TDMS Study 05127-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Mason BARIUM CHLORIDE DIHYDRATE DATE: 09/16/94 EXPERIMENT: 05127 TEST: 02 TIME: 22:02:42 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01ES55115 ROUTE: DOSED WATER NTP C#: C61074 PATHOLOGIST: A. RUSSFIELD S. EUSTIS CAS: 10326279 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Mason BARIUM CHLORIDE DIHYDRATE DATE: 09/16/94 EXPERIMENT: 05127 TEST: 02 TIME: 22:02:42 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES55115 ROUTE: DOSED WATER NTP C#: C61074 PATHOLOGIST: A. RUSSFIELD S. EUSTIS CAS: 10326279 MICE(B6C3F1) ---------------------------- 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 Epididymis Gallbladder Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Mason BARIUM CHLORIDE DIHYDRATE DATE: 09/16/94 EXPERIMENT: 05127 TEST: 02 TIME: 22:02:42 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES55115 ROUTE: DOSED WATER NTP C#: C61074 PATHOLOGIST: A. RUSSFIELD S. EUSTIS CAS: 10326279 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF BARIUM CHLORIDE DIHYDRATE ==================================================================================================== MALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Liver Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma All Organs Hemangioma Benign Tumors Malignant and Benign Tumors ==================================================================================================== FEMALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Liver Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma Thyroid Gland: Follicular Cell Adenoma All Organs Malignant Lymphoma And Histiocytic Sarcoma Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 09/16/94 EXPERIMENT: 05127 TEST: 02 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/58 (0%) 0/60 (0%) 3/58 (5%) 0/59 (0%) | 2/60 (3%) 0/60 (0%) 0/60 (0%) 1/58 (2%) | |ADJUSTED (b) | 0.0% 0.0% 7.7% 0.0% | 5.3% 0.0% 0.0% 4.0% | |INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/6 (0%) | |TERMINAL (d) | 0/43 (0%) 0/43 (0%) 3/39 (8%) 0/31 (0%) | 2/38 (5%) 0/37 (0%) 0/36 (0%) 0/13 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 725 (T) --- | 735 (T) --- --- 643 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.427 (e) P=0.105 (e) | P=0.664 P=0.244N P=0.250N P=0.689 | |INCIDENTAL TUMOR | P=0.427 (e) P=0.105 (e) | P=0.632N P=0.244N P=0.250N P=0.733N | |LOGISTIC REGRESSION | P=0.427 (e) P=0.105 (e) | P=0.632N P=0.244N P=0.250N P=0.720N | |COCHRAN-ARMITAGE | P=0.516 | P=0.493N | |FISHER EXACT | (e) P=0.122 (e) | P=0.248N P=0.248N P=0.513N | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 5/60 (8%) 2/60 (3%) 1/59 (2%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 11.1% 4.7% 2.6% 5.6% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/6 (0%) | |TERMINAL (d) | 5/45 (11%) 2/43 (5%) 1/39 (3%) 1/32 (3%) | 0/38 (0%) 0/37 (0%) 0/36 (0%) 0/13 (0%) | |FIRST INCIDENCE (DAYS) | 725 (T) 725 (T) 725 (T) 626 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.280N P=0.235N P=0.139N P=0.362N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.210N P=0.235N P=0.139N P=0.237N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.242N P=0.235N P=0.139N P=0.306N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.174N | (e) | |FISHER EXACT | P=0.219N P=0.107N P=0.219N | (e) (e) (e) | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 02 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 6/60 (10%) 2/60 (3%) 1/59 (2%) 2/60 (3%) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 13.3% 4.7% 2.6% 5.6% | 2.6% 2.7% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/6 (0%) | |TERMINAL (d) | 6/45 (13%) 2/43 (5%) 1/39 (3%) 1/32 (3%) | 1/38 (3%) 1/37 (3%) 0/36 (0%) 0/13 (0%) | |FIRST INCIDENCE (DAYS) | 725 (T) 725 (T) 725 (T) 