TDMS Study 05103-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL DATE: 05/19/95 EXPERIMENT: 05103 TEST: 04 TIME: 19:23:07 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-85234 ROUTE: DOSED FEED NTP C#: 55516C PATHOLOGIST: DR J. HEATH LEININGER, JOEL CAS: 3296-90-0 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL DATE: 05/19/95 EXPERIMENT: 05103 TEST: 04 TIME: 19:23:07 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-85234 ROUTE: DOSED FEED NTP C#: 55516C PATHOLOGIST: DR J. HEATH LEININGER, JOEL CAS: 3296-90-0 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 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL DATE: 05/19/95 EXPERIMENT: 05103 TEST: 04 TIME: 19:23:07 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-85234 ROUTE: DOSED FEED NTP C#: 55516C PATHOLOGIST: DR J. HEATH LEININGER, JOEL CAS: 3296-90-0 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL ==================================================================================================== MALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Harderian Gland Adenoma Carcinoma Carcinoma or Adenoma Intestine Small: Jejunum Carcinoma Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Stomach, Forestomach Squamous Cell Carcinoma Squamous Cell Carcinoma or Papilloma Squamous Thyroid Gland: Follicular Cell Adenoma All Organs Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== FEMALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Harderian Gland Adenoma Carcinoma Carcinoma or Adenoma Liver Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Mammary Gland Carcinoma Skin Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma Hemangiosarcoma Sarcoma Stomach, Forestomach Squamous Cell Carcinoma or Papilloma Squamous Squamous Cell Papilloma Uterus Carcinoma Sarcoma Stromal All Organs Hemangiosarcoma Hemangiosarcoma or Hemangioma Malignant Lymphoma And Histiocytic Sarcoma Benign Tumors Malignant Tumors Malignant and Benign Tumors NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL DATE: 05/19/95 EXPERIMENT: 05103 TEST: 04 TIME: 19:23:07 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-85234 ROUTE: DOSED FEED NTP C#: 55516C PATHOLOGIST: DR J. HEATH LEININGER, JOEL CAS: 3296-90-0 ==================================================================================================== DATE: 05/19/95 EXPERIMENT: 05103 TEST: 04 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.0312% 0.0625% 0.125% | UNTREATD 0.0312% 0.0625% 0.125% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/59 (0%) 2/59 (3%) 0/60 (0%) 0/59 (0%) | 0/59 (0%) 1/60 (2%) 0/60 (0%) 0/59 (0%) | |ADJUSTED (b) | 0.0% 5.7% 0.0% 0.0% | 0.0% 3.3% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/42 (0%) 2/35 (6%) 0/35 (0%) 0/30 (0%) | 0/37 (0%) 1/30 (3%) 0/26 (0%) 0/11 (0%) | |FIRST INCIDENCE (DAYS) | --- 736 (T) --- --- | --- 743 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.467N P=0.199 (e) (e) | P=0.739N P=0.458 (e) (e) | |INCIDENTAL TUMOR | P=0.467N P=0.199 (e) (e) | P=0.739N P=0.458 (e) (e) | |LOGISTIC REGRESSION | P=0.467N P=0.199 (e) (e) | P=0.739N P=0.458 (e) (e) | |COCHRAN-ARMITAGE | P=0.404N | P=0.568N | |FISHER EXACT | P=0.248 (e) (e) | P=0.504 (e) (e) | |=================================================================================================================================| | | |Bone Marrow | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/59 (0%) 2/60 (3%) 0/60 (0%) 0/59 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 5.6% 0.0% 0.0% | 0.0% 0.0% 0.0% 7.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/42 (0%) 2/36 (6%) 0/35 (0%) 0/30 (0%) | 0/37 (0%) 0/30 (0%) 0/26 (0%) 0/11 (0%) | |FIRST INCIDENCE (DAYS) | --- 736 (T) --- --- | --- --- --- 677 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.468N P=0.205 (e) (e) | P=0.087 (e) (e) P=0.301 | |INCIDENTAL TUMOR | P=0.468N P=0.205 (e) (e) | P=0.331 (e) (e) P=0.826 | |LOGISTIC REGRESSION | P=0.468N P=0.205 (e) (e) | P=0.167 (e) (e) P=0.445 | |COCHRAN-ARMITAGE | P=0.405N | P=0.198 | |FISHER EXACT | P=0.252 (e) (e) | (e) (e) P=0.500 | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05103 TEST: 04 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.0312% 0.0625% 0.125% | UNTREATD 0.0312% 0.0625% 0.125% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 6/60 (10%) 13/60 (22%) 21/59 (36%) | 3/60 (5%) 7/60 (12%) 8/60 (13%) 19/60 (32%) | |ADJUSTED (b) | 7.1% 15.6% 32.2% 50.3% | 5.7% 19.1% 23.7% 58.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 1/10 (10%) 3/10 (30%) | 1/8 (13%) 1/10 (10%) 0/9 (0%) 4/10 (40%) | |TERMINAL (d) | 3/42 (7%) 4/36 (11%) 9/35 (26%) 11/30 (37%) | 0/37 (0%) 3/30 (10%) 4/26 (15%) 3/11 (27%) | |FIRST INCIDENCE (DAYS) | 736 (T) 656 456 (I) 456 (I) | 447 456 (I) 557 456 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.182 P=0.003 ** P<0.001 ** | P<0.001 ** P=0.147 P=0.072 P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P=0.290 P=0.011 * P<0.001 ** | P<0.001 ** P=0.262 P=0.096 P=0.002 ** | |LOGISTIC REGRESSION | P<0.001 ** P=0.205 P=0.006 ** P<0.001 ** | P<0.001 ** P=0.245 P=0.103 P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** | |FISHER EXACT | P=0.245 P=0.007 ** P<0.001 ** | P=0.161 P=0.102 P<0.001 ** | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 1/60 (2%) 4/60 (7%) 4/59 (7%) | 1/60 (2%) 6/60 (10%) 5/60 (8%) 7/60 (12%) | |ADJUSTED (b) | 2.3% 2.8% 10.1% 10.9% | 2.5% 17.6% 16.1% 25.