* P=0.059N P=0.014N* | |COCHRAN-ARMITAGE | P=0.015N* | P=0.066N | |FISHER EXACT | P=0.210N P=0.014N* P=0.014N* | P=0.019N* P=0.140N P=0.017N* | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.05% 0.17% 0.5% | UNTREATD 0.05% 0.17% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Intestine Small: Site Unspecified | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 5.3% 0.0% 0.0% 39.4% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/19 (5%) 0/20 (0%) 0/8 (0%) 0/2 (0%) | 0/22 (0%) 0/26 (0%) 0/37 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | 733 (T) --- --- 700 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.007 ** P=0.490N P=0.672N P=0.065 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.102 P=0.490N P=0.672N P=0.348 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.038 * P=0.490N P=0.672N P=0.189 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.189 | (e) | |FISHER EXACT | P=0.500N P=0.500N P=0.500 | (e) (e) (e) | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/60 (7%) 3/60 (5%) 0/60 (0%) 0/60 (0%) | 1/60 (2%) 1/60 (2%) 1/59 (2%) 0/60 (0%) | |ADJUSTED (b) | 19.6% 8.9% 0.0% 0.0% | 3.0% 3.8% 2.7% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 3/19 (16%) 0/20 (0%) 0/8 (0%) 0/2 (0%) | 0/22 (0%) 1/26 (4%) 1/37 (3%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | 716 586 --- --- | 700 740 (T) 740 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.146N P=0.494N P=0.215N P=0.483N | P=0.314N P=0.749N P=0.677N P=0.488N | |INCIDENTAL TUMOR | P=0.059N P=0.520N P=0.129N P=0.311N | P=0.306N P=0.736 P=0.731 P=0.489N | |LOGISTIC REGRESSION | P=0.055N P=0.521N P=0.167N P=0.320N | P=0.314N P=0.762N P=0.737N P=0.500N | |COCHRAN-ARMITAGE | P=0.031N* | P=0.322N | |FISHER EXACT | P=0.500N P=0.059N P=0.059N | P=0.752N P=0.748 P=0.500N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.05% 0.17% 0.5% | UNTREATD 0.05% 0.17% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/60 (0%) 2/60 (3%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/59 (0%) 0/60 (0%) | |ADJUSTED (b) | 5.3% 0.0% 16.5% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/19 (5%) 0/20 (0%) 1/8 (13%) 0/2 (0%) | 0/22 (0%) 0/26 (0%) 0/37 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | 733 (T) --- 686 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.672 P=0.490N P=0.273 P=0.916N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.750 P=0.490N P=0.363 P=0.916N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.687N P=0.490N P=0.345 P=0.916N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.458N | (e) | |FISHER EXACT | P=0.500N P=0.500 P=0.500N | (e) (e) (e) | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/60 (8%) 3/60 (5%) 2/60 (3%) 0/60 (0%) | 1/60 (2%) 1/60 (2%) 1/59 (2%) 0/60 (0%) | |ADJUSTED (b) | 24.6% 8.9% 16.5% 0.0% | 3.0% 3.8% 2.7% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 4/19 (21%) 0/20 (0%) 1/8 (13%) 0/2 (0%) | 0/22 (0%) 1/26 (4%) 1/37 (3%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | 716 586 686 --- | 700 740 (T) 740 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.222N P=0.350N P=0.597N P=0.430N | P=0.314N P=0.749N P=0.677N P=0.488N | |INCIDENTAL TUMOR | P=0.084N P=0.372N P=0.419N P=0.276N | P=0.306N P=0.736 P=0.731 P=0.489N | |LOGISTIC REGRESSION | P=0.070N P=0.378N P=0.479N P=0.265N | P=0.314N P=0.762N P=0.737N P=0.500N | |COCHRAN-ARMITAGE | P=0.029N* | P=0.322N | |FISHER EXACT | P=0.359N P=0.219N P=0.029N* | P=0.752N P=0.748 P=0.500N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.05% 0.17% 0.5% | UNTREATD 0.05% 0.17% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 24.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/19 (0%) 0/20 (0%) 0/8 (0%) 0/2 (0%) | 0/22 (0%) 0/26 (0%) 0/37 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 658 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.004 ** (e) (e) P=0.073 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.052 (e) (e) P=0.287 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.015 * (e) (e) P=0.132 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.042 * | (e) | |FISHER EXACT | (e) (e) P=0.248 | (e) (e) (e) | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 4.5% 24.0% | 0.0% 0.0% 2.7% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/19 (0%) 0/20 (0%) 0/8 (0%) 0/2 (0%) | 0/22 (0%) 0/26 (0%) 1/37 (3%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 686 658 | --- --- 740 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.015 * (e) P=0.438 P=0.073 | P=0.810N (e) P=0.604 (e) | |INCIDENTAL TUMOR | P=0.108 (e) P=0.604 P=0.287 | P=0.810N (e) P=0.604 (e) | |LOGISTIC REGRESSION | P=0.033 * (e) P=0.463 P=0.132 | P=0.810N (e) P=0.605 (e) | |COCHRAN-ARMITAGE | P=0.083 | P=0.787N | |FISHER EXACT | (e) P=0.500 P=0.248 | (e) P=0.500 (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.05% 0.17% 0.5% | UNTREATD 0.05% 0.17% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 2/60 (3%) 1/60 (2%) 7/60 (12%) | 0/60 (0%) 2/60 (3%) 5/60 (8%) 4/60 (7%) | |ADJUSTED (b) | 5.3% 7.9% 2.6% 75.0% | 0.0% 6.4% 13.5% 15.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/19 (5%) 1/20 (5%) 0/8 (0%) 1/2 (50%) | 0/22 (0%) 1/26 (4%) 5/37 (14%) 3/23 (13%) | |FIRST INCIDENCE (DAYS) | 733 (T) 656 607 498 | --- 645 740 (T) 720 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.508 P=0.650 P<0.001 ** | P=0.082 P=0.252 P=0.095 P=0.072 | |INCIDENTAL TUMOR | P=0.001 ** P=0.488 P=0.615 P=0.012 * | P=0.095 P=0.212 P=0.095 P=0.070 | |LOGISTIC REGRESSION | P<0.001 ** P=0.488 P=0.736 P=0.007 ** | P=0.101 P=0.239 P=0.095 P=0.068 | |COCHRAN-ARMITAGE | P=0.005 ** | P=0.101 | |FISHER EXACT | P=0.500 P=0.752N P=0.031 * | P=0.248 P=0.029 * P=0.059 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 2/60 (3%) 1/60 (2%) 7/60 (12%) | 0/60 (0%) 2/60 (3%) 5/60 (8%) 5/60 (8%) | |ADJUSTED (b) | 5.3% 7.9% 2.6% 75.0% | 0.0% 6.4% 13.5% 18.