TDMS Study 05102-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus BENZETHONIUM CHLORIDE DATE: 05/19/95 EXPERIMENT: 05102 TEST: 06 TIME: 18:49:16 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-75177 ROUTE: DERMAL,SOLUTION NTP C#: 61494B PATHOLOGIST: A. SINGER S. EUSTIS CAS: 121-54-0 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus BENZETHONIUM CHLORIDE DATE: 05/19/95 EXPERIMENT: 05102 TEST: 06 TIME: 18:49:16 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75177 ROUTE: DERMAL,SOLUTION NTP C#: 61494B PATHOLOGIST: A. SINGER S. EUSTIS CAS: 121-54-0 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 DATE: 05/19/95 EXPERIMENT: 05102 TEST: 06 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZETHONIUM CHLORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | | | | | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # # # | |----------- | | | |OVERALL (a) | 2/65 (3%) 3/60 (5%) | 2/63 (3%) 0/2 (0%) 0/2 (0%) 2/60 (3%) | |ADJUSTED (b) | 4.4% 6.5% | 5.3% 0.0% 0.0% 5.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) | 0/8 (0%) 0/0 0/0 0/6 (0%) | |TERMINAL (d) | 1/43 (2%) 1/39 (3%) | 2/38 (5%) 0/1 (0%) 0/1 (0%) 2/34 (6%) | |FIRST INCIDENCE (DAYS) | 655 456 (I) | 729 (T) --- --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.478 | P=0.580 P=0.979N P=0.979N P=0.655 | |INCIDENTAL TUMOR | P=0.651 | P=0.580 P=0.979N P=0.979N P=0.655 | |LOGISTIC REGRESSION | P=0.460 | P=0.580 P=0.979N P=0.979N P=0.655 | |COCHRAN-ARMITAGE | | P=0.601 | |FISHER EXACT | P=0.462 | P=0.939N P=0.939N P=0.672 | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # # # | |----------- | | | |OVERALL (a) | 1/65 (2%) 0/60 (0%) | 2/63 (3%) 0/2 (0%) 0/2 (0%) 1/60 (2%) | |ADJUSTED (b) | 2.3% 0.0% | 5.0% 0.0% 0.0% 2.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/0 0/0 0/6 (0%) | |TERMINAL (d) | 1/43 (2%) 0/39 (0%) | 1/38 (3%) 0/1 (0%) 0/1 (0%) 1/34 (3%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- | 698 --- --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.519N | P=0.466N P=0.980N P=0.980N P=0.535N | |INCIDENTAL TUMOR | P=0.519N | P=0.443N P=0.999N P=0.999N P=0.514N | |LOGISTIC REGRESSION | P=0.519N | P=0.461N P=0.989N P=0.977N P=0.531N | |COCHRAN-ARMITAGE | | P=0.451N | |FISHER EXACT | P=0.520N | P=0.939N P=0.939N P=0.518N | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05102 TEST: 06 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZETHONIUM CHLORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | | | | | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # # # | |----------- | | | |OVERALL (a) | 3/65 (5%) 3/60 (5%) | 4/63 (6%) 0/2 (0%) 0/2 (0%) 3/60 (5%) | |ADJUSTED (b) | 6.7% 6.5% | 10.1% 0.0% 0.0% 8.