TDMS Study 05109-12 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus TRIETHANOLAMINE DATE: 05/20/95 EXPERIMENT: 05109 TEST: 12 TIME: 00:27:05 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-85226 ROUTE: DERMAL,SOLUTION NTP C#: 61621D PATHOLOGIST: R. PERSING S. GRUMBEIN CAS: 102-71-6 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus TRIETHANOLAMINE DATE: 05/20/95 EXPERIMENT: 05109 TEST: 12 TIME: 00:27:05 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-85226 ROUTE: DERMAL,SOLUTION NTP C#: 61621D PATHOLOGIST: R. PERSING S. GRUMBEIN CAS: 102-71-6 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: Battelle Columbus TRIETHANOLAMINE DATE: 05/20/95 EXPERIMENT: 05109 TEST: 12 TIME: 00:27:05 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-85226 ROUTE: DERMAL,SOLUTION NTP C#: 61621D PATHOLOGIST: R. PERSING S. GRUMBEIN CAS: 102-71-6 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF TRIETHANOLAMINE ==================================================================================================== MALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Liver Hepatoblastoma Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma All Organs Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== FEMALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Bone Osteosarcoma Liver Hepatocellular Adenoma Hepatocellular Carcinoma Hepatocellular Carcinoma or Hepatoblastoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Ovary Cystadenoma All Organs Hemangiosarcoma Hemangiosarcoma or Hemangioma Malignant Lymphoma And Histiocytic Sarcoma Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 05/20/95 EXPERIMENT: 05109 TEST: 12 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 200 630 2000 | 0 MG/KG 100 300 1000 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |Bone | | Osteosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 2/60 (3%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 4.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/46 (0%) 0/40 (0%) 0/39 (0%) 0/41 (0%) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- --- 551 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.043 * (e) (e) P=0.250 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.057 (e) (e) P=0.420 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.039 * (e) (e) P=0.225 | |COCHRAN-ARMITAGE | (e) | P=0.042 * | |FISHER EXACT | (e) (e) (e) | (e) (e) P=0.248 | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/60 (7%) 5/60 (8%) 5/60 (8%) 1/60 (2%) | 1/60 (2%) 1/60 (2%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 8.7% 12.5% 12.4% 2.1% | 2.6% 2.5% 2.6% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 4/46 (9%) 5/40 (13%) 4/39 (10%) 0/41 (0%) | 1/39 (3%) 1/40 (3%) 1/38 (3%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 694 606 | 729 (T) 729 (T) 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.113N P=0.413 P=0.400 P=0.212N | P=0.342N P=0.756N P=0.756 P=0.510N | |INCIDENTAL TUMOR | P=0.082N P=0.413 P=0.478 P=0.145N | P=0.342N P=0.756N P=0.756 P=0.510N | |LOGISTIC REGRESSION | P=0.100N P=0.413 P=0.425 P=0.185N | P=0.342N P=0.756N P=0.756 P=0.510N | |COCHRAN-ARMITAGE | P=0.097N | P=0.328N | |FISHER EXACT | P=0.500 P=0.500 P=0.182N | P=0.752N P=0.752N P=0.500N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05109 TEST: 12 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 200 630 2000 | 0 MG/KG 100 300 1000 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 2.2% 0.0% 0.0% 4.9% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/46 (2%) 0/40 (0%) 0/39 (0%) 2/41 (5%) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- --- 729 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.177 P=0.528N P=0.533N P=0.460 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.177 P=0.528N P=0.533N P=0.460 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.177 P=0.528N P=0.533N P=0.460 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.186 | (e) | |FISHER EXACT | P=0.500N P=0.500N P=0.500 | (e) (e) (e) | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/60 (3%) 3/60 (5%) 1/60 (2%) 1/60 (2%) | 0/60 (0%) 3/60 (5%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 4.3% 7.5% 2.6% 2.4% | 0.0% 7.5% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/46 (4%) 