TDMS Study 05087-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus TRIAMTERENE DATE: 09/11/94 EXPERIMENT: 05087 TEST: 02 TIME: 13:47:26 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-45041 ROUTE: DOSED FEED NTP C#: 56042B PATHOLOGIST: L. MEZZA S. EUSTIS CAS: 396-01-0 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus TRIAMTERENE DATE: 09/11/94 EXPERIMENT: 05087 TEST: 02 TIME: 13:47:26 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-45041 ROUTE: DOSED FEED NTP C#: 56042B PATHOLOGIST: L. MEZZA S. EUSTIS CAS: 396-01-0 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 Gland Bone Marrow Brain Clitoral Gland Epididymis Gallbladder Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus TRIAMTERENE DATE: 09/11/94 EXPERIMENT: 05087 TEST: 02 TIME: 13:47:26 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-45041 ROUTE: DOSED FEED NTP C#: 56042B PATHOLOGIST: L. MEZZA S. EUSTIS CAS: 396-01-0 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF TRIAMTERENE ==================================================================================================== MALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Intestine Small Carcinoma or Adenoma Liver Hepatocellular Carcinoma Hepatocellular Carcinoma or Hepatoblastoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma ==================================================================================================== FEMALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Liver Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma All Organs Benign Tumors ==================================================================================================== DATE: 09/11/94 EXPERIMENT: 05087 TEST: 02 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIAMTERENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 100PPM 200PPM 400PPM | 0PPM 100PPM 200PPM 400PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/70 (0%) 0/64 (0%) 0/61 (0%) 0/70 (0%) | 3/70 (4%) 0/62 (0%) 3/60 (5%) 2/70 (3%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 7.6% 0.0% 7.0% 4.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/4 (0%) 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/0 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | |TERMINAL (d) | 0/47 (0%) 0/45 (0%) 0/46 (0%) 0/46 (0%) | 2/38 (5%) 0/43 (0%) 3/43 (7%) 2/43 (5%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 723 --- 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.559N P=0.105N P=0.608N P=0.449N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.531N P=0.124N P=0.636N P=0.419N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.557N P=0.107N P=0.628N P=0.449N | |COCHRAN-ARMITAGE | (e) | P=0.583N | |FISHER EXACT | (e) (e) (e) | P=0.146N P=0.584 P=0.500N | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 1/64 (2%) 3/61 (5%) 1/70 (1%) | 1/70 (1%) 3/62 (5%) 2/60 (3%) 0/70 (0%) | |ADJUSTED (b) | 0.0% 2.2% 6.3% 2.2% | 2.6% 7.0% 4.7% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/4 (0%) 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/0 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | |TERMINAL (d) | 0/47 (0%) 1/45 (2%) 2/46 (4%) 1/46 (2%) | 1/38 (3%) 3/43 (7%) 2/43 (5%) 0/43 (0%) | |FIRST INCIDENCE (DAYS) | --- 729 (T) 682 729 (T) | 729 (T) 729 (T) 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.350 P=0.491 P=0.121 P=0.496 | P=0.214N P=0.350 P=0.543 P=0.475N | |INCIDENTAL TUMOR | P=0.353 P=0.491 P=0.159 P=0.496 | P=0.214N P=0.350 P=0.543 P=0.475N | |LOGISTIC REGRESSION | P=0.341 P=0.491 P=0.120 P=0.496 | P=0.214N P=0.350 P=0.543 P=0.475N | |COCHRAN-ARMITAGE | P=0.360 | P=0.242N | |FISHER EXACT | P=0.478 P=0.098 P=0.500 | P=0.265 P=0.442 P=0.500N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05087 TEST: 02 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIAMTERENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 100PPM 200PPM 400PPM | 0PPM 100PPM 200PPM 400PPM | | | | | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/70 (1%) 1/64 (2%) 3/61 (5%) 2/70 (3%) | 1/70 (1%) 3/62 (5%) 2/60 (3%) 0/70 (0%) | |ADJUSTED (b) | 2.0% 2.2% 6.3% 4.3% | 2.6% 7.0% 4.7% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/4 (0%) 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/0 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | |TERMINAL (d) | 0/47 (0%) 1/45 (2%) 2/46 (4%) 2/46 (4%) | 1/38 (3%) 3/43 (7%) 2/43 (5%) 0/43 (0%) | |FIRST INCIDENCE (DAYS) | 585 729 (T) 682 729 (T) | 729 (T) 729 (T) 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.323 