TDMS Study 05217-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst T-BUTYLHYDROQUINONE DATE: 04/04/96 EXPERIMENT: 05217 TEST: 05 TIME: 09:19:12 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-85219 ROUTE: DOSED FEED NTP C#: C62157 PATHOLOGIST: D.R. FARNELL CAS: 1948-33-0 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst T-BUTYLHYDROQUINONE DATE: 04/04/96 EXPERIMENT: 05217 TEST: 05 TIME: 09:19:12 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-85219 ROUTE: DOSED FEED NTP C#: C62157 PATHOLOGIST: D.R. FARNELL CAS: 1948-33-0 MICE(B6C3F1) ---------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED. ---------------- Adrenal Cortex Adrenal Medulla Bone Marrow Brain Clitoral Gland Epididymis Gallbladder Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst T-BUTYLHYDROQUINONE DATE: 04/04/96 EXPERIMENT: 05217 TEST: 05 TIME: 09:19:12 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-85219 ROUTE: DOSED FEED NTP C#: C62157 PATHOLOGIST: D.R. FARNELL CAS: 1948-33-0 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF T-BUTYLHYDROQUINONE ==================================================================================================== MALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Liver Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Spleen Hemangiosarcoma All Organs Hemangiosarcoma Hemangiosarcoma or Hemangioma Benign Tumors ==================================================================================================== FEMALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Harderian Gland Adenoma Carcinoma or Adenoma Liver Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma All Organs Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type Malignant and Benign Tumors ==================================================================================================== DATE: 04/04/96 EXPERIMENT: 05217 TEST: 05 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.125% 0.25% 0.5% | UNTREATD 0.125% 0.25% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 4/60 (7%) 1/59 (2%) 2/60 (3%) | 0/60 (0%) 0/59 (0%) 0/59 (0%) 0/60 (0%) | |ADJUSTED (b) | 2.6% 8.7% 2.7% 4.8% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/8 (0%) 0/9 (0%) 0/6 (0%) | |TERMINAL (d) | 1/39 (3%) 4/46 (9%) 1/37 (3%) 2/42 (5%) | 0/38 (0%) 0/35 (0%) 0/40 (0%) 0/43 (0%) | |FIRST INCIDENCE (DAYS) | 727 (T) 727 (T) 727 (T) 727 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.592N P=0.233 P=0.750 P=0.526 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.592N P=0.233 P=0.750 P=0.526 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.592N P=0.233 P=0.750 P=0.526 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.595 | (e) | |FISHER EXACT | P=0.182 P=0.748 P=0.500 | (e) (e) (e) | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 8/60 (13%) 4/60 (7%) 3/60 (5%) | 0/60 (0%) 0/60 (0%) 6/60 (10%) 1/60 (2%) | |ADJUSTED (b) | 7.7% 17.4% 10.5% 7.0% | 0.0% 0.0% 15.0% 2.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/8 (0%) 0/9 (0%) 0/6 (0%) | |TERMINAL (d) | 3/39 (8%) 8/46 (17%) 4/38 (11%) 2/42 (5%) | 0/38 (0%) 0/35 (0%) 6/40 (15%) 1/43 (2%) | |FIRST INCIDENCE (DAYS) | 727 (T) 727 (T) 727 (T) 688 | --- --- 734 (T) 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.331N P=0.159 P=0.486 P=0.631N | P=0.294 (e) P=0.020 * P=0.525 | |INCIDENTAL TUMOR | P=0.357N P=0.159 P=0.486 P=0.600 | P=0.294 (e) P=0.020 * P=0.525 | |LOGISTIC REGRESSION | P=0.351N P=0.159 P=0.486 P=0.660N | P=0.294 (e) P=0.020 * P=0.525 | |COCHRAN-ARMITAGE | P=0.339N | P=0.238 | |FISHER EXACT | P=0.102 P=0.500 P=0.660N | (e) P=0.014 * P=0.500 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 05 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.125% 0.25% 0.5% | UNTREATD 0.125% 0.25% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 0/60 (0%) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 5.3% 0.0% | 0.0% 2.9% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/8 (0%) 0/9 (0%) 0/6 (0%) | |TERMINAL (d) | 0/39 (0%) 0/46 (0%) 2/38 (5%) 0/42 (0%) | 0/38 (0%) 1/35 (3%) 0/40 (0%) 0/43 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 727 (T) --- | --- 734 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.598 (e) P=0.233 (e) | P=0.542N P=0.484 (e) (e) | |INCIDENTAL TUMOR | P=0.598 (e) P=0.233 (e) | P=0.542N P=0.484 (e) (e) | |LOGISTIC REGRESSION | P=0.598 (e) P=0.233 (e) | P=0.542N P=0.484 (e) (e) | |COCHRAN-ARMITAGE | P=0.595 | P=0.567N | |FISHER EXACT | (e) P=0.248 (e) | P=0.500 (e) (e) | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 8/60 (13%) 6/60 (10%) 3/60 (5%) | 0/60 (0%) 1/60 (2%) 6/60 (10%) 1/60 (2%) | |ADJUSTED (b) | 7.7% 17.4% 15.8% 7.0% | 0.0% 2.9% 15.0% 2.