3/40 (8%) 1/39 (3%) 1/41 (2%) | 0/39 (0%) 3/40 (8%) 0/38 (0%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) 729 (T) | --- 729 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.333N P=0.436 P=0.558N P=0.540N | P=0.289N P=0.126 (e) (e) | |INCIDENTAL TUMOR | P=0.333N P=0.436 P=0.558N P=0.540N | P=0.289N P=0.126 (e) (e) | |LOGISTIC REGRESSION | P=0.333N P=0.436 P=0.558N P=0.540N | P=0.289N P=0.126 (e) (e) | |COCHRAN-ARMITAGE | P=0.312N | P=0.276N | |FISHER EXACT | P=0.500 P=0.500N P=0.500N | P=0.122 (e) (e) | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05109 TEST: 12 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 200 630 2000 | 0 MG/KG 100 300 1000 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |Liver | | Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 3/60 (5%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 7.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/46 (0%) 0/40 (0%) 0/39 (0%) 2/41 (5%) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 675 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.008 ** (e) (e) P=0.106 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.010 * (e) (e) P=0.164 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.009 ** (e) (e) P=0.117 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.009 ** | (e) | |FISHER EXACT | (e) (e) P=0.122 | (e) (e) (e) | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 28/60 (47%) 29/60 (48%) 30/60 (50%) 41/60 (68%) | 24/60 (40%) 24/60 (40%) 25/60 (42%) 41/60 (68%) | |ADJUSTED (b) | 54.6% 63.9% 67.9% 80.1% | 56.6% 55.2% 59.0% 95.3% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 2/10 (20%) 1/10 (10%) 4/10 (40%) | 2/10 (20%) 2/10 (20%) 1/10 (10%) 1/10 (10%) | |TERMINAL (d) | 23/46 (50%) 24/40 (60%) 25/39 (64%) 31/41 (76%) | 21/39 (54%) 21/40 (53%) 21/38 (55%) 35/37 (95%) | |FIRST INCIDENCE (DAYS) | 367 456 (I) 456 (I) 456 (I) | 457 (I) 457 (I) 457 (I) 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.003 ** P=0.265 P=0.165 P=0.005 ** | P<0.001 ** P=0.534N P=0.462 P<0.001 ** | |INCIDENTAL TUMOR | P=0.006 ** P=0.487 P=0.356 P=0.012 * | P<0.001 ** P=0.497N P=0.568N P<0.001 ** | |LOGISTIC REGRESSION | P=0.003 ** P=0.460 P=0.307 P=0.010 * | P<0.001 ** P=0.476N P=0.579N P<0.001 ** | |COCHRAN-ARMITAGE | P=0.005 ** | P<0.001 ** | |FISHER EXACT | P=0.500 P=0.428 P=0.013 * | P=0.574N P=0.500 P=0.002 ** | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05109 TEST: 12 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 200 630 2000 | 0 MG/KG 100 300 1000 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 16/60 (27%) 22/60 (37%) 15/60 (25%) 15/60 (25%) | 1/60 (2%) 4/60 (7%) 7/60 (12%) 5/60 (8%) | |ADJUSTED (b) | 32.4% 44.9% 33.2% 31.2% | 2.6% 9.0% 15.7% 12.8% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 2/10 (20%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 13/46 (28%) 14/40 (35%) 9/39 (23%) 9/41 (22%) | 1/39 (3%) 2/40 (5%) 4/38 (11%) 4/37 (11%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 507 456 (I) | 729 (T) 557 434 591 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.327N P=0.095 P=0.477 P=0.543 | P=0.203 P=0.201 P=0.038 * P=0.098 | |INCIDENTAL TUMOR | P=0.154N P=0.259 P=0.346N P=0.313N | P=0.211 P=0.314 P=0.031 * P=0.119 | |LOGISTIC REGRESSION | P=0.169N P=0.286 P=0.374N P=0.347N | P=0.270 P=0.189 P=0.034 * P=0.109 | |COCHRAN-ARMITAGE | P=0.260N | P=0.220 | |FISHER EXACT | P=0.163 P=0.500N P=0.500N | P=0.182 P=0.031 * P=0.103 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 16/60 (27%) 22/60 (37%) 15/60 (25%) 17/60 (28%) | 1/60 (2%) 4/60 (7%) 7/60 (12%) 5/60 (8%) | |ADJUSTED (b) | 32.4% 44.9% 33.2% 35.5% | 2.6% 9.0% 15.7% 12.8% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 2/10 (20%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 13/46 (28%) 14/40 (35%) 9/39 (23%) 11/41 (27%) | 1/39 (3%) 2/40 (5%) 4/38 (11%) 4/37 (11%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 507 456 (I) | 729 (T) 557 434 591 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.500N P=0.095 P=0.477 P=0.380 | P=0.203 P=0.201 P=0.038 * P=0.098 | |INCIDENTAL TUMOR | P=0.306N P=0.259 P=0.346N P=0.490N | P=0.211 P=0.314 P=0.031 * P=0.119 | |LOGISTIC REGRESSION | P=0.328N P=0.286 P=0.374N P=0.526N | P=0.270 P=0.189 P=0.034 * P=0.109 | |COCHRAN-ARMITAGE | P=0.435N | P=0.220 | |FISHER EXACT | P=0.163 P=0.500N P=0.500 | P=0.182 P=0.031 * P=0.103 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05109 TEST: 12 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 200 630 2000 | 0 MG/KG 100 300 1000 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 33/60 (55%) 38/60 (63%) 34/60 (57%) 47/60 (78%) | 25/60 (42%) 28/60 (47%) 29/60 (48%) 42/60 (70%) | |ADJUSTED (b) | 63.2% 74.1% 73.7% 86.9% | 59.0% 61.6% 65.2% 95.4% | |INTERIM SACRIFICE 1 (c)| 2/10 (20%) 4/10 (40%) 1/10 (10%) 5/10 (50%) | 2/10 (20%) 2/10 (20%) 1/10 (10%) 1/10 (10%) | |TERMINAL (d) | 27/46 (59%) 27/40 (68%) 27/39 (69%) 34/41 (83%) | 22/39 (56%) 23/40 (58%) 23/38 (61%) 35/37 (95%) | |FIRST INCIDENCE (DAYS) | 367 456 (I) 456 (I) 456 (I) | 457 (I) 457 (I) 434 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.005 ** P=0.089 P=0.191 P=0.002 ** | P<0.001 ** P=0.402 P=0.256 P<0.001 ** | |INCIDENTAL TUMOR | P=0.007 ** P=0.267 P=0.480 P=0.007 ** | P<0.001 ** P=0.505 P=0.326 P<0.001 ** | |LOGISTIC REGRESSION | P=0.004 ** P=0.207 P=0.384 P=0.005 ** | P<0.001 ** P=0.454 P=0.357 P<0.001 ** | |COCHRAN-ARMITAGE | P=0.005 ** | P<0.001 ** | |FISHER EXACT | P=0.229 P=0.500 P=0.006 ** | P=0.357 P=0.291 P=0.002 ** | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 33/60 (55%) 38/60 (63%) 34/60 (57%) 47/60 (78%) | 25/60 (42%) 28/60 (47%) 29/60 (48%) 42/60 (70%) | |ADJUSTED (b) | 63.2% 74.1% 73.7% 86.9% | 59.0% 61.6% 65.2% 95.4% | |INTERIM SACRIFICE 1 (c)| 2/10 (20%) 4/10 (40%) 1/10 (10%) 5/10 (50%) | 2/10 (20%) 2/10 (20%) 1/10 (10%) 1/10 (10%) | |TERMINAL (d) | 27/46 (59%) 27/40 (68%) 27/39 (69%) 34/41 (83%) | 22/39 (56%) 23/40 (58%) 23/38 (61%) 35/37 (95%) | |FIRST INCIDENCE (DAYS) | 367 456 (I) 456 (I) 456 (I) | 457 (I) 457 (I) 434 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.005 ** P=0.089 P=0.191 P=0.002 ** | P<0.001 ** P=0.402 P=0.256 P<0.001 ** | |INCIDENTAL TUMOR | P=0.007 ** P=0.267 P=0.480 P=0.007 ** | P<0.001 ** P=0.505 P=0.326 P<0.001 ** | |LOGISTIC REGRESSION | P=0.004 ** P=0.207 P=0.384 P=0.005 ** | P<0.001 ** P=0.454 P=0.357 P<0.001 ** | |COCHRAN-ARMITAGE | P=0.005 ** | P<0.001 ** | |FISHER EXACT | P=0.229 P=0.500 P=0.006 ** | P=0.357 P=0.291 P=0.002 ** | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05109 TEST: 12 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 200 630 2000 | 0 MG/KG 100 300 1000 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 15/60 (25%) 15/60 (25%) 14/60 (23%) 10/60 (17%) | 2/60 (3%) 5/60 (8%) 2/60 (3%) 5/59 (8%) | |ADJUSTED (b) | 32.6% 36.4% 35.9% 23.7% | 5.1% 11.6% 5.3% 13.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 15/46 (33%) 14/40 (35%) 14/39 (36%) 9/41 (22%) | 2/39 (5%) 4/40 (10%) 2/38 (5%) 4/36 (11%) | |FIRST INCIDENCE (DAYS) | 729 (T) 621 729 (T) 675 | 729 (T) 457 (I) 729 (T) 521 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.160N P=0.410 P=0.465 P=0.274N | P=0.234 P=0.227 P=0.686 P=0.196 | |INCIDENTAL TUMOR | P=0.134N P=0.410 P=0.465 P=0.233N | P=0.248 P=0.227 P=0.686 P=0.191 | |LOGISTIC REGRESSION | P=0.137N P=0.489 P=0.465 P=0.228N | P=0.266 P=0.234 P=0.686 P=0.219 | |COCHRAN-ARMITAGE | P=0.130N | P=0.265 | |FISHER EXACT | P=0.583N P=0.500N P=0.184N | P=0.219 P=0.691N P=0.213 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/60 (3%) 5/60 (8%) 1/60 (2%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 2/59 (3%) | |ADJUSTED (b) | 4.3% 11.7% 2.4% 2.0% | 0.0% 0.0% 2.6% 4.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/46 (4%) 3/40 (8%) 0/39 (0%) 0/41 (0%) | 0/39 (0%) 0/40 (0%) 1/38 (3%) 1/36 (3%) | |FIRST INCIDENCE (DAYS) | 729 (T) 666 677 579 | --- --- 729 (T) 415 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.210N P=0.175 P=0.553N P=0.527N | P=0.084 (e) P=0.495 P=0.237 | |INCIDENTAL TUMOR | P=0.125N P=0.306 P=0.419N P=0.408N | P=0.105 (e) P=0.495 P=0.231 | |LOGISTIC REGRESSION | P=0.139N P=0.201 P=0.526N P=0.501N | P=0.085 (e) P=0.495 P=0.207 | |COCHRAN-ARMITAGE | P=0.192N | P=0.088 | |FISHER EXACT | P=0.219 P=0.500N P=0.500N | (e) P=0.500 P=0.244 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05109 TEST: 12 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 200 630 2000 | 0 MG/KG 100 300 1000 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 16/60 (27%) 19/60 (32%) 15/60 (25%) 11/60 (18%) | 2/60 (3%) 5/60 (8%) 3/60 (5%) 7/59 (12%) | |ADJUSTED (b) | 34.8% 43.9% 37.4% 25.2% | 5.1% 11.6% 7.9% 17.