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/42 (0%) 1/36 (3%) 2/35 (6%) 1/30 (3%) | 0/37 (0%) 4/30 (13%) 3/26 (12%) 0/11 (0%) | |FIRST INCIDENCE (DAYS) | 674 736 (T) 666 589 | 646 627 669 575 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.047 * P=0.732 P=0.153 P=0.127 | P=0.002 ** P=0.043 * P=0.073 P=0.007 ** | |INCIDENTAL TUMOR | P=0.163 P=0.669N P=0.460 P=0.487 | P=0.088 P=0.067 P=0.224 P=0.395 | |LOGISTIC REGRESSION | P=0.064 P=0.751 P=0.173 P=0.163 | P=0.096 P=0.054 P=0.096 P=0.022 * | |COCHRAN-ARMITAGE | P=0.074 | P=0.058 | |FISHER EXACT | P=0.752N P=0.182 P=0.177 | P=0.057 P=0.103 P=0.031 * | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05103 TEST: 04 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.0312% 0.0625% 0.125% | UNTREATD 0.0312% 0.0625% 0.125% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/60 (7%) 7/60 (12%) 17/60 (28%) 25/59 (42%) | 4/60 (7%) 13/60 (22%) 13/60 (22%) 23/60 (38%) | |ADJUSTED (b) | 9.3% 18.2% 40.4% 56.8% | 8.1% 34.4% 37.5% 66.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 1/10 (10%) 3/10 (30%) | 1/8 (13%) 1/10 (10%) 0/9 (0%) 4/10 (40%) | |TERMINAL (d) | 3/42 (7%) 5/36 (14%) 11/35 (31%) 12/30 (40%) | 0/37 (0%) 7/30 (23%) 7/26 (27%) 3/11 (27%) | |FIRST INCIDENCE (DAYS) | 674 656 456 (I) 456 (I) | 447 456 (I) 557 456 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.194 P<0.001 ** P<0.001 ** | P<0.001 ** P=0.015 * P=0.010 * P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P=0.354 P=0.007 ** P<0.001 ** | P<0.001 ** P=0.037 * P=0.035 * P=0.004 ** | |LOGISTIC REGRESSION | P<0.001 ** P=0.221 P=0.001 ** P<0.001 ** | P<0.001 ** P=0.028 * P=0.018 * P=0.002 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** | |FISHER EXACT | P=0.264 P=0.002 ** P<0.001 ** | P=0.017 * P=0.017 * P<0.001 ** | |=================================================================================================================================| | | |Intestine Small: Jejunum | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 2/59 (3%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 5.9% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/42 (0%) 0/36 (0%) 0/35 (0%) 1/30 (3%) | 0/37 (0%) 0/30 (0%) 0/26 (0%) 0/11 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 669 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.035 * (e) (e) P=0.188 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.056 (e) (e) P=0.336 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.040 * (e) (e) P=0.214 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.045 * | (e) | |FISHER EXACT | (e) (e) P=0.244 | (e) (e) (e) | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05103 TEST: 04 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.0312% 0.0625% 0.125% | UNTREATD 0.0312% 0.0625% 0.125% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Intestine Small: Site Unspecified | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 2/59 (3%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 1.8% 0.0% 5.9% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/9 (11%) 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/42 (0%) 0/36 (0%) 0/35 (0%) 1/30 (3%) | 0/37 (0%) 0/30 (0%) 0/26 (0%) 0/11 (0%) | |FIRST INCIDENCE (DAYS) | --- 456 (I) --- 669 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.122 P=0.479 (e) P=0.188 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.170 P=0.479 (e) P=0.336 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.139 P=0.592 (e) P=0.214 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.137 | (e) | |FISHER EXACT | P=0.500 (e) P=0.244 | (e) (e) (e) | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/59 (2%) 1/59 (2%) 1/59 (2%) 2/59 (3%) | 1/59 (2%) 3/60 (5%) 2/58 (3%) 2/59 (3%) | |ADJUSTED (b) | 2.4% 2.8% 2.9% 6.3% | 2.1% 10.0% 6.4% 13.2% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 1/42 (2%) 1/36 (3%) 1/35 (3%) 1/30 (3%) | 0/37 (0%) 3/30 (10%) 0/26 (0%) 1/11 (9%) | |FIRST INCIDENCE (DAYS) | 736 (T) 736 (T) 736 (T) 705 | 569 743 (T) 707 669 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.260 P=0.727 P=0.721 P=0.392 | P=0.164 P=0.252 P=0.456 P=0.274 | |INCIDENTAL TUMOR | P=0.331 P=0.727 P=0.721 P=0.576 | P=0.503 P=0.263 P=0.696N P=0.585 | |LOGISTIC REGRESSION | P=0.290 P=0.727 P=0.721 P=0.437 | P=0.329 P=0.295 P=0.494 P=0.444 | |COCHRAN-ARMITAGE | P=0.351 | P=0.497 | |FISHER EXACT | P=0.752N P=0.752N P=0.500 | P=0.316 P=0.494 P=0.500 | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05103 TEST: 04 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.0312% 0.0625% 0.125% | UNTREATD 0.0312% 0.0625% 0.125% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/59 (0%) 0/60 (0%) 3/60 (5%) 2/59 (3%) | 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/59 (0%) | |ADJUSTED (b) | 0.0% 0.0% 8.0% 6.7% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/42 (0%) 0/36 (0%) 2/35 (6%) 2/30 (7%) | 0/37 (0%) 0/30 (0%) 0/26 (0%) 0/11 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 669 736 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.060 (e) P=0.100 P=0.168 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.082 (e) P=0.170 P=0.168 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.073 (e) P=0.113 P=0.168 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.096 | (e) | |FISHER EXACT | (e) P=0.125 P=0.248 | (e) (e) (e) | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/59 (2%) 2/60 (3%) 0/59 (0%) 2/59 (3%) | 0/59 (0%) 0/60 (0%) 0/59 (0%) 0/59 (0%) | |ADJUSTED (b) | 2.4% 5.6% 0.0% 6.7% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 1/42 (2%) 2/36 (6%) 0/35 (0%) 2/30 (7%) | 0/37 (0%) 0/30 (0%) 0/26 (0%) 0/11 (0%) | |FIRST INCIDENCE (DAYS) | 736 (T) 736 (T) --- 736 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.365 P=0.446 P=0.536N P=0.383 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.365 P=0.446 P=0.536N P=0.383 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.365 P=0.446 P=0.536N P=0.383 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.468 | (e) | |FISHER EXACT | P=0.506 P=0.500N P=0.500 | (e) (e) (e) | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05103 