P=0.751 P=0.304 P=0.490 | P=0.214N P=0.350 P=0.543 P=0.475N | |INCIDENTAL TUMOR | P=0.287 P=0.721N P=0.363 P=0.417 | P=0.214N P=0.350 P=0.543 P=0.475N | |LOGISTIC REGRESSION | P=0.307 P=0.751 P=0.306 P=0.482 | P=0.214N P=0.350 P=0.543 P=0.475N | |COCHRAN-ARMITAGE | P=0.335 | P=0.242N | |FISHER EXACT | P=0.729 P=0.260 P=0.500 | P=0.265 P=0.442 P=0.500N | |=================================================================================================================================| | | |Intestine Small | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 0/64 (0%) 0/61 (0%) 2/70 (3%) | 1/70 (1%) 0/62 (0%) 0/60 (0%) 0/70 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 4.3% | 2.6% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/4 (0%) 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/0 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | |TERMINAL (d) | 0/47 (0%) 0/45 (0%) 0/46 (0%) 2/46 (4%) | 1/38 (3%) 0/43 (0%) 0/43 (0%) 0/43 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 729 (T) | 729 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.047 * (e) (e) P=0.234 | P=0.292N P=0.475N P=0.475N P=0.475N | |INCIDENTAL TUMOR | P=0.047 * (e) (e) P=0.234 | P=0.292N P=0.475N P=0.475N P=0.475N | |LOGISTIC REGRESSION | P=0.047 * (e) (e) P=0.234 | P=0.292N P=0.475N P=0.475N P=0.475N | |COCHRAN-ARMITAGE | P=0.051 | P=0.308N | |FISHER EXACT | (e) (e) P=0.248 | P=0.530N P=0.538N P=0.500N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05087 TEST: 02 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIAMTERENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 100PPM 200PPM 400PPM | 0PPM 100PPM 200PPM 400PPM | | | | | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/70 (1%) 1/64 (2%) 3/61 (5%) 0/70 (0%) | 1/70 (1%) 0/62 (0%) 1/60 (2%) 0/70 (0%) | |ADJUSTED (b) | 2.1% 2.2% 6.5% 0.0% | 2.4% 0.0% 2.3% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/4 (0%) 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/0 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | |TERMINAL (d) | 1/47 (2%) 1/45 (2%) 3/46 (7%) 0/46 (0%) | 0/38 (0%) 0/43 (0%) 1/43 (2%) 0/43 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) --- | 711 --- 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.413N P=0.752 P=0.298 P=0.504N | P=0.389N P=0.490N P=0.739N P=0.486N | |INCIDENTAL TUMOR | P=0.413N P=0.752 P=0.298 P=0.504N | P=0.347N P=0.557N P=0.743 P=0.419N | |LOGISTIC REGRESSION | P=0.413N P=0.752 P=0.298 P=0.504N | P=0.380N P=0.485N P=0.745N P=0.474N | |COCHRAN-ARMITAGE | P=0.407N | P=0.403N | |FISHER EXACT | P=0.729 P=0.260 P=0.500N | P=0.530N P=0.712 P=0.500N | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 18/70 (26%) 25/64 (39%) 21/61 (34%) 20/70 (29%) | 12/70 (17%) 24/62 (39%) 25/60 (42%) 36/70 (51%) | |ADJUSTED (b) | 37.2% 51.6% 42.3% 42.6% | 28.4% 53.0% 53.9% 78.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/4 (0%) 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/0 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 1/10 (10%) 3/10 (30%) 2/10 (20%) 0/0 | 2/10 (20%) 2/10 (20%) 2/10 (20%) 0/0 | |TERMINAL (d) | 17/47 (36%) 22/45 (49%) 18/46 (39%) 19/46 (41%) | 9/38 (24%) 22/43 (51%) 22/43 (51%) 33/43 (77%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 456 (I) 711 | 456 (I) 456 (I) 456 (I) 579 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.353 P=0.090 P=0.320 P=0.310 | P<0.001 ** P=0.031 * P=0.022 * P<0.001 ** | |INCIDENTAL TUMOR | P=0.340 P=0.090 P=0.320 P=0.310 | P<0.001 ** P=0.029 * P=0.018 * P<0.001 ** | |LOGISTIC REGRESSION | P=0.447 P=0.100 P=0.334 P=0.351 | P<0.001 ** P=0.021 * P=0.013 * P<0.001 ** | |COCHRAN-ARMITAGE | P=0.510N | P<0.001 ** | |FISHER EXACT | P=0.071 P=0.185 P=0.425 | P=0.005 ** P=0.002 ** P<0.001 ** | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05087 TEST: 02 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIAMTERENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 100PPM 200PPM 400PPM | 0PPM 100PPM 200PPM 400PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/70 (7%) 7/64 (11%) 3/61 (5%) 13/70 (19%) | 4/70 (6%) 4/62 (6%) 3/60 (5%) 8/70 (11%) | |ADJUSTED (b) | 10.6% 14.8% 6.5% 28.3% | 10.0% 9.3% 7.0% 18.