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/19 (5%) 1/20 (5%) 0/8 (0%) 1/2 (50%) | 0/22 (0%) 1/26 (4%) 5/37 (14%) 3/23 (13%) | |FIRST INCIDENCE (DAYS) | 733 (T) 656 607 498 | --- 645 740 (T) 720 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.508 P=0.650 P<0.001 ** | P=0.033 * P=0.252 P=0.095 P=0.041 * | |INCIDENTAL TUMOR | P=0.001 ** P=0.488 P=0.615 P=0.012 * | P=0.045 * P=0.212 P=0.095 P=0.038 * | |LOGISTIC REGRESSION | P<0.001 ** P=0.488 P=0.736 P=0.007 ** | P=0.042 * P=0.239 P=0.095 P=0.036 * | |COCHRAN-ARMITAGE | P=0.005 ** | P=0.044 * | |FISHER EXACT | P=0.500 P=0.752N P=0.031 * | P=0.248 P=0.029 * P=0.029 * | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.05% 0.17% 0.5% | UNTREATD 0.05% 0.17% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 2/60 (3%) 1/60 (2%) 7/60 (12%) | 0/60 (0%) 2/60 (3%) 5/60 (8%) 5/60 (8%) | |ADJUSTED (b) | 5.3% 7.9% 2.6% 75.0% | 0.0% 6.4% 13.5% 18.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/19 (5%) 1/20 (5%) 0/8 (0%) 1/2 (50%) | 0/22 (0%) 1/26 (4%) 5/37 (14%) 3/23 (13%) | |FIRST INCIDENCE (DAYS) | 733 (T) 656 607 498 | --- 645 740 (T) 720 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.508 P=0.650 P<0.001 ** | P=0.033 * P=0.252 P=0.095 P=0.041 * | |INCIDENTAL TUMOR | P=0.001 ** P=0.488 P=0.615 P=0.012 * | P=0.045 * P=0.212 P=0.095 P=0.038 * | |LOGISTIC REGRESSION | P<0.001 ** P=0.488 P=0.736 P=0.007 ** | P=0.042 * P=0.239 P=0.095 P=0.036 * | |COCHRAN-ARMITAGE | P=0.005 ** | P=0.044 * | |FISHER EXACT | P=0.500 P=0.752N P=0.031 * | P=0.248 P=0.029 * P=0.029 * | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/60 (12%) 2/60 (3%) 2/60 (3%) 1/60 (2%) | 1/60 (2%) 1/60 (2%) 2/60 (3%) 1/60 (2%) | |ADJUSTED (b) | 28.9% 10.0% 9.6% 7.1% | 4.5% 3.8% 5.4% 4.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 4/19 (21%) 2/20 (10%) 0/8 (0%) 0/2 (0%) | 1/22 (5%) 1/26 (4%) 2/37 (5%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | 650 733 (T) 453 695 | 740 (T) 740 (T) 740 (T) 740 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.405N P=0.073N P=0.294N P=0.414N | P=0.656 P=0.725N P=0.678 P=0.753N | |INCIDENTAL TUMOR | P=0.126N P=0.087N P=0.080N P=0.157N | P=0.656 P=0.725N P=0.678 P=0.753N | |LOGISTIC REGRESSION | P=0.123N P=0.084N P=0.120N P=0.149N | P=0.656 P=0.725N P=0.678 P=0.753N | |COCHRAN-ARMITAGE | P=0.054N | P=0.640N | |FISHER EXACT | P=0.081N P=0.081N P=0.031N* | P=0.752N P=0.500 P=0.752N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.05% 0.17% 0.5% | UNTREATD 0.05% 0.17% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 2/60 (3%) | |ADJUSTED (b) | 5.3% 2.2% 0.0% 14.3% | 0.0% 0.0% 0.0% 5.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/19 (5%) 0/20 (0%) 0/8 (0%) 0/2 (0%) | 0/22 (0%) 0/26 (0%) 0/37 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | 733 (T) 558 --- 716 | --- --- --- 590 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.418 P=0.759N P=0.672N P=0.376 | P=0.037 * (e) (e) P=0.238 | |INCIDENTAL TUMOR | P=0.603 P=0.755N P=0.672N P=0.603 | P=0.025 * (e) (e) P=0.143 | |LOGISTIC REGRESSION | P=0.616 P=0.759 P=0.672N P=0.506 | P=0.041 * (e) (e) P=0.237 | |COCHRAN-ARMITAGE | P=0.678 | P=0.042 * | |FISHER EXACT | P=0.752N P=0.500N P=0.752N | (e) (e) P=0.248 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/60 (13%) 3/60 (5%) 2/60 (3%) 2/60 (3%) | 1/60 (2%) 1/60 (2%) 2/60 (3%) 3/60 (5%) | |ADJUSTED (b) | 33.7% 12.0% 9.6% 20.4% | 4.5% 3.8% 5.4% 10.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 5/19 (26%) 2/20 (10%) 0/8 (0%) 0/2 (0%) | 1/22 (5%) 1/26 (4%) 2/37 (5%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | 650 558 453 695 | 740 (T) 740 (T) 740 (T) 590 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.574N P=0.092N P=0.233N P=0.642N | P=0.155 P=0.725N P=0.678 P=0.314 | |INCIDENTAL TUMOR | P=0.196N P=0.106N P=0.059N P=0.265N | P=0.133 P=0.725N P=0.678 P=0.237 | |LOGISTIC REGRESSION | P=0.175N P=0.111N P=0.080N P=0.261N | P=0.177 P=0.725N P=0.678 P=0.306 | |COCHRAN-ARMITAGE | P=0.076N | P=0.180 | |FISHER EXACT | P=0.102N P=0.047N* P=0.047N* | P=0.752N P=0.500 P=0.309 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.05% 0.17% 0.5% | UNTREATD 0.05% 0.17% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Mammary Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 2/60 (3%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 6.2% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/19 (0%) 0/20 (0%) 0/8 (0%) 0/2 (0%) | 0/22 (0%) 0/26 (0%) 0/37 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 700 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.222N P=0.250N P=0.190N P=0.223N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.220N P=0.330N P=0.462N P=0.225N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.236N P=0.236N P=0.218N P=0.236N | |COCHRAN-ARMITAGE | (e) | P=0.239N | |FISHER EXACT | (e) (e) (e) | P=0.248N P=0.248N P=0.248N | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 5/60 (8%) 5/60 (8%) 3/60 (5%) 4/60 (7%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 12.1% 15.7% 7.8% 9.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 1/10 (10%) 0/9 (0%) 0/10 (0%) 1/9 (11%) | |TERMINAL (d) | 0/19 (0%) 0/20 (0%) 0/8 (0%) 0/2 (0%) | 0/22 (0%) 3/26 (12%) 2/37 (5%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 358 (I) 628 722 358 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.440N P=0.604N P=0.244N P=0.519N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.412N P=0.612N P=0.522N P=0.442N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.430N P=0.629 P=0.363N P=0.481N | |COCHRAN-ARMITAGE | (e) | P=0.431N | |FISHER EXACT | (e) (e) (e) | P=0.628N P=0.359N P=0.500N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.05% 0.17% 0.5% | UNTREATD 0.05% 0.17% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 7/60 (12%) 5/60 (8%) 3/60 (5%) 4/60 (7%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 17.5% 15.7% 7.8% 9.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 1/10 (10%) 0/9 (0%) 0/10 (0%) 1/9 (11%) | |TERMINAL (d) | 0/19 (0%) 0/20 (0%) 0/8 (0%) 0/2 (0%) | 0/22 (0%) 3/26 (12%) 2/37 (5%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 358 (I) 628 722 358 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.274N P=0.372N P=0.091N P=0.278N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.243N P=0.412N P=0.366N P=0.209N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.272N P=0.380N P=0.160N P=0.253N | |COCHRAN-ARMITAGE | (e) | P=0.272N | |FISHER EXACT | (e) (e) (e) | P=0.381N P=0.161N P=0.264N | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 2/60 (3%) 3/60 (5%) 1/60 (2%) | 21/60 (35%) 22/60 (37%) 23/60 (38%) 26/60 (43%) | |ADJUSTED (b) | 14.6% 10.0% 29.2% 20.0% | 62.0% 55.8% 51.9% 69.