TDMS Study 05087-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TRIAMTERENE DATE: 09/11/94
EXPERIMENT: 05087 TEST: 01 TIME: 11:29:42
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-45041 ROUTE: DOSED FEED NTP C#: 56042B
PATHOLOGIST: M. RYAN 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: 01 TIME: 11:29:42
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-45041 ROUTE: DOSED FEED NTP C#: 56042B
PATHOLOGIST: M. RYAN S. EUSTIS CAS: 396-01-0
RATS(FISCHER344)
----------------------------
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
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: 01 TIME: 11:29:42
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-45041 ROUTE: DOSED FEED NTP C#: 56042B
PATHOLOGIST: M. RYAN S. EUSTIS CAS: 396-01-0
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF TRIAMTERENE
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Liver Hepatocellular Adenoma
Testes Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear,
or Undifferentiated
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Liver Hepatocellular Adenoma
Uterus Leiomyoma
All Organs Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 01 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 150 PPM 300 PPM 600 PPM | 0 PPM 150 PPM 300 PPM 600 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/70 (1%) 1/60 (2%) 0/61 (0%) 0/70 (0%) | 2/70 (3%) 0/61 (0%) 1/63 (2%) 0/70 (0%) |
|ADJUSTED (b) | 3.6% 4.0% 0.0% 0.0% | 6.9% 0.0% 2.9% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/25 (0%) 1/25 (4%) 0/19 (0%) 0/27 (0%) | 2/29 (7%) 0/34 (0%) 1/34 (3%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 719 729 (T) --- --- | 729 (T) --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.244N P=0.752 P=0.557N P=0.507N | P=0.186N P=0.204N P=0.444N P=0.238N |
|INCIDENTAL TUMOR | P=0.221N P=0.743N P=0.388N P=0.484N | P=0.186N P=0.204N P=0.444N P=0.238N |
|LOGISTIC REGRESSION | P=0.234N P=0.764 P=0.509N P=0.488N | P=0.186N P=0.204N P=0.444N P=0.238N |
|COCHRAN-ARMITAGE | P=0.237N | P=0.188N |
|FISHER EXACT | P=0.712 P=0.534N P=0.500N | P=0.284N P=0.540N P=0.248N |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/70 (14%) 11/60 (18%) 8/61 (13%) 7/69 (10%) | 0/70 (0%) 1/61 (2%) 0/63 (0%) 1/70 (1%) |
|ADJUSTED (b) | 33.8% 38.1% 29.0% 25.7% | 0.0% 2.9% 0.0% 3.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 7/25 (28%) 8/25 (32%) 3/19 (16%) 6/26 (23%) | 0/29 (0%) 1/34 (3%) 0/34 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 456 (I) 674 668 712 | --- 729 (T) --- 707 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.181N P=0.502 P=0.546N P=0.269N | P=0.394 P=0.532 (e) P=0.500 |
|INCIDENTAL TUMOR | P=0.162N P=0.538 P=0.340N P=0.260N | P=0.376 P=0.532 (e) P=0.438 |
|LOGISTIC REGRESSION | P=0.164N P=0.561 P=0.346N P=0.256N | P=0.388 P=0.532 (e) P=0.491 |
|COCHRAN-ARMITAGE | P=0.191N | P=0.414 |
|FISHER EXACT | P=0.349 P=0.526N P=0.314N | P=0.466 (e) P=0.500 |
|=================================================================================================================================|
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 01 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 150 PPM 300 PPM 600 PPM | 0 PPM 150 PPM 300 PPM 600 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/70 (1%) 2/60 (3%) 0/61 (0%) 0/69 (0%) | 1/70 (1%) 1/61 (2%) 0/63 (0%) 0/70 (0%) |
|ADJUSTED (b) | 4.0% 8.0% 0.0% 0.0% | 2.2% 2.9% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/25 (4%) 2/25 (8%) 0/19 (0%) 0/26 (0%) | 0/29 (0%) 1/34 (3%) 0/34 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) --- --- | 573 729 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.193N P=0.500 P=0.555N P=0.492N | P=0.237N P=0.738N P=0.496N P=0.504N |
