TDMS Study 05087-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TRIAMTERENE DATE: 09/11/94
EXPERIMENT: 05087 TEST: 03 TIME: 15:33:27
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: 03 TIME: 15:33:27
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: 03 TIME: 15:33:27
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
------- ------------
Harderian Gland Adenoma
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
All Organs Benign Tumors
====================================================================================================
FEMALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
All Organs Benign Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 03 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0PPM 400 PPM | 0PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) | 2/60 (3%) 2/60 (3%) |
|ADJUSTED (b) | 0.0% 2.6% | 5.0% 5.3% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/43 (0%) 1/39 (3%) | 2/40 (5%) 2/38 (5%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) | 730 (T) 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.481 | P=0.676 |
|INCIDENTAL TUMOR | P=0.481 | P=0.676 |
|LOGISTIC REGRESSION | P=0.481 | P=0.676 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500 | P=0.691N |
|=================================================================================================================================|
| |
|Bone |
| Fibrosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/60 (0%) | 2/60 (3%) 0/60 (0%) |
|ADJUSTED (b) | 2.3% 0.0% | 5.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 1/43 (2%) 0/39 (0%) | 2/40 (5%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- | 730 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.519N | P=0.250N |
|INCIDENTAL TUMOR | P=0.519N | P=0.250N |
|LOGISTIC REGRESSION | P=0.519N | P=0.250N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500N | P=0.248N |
|=================================================================================================================================|
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 03 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0PPM 400 PPM | 0PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 6/60 (10%) | 0/60 (0%) 3/60 (5%) |
|ADJUSTED (b) | 2.3% 15.4% | 0.0% 7.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 1/43 (2%) 6/39 (15%) | 0/40 (0%) 1/38 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) | --- 687 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.044 * | P=0.113 |
|INCIDENTAL TUMOR | P=0.044 * | P=0.182 |
|LOGISTIC REGRESSION | P=0.044 * | P=0.119 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.057 | P=0.122 |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/57 (4%) 0/59 (0%) | 1/59 (2%) 0/57 (0%) |
|ADJUSTED (b) | 4.0% 0.0% | 2.5% 0.0% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 1/42 (2%) 0/39 (0%) | 1/40 (3%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | 463 (I) --- | 730 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.248N | P=0.510N |
|INCIDENTAL TUMOR | P=0.248N | P=0.510N |
|LOGISTIC REGRESSION | P=0.227N | P=0.510N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.239N | P=0.509N |
|=================================================================================================================================|
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 03 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0PPM 400 PPM | 0PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 4.7% 2.6% | 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 2/43 (5%) 1/39 (3%) | 0/40 (0%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) | --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.534N | (e) (e) |
|INCIDENTAL TUMOR | P=0.534N | (e) (e) |
|LOGISTIC REGRESSION | P=0.534N | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500N | (e) |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 21/60 (35%) 37/60 (62%) | 7/60 (12%) 28/60 (47%) |
|ADJUSTED (b) | 44.7% 82.0% | 17.5% 70.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 17/43 (40%) 31/39 (79%) | 7/40 (18%) 26/38 (68%) |
|FIRST INCIDENCE (DAYS) | 701 463 (I) | 730 (T) 687 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** | P<0.001 ** |
|INCIDENTAL TUMOR | P=0.001 ** | P<0.001 ** |
|LOGISTIC REGRESSION | P<0.001 ** | P<0.001 ** |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.003 ** | P<0.001 ** |
|=================================================================================================================================|
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 03 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0PPM 400 PPM | 0PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/60 (15%) 11/60 (18%) | 6/60 (10%) 11/60 (18%) |
|ADJUSTED (b) | 19.3% 25.0% | 13.4% 28.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 1/10 (10%) 0/9 (0%) |
|TERMINAL (d) | 6/43 (14%) 7/39 (18%) | 4/40 (10%) 10/38 (26%) |
|FIRST INCIDENCE (DAYS) | 622 494 | 463 (I) 676 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.329 | P=0.124 |
|INCIDENTAL TUMOR | P=0.486 | P=0.139 |
|LOGISTIC REGRESSION | P=0.519 | P=0.141 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.404 | P=0.148 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/60 (15%) 12/60 (20%) | 6/60 (10%) 11/60 (18%) |
|ADJUSTED (b) | 19.3% 26.7% | 13.4% 28.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 1/10 (10%) 0/9 (0%) |