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 2/19 (11%) 2/20 (10%) 2/8 (25%) 0/2 (0%) | 10/22 (45%) 10/26 (38%) 16/37 (43%) 12/23 (52%) | |FIRST INCIDENCE (DAYS) | 716 733 (T) 692 722 | 589 548 456 568 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.285 P=0.469N P=0.285 P=0.573 | P=0.189 P=0.510N P=0.162N P=0.292 | |INCIDENTAL TUMOR | P=0.566 P=0.500N P=0.478 P=0.598N | P=0.166 P=0.438 P=0.360 P=0.208 | |LOGISTIC REGRESSION | P=0.532 P=0.470N P=0.394 P=0.729 | P=0.162 P=0.510 P=0.578N P=0.211 | |COCHRAN-ARMITAGE | P=0.274N | P=0.191 | |FISHER EXACT | P=0.500N P=0.660N P=0.309N | P=0.500 P=0.425 P=0.227 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.05% 0.17% 0.5% | UNTREATD 0.05% 0.17% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 2/60 (3%) 3/60 (5%) 1/60 (2%) | 22/60 (37%) 22/60 (37%) 23/60 (38%) 26/60 (43%) | |ADJUSTED (b) | 14.6% 10.0% 29.2% 20.0% | 63.3% 55.8% 51.9% 69.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 2/19 (11%) 2/20 (10%) 2/8 (25%) 0/2 (0%) | 10/22 (45%) 10/26 (38%) 16/37 (43%) 12/23 (52%) | |FIRST INCIDENCE (DAYS) | 716 733 (T) 692 722 | 589 548 456 568 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.285 P=0.469N P=0.285 P=0.573 | P=0.224 P=0.444N P=0.121N P=0.356 | |INCIDENTAL TUMOR | P=0.566 P=0.500N P=0.478 P=0.598N | P=0.206 P=0.504 P=0.406 P=0.275 | |LOGISTIC REGRESSION | P=0.532 P=0.470N P=0.394 P=0.729 | P=0.197 P=0.571N P=0.494N P=0.277 | |COCHRAN-ARMITAGE | P=0.274N | P=0.226 | |FISHER EXACT | P=0.500N P=0.660N P=0.309N | P=0.575N P=0.500 P=0.288 | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 2/60 (3%) 3/60 (5%) 1/60 (2%) | 26/60 (43%) 27/60 (45%) 25/60 (42%) 29/60 (48%) | |ADJUSTED (b) | 14.6% 10.0% 29.2% 20.0% | 66.5% 65.7% 55.4% 71.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 1/10 (10%) 0/9 (0%) 0/10 (0%) 1/9 (11%) | |TERMINAL (d) | 2/19 (11%) 2/20 (10%) 2/8 (25%) 0/2 (0%) | 10/22 (45%) 13/26 (50%) 17/37 (46%) 12/23 (52%) | |FIRST INCIDENCE (DAYS) | 716 733 (T) 692 722 | 358 (I) 548 456 358 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.285 P=0.469N P=0.285 P=0.573 | P=0.323 P=0.499N P=0.066N P=0.419 | |INCIDENTAL TUMOR | P=0.566 P=0.500N P=0.478 P=0.598N | P=0.317 P=0.451 P=0.495 P=0.387 | |LOGISTIC REGRESSION | P=0.532 P=0.470N P=0.394 P=0.729 | P=0.248 P=0.508 P=0.382N P=0.333 | |COCHRAN-ARMITAGE | P=0.274N | P=0.326 | |FISHER EXACT | P=0.500N P=0.660N P=0.309N | P=0.500 P=0.500N P=0.357 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.05% 0.17% 0.5% | UNTREATD 0.05% 0.17% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Papilloma Squamous or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 1/60 (2%) 2/60 (3%) 4/60 (7%) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 5.3% 3.2% 6.5% 28.1% | 4.5% 2.3% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/19 (5%) 0/20 (0%) 0/8 (0%) 0/2 (0%) | 1/22 (5%) 0/26 (0%) 0/37 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | 733 (T) 658 406 481 | 740 (T) 628 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.008 ** P=0.758N P=0.367 P=0.020 * | P=0.295N P=0.736N P=0.396N P=0.491N | |INCIDENTAL TUMOR | P=0.134 P=0.743 P=0.561 P=0.171 | P=0.386N P=0.716N P=0.396N P=0.491N | |LOGISTIC REGRESSION | P=0.052 P=0.754 P=0.501 P=0.097 | P=0.299N P=0.762N P=0.396N P=0.491N | |COCHRAN-ARMITAGE | P=0.074 | P=0.299N | |FISHER EXACT | P=0.752N P=0.500 P=0.182 | P=0.752N P=0.500N P=0.500N | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 2/60 (3%) 1/60 (2%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 2/60 (3%) | |ADJUSTED (b) | 0.0% 5.5% 4.3% 3.2% | 0.0% 0.0% 0.0% 8.2% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/9 (11%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/19 (0%) 0/20 (0%) 0/8 (0%) 0/2 (0%) | 0/22 (0%) 0/26 (0%) 0/37 (0%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | --- 357 (I) 680 590 | --- --- --- 733 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.429 P=0.246 P=0.447 P=0.417 | P=0.031 * (e) (e) P=0.245 | |INCIDENTAL TUMOR | P=0.640 P=0.206 P=0.604 P=0.531 | P=0.054 (e) (e) P=0.251 | |LOGISTIC REGRESSION | P=0.631 P=0.249 P=0.468 P=0.504 | P=0.039 * (e) (e) P=0.248 | |COCHRAN-ARMITAGE | P=0.617 | P=0.042 * | |FISHER EXACT | P=0.248 P=0.500 P=0.500 | (e) (e) P=0.248 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.05% 0.17% 0.5% | UNTREATD 0.05% 0.17% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 3/60 (5%) 3/60 (5%) 5/60 (8%) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 2/60 (3%) | |ADJUSTED (b) | 5.3% 8.5% 10.6% 30.4% | 4.5% 2.3% 0.0% 8.2% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/9 (11%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/19 (5%) 0/20 (0%) 0/8 (0%) 0/2 (0%) | 1/22 (5%) 0/26 (0%) 0/37 (0%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | 733 (T) 357 (I) 406 481 | 740 (T) 628 --- 733 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.010 ** P=0.315 P=0.191 P=0.008 ** | P=0.317 P=0.736N P=0.396N P=0.510 | |INCIDENTAL TUMOR | P=0.173 P=0.266 P=0.395 P=0.102 | P=0.274 P=0.716N P=0.396N P=0.517 | |LOGISTIC REGRESSION | P=0.085 P=0.306 P=0.294 P=0.055 | P=0.333 P=0.762N P=0.396N P=0.518 | |COCHRAN-ARMITAGE | P=0.102 | P=0.335 | |FISHER EXACT | P=0.309 P=0.309 P=0.103 | P=0.752N P=0.500N P=0.500 | |=================================================================================================================================| | | |Oral Mucosa | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 1/60 (2%) 1/60 (2%) 2/60 (3%) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 3.2% 2.0% 9.1% | 4.5% 2.3% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/19 (0%) 0/20 (0%) 0/8 (0%) 0/2 (0%) | 1/22 (5%) 0/26 (0%) 0/37 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | --- 658 406 481 | 740 (T) 628 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.127 P=0.494 P=0.496 P=0.162 | P=0.295N P=0.736N P=0.396N P=0.491N | |INCIDENTAL TUMOR | P=0.428 P=0.459 P=0.669 P=0.423 | P=0.386N P=0.716N