TDMS Study 05043-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Mason 2,4-DIAMINOPHENOL DIHYDROCHLORIDE DATE: 09/05/94 EXPERIMENT: 05043 TEST: 02 TIME: 19:08:48 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01CP9561903 ROUTE: GAVAGE NTP C#: C60026 PATHOLOGIST: S. WYAND S. EUSTIS CAS: 137-09-7 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Mason 2,4-DIAMINOPHENOL DIHYDROCHLORIDE DATE: 09/05/94 EXPERIMENT: 05043 TEST: 02 TIME: 19:08:48 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01CP9561903 ROUTE: GAVAGE NTP C#: C60026 PATHOLOGIST: S. WYAND S. EUSTIS CAS: 137-09-7 MICE(B6C3F1) ---------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED. ---------------- Adrenal Gland Bone Marrow Brain Epididymis Gallbladder Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Mason 2,4-DIAMINOPHENOL DIHYDROCHLORIDE DATE: 09/05/94 EXPERIMENT: 05043 TEST: 02 TIME: 19:08:48 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01CP9561903 ROUTE: GAVAGE NTP C#: C60026 PATHOLOGIST: S. WYAND S. EUSTIS CAS: 137-09-7 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF 2,4-DIAMINOPHENOL DIHYDROCHLORIDE ==================================================================================================== MALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Kidney: Renal Tubule Adenoma Carcinoma or Adenoma Liver Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Alveolar/Bronchiolar Carcinoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma ==================================================================================================== FEMALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma Benign Lung Alveolar/Bronchiolar Carcinoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma ==================================================================================================== DATE: 09/05/94 EXPERIMENT: 05043 TEST: 02 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE .019 G/ .038 G/ | VEHICLE .019 G/ .038 /G | | | 72VM KG 72LM KG 72HM | 72VF KG 72LF KG 72HF | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 0/15 (0%) 2/49 (4%) | 0/46 (0%) 1/12 (8%) 0/44 (0%) | |ADJUSTED (b) | 6.0% 0.0% 5.7% | 0.0% 100.0% 0.0% | |TERMINAL (d) | 1/29 (3%) 0/0 2/35 (6%) | 0/30 (0%) 1/1 (100%) 0/23 (0%) | |FIRST INCIDENCE (DAYS) | 602 --- 729 (T) | --- 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.536N P=0.485N P=0.629N | P=0.647 P=0.004 ** (e) | |INCIDENTAL TUMOR | P=0.536N P=0.383N P=0.625N | P=0.647 P=0.004 ** (e) | |LOGISTIC REGRESSION | P=0.555N P=0.641N P=0.657N | P=0.647 P=0.004 ** (e) | |COCHRAN-ARMITAGE | P=0.608N | P=0.696 | |FISHER EXACT | P=0.583N P=0.691N | P=0.207 (e) | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) | 1/50 (2%) 1/50 (2%) 1/50 (2%) | |ADJUSTED (b) | 6.2% 2.9% 2.8% | 2.9% 3.2% 3.2% | |TERMINAL (d) | 1/30 (3%) 0/33 (0%) 1/36 (3%) | 1/34 (3%) 1/31 (3%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 669 719 729 (T) | 729 (T) 729 (T) 667 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.330N P=0.472N P=0.442N | P=0.581 P=0.741 P=0.710 | |INCIDENTAL TUMOR | P=0.354N P=0.655N P=0.458N | P=0.604 P=0.741 P=0.739 | |LOGISTIC REGRESSION | P=0.336N P=0.475N P=0.455N | P=0.598 P=0.741 P=0.736 | |COCHRAN-ARMITAGE | P=0.378N | P=0.640 | |FISHER EXACT | P=0.500N P=0.500N | P=0.753N P=0.753N | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05043 TEST: 02 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE .019 G/ .038 G/ | VEHICLE .019 G/ .038 /G | | | 72VM KG 72LM KG 72HM | 72VF KG 72LF KG 72HF | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/48 (0%) 3/50 (6%) | 0/50 (0%) 0/39 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 8.0% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/30 (0%) 0/31 (0%) 2/36 (6%) | 0/34 (0%) 0/23 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 688 | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.051 (e) P=0.158 | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.052 (e) P=0.145 | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.047 * (e) P=0.146 | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.038 * | (e) | |FISHER EXACT | (e) P=0.121 | (e) (e) | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/48 (0%) 3/50 (6%) | 0/50 (0%) 1/39 (3%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 8.0% | 0.0% 4.3% 0.0% | |TERMINAL (d) | 0/30 (0%) 0/31 (0%) 2/36 (6%) | 0/34 (0%) 1/23 (4%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 688 | --- 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.051 (e) P=0.158 | P=0.693 P=0.422 (e) | |INCIDENTAL TUMOR | P=0.052 (e) P=0.145 | P=0.693 P=0.422 (e) | |LOGISTIC REGRESSION | P=0.047 * (e) P=0.146 | P=0.693 P=0.422 (e) | |COCHRAN-ARMITAGE | P=0.038 * | P=0.723 | |FISHER EXACT | (e) P=0.121 | P=0.438 (e) | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05043 TEST: 02 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE .019 G/ .038 G/ | VEHICLE .019 G/ .038 /G | | | 72VM KG 72LM KG 72HM | 72VF KG 72LF KG 72HF | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/50 (22%) 14/50 (28%) 5/50 (10%) | 3/50 (6%) 3/50 (6%) 3/50 (6%) | |ADJUSTED (b) | 32.4% 37.9% 13.1% | 8.8% 8.8% 10.7% | |TERMINAL (d) | 8/30 (27%) 11/33 (33%) 4/36 (11%) | 3/34 (9%) 1/31 (3%) 3/28 (11%) | |FIRST INCIDENCE (DAYS) | 483 483 579 | 729 (T) 700 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.038N* P=0.423 P=0.044N* | P=0.475 P=0.615 P=0.571 | |INCIDENTAL TUMOR | P=0.045N* P=0.401 P=0.051N | P=0.508 P=0.634 P=0.571 | |LOGISTIC REGRESSION | P=0.052N P=0.380 P=0.056N | P=0.466 P=0.632 P=0.571 | |COCHRAN-ARMITAGE | P=0.085N | P=0.583 | |FISHER EXACT | P=0.322 P=0.086N | P=0.661N P=0.661N | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 6/50 (12%) 3/50 (6%) | 1/50 (2%) 4/50 (8%) 0/50 (0%) | |ADJUSTED (b) | 13.1% 15.7% 8.0% | 2.6% 10.7% 0.0% | |TERMINAL (d) | 1/30 (3%) 3/33 (9%) 2/36 (6%) | 0/34 (0%) 1/31 (3%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 469 590 688 | 710 619 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.230N P=0.546 P=0.283N | P=0.484N P=0.163 P=0.561N | |INCIDENTAL TUMOR | P=0.237N P=0.548N P=0.315N | P=0.400N P=0.208 P=0.500N | |LOGISTIC REGRESSION | P=0.298N P=0.500 P=0.358N | P=0.422N P=0.247 P=0.534N | |COCHRAN-ARMITAGE | P=0.303N | P=0.390N | |FISHER EXACT | P=0.500 P=0.357N | P=0.181 P=0.500N | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05043 TEST: 02 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE .019 G/ .038 G/ | VEHICLE .019 G/ .038 /G | | | 72VM KG 72LM KG 72HM | 72VF KG 72LF KG 72HF | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 15/50 (30%) 18/50 (36%) 