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 16/46 (35%) 16/40 (40%) 14/39 (36%) 9/41 (22%) | 2/39 (5%) 4/40 (10%) 3/38 (8%) 5/36 (14%) | |FIRST INCIDENCE (DAYS) | 729 (T) 621 677 579 | 729 (T) 457 (I) 729 (T) 415 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.113N P=0.186 P=0.453 P=0.286N | P=0.068 P=0.227 P=0.488 P=0.073 | |INCIDENTAL TUMOR | P=0.069N P=0.255 P=0.503 P=0.210N | P=0.079 P=0.227 P=0.488 P=0.065 | |LOGISTIC REGRESSION | P=0.086N P=0.259 P=0.487 P=0.217N | P=0.084 P=0.234 P=0.488 P=0.083 | |COCHRAN-ARMITAGE | P=0.086N | P=0.083 | |FISHER EXACT | P=0.344 P=0.500N P=0.191N | P=0.219 P=0.500 P=0.077 | |=================================================================================================================================| | | |Ovary | | Cystadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 5/59 (8%) 0/60 (0%) 4/59 (7%) 2/60 (3%) | |ADJUSTED (b) | | 12.3% 0.0% 10.5% 5.4% | |INTERIM SACRIFICE 1 (c)| | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | | 4/39 (10%) 0/40 (0%) 4/38 (11%) 2/37 (5%) | |FIRST INCIDENCE (DAYS) | | 572 --- 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.435N P=0.031N* P=0.508N P=0.234N | |INCIDENTAL TUMOR | | P=0.435N P=0.017N* P=0.430N P=0.196N | |LOGISTIC REGRESSION | | P=0.406N P=0.029N* P=0.479N P=0.204N | |COCHRAN-ARMITAGE | | P=0.401N | |FISHER EXACT | | P=0.027N* P=0.500N P=0.213N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05109 TEST: 12 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 200 630 2000 | 0 MG/KG 100 300 1000 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |Ovary | | Luteoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 3/59 (5%) 2/60 (3%) 0/59 (0%) 0/60 (0%) | |ADJUSTED (b) | | 7.7% 5.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | | 3/39 (8%) 2/40 (5%) 0/38 (0%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | | 729 (T) 729 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.088N P=0.488N P=0.126N P=0.130N | |INCIDENTAL TUMOR | | P=0.088N P=0.488N P=0.126N P=0.130N | |LOGISTIC REGRESSION | | P=0.088N P=0.488N P=0.126N P=0.130N | |COCHRAN-ARMITAGE | | P=0.081N | |FISHER EXACT | | P=0.492N P=0.122N P=0.119N | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/58 (0%) 0/59 (0%) 0/56 (0%) 0/59 (0%) | 4/54 (7%) 6/59 (10%) 4/59 (7%) 5/59 (8%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 10.1% 15.4% 10.8% 12.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/45 (0%) 0/39 (0%) 0/38 (0%) 0/40 (0%) | 2/34 (6%) 6/39 (15%) 4/37 (11%) 4/37 (11%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 487 729 (T) 729 (T) 647 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.563 P=0.444 P=0.606N P=0.537 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.543N P=0.407 P=0.601N P=0.631N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.574N P=0.462 P=0.572N P=0.578 | |COCHRAN-ARMITAGE | (e) | P=0.583 | |FISHER EXACT | (e) (e) (e) | P=0.429 P=0.591N P=0.556 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05109 TEST: 12 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 200 630 2000 | 0 MG/KG 100 300 1000 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |Pituitary Gland: Pars Intermedia | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/58 (0%) 0/59 (0%) 0/56 (0%) 0/59 (0%) | 0/54 (0%) 1/59 (2%) 0/59 (0%) 2/59 (3%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 2.6% 0.0% 5.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/45 (0%) 0/39 (0%) 0/38 (0%) 0/40 (0%) | 0/34 (0%) 1/39 (3%) 0/37 (0%) 1/37 (3%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- 729 (T) --- 670 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.151 P=0.527 (e) P=0.249 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.195 P=0.527 (e) P=0.340 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.160 P=0.527 (e) P=0.267 | |COCHRAN-ARMITAGE | (e) | P=0.157 | |FISHER EXACT | (e) (e) (e) | P=0.522 (e) P=0.270 | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | 1/60 (2%) 3/60 (5%) 2/60 (3%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 2.4% | 2.4% 7.0% 4.8% 2.