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) | 0/8 (0%) 0/0 0/0 0/6 (0%) | |TERMINAL (d) | 2/43 (5%) 1/39 (3%) | 3/38 (8%) 0/1 (0%) 0/1 (0%) 3/34 (9%) | |FIRST INCIDENCE (DAYS) | 655 456 (I) | 698 --- --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.634 | P=0.521N P=0.903N P=0.903N P=0.558N | |INCIDENTAL TUMOR | P=0.541N | P=0.505N P=0.944N P=0.944N P=0.544N | |LOGISTIC REGRESSION | P=0.625 | P=0.513N P=0.930N P=0.909N P=0.551N | |COCHRAN-ARMITAGE | | P=0.493N | |FISHER EXACT | P=0.621 | P=0.880N P=0.880N P=0.527N | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/59 (3%) 1/60 (2%) | 0/60 (0%) 0/0 (0%) 0/0 (0%) 0/58 (0%) | |ADJUSTED (b) | 4.8% 2.6% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/0 0/0 0/6 (0%) | |TERMINAL (d) | 2/42 (5%) 1/39 (3%) | 0/38 (0%) 0/0 0/0 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.526N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.526N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.526N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | | (e) | |FISHER EXACT | P=0.494N | (e) (e) (e) | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05102 TEST: 06 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZETHONIUM CHLORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | | | | | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/63 (5%) 2/60 (3%) | 1/63 (2%) 0/0 (0%) 0/0 (0%) 0/60 (0%) | |ADJUSTED (b) | 6.4% 4.9% | 2.2% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/0 0/0 0/6 (0%) | |TERMINAL (d) | 0/43 (0%) 1/39 (3%) | 0/38 (0%) 0/0 0/0 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 577 719 | 674 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.531N | P=0.386N P=1.000N P=1.000N P=0.513N | |INCIDENTAL TUMOR | P=0.307N | P=0.350N (e) (e) P=0.479N | |LOGISTIC REGRESSION | P=0.518N | P=0.350N (e) (e) P=0.479N | |COCHRAN-ARMITAGE | | P=0.378N | |FISHER EXACT | P=0.523N | P=1.000N P=1.000N P=0.512N | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 30/63 (48%) 29/60 (48%) | 23/63 (37%) 0/0 (0%) 0/0 (0%) 19/60 (32%) | |ADJUSTED (b) | 57.8% 58.2% | 52.4% 0.0% 0.0% 52.0% | |INTERIM SACRIFICE 1 (c)| 4/10 (40%) 4/10 (40%) | 1/8 (13%) 0/0 0/0 1/6 (17%) | |TERMINAL (d) | 22/43 (51%) 19/39 (49%) | 18/38 (47%) 0/0 0/0 17/34 (50%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) | 456 (I) --- --- 456 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.489 | P=0.433N P=0.932N P=0.874N P=0.454N | |INCIDENTAL TUMOR | P=0.567N | P=0.404N (e) (e) P=0.430N | |LOGISTIC REGRESSION | P=0.547 | P=0.404N (e) (e) P=0.430N | |COCHRAN-ARMITAGE | | P=0.330N | |FISHER EXACT | P=0.540 | P=1.000N P=1.000N P=0.354N | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05102 TEST: 06 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZETHONIUM CHLORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/63 (21%) 16/60 (27%) | 14/63 (22%) 0/0 (0%) 0/0 (0%) 11/60 (18%) | |ADJUSTED (b) | 25.5% 34.6% | 31.7% 0.0% 0.0% 26.2% | |INTERIM SACRIFICE 1 (c)| 2/10 (20%) 2/10 (20%) | 0/8 (0%) 0/0 0/0 0/6 (0%) | |TERMINAL (d) | 7/43 (16%) 10/39 (26%) | 9/38 (24%) 0/0 0/0 5/34 (15%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) | 544 --- --- 485 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.272 | P=0.416N P=0.888N P=0.833N P=0.433N | |INCIDENTAL TUMOR | P=0.419 | P=0.330N (e) (e) P=0.358N | |LOGISTIC REGRESSION | P=0.285 | P=0.330N (e) (e) P=0.358N | |COCHRAN-ARMITAGE | | P=0.350N | |FISHER EXACT | P=0.283 | P=1.000N P=1.000N P=0.378N | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/63 (21%) 16/60 (27%) | 15/63 (24%) 0/0 (0%) 0/0 (0%) 11/60 (18%) | |ADJUSTED (b) | 25.5% 34.6% | 