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/4 (0%) 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/0 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | |TERMINAL (d) | 5/47 (11%) 5/45 (11%) 3/46 (7%) 13/46 (28%) | 3/38 (8%) 4/43 (9%) 3/43 (7%) 8/43 (19%) | |FIRST INCIDENCE (DAYS) | 729 (T) 557 729 (T) 729 (T) | 589 729 (T) 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.019 * P=0.353 P=0.368N P=0.030 * | P=0.136 P=0.575N P=0.438N P=0.248 | |INCIDENTAL TUMOR | P=0.014 * P=0.400 P=0.368N P=0.030 * | P=0.163 P=0.510N P=0.391N P=0.306 | |LOGISTIC REGRESSION | P=0.016 * P=0.360 P=0.368N P=0.030 * | P=0.148 P=0.602N P=0.462N P=0.252 | |COCHRAN-ARMITAGE | P=0.026 * | P=0.120 | |FISHER EXACT | P=0.321 P=0.438N P=0.037 * | P=0.571 P=0.586N P=0.183 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/70 (7%) 8/64 (13%) 4/61 (7%) 13/70 (19%) | 4/70 (6%) 4/62 (6%) 3/60 (5%) 8/70 (11%) | |ADJUSTED (b) | 10.6% 16.6% 8.7% 28.3% | 10.0% 9.3% 7.0% 18.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/4 (0%) 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/0 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | |TERMINAL (d) | 5/47 (11%) 5/45 (11%) 4/46 (9%) 13/46 (28%) | 3/38 (8%) 4/43 (9%) 3/43 (7%) 8/43 (19%) | |FIRST INCIDENCE (DAYS) | 729 (T) 557 729 (T) 729 (T) | 589 729 (T) 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.027 * P=0.256 P=0.513N P=0.030 * | P=0.136 P=0.575N P=0.438N P=0.248 | |INCIDENTAL TUMOR | P=0.020 * P=0.296 P=0.513N P=0.030 * | P=0.163 P=0.510N P=0.391N P=0.306 | |LOGISTIC REGRESSION | P=0.021 * P=0.259 P=0.513N P=0.030 * | P=0.148 P=0.602N P=0.462N P=0.252 | |COCHRAN-ARMITAGE | P=0.034 * | P=0.120 | |FISHER EXACT | P=0.225 P=0.587N P=0.037 * | P=0.571 P=0.586N P=0.183 | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05087 TEST: 02 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIAMTERENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 100PPM 200PPM 400PPM | 0PPM 100PPM 200PPM 400PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 21/70 (30%) 29/64 (45%) 21/61 (34%) 29/70 (41%) | 15/70 (21%) 28/62 (45%) 27/60 (45%) 37/70 (53%) | |ADJUSTED (b) | 43.5% 57.7% 42.3% 61.7% | 34.9% 61.9% 58.3% 80.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/4 (0%) 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/0 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 1/10 (10%) 3/10 (30%) 2/10 (20%) 0/0 | 2/10 (20%) 2/10 (20%) 2/10 (20%) 0/0 | |TERMINAL (d) | 20/47 (43%) 24/45 (53%) 18/46 (39%) 28/46 (61%) | 11/38 (29%) 26/43 (60%) 24/43 (56%) 34/43 (79%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 456 (I) 711 | 456 (I) 456 (I) 456 (I) 579 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.067 P=0.068 P=0.547 P=0.043 * | P<0.001 ** P=0.029 * P=0.045 * P<0.001 ** | |INCIDENTAL TUMOR | P=0.052 P=0.077 P=0.546 P=0.043 * | P<0.001 ** P=0.032 * P=0.042 * P<0.001 ** | |LOGISTIC REGRESSION | P=0.096 P=0.073 P=0.567 P=0.053 | P<0.001 ** P=0.018 * P=0.026 * P<0.001 ** | |COCHRAN-ARMITAGE | P=0.198 | P<0.001 ** | |FISHER EXACT | P=0.049 * P=0.361 P=0.108 | P=0.003 ** P=0.004 ** P<0.001 ** | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 21/70 (30%) 30/64 (47%) 21/61 (34%) 29/70 (41%) | 15/70 (21%) 28/62 (45%) 27/60 (45%) 37/70 (53%) | |ADJUSTED (b) | 43.5% 58.6% 42.3% 61.7% | 34.9% 61.9% 58.3% 80.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/4 (0%) 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/0 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 1/10 (10%) 3/10 (30%) 2/10 (20%) 0/0 | 2/10 (20%) 2/10 (20%) 2/10 (20%) 0/0 | |TERMINAL (d) | 20/47 (43%) 24/45 (53%) 18/46 (39%) 28/46 (61%) | 11/38 (29%) 26/43 (60%) 24/43 (56%) 34/43 (79%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 456 (I) 711 | 456 (I) 456 (I) 456 (I) 579 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.078 P=0.049 * P=0.547 P=0.043 * | P<0.001 ** P=0.029 * P=0.045 * P<0.001 ** | |INCIDENTAL TUMOR | P=0.061 P=0.056 P=0.546 P=0.043 * | P<0.001 ** P=0.032 * P=0.042 * P<0.001 ** | |LOGISTIC REGRESSION | P=0.108 P=0.051 P=0.567 P=0.053 | P<0.001 ** P=0.018 * P=0.026 * P<0.001 ** | |COCHRAN-ARMITAGE | P=0.217 | P<0.001 ** | |FISHER EXACT | P=0.033 * P=0.361 P=0.108 | P=0.003 ** P=0.004 ** P<0.001 ** | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05087 TEST: 02 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIAMTERENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 100PPM 200PPM 400PPM | 0PPM 100PPM 200PPM 400PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/70 (7%) 10/64 (16%) 10/61 (16%) 9/70 (13%) | 5/70 (7%) 5/62 (8%) 2/60 (3%) 1/70 (1%) | |ADJUSTED (b) | 9.6% 21.4% 21.7% 19.6% | 12.3% 11.6% 4.3% 2.