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/46 (0%) 0/40 (0%) 0/39 (0%) 1/41 (2%) | 0/39 (0%) 2/40 (5%) 1/38 (3%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 729 (T) | 698 578 603 680 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.216 (e) (e) P=0.477 | P=0.435N P=0.322 P=0.502 P=0.755 | |INCIDENTAL TUMOR | P=0.216 (e) (e) P=0.477 | P=0.354N P=0.453 P=0.699 P=0.565N | |LOGISTIC REGRESSION | P=0.216 (e) (e) P=0.477 | P=0.337N P=0.318 P=0.510 P=0.756N | |COCHRAN-ARMITAGE | P=0.221 | P=0.422N | |FISHER EXACT | (e) (e) P=0.500 | P=0.309 P=0.500 P=0.752N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05109 TEST: 12 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 200 630 2000 | 0 MG/KG 100 300 1000 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | 1/60 (2%) 3/60 (5%) 2/60 (3%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 2.4% | 2.4% 7.0% 4.8% 2.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/46 (0%) 0/40 (0%) 0/39 (0%) 1/41 (2%) | 0/39 (0%) 2/40 (5%) 1/38 (3%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 729 (T) | 698 578 603 680 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.216 (e) (e) P=0.477 | P=0.435N P=0.322 P=0.502 P=0.755 | |INCIDENTAL TUMOR | P=0.216 (e) (e) P=0.477 | P=0.354N P=0.453 P=0.699 P=0.565N | |LOGISTIC REGRESSION | P=0.216 (e) (e) P=0.477 | P=0.337N P=0.318 P=0.510 P=0.756N | |COCHRAN-ARMITAGE | P=0.221 | P=0.422N | |FISHER EXACT | (e) (e) P=0.500 | P=0.309 P=0.500 P=0.752N | |=================================================================================================================================| | | |Skin | | Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | 1/60 (2%) 3/60 (5%) 2/60 (3%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 2.4% | 2.4% 7.0% 4.8% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/46 (0%) 0/40 (0%) 0/39 (0%) 1/41 (2%) | 0/39 (0%) 2/40 (5%) 1/38 (3%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 729 (T) | 698 578 603 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.216 (e) (e) P=0.477 | P=0.193N P=0.322 P=0.502 P=0.505N | |INCIDENTAL TUMOR | P=0.216 (e) (e) P=0.477 | P=0.155N P=0.453 P=0.699 P=0.331N | |LOGISTIC REGRESSION | P=0.216 (e) (e) P=0.477 | P=0.135N P=0.318 P=0.510 P=0.495N | |COCHRAN-ARMITAGE | P=0.221 | P=0.184N | |FISHER EXACT | (e) (e) P=0.500 | P=0.309 P=0.500 P=0.500N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05109 TEST: 12 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 200 630 2000 | 0 MG/KG 100 300 1000 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | 3/60 (5%) 1/60 (2%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 2.2% 0.0% 0.0% 2.4% | 7.7% 2.5% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/46 (2%) 0/40 (0%) 0/39 (0%) 1/41 (2%) | 3/39 (8%) 1/40 (3%) 0/38 (0%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- --- 729 (T) | 729 (T) 729 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.524 P=0.528N P=0.533N P=0.736 | P=0.117N P=0.296N P=0.126N P=0.130N | |INCIDENTAL TUMOR | P=0.524 P=0.528N P=0.533N P=0.736 | P=0.117N P=0.296N P=0.126N P=0.130N | |LOGISTIC REGRESSION | P=0.524 P=0.528N P=0.533N P=0.736 | P=0.117N P=0.296N P=0.126N P=0.130N | |COCHRAN-ARMITAGE | P=0.536 | P=0.110N | |FISHER EXACT | P=0.500N P=0.500N P=0.752N | P=0.309N P=0.122N P=0.122N | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 0/60 (0%) | | |ADJUSTED (b) | 0.0% 5.0% 0.0% 0.0% | | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | | |TERMINAL (d) | 0/46 (0%) 2/40 (5%) 0/39 (0%) 0/41 (0%) | | |FIRST INCIDENCE (DAYS) | --- 729 (T) --- --- | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.405N P=0.208 (e) (e) | | |INCIDENTAL TUMOR | P=0.405N P=0.208 (e) (e) | | |LOGISTIC REGRESSION | P=0.405N P=0.208 (e) (e) | | |COCHRAN-ARMITAGE | P=0.393N | | |FISHER EXACT | P=0.248 (e) (e) | | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05109 TEST: 12 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 200 630 2000 | 0 MG/KG 100 300 1000 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/60 (3%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | 4/60 (7%) 2/60 (3%) 5/60 (8%) 6/60 (10%) | |ADJUSTED (b) | 4.3% 0.0% 0.0% 2.4% | 10.3% 5.0% 13.2% 16.2% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/46 (4%) 0/40 (0%) 0/39 (0%) 1/41 (2%) | 4/39 (10%) 2/40 (5%) 5/38 (13%) 6/37 (16%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- --- 729 (T) | 729 (T) 729 (T) 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.685N P=0.270N P=0.276N P=0.540N | P=0.150 P=0.325N P=0.484 P=0.335 | |INCIDENTAL TUMOR | P=0.685N P=0.270N P=0.276N P=0.540N | P=0.150 P=0.325N P=0.484 P=0.335 | |LOGISTIC REGRESSION | P=0.685N P=0.270N P=0.276N P=0.540N | P=0.150 P=0.325N P=0.484 P=0.335 | |COCHRAN-ARMITAGE | P=0.672N | P=0.184 | |FISHER EXACT | P=0.248N P=0.248N P=0.500N | P=0.340N P=0.500 P=0.372 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/60 (3%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | 4/60 (7%) 2/60 (3%) 6/60 (10%) 6/60 (10%) | |ADJUSTED (b) | 4.3% 0.0% 0.0% 2.4% | 10.3% 5.0% 15.8% 16.2% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/46 (4%) 0/40 (0%) 0/39 (0%) 1/41 (2%) | 4/39 (10%) 2/40 (5%) 6/38 (16%) 6/37 (16%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- --- 729 (T) | 729 (T) 729 (T) 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.685N P=0.270N P=0.276N P=0.540N | P=0.162 P=0.325N P=0.352 P=0.335 | |INCIDENTAL TUMOR | P=0.685N P=0.270N P=0.276N P=0.540N | P=0.162 P=0.325N P=0.352 P=0.335 | |LOGISTIC REGRESSION | P=0.685N P=0.270N P=0.276N P=0.540N | P=0.162 P=0.325N P=0.352 P=0.335 | |COCHRAN-ARMITAGE | P=0.672N | P=0.198 | |FISHER EXACT | P=0.248N P=0.248N P=0.500N | P=0.340N P=0.372 P=0.372 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05109 TEST: 12 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 200 630 2000 | 0 MG/KG 100 300 1000 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 1/60 (2%) 1/60 (2%) 1/60 (2%) 3/60 (5%) | |ADJUSTED (b) | | 2.6% 2.5% 1.7% 5.9% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 1/10 (10%) 2/10 (20%) | |TERMINAL (d) | | 1/39 (3%) 1/40 (3%) 0/38 (0%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | | 729 (T) 729 (T) 457 (I) 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.150 P=0.756N P=0.757 P=0.301 | |INCIDENTAL TUMOR | | P=0.180 P=0.756N P=0.757 P=0.373 | |LOGISTIC REGRESSION | | P=0.140 P=0.756N P=0.747 P=0.275 | |COCHRAN-ARMITAGE | | P=0.157 | |FISHER EXACT | | P=0.752N P=0.752N P=0.309 | |=================================================================================================================================| | | |All Organs | | Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 2/60 (3%) | 0/60 (0%) 1/60 (2%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 2.2% 2.2% 0.0% 4.9% | 0.0% 2.5% 2.6% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/46 (2%) 0/40 (0%) 0/39 (0%) 2/41 (5%) | 0/39 (0%) 1/40 (3%) 1/38 (3%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 667 --- 729 (T) | --- 729 (T) 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.315 P=0.738 P=0.533N P=0.460 | P=0.551N P=0.505 P=0.495 (e) | |INCIDENTAL TUMOR | P=0.340 P=0.654N P=0.533N P=0.460 | P=0.551N P=0.505 P=0.495 (e) | |LOGISTIC REGRESSION | P=0.324 P=0.758 P=0.533N P=0.460 | P=0.551N P=0.505 P=0.495 (e) | |COCHRAN-ARMITAGE | P=0.326 | P=0.536N | |FISHER EXACT | P=0.752N P=0.500N P=0.500 | P=0.500 P=0.500 (e) | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05109 TEST: 12 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 200 630 2000 | 0 MG/KG 100 300 1000 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 4/60 (7%) 1/60 (2%) 1/60 (2%) | 4/60 (7%) 3/60 (5%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 4.3% 10.0% 2.6% 2.4% | 10.3% 7.5% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/46 (4%) 4/40 (10%) 1/39 (3%) 1/41 (2%) | 4/39 (10%) 3/40 (8%) 0/38 (0%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) 729 (T) | 729 (T) 729 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.265N P=0.275 P=0.558N P=0.540N | P=0.042N* P=0.486N P=0.066N P=0.070N | |INCIDENTAL TUMOR | P=0.265N P=0.275 P=0.558N P=0.540N | P=0.042N* P=0.486N P=0.066N P=0.070N | |LOGISTIC REGRESSION | P=0.265N P=0.275 P=0.558N P=0.540N | P=0.042N* P=0.486N P=0.066N P=0.070N | |COCHRAN-ARMITAGE | P=0.245N | P=0.039N* | |FISHER EXACT | P=0.340 P=0.500N P=0.500N | P=0.500N P=0.059N P=0.059N | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 5/60 (8%) 1/60 (2%) 3/60 (5%) | 4/60 (7%) 4/60 (7%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 6.5% 12.0% 2.6% 7.3% | 10.3% 10.0% 