33.0% 0.0% 0.0% 26.2% | |INTERIM SACRIFICE 1 (c)| 2/10 (20%) 2/10 (20%) | 0/8 (0%) 0/0 0/0 0/6 (0%) | |TERMINAL (d) | 7/43 (16%) 10/39 (26%) | 9/38 (24%) 0/0 0/0 5/34 (15%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) | 544 --- --- 485 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.272 | P=0.345N P=0.859N P=0.782N P=0.359N | |INCIDENTAL TUMOR | P=0.419 | P=0.253N (e) (e) P=0.278N | |LOGISTIC REGRESSION | P=0.285 | P=0.253N (e) (e) P=0.278N | |COCHRAN-ARMITAGE | | P=0.275N | |FISHER EXACT | P=0.283 | P=1.000N P=1.000N P=0.301N | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05102 TEST: 06 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZETHONIUM CHLORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 36/63 (57%) 37/60 (62%) | 31/63 (49%) 0/0 (0%) 0/0 (0%) 26/60 (43%) | |ADJUSTED (b) | 67.2% 72.1% | 65.3% 0.0% 0.0% 60.9% | |INTERIM SACRIFICE 1 (c)| 5/10 (50%) 4/10 (40%) | 1/8 (13%) 0/0 0/0 1/6 (17%) | |TERMINAL (d) | 26/43 (60%) 25/39 (64%) | 22/38 (58%) 0/0 0/0 18/34 (53%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) | 456 (I) --- --- 456 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.329 | P=0.427N P=0.793N P=0.726N P=0.437N | |INCIDENTAL TUMOR | P=0.495 | P=0.334N (e) (e) P=0.357N | |LOGISTIC REGRESSION | P=0.384 | P=0.334N (e) (e) P=0.357N | |COCHRAN-ARMITAGE | | P=0.297N | |FISHER EXACT | P=0.372 | P=1.000N P=1.000N P=0.319N | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 36/63 (57%) 37/60 (62%) | 31/63 (49%) 0/0 (0%) 0/0 (0%) 26/60 (43%) | |ADJUSTED (b) | 67.2% 72.1% | 65.3% 0.0% 0.0% 60.9% | |INTERIM SACRIFICE 1 (c)| 5/10 (50%) 4/10 (40%) | 1/8 (13%) 0/0 0/0 1/6 (17%) | |TERMINAL (d) | 26/43 (60%) 25/39 (64%) | 22/38 (58%) 0/0 0/0 18/34 (53%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) | 456 (I) --- --- 456 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.329 | P=0.427N P=0.793N P=0.726N P=0.437N | |INCIDENTAL TUMOR | P=0.495 | P=0.334N (e) (e) P=0.357N | |LOGISTIC REGRESSION | P=0.384 | P=0.334N (e) (e) P=0.357N | |COCHRAN-ARMITAGE | | P=0.297N | |FISHER EXACT | P=0.372 | P=1.000N P=1.000N P=0.319N | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05102 TEST: 06 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZETHONIUM CHLORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/60 (22%) 8/60 (13%) | 1/60 (2%) 0/0 (0%) 0/0 (0%) 2/60 (3%) | |ADJUSTED (b) | 29.4% 19.3% | 2.6% 0.0% 0.0% 4.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/0 0/0 0/6 (0%) | |TERMINAL (d) | 12/43 (28%) 6/39 (15%) | 1/38 (3%) 0/0 0/0 1/34 (3%) | |FIRST INCIDENCE (DAYS) | 637 687 | 729 (T) --- --- 479 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.228N | P=0.388 (e) (e) P=0.468 | |INCIDENTAL TUMOR | P=0.181N | P=0.538 (e) (e) P=0.619 | |LOGISTIC REGRESSION | P=0.173N | P=0.538 (e) (e) P=0.619 | |COCHRAN-ARMITAGE | | P=0.423 | |FISHER EXACT | P=0.168N | P=1.000N P=1.000N P=0.500 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 2/60 (3%) | 1/60 (2%) 0/0 (0%) 0/0 (0%) 1/60 (2%) | |ADJUSTED (b) | 2.3% 5.1% | 2.6% 0.0% 0.0% 2.