626 | 735 (T) 735 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.189N P=0.149N P=0.084N P=0.261N | P=0.347N P=0.756 P=0.511N P=0.713N | |INCIDENTAL TUMOR | P=0.137N P=0.149N P=0.084N P=0.161N | P=0.347N P=0.756 P=0.511N P=0.713N | |LOGISTIC REGRESSION | P=0.159N P=0.148N P=0.084N P=0.211N | P=0.347N P=0.756 P=0.511N P=0.713N | |COCHRAN-ARMITAGE | P=0.107N | P=0.225N | |FISHER EXACT | P=0.136N P=0.060N P=0.136N | P=0.752N P=0.500N P=0.500N | |=================================================================================================================================| | | |Intestine Large, Cecum | | Leiomyoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/59 (0%) 0/60 (0%) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 5.4% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/6 (0%) | |TERMINAL (d) | 0/45 (0%) 0/43 (0%) 0/39 (0%) 0/32 (0%) | 0/38 (0%) 2/37 (5%) 0/36 (0%) 0/13 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- 735 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.528N P=0.232 (e) (e) | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.528N P=0.232 (e) (e) | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.528N P=0.232 (e) (e) | |COCHRAN-ARMITAGE | (e) | P=0.353N | |FISHER EXACT | (e) (e) (e) | P=0.248 (e) (e) | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 02 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/59 (5%) 0/60 (0%) 2/56 (4%) 1/60 (2%) | 0/60 (0%) 0/59 (0%) 3/60 (5%) 0/60 (0%) | |ADJUSTED (b) | 6.8% 0.0% 5.3% 2.6% | 0.0% 0.0% 8.3% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/6 (0%) | |TERMINAL (d) | 3/44 (7%) 0/43 (0%) 2/38 (5%) 0/32 (0%) | 0/38 (0%) 0/36 (0%) 3/36 (8%) 0/13 (0%) | |FIRST INCIDENCE (DAYS) | 725 (T) --- 725 (T) 626 | --- --- 735 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.479N P=0.125N P=0.567N P=0.412N | P=0.273 (e) P=0.111 (e) | |INCIDENTAL TUMOR | P=0.368N P=0.125N P=0.567N P=0.241N | P=0.273 (e) P=0.111 (e) | |LOGISTIC REGRESSION | P=0.436N P=0.125N P=0.567N P=0.356N | P=0.273 (e) P=0.111 (e) | |COCHRAN-ARMITAGE | P=0.371N | P=0.517 | |FISHER EXACT | P=0.119N P=0.525N P=0.303N | (e) P=0.122 (e) | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/59 (5%) 1/60 (2%) 2/56 (4%) 1/60 (2%) | 0/60 (0%) 1/59 (2%) 4/60 (7%) 0/60 (0%) | |ADJUSTED (b) | 6.8% 2.1% 5.3% 2.6% | 0.0% 2.6% 10.7% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/6 (0%) | |TERMINAL (d) | 3/44 (7%) 0/43 (0%) 2/38 (5%) 0/32 (0%) | 0/38 (0%) 0/36 (0%) 3/36 (8%) 0/13 (0%) | |FIRST INCIDENCE (DAYS) | 725 (T) 602 725 (T) 626 | --- 719 720 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.395N P=0.313N P=0.567N P=0.412N | P=0.292 P=0.500 P=0.060 (e) | |INCIDENTAL TUMOR | P=0.215N P=0.222N P=0.567N P=0.241N | P=0.550 P=0.545 P=0.079 (e) | |LOGISTIC REGRESSION | P=0.339N P=0.301N P=0.567N P=0.356N | P=0.357 P=0.493 P=0.064 (e) | |COCHRAN-ARMITAGE | P=0.296N | P=0.585 | |FISHER EXACT | P=0.303N P=0.525N P=0.303N | P=0.496 P=0.059 (e) | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 02 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/60 (3%) 1/60 (2%) 0/58 (0%) 1/60 (2%) | 1/60 (2%) 2/60 (3%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 4.4% 2.1% 0.0% 3.1% | 2.6% 5.1% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/6 (0%) | |TERMINAL (d) | 2/45 (4%) 0/43 (0%) 0/39 (0%) 1/32 (3%) | 1/38 (3%) 0/37 (0%) 0/36 (0%) 0/13 (0%) | |FIRST INCIDENCE (DAYS) | 725 (T) 578 --- 725 (T) | 735 (T) 719 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.451N P=0.511N P=0.270N P=0.618N | P=0.290N P=0.494 P=0.511N P=0.713N | |INCIDENTAL TUMOR | P=0.323N P=0.392N P=0.270N P=0.618N | P=0.102N P=0.550 P=0.511N P=0.713N | |LOGISTIC REGRESSION | P=0.401N P=0.500N P=0.270N P=0.618N | P=0.250N P=0.496 P=0.511N P=0.713N | |COCHRAN-ARMITAGE | P=0.371N | P=0.168N | |FISHER EXACT | P=0.500N P=0.256N P=0.500N | P=0.500 P=0.500N P=0.500N | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 25/60 (42%) 21/60 (35%) 17/58 (29%) 10/60 (17%) | 13/60 (22%) 14/60 (23%) 15/60 (25%) 5/60 (8%) | |ADJUSTED (b) | 51.9% 45.4% 39.4% 26.3% | 32.1% 35.1% 37.4% 31.3% | |INTERIM SACRIFICE 1 (c)| 1/9 (11%) 1/10 (10%) 2/10 (20%) 2/10 (20%) | 0/10 (0%) 1/7 (14%) 1/10 (10%) 0/6 (0%) | |TERMINAL (d) | 22/45 (49%) 18/43 (42%) 14/39 (36%) 6/32 (19%) | 11/38 (29%) 12/37 (32%) 12/36 (33%) 3/13 (23%) | |FIRST INCIDENCE (DAYS) | 457 (I) 459 (I) 403 457 (I) | 561 464 (I) 462 (I) 666 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.024N* P=0.347N P=0.193N P=0.037N* | P=0.490 P=0.456 P=0.373 P=0.604 | |INCIDENTAL TUMOR | P=0.007N** P=0.297N P=0.153N P=0.010N* | P=0.423N P=0.426 P=0.359 P=0.383N | |LOGISTIC REGRESSION | P=0.005N** P=0.303N P=0.137N P=0.008N** | P=0.288N P=0.481 P=0.434 P=0.350N | |COCHRAN-ARMITAGE | P=0.001N** | P=0.028N* | |FISHER EXACT | P=0.287N P=0.113N P=0.002N** | P=0.500 P=0.415 P=0.036N* | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 02 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/60 (8%) 7/60 (12%) 7/58 (12%) 3/60 (5%) | 4/60 (7%) 2/60 (3%) 6/60 (10%) 1/60 (2%) | |ADJUSTED (b) | 10.8% 15.2% 15.1% 8.5% | 9.9% 4.9% 15.6% 6.7% | |INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/6 (0%) | |TERMINAL (d) | 4/45 (9%) 5/43 (12%) 3/39 (8%) 2/32 (6%) | 3/38 (8%) 1/37 (3%) 4/36 (11%) 0/13 (0%) | |FIRST INCIDENCE (DAYS) | 693 529 403 605 | 580 607 714 720 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.411N P=0.355 P=0.319 P=0.537N | P=0.508 P=0.346N P=0.353 P=0.533N | |INCIDENTAL TUMOR | P=0.145N P=0.416 P=0.458 P=0.340N | P=0.380N P=0.379N P=0.416 P=0.316N | |LOGISTIC REGRESSION | P=0.269N P=0.507 P=0.356 P=0.461N | P=0.523N P=0.343N P=0.383 P=0.395N | |COCHRAN-ARMITAGE | P=0.241N | P=0.254N | |FISHER EXACT | P=0.381 P=0.357 P=0.359N | P=0.340N P=0.372 P=0.182N | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/60 (8%) 7/60 (12%) 7/58 (12%) 3/60 (5%) | 4/60 (7%) 2/60 (3%) 6/60 (10%) 1/60 (2%) | |ADJUSTED (b) | 10.8% 15.2% 15.1% 8.5% | 9.9% 4.9% 15.6% 6.7% | |INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/6 (0%) | |TERMINAL (d) | 4/45 (9%) 5/43 (12%) 3/39 (8%) 2/32 (6%) | 3/38 (8%) 1/37 (3%) 4/36 (11%) 0/13 (0%) | |FIRST INCIDENCE (DAYS) | 693 529 403 605 | 580 607 714 720 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.411N P=0.355 P=0.319 P=0.537N | P=0.508 P=0.346N P=0.353 P=0.533N | |INCIDENTAL TUMOR | P=0.145N P=0.416 P=0.458 P=0.340N | P=0.380N P=0.379N P=0.416 P=0.316N | |LOGISTIC REGRESSION | P=0.269N P=0.507 P=0.356 P=0.461N | P=0.523N P=0.343N P=0.383 P=0.395N | |COCHRAN-ARMITAGE | P=0.241N | P=0.254N | |FISHER EXACT | P=0.381 P=0.357 P=0.359N | P=0.340N P=0.372 P=0.182N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 02 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 28/60 (47%) 25/60 (42%) 20/58 (34%) 13/60 (22%) | 16/60 (27%) 15/60 (25%) 20/60 (33%) 6/60 (10%) | |ADJUSTED (b) | 58.2% 51.9% 44.5% 33.6% | 38.5% 36.6% 48.0% 35.9% | |INTERIM SACRIFICE 1 (c)| 1/9 (11%) 1/10 (10%) 2/10 (20%) 2/10 (20%) | 0/10 (0%) 1/7 (14%) 1/10 (10%) 0/6 (0%) | |TERMINAL (d) | 25/45 (56%) 20/43 (47%) 15/39 (38%) 8/32 (25%) | 13/38 (34%) 12/37 (32%) 15/36 (42%) 3/13 (23%) | |FIRST INCIDENCE (DAYS) | 457 (I) 459 (I) 403 457 (I) | 561 464 (I) 462 (I) 666 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.040N* P=0.430N P=0.223N P=0.062N | P=0.403 P=0.542N P=0.239 P=0.583N | |INCIDENTAL TUMOR | P=0.004N** P=0.345N P=0.140N P=0.013N* | P=0.358N P=0.582 P=0.254 P=0.248N | |LOGISTIC REGRESSION | P=0.006N** P=0.371N P=0.150N P=0.013N* | P=0.321N P=0.521N P=0.290 P=0.270N | |COCHRAN-ARMITAGE | P=0.002N** | P=0.023N* | |FISHER EXACT | P=0.357N P=0.123N