2.6% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 3/46 (7%) 4/40 (10%) 1/39 (3%) 3/41 (7%) | 4/39 (10%) 4/40 (10%) 1/38 (3%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 667 729 (T) 729 (T) | 729 (T) 729 (T) 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.513N P=0.289 P=0.366N P=0.609 | P=0.037N* P=0.630N P=0.187N P=0.070N | |INCIDENTAL TUMOR | P=0.496N P=0.364 P=0.366N P=0.609 | P=0.037N* P=0.630N P=0.187N P=0.070N | |LOGISTIC REGRESSION | P=0.496N P=0.324 P=0.366N P=0.609 | P=0.037N* P=0.630N P=0.187N P=0.070N | |COCHRAN-ARMITAGE | P=0.485N | P=0.034N* | |FISHER EXACT | P=0.359 P=0.309N P=0.660N | P=0.641N P=0.182N P=0.059N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05109 TEST: 12 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 200 630 2000 | 0 MG/KG 100 300 1000 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 1/60 (2%) | 0/60 (0%) 2/60 (3%) 2/60 (3%) 3/60 (5%) | |ADJUSTED (b) | 0.0% 0.0% 2.6% 2.3% | 0.0% 4.2% 4.7% 6.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/46 (0%) 0/40 (0%) 1/39 (3%) 0/41 (0%) | 0/39 (0%) 1/40 (3%) 1/38 (3%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 729 (T) 678 | --- 414 579 521 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.316 (e) P=0.467 P=0.483 | P=0.164 P=0.248 P=0.249 P=0.133 | |INCIDENTAL TUMOR | P=0.356 (e) P=0.467 P=0.718 | P=0.213 P=0.130 P=0.374 P=0.222 | |LOGISTIC REGRESSION | P=0.325 (e) P=0.467 P=0.500 | P=0.152 P=0.221 P=0.240 P=0.111 | |COCHRAN-ARMITAGE | P=0.325 | P=0.163 | |FISHER EXACT | (e) P=0.500 P=0.500 | P=0.248 P=0.248 P=0.122 | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma And Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/60 (7%) 1/60 (2%) 9/60 (15%) 2/60 (3%) | 6/60 (10%) 12/60 (20%) 8/60 (13%) 18/60 (30%) | |ADJUSTED (b) | 8.7% 2.5% 22.3% 4.7% | 15.4% 26.7% 19.5% 41.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 4/46 (9%) 1/40 (3%) 8/39 (21%) 1/41 (2%) | 6/39 (15%) 8/40 (20%) 6/38 (16%) 12/37 (32%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 645 678 | 729 (T) 414 579 317 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.415N P=0.224N P=0.068 P=0.390N | P=0.005 ** P=0.117 P=0.379 P=0.005 ** | |INCIDENTAL TUMOR | P=0.385N P=0.224N P=0.089 P=0.303N | P=0.006 ** P=0.130 P=0.505 P=0.007 ** | |LOGISTIC REGRESSION | P=0.392N P=0.224N P=0.080 P=0.355N | P=0.006 ** P=0.119 P=0.413 P=0.007 ** | |COCHRAN-ARMITAGE | P=0.383N | P=0.006 ** | |FISHER EXACT | P=0.182N P=0.120 P=0.340N | P=0.100 P=0.389 P=0.006 ** | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05109 TEST: 12 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 200 630 2000 | 0 MG/KG 100 300 1000 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated | | Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/60 (7%) 1/60 (2%) 9/60 (15%) 1/60 (2%) | 6/60 (10%) 10/60 (17%) 6/60 (10%) 15/60 (25%) | |ADJUSTED (b) | 8.7% 2.5% 22.3% 2.4% | 15.4% 23.1% 15.1% 36.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 4/46 (9%) 1/40 (3%) 8/39 (21%) 1/41 (2%) | 6/39 (15%) 7/40 (18%) 5/38 (13%) 12/37 (32%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 645 729 (T) | 729 (T) 639 624 317 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.251N P=0.224N P=0.068 P=0.216N | P=0.013 * P=0.231 P=0.607 P=0.020 * | |INCIDENTAL TUMOR | P=0.239N P=0.224N P=0.089 P=0.216N | P=0.016 * P=0.308 P=0.568N P=0.019 * | |LOGISTIC REGRESSION | P=0.235N P=0.224N P=0.080 P=0.216N | P=0.018 * P=0.240 P=0.604N P=0.029 * | |COCHRAN-ARMITAGE | P=0.226N | P=0.020 * | |FISHER EXACT | P=0.182N P=0.120 P=0.182N | P=0.211 P=0.619N P=0.026 * | |=================================================================================================================================| | | |All Organs | | Osteosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 2/60 (3%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 1.7% 4.