|TERMINAL (d) | 6/43 (14%) 7/39 (18%) | 4/40 (10%) 10/38 (26%) |
|FIRST INCIDENCE (DAYS) | 622 494 | 463 (I) 676 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.254 | P=0.124 |
|INCIDENTAL TUMOR | P=0.436 | P=0.139 |
|LOGISTIC REGRESSION | P=0.468 | P=0.141 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.316 | P=0.148 |
|=================================================================================================================================|
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 03 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0PPM 400 PPM | 0PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 25/60 (42%) 39/60 (65%) | 11/60 (18%) 31/60 (52%) |
|ADJUSTED (b) | 52.1% 82.8% | 25.4% 75.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) | 1/10 (10%) 0/9 (0%) |
|TERMINAL (d) | 20/43 (47%) 31/39 (79%) | 9/40 (23%) 28/38 (74%) |
|FIRST INCIDENCE (DAYS) | 622 463 (I) | 463 (I) 676 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.003 ** | P<0.001 ** |
|INCIDENTAL TUMOR | P=0.005 ** | P<0.001 ** |
|LOGISTIC REGRESSION | P=0.002 ** | P<0.001 ** |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.009 ** | P<0.001 ** |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 25/60 (42%) 39/60 (65%) | 11/60 (18%) 31/60 (52%) |
|ADJUSTED (b) | 52.1% 82.8% | 25.4% 75.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) | 1/10 (10%) 0/9 (0%) |
|TERMINAL (d) | 20/43 (47%) 31/39 (79%) | 9/40 (23%) 28/38 (74%) |
|FIRST INCIDENCE (DAYS) | 622 463 (I) | 463 (I) 676 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.003 ** | P<0.001 ** |
|INCIDENTAL TUMOR | P=0.005 ** | P<0.001 ** |
|LOGISTIC REGRESSION | P=0.002 ** | P<0.001 ** |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.009 ** | P<0.001 ** |
|=================================================================================================================================|
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 03 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0PPM 400 PPM | 0PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/60 (10%) 10/60 (17%) | 2/60 (3%) 0/60 (0%) |
|ADJUSTED (b) | 14.0% 24.6% | 5.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 6/43 (14%) 9/39 (23%) | 2/40 (5%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 494 | 730 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.154 | P=0.250N |
|INCIDENTAL TUMOR | P=0.154 | P=0.250N |
|LOGISTIC REGRESSION | P=0.183 | P=0.250N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.211 | P=0.248N |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/60 (12%) 6/60 (10%) | 1/60 (2%) 1/60 (2%) |
|ADJUSTED (b) | 15.7% 15.4% | 2.5% 2.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 6/43 (14%) 6/39 (15%) | 1/40 (3%) 1/38 (3%) |
|FIRST INCIDENCE (DAYS) | 534 729 (T) | 730 (T) 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.570N | P=0.750 |
|INCIDENTAL TUMOR | P=0.569N | P=0.750 |
|LOGISTIC REGRESSION | P=0.530N | P=0.750 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500N | P=0.752N |
|=================================================================================================================================|
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 03 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0PPM 400 PPM | 0PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/60 (22%) 16/60 (27%) | 3/60 (5%) 1/60 (2%) |
|ADJUSTED (b) | 29.4% 39.7% | 7.5% 2.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 12/43 (28%) 15/39 (38%) | 3/40 (8%) 1/38 (3%) |
|FIRST INCIDENCE (DAYS) | 534 494 | 730 (T) 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.231 | P=0.324N |
|INCIDENTAL TUMOR | P=0.227 | P=0.324N |
|LOGISTIC REGRESSION | P=0.287 | P=0.324N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.335 | P=0.309N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/58 (2%) | 1/59 (2%) 3/56 (5%) |
|ADJUSTED (b) | 0.0% 2.6% | 2.6% 8.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/43 (0%) 1/39 (3%) | 1/39 (3%) 3/35 (9%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) | 730 (T) 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.481 | P=0.267 |
|INCIDENTAL TUMOR | P=0.481 | P=0.267 |
|LOGISTIC REGRESSION | P=0.481 | P=0.267 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.492 | P=0.290 |
|=================================================================================================================================|
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 03 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0PPM 400 PPM | 0PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/58 (2%) | 1/59 (2%) 4/56 (7%) |
|ADJUSTED (b) | 0.0% 2.6% | 2.6% 11.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/43 (0%) 1/39 (3%) | 1/39 (3%) 4/35 (11%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) | 730 (T) 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.481 | P=0.148 |
|INCIDENTAL TUMOR | P=0.481 | P=0.148 |
|LOGISTIC REGRESSION | P=0.481 | P=0.148 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.492 | P=0.166 |
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/57 (4%) 0/60 (0%) | 3/59 (5%) 0/60 (0%) |
|ADJUSTED (b) | 4.8% 0.0% | 7.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 2/42 (5%) 0/39 (0%) | 2/40 (5%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- | 555 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.255N | P=0.128N |