|INCIDENTAL TUMOR | P=0.193N P=0.500 P=0.555N P=0.492N | P=0.225N P=0.743N P=0.557N P=0.455N |
|LOGISTIC REGRESSION | P=0.193N P=0.500 P=0.555N P=0.492N | P=0.237N P=0.752 P=0.529N P=0.500N |
|COCHRAN-ARMITAGE | P=0.191N | P=0.236N |
|FISHER EXACT | P=0.442 P=0.534N P=0.504N | P=0.716 P=0.526N P=0.500N |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/70 (16%) 12/60 (20%) 8/61 (13%) 7/69 (10%) | 1/70 (1%) 2/61 (3%) 0/63 (0%) 1/70 (1%) |
|ADJUSTED (b) | 37.5% 41.8% 29.0% 25.7% | 2.2% 5.9% 0.0% 3.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 8/25 (32%) 9/25 (36%) 3/19 (16%) 6/26 (23%) | 0/29 (0%) 2/34 (6%) 0/34 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 456 (I) 674 668 712 | 573 729 (T) --- 707 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.117N P=0.502 P=0.460N P=0.191N | P=0.512N P=0.542 P=0.496N P=0.758 |
|INCIDENTAL TUMOR | P=0.100N P=0.538 P=0.264N P=0.183N | P=0.508N P=0.537 P=0.557N P=0.753 |
|LOGISTIC REGRESSION | P=0.101N P=0.564 P=0.257N P=0.180N | P=0.509N P=0.497 P=0.529N P=0.759 |
|COCHRAN-ARMITAGE | P=0.126N | P=0.490N |
|FISHER EXACT | P=0.341 P=0.433N P=0.235N | P=0.448 P=0.526N P=0.752N |
|=================================================================================================================================|
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 01 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 150 PPM 300 PPM 600 PPM | 0 PPM 150 PPM 300 PPM 600 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/70 (4%) 2/60 (3%) 5/61 (8%) 3/69 (4%) | 3/62 (5%) 3/60 (5%) 4/63 (6%) 3/68 (4%) |
|ADJUSTED (b) | 6.8% 6.1% 13.1% 11.1% | 11.5% 8.3% 10.5% 9.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 2/10 (20%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/25 (0%) 1/25 (4%) 1/19 (5%) 3/27 (11%) | 3/26 (12%) 2/34 (6%) 2/34 (6%) 2/28 (7%) |
|FIRST INCIDENCE (DAYS) | 456 (I) 610 456 (I) 729 (T) | 729 (T) 708 619 541 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.503 P=0.488N P=0.356 P=0.644N | P=0.555 P=0.540N P=0.619 P=0.636N |
|INCIDENTAL TUMOR | P=0.517 P=0.413N P=0.440 P=0.644N | P=0.534N P=0.564N P=0.595 P=0.581N |
|LOGISTIC REGRESSION | P=0.496 P=0.562N P=0.261 P=0.647N | P=0.578N P=0.564N P=0.593 P=0.625N |
|COCHRAN-ARMITAGE | P=0.493 | P=0.535N |
|FISHER EXACT | P=0.573N P=0.285 P=0.653 | P=0.644 P=0.509 P=0.615N |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/70 (4%) 2/60 (3%) 5/61 (8%) 3/69 (4%) | 4/62 (6%) 3/60 (5%) 4/63 (6%) 3/68 (4%) |
|ADJUSTED (b) | 6.8% 6.1% 13.1% 11.1% | 14.4% 8.3% 10.5% 9.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 2/10 (20%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/25 (0%) 1/25 (4%) 1/19 (5%) 3/27 (11%) | 3/26 (12%) 2/34 (6%) 2/34 (6%) 2/28 (7%) |
|FIRST INCIDENCE (DAYS) | 456 (I) 610 456 (I) 729 (T) | 715 708 619 541 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.503 P=0.488N P=0.356 P=0.644N | P=0.469N P=0.369N P=0.524N P=0.475N |
|INCIDENTAL TUMOR | P=0.517 P=0.413N P=0.440 P=0.644N | P=0.401N P=0.411N P=0.562N P=0.419N |
|LOGISTIC REGRESSION | P=0.496 P=0.562N P=0.261 P=0.647N | P=0.440N P=0.390N P=0.547N P=0.456N |
|COCHRAN-ARMITAGE | P=0.493 | P=0.403N |
|FISHER EXACT | P=0.573N P=0.285 P=0.653 | P=0.518N P=0.632N P=0.448N |
|=================================================================================================================================|
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 01 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 150 PPM 300 PPM 600 PPM | 0 PPM 150 PPM 300 PPM 600 PPM |