P=0.003N** | P=0.500N P=0.275 P=0.016N* | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 28/60 (47%) 25/60 (42%) 20/58 (34%) 13/60 (22%) | 16/60 (27%) 15/60 (25%) 20/60 (33%) 6/60 (10%) | |ADJUSTED (b) | 58.2% 51.9% 44.5% 33.6% | 38.5% 36.6% 48.0% 35.9% | |INTERIM SACRIFICE 1 (c)| 1/9 (11%) 1/10 (10%) 2/10 (20%) 2/10 (20%) | 0/10 (0%) 1/7 (14%) 1/10 (10%) 0/6 (0%) | |TERMINAL (d) | 25/45 (56%) 20/43 (47%) 15/39 (38%) 8/32 (25%) | 13/38 (34%) 12/37 (32%) 15/36 (42%) 3/13 (23%) | |FIRST INCIDENCE (DAYS) | 457 (I) 459 (I) 403 457 (I) | 561 464 (I) 462 (I) 666 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.040N* P=0.430N P=0.223N P=0.062N | P=0.403 P=0.542N P=0.239 P=0.583N | |INCIDENTAL TUMOR | P=0.004N** P=0.345N P=0.140N P=0.013N* | P=0.358N P=0.582 P=0.254 P=0.248N | |LOGISTIC REGRESSION | P=0.006N** P=0.371N P=0.150N P=0.013N* | P=0.321N P=0.521N P=0.290 P=0.270N | |COCHRAN-ARMITAGE | P=0.002N** | P=0.023N* | |FISHER EXACT | P=0.357N P=0.123N P=0.003N** | P=0.500N P=0.275 P=0.016N* | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 02 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 15/60 (25%) 11/60 (18%) 8/59 (14%) 7/60 (12%) | 4/60 (7%) 2/60 (3%) 3/60 (5%) 2/60 (3%) | |ADJUSTED (b) | 30.8% 23.4% 20.5% 20.2% | 9.6% 5.4% 8.3% 10.4% | |INTERIM SACRIFICE 1 (c)| 1/9 (11%) 1/10 (10%) 0/10 (0%) 1/10 (10%) | 1/10 (10%) 0/7 (0%) 0/10 (0%) 1/6 (17%) | |TERMINAL (d) | 12/45 (27%) 8/43 (19%) 8/39 (21%) 6/32 (19%) | 3/38 (8%) 2/37 (5%) 3/36 (8%) 1/13 (8%) | |FIRST INCIDENCE (DAYS) | 406 457 (I) 725 (T) 457 (I) | 464 (I) 735 (T) 735 (T) 462 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.138N P=0.287N P=0.144N P=0.176N | P=0.456 P=0.376N P=0.525N P=0.599 | |INCIDENTAL TUMOR | P=0.078N P=0.244N P=0.113N P=0.122N | P=0.456 P=0.376N P=0.525N P=0.599 | |LOGISTIC REGRESSION | P=0.064N P=0.254N P=0.102N P=0.081N | P=0.542N P=0.343N P=0.494N P=0.511N | |COCHRAN-ARMITAGE | P=0.036N* | P=0.334N | |FISHER EXACT | P=0.253N P=0.088N P=0.049N* | P=0.340N P=0.500N P=0.340N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/60 (0%) 0/59 (0%) 3/60 (5%) | 0/60 (0%) 1/60 (2%) 2/60 (3%) 0/60 (0%) | |ADJUSTED (b) | 2.2% 0.0% 0.0% 7.9% | 0.0% 1.7% 4.5% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/6 (0%) | |TERMINAL (d) | 1/45 (2%) 0/43 (0%) 0/39 (0%) 2/32 (6%) | 0/38 (0%) 0/37 (0%) 0/36 (0%) 0/13 (0%) | |FIRST INCIDENCE (DAYS) | 725 (T) --- --- 399 | --- 377 645 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.050 * P=0.509N P=0.529N P=0.220 | P=0.569 P=0.497 P=0.253 (e) | |INCIDENTAL TUMOR | P=0.079 P=0.509N P=0.529N P=0.286 | P=0.493N P=0.669 P=0.397 (e) | |LOGISTIC REGRESSION | P=0.082 P=0.509N P=0.529N P=0.304 | P=0.535N P=0.669 P=0.238 (e) | |COCHRAN-ARMITAGE | P=0.080 | P=0.606N | |FISHER EXACT | P=0.500N P=0.504N P=0.309 | P=0.500 P=0.248 (e) | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 02 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 16/60 (27%) 11/60 (18%) 8/59 (14%) 10/60 (17%) | 4/60 (7%) 3/60 (5%) 5/60 (8%) 2/60 (3%) | |ADJUSTED (b) | 32.9% 23.4% 20.5% 27.6% | 9.6% 7.0% 12.5% 10.4% | |INTERIM SACRIFICE 1 (c)| 1/9 (11%) 1/10 (10%) 0/10 (0%) 1/10 (10%) | 1/10 (10%) 0/7 (0%) 0/10 (0%) 1/6 (17%) | |TERMINAL (d) | 13/45 (29%) 8/43 (19%) 8/39 (21%) 8/32 (25%) | 3/38 (8%) 2/37 (5%) 3/36 (8%) 1/13 (8%) | |FIRST INCIDENCE (DAYS) | 406 457 (I) 725 (T) 399 | 464 (I) 377 645 462 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.348N P=0.223N P=0.104N P=0.379N | P=0.411 P=0.539N P=0.486 P=0.599 | |INCIDENTAL TUMOR | P=0.218N P=0.185N P=0.080N P=0.265N | P=0.550 P=0.476N P=0.570 P=0.599 | |LOGISTIC REGRESSION | P=0.187N P=0.192N P=0.070N P=0.193N | P=0.489N P=0.495N P=0.505 P=0.511N | |COCHRAN-ARMITAGE | P=0.122N | P=0.330N | |FISHER EXACT | P=0.191N P=0.060N P=0.134N | P=0.500N P=0.500 P=0.340N | |=================================================================================================================================| | | |Ovary | | Cystadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 0/59 (0%) 0/59 (0%) 3/59 (5%) 0/59 (0%) | |ADJUSTED (b) | | 0.0% 0.0% 8.1% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/6 (0%) | |TERMINAL (d) | | 0/38 (0%) 0/36 (0%) 2/36 (6%) 0/13 (0%) | |FIRST INCIDENCE (DAYS) | | --- --- 723 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.279 (e) P=0.115 (e) | |INCIDENTAL TUMOR | | P=0.449 (e) P=0.154 (e) | |LOGISTIC REGRESSION | | P=0.325 (e) P=0.124 (e) | |COCHRAN-ARMITAGE | | P=0.515 | |FISHER EXACT | | (e) P=0.122 (e) | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 02 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/56 (2%) 1/59 (2%) 2/55 (4%) 0/53 (0%) | 9/58 (16%) 6/58 (10%) 5/57 (9%) 2/53 (4%) | |ADJUSTED (b) | 2.4% 2.4% 5.3% 0.0% | 23.4% 16.4% 13.9% 15.4% | |INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/6 (0%) | |TERMINAL (d) | 1/41 (2%) 1/42 (2%) 2/38 (5%) 0/29 (0%) | 8/37 (22%) 5/35 (14%) 5/36 (14%) 2/13 (15%) | |FIRST INCIDENCE (DAYS) | 725 (T) 725 (T) 725 (T) --- | 605 655 735 (T) 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.469N P=0.756N P=0.473 P=0.569N | P=0.218N P=0.323N P=0.201N P=0.361N | |INCIDENTAL TUMOR | P=0.469N P=0.756N P=0.473 P=0.569N | P=0.184N P=0.309N P=0.242N P=0.362N | |LOGISTIC REGRESSION | P=0.469N P=0.756N P=0.473 P=0.569N | P=0.130N P=0.297N P=0.167N P=0.219N | |COCHRAN-ARMITAGE | P=0.390N | P=0.030N* | |FISHER EXACT | P=0.739N P=0.493 P=0.514N | P=0.291N P=0.206N P=0.037N* | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/56 (0%) 0/59 (0%) 0/55 (0%) 0/53 (0%) | 0/58 (0%) 0/58 (0%) 2/57 (4%) 0/53 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 5.6% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/6 (0%) | |TERMINAL (d) | 0/41 (0%) 0/42 (0%) 0/38 (0%) 0/29 (0%) | 0/37 (0%) 0/35 (0%) 2/36 (6%) 0/13 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- 735 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.389 (e) P=0.232 (e) | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.389 (e) P=0.232 (e) | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.389 (e) P=0.232 (e) | |COCHRAN-ARMITAGE | (e) | P=0.556 | |FISHER EXACT | (e) (e) (e) | (e) P=0.243 (e) | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 02 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/56 (2%) 1/59 (2%) 2/55 (4%) 0/53 (0%) | 9/58 (16%) 6/58 (10%) 7/57 (12%) 2/53 (4%) | |ADJUSTED (b) | 2.4% 2.4% 5.3% 0.0% | 23.4% 16.4% 19.4% 15.4% | |INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/6 (0%) | |TERMINAL (d) | 1/41 (2%) 1/42 (2%) 2/38 (5%) 0/29 (0%) | 8/37 (22%) 5/35 (14%) 7/36 (19%) 2/13 (15%) | |FIRST INCIDENCE (DAYS) | 725 (T) 725 (T) 725 (T) --- | 605 655 735 (T) 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.469N P=0.756N P=0.473 P=0.569N | P=0.313N P=0.323N P=0.407N P=0.361N | |INCIDENTAL TUMOR | P=0.469N P=0.756N P=0.473 P=0.569N | P=0.271N P=0.309N P=0.459N P=0.362N | |LOGISTIC REGRESSION | P=0.469N P=0.756N P=0.473 P=0.569N | P=0.193N P=0.297N P=0.352N P=0.219N | |COCHRAN-ARMITAGE | P=0.390N | P=0.044N* | |FISHER EXACT | P=0.739N P=0.493 P=0.514N | P=0.291N P=0.409N P=0.037N* | |=================================================================================================================================| | | |Skin | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/59 (0%) 1/60 (2%) | 3/60 (5%) 1/60 (2%) 1/60 (2%) 3/60 (5%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 3.1% | 6.9% 2.7% 2.4% 14.3% | |INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/6 (0%) | |TERMINAL (d) | 0/45 (0%) 0/43 (0%) 0/39 (0%) 1/32 (3%) | 1/38 (3%) 1/37 (3%) 0/36 (0%) 0/13 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 