8/50 (16%) | 4/50 (8%) 7/50 (14%) 3/50 (6%) | |ADJUSTED (b) | 40.4% 46.3% 20.7% | 11.2% 18.7% 10.7% | |TERMINAL (d) | 9/30 (30%) 13/33 (39%) 6/36 (17%) | 3/34 (9%) 2/31 (6%) 3/28 (11%) | |FIRST INCIDENCE (DAYS) | 469 483 579 | 710 619 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.031N* P=0.452 P=0.037N* | P=0.557 P=0.223 P=0.614N | |INCIDENTAL TUMOR | P=0.033N* P=0.497 P=0.043N* | P=0.502N P=0.264 P=0.590N | |LOGISTIC REGRESSION | P=0.045N* P=0.388 P=0.051N | P=0.537N P=0.322 P=0.640N | |COCHRAN-ARMITAGE | P=0.072N | P=0.432N | |FISHER EXACT | P=0.335 P=0.077N | P=0.262 P=0.500N | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 15/50 (30%) 18/50 (36%) 8/50 (16%) | 4/50 (8%) 7/50 (14%) 3/50 (6%) | |ADJUSTED (b) | 40.4% 46.3% 20.7% | 11.2% 18.7% 10.7% | |TERMINAL (d) | 9/30 (30%) 13/33 (39%) 6/36 (17%) | 3/34 (9%) 2/31 (6%) 3/28 (11%) | |FIRST INCIDENCE (DAYS) | 469 483 579 | 710 619 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.031N* P=0.452 P=0.037N* | P=0.557 P=0.223 P=0.614N | |INCIDENTAL TUMOR | P=0.033N* P=0.497 P=0.043N* | P=0.502N P=0.264 P=0.590N | |LOGISTIC REGRESSION | P=0.045N* P=0.388 P=0.051N | P=0.537N P=0.322 P=0.640N | |COCHRAN-ARMITAGE | P=0.072N | P=0.432N | |FISHER EXACT | P=0.335 P=0.077N | P=0.262 P=0.500N | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05043 TEST: 02 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE .019 G/ .038 G/ | VEHICLE .019 G/ .038 /G | | | 72VM KG 72LM KG 72HM | 72VF KG 72LF KG 72HF | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/19 (11%) 7/50 (14%) | 1/50 (2%) 1/20 (5%) 3/50 (6%) | |ADJUSTED (b) | 6.7% 35.0% 18.7% | 2.9% 16.7% 10.7% | |TERMINAL (d) | 2/30 (7%) 1/3 (33%) 6/36 (17%) | 1/34 (3%) 1/6 (17%) 3/28 (11%) | |FIRST INCIDENCE (DAYS) | 729 (T) 613 613 | 729 (T) 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.112 P=0.154 P=0.130 | P=0.173 P=0.344 P=0.237 | |INCIDENTAL TUMOR | P=0.108 P=0.195 P=0.131 | P=0.173 P=0.344 P=0.237 | |LOGISTIC REGRESSION | P=0.098 P=0.139 P=0.117 | P=0.173 P=0.344 P=0.237 | |COCHRAN-ARMITAGE | P=0.060 | P=0.226 | |FISHER EXACT | P=0.303 P=0.080 | P=0.493 P=0.309 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/19 (11%) 0/50 (0%) | 1/50 (2%) 4/20 (20%) 0/50 (0%) | |ADJUSTED (b) | 3.3% 66.7% 0.0% | 2.6% 51.6% 0.0% | |TERMINAL (d) | 1/30 (3%) 2/3 (67%) 0/36 (0%) | 0/34 (0%) 3/6 (50%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) --- | 705 726 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.324N P=0.005 ** P=0.464N | P=0.490N P=0.011 * P=0.566N | |INCIDENTAL TUMOR | P=0.324N P=0.005 ** P=0.464N | P=0.455N P<0.001 ** P=0.500N | |LOGISTIC REGRESSION | P=0.324N P=0.005 ** P=0.464N | P=0.506N P<0.001 ** P=0.530N | |COCHRAN-ARMITAGE | P=0.375N | P=0.401N | |FISHER EXACT | P=0.182 P=0.500N | P=0.021 * P=0.500N | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05043 TEST: 02 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE .019 G/ .038 G/ | VEHICLE .019 G/ .038 /G | | | 72VM KG 72LM KG 72HM | 72VF KG 72LF KG 72HF | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 4/19 (21%) 7/50 (14%) | 2/50 (4%) 5/20 (25%) 3/50 (6%) | |ADJUSTED (b) | 10.0% 100.0% 18.7% | 5.4% 67.7% 10.7% | |TERMINAL (d) | 3/30 (10%) 3/3 (100%) 6/36 (17%) | 1/34 (3%) 4/6 (67%) 3/28 (11%) | |FIRST INCIDENCE (DAYS) | 729 (T) 613 613 | 