| | | |
|=================================================================================================================================|
| |
|Ear |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/70 (3%) 0/60 (0%) 0/61 (0%) 0/70 (0%) | 0/70 (0%) 0/61 (0%) 0/63 (0%) 0/70 (0%) |
|ADJUSTED (b) | 6.7% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/25 (4%) 0/25 (0%) 0/19 (0%) 0/27 (0%) | 0/29 (0%) 0/34 (0%) 0/34 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 653 --- --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.114N P=0.234N P=0.260N P=0.223N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.105N P=0.223N P=0.205N P=0.223N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.109N P=0.225N P=0.226N P=0.222N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.118N | (e) |
|FISHER EXACT | P=0.288N P=0.284N P=0.248N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/70 (3%) 1/60 (2%) 5/61 (8%) 1/69 (1%) | 3/70 (4%) 0/61 (0%) 2/63 (3%) 1/70 (1%) |
|ADJUSTED (b) | 6.5% 4.0% 14.8% 2.1% | 9.0% 0.0% 5.9% 3.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/25 (4%) 1/25 (4%) 1/19 (5%) 0/27 (0%) | 2/29 (7%) 0/34 (0%) 2/34 (6%) 1/29 (3%) |
|FIRST INCIDENCE (DAYS) | 624 729 (T) 572 522 | 660 --- 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.490N P=0.494N P=0.221 P=0.469N | P=0.353N P=0.105N P=0.444N P=0.322N |
|INCIDENTAL TUMOR | P=0.491N P=0.406N P=0.412 P=0.479N | P=0.359N P=0.126N P=0.478N P=0.334N |
|LOGISTIC REGRESSION | P=0.481N P=0.480N P=0.232 P=0.489N | P=0.359N P=0.114N P=0.486N P=0.323N |
|COCHRAN-ARMITAGE | P=0.513N | P=0.330N |
|FISHER EXACT | P=0.558N P=0.167 P=0.505N | P=0.150N P=0.550N P=0.310N |
|=================================================================================================================================|
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 01 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 150 PPM 300 PPM 600 PPM | 0 PPM 150 PPM 300 PPM 600 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/70 (0%) 6/60 (10%) 4/61 (7%) 3/69 (4%) | 0/70 (0%) 0/61 (0%) 0/63 (0%) 2/70 (3%) |
|ADJUSTED (b) | 0.0% 20.9% 15.6% 9.3% | 0.0% 0.0% 0.0% 6.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/25 (0%) 4/25 (16%) 2/19 (11%) 2/27 (7%) | 0/29 (0%) 0/34 (0%) 0/34 (0%) 2/29 (7%) |
|FIRST INCIDENCE (DAYS) | --- 610 668 508 | --- --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.368 P=0.020 * P=0.054 P=0.140 | P=0.039 * (e) (e) P=0.238 |
|INCIDENTAL TUMOR | P=0.356 P=0.028 * P=0.078 P=0.107 | P=0.039 * (e) (e) P=0.238 |
|LOGISTIC REGRESSION | P=0.361 P=0.020 * P=0.067 P=0.130 | P=0.039 * (e) (e) P=0.238 |
|COCHRAN-ARMITAGE | P=0.347 | P=0.053 |
|FISHER EXACT | P=0.008 ** P=0.045 * P=0.120 | (e) (e) P=0.248 |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/70 (3%) 0/60 (0%) 0/61 (0%) 0/70 (0%) | 1/70 (1%) 2/61 (3%) 0/63 (0%) 1/70 (1%) |
|ADJUSTED (b) | 8.0% 0.0% 0.0% 0.0% | 3.4% 5.1% 0.0% 2.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/25 (8%) 0/25 (0%) 0/19 (0%) 0/27 (0%) | 1/29 (3%) 1/34 (3%) 0/34 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- --- --- | 729 (T) 662 --- 698 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.119N P=0.237N P=0.300N P=0.221N | P=0.526N P=0.539 P=0.468N P=0.751 |
|INCIDENTAL TUMOR | P=0.119N P=0.237N P=0.300N P=0.221N | P=0.544N P=0.490 P=0.468N P=0.726 |
|LOGISTIC REGRESSION | P=0.119N P=0.237N P=0.300N P=0.221N | P=0.516N P=0.513 P=0.468N P=0.751 |
|COCHRAN-ARMITAGE | P=0.118N | P=0.490N |
|FISHER EXACT | P=0.288N P=0.284N P=0.248N | P=0.448 P=0.526N P=0.752N |