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/0 0/0 0/6 (0%) | |TERMINAL (d) | 1/43 (2%) 2/39 (5%) | 1/38 (3%) 0/0 0/0 1/34 (3%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) | 729 (T) --- --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.466 | P=0.654 (e) (e) P=0.737 | |INCIDENTAL TUMOR | P=0.466 | P=0.654 (e) (e) P=0.737 | |LOGISTIC REGRESSION | P=0.466 | P=0.654 (e) (e) P=0.737 | |COCHRAN-ARMITAGE | | P=0.683 | |FISHER EXACT | P=0.500 | P=1.000N P=1.000N P=0.752N | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05102 TEST: 06 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZETHONIUM CHLORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 14/60 (23%) 10/60 (17%) | 2/60 (3%) 0/0 (0%) 0/0 (0%) 3/60 (5%) | |ADJUSTED (b) | 31.7% 24.2% | 5.3% 0.0% 0.0% 7.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/0 0/0 0/6 (0%) | |TERMINAL (d) | 13/43 (30%) 8/39 (21%) | 2/38 (5%) 0/0 0/0 2/34 (6%) | |FIRST INCIDENCE (DAYS) | 637 687 | 729 (T) --- --- 479 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.327N | P=0.392 (e) (e) P=0.454 | |INCIDENTAL TUMOR | P=0.274N | P=0.508 (e) (e) P=0.571 | |LOGISTIC REGRESSION | P=0.256N | P=0.508 (e) (e) P=0.571 | |COCHRAN-ARMITAGE | | P=0.439 | |FISHER EXACT | P=0.247N | P=1.000N P=1.000N P=0.500 | |=================================================================================================================================| | | |Ovary | | Cystadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 3/61 (5%) 0/0 (0%) 0/0 (0%) 2/58 (3%) | |ADJUSTED (b) | | 7.9% 0.0% 0.0% 5.9% | |INTERIM SACRIFICE 1 (c)| | 0/8 (0%) 0/0 0/0 0/6 (0%) | |TERMINAL (d) | | 3/38 (8%) 0/0 0/0 2/34 (6%) | |FIRST INCIDENCE (DAYS) | | 729 (T) --- --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.490N (e) (e) P=0.551N | |INCIDENTAL TUMOR | | P=0.490N (e) (e) P=0.551N | |LOGISTIC REGRESSION | | P=0.490N (e) (e) P=0.551N | |COCHRAN-ARMITAGE | | P=0.462N | |FISHER EXACT | | P=1.000N P=1.000N P=0.524N | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05102 TEST: 06 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZETHONIUM CHLORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/58 (0%) 0/58 (0%) | 6/60 (10%) 0/0 (0%) 0/0 (0%) 5/55 (9%) | |ADJUSTED (b) | 0.0% 0.0% | 15.8% 0.0% 0.0% 14.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/0 0/0 0/5 (0%) | |TERMINAL (d) | 0/41 (0%) 0/38 (0%) | 6/38 (16%) 0/0 0/0 4/34 (12%) | |FIRST INCIDENCE (DAYS) | --- --- | 729 (T) --- --- 720 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) | P=0.537N (e) (e) P=0.578N | |INCIDENTAL TUMOR | (e) (e) | P=0.536N (e) (e) P=0.578N | |LOGISTIC REGRESSION | (e) (e) | P=0.536N (e) (e) P=0.578N | |COCHRAN-ARMITAGE | | P=0.518N | |FISHER EXACT | (e) | P=1.000N P=1.000N P=0.561N | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # # # | |----------- | | | |OVERALL (a) | 0/65 (0%) 0/60 (0%) | 3/63 (5%) 0/2 (0%) 0/2 (0%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 0.0% | 7.6% 0.0% 0.0% 2.