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/8 (0%) 0/9 (0%) 0/6 (0%) | |TERMINAL (d) | 3/39 (8%) 8/46 (17%) 6/38 (16%) 2/42 (5%) | 0/38 (0%) 1/35 (3%) 6/40 (15%) 1/43 (2%) | |FIRST INCIDENCE (DAYS) | 727 (T) 727 (T) 727 (T) 688 | --- 734 (T) 734 (T) 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.367N P=0.159 P=0.228 P=0.631N | P=0.379 P=0.484 P=0.020 * P=0.525 | |INCIDENTAL TUMOR | P=0.392N P=0.159 P=0.228 P=0.600 | P=0.379 P=0.484 P=0.020 * P=0.525 | |LOGISTIC REGRESSION | P=0.389N P=0.159 P=0.228 P=0.660N | P=0.379 P=0.484 P=0.020 * P=0.525 | |COCHRAN-ARMITAGE | P=0.376N | P=0.313 | |FISHER EXACT | P=0.102 P=0.245 P=0.660N | P=0.500 P=0.014 * P=0.500 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 05 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.125% 0.25% 0.5% | UNTREATD 0.125% 0.25% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Intestine Small: Jejunum | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 1/60 (2%) 3/60 (5%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 2.2% 7.3% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/8 (0%) 0/9 (0%) 0/6 (0%) | |TERMINAL (d) | 0/39 (0%) 1/46 (2%) 2/38 (5%) 0/42 (0%) | 0/38 (0%) 0/35 (0%) 0/40 (0%) 0/43 (0%) | |FIRST INCIDENCE (DAYS) | --- 727 (T) 654 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.632N P=0.533 P=0.123 (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.580 P=0.533 P=0.120 (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.629 P=0.533 P=0.118 (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.633 | (e) | |FISHER EXACT | P=0.500 P=0.122 (e) | (e) (e) (e) | |=================================================================================================================================| | | |Intestine Small: Site Unspecified | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 1/60 (2%) 3/60 (5%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 2.6% 2.2% 7.3% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/8 (0%) 0/9 (0%) 0/6 (0%) | |TERMINAL (d) | 1/39 (3%) 1/46 (2%) 2/38 (5%) 0/42 (0%) | 0/38 (0%) 0/35 (0%) 0/40 (0%) 0/43 (0%) | |FIRST INCIDENCE (DAYS) | 727 (T) 727 (T) 654 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.407N P=0.724N P=0.304 P=0.485N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.459N P=0.724N P=0.300 P=0.485N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.415N P=0.724N P=0.298 P=0.485N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.409N | (e) | |FISHER EXACT | P=0.752N P=0.309 P=0.500N | (e) (e) (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 05 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.125% 0.25% 0.5% | UNTREATD 0.125% 0.25% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 2/60 (3%) | 1/60 (2%) 0/60 (0%) 1/57 (2%) 0/60 (0%) | |ADJUSTED (b) | 2.6% 2.1% 0.0% 4.8% | 2.4% 0.0% 2.5% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/8 (0%) 0/9 (0%) 0/6 (0%) | |TERMINAL (d) | 1/39 (3%) 0/46 (0%) 0/38 (0%) 2/42 (5%) | 0/38 (0%) 0/35 (0%) 1/40 (3%) 0/43 (0%) | |FIRST INCIDENCE (DAYS) | 727 (T) 710 --- 727 (T) | 667 --- 734 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.368 P=0.727N P=0.505N P=0.526 | P=0.376N P=0.505N P=0.749N P=0.473N | |INCIDENTAL TUMOR | P=0.308 P=0.647 P=0.505N P=0.526 | P=0.385N P=0.388N P=0.730N P=0.455N | |LOGISTIC REGRESSION | P=0.359 P=0.749N P=0.505N P=0.526 | P=0.396N P=0.501N P=0.760 P=0.500N | |COCHRAN-ARMITAGE | P=0.367 | P=0.407N | |FISHER EXACT | P=0.752N P=0.500N P=0.500 | P=0.500N P=0.739 P=0.500N | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/60 (5%) 1/60 (2%) 1/60 (2%) 2/60 (3%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 7.1% 2.2% 2.6% 4.3% | 2.0% 0.0% 0.0% 2.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/8 (0%) 0/9 (0%) 0/6 (0%) | |TERMINAL (d) | 2/39 (5%) 1/46 (2%) 1/38 (3%) 1/42 (2%) | 0/38 (0%) 0/35 (0%) 0/40 (0%) 1/43 (2%) | |FIRST INCIDENCE (DAYS) | 595 727 (T) 727 (T) 589 | 461 --- --- 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.471N P=0.262N P=0.317N P=0.478N | P=0.610 P=0.500N P=0.504N P=0.747N | |INCIDENTAL TUMOR | P=0.330N P=0.264N P=0.278N P=0.294N | P=0.654 P=0.227N P=0.500N P=0.630N | |LOGISTIC REGRESSION | P=0.479N P=0.298N P=0.310N P=0.501N | P=0.601 P=0.478N P=0.467N P=0.758N | |COCHRAN-ARMITAGE | P=0.474N | P=0.595 | |FISHER EXACT | P=0.309N P=0.309N P=0.500N | P=0.500N P=0.500N P=0.752N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 05 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.125% 0.25% 0.5% | UNTREATD 0.125% 0.25% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 29/60 (48%) 23/60 (38%) 23/60 (38%) 14/60 (23%) | 9/60 (15%) 20/60 (33%) 17/60 (28%) 5/60 (8%) | |ADJUSTED (b) | 61.2% 48.7% 53.8% 31.7% | 22.7% 51.0% 38.1% 11.6% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 1/10 (10%) 1/9 (11%) 0/9 (0%) | 0/9 (0%) 0/8 (0%) 1/9 (11%) 0/6 (0%) | |TERMINAL (d) | 21/39 (54%) 22/46 (48%) 19/38 (50%) 12/42 (29%) | 8/38 (21%) 16/35 (46%) 13/40 (33%) 5/43 (12%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 409 630 | 582 598 457 (I) 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.003N** P=0.055N P=0.221N P=0.003N** | P=0.026N* P=0.008 ** P=0.079 P=0.135N | |INCIDENTAL TUMOR | P=0.004N** P=0.140N P=0.167N P=0.004N** | P=0.044N* P=0.010 ** P=0.061 P=0.183N | |LOGISTIC REGRESSION | P=0.003N** P=0.128N P=0.189N P=0.003N** | P=0.031N* P=0.011 * P=0.068 P=0.140N | |COCHRAN-ARMITAGE | P=0.004N** | P=0.064N | |FISHER EXACT | P=0.179N P=0.179N P=0.004N** | P=0.016 * P=0.060 P=0.197N | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/60 (13%) 11/60 (18%) 12/60 (20%) 9/60 (15%) | 8/60 (13%) 9/60 (15%) 8/60 (13%) 5/60 (8%) | |ADJUSTED (b) | 19.1% 22.8% 25.8% 19.0% | 18.4% 20.6% 17.6% 11.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 1/9 (11%) | 0/9 (0%) 1/8 (13%) 0/9 (0%) 0/6 (0%) | |TERMINAL (d) | 6/39 (15%) 9/46 (20%) 6/38 (16%) 5/42 (12%) | 4/38 (11%) 4/35 (11%) 4/40 (10%) 5/43 (12%) | |FIRST INCIDENCE (DAYS) | 619 619 409 456 (I) | 461 457 (I) 548 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.495 P=0.437 P=0.224 P=0.532 | P=0.142N P=0.459 P=0.561N P=0.216N | |INCIDENTAL TUMOR | P=0.476N P=0.358 P=0.314 P=0.571 | P=0.272N P=0.574 P=0.589 P=0.304N | |LOGISTIC REGRESSION | P=0.529 P=0.342 P=0.228 P=0.496 | P=0.336N P=0.502 P=0.485 P=0.259N | |COCHRAN-ARMITAGE | P=0.500 | P=0.196N | |FISHER EXACT | P=0.309 P=0.232 P=0.500 | P=0.500 P=0.605N P=0.279N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 05 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.125% 0.25% 0.5% | UNTREATD 0.125% 0.25% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/60 (13%) 11/60 (18%) 12/60 (20%) 9/60 (15%) | 8/60 (13%) 9/60 (15%) 9/60 (15%) 5/60 (8%) | |ADJUSTED (b) | 19.1% 22.8% 25.8% 19.0% | 18.4% 20.6% 19.9% 11.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 1/9 (11%) | 0/9 (0%) 1/8 (13%) 0/9 (0%) 0/6 (0%) | |TERMINAL (d) | 6/39 (15%) 9/46 (20%) 6/38 (16%) 5/42 (12%) | 4/38 (11%) 4/35 (11%) 5/40 (13%) 5/43 (12%) | |FIRST INCIDENCE (DAYS) | 619 619 409 456 (I) | 461 457 (I) 548 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.495 P=0.437 P=0.224 P=0.532 | P=0.150N P=0.459 P=0.543 P=0.216N | |INCIDENTAL TUMOR | P=0.476N P=0.358 P=0.314 P=0.571 | P=0.283N P=0.574 P=0.482 P=0.304N | |LOGISTIC REGRESSION | P=0.529 P=0.342 P=0.228 P=0.496 | P=0.345N P=0.502 P=0.383 P=0.259N | |COCHRAN-ARMITAGE | P=0.500 | P=0.208N | |FISHER EXACT | P=0.309 P=0.232 P=0.500 | P=0.500 P=0.500 P=0.279N | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 32/60 (53%) 29/60 (48%) 30/60 (50%) 18/60 (30%) | 17/60 (28%) 29/60 (48%) 24/60 (40%) 10/60 (17%) | |ADJUSTED (b) | 66.4% 59.0% 64.3% 38.7% | 38.9% 65.3% 49.6% 23.3% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 1/10 (10%) 1/9 (11%) 1/9 (11%) | 0/9 (0%) 1/8 (13%) 1/9 (11%) 0/6 (0%) | |TERMINAL (d) | 23/39 (59%) 26/46 (57%) 22/38 (58%) 14/42 (33%) | 12/38 (32%) 20/35 (57%) 16/40 (40%) 10/43 (23%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 409 456 (I) | 461 457 (I) 457 (I) 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.008N** P=0.133N P=0.489N P=0.007N** | P=0.007N** P=0.014 * P=0.185 P=0.050N | |INCIDENTAL TUMOR | P=0.003N** P=0.311N P=0.366N P=0.008N** | P=0.021N* P=0.017 * P=0.112 P=0.094N | |LOGISTIC REGRESSION | P=0.005N** P=0.391N P=0.454N P=0.007N** | P=0.021N* P=0.014 * P=0.090 P=0.065N | |COCHRAN-ARMITAGE | P=0.006N** | P=0.021N* | |FISHER EXACT | P=0.358N P=0.428N P=0.008N** | P=0.019 * P=0.124 P=0.095N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 05 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.125% 0.25% 0.5% | UNTREATD 0.125% 0.25% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 32/60 (53%) 29/60 (48%) 30/60 (50%) 18/60 (30%) | 17/60 (28%) 29/60 (48%) 24/60 (40%) 10/60 (17%) | |ADJUSTED (b) | 66.4% 59.0% 64.3% 38.7% | 38.9% 65.3% 49.6% 23.3% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 1/10 (10%) 1/9 (11%) 1/9 (11%) | 0/9 (0%) 1/8 (13%) 1/9 (11%) 0/6 (0%) | |TERMINAL (d) | 23/39 (59%) 26/46 (57%) 22/38 (58%) 14/42 (33%) | 12/38 (32%) 20/35 (57%) 16/40 (40%) 10/43 (23%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 409 456 (I) | 461 457 (I) 457 (I) 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.008N** P=0.133N P=0.489N P=0.007N** | P=0.007N** P=0.014 * P=0.185 P=0.050N | |INCIDENTAL TUMOR | P=0.003N** P=0.311N P=0.366N P=0.008N** | P=0.021N* P=0.017 * P=0.112 P=0.094N | |LOGISTIC REGRESSION | P=0.005N** P=0.391N P=0.454N P=0.007N** | P=0.021N* P=0.014 * P=0.090 P=0.065N | |COCHRAN-ARMITAGE | P=0.006N** | P=0.021N* | |FISHER EXACT | P=0.358N P=0.428N P=0.008N** | P=0.019 * P=0.124 P=0.095N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/60 (20%) 11/58 (19%) 11/60 (18%) 10/60 (17%) | 4/60 (7%) 2/60 (3%) 4/60 (7%) 3/60 (5%) | |ADJUSTED (b) | 28.1% 23.3% 24.7% 21.4% | 9.5% 5.3% 10.0% 7.