|=================================================================================================================================|
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 01 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 150 PPM 300 PPM 600 PPM | 0 PPM 150 PPM 300 PPM 600 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/70 (3%) 1/60 (2%) 1/61 (2%) 0/70 (0%) | 1/70 (1%) 2/61 (3%) 0/63 (0%) 1/70 (1%) |
|ADJUSTED (b) | 8.0% 4.0% 2.3% 0.0% | 3.4% 5.1% 0.0% 2.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/25 (8%) 1/25 (4%) 0/19 (0%) 0/27 (0%) | 1/29 (3%) 1/34 (3%) 0/34 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 617 --- | 729 (T) 662 --- 698 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.151N P=0.500N P=0.550N P=0.221N | P=0.526N P=0.539 P=0.468N P=0.751 |
|INCIDENTAL TUMOR | P=0.139N P=0.500N P=0.469N P=0.221N | P=0.544N P=0.490 P=0.468N P=0.726 |
|LOGISTIC REGRESSION | P=0.142N P=0.500N P=0.481N P=0.221N | P=0.516N P=0.513 P=0.468N P=0.751 |
|COCHRAN-ARMITAGE | P=0.154N | P=0.490N |
|FISHER EXACT | P=0.558N P=0.552N P=0.248N | P=0.448 P=0.526N P=0.752N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/70 (0%) 0/60 (0%) 0/61 (0%) 0/70 (0%) | 4/70 (6%) 0/61 (0%) 4/63 (6%) 1/70 (1%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 10.6% 0.0% 10.6% 3.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/25 (0%) 0/25 (0%) 0/19 (0%) 0/27 (0%) | 1/29 (3%) 0/34 (0%) 2/34 (6%) 1/29 (3%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 451 --- 662 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.285N P=0.055N P=0.596N P=0.194N |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.269N P=0.086N P=0.594 P=0.163N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.274N P=0.069N P=0.636 P=0.187N |
|COCHRAN-ARMITAGE | (e) | P=0.257N |
|FISHER EXACT | (e) (e) (e) | P=0.078N P=0.581 P=0.183N |
|=================================================================================================================================|
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 01 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 150 PPM 300 PPM 600 PPM | 0 PPM 150 PPM 300 PPM 600 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/70 (0%) 0/60 (0%) 0/61 (0%) 1/70 (1%) | 20/70 (29%) 16/61 (26%) 16/63 (25%) 13/70 (19%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 3.7% | 48.8% 42.8% 42.3% 34.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/25 (0%) 0/25 (0%) 0/19 (0%) 1/27 (4%) | 10/29 (34%) 13/34 (38%) 13/34 (38%) 7/29 (24%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 729 (T) | 456 (I) 662 383 466 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.215 (e) (e) P=0.515 | P=0.144N P=0.164N P=0.177N P=0.153N |
|INCIDENTAL TUMOR | P=0.215 (e) (e) P=0.515 | P=0.117N P=0.292N P=0.277N P=0.129N |
|LOGISTIC REGRESSION | P=0.215 (e) (e) P=0.515 | P=0.126N P=0.230N P=0.266N P=0.124N |
|COCHRAN-ARMITAGE | P=0.209 | P=0.094N |
|FISHER EXACT | (e) (e) P=0.500 | P=0.460N P=0.415N P=0.116N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/70 (0%) 0/60 (0%) 0/61 (0%) 1/70 (1%) | 23/70 (33%) 16/61 (26%) 19/63 (30%) 14/70 (20%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 3.7% | 53.9% 42.8% 47.8% 37.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/25 (0%) 0/25 (0%) 0/19 (0%) 1/27 (4%) | 11/29 (38%) 13/34 (38%) 14/34 (41%) 8/29 (28%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 729 (T) | 451 662 383 466 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.215 (e) (e) P=0.515 | P=0.114N P=0.064N P=0.184N P=0.091N |