705 726 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.238 P=0.001 ** P=0.239 | P=0.309 P=0.003 ** P=0.400 | |INCIDENTAL TUMOR | P=0.234 P=0.002 ** P=0.241 | P=0.336 P<0.001 ** P=0.430 | |LOGISTIC REGRESSION | P=0.216 P=0.002 ** P=0.221 | P=0.275 P<0.001 ** P=0.391 | |COCHRAN-ARMITAGE | P=0.139 | P=0.428 | |FISHER EXACT | P=0.085 P=0.159 | P=0.018 * P=0.500 | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 2/50 (4%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% | 2.9% 6.5% 0.0% | |TERMINAL (d) | 0/30 (0%) 0/33 (0%) 0/36 (0%) | 1/34 (3%) 2/31 (6%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- | 729 (T) 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.413N P=0.468 P=0.539N | |INCIDENTAL TUMOR | (e) (e) (e) | P=0.413N P=0.468 P=0.539N | |LOGISTIC REGRESSION | (e) (e) (e) | P=0.413N P=0.468 P=0.539N | |COCHRAN-ARMITAGE | (e) | P=0.360N | |FISHER EXACT | (e) (e) | P=0.500 P=0.500N | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05043 TEST: 02 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE .019 G/ .038 G/ | VEHICLE .019 G/ .038 /G | | | 72VM KG 72LM KG 72HM | 72VF KG 72LF KG 72HF | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/41 (0%) 0/15 (0%) 0/50 (0%) | 7/46 (15%) 3/13 (23%) 4/44 (9%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% | 19.0% 100.0% 16.7% | |TERMINAL (d) | 0/23 (0%) 0/0 0/36 (0%) | 5/34 (15%) 1/1 (100%) 4/24 (17%) | |FIRST INCIDENCE (DAYS) | --- --- --- | 670 516 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.439N P=0.351 P=0.484N | |INCIDENTAL TUMOR | (e) (e) (e) | P=0.387N P=0.027 * P=0.442N | |LOGISTIC REGRESSION | (e) (e) (e) | P=0.405N P=0.062 P=0.485N | |COCHRAN-ARMITAGE | (e) | P=0.247N | |FISHER EXACT | (e) (e) | P=0.383 P=0.287N | |=================================================================================================================================| | | |Skin | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 3/50 (6%) 4/50 (8%) | 0/50 (0%) 2/50 (4%) 1/50 (2%) | |ADJUSTED (b) | 5.7% 8.1% 8.8% | 0.0% 5.1% 3.0% | |TERMINAL (d) | 0/30 (0%) 2/33 (6%) 0/36 (0%) | 0/34 (0%) 0/31 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 607 449 453 | --- 631 662 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.334 P=0.535 P=0.412 | P=0.317 P=0.229 P=0.462 | |INCIDENTAL TUMOR | P=0.248 P=0.463 P=0.332 | P=0.353 P=0.314 P=0.500 | |LOGISTIC REGRESSION | P=0.218 P=0.498 P=0.243 | P=0.360 P=0.242 P=0.494 | |COCHRAN-ARMITAGE | P=0.264 | P=0.360 | |FISHER EXACT | P=0.500 P=0.339 | P=0.247 P=0.500 | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05043 TEST: 02 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE .019 G/ .038 G/ | VEHICLE .019 G/ .038 /G | | | 72VM KG 72LM KG 72HM | 72VF KG 72LF KG 72HF | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/19 (5%) 0/50 (0%) | 0/50 (0%) 1/24 (4%) 0/50 (0%) | |ADJUSTED (b) | 6.7% 2.3% 0.0% | 0.0% 2.5% 0.0% | |TERMINAL (d) | 2/30 (7%) 0/3 (0%) 0/36 (0%) | 0/34 (0%) 0/9 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 570 --- | --- 620 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.138N P=0.634 P=0.199N | P=0.707 P=0.490 (e) | |INCIDENTAL TUMOR | P=0.134N P=0.698 P=0.199N | P=0.760 P=0.638 (e) | |LOGISTIC REGRESSION | P=0.155N P=0.595 P=0.199N | P=0.710N P=0.365 (e) | |COCHRAN-ARMITAGE | P=0.169N | P=0.712 | |FISHER EXACT | P=0.626 P=0.247N | P=0.324 (e) | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma or Papilloma Squamous | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) | 2/50 (4%) 2/50 (4%) 3/50 (6%) | |ADJUSTED (b) | 6.7% 3.0% 2.8% | 5.9% 6.5% 10.7% | |TERMINAL (d) | 2/30 (7%) 1/33 (3%) 1/36 (3%) | 2/34 (6%) 2/31 (6%) 3/28 (11%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) | 729 (T) 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.322N P=0.467N P=0.436N | P=0.324 P=0.662 P=0.411 | |INCIDENTAL TUMOR | P=0.322N P=0.467N P=0.436N | P=0.324 P=0.662 P=0.411 | |LOGISTIC REGRESSION | P=0.322N P=0.467N P=0.436N | P=0.324 P=0.662 P=0.411 | |COCHRAN-ARMITAGE | P=0.378N | P=0.406 | |FISHER EXACT | P=0.500N P=0.500N | P=0.691N P=0.500 | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05043 TEST: 02 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE .019 G/ .038 G/ | VEHICLE .019 G/ .038 /G | | | 72VM KG 72LM KG 72HM | 72VF KG 72LF KG 72HF | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) | 1/50 (2%) 2/50 (4%) 3/50 (6%) | |ADJUSTED (b) | 6.7% 3.0% 2.8% | 2.9% 6.5% 10.7% | |TERMINAL (d) | 2/30 (7%) 1/33 (3%) 1/36 (3%) | 1/34 (3%) 2/31 (6%) 3/28 (11%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) | 729 (T) 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.322N P=0.467N P=0.436N | P=0.165 P=0.468 P=0.237 | |INCIDENTAL TUMOR | P=0.322N P=0.467N P=0.436N | P=0.165 P=0.468 P=0.237 | |LOGISTIC REGRESSION | P=0.322N P=0.467N P=0.436N | P=0.165 P=0.468 P=0.237 | |COCHRAN-ARMITAGE | P=0.378N | P=0.222 | |FISHER EXACT | P=0.500N P=0.500N | P=0.500 P=0.309 | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/16 (0%) 2/50 (4%) | | |ADJUSTED (b) | 0.0% 0.0% 5.6% | | |TERMINAL (d) | 0/30 (0%) 0/1 (0%) 2/36 (6%) | | |FIRST INCIDENCE (DAYS) | --- --- 729 (T) | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.171 (e) P=0.279 | | |INCIDENTAL TUMOR | P=0.171 (e) P=0.279 | | |LOGISTIC REGRESSION | P=0.171 (e) P=0.279 | | |COCHRAN-ARMITAGE | P=0.125 | | |FISHER EXACT | (e) P=0.247 | | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05043 TEST: 02 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE .019 G/ .038 G/ | VEHICLE .019 G/ .038 /G | | | 72VM KG 72LM KG 72HM | 72VF KG 72LF KG 72HF | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 0/15 (0%) 2/49 (4%) | 0/50 (0%) 0/13 (0%) 0/50 (0%) | |ADJUSTED (b) | 6.9% 0.0% 5.6% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/29 (7%) 0/0 2/36 (6%) | 0/34 (0%) 0/0 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- 729 (T) | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.514N (e) P=0.615N | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.514N (e) P=0.615N | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.514N (e) P=0.615N | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.608N | (e) | |FISHER EXACT | P=0.583N P=0.691N | (e) (e) | |=================================================================================================================================| | | |All Organs | | Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 1/50 (2%) 2/50 (4%) | |ADJUSTED (b) | 0.0% 2.3% 2.8% | 0.0% 3.2% 7.1% | |TERMINAL (d) | 0/30 (0%) 0/33 (0%) 1/36 (3%) | 0/34 (0%) 1/31 (3%) 2/28 (7%) | |FIRST INCIDENCE (DAYS) | --- 571 729 (T) | --- 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.369 P=0.525 P=0.536 | P=0.112 P=0.482 P=0.196 | |INCIDENTAL TUMOR | P=0.362 P=0.617 P=0.536 | P=0.112 P=0.482 P=0.196 | |LOGISTIC REGRESSION | P=0.328 P=0.485 P=0.536 | P=0.112 P=0.482 P=0.196 | |COCHRAN-ARMITAGE | P=0.331 | P=0.142 | |FISHER EXACT | P=0.500 P=0.500 | P=0.500 P=0.247 | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05043 TEST: 02 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE .019 G/ .038 G/ | VEHICLE .019 G/ .038 /G | | | 72VM KG 72LM KG 72HM | 72VF KG 72LF KG 72HF | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) | |ADJUSTED (b) | 9.0% 2.3% 5.2% | 0.0% 2.5% 0.0% | |TERMINAL (d) | 2/30 (7%) 0/33 (0%) 1/36 (3%) | 0/34 (0%) 0/31 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 543 570 657 | --- 620 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.336N P=0.270N P=0.424N | P=0.707 P=0.490 (e) | |INCIDENTAL TUMOR | P=0.392N P=0.281N P=0.496N | P=0.760 P=0.638 (e) | |LOGISTIC REGRESSION | P=0.393N P=0.304N P=0.473N | P=0.723N P=0.513 (e) | |COCHRAN-ARMITAGE | P=0.399N | P=0.731 | |FISHER EXACT | P=0.309N P=0.500N | P=0.500 (e) | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 3/50 (6%) | 0/50 (0%) 2/50 (4%) 2/50 (4%) | |ADJUSTED (b) | 9.0% 4.5% 7.9% | 0.0% 5.6% 7.1% | |TERMINAL (d) | 2/30 (7%) 0/33 (0%) 2/36 (6%) | 0/34 (0%) 1/31 (3%) 2/28 (7%) | |FIRST INCIDENCE (DAYS) | 543 570 657 | --- 620 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.508N P=0.450N P=0.580N | P=0.138 P=0.224 P=0.196 | |INCIDENTAL TUMOR | P=0.560N P=0.423N P=0.645N | P=0.139 P=0.302 P=0.196 | |LOGISTIC REGRESSION | P=0.585N P=0.506N P=0.628N | P=0.146 P=0.234 P=0.196 | |COCHRAN-ARMITAGE | P=0.588N | P=0.176 | |FISHER EXACT | P=0.500N P=0.661N | P=0.247 P=0.247 | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05043 TEST: 02 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE .019 G/ .038 G/ | VEHICLE .019 G/ .038 /G | | | 72VM KG 72LM KG 72HM | 72VF KG 72LF KG 72HF | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma And Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 6/50 (12%) 4/50 (8%) 5/50 (10%) | 12/50 (24%) 10/50 (20%) 7/50 (14%) | |ADJUSTED (b) | 15.6% 10.4% 13.3% | 29.5% 29.9% 22.3% | |TERMINAL (d) | 1/30 (3%) 1/33 (3%) 4/36 (11%) | 6/34 (18%) 8/31 (26%) 5/28 (18%) | |FIRST INCIDENCE (DAYS) | 469 590 621 | 558 683 410 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.341N P=0.327N P=0.397N | P=0.272N P=0.505N P=0.311N | |INCIDENTAL TUMOR | P=0.367N P=0.279N P=0.426N | P=0.188N P=0.431N P=0.210N | |LOGISTIC REGRESSION | P=0.428N P=0.375N P=0.496N | P=0.202N P=0.455N P=0.219N | |COCHRAN-ARMITAGE | P=0.434N | P=0.127N | |FISHER EXACT | P=0.370N P=0.500N | P=0.405N P=0.154N | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 4/50 (8%) 5/50 (10%) | 11/50 (22%) 9/50 (18%) 7/50 (14%) | |ADJUSTED (b) | 13.4% 10.4% 13.3% | 27.5% 28.0% 22.3% | |TERMINAL (d) | 1/30 (3%) 1/33 (3%) 4/36 (11%) | 6/34 (18%) 8/31 (26%) 5/28 (18%) | |FIRST INCIDENCE (DAYS) | 469 590 621 | 558 704 410 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.470N P=0.453N P=0.530N | P=0.336N P=0.496N P=0.385N | |INCIDENTAL TUMOR | P=0.510N P=0.452N P=0.569N | P=0.263N P=0.431N P=0.291N | |LOGISTIC REGRESSION | P=0.554N P=0.501N P=0.614N | P=0.270N P=0.449N