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 2/9 (22%) 1/9 (11%) | 1/9 (11%) 0/8 (0%) 0/9 (0%) 0/6 (0%) | |TERMINAL (d) | 9/39 (23%) 9/44 (20%) 7/38 (18%) 7/42 (17%) | 3/38 (8%) 1/35 (3%) 4/40 (10%) 3/43 (7%) | |FIRST INCIDENCE (DAYS) | 647 456 (I) 456 (I) 456 (I) | 457 (I) 706 734 (T) 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.365N P=0.393N P=0.536N P=0.364N | P=0.451N P=0.374N P=0.618N P=0.473N | |INCIDENTAL TUMOR | P=0.312N P=0.568N P=0.510N P=0.428N | P=0.456N P=0.331N P=0.618N P=0.473N | |LOGISTIC REGRESSION | P=0.365N P=0.508N P=0.511N P=0.410N | P=0.476N P=0.341N P=0.631N P=0.484N | |COCHRAN-ARMITAGE | P=0.356N | P=0.519N | |FISHER EXACT | P=0.536N P=0.500N P=0.407N | P=0.340N P=0.641N P=0.500N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 05 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.125% 0.25% 0.5% | UNTREATD 0.125% 0.25% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/60 (5%) 5/58 (9%) 3/60 (5%) 6/60 (10%) | 2/60 (3%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 7.0% 11.0% 7.2% 13.3% | 5.3% 0.0% 2.5% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/8 (0%) 0/9 (0%) 0/6 (0%) | |TERMINAL (d) | 1/39 (3%) 4/44 (9%) 1/38 (3%) 4/42 (10%) | 2/38 (5%) 0/35 (0%) 1/40 (3%) 0/43 (0%) | |FIRST INCIDENCE (DAYS) | 651 654 666 595 | 734 (T) --- 734 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.242 P=0.418 P=0.648 P=0.266 | P=0.166N P=0.257N P=0.482N P=0.212N | |INCIDENTAL TUMOR | P=0.191 P=0.158 P=0.666 P=0.226 | P=0.166N P=0.257N P=0.482N P=0.212N | |LOGISTIC REGRESSION | P=0.234 P=0.355 P=0.657 P=0.242 | P=0.166N P=0.257N P=0.482N P=0.212N | |COCHRAN-ARMITAGE | P=0.241 | P=0.188N | |FISHER EXACT | P=0.340 P=0.660N P=0.245 | P=0.248N P=0.500N P=0.248N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 15/60 (25%) 16/58 (28%) 13/60 (22%) 15/60 (25%) | 6/60 (10%) 2/60 (3%) 5/60 (8%) 3/60 (5%) | |ADJUSTED (b) | 33.7% 33.5% 28.8% 31.2% | 14.6% 5.3% 12.5% 7.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 2/9 (22%) 1/9 (11%) | 1/9 (11%) 0/8 (0%) 0/9 (0%) 0/6 (0%) | |TERMINAL (d) | 10/39 (26%) 13/44 (30%) 8/38 (21%) 10/42 (24%) | 5/38 (13%) 1/35 (3%) 5/40 (13%) 3/43 (7%) | |FIRST INCIDENCE (DAYS) | 647 456 (I) 456 (I) 456 (I) | 457 (I) 706 734 (T) 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.484N P=0.531N P=0.456N P=0.529N | P=0.235N P=0.164N P=0.467N P=0.212N | |INCIDENTAL TUMOR | P=0.444N P=0.312 P=0.426N P=0.562 | P=0.238N P=0.139N P=0.467N P=0.212N | |LOGISTIC REGRESSION | P=0.454N P=0.364 P=0.427N P=0.582 | P=0.252N P=0.139N P=0.477N P=0.221N | |COCHRAN-ARMITAGE | P=0.475N | P=0.300N | |FISHER EXACT | P=0.456 P=0.415N P=0.583N | P=0.136N P=0.500N P=0.245N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 05 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.125% 0.25% 0.5% | UNTREATD 0.125% 0.25% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Ovary | | Cystadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 2/59 (3%) 2/57 (4%) 4/56 (7%) 2/56 (4%) | |ADJUSTED (b) | | 5.4% 5.3% 9.5% 5.1% | |INTERIM SACRIFICE 1 (c)| | 0/9 (0%) 0/8 (0%) 1/9 (11%) 0/6 (0%) | |TERMINAL (d) | | 2/37 (5%) 1/34 (3%) 3/38 (8%) 2/39 (5%) | |FIRST INCIDENCE (DAYS) | | 734 (T) 654 457 (I) 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.566 P=0.671 P=0.348 P=0.676N | |INCIDENTAL TUMOR | | P=0.567 P=0.691 P=0.348 P=0.676N | |LOGISTIC REGRESSION | | P=0.542 P=0.676 P=0.319 P=0.676N | |COCHRAN-ARMITAGE | | P=0.521 | |FISHER EXACT | | P=0.678 P=0.315 P=0.671 | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/55 (2%) 0/52 (0%) 0/53 (0%) 0/57 (0%) | 5/58 (9%) 5/52 (10%) 5/55 (9%) 4/55 (7%) | |ADJUSTED (b) | 2.5% 0.0% 0.0% 0.0% | 12.3% 16.1% 13.2% 10.5% | |INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 0/8 (0%) 0/8 (0%) | 0/9 (0%) 0/8 (0%) 0/9 (0%) 0/6 (0%) | |TERMINAL (d) | 0/36 (0%) 0/39 (0%) 0/33 (0%) 0/40 (0%) | 3/36 (8%) 5/31 (16%) 5/38 (13%) 4/38 (11%) | |FIRST INCIDENCE (DAYS) | 723 --- --- --- | 567 734 (T) 734 (T) 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.306N P=0.472N P=0.505N P=0.490N | P=0.351N P=0.550 P=0.600N P=0.465N | |INCIDENTAL