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/4 (0%) 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/0 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 2/10 (20%) 1/10 (10%) 0/10 (0%) 0/0 | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/0 | |TERMINAL (d) | 3/47 (6%) 9/45 (20%) 10/46 (22%) 9/46 (20%) | 4/38 (11%) 5/43 (12%) 1/43 (2%) 1/43 (2%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 729 (T) 729 (T) | 457 (I) 729 (T) 528 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.151 P=0.121 P=0.127 P=0.057 | P=0.042N* P=0.559N P=0.181N P=0.144N | |INCIDENTAL TUMOR | P=0.151 P=0.121 P=0.127 P=0.057 | P=0.056N P=0.559N P=0.221N P=0.144N | |LOGISTIC REGRESSION | P=0.208 P=0.118 P=0.123 P=0.167 | P=0.036N* P=0.590N P=0.222N P=0.084N | |COCHRAN-ARMITAGE | P=0.264 | P=0.048N* | |FISHER EXACT | P=0.100 P=0.083 P=0.199 | P=0.549 P=0.289N P=0.104N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/70 (9%) 3/64 (5%) 6/61 (10%) 5/70 (7%) | 0/70 (0%) 1/62 (2%) 0/60 (0%) 3/70 (4%) | |ADJUSTED (b) | 12.5% 6.2% 12.7% 10.9% | 0.0% 2.3% 0.0% 7.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/4 (0%) 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/0 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | |TERMINAL (d) | 5/47 (11%) 1/45 (2%) 5/46 (11%) 5/46 (11%) | 0/38 (0%) 1/43 (2%) 0/43 (0%) 3/43 (7%) | |FIRST INCIDENCE (DAYS) | 623 522 682 729 (T) | --- 729 (T) --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.554 P=0.267N P=0.606 P=0.516N | P=0.050 * P=0.525 (e) P=0.144 | |INCIDENTAL TUMOR | P=0.465 P=0.110N P=0.593N P=0.556N | P=0.050 * P=0.525 (e) P=0.144 | |LOGISTIC REGRESSION | P=0.466 P=0.174N P=0.619 P=0.532N | P=0.050 * P=0.525 (e) P=0.144 | |COCHRAN-ARMITAGE | P=0.551N | P=0.051 | |FISHER EXACT | P=0.293N P=0.519 P=0.500N | P=0.470 (e) P=0.122 | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05087 TEST: 02 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIAMTERENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 100PPM 200PPM 400PPM | 0PPM 100PPM 200PPM 400PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/70 (16%) 13/64 (20%) 16/61 (26%) 14/70 (20%) | 5/70 (7%) 6/62 (10%) 2/60 (3%) 3/70 (4%) | |ADJUSTED (b) | 21.5% 26.7% 34.0% 30.4% | 12.3% 14.0% 4.3% 7.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/4 (0%) 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/0 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 2/10 (20%) 1/10 (10%) 0/10 (0%) 0/0 | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/0 | |TERMINAL (d) | 8/47 (17%) 10/45 (22%) 15/46 (33%) 14/46 (30%) | 4/38 (11%) 6/43 (14%) 1/43 (2%) 3/43 (7%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 682 729 (T) | 457 (I) 729 (T) 528 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.196 P=0.375 P=0.179 P=0.158 | P=0.179N P=0.578 P=0.181N P=0.432N | |INCIDENTAL TUMOR | P=0.151 P=0.501 P=0.198 P=0.140 | P=0.215N P=0.578 P=0.221N P=0.432N | |LOGISTIC REGRESSION | P=0.228 P=0.370 P=0.180 P=0.268 | P=0.153N P=0.547 P=0.222N P=0.300N | |COCHRAN-ARMITAGE | P=0.306 | P=0.188N | |FISHER EXACT | P=0.320 P=0.103 P=0.330 | P=0.415 P=0.289N P=0.359N | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/69 (0%) 0/62 (0%) 0/55 (0%) 0/68 (0%) | 7/69 (10%) 5/59 (8%) 3/58 (5%) 5/68 (7%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 18.4% 12.2% 7.1% 11.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/4 (0%) 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/0 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | |TERMINAL (d) | 0/46 (0%) 0/44 (0%) 0/43 (0%) 0/44 (0%) | 7/38 (18%) 5/41 (12%) 3/42 (7%) 5/43 (12%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 729 (T) 729 (T) 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.249N P=0.325N P=0.120N P=0.294N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.249N P=0.325N P=0.120N P=0.294N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.249N P=0.325N P=0.120N P=0.294N | |COCHRAN-ARMITAGE | (e) | P=0.313N | |FISHER EXACT | (e) (e) (e) | P=0.495N P=0.243N P=0.392N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05087 TEST: 02 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIAMTERENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 100PPM 200PPM 400PPM | 0PPM 100PPM 200PPM 400PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Intermedia | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/69 (0%) 0/62 (0%) 0/55 (0%) 0/68 (0%) | 0/69 (0%) 0/59 (0%) 2/58 (3%) 1/68 (1%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 4.8% 2.