P=0.396N P=0.491N | |LOGISTIC REGRESSION | P=0.217 P=0.496 P=0.555 P=0.239 | P=0.299N P=0.762N P=0.396N P=0.491N | |COCHRAN-ARMITAGE | P=0.193 | P=0.299N | |FISHER EXACT | P=0.500 P=0.500 P=0.248 | P=0.752N P=0.500N P=0.500N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.05% 0.17% 0.5% | UNTREATD 0.05% 0.17% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Ovary | | Granulosa Cell Tumor: Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 0/60 (0%) 0/60 (0%) 2/60 (3%) 0/60 (0%) | |ADJUSTED (b) | | 0.0% 0.0% 5.4% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | | 0/22 (0%) 0/26 (0%) 2/37 (5%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | | --- --- 740 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.725N (e) P=0.358 (e) | |INCIDENTAL TUMOR | | P=0.725N (e) P=0.358 (e) | |LOGISTIC REGRESSION | | P=0.725N (e) P=0.358 (e) | |COCHRAN-ARMITAGE | | P=0.701N | |FISHER EXACT | | (e) P=0.248 (e) | |=================================================================================================================================| | | |Pancreas | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 1/60 (2%) 4/60 (7%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 5.0% 18.0% 7.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 1/6 (17%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/19 (0%) 1/20 (5%) 0/8 (0%) 0/2 (0%) | 0/22 (0%) 0/26 (0%) 0/37 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | --- 733 (T) 649 357 (I) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.073 P=0.510 P=0.031 * P=0.142 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.226 P=0.510 P=0.144 P=0.206 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.220 P=0.510 P=0.044 * P=0.280 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.274 | (e) | |FISHER EXACT | P=0.500 P=0.059 P=0.248 | (e) (e) (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.05% 0.17% 0.5% | UNTREATD 0.05% 0.17% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 21/60 (35%) 8/59 (14%) 14/58 (24%) 10/58 (17%) | 24/60 (40%) 23/60 (38%) 18/60 (30%) 22/60 (37%) | |ADJUSTED (b) | 64.5% 27.7% 58.0% 36.1% | 62.3% 64.9% 42.3% 56.5% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/9 (0%) 0/8 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 2/9 (22%) | |TERMINAL (d) | 10/19 (53%) 3/20 (15%) 3/8 (38%) 0/2 (0%) | 9/22 (41%) 14/26 (54%) 13/37 (35%) 8/23 (35%) | |FIRST INCIDENCE (DAYS) | 357 (I) 586 502 509 | 537 601 610 358 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.161 P=0.009N** P=0.559 P=0.407 | P=0.446N P=0.374N P=0.015N* P=0.402N | |INCIDENTAL TUMOR | P=0.263N P=0.005N** P=0.247N P=0.126N | P=0.385N P=0.565N P=0.271N P=0.431N | |LOGISTIC REGRESSION | P=0.118N P=0.006N** P=0.205N P=0.021N* | P=0.433N P=0.488N P=0.096N P=0.434N | |COCHRAN-ARMITAGE | P=0.117N | P=0.422N | |FISHER EXACT | P=0.006N** P=0.138N P=0.023N* | P=0.500N P=0.169N P=0.426N | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/59 (0%) 0/58 (0%) 0/58 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 2/60 (3%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 7.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/8 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/19 (0%) 0/20 (0%) 0/8 (0%) 0/2 (0%) | 0/22 (0%) 0/26 (0%) 0/37 (0%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- --- 723 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.038 * (e) (e) P=0.259 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.054 (e) (e) P=0.251 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.040 * (e) (e) P=0.247 | |COCHRAN-ARMITAGE | (e) | P=0.042 * | |FISHER EXACT | (e) (e) (e) | (e) (e) P=0.248 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.05% 0.17% 0.5% | UNTREATD 0.05% 0.17% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 21/60 (35%) 8/59 (14%) 14/58 (24%) 10/58 (17%) | 24/60 (40%) 23/60 (38%) 18/60 (30%) 24/60 (40%) | |ADJUSTED (b) | 64.5% 27.7% 58.0% 36.1% | 62.3% 64.9% 42.3% 60.7% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/9 (0%) 0/8 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 2/9 (22%) | |TERMINAL (d) | 10/19 (53%) 3/20 (15%) 3/8 (38%) 0/2 (0%) | 9/22 (41%) 14/26 (54%) 13/37 (35%) 9/23 (39%) | |FIRST INCIDENCE (DAYS) | 357 (I) 586 502 509 | 537 601 610 358 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.161 P=0.009N** P=0.559 P=0.407 | P=0.477 P=0.374N P=0.015N* P=0.522N | |INCIDENTAL TUMOR | P=0.263N P=0.005N** P=0.247N P=0.126N | P=0.530 P=0.565N P=0.271N P=0.573 | |LOGISTIC REGRESSION | P=0.118N P=0.006N** P=0.205N P=0.021N* | P=0.477 P=0.488N P=0.096N P=0.565 | |COCHRAN-ARMITAGE | P=0.117N | P=0.493 | |FISHER EXACT | P=0.006N** P=0.138N P=0.023N* | P=0.500N P=0.169N P=0.574N | |=================================================================================================================================| | | |Skin | | Basal Cell Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 1/60 (2%) 2/60 (3%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 3.6% 3.3% 8.1% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/19 (0%) 0/20 (0%) 0/8 (0%) 0/2 (0%) | 0/22 (0%) 0/26 (0%) 0/37 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | 695 672 590 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.493N P=0.753 P=0.373 P=0.638N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.266N P=0.717 P=0.574 P=0.455N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.401N P=0.755 P=0.465 P=0.608N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.335N | (e) | |FISHER EXACT | P=0.752N P=0.500 P=0.500N | (e) (e) (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.05% 0.17% 0.5% | UNTREATD 0.05% 0.17% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Skin | | Basal Cell Adenoma, Basosquamous Tumor Benign, or Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 1/60 (2%) 2/60 (3%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 8.6% 3.3% 8.1% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/19 (5%) 0/20 (0%) 0/8 (0%) 0/2 (0%) | 0/22 (0%) 0/26 (0%) 0/37 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | 695 672 590 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.420N P=0.502N P=0.510 P=0.551N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.220N P=0.542N P=0.683 P=0.397N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.288N P=0.514N P=0.641 P=0.416N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.212N | (e) | |FISHER EXACT | P=0.500N P=0.691N P=0.248N | (e) (e) (e) | |=================================================================================================================================| | | |Skin | | Basal Cell Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 0.0% 15.0% 0.0% | 0.0% 0.0% 0.0% 4.