725 (T) | 561 735 (T) 707 561 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.152 (e) (e) P=0.432 | P=0.209 P=0.313N P=0.297N P=0.329 | |INCIDENTAL TUMOR | P=0.152 (e) (e) P=0.432 | P=0.554 P=0.348N P=0.284N P=0.616N | |LOGISTIC REGRESSION | P=0.152 (e) (e) P=0.432 | P=0.466 P=0.306N P=0.306N P=0.661 | |COCHRAN-ARMITAGE | P=0.194 | P=0.481 | |FISHER EXACT | (e) (e) P=0.500 | P=0.309N P=0.309N P=0.660N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 02 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/59 (2%) 0/60 (0%) 2/58 (3%) 2/60 (3%) | 0/60 (0%) 2/60 (3%) 2/60 (3%) 1/58 (2%) | |ADJUSTED (b) | 2.3% 0.0% 4.8% 6.3% | 0.0% 5.3% 5.4% 7.7% | |INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/6 (0%) | |TERMINAL (d) | 1/44 (2%) 0/43 (0%) 1/39 (3%) 2/32 (6%) | 0/38 (0%) 1/37 (3%) 1/36 (3%) 1/13 (8%) | |FIRST INCIDENCE (DAYS) | 725 (T) --- 629 725 (T) | --- 721 723 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.149 P=0.505N P=0.465 P=0.389 | P=0.194 P=0.234 P=0.231 P=0.287 | |INCIDENTAL TUMOR | P=0.237 P=0.505N P=0.591 P=0.389 | P=0.441 P=0.261 P=0.307 P=0.287 | |LOGISTIC REGRESSION | P=0.180 P=0.505N P=0.483 P=0.389 | P=0.251 P=0.235 P=0.242 P=0.287 | |COCHRAN-ARMITAGE | P=0.230 | P=0.476 | |FISHER EXACT | P=0.496N P=0.494 P=0.506 | P=0.248 P=0.248 P=0.492 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 1/58 (2%) 0/58 (0%) 0/59 (0%) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 2/59 (3%) | |ADJUSTED (b) | 2.2% 2.4% 0.0% 0.0% | 0.0% 2.7% 0.0% 15.4% | |INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/6 (0%) | |TERMINAL (d) | 1/45 (2%) 1/41 (2%) 0/39 (0%) 0/32 (0%) | 0/38 (0%) 1/37 (3%) 0/36 (0%) 2/13 (15%) | |FIRST INCIDENCE (DAYS) | 725 (T) 725 (T) --- --- | --- 735 (T) --- 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.272N P=0.741 P=0.529N P=0.568N | P=0.026 * P=0.495 (e) P=0.052 | |INCIDENTAL TUMOR | P=0.272N P=0.741 P=0.529N P=0.568N | P=0.026 * P=0.495 (e) P=0.052 | |LOGISTIC REGRESSION | P=0.272N P=0.741 P=0.529N P=0.568N | P=0.026 * P=0.495 (e) P=0.052 | |COCHRAN-ARMITAGE | P=0.228N | P=0.146 | |FISHER EXACT | P=0.744 P=0.508N P=0.504N | P=0.500 (e) P=0.244 | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 02 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 3/60 (5%) 1/60 (2%) 4/60 (7%) 0/60 (0%) | |ADJUSTED (b) | | 7.4% 2.7% 11.1% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/6 (0%) | |TERMINAL (d) | | 2/38 (5%) 1/37 (3%) 4/36 (11%) 0/13 (0%) | |FIRST INCIDENCE (DAYS) | | 580 735 (T) 735 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.462N P=0.316N P=0.480 P=0.311N | |INCIDENTAL TUMOR | | P=0.432N P=0.334N P=0.458 P=0.259N | |LOGISTIC REGRESSION | | P=0.354N P=0.310N P=0.511 P=0.221N | |COCHRAN-ARMITAGE | | P=0.182N | |FISHER EXACT | | P=0.309N P=0.500 P=0.122N | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 3/60 (5%) 2/60 (3%) 4/60 (7%) 0/60 (0%) | |ADJUSTED (b) | | 7.4% 5.4% 11.1% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/6 (0%) | |TERMINAL (d) | | 2/38 (5%) 2/37 (5%) 4/36 (11%) 0/13 (0%) | |FIRST INCIDENCE (DAYS) | | 580 735 (T) 735 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.416N P=0.512N P=0.480 P=0.311N | |INCIDENTAL TUMOR | | P=0.389N P=0.530N P=0.458 P=0.259N | |LOGISTIC REGRESSION | | P=0.310N P=0.507N P=0.511 P=0.221N | |COCHRAN-ARMITAGE | | P=0.145N | |FISHER EXACT | | P=0.500N P=0.500 P=0.122N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 02 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/59 (3%) 3/60 (5%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 0.0% 5.1% 8.5% | 0.0% 0.0% 2.8% 5.0% | |INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/6 (0%) | |TERMINAL (d) | 0/45 (0%) 0/43 (0%) 2/39 (5%) 2/32 (6%) | 0/38 (0%) 0/37 (0%) 1/36 (3%) 0/13 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 