|INCIDENTAL TUMOR | P=0.255N | P=0.105N |
|LOGISTIC REGRESSION | P=0.255N | P=0.118N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.235N | P=0.119N |
|=================================================================================================================================|
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 03 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0PPM 400 PPM | 0PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 4/60 (7%) 1/60 (2%) | 3/60 (5%) 0/60 (0%) |
|ADJUSTED (b) | 9.3% 2.6% | 7.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 4/43 (9%) 1/39 (3%) | 2/40 (5%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) | 555 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.210N | P=0.128N |
|INCIDENTAL TUMOR | P=0.210N | P=0.129N |
|LOGISTIC REGRESSION | P=0.210N | P=0.121N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.182N | P=0.122N |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 4/60 (7%) 2/60 (3%) | 3/60 (5%) 0/60 (0%) |
|ADJUSTED (b) | 9.3% 5.1% | 7.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 4/43 (9%) 2/39 (5%) | 2/40 (5%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) | 555 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.383N | P=0.128N |
|INCIDENTAL TUMOR | P=0.383N | P=0.129N |
|LOGISTIC REGRESSION | P=0.383N | P=0.121N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.340N | P=0.122N |
|=================================================================================================================================|
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 03 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0PPM 400 PPM | 0PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma And Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 5/60 (8%) 9/60 (15%) | 9/60 (15%) 17/60 (28%) |
|ADJUSTED (b) | 10.4% 19.4% | 19.9% 34.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 2/9 (22%) |
|TERMINAL (d) | 2/43 (5%) 3/39 (8%) | 5/40 (13%) 8/38 (21%) |
|FIRST INCIDENCE (DAYS) | 440 522 | 534 463 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.177 | P=0.062 |
|INCIDENTAL TUMOR | P=0.345 | P=0.092 |
|LOGISTIC REGRESSION | P=0.328 | P=0.094 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.197 | P=0.060 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 5/60 (8%) 9/60 (15%) | 9/60 (15%) 17/60 (28%) |
|ADJUSTED (b) | 10.4% 19.4% | 19.9% 34.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 2/9 (22%) |
|TERMINAL (d) | 2/43 (5%) 3/39 (8%) | 5/40 (13%) 8/38 (21%) |
|FIRST INCIDENCE (DAYS) | 440 522 | 534 463 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.177 | P=0.062 |
|INCIDENTAL TUMOR | P=0.345 | P=0.092 |
|LOGISTIC REGRESSION | P=0.328 | P=0.094 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.197 | P=0.060 |
|=================================================================================================================================|
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 03 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0PPM 400 PPM | 0PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 26/60 (43%) 40/60 (67%) | 12/60 (20%) 31/60 (52%) |
|ADJUSTED (b) | 54.0% 86.8% | 30.0% 75.6% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 1/10 (10%) | 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 21/43 (49%) 33/39 (85%) | 12/40 (30%) 28/38 (74%) |
|FIRST INCIDENCE (DAYS) | 463 (I) 463 (I) | 730 (T) 687 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.002 ** | P<0.001 ** |
|INCIDENTAL TUMOR | P=0.003 ** | P<0.001 ** |
|LOGISTIC REGRESSION | P=0.002 ** | P<0.001 ** |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.008 ** | P<0.001 ** |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 25/60 (42%) 26/60 (43%) | 24/60 (40%) 30/60 (50%) |
|ADJUSTED (b) | 49.8% 52.0% | 48.7% 60.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 1/10 (10%) 2/9 (22%) |
|TERMINAL (d) | 18/43 (42%) 15/39 (38%) | 15/40 (38%) 19/38 (50%) |
|FIRST INCIDENCE (DAYS) | 440 494 | 463 (I) 463 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.369 | P=0.161 |
|INCIDENTAL TUMOR | P=0.465N | P=0.244 |
|LOGISTIC REGRESSION | P=0.426N | P=0.247 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500 | P=0.179 |
|=================================================================================================================================|
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 03 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0PPM 400 PPM | 0PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 38/60 (63%) 45/60 (75%) | 30/60 (50%) 45/60 (75%) |
|ADJUSTED (b) | 74.4% 88.2% | 61.0% 88.2% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 1/10 (10%) | 1/10 (10%) 2/9 (22%) |
|TERMINAL (d) | 30/43 (70%) 33/39 (85%) | 21/40 (53%) 32/38 (84%) |
|FIRST INCIDENCE (DAYS) | 440 463 (I) | 463 (I) 463 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.053 | P=0.006 ** |
|INCIDENTAL TUMOR | P=0.107 | P=0.004 ** |
|LOGISTIC REGRESSION | P=0.143 | P=0.003 ** |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.118 | P=0.004 ** |
|=================================================================================================================================|
(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): 463
Female interim sacrifices(days): 463
(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).