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/19 (0%) 0/20 (0%) 1/8 (13%) 0/2 (0%) | 0/22 (0%) 0/26 (0%) 0/37 (0%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | --- --- 646 --- | --- --- --- 740 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.582 (e) P=0.149 (e) | P=0.190 (e) (e) P=0.509 | |INCIDENTAL TUMOR | P=0.667 (e) P=0.193 (e) | P=0.190 (e) (e) P=0.509 | |LOGISTIC REGRESSION | P=0.689 (e) P=0.192 (e) | P=0.190 (e) (e) P=0.509 | |COCHRAN-ARMITAGE | P=0.701N | P=0.213 | |FISHER EXACT | (e) P=0.248 (e) | (e) (e) P=0.500 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.05% 0.17% 0.5% | UNTREATD 0.05% 0.17% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Skin | | Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign, | | malignant or NOS), or Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 1/60 (2%) 4/60 (7%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 8.6% 3.3% 21.9% 0.0% | 0.0% 0.0% 0.0% 4.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/19 (5%) 0/20 (0%) 1/8 (13%) 0/2 (0%) | 0/22 (0%) 0/26 (0%) 0/37 (0%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | 695 672 590 --- | --- --- --- 740 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.545N P=0.502N P=0.156 P=0.551N | P=0.190 (e) (e) P=0.509 | |INCIDENTAL TUMOR | P=0.299N P=0.542N P=0.293 P=0.397N | P=0.190 (e) (e) P=0.509 | |LOGISTIC REGRESSION | P=0.348N P=0.514N P=0.262 P=0.416N | P=0.190 (e) (e) P=0.509 | |COCHRAN-ARMITAGE | P=0.236N | P=0.213 | |FISHER EXACT | P=0.500N P=0.340 P=0.248N | (e) (e) P=0.500 | |=================================================================================================================================| | | |Skin | | Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal | | Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 12/60 (20%) 8/60 (13%) 8/60 (13%) 4/60 (7%) | 0/60 (0%) 1/60 (2%) 2/60 (3%) 2/60 (3%) | |ADJUSTED (b) | 40.5% 34.5% 40.6% 59.4% | 0.0% 3.8% 4.9% 8.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 4/19 (21%) 6/20 (30%) 1/8 (13%) 1/2 (50%) | 0/22 (0%) 1/26 (4%) 1/37 (3%) 2/23 (9%) | |FIRST INCIDENCE (DAYS) | 628 658 590 596 | --- 740 (T) 638 740 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.441 P=0.229N P=0.516 P=0.595N | P=0.205 P=0.533 P=0.311 P=0.247 | |INCIDENTAL TUMOR | P=0.154N P=0.268N P=0.183N P=0.108N | P=0.145 P=0.533 P=0.212 P=0.247 | |LOGISTIC REGRESSION | P=0.187N P=0.254N P=0.384N P=0.150N | P=0.224 P=0.533 P=0.248 P=0.247 | |COCHRAN-ARMITAGE | P=0.037N* | P=0.225 | |FISHER EXACT | P=0.232N P=0.232N P=0.029N* | P=0.500 P=0.248 P=0.248 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.05% 0.17% 0.5% | UNTREATD 0.05% 0.17% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Skin | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 2/60 (3%) 3/60 (5%) 0/60 (0%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 10.1% 6.0% 23.4% 0.0% | 2.9% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/19 (5%) 0/20 (0%) 1/8 (13%) 0/2 (0%) | 0/22 (0%) 0/26 (0%) 0/37 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | 632 558 663 --- | 699 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.359N P=0.509N P=0.442 P=0.333N | P=0.460N P=0.518N P=0.463N P=0.494N | |INCIDENTAL TUMOR | P=0.138N P=0.514N P=0.552 P=0.185N | P=0.434N P=0.581N P=0.688N P=0.489N | |LOGISTIC REGRESSION | P=0.166N P=0.509N P=0.581 P=0.169N | P=0.470N P=0.499N P=0.486N P=0.500N | |COCHRAN-ARMITAGE | P=0.110N | P=0.469N | |FISHER EXACT | P=0.500N P=0.660N P=0.122N | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 7/60 (12%) 4/60 (7%) 2/60 (3%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 23.1% 17.7% 11.4% 3.3% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 2/19 (11%) 3/20 (15%) 0/8 (0%) 0/2 (0%) | 0/22 (0%) 0/26 (0%) 0/37 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | 628 658 650 596 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.244N P=0.276N P=0.232N P=0.236N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.067N P=0.293N P=0.071N P=0.056N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.075N P=0.283N P=0.122N P=0.074N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.032N* | (e) | |FISHER EXACT | P=0.264N P=0.081N P=0.031N* | (e) (e) (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.05% 0.17% 0.5% | UNTREATD 0.05% 0.17% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Skin | | Squamous Cell Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 4.9% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/19 (0%) 0/20 (0%) 0/8 (0%) 0/2 (0%) | 0/22 (0%) 0/26 (0%) 1/37 (3%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- 638 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.707N (e) P=0.311 (e) | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.676 (e) P=0.212 (e) | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.704N (e) P=0.248 (e) | |COCHRAN-ARMITAGE | (e) | P=0.701N | |FISHER EXACT | (e) (e) (e) | (e) P=0.248 (e) | |=================================================================================================================================| | | |Skin | | Squamous Cell Carcinoma, Basal Cell Carcinoma, Basosquamous Tumor | | (malignant or NOS), or Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 0.0% 15.0% 0.0% | 0.0% 0.0% 4.9% 4.