|INCIDENTAL TUMOR | P=0.215 (e) (e) P=0.515 | P=0.081N P=0.132N P=0.298N P=0.059N |
|LOGISTIC REGRESSION | P=0.215 (e) (e) P=0.515 | P=0.092N P=0.095N P=0.280N P=0.065N |
|COCHRAN-ARMITAGE | P=0.209 | P=0.068N |
|FISHER EXACT | (e) (e) P=0.500 | P=0.263N P=0.442N P=0.062N |
|=================================================================================================================================|
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 01 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 150 PPM 300 PPM 600 PPM | 0 PPM 150 PPM 300 PPM 600 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/70 (0%) 0/60 (0%) 0/61 (0%) 1/70 (1%) | 23/70 (33%) 16/61 (26%) 19/63 (30%) 14/70 (20%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 3.7% | 53.9% 42.8% 47.8% 37.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/25 (0%) 0/25 (0%) 0/19 (0%) 1/27 (4%) | 11/29 (38%) 13/34 (38%) 14/34 (41%) 8/29 (28%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 729 (T) | 451 662 383 466 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.215 (e) (e) P=0.515 | P=0.114N P=0.064N P=0.184N P=0.091N |
|INCIDENTAL TUMOR | P=0.215 (e) (e) P=0.515 | P=0.081N P=0.132N P=0.298N P=0.059N |
|LOGISTIC REGRESSION | P=0.215 (e) (e) P=0.515 | P=0.092N P=0.095N P=0.280N P=0.065N |
|COCHRAN-ARMITAGE | P=0.209 | P=0.068N |
|FISHER EXACT | (e) (e) P=0.500 | P=0.263N P=0.442N P=0.062N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/70 (11%) 7/60 (12%) 7/60 (12%) 9/69 (13%) | 22/70 (31%) 21/61 (34%) 25/63 (40%) 28/70 (40%) |
|ADJUSTED (b) | 26.6% 21.7% 22.1% 28.9% | 56.3% 51.5% 60.4% 73.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | 1/10 (10%) 1/10 (10%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 5/25 (20%) 3/25 (12%) 2/19 (11%) 6/26 (23%) | 13/29 (45%) 15/34 (44%) 18/34 (53%) 19/29 (66%) |
|FIRST INCIDENCE (DAYS) | 539 456 (I) 626 522 | 451 456 (I) 635 466 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.448 P=0.488N P=0.562N P=0.551 | P=0.073 P=0.311N P=0.558 P=0.171 |
|INCIDENTAL TUMOR | P=0.447 P=0.494N P=0.414N P=0.521 | P=0.058 P=0.498N P=0.339 P=0.120 |
|LOGISTIC REGRESSION | P=0.439 P=0.456N P=0.469N P=0.546 | P=0.056 P=0.465N P=0.362 P=0.115 |
|COCHRAN-ARMITAGE | P=0.429 | P=0.152 |
|FISHER EXACT | P=0.590 P=0.590 P=0.487 | P=0.429 P=0.208 P=0.189 |
|=================================================================================================================================|
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 01 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 150 PPM 300 PPM 600 PPM | 0 PPM 150 PPM 300 PPM 600 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/70 (11%) 7/60 (12%) 7/60 (12%) 9/69 (13%) | 22/70 (31%) 22/61 (36%) 25/63 (40%) 28/70 (40%) |
|ADJUSTED (b) | 26.6% 21.7% 22.1% 28.9% | 56.3% 54.1% 60.4% 73.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | 1/10 (10%) 1/10 (10%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 5/25 (20%) 3/25 (12%) 2/19 (11%) 6/26 (23%) | 13/29 (45%) 16/34 (47%) 18/34 (53%) 19/29 (66%) |
|FIRST INCIDENCE (DAYS) | 539 456 (I) 626 522 | 451 456 (I) 635 466 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.448 P=0.488N P=0.562N P=0.551 | P=0.082 P=0.372N P=0.558 P=0.171 |
|INCIDENTAL TUMOR | P=0.447 P=0.494N P=0.414N P=0.521 | P=0.066 P=0.571N P=0.339 P=0.120 |
|LOGISTIC REGRESSION | P=0.439 P=0.456N P=0.469N P=0.546 | P=0.064 P=0.542N P=0.362 P=0.115 |
|COCHRAN-ARMITAGE | P=0.429 | P=0.168 |
|FISHER EXACT | P=0.590 P=0.590 P=0.487 | P=0.353 P=0.208 P=0.189 |
|=================================================================================================================================|