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/0 0/0 0/6 (0%) | |TERMINAL (d) | 0/43 (0%) 0/39 (0%) | 2/38 (5%) 0/1 (0%) 0/1 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | --- --- | 698 --- --- 691 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) | P=0.288N P=0.943N P=0.943N P=0.339N | |INCIDENTAL TUMOR | (e) (e) | P=0.253N P=0.979N P=0.979N P=0.306N | |LOGISTIC REGRESSION | (e) (e) | P=0.284N P=0.963N P=0.944N P=0.336N | |COCHRAN-ARMITAGE | | P=0.274N | |FISHER EXACT | (e) | P=0.909N P=0.909N P=0.328N | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05102 TEST: 06 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZETHONIUM CHLORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | | | | | |=================================================================================================================================| | | |Skin | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # # # | |----------- | | | |OVERALL (a) | 0/65 (0%) 0/60 (0%) | 2/63 (3%) 0/2 (0%) 0/2 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% | 5.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/0 0/0 0/6 (0%) | |TERMINAL (d) | 0/43 (0%) 0/39 (0%) | 1/38 (3%) 0/1 (0%) 0/1 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | --- --- | 698 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) | P=0.193N P=0.980N P=0.980N P=0.261N | |INCIDENTAL TUMOR | (e) (e) | P=0.174N P=0.999N P=0.999N P=0.240N | |LOGISTIC REGRESSION | (e) (e) | P=0.189N P=0.989N P=0.977N P=0.257N | |COCHRAN-ARMITAGE | | P=0.184N | |FISHER EXACT | (e) | P=0.939N P=0.939N P=0.260N | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # # # | |----------- | | | |OVERALL (a) | 0/65 (0%) 0/60 (0%) | 3/63 (5%) 0/2 (0%) 0/2 (0%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 0.0% | 7.6% 0.0% 0.0% 2.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/0 0/0 0/6 (0%) | |TERMINAL (d) | 0/43 (0%) 0/39 (0%) | 2/38 (5%) 0/1 (0%) 0/1 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | --- --- | 698 --- --- 691 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) | P=0.288N P=0.943N P=0.943N P=0.339N | |INCIDENTAL TUMOR | (e) (e) | P=0.253N P=0.979N P=0.979N P=0.306N | |LOGISTIC REGRESSION | (e) (e) | P=0.284N P=0.963N P=0.944N P=0.336N | |COCHRAN-ARMITAGE | | P=0.274N | |FISHER EXACT | (e) | P=0.909N P=0.909N P=0.328N | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05102 TEST: 06 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZETHONIUM CHLORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | | | | | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 3/60 (5%) | 1/60 (2%) 0/0 (0%) 0/0 (0%) 3/59 (5%) | |ADJUSTED (b) | 0.0% 7.2% | 2.3% 0.0% 0.0% 7.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/0 0/0 0/6 (0%) | |TERMINAL (d) | 0/43 (0%) 2/39 (5%) | 0/38 (0%) 0/0 0/0 1/34 (3%) | |FIRST INCIDENCE (DAYS) | --- 687 | 689 --- --- 589 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.112 | P=0.223 P=0.999N P=0.999N P=0.285 | |INCIDENTAL TUMOR | P=0.162 | P=0.257 (e) (e) P=0.315 | |LOGISTIC REGRESSION | P=0.118 | P=0.257 (e) (e) P=0.315 | |COCHRAN-ARMITAGE | | P=0.243 | |FISHER EXACT | P=0.122 | P=1.000N P=1.000N P=0.303 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 1/60 (2%) | 3/60 (5%) 0/0 (0%) 0/0 (0%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 2.6% | 7.3% 0.0% 0.0% 2.