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/4 (0%) 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/0 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | |TERMINAL (d) | 0/46 (0%) 0/44 (0%) 0/43 (0%) 0/44 (0%) | 0/38 (0%) 0/41 (0%) 2/42 (5%) 1/43 (2%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.269 (e) P=0.261 P=0.525 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.269 (e) P=0.261 P=0.525 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.269 (e) P=0.261 P=0.525 | |COCHRAN-ARMITAGE | (e) | P=0.256 | |FISHER EXACT | (e) (e) (e) | (e) P=0.207 P=0.496 | |=================================================================================================================================| | | |Skin | | Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, | | Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 0/64 (0%) 0/61 (0%) 0/70 (0%) | 0/70 (0%) 0/62 (0%) 0/60 (0%) 2/70 (3%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 4.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/4 (0%) 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/0 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | |TERMINAL (d) | 0/47 (0%) 0/45 (0%) 0/46 (0%) 0/46 (0%) | 0/38 (0%) 0/43 (0%) 0/43 (0%) 1/43 (2%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- --- 712 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.051 (e) (e) P=0.264 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.077 (e) (e) P=0.299 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.054 (e) (e) P=0.269 | |COCHRAN-ARMITAGE | (e) | P=0.053 | |FISHER EXACT | (e) (e) (e) | (e) (e) P=0.248 | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05087 TEST: 02 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIAMTERENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 100PPM 200PPM 400PPM | 0PPM 100PPM 200PPM 400PPM | | | | | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 0/64 (0%) 0/61 (0%) 0/70 (0%) | 3/70 (4%) 0/62 (0%) 1/60 (2%) 3/70 (4%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 7.1% 0.0% 2.3% 5.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/4 (0%) 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/0 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | |TERMINAL (d) | 0/47 (0%) 0/45 (0%) 0/46 (0%) 0/46 (0%) | 1/38 (3%) 0/43 (0%) 1/43 (2%) 0/43 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 530 --- 729 (T) 522 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.480 P=0.109N P=0.275N P=0.581N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.459 P=0.257N P=0.371N P=0.684 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.547N P=0.122N P=0.303N P=0.343N | |COCHRAN-ARMITAGE | (e) | P=0.434 | |FISHER EXACT | (e) (e) (e) | P=0.146N P=0.370N P=0.660N | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, Sarcoma, | | Neurofibroma, or Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/70 (1%) 0/64 (0%) 0/61 (0%) 0/70 (0%) | 3/70 (4%) 0/62 (0%) 1/60 (2%) 3/70 (4%) | |ADJUSTED (b) | 2.1% 0.0% 0.0% 0.0% | 7.1% 0.0% 2.3% 5.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/4 (0%) 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/0 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | |TERMINAL (d) | 1/47 (2%) 0/45 (0%) 0/46 (0%) 0/46 (0%) | 1/38 (3%) 0/43 (0%) 1/43 (2%) 0/43 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- --- --- | 530 --- 729 (T) 522 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.308N P=0.509N P=0.504N P=0.504N | P=0.480 P=0.109N P=0.275N P=0.581N | |INCIDENTAL TUMOR | P=0.308N P=0.509N P=0.504N P=0.504N | P=0.459 P=0.257N P=0.371N P=0.684 | |LOGISTIC REGRESSION | P=0.308N P=0.509N P=0.504N P=0.504N | P=0.547N P=0.122N P=0.303N P=0.343N | |COCHRAN-ARMITAGE | P=0.308N | P=0.434 | |FISHER EXACT | P=0.522N P=0.534N P=0.500N | P=0.146N P=0.370N P=0.660N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05087 TEST: 02 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIAMTERENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 100PPM 200PPM 400PPM | 0PPM 100PPM 200PPM 400PPM | | | | | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/70 (0%) 1/64 (2%) 2/61 (3%) 0/70 (0%) | 1/69 (1%) 0/62 (0%) 3/59 (5%) 1/70 (1%) | |ADJUSTED (b) | 0.0% 2.2% 4.3% 0.0% | 2.6% 0.0% 7.1% 2.