TEST: 04 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.0312% 0.0625% 0.125% | UNTREATD 0.0312% 0.0625% 0.125% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 22/59 (37%) 24/60 (40%) 20/59 (34%) 21/59 (36%) | 16/59 (27%) 12/60 (20%) 6/59 (10%) 17/59 (29%) | |ADJUSTED (b) | 44.8% 54.3% 48.9% 51.3% | 39.4% 36.8% 19.4% 74.6% | |INTERIM SACRIFICE 1 (c)| 4/10 (40%) 4/9 (44%) 1/10 (10%) 2/10 (20%) | 0/8 (0%) 0/10 (0%) 1/9 (11%) 1/10 (10%) | |TERMINAL (d) | 16/42 (38%) 17/36 (47%) 15/35 (43%) 12/30 (40%) | 13/37 (35%) 10/30 (33%) 4/26 (15%) 7/11 (64%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 456 (I) 447 | 569 627 456 (I) 456 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.301 P=0.221 P=0.499 P=0.273 | P=0.002 ** P=0.458N P=0.074N P=0.002 ** | |INCIDENTAL TUMOR | P=0.492N P=0.310 P=0.445N P=0.558 | P=0.076 P=0.377N P=0.053N P=0.120 | |LOGISTIC REGRESSION | P=0.442N P=0.410 P=0.442N P=0.542N | P=0.095 P=0.313N P=0.010N* P=0.124 | |COCHRAN-ARMITAGE | P=0.393N | P=0.419 | |FISHER EXACT | P=0.454 P=0.424N P=0.500N | P=0.242N P=0.016N* P=0.500 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/59 (19%) 17/60 (28%) 15/59 (25%) 9/59 (15%) | 5/59 (8%) 8/60 (13%) 5/59 (8%) 3/59 (5%) | |ADJUSTED (b) | 22.7% 39.7% 34.3% 22.2% | 13.5% 20.2% 17.2% 19.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 2/10 (20%) | 0/8 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 5/42 (12%) 11/36 (31%) 7/35 (20%) 3/30 (10%) | 5/37 (14%) 2/30 (7%) 4/26 (15%) 1/11 (9%) | |FIRST INCIDENCE (DAYS) | 478 543 579 456 (I) | 743 (T) 579 557 642 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.471N P=0.094 P=0.183 P=0.582 | P=0.411 P=0.211 P=0.423 P=0.345 | |INCIDENTAL TUMOR | P=0.070N P=0.157 P=0.555 P=0.170N | P=0.284N P=0.426 P=0.412 P=0.605 | |LOGISTIC REGRESSION | P=0.103N P=0.211 P=0.536 P=0.210N | P=0.384N P=0.259 P=0.579 P=0.515 | |COCHRAN-ARMITAGE | P=0.234N | P=0.189N | |FISHER EXACT | P=0.152 P=0.253 P=0.403N | P=0.290 P=0.629N P=0.358N | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05103 TEST: 04 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.0312% 0.0625% 0.125% | UNTREATD 0.0312% 0.0625% 0.125% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/59 (19%) 17/60 (28%) 15/59 (25%) 9/59 (15%) | 5/59 (8%) 8/60 (13%) 5/59 (8%) 3/59 (5%) | |ADJUSTED (b) | 22.7% 39.7% 34.3% 22.2% | 13.5% 20.2% 17.2% 19.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 2/10 (20%) | 0/8 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 5/42 (12%) 11/36 (31%) 7/35 (20%) 3/30 (10%) | 5/37 (14%) 2/30 (7%) 4/26 (15%) 1/11 (9%) | |FIRST INCIDENCE (DAYS) | 478 543 579 456 (I) | 743 (T) 579 557 642 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.471N P=0.094 P=0.183 P=0.582 | P=0.411 P=0.211 P=0.423 P=0.345 | |INCIDENTAL TUMOR | P=0.070N P=0.157 P=0.555 P=0.170N | P=0.284N P=0.426 P=0.412 P=0.605 | |LOGISTIC REGRESSION | P=0.103N P=0.211 P=0.536 P=0.210N | P=0.384N P=0.259 P=0.579 P=0.515 | |COCHRAN-ARMITAGE | P=0.234N | P=0.189N | |FISHER EXACT | P=0.152 P=0.253 P=0.403N | P=0.290 P=0.629N P=0.358N | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 31/59 (53%) 36/60 (60%) 28/59 (47%) 27/59 (46%) | 20/59 (34%) 19/60 (32%) 10/59 (17%) 19/59 (32%) | |ADJUSTED (b) | 58.1% 74.4% 61.6% 59.4% | 49.5% 48.7% 31.8% 77.5% | |INTERIM SACRIFICE 1 (c)| 4/10 (40%) 4/9 (44%) 1/10 (10%) 4/10 (40%) | 0/8 (0%) 0/10 (0%) 1/9 (11%) 1/10 (10%) | |TERMINAL (d) | 20/42 (48%) 24/36 (67%) 18/35 (51%) 13/30 (43%) | 17/37 (46%) 11/30 (37%) 7/26 (27%) 7/11 (64%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 456 (I) 447 | 569 579 456 (I) 456 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.482 P=0.093 P=0.508 P=0.389 | P=0.006 ** P=0.415 P=0.146N P=0.002 ** | |INCIDENTAL TUMOR | P=0.085N P=0.203 P=0.227N P=0.197N | P=0.280 P=0.502N P=0.117N P=0.165 | |LOGISTIC REGRESSION | P=0.115N P=0.214 P=0.238N P=0.298N | P=0.240 P=0.568N P=0.021N* P=0.149 | |COCHRAN-ARMITAGE | P=0.143N | P=0.393N | |FISHER EXACT | P=0.263 P=0.356N P=0.290N | P=0.474N P=0.028N* P=0.500N | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05103 TEST: 04 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.0312% 0.0625% 0.125% | UNTREATD 0.0312% 0.0625% 0.125% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 31/59 (53%) 36/60 (60%) 28/59 (47%) 27/59 (46%) | 20/59 (34%) 19/60 (32%) 10/59 (17%) 19/59 (32%) | |ADJUSTED (b) | 58.1% 74.4% 61.6% 59.4% | 49.5% 48.7% 31.8% 77.5% | |INTERIM SACRIFICE 1 (c)| 4/10 (40%) 4/9 (44%) 1/10 (10%) 4/10 (40%) | 0/8 (0%) 0/10 (0%) 1/9 (11%) 1/10 (10%) | |TERMINAL (d) | 20/42 (48%) 24/36 (67%) 18/35 (51%) 13/30 (43%) | 17/37 (46%) 11/30 (37%) 7/26 (27%) 7/11 (64%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 456 (I) 447 | 569 579 456 (I) 456 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.482 P=0.093 P=0.508 P=0.389 | P=0.006 ** P=0.415 P=0.146N P=0.002 ** | |INCIDENTAL TUMOR | P=0.085N P=0.203 P=0.227N P=0.197N | P=0.280 P=0.502N P=0.117N P=0.165 | |LOGISTIC REGRESSION | P=0.115N P=0.214 P=0.238N P=0.298N | P=0.240 P=0.568N P=0.021N* P=0.149 | |COCHRAN-ARMITAGE | P=0.143N | P=0.393N | |FISHER EXACT | P=0.263 P=0.356N P=0.290N | P=0.474N P=0.028N* P=0.500N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 14/60 (23%) 5/60 (8%) 16/60 (27%) 21/59 (36%) | 4/60 (7%) 3/60 (5%) 9/60 (15%) 19/60 (32%) | |ADJUSTED (b) | 29.6% 11.9% 35.3% 57.6% | 9.3% 8.8% 29.1% 65.5% | |INTERIM SACRIFICE 1 (c)| 2/10 (20%) 1/9 (11%) 4/10 (40%) 0/10 (0%) | 1/8 (13%) 0/10 (0%) 0/9 (0%) 2/10 (20%) | |TERMINAL (d) | 10/42 (24%) 3/36 (8%) 9/35 (26%) 15/30 (50%) | 2/37 (5%) 2/30 (7%) 5/26 (19%) 4/11 (36%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 456 (I) 593 | 456 (I) 619 669 456 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.002 ** P=0.049N* P=0.278 P=0.017 * | P<0.001 ** P=0.553N P=0.056 P<0.001 ** | |INCIDENTAL TUMOR | P=0.009 ** P=0.028N* P=0.368 P=0.111 | P<0.001 ** P=0.527N P=0.208 P=0.005 ** | |LOGISTIC REGRESSION | P=0.007 ** P=0.025N* P=0.422 P=0.057 | P<0.001 ** P=0.506N P=0.106 P<0.001 ** | |COCHRAN-ARMITAGE | P=0.010 ** | P<0.001 ** | |FISHER EXACT | P=0.022N* P=0.417 P=0.103 | P=0.500N P=0.120 P<0.001 ** | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05103 TEST: 04 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.0312% 0.0625% 0.125% | UNTREATD 0.0312% 0.0625% 0.125% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/60 (5%) 7/60 (12%) 8/60 (13%) 12/59 (20%) | 3/60 (5%) 2/60 (3%) 6/60 (10%) 5/60 (8%) | |ADJUSTED (b) | 7.1% 18.7% 19.9% 34.7% | 6.9% 6.7% 17.4% 33.