P=0.290N | |COCHRAN-ARMITAGE | P=0.568 | P=0.181N | |FISHER EXACT | P=0.500N P=0.630N | P=0.402N P=0.218N | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05043 TEST: 02 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE .019 G/ .038 G/ | VEHICLE .019 G/ .038 /G | | | 72VM KG 72LM KG 72HM | 72VF KG 72LF KG 72HF | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 17/50 (34%) 15/50 (30%) 20/50 (40%) | 14/50 (28%) 12/50 (24%) 13/50 (26%) | |ADJUSTED (b) | 50.8% 40.8% 50.9% | 35.9% 32.1% 42.7% | |TERMINAL (d) | 14/30 (47%) 12/33 (36%) 17/36 (47%) | 10/34 (29%) 7/31 (23%) 11/28 (39%) | |FIRST INCIDENCE (DAYS) | 483 483 579 | 340 256 479 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.539N P=0.297N P=0.561N | P=0.410 P=0.512N P=0.441 | |INCIDENTAL TUMOR | P=0.499 P=0.308N P=0.572 | P=0.539N P=0.396N P=0.557 | |LOGISTIC REGRESSION | P=0.464 P=0.325N P=0.535 | P=0.535 P=0.426N P=0.535 | |COCHRAN-ARMITAGE | P=0.300 | P=0.455N | |FISHER EXACT | P=0.415N P=0.339 | P=0.410N P=0.500N | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 17/50 (34%) 15/50 (30%) 17/50 (34%) | 15/50 (30%) 21/50 (42%) 8/50 (16%) | |ADJUSTED (b) | 41.4% 36.6% 38.4% | 36.2% 51.9% 24.7% | |TERMINAL (d) | 6/30 (20%) 8/33 (24%) 9/36 (25%) | 8/34 (24%) 12/31 (39%) 5/28 (18%) | |FIRST INCIDENCE (DAYS) | 469 449 453 | 558 337 410 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.343N P=0.329N P=0.374N | P=0.241N P=0.114 P=0.212N | |INCIDENTAL TUMOR | P=0.425N P=0.356N P=0.466N | P=0.106N P=0.169 P=0.110N | |LOGISTIC REGRESSION | P=0.488N P=0.319N P=0.555N | P=0.128N P=0.118 P=0.127N | |COCHRAN-ARMITAGE | P=0.542N | P=0.077N | |FISHER EXACT | P=0.415N P=0.583N | P=0.149 P=0.077N | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05043 TEST: 02 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE .019 G/ .038 G/ | VEHICLE .019 G/ .038 /G | | | 72VM KG 72LM KG 72HM | 72VF KG 72LF KG 72HF | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 30/50 (60%) 27/50 (54%) 32/50 (64%) | 24/50 (48%) 29/50 (58%) 17/50 (34%) | |ADJUSTED (b) | 71.4% 63.7% 69.5% | 55.4% 65.8% 52.1% | |TERMINAL (d) | 18/30 (60%) 18/33 (55%) 22/36 (61%) | 15/34 (44%) 16/31 (52%) 13/28 (46%) | |FIRST INCIDENCE (DAYS) | 469 449 453 | 340 256 410 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.340N P=0.225N P=0.357N | P=0.370N P=0.153 P=0.356N | |INCIDENTAL TUMOR | P=0.441N P=0.231N P=0.450N | P=0.149N P=0.275 P=0.195N | |LOGISTIC REGRESSION | P=0.512N P=0.243N P=0.575N | P=0.169N P=0.177 P=0.208N | |COCHRAN-ARMITAGE | P=0.380 | P=0.096N | |FISHER EXACT | P=0.343N P=0.418 | P=0.212 P=0.111N | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for intercurrent mortality. (d) Observed incidence at terminal kill. (f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between the controls and that dosed group. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. The incidental tumor test regards these lesions as non-fatal. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fisher's exact tests compare directly the overall incidence rates. For all tests, a negative trend is indicated by "N". (e) Value of Statistic cannot be computed. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01). --multipart-boundary Content-type: text/plain Range: bytes 99541-99541/99541 --multipart-boundary--