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/4 (0%) 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/0 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | |TERMINAL (d) | 0/47 (0%) 1/45 (2%) 2/46 (4%) 0/46 (0%) | 1/38 (3%) 0/43 (0%) 3/42 (7%) 0/43 (0%) | |FIRST INCIDENCE (DAYS) | --- 729 (T) 729 (T) --- | 729 (T) --- 729 (T) 623 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.618N P=0.491 P=0.234 (e) | P=0.505 P=0.475N P=0.342 P=0.725N | |INCIDENTAL TUMOR | P=0.618N P=0.491 P=0.234 (e) | P=0.595 P=0.475N P=0.342 P=0.573N | |LOGISTIC REGRESSION | P=0.618N P=0.491 P=0.234 (e) | P=0.506 P=0.475N P=0.342 P=0.743N | |COCHRAN-ARMITAGE | P=0.609N | P=0.482 | |FISHER EXACT | P=0.478 P=0.215 (e) | P=0.527N P=0.253 P=0.748N | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma or Papilloma Squamous | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/70 (0%) 0/64 (0%) 0/61 (0%) 1/70 (1%) | 0/70 (0%) 0/62 (0%) 2/60 (3%) 1/70 (1%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 2.2% | 0.0% 0.0% 4.7% 2.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/4 (0%) 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/0 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | |TERMINAL (d) | 0/47 (0%) 0/45 (0%) 0/46 (0%) 1/46 (2%) | 0/38 (0%) 0/43 (0%) 2/43 (5%) 1/43 (2%) | |FIRST INCIDENCE (DAYS) | --- --- --- 729 (T) | --- --- 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.199 (e) (e) P=0.496 | P=0.264 (e) P=0.266 P=0.525 | |INCIDENTAL TUMOR | P=0.199 (e) (e) P=0.496 | P=0.264 (e) P=0.266 P=0.525 | |LOGISTIC REGRESSION | P=0.199 (e) (e) P=0.496 | P=0.264 (e) P=0.266 P=0.525 | |COCHRAN-ARMITAGE | P=0.206 | P=0.257 | |FISHER EXACT | (e) (e) P=0.500 | (e) P=0.211 P=0.500 | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05087 TEST: 02 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIAMTERENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 100PPM 200PPM 400PPM | 0PPM 100PPM 200PPM 400PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/70 (0%) 1/64 (2%) 1/61 (2%) 2/70 (3%) | 1/69 (1%) 1/61 (2%) 1/60 (2%) 1/70 (1%) | |ADJUSTED (b) | 0.0% 2.2% 2.2% 4.3% | 2.6% 2.3% 2.3% 2.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/4 (0%) 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/0 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | |TERMINAL (d) | 0/47 (0%) 1/45 (2%) 1/46 (2%) 1/46 (2%) | 1/38 (3%) 1/43 (2%) 1/43 (2%) 1/43 (2%) | |FIRST INCIDENCE (DAYS) | --- 729 (T) 729 (T) 711 | 729 (T) 729 (T) 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.154 P=0.491 P=0.496 P=0.237 | P=0.607N P=0.734N P=0.734N P=0.734N | |INCIDENTAL TUMOR | P=0.151 P=0.491 P=0.496 P=0.237 | P=0.607N P=0.734N P=0.734N P=0.734N | |LOGISTIC REGRESSION | P=0.149 P=0.491 P=0.496 P=0.228 | P=0.607N P=0.734N P=0.734N P=0.734N | |COCHRAN-ARMITAGE | P=0.162 | P=0.618N | |FISHER EXACT | P=0.478 P=0.466 P=0.248 | P=0.720 P=0.716 P=0.748N | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/70 (0%) 1/64 (2%) 1/61 (2%) 2/70 (3%) | 2/69 (3%) 1/61 (2%) 1/60 (2%) 1/70 (1%) | |ADJUSTED (b) | 0.0% 2.2% 2.2% 4.3% | 5.3% 2.3% 2.3% 2.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/4 (0%) 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/0 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | |TERMINAL (d) | 0/47 (0%) 1/45 (2%) 1/46 (2%) 1/46 (2%) | 2/38 (5%) 1/43 (2%) 1/43 (2%) 1/43 (2%) | |FIRST INCIDENCE (DAYS) | --- 729 (T) 729 (T) 711 | 729 (T) 729 (T) 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.154 P=0.491 P=0.496 P=0.237 | P=0.378N P=0.457N P=0.457N P=0.457N | |INCIDENTAL TUMOR | P=0.151 P=0.491 P=0.496 P=0.237 | P=0.378N P=0.457N P=0.457N P=0.457N | |LOGISTIC REGRESSION | P=0.149 P=0.491 P=0.496 P=0.228 | P=0.378N P=0.457N P=0.457N P=0.457N | |COCHRAN-ARMITAGE | P=0.162 | P=0.399N | |FISHER EXACT | P=0.478 P=0.466 P=0.248 | P=0.546N P=0.553N P=0.495N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05087 TEST: 02 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIAMTERENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 100PPM 200PPM 400PPM | 0PPM 100PPM 200PPM 400PPM | | | | | |=================================================================================================================================| | | |Uterus | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 0/70 (0%) 2/62 (3%) 0/60 (0%) 0/70 (0%) | |ADJUSTED (b) | | 0.0% 4.7% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/2 (0%) 0/0 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | |TERMINAL (d) | | 0/38 (0%) 2/43 (5%) 0/43 (0%) 0/43 (0%) | |FIRST INCIDENCE (DAYS) | | --- 729 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.385N P=0.266 (e) (e) | |INCIDENTAL TUMOR | | P=0.385N P=0.266 (e) (e) | |LOGISTIC REGRESSION | | P=0.385N P=0.266 (e) (e) | |COCHRAN-ARMITAGE | | P=0.403N | |FISHER EXACT | | P=0.219 (e) (e) | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 0/70 (0%) 1/62 (2%) 2/60 (3%) 2/70 (3%) | |ADJUSTED (b) | | 0.0% 2.3% 4.7% 4.7% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/2 (0%) 0/0 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | |TERMINAL (d) | | 0/38 (0%) 1/43 (2%) 2/43 (5%) 2/43 (5%) | |FIRST INCIDENCE (DAYS) | | --- 729 (T) 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.179 P=0.525 P=0.266 P=0.266 | |INCIDENTAL TUMOR | | P=0.179 P=0.525 P=0.266 P=0.266 | |LOGISTIC REGRESSION | | P=0.179 P=0.525 P=0.266 P=0.266 | |COCHRAN-ARMITAGE | | P=0.173 | |FISHER EXACT | | P=0.470 P=0.211 P=0.248 | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05087 TEST: 02 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIAMTERENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 100PPM 200PPM 400PPM | 0PPM 100PPM 200PPM 400PPM | | | | | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/70 (1%) 2/64 (3%) 4/61 (7%) 0/70 (0%) | 2/70 (3%) 1/62 (2%) 5/60 (8%) 2/70 (3%) | |ADJUSTED (b) | 2.1% 4.4% 8.7% 0.0% | 5.0% 2.3% 11.6% 4.2% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/4 (0%) 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/0 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | |TERMINAL (d) | 1/47 (2%) 2/45 (4%) 4/46 (9%) 0/46 (0%) | 1/38 (3%) 1/43 (2%) 5/43 (12%) 1/43 (2%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) --- | 711 729 (T) 729 (T) 623 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.377N P=0.485 P=0.174 P=0.504N | P=0.504 P=0.466N P=0.267 P=0.646N | |INCIDENTAL TUMOR | P=0.377N P=0.485 P=0.174 P=0.504N | P=0.580N P=0.505N P=0.245 P=0.492N | |LOGISTIC REGRESSION | P=0.377N P=0.485 P=0.174 P=0.504N | P=0.515 P=0.472N P=0.248 P=0.655N | |COCHRAN-ARMITAGE | P=0.370N | P=0.469 | |FISHER EXACT | P=0.466 P=0.143 P=0.500N | P=0.546N P=0.162 P=0.690N | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/70 (1%) 3/64 (5%) 5/61 (8%) 0/70 (0%) | 2/70 (3%) 1/62 (2%) 5/60 (8%) 2/70 (3%) | |ADJUSTED (b) | 2.1% 6.7% 10.9% 0.0% | 5.0% 2.3% 11.6% 4.2% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/4 (0%) 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/0 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | |TERMINAL (d) | 1/47 (2%) 3/45 (7%) 5/46 (11%) 0/46 (0%) | 1/38 (3%) 1/43 (2%) 5/43 (12%) 1/43 (2%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) --- | 711 729 (T) 729 (T) 623 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.348N P=0.290 P=0.099 P=0.504N | P=0.504 P=0.466N P=0.267 P=0.646N | |INCIDENTAL TUMOR | P=0.348N P=0.290 P=0.099 P=0.504N | P=0.580N P=0.505N P=0.245 P=0.492N | |LOGISTIC REGRESSION | P=0.348N P=0.290 P=0.099 P=0.504N | P=0.515 P=0.472N P=0.248 P=0.655N | |COCHRAN-ARMITAGE | P=0.341N | P=0.469 | |FISHER EXACT | P=0.277 P=0.076 P=0.500N | P=0.546N P=0.162 P=0.690N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05087 TEST: 02 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIAMTERENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 100PPM 200PPM 400PPM | 0PPM 100PPM 200PPM 400PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma And Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 6/70 (9%) 3/64 (5%) 5/61 (8%) 5/70 (7%) | 12/70 (17%) 9/62 (15%) 14/60 (23%) 11/70 (16%) | |ADJUSTED (b) | 12.5% 6.7% 10.6% 10.6% | 28.4% 19.8% 29.4% 22.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/4 (0%) 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/0 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/0 | |TERMINAL (d) | 5/47 (11%) 3/45 (7%) 4/46 (9%) 4/46 (9%) | 8/38 (21%) 7/43 (16%) 10/43 (23%) 5/43 (12%) | |FIRST INCIDENCE (DAYS) | 690 729 (T) 641 620 | 530 629 457 (I) 613 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.554N P=0.268N P=0.512N P=0.515N | P=0.483N P=0.229N P=0.533 P=0.372N | |INCIDENTAL TUMOR | P=0.530 P=0.264N P=0.470N P=0.554N | P=0.273N P=0.316N P=0.444 P=0.215N | |LOGISTIC REGRESSION | P=0.556 P=0.262N P=0.502N P=0.535N | P=0.219N P=0.163N P=0.557 P=0.110N | |COCHRAN-ARMITAGE | P=0.537N | P=0.538N | |FISHER EXACT | P=0.293N P=0.596N P=0.500N | P=0.433N P=0.254 P=0.500N | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 6/70 (9%) 3/64 (5%) 5/61 (8%) 5/70 (7%) | 12/70 (17%) 9/62 (15%) 14/60 (23%) 11/70 (16%) | |ADJUSTED (b) | 12.5% 6.7% 10.6% 10.6% | 28.4% 19.8% 29.4% 22.