TUMOR | P=0.382N P=0.872N P=0.473N P=0.748N | P=0.467N P=0.481 P=0.514 P=0.602 | |LOGISTIC REGRESSION | P=0.302N P=0.501N P=0.514N P=0.489N | P=0.369N P=0.549 P=0.627 P=0.507N | |COCHRAN-ARMITAGE | P=0.302N | P=0.437N | |FISHER EXACT | P=0.514N P=0.509N P=0.491N | P=0.558 P=0.595 P=0.534N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 05 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.125% 0.25% 0.5% | UNTREATD 0.125% 0.25% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/55 (2%) 0/52 (0%) 0/53 (0%) 0/57 (0%) | 5/58 (9%) 6/52 (12%) 5/55 (9%) 4/55 (7%) | |ADJUSTED (b) | 2.5% 0.0% 0.0% 0.0% | 12.3% 18.0% 13.2% 10.5% | |INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 0/8 (0%) 0/8 (0%) | 0/9 (0%) 0/8 (0%) 0/9 (0%) 0/6 (0%) | |TERMINAL (d) | 0/36 (0%) 0/39 (0%) 0/33 (0%) 0/40 (0%) | 3/36 (8%) 5/31 (16%) 5/38 (13%) 4/38 (11%) | |FIRST INCIDENCE (DAYS) | 723 --- --- --- | 567 598 734 (T) 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.306N P=0.472N P=0.505N P=0.490N | P=0.310N P=0.423 P=0.600N P=0.465N | |INCIDENTAL TUMOR | P=0.382N P=0.872N P=0.473N P=0.748N | P=0.476N P=0.322 P=0.514 P=0.602 | |LOGISTIC REGRESSION | P=0.302N P=0.501N P=0.514N P=0.489N | P=0.338N P=0.413 P=0.627 P=0.507N | |COCHRAN-ARMITAGE | P=0.302N | P=0.393N | |FISHER EXACT | P=0.514N P=0.509N P=0.491N | P=0.423 P=0.595 P=0.534N | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 2/60 (3%) 2/60 (3%) 2/60 (3%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 5.3% 5.1% 5.0% 2.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/8 (0%) 0/9 (0%) 0/6 (0%) | |TERMINAL (d) | 0/39 (0%) 0/46 (0%) 0/38 (0%) 0/42 (0%) | 2/38 (5%) 1/35 (3%) 2/40 (5%) 0/43 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 734 (T) 623 734 (T) 703 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.315N P=0.675 P=0.676N P=0.450N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.405N P=0.641 P=0.676N P=0.446N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.340N P=0.690 P=0.676N P=0.463N | |COCHRAN-ARMITAGE | (e) | P=0.373N | |FISHER EXACT | (e) (e) (e) | P=0.691N P=0.691N P=0.500N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 05 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.125% 0.25% 0.5% | UNTREATD 0.125% 0.25% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 2/60 (3%) 2/60 (3%) 2/60 (3%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 5.3% 5.1% 5.0% 2.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/8 (0%) 0/9 (0%) 0/6 (0%) | |TERMINAL (d) | 0/39 (0%) 0/46 (0%) 0/38 (0%) 0/42 (0%) | 2/38 (5%) 1/35 (3%) 2/40 (5%) 0/43 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 734 (T) 623 734 (T) 703 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.315N P=0.675 P=0.676N P=0.450N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.405N P=0.641 P=0.676N P=0.446N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.340N P=0.690 P=0.676N P=0.463N | |COCHRAN-ARMITAGE | (e) | P=0.373N | |FISHER EXACT | (e) (e) (e) | P=0.691N P=0.691N P=0.500N | |=================================================================================================================================| | | |Skin | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 1/60 (2%) 1/60 (2%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 4.6% 2.2% 2.6% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/8 (0%) 0/9 (0%) 0/6 (0%) | |TERMINAL (d) | 1/39 (3%) 1/46 (2%) 1/38 (3%) 0/42 (0%) | 0/38 (0%) 0/35 (0%) 0/40 (0%) 0/43 (0%) | |FIRST INCIDENCE (DAYS) | 619 727 (T) 727 (T) --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.154N P=0.457N P=0.508N P=0.236N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.105N P=0.462N P=0.460N P=0.123N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.155N P=0.494N P=0.504N P=0.238N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.153N | (e) | |FISHER EXACT | P=0.500N P=0.500N P=0.248N | (e) (e) (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 05 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.125% 0.25% 0.5% | UNTREATD 0.125% 0.25% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Skin | | Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 2/60 (3%) 2/60 (3%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 5.3% 5.1% 2.5% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/8 (0%) 0/9 (0%) 0/6 (0%) | |TERMINAL (d) | 0/39 (0%) 0/46 (0%) 0/38 (0%) 0/42 (0%) | 2/38 (5%) 1/35 (3%) 1/40 (3%) 0/43 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 734 (T) 623 734 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.105N P=0.675 P=0.482N P=0.212N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.150N P=0.641 