TDMS Study 05025-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst ETHYLENE GLYCOL DATE: 09/04/94 EXPERIMENT: 05025 TEST: 01 TIME: 06:15:46 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01CP9565102 ROUTE: DOSED FEED NTP C#: 00920A PATHOLOGIST: D. FARNELL S. EUSTIS CAS: 107-21-1 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst ETHYLENE GLYCOL DATE: 09/04/94 EXPERIMENT: 05025 TEST: 01 TIME: 06:15:46 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01CP9565102 ROUTE: DOSED FEED NTP C#: 00920A PATHOLOGIST: D. FARNELL S. EUSTIS CAS: 107-21-1 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 Gland Bone Marrow Brain 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: Southern Research Inst ETHYLENE GLYCOL DATE: 09/04/94 EXPERIMENT: 05025 TEST: 01 TIME: 06:15:46 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01CP9565102 ROUTE: DOSED FEED NTP C#: 00920A PATHOLOGIST: D. FARNELL S. EUSTIS CAS: 107-21-1 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF ETHYLENE GLYCOL ==================================================================================================== MALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma: Benign, Complex, Malignant, NOS Harderian Gland Carcinoma or Adenoma Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma All Organs Benign Tumors ==================================================================================================== FEMALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma: Benign, Complex, Malignant, NOS Lung Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma All Organs Malignant Lymphoma And Histiocytic Sarcoma Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type Benign Tumors ==================================================================================================== DATE: 09/04/94 EXPERIMENT: 05025 TEST: 01 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.625% 1.25% 2.5% | UNTREATD 1.25% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/54 (7%) 0/20 (0%) 0/21 (0%) 3/54 (6%) | 0/49 (0%) 0/21 (0%) 0/21 (0%) 0/50 (0%) | |ADJUSTED (b) | 13.8% 0.0% 0.0% 13.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 4/29 (14%) 0/0 0/0 3/23 (13%) | 0/33 (0%) 0/1 (0%) 0/0 0/37 (0%) | |FIRST INCIDENCE (DAYS) | 731 (T) --- --- 731 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.550N (e) (e) P=0.628N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.550N (e) (e) P=0.628N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.550N (e) (e) P=0.628N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.495N | (e) | |FISHER EXACT | P=0.275N P=0.260N P=0.500N | (e) (e) (e) | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/54 (2%) 1/21 (5%) 0/21 (0%) 0/53 (0%) | 0/48 (0%) 2/21 (10%) 1/21 (5%) 0/50 (0%) | |ADJUSTED (b) | 3.4% 100.0% 0.0% 0.0% | 0.0% 100.0% 0.0% 0.0% | |TERMINAL (d) | 1/29 (3%) 1/1 (100%) 0/0 0/23 (0%) | 0/32 (0%) 1/1 (100%) 0/0 0/37 (0%) | |FIRST INCIDENCE (DAYS) | 731 (T) 731 (T) --- --- | --- 633 500 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.292N P=0.041 * (e) P=0.546N | P=0.407N P=0.032 * P=0.496 (e) | |INCIDENTAL TUMOR | P=0.292N P=0.041 * (e) P=0.546N | P=0.453N P=0.045 * P=0.581 (e) | |LOGISTIC REGRESSION | P=0.290N P=0.041 * (e) P=0.546N | P=0.418N P=0.039 * P=0.552 (e) | |COCHRAN-ARMITAGE | P=0.243N | P=0.414N | |FISHER EXACT | P=0.484 P=0.720N P=0.505N | P=0.090 P=0.304 (e) | |=================================================================================================================================| DATE: 09/04/94 EXPERIMENT: 05025 TEST: 01 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.625% 1.25% 2.5% | UNTREATD 1.25% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/54 (0%) 0/54 (0%) 2/54 (4%) 2/54 (4%) | 2/50 (4%) 1/50 (2%) 1/51 (2%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 6.3% 7.5% | 6.1% 3.3% 3.3% 0.0% | |TERMINAL (d) | 0/29 (0%) 0/32 (0%) 2/32 (6%) 1/23 (4%) | 2/33 (6%) 1/30 (3%) 1/30 (3%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 731 (T) 681 | 731 (T) 731 (T) 731 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.055 (e) P=0.260 P=0.211 | P=0.137N P=0.533N P=0.533N P=0.213N | |INCIDENTAL TUMOR | P=0.073 (e) P=0.260 P=0.274 | P=0.137N P=0.533N P=0.533N P=0.213N | |LOGISTIC REGRESSION | P=0.059 (e) P=0.260 P=0.209 | P=0.137N P=0.533N P=0.533N P=0.213N | |COCHRAN-ARMITAGE | P=0.086 | P=0.152N | |FISHER EXACT | (e) P=0.248 P=0.248 | P=0.500N P=0.492N P=0.247N | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/54 (0%) 0/54 (0%) 0/54 (0%) 1/54 (2%) | 0/50 (0%) 1/50 (2%) 1/51 (2%) 2/50 (4%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 4.3% | 0.0% 3.3% 3.0% 5.4% | |TERMINAL (d) | 0/29 (0%) 0/32 (0%) 0/32 (0%) 1/23 (4%) | 0/33 (0%) 1/30 (3%) 0/30 (0%) 2/37 (5%) | |FIRST INCIDENCE (DAYS) | --- --- --- 731 (T) | --- 731 (T) 700 731 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.160 (e) (e) P=0.454 | P=0.190 P=0.481 P=0.500 P=0.264 | |INCIDENTAL TUMOR | P=0.160 (e) (e) P=0.454 | P=0.172 P=0.481 P=0.500 P=0.264 | |LOGISTIC REGRESSION | P=0.160 (e) (e) P=0.454 | P=0.174 P=0.481 P=0.497 P=0.264 | |COCHRAN-ARMITAGE | P=0.198 | P=0.153 | |FISHER EXACT | (e) (e) P=0.500 | P=0.500 P=0.505 P=0.247 | |=================================================================================================================================| DATE: 09/04/94 EXPERIMENT: 05025 TEST: 01 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.625% 1.25% 2.5% | UNTREATD 1.25% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/54 (0%) 0/54 (0%) 2/54 (4%) 3/54 (6%) | 2/50 (4%) 2/50 (4%) 2/51 (4%) 2/50 (4%) | |ADJUSTED (b) | 0.0% 0.0% 6.3% 11.7% | 6.1% 6.7% 6.3% 5.4% | |TERMINAL (d) | 0/29 (0%) 0/32 (0%) 2/32 (6%) 2/23 (9%) | 2/33 (6%) 2/30 (7%) 1/30 (3%) 2/37 (5%) | |FIRST INCIDENCE (DAYS) | --- --- 731 (T) 681 | 731 (T) 731 (T) 700 731 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.014 * (e) P=0.260 P=0.095 | P=0.533N P=0.661 P=0.668 P=0.654N | |INCIDENTAL TUMOR | P=0.019 * (e) P=0.260 P=0.125 | P=0.549N P=0.661 P=0.668 P=0.654N | |LOGISTIC REGRESSION | P=0.016 * (e) P=0.260 P=0.098 | P=0.550N P=0.661 P=0.680 P=0.654N | |COCHRAN-ARMITAGE | P=0.028 * | P=0.596N | |FISHER EXACT | (e) P=0.248 P=0.121 | P=0.691N P=0.684N P=0.691N | |=================================================================================================================================| | | |Intestine Small: Jejunum | | Polyp Adenomatous | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/54 (4%) 0/54 (0%) 0/54 (0%) 1/54 (2%) | 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) | |ADJUSTED (b) | 6.9% 0.0% 0.0% 4.3% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/29 (7%) 0/32 (0%) 0/32 (0%) 1/23 (4%) | 0/33 (0%) 0/30 (0%) 0/30 (0%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | 731 (T) --- --- 731 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.523N P=0.216N P=0.216N P=0.581N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.523N P=0.216N P=0.216N P=0.581N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.523N P=0.216N P=0.216N P=0.581N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.461N | (e) | |FISHER EXACT | P=0.248N P=0.248N P=0.500N | (e) (e) (e) | |=================================================================================================================================| DATE: 09/04/94 EXPERIMENT: 05025 TEST: 01 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.625% 1.25% 2.5% | UNTREATD 1.25% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 9/54 (17%) 6/53 (11%) 5/53 (9%) 10/54 (19%) | 8/50 (16%) 5/50 (10%) 8/51 (16%) 7/50 (14%) | |ADJUSTED (b) | 29.3% 17.4% 15.6% 38.7% | 22.7% 15.7% 22.9% 18.1% | |TERMINAL (d) | 8/29 (28%) 5/32 (16%) 5/32 (16%) 8/23 (35%) | 6/33 (18%) 4/30 (13%) 5/30 (17%) 6/37 (16%) | |FIRST INCIDENCE (DAYS) | 469 599 731 (T) 317 | 696 679 634 639 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.180 P=0.211N P=0.140N P=0.292 | P=0.444N P=0.338N P=0.540 P=0.414N | |INCIDENTAL TUMOR | P=0.214 P=0.233N P=0.133N P=0.352 | P=0.541N P=0.323N P=0.587 P=0.488N | |LOGISTIC REGRESSION | P=0.229 P=0.192N P=0.159N P=0.377 | P=0.505N P=0.303N P=0.583 P=0.449N | |COCHRAN-ARMITAGE | P=0.374 | P=0.553N | |FISHER EXACT | P=0.303N P=0.206N P=0.500 | P=0.277N P=0.590N P=0.500N | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/54 (19%) 17/53 (32%) 12/53 (23%) 9/54 (17%) | 3/50 (6%) 5/50 (10%) 6/51 (12%) 3/50 (6%) | |ADJUSTED (b) | 26.4% 41.0% 30.8% 28.0% | 7.7% 15.3% 17.9% 7.2% | |TERMINAL (d) | 3/29 (10%) 8/32 (25%) 6/32 (19%) 2/23 (9%) | 0/33 (0%) 3/30 (10%) 4/30 (13%) 1/37 (3%) | |FIRST INCIDENCE (DAYS) | 538 601 517 519 | 655 679 612 659 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.451N P=0.199 P=0.485 P=0.557 | P=0.443N P=0.320 P=0.219 P=0.619N | |INCIDENTAL TUMOR | P=0.312N P=0.230 P=0.365 P=0.521N | P=0.546N P=0.325 P=0.235 P=0.627 | |LOGISTIC REGRESSION | P=0.534N P=0.189 P=0.341 P=0.481 | P=0.449N P=0.344 P=0.238 P=0.620N | |COCHRAN-ARMITAGE | P=0.250N | P=0.516N | |FISHER EXACT | P=0.082 P=0.387 P=0.500N | P=0.357 P=0.254 P=0.661N | |=================================================================================================================================| DATE: 09/04/94 EXPERIMENT: 05025 TEST: 01 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.625% 1.25% 2.5% | UNTREATD 1.25% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 19/54 (35%) 23/53 (43%) 16/53 (30%) 18/54 (33%) | 10/50 (20%) 9/50 (18%) 14/51 (27%) 10/50 (20%) | |ADJUSTED (b) | 50.2% 54.3% 41.5% 56.6% | 26.5% 27.9% 38.6% 24.4% | |TERMINAL (d) | 11/29 (38%) 13/32 (41%) 10/32 (31%) 10/23 (43%) | 6/33 (18%) 7/30 (23%) 9/30 (30%) 7/37 (19%) | |FIRST INCIDENCE (DAYS) | 469 599 517 317 | 655 679 612 639 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.448 P=0.472 P=0.258N P=0.397 | P=0.484N P=0.581N P=0.195 P=0.500N | |INCIDENTAL TUMOR | P=0.514N P=0.550 P=0.309N P=0.510 | P=0.466 P=0.565N P=0.222 P=0.587 | |LOGISTIC REGRESSION | P=0.427 P=0.457 P=0.333N P=0.399 | P=0.537N P=0.539N P=0.278 P=0.573N | |COCHRAN-ARMITAGE | P=0.309N | P=0.468 | |FISHER EXACT | P=0.251 P=0.365N P=0.500N | P=0.500N P=0.260 P=0.598N | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 19/54 (35%) 23/53 (43%) 16/53 (30%) 18/54 (33%) | 10/50 (20%) 9/50 (18%) 14/51 (27%) 10/50 (20%) | |ADJUSTED (b) | 50.2% 54.3% 41.5% 56.6% | 26.5% 27.9% 38.6% 24.4% | |TERMINAL (d) | 11/29 (38%) 13/32 (41%) 10/32 (31%) 10/23 (43%) | 6/33 (18%) 7/30 (23%) 9/30 (30%) 7/37 (19%) | |FIRST INCIDENCE (DAYS) | 469 599 517 317 | 655 679 612 639 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.448 P=0.472 P=0.258N P=0.397 | P=0.484N P=0.581N P=0.195 P=0.500N | |INCIDENTAL TUMOR | P=0.514N P=0.550 P=0.309N P=0.510 | P=0.466 P=0.565N P=0.222 P=0.587 | |LOGISTIC REGRESSION | P=0.427 P=0.457 P=0.333N P=0.399 | P=0.537N P=0.539N P=0.278 P=0.573N | |COCHRAN-ARMITAGE | P=0.309N | P=0.468 | |FISHER EXACT | P=0.251 P=0.365N P=0.500N | P=0.500N P=0.260 P=0.598N | |=================================================================================================================================| DATE: 09/04/94 EXPERIMENT: 05025 TEST: 01 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.625% 1.25% 2.5% | UNTREATD 1.25% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/54 (13%) 2/25 (8%) 8/32 (25%) 3/54 (6%) | 0/50 (0%) 4/50 (8%) 4/51 (8%) 1/50 (2%) | |ADJUSTED (b) | 24.1% 50.0% 80.0% 11.1% | 0.0% 10.9% 12.0% 2.7% | |TERMINAL (d) | 7/29 (24%) 2/4 (50%) 8/10 (80%) 2/23 (9%) | 0/33 (0%) 2/30 (7%) 3/30 (10%) 1/37 (3%) | |FIRST INCIDENCE (DAYS) | 731 (T) 731 (T) 731 (T) 386 | --- 472 548 731 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.275N P=0.315 P=0.003 ** P=0.260N | P=0.566N P=0.058 P=0.055 P=0.523 | |INCIDENTAL TUMOR | P=0.272N P=0.315 P=0.003 ** P=0.266N | P=0.544 P=0.076 P=0.065 P=0.523 | |LOGISTIC REGRESSION | P=0.243N P=0.315 P=0.003 ** P=0.211N | P=0.568 P=0.068 P=0.063 P=0.523 | |COCHRAN-ARMITAGE | P=0.195N | P=0.570 | |FISHER EXACT | P=0.410N P=0.130 P=0.160N | P=0.059 P=0.061 P=0.500 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/54 (2%) 2/25 (8%) 2/32 (6%) 0/54 (0%) | 1/50 (2%) 2/50 (4%) 2/51 (4%) 0/50 (0%) | |ADJUSTED (b) | 3.4% 50.0% 20.0% 0.0% | 3.0% 6.2% 6.5% 0.0% | |TERMINAL (d) | 1/29 (3%) 