725 (T) 605 | --- --- 735 (T) 673 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.012 * (e) P=0.208 P=0.079 | P=0.091 (e) P=0.489 P=0.357 | |INCIDENTAL TUMOR | P=0.025 * (e) P=0.208 P=0.150 | P=0.214 (e) P=0.489 P=0.682 | |LOGISTIC REGRESSION | P=0.016 * (e) P=0.208 P=0.100 | P=0.126 (e) P=0.489 P=0.401 | |COCHRAN-ARMITAGE | P=0.026 * | P=0.225 | |FISHER EXACT | (e) P=0.244 P=0.122 | (e) P=0.500 P=0.500 | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 1/60 (2%) 2/59 (3%) 3/60 (5%) | 1/60 (2%) 3/60 (5%) 3/60 (5%) 1/60 (2%) | |ADJUSTED (b) | 6.7% 2.1% 4.8% 9.4% | 2.6% 7.7% 8.1% 7.7% | |INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/6 (0%) | |TERMINAL (d) | 3/45 (7%) 0/43 (0%) 1/39 (3%) 3/32 (9%) | 1/38 (3%) 1/37 (3%) 2/36 (6%) 1/13 (8%) | |FIRST INCIDENCE (DAYS) | 725 (T) 578 629 725 (T) | 735 (T) 719 723 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.318 P=0.319N P=0.558N P=0.498 | P=0.342 P=0.301 P=0.290 P=0.506 | |INCIDENTAL TUMOR | P=0.498 P=0.228N P=0.460N P=0.498 | P=0.558N P=0.338 P=0.351 P=0.506 | |LOGISTIC REGRESSION | P=0.386 P=0.307N P=0.530N P=0.498 | P=0.426 P=0.300 P=0.310 P=0.506 | |COCHRAN-ARMITAGE | P=0.454 | P=0.481N | |FISHER EXACT | P=0.309N P=0.508N P=0.660N | P=0.309 P=0.309 P=0.752N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 02 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 1/60 (2%) 4/59 (7%) 5/60 (8%) | 1/60 (2%) 3/60 (5%) 4/60 (7%) 2/60 (3%) | |ADJUSTED (b) | 6.7% 2.1% 9.8% 14.6% | 2.6% 7.7% 10.8% 12.3% | |INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/6 (0%) | |TERMINAL (d) | 3/45 (7%) 0/43 (0%) 3/39 (8%) 4/32 (13%) | 1/38 (3%) 1/37 (3%) 3/36 (8%) 1/13 (8%) | |FIRST INCIDENCE (DAYS) | 725 (T) 578 629 605 | 735 (T) 719 723 673 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.062 P=0.319N P=0.429 P=0.202 | P=0.108 P=0.301 P=0.167 P=0.195 | |INCIDENTAL TUMOR | P=0.166 P=0.228N P=0.511 P=0.290 | P=0.396 P=0.338 P=0.207 P=0.358 | |LOGISTIC REGRESSION | P=0.095 P=0.307N P=0.459 P=0.249 | P=0.177 P=0.300 P=0.181 P=0.272 | |COCHRAN-ARMITAGE | P=0.140 | P=0.466 | |FISHER EXACT | P=0.309N P=0.491 P=0.359 | P=0.309 P=0.182 P=0.500 | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma And Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 8/60 (13%) 3/60 (5%) 9/59 (15%) 3/60 (5%) | 15/60 (25%) 10/60 (17%) 13/60 (22%) 6/60 (10%) | |ADJUSTED (b) | 17.8% 7.0% 21.6% 9.4% | 35.1% 26.0% 32.1% 37.9% | |INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/6 (0%) | |TERMINAL (d) | 8/45 (18%) 3/43 (7%) 7/39 (18%) 3/32 (9%) | 11/38 (29%) 9/37 (24%) 10/36 (28%) 4/13 (31%) | |FIRST INCIDENCE (DAYS) | 725 (T) 725 (T) 588 725 (T) | 541 561 360 658 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.409N P=0.115N P=0.381 P=0.241N | P=0.458 P=0.205N P=0.448N P=0.583 | |INCIDENTAL TUMOR | P=0.319N P=0.115N P=0.475 P=0.241N | P=0.284N P=0.184N P=0.388N P=0.296N | |LOGISTIC REGRESSION | P=0.340N P=0.115N P=0.429 P=0.241N | P=0.320N P=0.191N P=0.400N P=0.314N | |COCHRAN-ARMITAGE | P=0.205N | P=0.040N* | |FISHER EXACT | P=0.102N P=0.485 P=0.102N | P=0.184N P=0.415N P=0.026N* | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 02 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 8/60 (13%) 3/60 (5%) 9/59 (15%) 3/60 (5%) | 15/60 (25%) 10/60 (17%) 13/60 (22%) 6/60 (10%) | |ADJUSTED (b) | 17.8% 7.0% 21.6% 9.4% | 35.1% 26.0% 32.1% 37.9% | |INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/6 (0%) | |TERMINAL (d) | 8/45 (18%) 3/43 (7%) 7/39 (18%) 3/32 (9%) | 11/38 (29%) 9/37 (24%) 10/36 (28%) 4/13 (31%) | |FIRST INCIDENCE (DAYS) | 725 (T) 725 (T) 588 725 (T) | 541 561 360 658 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.409N P=0.115N P=0.381 P=0.241N | P=0.458 P=0.205N P=0.448N P=0.583 | |INCIDENTAL TUMOR | P=0.319N P=0.115N P=0.475 