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/0 0/0 0/6 (0%) | |TERMINAL (d) | 0/43 (0%) 1/39 (3%) | 2/38 (5%) 0/0 0/0 1/34 (3%) | |FIRST INCIDENCE (DAYS) | --- 729 (T) | 660 --- --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.481 | P=0.287N P=1.000N P=1.000N P=0.345N | |INCIDENTAL TUMOR | P=0.481 | P=0.269N (e) (e) P=0.327N | |LOGISTIC REGRESSION | P=0.481 | P=0.269N (e) (e) P=0.327N | |COCHRAN-ARMITAGE | | P=0.249N | |FISHER EXACT | P=0.500 | P=1.000N P=1.000N P=0.309N | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05102 TEST: 06 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZETHONIUM CHLORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 2/60 (3%) | 4/60 (7%) 0/0 (0%) 0/0 (0%) 1/60 (2%) | |ADJUSTED (b) | 2.3% 5.1% | 9.9% 0.0% 0.0% 2.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/0 0/0 0/6 (0%) | |TERMINAL (d) | 1/43 (2%) 2/39 (5%) | 3/38 (8%) 0/0 0/0 1/34 (3%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) | 660 --- --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.466 | P=0.174N P=1.000N P=1.000N P=0.215N | |INCIDENTAL TUMOR | P=0.466 | P=0.162N (e) (e) P=0.202N | |LOGISTIC REGRESSION | P=0.466 | P=0.162N (e) (e) P=0.202N | |COCHRAN-ARMITAGE | | P=0.143N | |FISHER EXACT | P=0.500 | P=1.000N P=1.000N P=0.182N | |=================================================================================================================================| | | |All Organs | | Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # # # | |----------- | | | |OVERALL (a) | 2/65 (3%) 2/60 (3%) | 3/63 (5%) 0/2 (0%) 0/2 (0%) 2/60 (3%) | |ADJUSTED (b) | 4.7% 4.7% | 7.9% 0.0% 0.0% 4.2% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/0 0/0 0/6 (0%) | |TERMINAL (d) | 2/43 (5%) 1/39 (3%) | 3/38 (8%) 0/1 (0%) 0/1 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 684 | 729 (T) --- --- 316 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.669 | P=0.493N P=0.944N P=0.944N P=0.542N | |INCIDENTAL TUMOR | P=0.640N | P=0.424N P=0.944N P=0.944N P=0.429N | |LOGISTIC REGRESSION | P=0.683 | P=0.471N P=0.944N P=0.944N P=0.513N | |COCHRAN-ARMITAGE | | P=0.477N | |FISHER EXACT | P=0.660 | P=0.909N P=0.909N P=0.523N | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05102 TEST: 06 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZETHONIUM CHLORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | | | | | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # # # | |----------- | | | |OVERALL (a) | 4/65 (6%) 6/60 (10%) | 3/63 (5%) 0/2 (0%) 1/2 (50%) 3/60 (5%) | |ADJUSTED (b) | 8.5% 14.4% | 6.5% 0.0% 50.0% 7.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/0 0/0 0/6 (0%) | |TERMINAL (d) | 1/43 (2%) 4/39 (10%) | 0/38 (0%) 0/1 (0%) 0/1 (0%) 1/34 (3%) | |FIRST INCIDENCE (DAYS) | 577 687 | 660 --- 591 589 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.330 | P=0.598 P=0.958N P=0.107 P=0.626 | |INCIDENTAL TUMOR | P=0.534 | P=0.548N (e) P=0.282 P=0.643N | |LOGISTIC REGRESSION | P=0.342 | P=0.581 P=0.942N P=0.130 P=0.614 | |COCHRAN-ARMITAGE | | P=0.597N | |FISHER EXACT | P=0.322 | P=0.909N P=0.120 P=0.637 | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # # # | |----------- | | | |OVERALL (a) | 6/65 (9%) 8/60 (13%) | 6/63 (10%) 0/2 (0%) 1/2 (50%) 5/60 (8%) | |ADJUSTED (b) | 12.9% 18.6% | 13.9% 0.0% 50.0% 11.