| |
|Skin |
| Basosquamous Tumor Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/70 (3%) 0/60 (0%) 0/61 (0%) 0/70 (0%) | 0/70 (0%) 0/61 (0%) 0/63 (0%) 0/70 (0%) |
|ADJUSTED (b) | 6.6% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/25 (4%) 0/25 (0%) 0/19 (0%) 0/27 (0%) | 0/29 (0%) 0/34 (0%) 0/34 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 645 --- --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.114N P=0.234N P=0.261N P=0.223N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.105N P=0.223N P=0.205N P=0.223N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.109N P=0.226N P=0.226N P=0.222N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.118N | (e) |
|FISHER EXACT | P=0.288N P=0.284N P=0.248N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 01 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 150 PPM 300 PPM 600 PPM | 0 PPM 150 PPM 300 PPM 600 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/70 (3%) 2/60 (3%) 1/61 (2%) 1/70 (1%) | 0/70 (0%) 0/61 (0%) 0/63 (0%) 1/70 (1%) |
|ADJUSTED (b) | 6.6% 8.0% 2.3% 3.7% | 0.0% 0.0% 0.0% 2.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/25 (4%) 2/25 (8%) 0/19 (0%) 1/27 (4%) | 0/29 (0%) 0/34 (0%) 0/34 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 645 729 (T) 617 729 (T) | --- --- --- 698 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.323N P=0.690N P=0.509N P=0.473N | P=0.183 (e) (e) P=0.484 |
|INCIDENTAL TUMOR | P=0.309N P=0.681N P=0.373N P=0.473N | P=0.181 (e) (e) P=0.438 |
|LOGISTIC REGRESSION | P=0.317N P=0.677N P=0.487N P=0.474N | P=0.192 (e) (e) P=0.492 |
|COCHRAN-ARMITAGE | P=0.330N | P=0.208 |
|FISHER EXACT | P=0.630 P=0.552N P=0.500N | (e) (e) P=0.500 |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/70 (0%) 2/60 (3%) 1/61 (2%) 0/70 (0%) | 0/70 (0%) 0/61 (0%) 0/63 (0%) 0/70 (0%) |
|ADJUSTED (b) | 0.0% 8.0% 5.3% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/25 (0%) 2/25 (8%) 1/19 (5%) 0/27 (0%) | 0/29 (0%) 0/34 (0%) 0/34 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) 729 (T) --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.448N P=0.237 P=0.445 (e) | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.448N P=0.237 P=0.445 (e) | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.448N P=0.237 P=0.445 (e) | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.453N | (e) |
|FISHER EXACT | P=0.211 P=0.466 (e) | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 01 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 150 PPM 300 PPM 600 PPM | 0 PPM 150 PPM 300 PPM 600 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, |
| Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/70 (4%) 5/60 (8%) 3/61 (5%) 1/70 (1%) | 0/70 (0%) 0/61 (0%) 0/63 (0%) 1/70 (1%) |
|ADJUSTED (b) | 10.5% 18.2% 10.4% 3.7% | 0.0% 0.0% 0.0% 2.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/25 (8%) 4/25 (16%) 1/19 (5%) 1/27 (4%) | 0/29 (0%) 0/34 (0%) 0/34 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 645 652 617 729 (T) | --- --- --- 698 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.147N P=0.366 P=0.613 P=0.279N | P=0.183 (e) (e) P=0.484 |
|INCIDENTAL TUMOR | P=0.134N P=0.377 P=0.579N P=0.279N | P=0.181 (e) (e) P=0.438 |
|LOGISTIC REGRESSION | P=0.138N P=0.384 P=0.637N P=0.279N | P=0.192 (e) (e) P=0.492 |
|COCHRAN-ARMITAGE | P=0.155N | P=0.208 |
|FISHER EXACT | P=0.277 P=0.592 P=0.310N | (e) (e) P=0.500 |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/70 (1%) 2/60 (3%) 3/61 (5%) 2/70 (3%) | 0/70 (0%) 2/61 (3%) 0/63 (0%) 0/70 (0%) |