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/10 (10%) | 1/8 (13%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 3/42 (7%) 6/36 (17%) 5/35 (14%) 9/30 (30%) | 1/37 (3%) 2/30 (7%) 3/26 (12%) 2/11 (18%) | |FIRST INCIDENCE (DAYS) | 736 (T) 646 572 456 (I) | 456 (I) 743 (T) 428 669 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.002 ** P=0.108 P=0.068 P=0.002 ** | P=0.012 * P=0.555N P=0.177 P=0.044 * | |INCIDENTAL TUMOR | P=0.005 ** P=0.140 P=0.122 P=0.005 ** | P=0.176 P=0.445N P=0.315 P=0.541 | |LOGISTIC REGRESSION | P=0.005 ** P=0.125 P=0.090 P=0.006 ** | P=0.100 P=0.508N P=0.245 P=0.176 | |COCHRAN-ARMITAGE | P=0.009 ** | P=0.191 | |FISHER EXACT | P=0.161 P=0.102 P=0.011 * | P=0.500N P=0.245 P=0.359 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 17/60 (28%) 12/60 (20%) 20/60 (33%) 26/59 (44%) | 7/60 (12%) 5/60 (8%) 15/60 (25%) 21/60 (35%) | |ADJUSTED (b) | 36.2% 29.6% 43.0% 67.5% | 15.8% 15.3% 43.2% 72.9% | |INTERIM SACRIFICE 1 (c)| 2/10 (20%) 1/9 (11%) 4/10 (40%) 1/10 (10%) | 2/8 (25%) 0/10 (0%) 0/9 (0%) 2/10 (20%) | |TERMINAL (d) | 13/42 (31%) 9/36 (25%) 11/35 (31%) 18/30 (60%) | 3/37 (8%) 4/30 (13%) 8/26 (31%) 5/11 (45%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 456 (I) 456 (I) | 456 (I) 619 428 456 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.001 ** P=0.334N P=0.206 P=0.005 ** | P<0.001 ** P=0.458N P=0.019 * P<0.001 ** | |INCIDENTAL TUMOR | P=0.009 ** P=0.228N P=0.366 P=0.043 * | P<0.001 ** P=0.366N P=0.110 P=0.021 * | |LOGISTIC REGRESSION | P=0.006 ** P=0.228N P=0.342 P=0.025 * | P<0.001 ** P=0.390N P=0.046 * P<0.001 ** | |COCHRAN-ARMITAGE | P=0.010 * | P<0.001 ** | |FISHER EXACT | P=0.197N P=0.346 P=0.055 | P=0.381N P=0.049 * P=0.002 ** | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05103 TEST: 04 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.0312% 0.0625% 0.125% | UNTREATD 0.0312% 0.0625% 0.125% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/59 (0%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 3/60 (5%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 3.8% 8.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/42 (0%) 0/36 (0%) 0/35 (0%) 0/30 (0%) | 0/37 (0%) 0/30 (0%) 1/26 (4%) 0/11 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- 743 (T) 520 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.006 ** (e) P=0.430 P=0.083 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.038 * (e) P=0.430 P=0.241 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.023 * (e) P=0.430 P=0.149 | |COCHRAN-ARMITAGE | (e) | P=0.020 * | |FISHER EXACT | (e) (e) (e) | (e) P=0.500 P=0.122 | |=================================================================================================================================| | | |Ovary | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 2/59 (3%) 0/59 (0%) 1/60 (2%) 0/57 (0%) | |ADJUSTED (b) | | 5.6% 0.0% 3.8% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/8 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | | 2/36 (6%) 0/29 (0%) 1/26 (4%) 0/11 (0%) | |FIRST INCIDENCE (DAYS) | | 743 (T) --- 743 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.375N P=0.287N P=0.613N P=0.521N | |INCIDENTAL TUMOR | | P=0.375N P=0.287N P=0.613N P=0.521N | |LOGISTIC REGRESSION | | P=0.375N P=0.287N P=0.613N P=0.521N | |COCHRAN-ARMITAGE | | P=0.192N | |FISHER EXACT | | P=0.248N P=0.494N P=0.257N | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05103 TEST: 04 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.0312% 0.0625% 0.125% | UNTREATD 0.0312% 0.0625% 0.125% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Ovary | | Luteoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 0/59 (0%) 0/59 (0%) 2/60 (3%) 0/57 (0%) | |ADJUSTED (b) | | 0.0% 0.0% 7.7% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/8 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | | 0/36 (0%) 0/29 (0%) 2/26 (8%) 0/11 (0%) | |FIRST INCIDENCE (DAYS) | | --- --- 743 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.376 (e) P=0.170 (e) | |INCIDENTAL TUMOR | | P=0.376 (e) P=0.170 (e) | |LOGISTIC REGRESSION | | P=0.376 (e) P=0.170 (e) | |COCHRAN-ARMITAGE | | P=0.589 | |FISHER EXACT | | (e) P=0.252 (e) | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/57 (0%) 0/54 (0%) 0/59 (0%) 0/54 (0%) | 4/58 (7%) 8/58 (14%) 3/57 (5%) 5/56 (9%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 10.8% 24.0% 9.6% 21.9% | |INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) | 0/8 (0%) 0/10 (0%) 1/9 (11%) 0/10 (0%) | |TERMINAL (d) | 0/42 (0%) 0/34 (0%) 0/35 (0%) 0/30 (0%) | 4/37 (11%) 5/29 (17%) 2/25 (8%) 1/11 (9%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 743 (T) 619 456 (I) 537 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.129 P=0.098 P=0.640 P=0.093 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.423 P=0.165 P=0.640 P=0.314 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.414 P=0.128 P=0.640 P=0.346 | |COCHRAN-ARMITAGE | (e) | P=0.526N | |FISHER EXACT | (e) (e) (e) | P=0.181 P=0.510N P=0.478 | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05103 TEST: 04 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.0312% 0.0625% 0.125% | UNTREATD 0.0312% 0.0625% 0.125% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/57 (0%) 0/54 (0%) 0/59 (0%) 1/54 (2%) | 4/58 (7%) 8/58 (14%) 4/57 (7%) 5/56 (9%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 1.8% | 10.8% 24.0% 13.5% 21.9% | |INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) | 0/8 (0%) 0/10 (0%) 1/9 (11%) 0/10 (0%) | |TERMINAL (d) | 0/42 (0%) 0/34 (0%) 0/35 (0%) 0/30 (0%) | 4/37 (11%) 5/29 (17%) 3/25 (12%) 1/11 (9%) | |FIRST INCIDENCE (DAYS) | --- --- --- 447 | 743 (T) 619 456 (I) 537 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.196 (e) (e) P=0.493 | P=0.105 P=0.098 P=0.456 P=0.093 | |INCIDENTAL TUMOR | P=0.325 (e) (e) P=0.718 | P=0.371 P=0.165 P=0.456 P=0.314 | |LOGISTIC REGRESSION | P=0.154 (e) (e) P=0.993 | P=0.375 P=0.128 P=0.456 P=0.346 | |COCHRAN-ARMITAGE | P=0.193 | P=0.542N | |FISHER EXACT | (e) (e) P=0.486 | P=0.181 P=0.632 P=0.478 | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 0/59 (0%) | 0/60 (0%) 2/60 (3%) 4/60 (7%) 12/60 (20%) | |ADJUSTED (b) | 0.0% 0.0% 5.7% 0.0% | 0.0% 5.9% 11.1% 42.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/42 (0%) 0/36 (0%) 2/35 (6%) 0/30 (0%) | 0/37 (0%) 0/30 (0%) 1/26 (4%) 1/11 (9%) | |FIRST INCIDENCE (DAYS) | --- --- 736 (T) --- | --- 677 536 480 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.531 (e) P=0.199 (e) | P<0.001 ** P=0.212 P=0.053 P<0.001 ** | |INCIDENTAL TUMOR | P=0.531 (e) P=0.199 (e) | P=0.002 ** P=0.500 P=0.141 P=0.017 * | |LOGISTIC REGRESSION | P=0.531 (e) P=0.199 (e) | P<0.001 ** P=0.232 P=0.063 P<0.001 ** | |COCHRAN-ARMITAGE | P=0.591 | P<0.001 ** | |FISHER EXACT | (e) P=0.248 (e) | P=0.248 P=0.059 P<0.001 ** | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05103 TEST: 04 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.0312% 0.0625% 0.125% | UNTREATD 0.0312% 0.0625% 0.125% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 0/59 (0%) | 0/60 (0%) 2/60 (3%) 4/60 (7%) 12/60 (20%) | |ADJUSTED (b) | 0.0% 0.0% 5.7% 0.0% | 0.0% 5.9% 11.1% 42.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/42 (0%) 0/36 (0%) 2/35 (6%) 0/30 (0%) | 0/37 (0%) 0/30 (0%) 1/26 (4%) 1/11 (9%) | |FIRST INCIDENCE (DAYS) | --- --- 736 (T) --- | --- 677 536 480 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.531 (e) P=0.199 (e) | P<0.001 ** P=0.212 P=0.053 P<0.001 ** | |INCIDENTAL TUMOR | P=0.531 (e) P=0.199 (e) | P=0.002 ** P=0.500 P=0.141 P=0.017 * | |LOGISTIC REGRESSION | P=0.531 (e) P=0.199 (e) | P<0.001 ** P=0.232 P=0.063 P<0.001 ** | |COCHRAN-ARMITAGE | P=0.591 | P<0.001 ** | |FISHER EXACT | (e) P=0.248 (e) | P=0.248 P=0.059 P<0.001 ** | |=================================================================================================================================| | | |Skin | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 0/59 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 2/60 (3%) | |ADJUSTED (b) | 0.0% 2.8% 0.0% 0.0% | 0.0% 0.0% 0.0% 15.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/42 (0%) 1/36 (3%) 0/35 (0%) 0/30 (0%) | 0/37 (0%) 0/30 (0%) 0/26 (0%) 1/11 (9%) | |FIRST INCIDENCE (DAYS) | --- 736 (T) --- --- | --- --- --- 677 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.614N P=0.469 (e) (e) | P=0.005 ** (e) (e) P=0.051 | |INCIDENTAL TUMOR | P=0.614N P=0.469 (e) (e) | P=0.033 * (e) (e) P=0.221 | |LOGISTIC REGRESSION | P=0.614N P=0.469 (e) (e) | P=0.017 * (e) (e) P=0.118 | |COCHRAN-ARMITAGE | P=0.570N | P=0.046 * | |FISHER EXACT | P=0.500 (e) (e) | (e) (e) P=0.248 | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05103 TEST: 04 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.0312% 0.0625% 0.125% | UNTREATD 0.0312% 0.0625% 0.125% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Skin | | Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 0/59 (0%) | 0/60 (0%) 1/60 (2%) 4/60 (7%) 11/60 (18%) | |ADJUSTED (b) | 0.0% 0.0% 5.7% 0.0% | 0.0% 3.1% 11.1% 38.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/42 (0%) 0/36 (0%) 2/35 (6%) 0/30 (0%) | 0/37 (0%) 0/30 (0%) 1/26 (4%) 1/11 (9%) | |FIRST INCIDENCE (DAYS) | --- --- 736 (T) --- | --- 696 536 480 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.531 (e) P=0.199 (e) | P<0.001 ** P=0.466 P=0.053 P<0.001 ** | |INCIDENTAL TUMOR | P=0.531 (e) P=0.199 (e) | P=0.002 ** P=0.718 P=0.141 P=0.021 * | |LOGISTIC REGRESSION | P=0.531 (e) P=0.199 (e) | P<0.001 ** P=0.494 P=0.063 P<0.001 ** | |COCHRAN-ARMITAGE | P=0.591 | P<0.001 ** | |FISHER EXACT | (e) P=0.248 (e) | P=0.500 P=0.059 P<0.001 ** | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/59 (0%) 3/60 (5%) 0/59 (0%) 0/59 (0%) | 0/59 (0%) 0/60 (0%) 0/59 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 8.3% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/42 (0%) 3/36 (8%) 0/35 (0%) 0/30 (0%) | 0/37 (0%) 0/30 (0%) 0/26 (0%) 0/11 (0%) | |FIRST INCIDENCE (DAYS) | --- 736 (T) --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.382N P=0.095 (e) (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.382N P=0.095 (e) (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.382N P=0.095 (e) (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.312N | (e) | |FISHER EXACT | P=0.125 (e) (e) | (e) (e) (e) | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05103 TEST: 04 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.0312% 0.0625% 0.125% | UNTREATD 0.0312% 0.0625% 0.125% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 2/59 (3%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 2.9% 5.9% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/42 (0%) 0/36 (0%) 1/35 (3%) 1/30 (3%) | 0/37 (0%) 0/30 (0%) 0/26 (0%) 0/11 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 736 (T) 669 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.049 * (e) P=0.464 P=0.188 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.073 (e) P=0.464 P=0.336 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.058 (e) P=0.464 P=0.214 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.068 | (e) | |FISHER EXACT | (e) P=0.500 P=0.244 | (e) (e) (e) | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma or Papilloma Squamous | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 3/60 (5%) 3/60 (5%) 5/59 (8%) | 0/60 (0%) 1/60 (2%) 5/60 (8%) 4/60 (7%) | |ADJUSTED (b) | 0.0% 8.0% 8.6% 13.9% | 0.0% 2.4% 16.6% 25.