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/0 0/0 0/6 (0%) | |TERMINAL (d) | 3/43 (7%) 5/39 (13%) | 3/38 (8%) 0/1 (0%) 0/1 (0%) 1/34 (3%) | |FIRST INCIDENCE (DAYS) | 577 684 | 660 --- 591 316 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.340 | P=0.498N P=0.836N P=0.221 P=0.554N | |INCIDENTAL TUMOR | P=0.567 | P=0.400N P=0.944N P=0.367 P=0.430N | |LOGISTIC REGRESSION | P=0.355 | P=0.479N P=0.865N P=0.249 P=0.536N | |COCHRAN-ARMITAGE | | P=0.479N | |FISHER EXACT | P=0.329 | P=0.823N P=0.205 P=0.534N | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05102 TEST: 06 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZETHONIUM CHLORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | | | | | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # # # | |----------- | | | |OVERALL (a) | 1/65 (2%) 1/60 (2%) | 3/63 (5%) 0/2 (0%) 0/2 (0%) 1/60 (2%) | |ADJUSTED (b) | 1.8% 2.1% | 7.0% 0.0% 0.0% 2.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/0 0/0 0/6 (0%) | |TERMINAL (d) | 0/43 (0%) 0/39 (0%) | 1/38 (3%) 0/1 (0%) 0/1 (0%) 1/34 (3%) | |FIRST INCIDENCE (DAYS) | 530 612 | 568 --- --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.748 | P=0.295N P=0.951N P=0.920N P=0.347N | |INCIDENTAL TUMOR | P=0.500 | P=0.269N P=0.999N P=0.687N P=0.318N | |LOGISTIC REGRESSION | P=0.736 | P=0.281N P=0.940N P=0.919N P=0.333N | |COCHRAN-ARMITAGE | | P=0.274N | |FISHER EXACT | P=0.732 | P=0.909N P=0.909N P=0.328N | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma And Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # # # | |----------- | | | |OVERALL (a) | 4/65 (6%) 4/60 (7%) | 10/63 (16%) 1/2 (50%) 0/2 (0%) 6/60 (10%) | |ADJUSTED (b) | 8.7% 8.8% | 23.0% 50.0% 0.0% 14.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/0 0/0 0/6 (0%) | |TERMINAL (d) | 3/43 (7%) 1/39 (3%) | 6/38 (16%) 0/1 (0%) 0/1 (0%) 3/34 (9%) | |FIRST INCIDENCE (DAYS) | 530 612 | 568 308 --- 249 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.603 | P=0.219N P=0.322 P=0.691N P=0.283N | |INCIDENTAL TUMOR | P=0.609 | P=0.136N P=0.599 P=0.568N P=0.192N | |LOGISTIC REGRESSION | P=0.603 | P=0.180N P=0.357 P=0.667N P=0.251N | |COCHRAN-ARMITAGE | | P=0.183N | |FISHER EXACT | P=0.596 | P=0.312 P=0.714N P=0.243N | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05102 TEST: 06 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZETHONIUM CHLORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated | | Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # # # | |----------- | | | |OVERALL (a) | 3/65 (5%) 3/60 (5%) | 7/63 (11%) 1/2 (50%) 0/2 (0%) 5/60 (8%) | |ADJUSTED (b) | 7.0% 6.9% | 16.9% 50.0% 0.0% 11.