|ADJUSTED (b) | 3.3% 6.2% 12.4% 4.7% | 0.0% 5.1% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/25 (0%) 1/25 (4%) 1/19 (5%) 0/27 (0%) | 0/29 (0%) 1/34 (3%) 0/34 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 709 611 691 558 | --- 611 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.423 P=0.510 P=0.245 P=0.523 | P=0.408N P=0.262 (e) (e) |
|INCIDENTAL TUMOR | P=0.448 P=0.612 P=0.433 P=0.577 | P=0.388N P=0.257 (e) (e) |
|LOGISTIC REGRESSION | P=0.428 P=0.518 P=0.308 P=0.518 | P=0.409N P=0.232 (e) (e) |
|COCHRAN-ARMITAGE | P=0.422 | P=0.401N |
|FISHER EXACT | P=0.442 P=0.260 P=0.500 | P=0.215 (e) (e) |
|=================================================================================================================================|
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 01 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 150 PPM 300 PPM 600 PPM | 0 PPM 150 PPM 300 PPM 600 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, Sarcoma, |
| Neurofibroma, or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/70 (1%) 2/60 (3%) 3/61 (5%) 2/70 (3%) | 1/70 (1%) 2/61 (3%) 0/63 (0%) 1/70 (1%) |
|ADJUSTED (b) | 3.3% 6.2% 12.4% 4.7% | 3.4% 5.1% 0.0% 3.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/25 (0%) 1/25 (4%) 1/19 (5%) 0/27 (0%) | 1/29 (3%) 1/34 (3%) 0/34 (0%) 1/29 (3%) |
|FIRST INCIDENCE (DAYS) | 709 611 691 558 | 729 (T) 611 --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.423 P=0.510 P=0.245 P=0.523 | P=0.509N P=0.542 P=0.468N P=0.762 |
|INCIDENTAL TUMOR | P=0.448 P=0.612 P=0.433 P=0.577 | P=0.491N P=0.537 P=0.468N P=0.762 |
|LOGISTIC REGRESSION | P=0.428 P=0.518 P=0.308 P=0.518 | P=0.514N P=0.504 P=0.468N P=0.762 |
|COCHRAN-ARMITAGE | P=0.422 | P=0.490N |
|FISHER EXACT | P=0.442 P=0.260 P=0.500 | P=0.448 P=0.526N P=0.752N |
|=================================================================================================================================|
| |
|Spleen |
| Leiomyosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/70 (3%) 0/60 (0%) 0/61 (0%) 0/70 (0%) | 0/70 (0%) 0/61 (0%) 0/63 (0%) 0/70 (0%) |
|ADJUSTED (b) | 8.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/25 (8%) 0/25 (0%) 0/19 (0%) 0/27 (0%) | 0/29 (0%) 0/34 (0%) 0/34 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.119N P=0.237N P=0.300N P=0.221N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.119N P=0.237N P=0.300N P=0.221N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.119N P=0.237N P=0.300N P=0.221N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.118N | (e) |
|FISHER EXACT | P=0.288N P=0.284N P=0.248N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 01 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 150 PPM 300 PPM 600 PPM | 0 PPM 150 PPM 300 PPM 600 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 52/70 (74%) 48/60 (80%) 55/61 (90%) 57/69 (83%) | |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 10/10 (100%) 1/10 (10%) 6/10 (60%) 10/10 (100%)| |
|TERMINAL (d) | 25/25 (100%) 25/25 (100%) 19/19 (100%) 27/27 (100%)| |
|FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 456 (I) 456 (I) | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.289 P=0.279N P=0.127 P=0.453 | |
|INCIDENTAL TUMOR | P=0.080 P=0.004N** P=0.356N P=0.396 | |
|LOGISTIC REGRESSION | P=0.053 P=0.012N* P=0.466N P=0.248 | |
|COCHRAN-ARMITAGE | P=0.112 | |
|FISHER EXACT | P=0.288 P=0.016 * P=0.162 | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/70 (16%) 7/59 (12%) 12/61 (20%) 10/69 (14%) | 5/70 (7%) 11/61 (18%) 6/63 (10%) 10/70 (14%) |