P=0.482N P=0.212N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.113N P=0.690 P=0.482N P=0.212N | |COCHRAN-ARMITAGE | (e) | P=0.126N | |FISHER EXACT | (e) (e) (e) | P=0.691N P=0.500N P=0.248N | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/60 (7%) 1/60 (2%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 1/59 (2%) 0/60 (0%) | |ADJUSTED (b) | 9.7% 2.2% 0.0% 0.0% | 0.0% 0.0% 2.4% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/8 (0%) 0/9 (0%) 0/6 (0%) | |TERMINAL (d) | 3/39 (8%) 1/46 (2%) 0/38 (0%) 0/42 (0%) | 0/38 (0%) 0/35 (0%) 0/40 (0%) 0/43 (0%) | |FIRST INCIDENCE (DAYS) | 647 727 (T) --- --- | --- --- 723 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.020N* P=0.144N P=0.068N P=0.060N | P=0.713 (e) P=0.515 (e) | |INCIDENTAL TUMOR | P=0.024N* P=0.207N P=0.067N P=0.092N | P=0.705 (e) P=0.545 (e) | |LOGISTIC REGRESSION | P=0.020N* P=0.166N P=0.066N P=0.063N | P=0.708 (e) P=0.509 (e) | |COCHRAN-ARMITAGE | P=0.020N* | P=0.694 | |FISHER EXACT | P=0.182N P=0.059N P=0.059N | (e) P=0.496 (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 05 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.125% 0.25% 0.5% | UNTREATD 0.125% 0.25% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma or Papilloma Squamous | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 1/60 (2%) 1/60 (2%) 2/60 (3%) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 2/60 (3%) | |ADJUSTED (b) | 0.0% 2.2% 2.6% 4.7% | 2.6% 2.0% 0.0% 4.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/8 (0%) 0/9 (0%) 0/6 (0%) | |TERMINAL (d) | 0/39 (0%) 1/46 (2%) 1/38 (3%) 1/42 (2%) | 1/38 (3%) 0/35 (0%) 0/40 (0%) 2/43 (5%) | |FIRST INCIDENCE (DAYS) | --- 727 (T) 727 (T) 688 | 734 (T) 494 --- 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.155 P=0.533 P=0.495 P=0.251 | P=0.405 P=0.751 P=0.490N P=0.543 | |INCIDENTAL TUMOR | P=0.114 P=0.533 P=0.495 P=0.111 | P=0.436 P=0.635N P=0.490N P=0.543 | |LOGISTIC REGRESSION | P=0.148 P=0.533 P=0.495 P=0.238 | P=0.369 P=0.759N P=0.490N P=0.543 | |COCHRAN-ARMITAGE | P=0.153 | P=0.367 | |FISHER EXACT | P=0.500 P=0.500 P=0.248 | P=0.752N P=0.500N P=0.500 | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 1/60 (2%) 1/60 (2%) 2/60 (3%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 2/60 (3%) | |ADJUSTED (b) | 0.0% 2.2% 2.6% 4.7% | 2.6% 0.0% 0.0% 4.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/8 (0%) 0/9 (0%) 0/6 (0%) | |TERMINAL (d) | 0/39 (0%) 1/46 (2%) 1/38 (3%) 1/42 (2%) | 1/38 (3%) 0/35 (0%) 0/40 (0%) 2/43 (5%) | |FIRST INCIDENCE (DAYS) | --- 727 (T) 727 (T) 688 | 734 (T) --- --- 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.155 P=0.533 P=0.495 P=0.251 | P=0.284 P=0.516N P=0.490N P=0.543 | |INCIDENTAL TUMOR | P=0.114 P=0.533 P=0.495 P=0.111 | P=0.284 P=0.516N P=0.490N P=0.543 | |LOGISTIC REGRESSION | P=0.148 P=0.533 P=0.495 P=0.238 | P=0.284 P=0.516N P=0.490N P=0.543 | |COCHRAN-ARMITAGE | P=0.153 | P=0.246 | |FISHER EXACT | P=0.500 P=0.500 P=0.248 | P=0.500N P=0.500N P=0.500 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 05 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.125% 0.25% 0.5% | UNTREATD 0.125% 0.25% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 1/60 (2%) 2/59 (3%) 0/60 (0%) | 1/60 (2%) 3/59 (5%) 2/59 (3%) 5/60 (8%) | |ADJUSTED (b) | 2.6% 2.2% 4.3% 0.0% | 2.6% 8.0% 5.1% 11.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/9 (11%) 0/9 (0%) | 0/9 (0%) 0/8 (0%) 0/9 (0%) 0/6 (0%) | |TERMINAL (d) | 1/39 (3%) 1/46 (2%) 1/38 (3%) 0/42 (0%) | 1/38 (3%) 2/34 (6%) 2/39 (5%) 4/43 (9%) | |FIRST INCIDENCE (DAYS) | 727 (T) 727 (T) 456 (I) --- | 734 (T) 612 734 (T) 728 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.372N P=0.724N P=0.482 P=0.485N | P=0.120 P=0.276 P=0.509 P=0.137 | |INCIDENTAL TUMOR | P=0.372N P=0.724N P=0.482 P=0.485N | P=0.080 P=0.249 P=0.509 P=0.140 | |LOGISTIC REGRESSION | P=0.365N P=0.724N P=0.499 P=0.485N | P=0.108 P=0.293 P=0.509 P=0.142 | |COCHRAN-ARMITAGE | P=0.367N | P=0.081 | |FISHER EXACT | P=0.752N P=0.494 P=0.500N | P=0.303 P=0.494 P=0.103 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 1/60 (2%) 2/59 (3%) 1/60 (2%) | 1/60 (2%) 3/59 (5%) 2/59 (3%) 5/60 (8%) | |ADJUSTED (b) | 2.6% 2.2% 4.3% 2.4% | 2.6% 8.0% 5.1% 11.