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/0 0/0 0/6 (0%) | |TERMINAL (d) | 3/43 (7%) 1/39 (3%) | 5/38 (13%) 0/1 (0%) 0/1 (0%) 2/34 (6%) | |FIRST INCIDENCE (DAYS) | 729 (T) 659 | 660 308 --- 249 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.628 | P=0.349N P=0.243 P=0.799N P=0.449N | |INCIDENTAL TUMOR | P=0.550N | P=0.251N P=0.584 P=0.867N P=0.350N | |LOGISTIC REGRESSION | P=0.646 | P=0.307N P=0.275 P=0.780N P=0.421N | |COCHRAN-ARMITAGE | | P=0.319N | |FISHER EXACT | P=0.621 | P=0.233 P=0.795N P=0.416N | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # # # | |----------- | | | |OVERALL (a) | 41/65 (63%) 34/60 (57%) | 31/63 (49%) 0/2 (0%) 0/2 (0%) 29/60 (48%) | |ADJUSTED (b) | 76.9% 66.1% | 69.7% 0.0% 0.0% 69.9% | |INTERIM SACRIFICE 1 (c)| 4/10 (40%) 4/10 (40%) | 1/8 (13%) 0/0 0/0 1/6 (17%) | |TERMINAL (d) | 31/43 (72%) 22/39 (56%) | 25/38 (66%) 0/1 (0%) 0/1 (0%) 22/34 (65%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) | 456 (I) --- --- 316 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.302N | P=0.396 P=0.336N P=0.322N P=0.477 | |INCIDENTAL TUMOR | P=0.164N | P=0.472 P=0.384N P=0.384N P=0.571 | |LOGISTIC REGRESSION | P=0.255N | P=0.456 P=0.395N P=0.270N P=0.541 | |COCHRAN-ARMITAGE | | P=0.513 | |FISHER EXACT | P=0.292N | P=0.270N P=0.270N P=0.533N | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05102 TEST: 06 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZETHONIUM CHLORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0MG/KG 1.5MG/KG | 0MG/KG .15MG/KG 0.5MG/KG 1.5MG/KG | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # # # | |----------- | | | |OVERALL (a) | 20/65 (31%) 24/60 (40%) | 30/63 (48%) 1/2 (50%) 1/2 (50%) 27/60 (45%) | |ADJUSTED (b) | 38.2% 48.5% | 58.7% 50.0% 50.0% 55.8% | |INTERIM SACRIFICE 1 (c)| 2/10 (20%) 2/10 (20%) | 0/8 (0%) 0/0 0/0 0/6 (0%) | |TERMINAL (d) | 12/43 (28%) 14/39 (36%) | 17/38 (45%) 0/1 (0%) 0/1 (0%) 13/34 (38%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) | 544 308 591 249 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.221 | P=0.504N P=0.631 P=0.661 P=0.539N | |INCIDENTAL TUMOR | P=0.309 | P=0.299N P=0.732 P=0.732 P=0.356N | |LOGISTIC REGRESSION | P=0.197 | P=0.462N P=0.654 P=0.594N P=0.512N | |COCHRAN-ARMITAGE | | P=0.427N | |FISHER EXACT | P=0.186 | P=0.730 P=0.730 P=0.456N | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # # # | |----------- | | | |OVERALL (a) | 51/65 (78%) 44/60 (73%) | 45/63 (71%) 1/2 (50%) 1/2 (50%) 43/60 (72%) | |ADJUSTED (b) | 89.3% 82.9% | 86.5% 50.0% 50.0% 82.6% | |INTERIM SACRIFICE 1 (c)| 5/10 (50%) 4/10 (40%) | 1/8 (13%) 0/0 0/0 1/6 (17%) | |TERMINAL (d) | 37/43 (86%) 30/39 (77%) | 31/38 (82%) 0/1 (0%) 0/1 (0%) 25/34 (74%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) | 456 (I) 308 591 249 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.347N | P=0.387 P=0.718N P=0.665N P=0.411 | |INCIDENTAL TUMOR | P=0.179N | P=0.520N P=0.625N P=0.625N P=0.536N | |LOGISTIC REGRESSION | P=0.265N | P=0.426 P=0.822 P=0.557N P=0.457 | |COCHRAN-ARMITAGE | | P=0.505 | |FISHER EXACT | P=0.322N | P=0.502N P=0.502N P=0.568 | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05102 TEST: 06 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZETHONIUM CHLORIDE TERMINAL SACRIFICE AT 105 WEEKS (a) Number of tumor-bearing animals / number of animals examined at site. (b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for intercurrent mortality. (c) Observed incidence at interim kill. Male interim sacrifices(days): 456 Female interim sacrifices(days): 456 (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).