P=0.241N | P=0.284N P=0.184N P=0.388N P=0.296N | |LOGISTIC REGRESSION | P=0.340N P=0.115N P=0.429 P=0.241N | P=0.320N P=0.191N P=0.400N P=0.314N | |COCHRAN-ARMITAGE | P=0.205N | P=0.040N* | |FISHER EXACT | P=0.102N P=0.485 P=0.102N | P=0.184N P=0.415N P=0.026N* | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 38/60 (63%) 31/60 (52%) 26/59 (44%) 21/60 (35%) | 26/60 (43%) 21/60 (35%) 28/60 (47%) 11/60 (18%) | |ADJUSTED (b) | 74.3% 61.6% 61.2% 52.4% | 61.4% 51.9% 69.5% 57.4% | |INTERIM SACRIFICE 1 (c)| 2/9 (22%) 3/10 (30%) 2/10 (20%) 3/10 (30%) | 1/10 (10%) 1/7 (14%) 1/10 (10%) 1/6 (17%) | |TERMINAL (d) | 32/45 (71%) 24/43 (56%) 23/39 (59%) 14/32 (44%) | 22/38 (58%) 18/37 (49%) 24/36 (67%) 6/13 (46%) | |FIRST INCIDENCE (DAYS) | 406 457 (I) 403 457 (I) | 464 (I) 464 (I) 462 (I) 462 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.068N P=0.197N P=0.087N P=0.082N | P=0.237 P=0.272N P=0.340 P=0.470 | |INCIDENTAL TUMOR | P=0.008N** P=0.124N P=0.045N* P=0.008N** | P=0.530 P=0.286N P=0.339 P=0.396N | |LOGISTIC REGRESSION | P=0.005N** P=0.127N P=0.031N* P=0.006N** | P=0.327N P=0.236N P=0.467 P=0.212N | |COCHRAN-ARMITAGE | P=0.001N** | P=0.006N** | |FISHER EXACT | P=0.134N P=0.027N* P=0.002N** | P=0.227N P=0.427 P=0.003N** | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 02 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 500 PPM 1250 PPM 2500 PPM | 0 PPM 500 PPM 1250 PPM 2500 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 16/60 (27%) 13/60 (22%) 17/59 (29%) 13/60 (22%) | 22/60 (37%) 20/60 (33%) 26/60 (43%) 11/60 (18%) | |ADJUSTED (b) | 34.8% 28.0% 36.2% 37.1% | 48.5% 44.8% 56.3% 55.9% | |INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/6 (0%) | |TERMINAL (d) | 15/45 (33%) 10/43 (23%) 10/39 (26%) 11/32 (34%) | 15/38 (39%) 13/37 (35%) 16/36 (44%) 5/13 (38%) | |FIRST INCIDENCE (DAYS) | 693 529 403 399 | 541 377 360 561 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.310 P=0.383N P=0.347 P=0.443 | P=0.174 P=0.463N P=0.274 P=0.321 | |INCIDENTAL TUMOR | P=0.385N P=0.298N P=0.582 P=0.580N | P=0.133N P=0.364N P=0.454 P=0.214N | |LOGISTIC REGRESSION | P=0.534 P=0.244N P=0.438 P=0.568N | P=0.475N P=0.447N P=0.302 P=0.242N | |COCHRAN-ARMITAGE | P=0.389N | P=0.026N* | |FISHER EXACT | P=0.335N P=0.477 P=0.335N | P=0.424N P=0.288 P=0.020N* | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 47/60 (78%) 36/60 (60%) 33/59 (56%) 29/60 (48%) | 36/60 (60%) 33/60 (55%) 40/60 (67%) 18/60 (30%) | |ADJUSTED (b) | 92.1% 69.0% 69.8% 71.4% | 78.0% 71.4% 83.2% 76.7% | |INTERIM SACRIFICE 1 (c)| 2/9 (22%) 3/10 (30%) 2/10 (20%) 3/10 (30%) | 1/10 (10%) 1/7 (14%) 1/10 (10%) 1/6 (17%) | |TERMINAL (d) | 41/45 (91%) 27/43 (63%) 25/39 (64%) 21/32 (66%) | 28/38 (74%) 24/37 (65%) 28/36 (78%) 8/13 (62%) | |FIRST INCIDENCE (DAYS) | 406 457 (I) 403 399 | 464 (I) 377 360 462 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.160N P=0.057N P=0.061N P=0.117N | P=0.084 P=0.442N P=0.235 P=0.186 | |INCIDENTAL TUMOR | P=0.004N** P=0.013N* P=0.005N** P=0.007N** | P=0.184N P=0.331N P=0.382 P=0.252N | |LOGISTIC REGRESSION | P=0.006N** P=0.016N* P=0.007N** P=0.003N** | P=0.380N P=0.392N P=0.302 P=0.307N | |COCHRAN-ARMITAGE | P=0.001N** | P<0.001N** | |FISHER EXACT | P=0.024N* P=0.008N** P<0.001N** | P=0.356N P=0.285 P<0.001N** | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05127 TEST: 02 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BARIUM CHLORIDE DIHYDRATE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS (a) Number of tumor-bearing animals / number of animals examined at site. (b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for intercurrent mortality. (c) Observed incidence at interim kill. Male interim sacrifices(days): 457 Female interim sacrifices(days): 462 (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).