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/4 (0%) 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/0 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/0 | |TERMINAL (d) | 5/47 (11%) 3/45 (7%) 4/46 (9%) 4/46 (9%) | 8/38 (21%) 7/43 (16%) 10/43 (23%) 5/43 (12%) | |FIRST INCIDENCE (DAYS) | 690 729 (T) 641 620 | 530 629 457 (I) 613 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.554N P=0.268N P=0.512N P=0.515N | P=0.483N P=0.229N P=0.533 P=0.372N | |INCIDENTAL TUMOR | P=0.530 P=0.264N P=0.470N P=0.554N | P=0.273N P=0.316N P=0.444 P=0.215N | |LOGISTIC REGRESSION | P=0.556 P=0.262N P=0.502N P=0.535N | P=0.219N P=0.163N P=0.557 P=0.110N | |COCHRAN-ARMITAGE | P=0.537N | P=0.538N | |FISHER EXACT | P=0.293N P=0.596N P=0.500N | P=0.433N P=0.254 P=0.500N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05087 TEST: 02 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIAMTERENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 100PPM 200PPM 400PPM | 0PPM 100PPM 200PPM 400PPM | | | | | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 24/70 (34%) 30/64 (47%) 31/61 (51%) 27/70 (39%) | 25/70 (36%) 33/62 (53%) 30/60 (50%) 36/70 (51%) | |ADJUSTED (b) | 47.5% 60.6% 61.7% 57.4% | 57.2% 71.4% 63.4% 78.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/4 (0%) 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/0 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 3/10 (30%) 4/10 (40%) 2/10 (20%) 0/0 | 3/10 (30%) 2/10 (20%) 2/10 (20%) 0/0 | |TERMINAL (d) | 21/47 (45%) 26/45 (58%) 27/46 (59%) 26/46 (57%) | 20/38 (53%) 30/43 (70%) 26/43 (60%) 33/43 (77%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 456 (I) 711 | 114 456 (I) 456 (I) 579 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.166 P=0.128 P=0.115 P=0.133 | P=0.038 * P=0.228 P=0.424 P=0.026 * | |INCIDENTAL TUMOR | P=0.156 P=0.128 P=0.127 P=0.133 | P=0.060 P=0.177 P=0.295 P=0.049 * | |LOGISTIC REGRESSION | P=0.273 P=0.143 P=0.119 P=0.245 | P=0.138 P=0.151 P=0.300 P=0.103 | |COCHRAN-ARMITAGE | P=0.433 | P=0.079 | |FISHER EXACT | P=0.095 P=0.041 * P=0.363 | P=0.032 * P=0.071 P=0.044 * | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 17/70 (24%) 17/64 (27%) 16/61 (26%) 22/70 (31%) | 20/70 (29%) 17/62 (27%) 22/60 (37%) 25/70 (36%) | |ADJUSTED (b) | 34.0% 34.0% 33.3% 46.8% | 45.5% 35.8% 45.6% 47.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/4 (0%) 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/0 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/0 | |TERMINAL (d) | 14/47 (30%) 12/45 (27%) 14/46 (30%) 21/46 (46%) | 14/38 (37%) 13/43 (30%) 17/43 (40%) 15/43 (35%) | |FIRST INCIDENCE (DAYS) | 585 522 641 620 | 530 250 457 (I) 522 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.165 P=0.522 P=0.524N P=0.192 | P=0.223 P=0.223N P=0.550N P=0.430 | |INCIDENTAL TUMOR | P=0.081 P=0.460N P=0.469N P=0.131 | P=0.449 P=0.307N P=0.561 P=0.548N | |LOGISTIC REGRESSION | P=0.073 P=0.543 P=0.502N P=0.155 | P=0.213 P=0.258N P=0.549N P=0.358N | |COCHRAN-ARMITAGE | P=0.196 | P=0.151 | |FISHER EXACT | P=0.458 P=0.478 P=0.226 | P=0.519N P=0.213 P=0.235 | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05087 TEST: 02 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIAMTERENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0PPM 100PPM 200PPM 400PPM | 0PPM 100PPM 200PPM 400PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 35/70 (50%) 42/64 (66%) 37/61 (61%) 38/70 (54%) | 37/70 (53%) 42/62 (68%) 43/60 (72%) 46/70 (66%) | |ADJUSTED (b) | 65.8% 77.6% 72.3% 79.2% | 76.8% 83.8% 82.6% 85.2% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/4 (0%) 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/0 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 3/10 (30%) 4/10 (40%) 2/10 (20%) 0/0 | 3/10 (30%) 2/10 (20%) 3/10 (30%) 0/0 | |TERMINAL (d) | 29/47 (62%) 33/45 (73%) 32/46 (70%) 36/46 (78%) | 27/38 (71%) 35/43 (81%) 34/43 (79%) 35/43 (81%) | |FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 456 (I) 620 | 114 250 456 (I) 522 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.215 P=0.097 P=0.384 P=0.124 | P=0.109 P=0.518 P=0.449 P=0.152 | |INCIDENTAL TUMOR | P=0.104 P=0.143 P=0.423 P=0.066 | P=0.271 P=0.316 P=0.264 P=0.262 | |LOGISTIC REGRESSION | P=0.255 P=0.089 P=0.404 P=0.170 | P=0.181 P=0.346 P=0.264 P=0.205 | |COCHRAN-ARMITAGE | P=0.510 | P=0.106 | |FISHER EXACT | P=0.049 * P=0.148 P=0.368 | P=0.059 P=0.021 * P=0.084 | |=================================================================================================================================| (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): 93 456 Female interim sacrifices(days): 93 456 (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).