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/10 (10%) | 0/8 (0%) 0/10 (0%) 0/9 (0%) 1/10 (10%) | |TERMINAL (d) | 0/42 (0%) 2/36 (6%) 3/35 (9%) 3/30 (10%) | 0/37 (0%) 0/30 (0%) 3/26 (12%) 2/11 (18%) | |FIRST INCIDENCE (DAYS) | --- 683 736 (T) 456 (I) | --- 625 639 456 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.015 * P=0.100 P=0.091 P=0.019 * | P=0.001 ** P=0.495 P=0.017 * P=0.006 ** | |INCIDENTAL TUMOR | P=0.026 * P=0.158 P=0.091 P=0.033 * | P=0.013 * P=0.527 P=0.032 * P=0.027 * | |LOGISTIC REGRESSION | P=0.025 * P=0.108 P=0.091 P=0.030 * | P=0.012 * P=0.505 P=0.028 * P=0.041 * | |COCHRAN-ARMITAGE | P=0.032 * | P=0.032 * | |FISHER EXACT | P=0.122 P=0.122 P=0.027 * | P=0.500 P=0.029 * P=0.059 | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05103 TEST: 04 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.0312% 0.0625% 0.125% | UNTREATD 0.0312% 0.0625% 0.125% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 3/60 (5%) 2/60 (3%) 3/59 (5%) | 0/60 (0%) 1/60 (2%) 5/60 (8%) 4/60 (7%) | |ADJUSTED (b) | 0.0% 8.0% 5.7% 8.3% | 0.0% 2.4% 16.6% 25.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 1/10 (10%) | 0/8 (0%) 0/10 (0%) 0/9 (0%) 1/10 (10%) | |TERMINAL (d) | 0/42 (0%) 2/36 (6%) 2/35 (6%) 2/30 (7%) | 0/37 (0%) 0/30 (0%) 3/26 (12%) 2/11 (18%) | |FIRST INCIDENCE (DAYS) | --- 683 736 (T) 456 (I) | --- 625 639 456 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.103 P=0.100 P=0.199 P=0.086 | P=0.001 ** P=0.495 P=0.017 * P=0.006 ** | |INCIDENTAL TUMOR | P=0.134 P=0.158 P=0.199 P=0.086 | P=0.013 * P=0.527 P=0.032 * P=0.027 * | |LOGISTIC REGRESSION | P=0.145 P=0.108 P=0.199 P=0.121 | P=0.012 * P=0.505 P=0.028 * P=0.041 * | |COCHRAN-ARMITAGE | P=0.160 | P=0.032 * | |FISHER EXACT | P=0.122 P=0.248 P=0.119 | P=0.500 P=0.029 * P=0.059 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/59 (0%) 3/60 (5%) 0/59 (0%) 4/59 (7%) | 3/59 (5%) 1/60 (2%) 3/60 (5%) 0/59 (0%) | |ADJUSTED (b) | 0.0% 8.3% 0.0% 12.4% | 8.1% 3.3% 10.6% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 0/42 (0%) 3/36 (8%) 0/35 (0%) 3/30 (10%) | 3/37 (8%) 1/30 (3%) 2/26 (8%) 0/11 (0%) | |FIRST INCIDENCE (DAYS) | --- 736 (T) --- 669 | 743 (T) 743 (T) 709 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.035 * P=0.095 (e) P=0.034 * | P=0.429N P=0.382N P=0.509 P=0.396N | |INCIDENTAL TUMOR | P=0.047 * P=0.095 (e) P=0.061 | P=0.303N P=0.382N P=0.634 P=0.396N | |LOGISTIC REGRESSION | P=0.045 * P=0.095 (e) P=0.044 * | P=0.355N P=0.382N P=0.588 P=0.396N | |COCHRAN-ARMITAGE | P=0.067 | P=0.135N | |FISHER EXACT | P=0.125 (e) P=0.059 | P=0.303N P=0.652N P=0.122N | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05103 TEST: 04 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.0312% 0.0625% 0.125% | UNTREATD 0.0312% 0.0625% 0.125% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/59 (2%) 3/60 (5%) 0/59 (0%) 4/59 (7%) | 3/59 (5%) 1/60 (2%) 3/60 (5%) 0/59 (0%) | |ADJUSTED (b) | 2.4% 8.3% 0.0% 12.4% | 8.1% 3.3% 10.6% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) | |TERMINAL (d) | 1/42 (2%) 3/36 (8%) 0/35 (0%) 3/30 (10%) | 3/37 (8%) 1/30 (3%) 2/26 (8%) 0/11 (0%) | |FIRST INCIDENCE (DAYS) | 736 (T) 736 (T) --- 669 | 743 (T) 743 (T) 709 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.096 P=0.252 P=0.536N P=0.104 | P=0.429N P=0.382N P=0.509 P=0.396N | |INCIDENTAL TUMOR | P=0.121 P=0.252 P=0.536N P=0.164 | P=0.303N P=0.382N P=0.634 P=0.396N | |LOGISTIC REGRESSION | P=0.118 P=0.252 P=0.536N P=0.131 | P=0.355N P=0.382N P=0.588 P=0.396N | |COCHRAN-ARMITAGE | P=0.164 | P=0.135N | |FISHER EXACT | P=0.316 P=0.500N P=0.182 | P=0.303N P=0.652N P=0.122N | |=================================================================================================================================| | | |Uterus | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 0/60 (0%) 1/60 (2%) 2/60 (3%) 2/60 (3%) | |ADJUSTED (b) | | 0.0% 3.3% 7.7% 7.5% | |INTERIM SACRIFICE 1 (c)| | 0/8 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | | 0/37 (0%) 1/30 (3%) 2/26 (8%) 0/11 (0%) | |FIRST INCIDENCE (DAYS) | | --- 743 (T) 743 (T) 615 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.032 * P=0.458 P=0.164 P=0.148 | |INCIDENTAL TUMOR | | P=0.086 P=0.458 P=0.164 P=0.455 | |LOGISTIC REGRESSION | | P=0.078 P=0.458 P=0.164 P=0.216 | |COCHRAN-ARMITAGE | | P=0.160 | |FISHER EXACT | | P=0.500 P=0.248 P=0.248 | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05103 TEST: 04 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.0312% 0.0625% 0.125% | UNTREATD 0.0312% 0.0625% 0.125% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 3/60 (5%) 1/60 (2%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | | 8.1% 3.3% 0.0% 8.3% | |INTERIM SACRIFICE 1 (c)| | 0/8 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | | 3/37 (8%) 1/30 (3%) 0/26 (0%) 0/11 (0%) | |FIRST INCIDENCE (DAYS) | | 743 (T) 743 (T) --- 733 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.487N P=0.382N P=0.189N P=0.698 | |INCIDENTAL TUMOR | | P=0.327N P=0.382N P=0.189N P=0.485N | |LOGISTIC