2/4 (50%) 2/10 (20%) 0/23 (0%) | 1/33 (3%) 1/30 (3%) 1/30 (3%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | 731 (T) 731 (T) 731 (T) --- | 731 (T) 696 730 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.321N P=0.019 * P=0.160 P=0.546N | P=0.269N P=0.468 P=0.471 P=0.477N | |INCIDENTAL TUMOR | P=0.321N P=0.019 * P=0.160 P=0.546N | P=0.291N P=0.478 P=0.478 P=0.477N | |LOGISTIC REGRESSION | P=0.321N P=0.019 * P=0.160 P=0.546N | P=0.273N P=0.485 P=0.478 P=0.477N | |COCHRAN-ARMITAGE | P=0.269N | P=0.295N | |FISHER EXACT | P=0.234 P=0.310 P=0.500N | P=0.500 P=0.508 P=0.500N | |=================================================================================================================================| DATE: 09/04/94 EXPERIMENT: 05025 TEST: 01 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.625% 1.25% 2.5% | UNTREATD 1.25% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/54 (13%) 3/25 (12%) 9/32 (28%) 3/54 (6%) | 1/50 (2%) 6/50 (12%) 6/51 (12%) 1/50 (2%) | |ADJUSTED (b) | 24.1% 75.0% 90.0% 11.1% | 3.0% 16.6% 18.0% 2.7% | |TERMINAL (d) | 7/29 (24%) 3/4 (75%) 9/10 (90%) 2/23 (9%) | 1/33 (3%) 3/30 (10%) 4/30 (13%) 1/37 (3%) | |FIRST INCIDENCE (DAYS) | 731 (T) 731 (T) 731 (T) 386 | 731 (T) 472 548 731 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.256N P=0.071 P<0.001 ** P=0.260N | P=0.337N P=0.051 P=0.049 * P=0.736N | |INCIDENTAL TUMOR | P=0.253N P=0.071 P<0.001 ** P=0.266N | P=0.404N P=0.065 P=0.057 P=0.736N | |LOGISTIC REGRESSION | P=0.208N P=0.071 P<0.001 ** P=0.211N | P=0.384N P=0.060 P=0.054 P=0.736N | |COCHRAN-ARMITAGE | P=0.178N | P=0.388N | |FISHER EXACT | P=0.608N P=0.074 P=0.160N | P=0.056 P=0.059 P=0.753N | |=================================================================================================================================| | | |Ovary | | Cystadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 2/49 (4%) 1/25 (4%) 1/25 (4%) 4/48 (8%) | |ADJUSTED (b) | | 5.3% 20.0% 16.7% 10.0% | |TERMINAL (d) | | 0/32 (0%) 1/5 (20%) 1/6 (17%) 2/35 (6%) | |FIRST INCIDENCE (DAYS) | | 606 731 (T) 731 (T) 469 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.277 P=0.689N P=0.667N P=0.371 | |INCIDENTAL TUMOR | | P=0.219 P=0.641N P=0.646N P=0.264 | |LOGISTIC REGRESSION | | P=0.227 P=0.730 P=0.727 P=0.325 | |COCHRAN-ARMITAGE | | P=0.224 | |FISHER EXACT | | P=0.738N P=0.738N P=0.329 | |=================================================================================================================================| DATE: 09/04/94 EXPERIMENT: 05025 TEST: 01 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.625% 1.25% 2.5% | UNTREATD 1.25% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/52 (0%) 0/21 (0%) 0/17 (0%) 0/49 (0%) | 17/47 (36%) 5/22 (23%) 7/23 (30%) 16/47 (34%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 47.8% 100.0% 100.0% 45.7% | |TERMINAL (d) | 0/27 (0%) 0/0 0/0 0/23 (0%) | 14/32 (44%) 2/2 (100%) 3/3 (100%) 16/35 (46%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 578 644 612 731 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.266N P=0.321 P=0.156 P=0.375N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.339N P=0.441 P=0.182 P=0.456N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.325N P=0.502 P=0.227 P=0.409N | |COCHRAN-ARMITAGE | (e) | P=0.538 | |FISHER EXACT | (e) (e) (e) | P=0.202N P=0.422N P=0.500N | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/52 (0%) 0/21 (0%) 0/17 (0%) 0/49 (0%) | 17/47 (36%) 5/22 (23%) 8/23 (35%) 16/47 (34%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 47.8% 100.0% 100.0% 45.7% | |TERMINAL (d) | 0/27 (0%) 0/0 0/0 0/23 (0%) | 14/32 (44%) 2/2 (100%) 3/3 (100%) 16/35 (46%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 578 644 500 731 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.278N P=0.321 P=0.102 P=0.375N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.352N P=0.441 P=0.131 P=0.456N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.360N P=0.502 P=0.197 P=0.409N | |COCHRAN-ARMITAGE | (e) | P=0.531 | |FISHER EXACT | (e) (e) (e) | P=0.202N P=0.564N P=0.500N | |=================================================================================================================================| DATE: 09/04/94 EXPERIMENT: 05025 TEST: 01 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.625% 1.25% 2.5% | UNTREATD 1.25% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/54 (4%) 2/54 (4%) 1/54 (2%) 2/54 (4%) | 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) | |ADJUSTED (b) | 6.9% 6.3% 3.1% 8.7% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/29 (7%) 2/32 (6%) 1/32 (3%) 2/23 (9%) | 0/33 (0%) 0/30 (0%) 0/30 (0%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | 731 (T) 731 (T) 731 (T) 731 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.538 P=0.660N P=0.465N P=0.610 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.538 P=0.660N P=0.465N P=0.610 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.538 P=0.660N P=0.465N P=0.610 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.577N | (e) | |FISHER EXACT | P=0.691N P=0.500N P=0.691N | (e) (e) (e) | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/54 (6%) 8/54 (15%) 6/54 (11%) 1/54 (2%) | 0/50 (0%) 0/50 (0%) 2/51 (4%) 0/50 (0%) | |ADJUSTED (b) | 8.5% 19.8% 15.6% 3.7% | 0.0% 0.0% 6.7% 0.0% | |TERMINAL (d) | 0/29 (0%) 4/32 (13%) 2/32 (6%) 0/23 (0%) | 0/33 (0%) 0/30 (0%) 2/30 (7%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | 598 514 584 697 | --- --- 731 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.222N P=0.168 P=0.287 P=0.350N | P=0.620 (e) P=0.217 (e) | |INCIDENTAL TUMOR | P=0.246N P=0.150 P=0.171 P=0.207N | P=0.620 (e) P=0.217 (e) | |LOGISTIC REGRESSION | P=0.263N P=0.116 P=0.161 P=0.417N | P=0.620 (e) P=0.217 (e) | |COCHRAN-ARMITAGE | P=0.140N | P=0.596 | |FISHER EXACT | P=0.101 P=0.244 P=0.309N | (e) P=0.252 (e) | |=================================================================================================================================| DATE: 09/04/94 EXPERIMENT: 05025 TEST: 01 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.625% 1.25% 2.5% | UNTREATD 1.25% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, Sarcoma, | | Neurofibroma, or Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 6/54 (11%) 11/54 (20%) 7/54 (13%) 5/54 (9%) | 1/50 (2%) 0/50 (0%) 2/51 (4%) 0/50 (0%) | |ADJUSTED (b) | 16.6% 27.1% 18.0% 17.5% | 2.7% 0.0% 6.7% 0.0% | |TERMINAL (d) | 2/29 (7%) 6/32 (19%) 2/32 (6%) 2/23 (9%) | 0/33 (0%) 0/30 (0%) 2/30 (7%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | 350 514 584 595 | 696 --- 731 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.417N P=0.240 P=0.554 P=0.607N | P=0.434N P=0.517N P=0.465 P=0.495N | |INCIDENTAL TUMOR | P=0.396N P=0.166 P=0.407 P=0.479N | P=0.450N P=0.500N P=0.478 P=0.531N | |LOGISTIC REGRESSION | P=0.460N P=0.161 P=0.511 P=0.566N | P=0.442N P=0.503N P=0.486 P=0.499N | |COCHRAN-ARMITAGE | P=0.261N | P=0.460N | |FISHER EXACT | P=0.145 P=0.500 P=0.500N | P=0.500N P=0.508 P=0.500N | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, or Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/54 (7%) 9/54 (17%) 7/54 (13%) 3/54 (6%) | 1/50 (2%) 0/50 (0%) 2/51 (4%) 0/50 (0%) | |ADJUSTED (b) | 10.5% 21.4% 18.0% 9.7% | 2.7% 0.0% 6.7% 0.0% | |TERMINAL (d) | 0/29 (0%) 4/32 (13%) 2/32 (6%) 0/23 (0%) | 0/33 (0%) 0/30 (0%) 2/30 (7%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | 350 514 584 595 | 696 --- 731 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.393N P=0.199 P=0.313 P=0.564N | P=0.434N P=0.517N P=0.465 P=0.495N | |INCIDENTAL TUMOR | P=0.367N P=0.123 P=0.162 P=0.393N | P=0.450N P=0.500N P=0.478 P=0.531N | |LOGISTIC REGRESSION | P=0.464N P=0.134 P=0.226 P=0.527N | P=0.442N P=0.503N P=0.486 P=0.499N | |COCHRAN-ARMITAGE | P=0.263N | P=0.460N | |FISHER EXACT | P=0.118 P=0.263 P=0.500N | P=0.500N P=0.508 P=0.500N | |=================================================================================================================================| DATE: 09/04/94 EXPERIMENT: 05025 TEST: 01 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.625% 1.25% 2.5% | UNTREATD 1.25% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/54 (2%) 1/54 (2%) 1/54 (2%) 2/54 (4%) | 1/50 (2%) 0/50 (0%) 0/51 (0%) 0/50 (0%) | |ADJUSTED (b) | 2.2% 2.0% 2.9% 6.2% | 2.7% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/29 (0%) 0/32 (0%) 0/32 (0%) 0/23 (0%) | 0/33 (0%) 0/30 (0%) 0/30 (0%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | 350 514 667 595 | 696 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.298 P=0.729N P=0.746N P=0.456 | P=0.305N P=0.517N P=0.523N P=0.495N | |INCIDENTAL TUMOR | P=0.422 P=0.607 P=0.689 P=0.540 | P=0.322N P=0.500N P=0.500N P=0.531N | |LOGISTIC REGRESSION | P=0.373 P=0.668 P=0.760 P=0.508 | P=0.304N P=0.503N P=0.502N P=0.499N | |COCHRAN-ARMITAGE | P=0.351 | P=0.305N | |FISHER EXACT | P=0.752N P=0.752N P=0.500 | P=0.500N P=0.495N P=0.500N | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/54 (4%) 0/53 (0%) 1/53 (2%) 0/53 (0%) | 0/49 (0%) 0/29 (0%) 1/28 (4%) 0/50 (0%) | |ADJUSTED (b) | 6.9% 0.0% 3.1% 0.0% | 0.0% 0.0% 12.5% 0.0% | |TERMINAL (d) | 2/29 (7%) 0/32 (0%) 1/32 (3%) 0/23 (0%) | 0/33 (0%) 0/9 (0%) 1/8 (13%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | 731 (T) --- 731 (T) --- | --- --- 731 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.217N P=0.216N P=0.465N P=0.290N | P=0.706 (e) P=0.221 (e) | |INCIDENTAL TUMOR | P=0.217N P=0.216N P=0.465N P=0.290N | P=0.706 (e) P=0.221 (e) | |LOGISTIC REGRESSION | P=0.217N P=0.216N P=0.465N P=0.290N | P=0.706 (e) P=0.221 (e) | |COCHRAN-ARMITAGE | P=0.191N | P=0.693 | |FISHER EXACT | P=0.252N P=0.507N P=0.252N | (e) P=0.364 (e) | |=================================================================================================================================| DATE: 09/04/94 EXPERIMENT: 05025 TEST: 01 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.625% 1.25% 2.5% | UNTREATD 1.25% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/53 (0%) 0/53 (0%) 1/54 (2%) 0/53 (0%) | 1/49 (2%) 1/50 (2%) 1/51 (2%) 3/50 (6%) | |ADJUSTED (b) | 0.0% 0.0% 3.1% 0.0% | 3.0% 2.6% 3.3% 8.1% | |TERMINAL (d) | 0/29 (0%) 0/32 (0%) 1/32 (3%) 0/23 (0%) | 1/33 (3%) 0/30 (0%) 1/30 (3%) 3/37 (8%) | |FIRST INCIDENCE (DAYS) | --- --- 731 (T) --- | 731 (T) 644 731 (T) 731 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.673 (e) P=0.520 (e) | P=0.205 P=0.744 P=0.741 P=0.346 | |INCIDENTAL TUMOR | P=0.673 (e) P=0.520 (e) | P=0.165 P=0.735N P=0.741 P=0.346 | |LOGISTIC REGRESSION | P=0.673 (e) P=0.520 (e) | P=0.182 P=0.759N P=0.741 P=0.346 | |COCHRAN-ARMITAGE | P=0.695 | P=0.167 | |FISHER EXACT | (e) P=0.505 (e) | P=0.747N P=0.742N P=0.316 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/53 (2%) 0/53 (0%) 1/54 (2%) 1/53 (2%) | 1/49 (2%) 1/50 (2%) 1/51 (2%) 3/50 (6%) | |ADJUSTED (b) | 3.4% 0.0% 3.1% 4.3% | 3.0% 2.6% 3.3% 8.1% | |TERMINAL (d) | 1/29 (3%) 0/32 (0%) 1/32 (3%) 1/23 (4%) | 1/33 (3%) 0/30 (0%) 1/30 (3%) 3/37 (8%) | |FIRST INCIDENCE (DAYS) | 731 (T) --- 731 (T) 731 (T) | 731 (T) 644 731 (T) 731 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.477 P=0.480N P=0.740N P=0.710 | P=0.205 P=0.744 P=0.741 P=0.346 | |INCIDENTAL TUMOR | P=0.477 P=0.480N P=0.740N P=0.710 | P=0.165 P=0.735N P=0.741 P=0.346 | |LOGISTIC REGRESSION | P=0.477 P=0.480N P=0.740N P=0.710 | P=0.182 P=0.759N P=0.741 P=0.346 | |COCHRAN-ARMITAGE | P=0.540 | P=0.167 | |FISHER EXACT | P=0.500N P=0.748N P=0.752N | P=0.747N P=0.742N P=0.316 | |=================================================================================================================================| DATE: 09/04/94 EXPERIMENT: 05025 TEST: 01 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.625% 1.25% 2.5% | UNTREATD 1.25% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 3/50 (6%) 3/50 (6%) 1/51 (2%) 1/50 (2%) | |ADJUSTED (b) | | 8.4% 8.7% 3.2% 2.7% | |TERMINAL (d) | | 2/33 (6%) 2/30 (7%) 0/30 (0%) 1/37 (3%) | |FIRST INCIDENCE (DAYS) | | 655 539 730 731 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.144N P=0.626 P=0.337N P=0.270N | |INCIDENTAL TUMOR | | P=0.156N P=0.646 P=0.321N P=0.290N | |LOGISTIC REGRESSION | | P=0.160N P=0.662 P=0.316N P=0.292N | |COCHRAN-ARMITAGE | | P=0.163N | |FISHER EXACT | | P=0.661N P=0.301N P=0.309N | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/54 (6%) 0/54 (0%) 1/54 (2%) 0/54 (0%) | 0/50 (0%) 0/50 (0%) 1/51 (2%) 0/50 (0%) | |ADJUSTED (b) | 10.3% 0.0% 3.1% 0.0% | 0.0% 0.0% 3.3% 0.0% | |TERMINAL (d) | 3/29 (10%) 0/32 (0%) 1/32 (3%) 0/23 (0%) | 0/33 (0%) 0/30 (0%) 1/30 (3%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | 731 (T) --- 731 (T) --- | --- --- 731 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.102N P=0.103N P=0.269N P=0.163N | P=0.706 (e) P=0.481 (e) | |INCIDENTAL TUMOR | P=0.102N P=0.103N P=0.269N P=0.163N | P=0.706 (e) P=0.481 (e) | |LOGISTIC REGRESSION | P=0.102N P=0.103N P=0.269N P=0.163N | P=0.706 (e) P=0.481 (e) | |COCHRAN-ARMITAGE | P=0.086N | P=0.695 | |FISHER EXACT | P=0.121N P=0.309N P=0.121N | (e) P=0.505 (e) | |=================================================================================================================================| DATE: 09/04/94 EXPERIMENT: 05025 TEST: 01 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.625% 1.25% 2.5% | UNTREATD 1.25% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/54 (6%) 0/54 (0%) 1/54 (2%) 1/54 (2%) | 0/50 (0%) 0/50 (0%) 1/51 (2%) 0/50 (0%) | |ADJUSTED (b) | 10.3% 0.0% 3.1% 4.3% | 0.0% 0.0% 3.3% 0.0% | |TERMINAL (d) | 3/29 (10%) 0/32 (0%) 1/32 (3%) 1/23 (4%) | 0/33 (0%) 0/30 (0%) 1/30 (3%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | 731 (T) --- 731 (T) 731 (T) | --- --- 731 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.359N P=0.103N P=0.269N P=0.390N | P=0.706 (e) P=0.481 (e) | |INCIDENTAL TUMOR | P=0.359N P=0.103N P=0.269N P=0.390N | P=0.706 (e) P=0.481 (e) | |LOGISTIC REGRESSION | P=0.359N P=0.103N P=0.269N P=0.390N | P=0.706 (e) P=0.481 (e) | |COCHRAN-ARMITAGE | P=0.296N | P=0.695 | |FISHER EXACT | P=0.121N P=0.309N P=0.309N | (e) P=0.505 (e) | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/54 (4%) 0/54 (0%) 0/54 (0%) 0/54 (0%) | 0/50 (0%) 0/50 (0%) 0/51 (0%) 0/50 (0%) | |ADJUSTED (b) | 5.8% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/29 (0%) 0/32 (0%) 0/32 (0%) 0/23 (0%) | 0/33 (0%) 0/30 (0%) 0/30 (0%) 0/37 (0%) | |FIRST INCIDENCE (DAYS) | 630 --- --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.120N P=0.207N P=0.227N P=0.256N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.122N P=0.176N P=0.282N P=0.252N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.118N P=0.225N P=0.234N P=0.257N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.115N | (e) | |FISHER EXACT | P=0.248N P=0.248N P=0.248N | (e) (e) (e) | |=================================================================================================================================| DATE: 09/04/94 EXPERIMENT: 05025 TEST: 01 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.625% 1.25% 2.5% | UNTREATD 1.25% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma And Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 8/54 (15%) 3/54 (6%) 5/54 (9%) 8/54 (15%) | 17/50 (34%) 13/50 (26%) 9/51 (18%) 7/50 (14%) | |ADJUSTED (b) | 23.8% 7.4% 15.6% 29.4% | 42.5% 35.2% 23.9% 16.5% | |TERMINAL (d) | 4/29 (14%) 1/32 (3%) 5/32 (16%) 5/23 (22%) | 11/33 (33%) 8/30 (27%) 4/30 (13%) 3/37 (8%) | |FIRST INCIDENCE (DAYS) | 630 578 731 (T) 597 | 520 476 612 500 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.239 P=0.076N P=0.229N P=0.460 | P=0.008N** P=0.354N P=0.101N P=0.015N* | |INCIDENTAL TUMOR | P=0.215 P=0.053N P=0.270N P=0.489 | P=0.014N* P=0.273N P=0.049N* P=0.023N* | |LOGISTIC REGRESSION | P=0.260 P=0.070N P=0.238N P=0.497 | P=0.010N** P=0.256N P=0.054N P=0.018N* | |COCHRAN-ARMITAGE | P=0.385 | P=0.010N** | |FISHER EXACT | P=0.101N P=0.278N P=0.606N | P=0.257N P=0.049N* P=0.017N* | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 6/54 (11%) 3/54 (6%) 5/54 (9%) 8/54 (15%) | 17/50 (34%) 13/50 (26%) 9/51 (18%) 7/50 (14%) | |ADJUSTED (b) | 19.0% 7.4% 15.6% 29.4% | 42.5% 35.2% 23.9% 16.5% | |TERMINAL (d) | 4/29 (14%) 1/32 (3%) 5/32 (16%) 5/23 (22%) | 11/33 (33%) 8/30 (27%) 4/30 (13%) 3/37 (8%) | |FIRST INCIDENCE (DAYS) | 637 578 731 (T) 597 | 520 476 612 500 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.100 P=0.195N P=0.438N P=0.257 | P=0.008N** P=0.354N P=0.101N P=0.015N* | |INCIDENTAL TUMOR | P=0.086 P=0.174N P=0.468N P=0.278 | P=0.014N* P=0.273N P=0.049N* P=0.023N* | |LOGISTIC REGRESSION | P=0.113 P=0.186N P=0.448N P=0.286 | P=0.010N** P=0.256N P=0.054N P=0.018N* | |COCHRAN-ARMITAGE | P=0.201 | P=0.010N** | |FISHER EXACT | P=0.244N P=0.500N P=0.388 | P=0.257N P=0.049N* P=0.017N* | |=================================================================================================================================| DATE: 09/04/94 EXPERIMENT: 05025 TEST: 01 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.625% 1.25% 2.5% | UNTREATD 1.25% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 17/54 (31%) 11/54 (20%) 13/54 (24%) 19/54 (35%) | 29/50 (58%) 19/50 (38%) 19/51 (37%) 26/50 (52%) | |ADJUSTED (b) | 54.3% 32.7% 40.6% 69.2% | 72.4% 47.7% 47.5% 64.7% | |TERMINAL (d) | 15/29 (52%) 10/32 (31%) 13/32 (41%) 15/23 (65%) | 22/33 (67%) 10/30 (33%) 10/30 (33%) 23/37 (62%) | |FIRST INCIDENCE (DAYS) | 469 599 731 (T) 317 | 578 472 500 469 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.042 * P=0.062N P=0.144N P=0.135 | P=0.272N P=0.105N P=0.101N P=0.172N | |INCIDENTAL TUMOR | P=0.060 P=0.066N P=0.142N P=0.195 | P=0.459N P=0.042N* P=0.039N* P=0.275N | |LOGISTIC REGRESSION | P=0.075 P=0.049N* P=0.171N P=0.225 | P=0.420N P=0.041N* P=0.041N* P=0.254N | |COCHRAN-ARMITAGE | P=0.236 | P=0.467N | |FISHER EXACT | P=0.136N P=0.260N P=0.419 | P=0.036N* P=0.029N* P=0.344N | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 22/54 (41%) 28/54 (52%) 23/54 (43%) 20/54 (37%) | 21/50 (42%) 21/50 (42%) 22/51 (43%) 17/50 (34%) | |ADJUSTED (b) | 52.1% 57.8% 53.5% 54.9% | 49.4% 53.0% 52.6% 37.5% | |TERMINAL (d) | 9/29 (31%) 12/32 (38%) 12/32 (38%) 7/23 (30%) | 12/33 (36%) 12/30 (40%) 11/30 (37%) 9/37 (24%) | |FIRST INCIDENCE (DAYS) | 350 514 517 498 | 520 476 367 500 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.498 P=0.401 P=0.517N P=0.477 | P=0.150N P=0.457 P=0.400 P=0.202N | |INCIDENTAL TUMOR | P=0.519N P=0.388 P=0.435 P=0.588N | P=0.268N P=0.548 P=0.522 P=0.325N | |LOGISTIC REGRESSION | P=0.419 P=0.376 P=0.449 P=0.410 | P=0.219N P=0.568 P=0.520 P=0.418N | |COCHRAN-ARMITAGE | P=0.236N | P=0.222N | |FISHER EXACT | P=0.167 P=0.500 P=0.422N | P=0.580N P=0.534 P=0.268N | |=================================================================================================================================| DATE: 09/04/94 EXPERIMENT: 05025 TEST: 01 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.625% 1.25% 2.5% | UNTREATD 1.25% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 34/54 (63%) 36/54 (67%) 31/54 (57%) 33/54 (61%) | 39/50 (78%) 33/50 (66%) 31/51 (61%) 36/50 (72%) | |ADJUSTED (b) | 79.0% 73.3% 72.1% 86.6% | 86.6% 74.7% 71.6% 75.0% | |TERMINAL (d) | 20/29 (69%) 19/32 (59%) 20/32 (63%) 18/23 (78%) | 27/33 (82%) 19/30 (63%) 18/30 (60%) 25/37 (68%) | |FIRST INCIDENCE (DAYS) | 350 514 517 317 | 520 472 367 457 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.229 P=0.416N P=0.226N P=0.254 | P=0.179N P=0.361N P=0.237N P=0.178N | |INCIDENTAL TUMOR | P=0.189 P=0.361N P=0.283N P=0.269 | P=0.377N P=0.157N P=0.067N P=0.332N | |LOGISTIC REGRESSION | P=0.107 P=0.324N P=0.283N P=0.148 | P=0.342N P=0.149N P=0.070N P=0.304N | |COCHRAN-ARMITAGE | P=0.370N | P=0.362N | |FISHER EXACT | P=0.420 P=0.347N P=0.500N | P=0.133N P=0.048N* P=0.322N | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for intercurrent mortality. (d) Observed incidence at terminal kill. (f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between the controls and that dosed group. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. The incidental tumor test regards these lesions as non-fatal. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fisher's exact tests compare directly the overall incidence rates. For all tests, a negative trend is indicated by "N". (e) Value of Statistic cannot be computed. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01).