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/9 (11%) 0/9 (0%) | 0/9 (0%) 0/8 (0%) 0/9 (0%) 0/6 (0%) | |TERMINAL (d) | 1/39 (3%) 1/46 (2%) 1/38 (3%) 1/42 (2%) | 1/38 (3%) 2/34 (6%) 2/39 (5%) 4/43 (9%) | |FIRST INCIDENCE (DAYS) | 727 (T) 727 (T) 456 (I) 727 (T) | 734 (T) 612 734 (T) 728 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.586 P=0.724N P=0.482 P=0.745N | P=0.120 P=0.276 P=0.509 P=0.137 | |INCIDENTAL TUMOR | P=0.586 P=0.724N P=0.482 P=0.745N | P=0.080 P=0.249 P=0.509 P=0.140 | |LOGISTIC REGRESSION | P=0.589 P=0.724N P=0.499 P=0.745N | P=0.108 P=0.293 P=0.509 P=0.142 | |COCHRAN-ARMITAGE | P=0.590 | P=0.081 | |FISHER EXACT | P=0.752N P=0.494 P=0.752N | P=0.303 P=0.494 P=0.103 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 05 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.125% 0.25% 0.5% | UNTREATD 0.125% 0.25% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 0/60 (0%) 0/60 (0%) 3/60 (5%) 1/60 (2%) | |ADJUSTED (b) | | 0.0% 0.0% 7.5% 2.3% | |INTERIM SACRIFICE 1 (c)| | 0/9 (0%) 0/8 (0%) 0/9 (0%) 0/6 (0%) | |TERMINAL (d) | | 0/38 (0%) 0/35 (0%) 3/40 (8%) 1/43 (2%) | |FIRST INCIDENCE (DAYS) | | --- --- 734 (T) 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.291 (e) P=0.130 P=0.525 | |INCIDENTAL TUMOR | | P=0.291 (e) P=0.130 P=0.525 | |LOGISTIC REGRESSION | | P=0.291 (e) P=0.130 P=0.525 | |COCHRAN-ARMITAGE | | P=0.248 | |FISHER EXACT | | (e) P=0.122 P=0.500 | |=================================================================================================================================| | | |All Organs | | Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 5.1% 0.0% 2.6% 0.0% | 0.0% 2.9% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/8 (0%) 0/9 (0%) 0/6 (0%) | |TERMINAL (d) | 2/39 (5%) 0/46 (0%) 1/38 (3%) 0/42 (0%) | 0/38 (0%) 1/35 (3%) 0/40 (0%) 0/43 (0%) | |FIRST INCIDENCE (DAYS) | 727 (T) --- 727 (T) --- | --- 734 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.186N P=0.203N P=0.509N P=0.222N | P=0.542N P=0.484 (e) (e) | |INCIDENTAL TUMOR | P=0.186N P=0.203N P=0.509N P=0.222N | P=0.542N P=0.484 (e) (e) | |LOGISTIC REGRESSION | P=0.186N P=0.203N P=0.509N P=0.222N | P=0.542N P=0.484 (e) (e) | |COCHRAN-ARMITAGE | P=0.188N | P=0.567N | |FISHER EXACT | P=0.248N P=0.500N P=0.248N | P=0.500 (e) (e) | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 05 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.125% 0.25% 0.5% | UNTREATD 0.125% 0.25% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 7/60 (12%) 3/60 (5%) 2/60 (3%) 2/60 (3%) | 2/60 (3%) 0/60 (0%) 1/60 (2%) 1/60 (2%) | |ADJUSTED (b) | 15.8% 6.5% 5.3% 4.3% | 4.6% 0.0% 2.4% 2.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/8 (0%) 0/9 (0%) 0/6 (0%) | |TERMINAL (d) | 4/39 (10%) 3/46 (7%) 2/38 (5%) 1/42 (2%) | 1/38 (3%) 0/35 (0%) 0/40 (0%) 1/43 (2%) | |FIRST INCIDENCE (DAYS) | 595 727 (T) 727 (T) 589 | 461 --- 723 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.058N P=0.120N P=0.093N P=0.081N | P=0.463N P=0.249N P=0.488N P=0.471N | |INCIDENTAL TUMOR | P=0.027N* P=0.153N P=0.064N P=0.027N* | P=0.439N P=0.112N P=0.448N P=0.353N | |LOGISTIC REGRESSION | P=0.048N* P=0.151N P=0.085N P=0.067N | P=0.500N P=0.232N P=0.503N P=0.502N | |COCHRAN-ARMITAGE | P=0.057N | P=0.500N | |FISHER EXACT | P=0.161N P=0.081N P=0.081N | P=0.248N P=0.500N P=0.500N | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 9/60 (15%) 3/60 (5%) 3/60 (5%) 2/60 (3%) | 2/60 (3%) 1/60 (2%) 1/60 (2%) 1/60 (2%) | |ADJUSTED (b) | 20.6% 6.5% 7.9% 4.3% | 4.6% 2.9% 2.4% 2.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/8 (0%) 0/9 (0%) 0/6 (0%) | |TERMINAL (d) | 6/39 (15%) 3/46 (7%) 3/38 (8%) 1/42 (2%) | 1/38 (3%) 1/35 (3%) 0/40 (0%) 1/43 (2%) | |FIRST INCIDENCE (DAYS) | 595 727 (T) 727 (T) 589 | 461 734 (T) 723 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.023N* P=0.041N* P=0.073N P=0.027N* | P=0.370N P=0.519N P=0.488N P=0.471N | |INCIDENTAL TUMOR | P=0.010N* P=0.053N P=0.051N P=0.008N** | P=0.348N P=0.374N P=0.448N P=0.353N | |LOGISTIC REGRESSION | P=0.020N* P=0.057N P=0.067N P=0.023N* | P=0.405N P=0.498N P=0.503N P=0.502N | |COCHRAN-ARMITAGE | P=0.023N* | P=0.409N | |FISHER EXACT | P=0.063N P=0.063N P=0.027N* | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 05 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.125% 0.25% 0.5% | UNTREATD 0.125% 0.25% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 1/60 (2%) 2/60 (3%) 1/60 (2%) | 2/60 (3%) 2/60 (3%) 3/60 (5%) 4/60 (7%) | |ADJUSTED (b) | 0.0% 2.2% 4.7% 2.4% | 5.0% 4.9% 6.8% 8.