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/19 (0%) 0/20 (0%) 1/8 (13%) 0/2 (0%) | 0/22 (0%) 0/26 (0%) 1/37 (3%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | --- --- 646 --- | --- --- 638 740 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.582 (e) P=0.149 (e) | P=0.334 (e) P=0.311 P=0.509 | |INCIDENTAL TUMOR | P=0.667 (e) P=0.193 (e) | P=0.236 (e) P=0.212 P=0.509 | |LOGISTIC REGRESSION | P=0.689 (e) P=0.192 (e) | P=0.341 (e) P=0.248 P=0.509 | |COCHRAN-ARMITAGE | P=0.701N | P=0.344 | |FISHER EXACT | (e) P=0.248 (e) | (e) P=0.248 P=0.500 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 22 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.05% 0.17% 0.5% | UNTREATD 0.05% 0.17% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 3/60 (5%) 2/60 (3%) 3/60 (5%) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 13.7% 15.0% 14.1% 58.0% | 0.0% 3.8% 0.0% 4.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/19 (5%) 3/20 (15%) 0/8 (0%) 1/2 (50%) | 0/22 (0%) 1/26 (4%) 0/37 (0%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | 706 733 (T) 686 624 | --- 740 (T) --- 740 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.036 * P=0.633N P=0.577 P=0.101 | P=0.451 P=0.533 (e) P=0.509 | |INCIDENTAL TUMOR | P=0.291 P=0.648 P=0.383N P=0.461 | P=0.451 P=0.533 (e) P=0.509 | |LOGISTIC REGRESSION | P=0.235 P=0.652N P=0.674N P=0.357 | P=0.451 P=0.533 (e) P=0.509 | |COCHRAN-ARMITAGE | P=0.597 | P=0.464 | |FISHER EXACT | P=0.660N P=0.500N P=0.660N | P=0.500 (e) P=0.500 | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 10/60 (17%) 7/60 (12%) 4/60 (7%) 4/60 (7%) | 0/60 (0%) 1/60 (2%) 2/60 (3%) 1/60 (2%) | |ADJUSTED (b) | 34.1% 32.3% 23.9% 59.4% | 0.0% 3.8% 4.9% 4.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 3/19 (16%) 6/20 (30%) 0/8 (0%) 1/2 (50%) | 0/22 (0%) 1/26 (4%) 1/37 (3%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | 628 658 650 596 | --- 740 (T) 638 740 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.369 P=0.293N P=0.335N P=0.544 | P=0.489 P=0.533 P=0.311 P=0.509 | |INCIDENTAL TUMOR | P=0.270N P=0.333N P=0.043N* P=0.190N | P=0.400 P=0.533 P=0.212 P=0.509 | |LOGISTIC REGRESSION | P=0.295N P=0.327N P=0.144N P=0.255N | P=0.496 P=0.533 P=0.248 P=0.509 | |COCHRAN-ARMITAGE | P=0.078N | P=0.495 | |FISHER EXACT | P=0.301N P=0.077N P=0.077N | P=0.500 P=0.248 P=0.500 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 23 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.05% 0.17% 0.5% | UNTREATD 0.05% 0.17% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 10/60 (17%) 7/60 (12%) 4/60 (7%) 4/60 (7%) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 34.1% 32.3% 23.9% 59.4% | 0.0% 3.8% 0.0% 4.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 3/19 (16%) 6/20 (30%) 0/8 (0%) 1/2 (50%) | 0/22 (0%) 1/26 (4%) 0/37 (0%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | 628 658 650 596 | --- 740 (T) --- 740 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.369 P=0.293N P=0.335N P=0.544 | P=0.451 P=0.533 (e) P=0.509 | |INCIDENTAL TUMOR | P=0.270N P=0.333N P=0.043N* P=0.190N | P=0.451 P=0.533 (e) P=0.509 | |LOGISTIC REGRESSION | P=0.295N P=0.327N P=0.144N P=0.255N | P=0.451 P=0.533 (e) P=0.509 | |COCHRAN-ARMITAGE | P=0.078N | P=0.464 | |FISHER EXACT | P=0.301N P=0.077N P=0.077N | P=0.500 (e) P=0.500 | |=================================================================================================================================| | | |Skin: Sebaceous Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 8.9% 0.0% 0.0% 6.7% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/19 (5%) 0/20 (0%) 0/8 (0%) 0/2 (0%) | 0/22 (0%) 0/26 (0%) 0/37 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | 701 --- --- 693 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.462 P=0.234N P=0.422N P=0.607 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.680 P=0.257N P=0.262N P=0.652N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.591 P=0.240N P=0.333N P=0.741N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.645N | (e) | |FISHER EXACT | P=0.248N P=0.248N P=0.500N | (e) (e) (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 24 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.05% 0.17% 0.5% | UNTREATD 0.05% 0.17% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma or Papilloma Squamous | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 3/60 (5%) 0/60 (0%) 2/60 (3%) | |ADJUSTED (b) | 0.0% 8.7% 0.0% 0.0% | 0.0% 11.5% 0.0% 6.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/19 (0%) 1/20 (5%) 0/8 (0%) 0/2 (0%) | 0/22 (0%) 3/26 (12%) 0/37 (0%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | --- 712 --- --- | --- 740 (T) --- 590 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.698N P=0.264 (e) (e) | P=0.403 P=0.150 (e) P=0.247 | |INCIDENTAL TUMOR | P=0.493N P=0.222 (e) (e) | P=0.330 P=0.150 (e) P=0.142 | |LOGISTIC REGRESSION | P=0.565N P=0.237 (e) (e) | P=0.421 P=0.150 (e) P=0.237 | |COCHRAN-ARMITAGE | P=0.365N | P=0.422 | |FISHER EXACT | P=0.248 (e) (e) | P=0.122 (e) P=0.248 | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 2/60 (3%) | |ADJUSTED (b) | 0.0% 8.7% 0.0% 0.0% | 0.0% 7.7% 0.0% 6.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/19 (0%) 1/20 (5%) 0/8 (0%) 0/2 (0%) | 0/22 (0%) 2/26 (8%) 0/37 (0%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | --- 712 --- --- | --- 740 (T) --- 590 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.698N P=0.264 (e) (e) | P=0.267 P=0.275 (e) P=0.247 | |INCIDENTAL TUMOR | P=0.493N P=0.222 (e) (e) | P=0.195 P=0.275 (e) P=0.142 | |LOGISTIC REGRESSION | P=0.565N P=0.237 (e) (e) | P=0.286 P=0.275 (e) P=0.237 | |COCHRAN-ARMITAGE | P=0.365N | P=0.289 | |FISHER EXACT | P=0.248 (e) (e) | P=0.248 (e) P=0.248 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 25 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.05% 0.17% 0.5% | UNTREATD 0.05% 0.17% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 39/59 (66%) 49/60 (82%) 49/60 (82%) 46/60 (77%) | | |ADJUSTED (b) | 95.0% 100.0% 100.0% 100.0% | | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 3/9 (33%) 1/9 (11%) 0/6 (0%) | | |TERMINAL (d) | 17/19 (89%) 20/20 (100%) 8/8 (100%) 2/2 (100%) | | |FIRST INCIDENCE (DAYS) | 481 357 (I) 357 (I) 370 | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.112 P<0.001 ** P<0.001 ** | | |INCIDENTAL TUMOR | P=0.083 P=0.009 ** P=0.005 ** P=0.018 * | | |LOGISTIC REGRESSION | P=0.017 * P=0.006 ** P<0.001 ** P<0.001 ** | | |COCHRAN-ARMITAGE | P=0.337 | | |FISHER EXACT | P=0.042 * P=0.042 * P=0.142 | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/60 (10%) 3/60 (5%) 3/59 (5%) 3/60 (5%) | 2/60 (3%) 2/60 (3%) 4/60 (7%) 6/60 (10%) | |ADJUSTED (b) | 20.7% 12.2% 11.5% 23.8% | 9.1% 7.7% 10.5% 20.2% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 2/19 (11%) 2/20 (10%) 0/8 (0%) 0/2 (0%) | 2/22 (9%) 2/26 (8%) 3/37 (8%) 3/23 (13%) | |FIRST INCIDENCE (DAYS) | 590 575 610 498 | 740 (T) 740 (T) 722 656 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.373 P=0.265N P=0.484N P=0.525 | P=0.050 P=0.635N P=0.572 P=0.159 | |INCIDENTAL TUMOR | P=0.369N P=0.256N P=0.289N P=0.266N | P=0.067 P=0.635N P=0.470 P=0.151 | |LOGISTIC REGRESSION | P=0.451N P=0.259N P=0.316N P=0.391N | P=0.059 P=0.635N P=0.475 P=0.141 | |COCHRAN-ARMITAGE | P=0.304N | P=0.061 | |FISHER EXACT | P=0.245N P=0.254N P=0.245N | P=0.691N P=0.340 P=0.136 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 26 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.05% 0.17% 0.5% | UNTREATD 0.05% 0.17% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/60 (10%) 3/60 (5%) 4/59 (7%) 4/60 (7%) | 2/60 (3%) 3/60 (5%) 5/60 (8%) 6/60 (10%) | |ADJUSTED (b) | 20.7% 12.2% 22.5% 26.5% | 9.1% 11.5% 12.5% 20.2% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 2/19 (11%) 2/20 (10%) 1/8 (13%) 0/2 (0%) | 2/22 (9%) 3/26 (12%) 3/37 (8%) 3/23 (13%) | |FIRST INCIDENCE (DAYS) | 590 575 610 498 | 740 (T) 740 (T) 638 656 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.157 P=0.265N P=0.594 P=0.350 | P=0.091 P=0.577 P=0.418 P=0.159 | |INCIDENTAL TUMOR | P=0.583 P=0.256N P=0.482N P=0.399N | P=0.090 P=0.577 P=0.271 P=0.151 | |LOGISTIC REGRESSION | P=0.535 P=0.259N P=0.474N P=0.529N | P=0.100 P=0.577 P=0.274 P=0.141 | |COCHRAN-ARMITAGE | P=0.466N | P=0.102 | |FISHER EXACT | P=0.245N P=0.382N P=0.372N | P=0.500 P=0.219 P=0.136 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 1/59 (2%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 2/60 (3%) | |ADJUSTED (b) | 0.0% 0.0% 3.6% 0.0% | 0.0% 0.0% 2.7% 6.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/19 (0%) 0/20 (0%) 0/8 (0%) 0/2 (0%) | 0/22 (0%) 0/26 (0%) 1/37 (3%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 659 --- | --- --- 740 (T) 720 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.787 (e) P=0.473 (e) | P=0.085 (e) P=0.604 P=0.269 | |INCIDENTAL TUMOR | P=0.758N (e) P=0.597 (e) | P=0.117 (e) P=0.604 P=0.249 | |LOGISTIC REGRESSION | P=0.805 (e) P=0.477 (e) | P=0.081 (e) P=0.605 P=0.242 | |COCHRAN-ARMITAGE | P=0.787N | P=0.083 | |FISHER EXACT | (e) P=0.496 (e) | (e) P=0.500 P=0.248 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 27 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.05% 0.17% 0.5% | UNTREATD 0.05% 0.17% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/60 (5%) 1/60 (2%) 1/59 (2%) 3/60 (5%) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 13.7% 2.2% 12.5% 37.8% | 0.0% 3.8% 0.0% 4.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 2/19 (11%) 0/20 (0%) 1/8 (13%) 0/2 (0%) | 0/22 (0%) 1/26 (4%) 0/37 (0%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | 695 558 733 (T) 596 | --- 740 (T) --- 740 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.055 P=0.305N P=0.602N P=0.144 | P=0.451 P=0.533 (e) P=0.509 | |INCIDENTAL TUMOR | P=0.225 P=0.316N P=0.496N P=0.454 | P=0.451 P=0.533 (e) P=0.509 | |LOGISTIC REGRESSION | P=0.283 P=0.317N P=0.514N P=0.474 | P=0.451 P=0.533 (e) P=0.509 | |COCHRAN-ARMITAGE | P=0.416 | P=0.464 | |FISHER EXACT | P=0.309N P=0.316N P=0.660N | P=0.500 (e) P=0.500 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/60 (5%) 1/60 (2%) 2/59 (3%) 3/60 (5%) | 0/60 (0%) 1/60 (2%) 1/60 (2%) 3/60 (5%) | |ADJUSTED (b) | 13.7% 2.2% 15.6% 37.8% | 0.0% 3.8% 2.7% 10.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 2/19 (11%) 0/20 (0%) 1/8 (13%) 0/2 (0%) | 0/22 (0%) 1/26 (4%) 1/37 (3%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | 695 558 659 596 | --- 740 (T) 740 (T) 720 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.063 P=0.305N P=0.590 P=0.144 | P=0.059 P=0.533 P=0.604 P=0.143 | |INCIDENTAL TUMOR | P=0.259 P=0.316N P=0.643N P=0.454 | P=0.077 P=0.533 P=0.604 P=0.131 | |LOGISTIC REGRESSION | P=0.290 P=0.317N P=0.663N P=0.474 | P=0.063 P=0.533 P=0.605 P=0.126 | |COCHRAN-ARMITAGE | P=0.428 | P=0.064 | |FISHER EXACT | P=0.309N P=0.508N P=0.660N | P=0.500 P=0.500 P=0.122 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 28 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.05% 0.17% 0.5% | UNTREATD 0.05% 0.17% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Tongue | | Squamous Cell Carcinoma or Papilloma Squamous | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 1/60 (2%) 1/60 (2%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 5.3% 1.7% 4.5% 20.4% | 0.0% 0.0% 0.0% 4.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/9 (11%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/19 (5%) 0/20 (0%) 0/8 (0%) 0/2 (0%) | 0/22 (0%) 0/26 (0%) 0/37 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | 733 (T) 357 (I) 686 695 | --- --- --- 733 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.094 P=0.754 P=0.628 P=0.118 | P=0.194 (e) (e) P=0.500 | |INCIDENTAL TUMOR | P=0.268 P=0.754 P=0.738 P=0.348 | P=0.272 (e) (e) P=0.511 | |LOGISTIC REGRESSION | P=0.313 P=0.752N P=0.689 P=0.228 | P=0.211 (e) (e) P=0.510 | |COCHRAN-ARMITAGE | P=0.360 | P=0.213 | |FISHER EXACT | P=0.752N P=0.752N P=0.500 | (e) (e) P=0.500 | |=================================================================================================================================| | | |Tongue | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/60 (0%) 1/60 (2%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 5.3% 0.0% 4.5% 20.4% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/19 (5%) 0/20 (0%) 0/8 (0%) 0/2 (0%) | 0/22 (0%) 0/26 (0%) 0/37 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | 733 (T) --- 686 695 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.034 * P=0.490N P=0.628 P=0.118 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.164 P=0.490N P=0.738 P=0.348 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.081 P=0.490N P=0.689 P=0.228 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.230 | (e) | |FISHER EXACT | P=0.500N P=0.752N P=0.500 | (e) (e) (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 29 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.05% 0.17% 0.5% | UNTREATD 0.05% 0.17% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 14/60 (23%) 13/60 (22%) 10/60 (17%) 6/60 (10%) | |ADJUSTED (b) | | 35.5% 33.6% 21.5% 18.9% | |INTERIM SACRIFICE 1 (c)| | 2/10 (20%) 2/9 (22%) 3/10 (30%) 0/9 (0%) | |TERMINAL (d) | | 2/22 (9%) 4/26 (15%) 5/37 (14%) 1/23 (4%) | |FIRST INCIDENCE (DAYS) | | 358 (I) 358 (I) 358 (I) 648 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.034N* P=0.474N P=0.101N P=0.056N | |INCIDENTAL TUMOR | | P=0.038N* P=0.568 P=0.507N P=0.063N | |LOGISTIC REGRESSION | | P=0.027N* P=0.500N P=0.259N P=0.044N* | |COCHRAN-ARMITAGE | | P=0.027N* | |FISHER EXACT | | P=0.500N P=0.247N P=0.042N* | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 37/60 (62%) 36/60 (60%) 20/60 (33%) 22/60 (37%) | 16/60 (27%) 21/60 (35%) 19/60 (32%) 16/60 (27%) | |ADJUSTED (b) | 80.0% 77.1% 61.7% 81.6% | 47.3% 49.7% 41.9% 40.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 10/19 (53%) 10/20 (50%) 2/8 (25%) 0/2 (0%) | 6/22 (27%) 7/26 (27%) 11/37 (30%) 4/23 (17%) | |FIRST INCIDENCE (DAYS) | 481 222 453 481 | 589 308 532 441 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.190 P=0.524N P=0.241N P=0.151 | P=0.365N P=0.308 P=0.345N P=0.533N | |INCIDENTAL TUMOR | P<0.001N** P=0.446N P<0.001N** P<0.001N** | P=0.278N P=0.192 P=0.147 P=0.572N | |LOGISTIC REGRESSION | P=0.001N** P=0.521N P<0.001N** P=0.007N** | P=0.443N P=0.212 P=0.442 P=0.509 | |COCHRAN-ARMITAGE | P=0.002N** | P=0.355N | |FISHER EXACT | P=0.500N P=0.002N** P=0.005N** | P=0.215 P=0.344 P=0.582N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 30 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.05% 0.17% 0.5% | UNTREATD 0.05% 0.17% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 2/60 (3%) 3/60 (5%) 4/60 (7%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 6.7% 9.5% 8.7% 22.7% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/19 (0%) 1/20 (5%) 0/8 (0%) 0/2 (0%) | 0/22 (0%) 0/26 (0%) 0/37 (0%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | 656 727 491 496 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.037 * P=0.681N P=0.384 P=0.127 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.372 P=0.644 P=0.676 P=0.529 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.172 P=0.682 P=0.488 P=0.273 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.231 | (e) | |FISHER EXACT | P=0.691N P=0.500 P=0.340 | (e) (e) (e) | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 50/60 (83%) 53/60 (88%) 50/60 (83%) 50/60 (83%) | 44/60 (73%) 46/60 (77%) 44/60 (73%) 43/60 (72%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 93.4% 93.8% 87.9% 91.4% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 3/9 (33%) 1/9 (11%) 1/6 (17%) | 2/10 (20%) 2/9 (22%) 3/10 (30%) 2/9 (22%) | |TERMINAL (d) | 19/19 (100%) 20/20 (100%) 8/8 (100%) 2/2 (100%) | 19/22 (86%) 23/26 (88%) 31/37 (84%) 19/23 (83%) | |FIRST INCIDENCE (DAYS) | 357 (I) 357 (I) 357 (I) 357 (I) | 358 (I) 358 (I) 358 (I) 358 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.382 P=0.008 ** P<0.001 ** | P=0.456N P=0.475N P=0.013N* P=0.441N | |INCIDENTAL TUMOR | P=0.587 P=0.144 P=0.641 P=0.451 | P=0.491N P=0.362 P=0.590 P=0.583 | |LOGISTIC REGRESSION | P=0.476 P=0.129 P=0.284 P=0.229 | P=0.439N P=0.407 P=0.479N P=0.572N | |COCHRAN-ARMITAGE | P=0.418N | P=0.377N | |FISHER EXACT | P=0.301 P=0.596N P=0.596N | P=0.417 P=0.582N P=0.500N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 31 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.05% 0.17% 0.5% | UNTREATD 0.05% 0.17% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 42/60 (70%) 40/60 (67%) 30/60 (50%) 26/60 (43%) | 32/60 (53%) 30/60 (50%) 30/60 (50%) 30/60 (50%) | |ADJUSTED (b) | 87.3% 82.4% 89.6% 88.8% | 72.5% 64.6% 63.6% 65.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/9 (11%) 0/9 (0%) 0/6 (0%) | 2/10 (20%) 1/9 (11%) 0/10 (0%) 2/9 (22%) | |TERMINAL (d) | 13/19 (68%) 12/20 (60%) 6/8 (75%) 0/2 (0%) | 11/22 (50%) 11/26 (42%) 20/37 (54%) 9/23 (39%) | |FIRST INCIDENCE (DAYS) | 481 222 384 481 | 358 (I) 308 456 358 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.072 P=0.476N P=0.417 P=0.080 | P=0.478N P=0.357N P=0.044N* P=0.413N | |INCIDENTAL TUMOR | P<0.001N** P=0.325N P=0.009N** P<0.001N** | P=0.361N P=0.437N P=0.524 P=0.430N | |LOGISTIC REGRESSION | P<0.001N** P=0.435N P=0.009N** P=0.003N** | P=0.538N P=0.437N P=0.527N P=0.508N | |COCHRAN-ARMITAGE | P=0.001N** | P=0.449N | |FISHER EXACT | P=0.422N P=0.020N* P=0.003N** | P=0.428N P=0.428N P=0.428N | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 51/60 (85%) 55/60 (92%) 51/60 (85%) 50/60 (83%) | 52/60 (87%) 53/60 (88%) 53/60 (88%) 53/60 (88%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 96.3% 98.1% 100.0% 98.1% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 4/9 (44%) 1/9 (11%) 1/6 (17%) | 4/10 (40%) 3/9 (33%) 3/10 (30%) 4/9 (44%) | |TERMINAL (d) | 19/19 (100%) 20/20 (100%) 8/8 (100%) 2/2 (100%) | 20/22 (91%) 25/26 (96%) 37/37 (100%) 22/23 (96%) | |FIRST INCIDENCE (DAYS) | 357 (I) 222 357 (I) 357 (I) | 358 (I) 308 358 (I) 358 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.331 P=0.009 ** P<0.001 ** | P=0.435 P=0.423N P=0.010N* P=0.545 | |INCIDENTAL TUMOR | P=0.152N P=0.125 P=0.743 P=0.712 | P=0.513 P=0.555 P=0.422 P=0.430 | |LOGISTIC REGRESSION | P=0.295N P=0.063 P=0.743 P=0.621 | P=0.420 P=0.491 P=0.548 P=0.390 | |COCHRAN-ARMITAGE | P=0.258N | P=0.494 | |FISHER EXACT | P=0.197 P=0.601N P=0.500N | P=0.500 P=0.500 P=0.500 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05128 TEST: 06 PAGE 32 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- D & C YELLOW NO. 11 MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 106 WEEKS (a) Number of tumor-bearing animals / number of animals examined at site. (b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for intercurrent mortality. (c) Observed incidence at interim kill. Male interim sacrifices(days): 357 Female interim sacrifices(days): 358 (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).