REGRESSION | | P=0.448N P=0.382N P=0.189N P=0.711N | |COCHRAN-ARMITAGE | | P=0.200N | |FISHER EXACT | | P=0.309N P=0.122N P=0.309N | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 0/60 (0%) 1/60 (2%) 0/60 (0%) 2/60 (3%) | |ADJUSTED (b) | | 0.0% 3.3% 0.0% 10.9% | |INTERIM SACRIFICE 1 (c)| | 0/8 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | | 0/37 (0%) 1/30 (3%) 0/26 (0%) 0/11 (0%) | |FIRST INCIDENCE (DAYS) | | --- 743 (T) --- 615 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.038 * P=0.458 (e) P=0.098 | |INCIDENTAL TUMOR | | P=0.154 P=0.458 (e) P=0.455 | |LOGISTIC REGRESSION | | P=0.087 P=0.458 (e) P=0.183 | |COCHRAN-ARMITAGE | | P=0.140 | |FISHER EXACT | | P=0.500 (e) P=0.248 | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05103 TEST: 04 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.0312% 0.0625% 0.125% | UNTREATD 0.0312% 0.0625% 0.125% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 3/60 (5%) 2/60 (3%) 0/60 (0%) 3/60 (5%) | |ADJUSTED (b) | | 8.1% 6.7% 0.0% 18.3% | |INTERIM SACRIFICE 1 (c)| | 0/8 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | | 3/37 (8%) 2/30 (7%) 0/26 (0%) 0/11 (0%) | |FIRST INCIDENCE (DAYS) | | 743 (T) 743 (T) --- 615 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.206 P=0.596N P=0.189N P=0.194 | |INCIDENTAL TUMOR | | P=0.479 P=0.596N P=0.189N P=0.677 | |LOGISTIC REGRESSION | | P=0.346 P=0.596N P=0.189N P=0.370 | |COCHRAN-ARMITAGE | | P=0.596 | |FISHER EXACT | | P=0.500N P=0.122N P=0.660N | |=================================================================================================================================| | | |All Organs | | Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 2/59 (3%) | 1/60 (2%) 2/60 (3%) 1/60 (2%) 2/60 (3%) | |ADJUSTED (b) | 0.0% 2.8% 0.0% 6.7% | 2.7% 5.6% 1.7% 7.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/10 (0%) 1/9 (11%) 0/10 (0%) | |TERMINAL (d) | 0/42 (0%) 1/36 (3%) 0/35 (0%) 2/30 (7%) | 1/37 (3%) 0/30 (0%) 0/26 (0%) 0/11 (0%) | |FIRST INCIDENCE (DAYS) | --- 736 (T) --- 736 (T) | 743 (T) 635 456 (I) 649 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.095 P=0.469 (e) P=0.168 | P=0.268 P=0.453 P=0.736 P=0.282 | |INCIDENTAL TUMOR | P=0.095 P=0.469 (e) P=0.168 | P=0.593N P=0.610 P=0.736 P=0.736 | |LOGISTIC REGRESSION | P=0.095 P=0.469 (e) P=0.168 | P=0.386 P=0.486 P=0.736 P=0.381 | |COCHRAN-ARMITAGE | P=0.137 | P=0.445 | |FISHER EXACT | P=0.500 (e) P=0.244 | P=0.500 P=0.752N P=0.500 | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05103 TEST: 04 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.0312% 0.0625% 0.125% | UNTREATD 0.0312% 0.0625% 0.125% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 5/60 (8%) 0/60 (0%) 4/59 (7%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 3/60 (5%) | |ADJUSTED (b) | 4.8% 13.3% 0.0% 13.3% | 0.0% 0.0% 0.0% 20.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 2/42 (5%) 4/36 (11%) 0/35 (0%) 4/30 (13%) | 0/37 (0%) 0/30 (0%) 0/26 (0%) 1/11 (9%) | |FIRST INCIDENCE (DAYS) | 736 (T) 656 --- 736 (T) | --- --- --- 672 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.296 P=0.165 P=0.279N P=0.195 | P<0.001 ** (e) (e) P=0.013 * | |INCIDENTAL TUMOR | P=0.341 P=0.218 P=0.279N P=0.195 | P=0.014 * (e) (e) P=0.185 | |LOGISTIC REGRESSION | P=0.346 P=0.185 P=0.279N P=0.195 | P=0.004 ** (e) (e) P=0.049 * | |COCHRAN-ARMITAGE | P=0.429 | P=0.012 * | |FISHER EXACT | P=0.219 P=0.248N P=0.332 | (e) (e) P=0.122 | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 6/60 (10%) 0/60 (0%) 5/59 (8%) | 1/60 (2%) 2/60 (3%) 1/60 (2%) 5/60 (8%) | |ADJUSTED (b) | 4.8% 16.0% 0.0% 16.7% | 2.7% 5.6% 1.7% 27.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/10 (0%) 1/9 (11%) 0/10 (0%) | |TERMINAL (d) | 2/42 (5%) 5/36 (14%) 0/35 (0%) 5/30 (17%) | 1/37 (3%) 0/30 (0%) 0/26 (0%) 1/11 (9%) | |FIRST INCIDENCE (DAYS) | 736 (T) 656 --- 736 (T) | 743 (T) 635 456 (I) 649 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.194 P=0.095 P=0.279N P=0.102 | P=0.005 ** P=0.453 P=0.736 P=0.008 ** | |INCIDENTAL TUMOR | P=0.227 P=0.128 P=0.279N P=0.102 | P=0.116 P=0.610 P=0.736 P=0.224 | |LOGISTIC REGRESSION | P=0.237 P=0.109 P=0.279N P=0.102 | P=0.017 * P=0.486 P=0.736 P=0.032 * | |COCHRAN-ARMITAGE | P=0.324 | P=0.048 * | |FISHER EXACT | P=0.136 P=0.248N P=0.213 | P=0.500 P=0.752N P=0.103 | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05103 TEST: 04 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.0312% 0.0625% 0.125% | UNTREATD 0.0312% 0.0625% 0.125% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 0/59 (0%) | 1/60 (2%) 4/60 (7%) 2/60 (3%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 4.8% 0.0% 0.0% | 2.7% 11.6% 7.3% 3.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/42 (0%) 0/36 (0%) 0/35 (0%) 0/30 (0%) | 1/37 (3%) 2/30 (7%) 1/26 (4%) 0/11 (0%) | |FIRST INCIDENCE (DAYS) | --- 586 --- --- | 743 (T) 579 726 610 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.442N P=0.224 (e) (e) | P=0.440 P=0.140 P=0.387 P=0.579 | |INCIDENTAL TUMOR | P=0.267N P=0.353 (e) (e) | P=0.443N P=0.208 P=0.575 P=0.688 | |LOGISTIC REGRESSION | P=0.409N P=0.236 (e) (e) | P=0.559N P=0.166 P=0.442 P=0.714 | |COCHRAN-ARMITAGE | P=0.408N | P=0.404N | |FISHER EXACT | P=0.248 (e) (e) | P=0.182 P=0.500 P=0.752N | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma And Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 5/60 (8%) 6/60 (10%) 4/59 (7%) | 6/60 (10%) 14/60 (23%) 11/60 (18%) 5/60 (8%) | |ADJUSTED (b) | 4.8% 12.7% 15.0% 12.1% | 15.0% 34.9% 33.5% 38.