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/46 (0%) 0/40 (0%) 0/39 (0%) 0/41 (0%) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- 320 551 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.093 (e) P=0.510 P=0.250 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.068 (e) P=0.227 P=0.420 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.059 (e) P=0.290 P=0.225 | |COCHRAN-ARMITAGE | (e) | P=0.090 | |FISHER EXACT | (e) (e) (e) | (e) P=0.500 P=0.248 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05109 TEST: 12 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 200 630 2000 | 0 MG/KG 100 300 1000 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |All Organs | | Osteosarcoma or Osteoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 2/60 (3%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 1.7% 4.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/46 (0%) 0/40 (0%) 0/39 (0%) 0/41 (0%) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- 320 551 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.093 (e) P=0.510 P=0.250 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.068 (e) P=0.227 P=0.420 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.059 (e) P=0.290 P=0.225 | |COCHRAN-ARMITAGE | (e) | P=0.090 | |FISHER EXACT | (e) (e) (e) | (e) P=0.500 P=0.248 | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 36/60 (60%) 40/60 (67%) 36/60 (60%) 45/60 (75%) | 36/60 (60%) 36/60 (60%) 33/60 (55%) 46/60 (77%) | |ADJUSTED (b) | 70.4% 84.9% 81.7% 86.3% | 79.7% 81.5% 76.3% 100.0% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 2/10 (20%) 1/10 (10%) 4/10 (40%) | 2/10 (20%) 3/10 (30%) 2/10 (20%) 3/10 (30%) | |TERMINAL (d) | 31/46 (67%) 33/40 (83%) 31/39 (79%) 34/41 (83%) | 30/39 (77%) 32/40 (80%) 28/38 (74%) 37/37 (100%)| |FIRST INCIDENCE (DAYS) | 367 456 (I) 456 (I) 456 (I) | 457 (I) 457 (I) 457 (I) 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.027 * P=0.073 P=0.189 P=0.016 * | P=0.002 ** P=0.510N P=0.393N P=0.011 * | |INCIDENTAL TUMOR | P=0.068 P=0.207 P=0.413 P=0.049 * | P=0.004 ** P=0.454N P=0.221N P=0.030 * | |LOGISTIC REGRESSION | P=0.040 * P=0.218 P=0.404 P=0.045 * | P=0.008 ** P=0.410N P=0.223N P=0.034 * | |COCHRAN-ARMITAGE | P=0.059 | P=0.016 * | |FISHER EXACT | P=0.285 P=0.574N P=0.059 | P=0.574N P=0.356N P=0.038 * | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05109 TEST: 12 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/KG 200 630 2000 | 0 MG/KG 100 300 1000 | | | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 20/60 (33%) 30/60 (50%) 25/60 (42%) 24/60 (40%) | 11/60 (18%) 22/60 (37%) 21/60 (35%) 25/60 (42%) | |ADJUSTED (b) | 40.6% 59.6% 53.2% 48.5% | 27.5% 46.4% 43.5% 52.5% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 2/10 (20%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 17/46 (37%) 20/40 (50%) 17/39 (44%) 16/41 (39%) | 10/39 (26%) 15/40 (38%) 12/38 (32%) 15/37 (41%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 507 456 (I) | 698 414 320 317 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.480 P=0.021 * P=0.095 P=0.181 | P=0.024 * P=0.030 * P=0.038 * P=0.005 ** | |INCIDENTAL TUMOR | P=0.360N P=0.093 P=0.324 P=0.468 | P=0.031 * P=0.047 * P=0.058 P=0.009 ** | |LOGISTIC REGRESSION | P=0.400N P=0.101 P=0.316 P=0.449 | P=0.028 * P=0.027 * P=0.038 * P=0.006 ** | |COCHRAN-ARMITAGE | P=0.527N | P=0.027 * | |FISHER EXACT | P=0.048 * P=0.225 P=0.285 | P=0.020 * P=0.031 * P=0.005 ** | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 41/60 (68%) 49/60 (82%) 43/60 (72%) 53/60 (88%) | 39/60 (65%) 46/60 (77%) 44/60 (73%) 52/60 (87%) | |ADJUSTED (b) | 78.7% 92.4% 89.5% 96.3% | 86.5% 90.1% 87.7% 100.0% | |INTERIM SACRIFICE 1 (c)| 2/10 (20%) 4/10 (40%) 1/10 (10%) 5/10 (50%) | 2/10 (20%) 3/10 (30%) 2/10 (20%) 3/10 (30%) | |TERMINAL (d) | 35/46 (76%) 36/40 (90%) 34/39 (87%) 39/41 (95%) | 33/39 (85%) 35/40 (88%) 32/38 (84%) 37/37 (100%)| |FIRST INCIDENCE (DAYS) | 367 456 (I) 456 (I) 456 (I) | 457 (I) 414 320 317 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.013 * P=0.012 * P=0.083 P=0.002 ** | P=0.006 ** P=0.171 P=0.195 P=0.003 ** | |INCIDENTAL TUMOR | P=0.014 * P=0.068 P=0.358 P=0.005 ** | P=0.004 ** P=0.256 P=0.335 P=0.003 ** | |LOGISTIC REGRESSION | P=0.008 ** P=0.043 * P=0.248 P=0.004 ** | P=0.006 ** P=0.187 P=0.318 P=0.003 ** | |COCHRAN-ARMITAGE | P=0.017 * | P=0.010 ** | |FISHER EXACT | P=0.070 P=0.421 P=0.007 ** | P=0.114 P=0.215 P=0.005 ** | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05109 TEST: 12 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE 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): 457 (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).