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/8 (0%) 0/9 (0%) 0/6 (0%) | |TERMINAL (d) | 0/39 (0%) 1/46 (2%) 0/38 (0%) 1/42 (2%) | 1/38 (3%) 1/35 (3%) 1/40 (3%) 2/43 (5%) | |FIRST INCIDENCE (DAYS) | --- 727 (T) 657 727 (T) | 673 562 618 418 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.366 P=0.533 P=0.240 P=0.515 | P=0.277 P=0.673 P=0.526 P=0.393 | |INCIDENTAL TUMOR | P=0.244 P=0.533 P=0.232 P=0.515 | P=0.155 P=0.690N P=0.510 P=0.484 | |LOGISTIC REGRESSION | P=0.361 P=0.533 P=0.236 P=0.515 | P=0.219 P=0.693 P=0.509 P=0.338 | |COCHRAN-ARMITAGE | P=0.367 | P=0.217 | |FISHER EXACT | P=0.500 P=0.248 P=0.500 | P=0.691N P=0.500 P=0.340 | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated | | Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/60 (7%) 2/60 (3%) 6/60 (10%) 4/60 (7%) | 3/60 (5%) 9/60 (15%) 10/60 (17%) 8/60 (13%) | |ADJUSTED (b) | 10.3% 4.3% 14.9% 8.7% | 7.1% 22.7% 24.3% 18.2% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 1/9 (11%) | 0/9 (0%) 0/8 (0%) 0/9 (0%) 0/6 (0%) | |TERMINAL (d) | 4/39 (10%) 2/46 (4%) 4/38 (11%) 3/42 (7%) | 1/38 (3%) 5/35 (14%) 9/40 (23%) 7/43 (16%) | |FIRST INCIDENCE (DAYS) | 727 (T) 727 (T) 673 456 (I) | 582 668 718 728 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.433 P=0.264N P=0.356 P=0.614N | P=0.271 P=0.061 P=0.050 * P=0.150 | |INCIDENTAL TUMOR | P=0.370 P=0.264N P=0.357 P=0.614N | P=0.200 P=0.092 P=0.044 * P=0.095 | |LOGISTIC REGRESSION | P=0.420 P=0.264N P=0.352 P=0.641 | P=0.229 P=0.060 P=0.044 * P=0.125 | |COCHRAN-ARMITAGE | P=0.431 | P=0.161 | |FISHER EXACT | P=0.340N P=0.372 P=0.641N | P=0.063 P=0.037 * P=0.102 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 05 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.125% 0.25% 0.5% | UNTREATD 0.125% 0.25% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 34/60 (57%) 39/60 (65%) 34/60 (57%) 27/60 (45%) | 23/60 (38%) 26/60 (43%) 27/60 (45%) 19/60 (32%) | |ADJUSTED (b) | 70.5% 77.8% 73.1% 56.0% | 52.7% 63.1% 59.5% 43.2% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 2/10 (20%) 3/9 (33%) 1/9 (11%) | 1/9 (11%) 0/8 (0%) 2/9 (22%) 0/6 (0%) | |TERMINAL (d) | 25/39 (64%) 35/46 (76%) 26/38 (68%) 21/42 (50%) | 18/38 (47%) 20/35 (57%) 22/40 (55%) 18/43 (42%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 409 456 (I) | 457 (I) 598 457 (I) 728 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.058N P=0.553N P=0.500 P=0.101N | P=0.069N P=0.247 P=0.365 P=0.152N | |INCIDENTAL TUMOR | P=0.045N* P=0.248 P=0.571N P=0.143N | P=0.147N P=0.270 P=0.283 P=0.270N | |LOGISTIC REGRESSION | P=0.052N P=0.273 P=0.544 P=0.121N | P=0.100N P=0.320 P=0.321 P=0.182N | |COCHRAN-ARMITAGE | P=0.052N | P=0.205N | |FISHER EXACT | P=0.227 P=0.573N P=0.137N | P=0.355 P=0.289 P=0.283N | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 21/60 (35%) 23/60 (38%) 25/60 (42%) 21/60 (35%) | 18/60 (30%) 23/60 (38%) 22/60 (37%) 22/60 (37%) | |ADJUSTED (b) | 47.1% 46.9% 49.8% 41.4% | 39.6% 48.1% 45.8% 44.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 2/9 (22%) | 0/9 (0%) 1/8 (13%) 0/9 (0%) 0/6 (0%) | |TERMINAL (d) | 16/39 (41%) 20/46 (43%) 13/38 (34%) 13/42 (31%) | 11/38 (29%) 11/35 (31%) 14/40 (35%) 16/43 (37%) | |FIRST INCIDENCE (DAYS) | 595 619 409 456 (I) | 461 457 (I) 548 418 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.519N P=0.488N P=0.278 P=0.509N | P=0.514N P=0.198 P=0.366 P=0.458 | |INCIDENTAL TUMOR | P=0.461N P=0.463 P=0.348 P=0.412N | P=0.225 P=0.327 P=0.290 P=0.292 | |LOGISTIC REGRESSION | P=0.484N P=0.326 P=0.275 P=0.566 | P=0.165 P=0.186 P=0.189 P=0.332 | |COCHRAN-ARMITAGE | P=0.518N | P=0.316 | |FISHER EXACT | P=0.425 P=0.287 P=0.576N | P=0.221 P=0.281 P=0.281 | |=================================================================================================================================| DATE: 04/04/96 EXPERIMENT: 05217 TEST: 05 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- T-BUTYLHYDROQUINONE MALE TERMINAL SACRIFICE AT 104 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.125% 0.25% 0.5% | UNTREATD 0.125% 0.25% 0.5% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 40/60 (67%) 46/60 (77%) 45/60 (75%) 39/60 (65%) | 33/60 (55%) 42/60 (70%) 38/60 (63%) 33/60 (55%) | |ADJUSTED (b) | 81.5% 88.4% 84.7% 74.8% | 67.2% 83.9% 74.4% 65.8% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 2/10 (20%) 3/9 (33%) 3/9 (33%) | 1/9 (11%) 1/8 (13%) 2/9 (22%) 0/6 (0%) | |TERMINAL (d) | 30/39 (77%) 40/46 (87%) 30/38 (79%) 29/42 (69%) | 22/38 (58%) 27/35 (77%) 27/40 (68%) 26/43 (60%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 409 456 (I) | 457 (I) 457 (I) 457 (I) 82 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.358N P=0.560N P=0.200 P=0.375N | P=0.120N P=0.058 P=0.359 P=0.333N | |INCIDENTAL TUMOR | P=0.358N P=0.121 P=0.213 P=0.493N | P=0.365N P=0.063 P=0.208 P=0.542N | |LOGISTIC REGRESSION | P=0.331N P=0.091 P=0.159 P=0.520N | P=0.247N P=0.033 * P=0.154 P=0.515N | |COCHRAN-ARMITAGE | P=0.333N | P=0.344N | |FISHER EXACT | P=0.156 P=0.211 P=0.500N | P=0.066 P=0.229 P=0.573N | |=================================================================================================================================| (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).