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 2/42 (5%) 3/36 (8%) 3/35 (9%) 3/30 (10%) | 5/37 (14%) 7/30 (23%) 6/26 (23%) 4/11 (36%) | |FIRST INCIDENCE (DAYS) | 736 (T) 586 662 592 | 285 386 543 610 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.215 P=0.171 P=0.102 P=0.213 | P=0.163 P=0.024 * P=0.054 P=0.126 | |INCIDENTAL TUMOR | P=0.401 P=0.229 P=0.277 P=0.244 | P=0.528N P=0.021 * P=0.079 P=0.069 | |LOGISTIC REGRESSION | P=0.291 P=0.192 P=0.122 P=0.278 | P=0.416N P=0.041 * P=0.068 P=0.112 | |COCHRAN-ARMITAGE | P=0.341 | P=0.231N | |FISHER EXACT | P=0.219 P=0.136 P=0.332 | P=0.042 * P=0.148 P=0.500N | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05103 TEST: 04 PAGE 22 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.0312% 0.0625% 0.125% | UNTREATD 0.0312% 0.0625% 0.125% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated | | Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 3/60 (5%) 6/60 (10%) 4/59 (7%) | 5/60 (8%) 10/60 (17%) 9/60 (15%) 4/60 (7%) | |ADJUSTED (b) | 4.8% 8.3% 15.0% 12.1% | 12.3% 25.3% 27.6% 36.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/8 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 2/42 (5%) 3/36 (8%) 3/35 (9%) 3/30 (10%) | 4/37 (11%) 5/30 (17%) 5/26 (19%) 4/11 (36%) | |FIRST INCIDENCE (DAYS) | 736 (T) 736 (T) 662 592 | 285 386 543 743 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.140 P=0.430 P=0.102 P=0.213 | P=0.194 P=0.091 P=0.092 P=0.167 | |INCIDENTAL TUMOR | P=0.244 P=0.430 P=0.277 P=0.244 | P=0.497 P=0.065 P=0.095 P=0.064 | |LOGISTIC REGRESSION | P=0.192 P=0.430 P=0.122 P=0.278 | P=0.439N P=0.136 P=0.105 P=0.556 | |COCHRAN-ARMITAGE | P=0.241 | P=0.293N | |FISHER EXACT | P=0.500 P=0.136 P=0.332 | P=0.135 P=0.197 P=0.500N | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 36/60 (60%) 33/60 (55%) 44/60 (73%) 49/59 (83%) | 28/60 (47%) 30/60 (50%) 31/60 (52%) 41/60 (68%) | |ADJUSTED (b) | 70.0% 70.9% 85.9% 97.9% | 61.2% 76.3% 76.1% 94.7% | |INTERIM SACRIFICE 1 (c)| 6/10 (60%) 4/9 (44%) 6/10 (60%) 6/10 (60%) | 2/8 (25%) 1/10 (10%) 3/9 (33%) 7/10 (70%) | |TERMINAL (d) | 27/42 (64%) 23/36 (64%) 28/35 (80%) 29/30 (97%) | 20/37 (54%) 21/30 (70%) 17/26 (65%) 9/11 (82%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 456 (I) 447 | 447 456 (I) 456 (I) 456 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.452 P=0.017 * P<0.001 ** | P<0.001 ** P=0.174 P=0.072 P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P=0.478N P=0.076 P=0.002 ** | P<0.001 ** P=0.298 P=0.237 P=0.004 ** | |LOGISTIC REGRESSION | P<0.001 ** P=0.424N P=0.074 P=0.002 ** | P<0.001 ** P=0.429 P=0.534 P=0.002 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P=0.008 ** | |FISHER EXACT | P=0.356N P=0.087 P=0.005 ** | P=0.428 P=0.358 P=0.013 * | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05103 TEST: 04 PAGE 23 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 0.0312% 0.0625% 0.125% | UNTREATD 0.0312% 0.0625% 0.125% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 17/60 (28%) 32/60 (53%) 24/60 (40%) 33/59 (56%) | 17/60 (28%) 32/60 (53%) 31/60 (52%) 36/60 (60%) | |ADJUSTED (b) | 35.2% 67.8% 52.9% 72.3% | 39.3% 66.2% 73.8% 91.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/9 (11%) 0/10 (0%) 3/10 (30%) | 1/8 (13%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 11/42 (26%) 21/36 (58%) 14/35 (40%) 18/30 (60%) | 12/37 (32%) 14/30 (47%) 16/26 (62%) 8/11 (73%) | |FIRST INCIDENCE (DAYS) | 478 456 (I) 572 447 | 285 386 397 456 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.001 ** P=0.002 ** P=0.066 P<0.001 ** | P<0.001 ** P=0.003 ** P=0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.027 * P=0.003 ** P=0.244 P=0.006 ** | P=0.004 ** P=0.008 ** P=0.005 ** P<0.001 ** | |LOGISTIC REGRESSION | P=0.016 * P=0.004 ** P=0.274 P=0.004 ** | P<0.001 ** P=0.003 ** P=0.007 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.010 ** | P=0.001 ** | |FISHER EXACT | P=0.004 ** P=0.124 P=0.002 ** | P=0.004 ** P=0.008 ** P<0.001 ** | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 43/60 (72%) 47/60 (78%) 51/60 (85%) 53/59 (90%) | 38/60 (63%) 43/60 (72%) 46/60 (77%) 49/60 (82%) | |ADJUSTED (b) | 78.0% 88.6% 92.7% 98.1% | 75.4% 87.6% 93.6% 97.9% | |INTERIM SACRIFICE 1 (c)| 6/10 (60%) 5/9 (56%) 6/10 (60%) 8/10 (80%) | 3/8 (38%) 1/10 (10%) 3/9 (33%) 7/10 (70%) | |TERMINAL (d) | 30/42 (71%) 30/36 (83%) 31/35 (89%) 29/30 (97%) | 25/37 (68%) 24/30 (80%) 23/26 (88%) 10/11 (91%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 456 (I) 447 | 285 386 397 456 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.077 P=0.018 * P<0.001 ** | P<0.001 ** P=0.083 P=0.009 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.012 * P=0.231 P=0.094 P=0.018 * | P=0.005 ** P=0.189 P=0.052 P=0.014 * | |LOGISTIC REGRESSION | P=0.006 ** P=0.172 P=0.045 * P=0.006 ** | P=0.001 ** P=0.226 P=0.196 P=0.006 ** | |COCHRAN-ARMITAGE | P=0.006 ** | P=0.015 * | |FISHER EXACT | P=0.264 P=0.060 P=0.011 * | P=0.218 P=0.081 P=0.020 * | |=================================================================================================================================| DATE: 05/19/95 EXPERIMENT: 05103 TEST: 04 PAGE 24 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS (a) Number of tumor-bearing animals / number of animals examined at site. (b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for intercurrent mortality. (c) Observed incidence at interim kill. Male interim sacrifices(days): 456 Female interim sacrifices(days): 456 (d) Observed incidence at terminal kill. (f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between the controls and that dosed group. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. The incidental tumor test regards these lesions as non-fatal. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fisher's exact tests compare directly the overall incidence rates. For all tests, a negative trend is indicated by "N". (e) Value of Statistic cannot be computed. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01).