|ADJUSTED (b) | 33.3% 21.7% 41.5% 29.1% | 17.2% 30.1% 17.1% 29.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 6/25 (24%) 4/25 (16%) 5/19 (26%) 6/27 (22%) | 5/29 (17%) 9/34 (26%) 5/34 (15%) 7/29 (24%) |
|FIRST INCIDENCE (DAYS) | 456 (I) 610 552 456 (I) | 729 (T) 666 723 634 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.534N P=0.210N P=0.367 P=0.428N | P=0.178 P=0.146 P=0.611 P=0.122 |
|INCIDENTAL TUMOR | P=0.536N P=0.172N P=0.551 P=0.498N | P=0.170 P=0.116 P=0.577 P=0.118 |
|LOGISTIC REGRESSION | P=0.532N P=0.210N P=0.559 P=0.444N | P=0.163 P=0.113 P=0.593 P=0.107 |
|COCHRAN-ARMITAGE | P=0.526 | P=0.251 |
|FISHER EXACT | P=0.357N P=0.357 P=0.514N | P=0.051 P=0.426 P=0.137 |
|=================================================================================================================================|
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 01 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 150 PPM 300 PPM 600 PPM | 0 PPM 150 PPM 300 PPM 600 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/70 (16%) 7/59 (12%) 12/61 (20%) 10/69 (14%) | 5/70 (7%) 11/61 (18%) 7/63 (11%) 10/70 (14%) |
|ADJUSTED (b) | 33.3% 21.7% 41.5% 29.1% | 17.2% 30.1% 20.0% 29.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 6/25 (24%) 4/25 (16%) 5/19 (26%) 6/27 (22%) | 5/29 (17%) 9/34 (26%) 6/34 (18%) 7/29 (24%) |
|FIRST INCIDENCE (DAYS) | 456 (I) 610 552 456 (I) | 729 (T) 666 723 634 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.534N P=0.210N P=0.367 P=0.428N | P=0.171 P=0.146 P=0.494 P=0.122 |
|INCIDENTAL TUMOR | P=0.536N P=0.172N P=0.551 P=0.498N | P=0.164 P=0.116 P=0.459 P=0.118 |
|LOGISTIC REGRESSION | P=0.532N P=0.210N P=0.559 P=0.444N | P=0.156 P=0.113 P=0.472 P=0.107 |
|COCHRAN-ARMITAGE | P=0.526 | P=0.245 |
|FISHER EXACT | P=0.357N P=0.357 P=0.514N | P=0.051 P=0.310 P=0.137 |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/70 (1%) 1/59 (2%) 2/61 (3%) 2/69 (3%) | 0/70 (0%) 0/61 (0%) 1/63 (2%) 1/70 (1%) |
|ADJUSTED (b) | 4.0% 2.6% 9.4% 6.7% | 0.0% 0.0% 2.9% 3.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/25 (4%) 0/25 (0%) 1/19 (5%) 1/27 (4%) | 0/29 (0%) 0/34 (0%) 1/34 (3%) 1/29 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 652 713 702 | --- --- 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.355 P=0.751N P=0.410 P=0.522 | P=0.222 (e) P=0.532 P=0.500 |
|INCIDENTAL TUMOR | P=0.365 P=0.751N P=0.500 P=0.527 | P=0.222 (e) P=0.532 P=0.500 |
|LOGISTIC REGRESSION | P=0.360 P=0.755N P=0.458 P=0.521 | P=0.222 (e) P=0.532 P=0.500 |
|COCHRAN-ARMITAGE | P=0.351 | P=0.247 |
|FISHER EXACT | P=0.707 P=0.448 P=0.495 | (e) P=0.474 P=0.500 |
|=================================================================================================================================|
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 01 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 150 PPM 300 PPM 600 PPM | 0 PPM 150 PPM 300 PPM 600 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/70 (1%) 1/59 (2%) 2/61 (3%) 2/69 (3%) | 0/70 (0%) 0/61 (0%) 2/63 (3%) 1/70 (1%) |
|ADJUSTED (b) | 4.0% 2.6% 9.4% 6.7% | 0.0% 0.0% 5.9% 3.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/25 (4%) 0/25 (0%) 1/19 (5%) 1/27 (4%) | 0/29 (0%) 0/34 (0%) 2/34 (6%) 1/29 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 652 713 702 | --- --- 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.355 P=0.751N P=0.410 P=0.522 | P=0.230 (e) P=0.274 P=0.500 |
|INCIDENTAL TUMOR | P=0.365 P=0.751N P=0.500 P=0.527 | P=0.230 (e) P=0.274 P=0.500 |
|LOGISTIC REGRESSION | P=0.360 P=0.755N P=0.458 P=0.521 | P=0.230 (e) P=0.274 P=0.500 |
|COCHRAN-ARMITAGE | P=0.351 | P=0.258 |
|FISHER EXACT | P=0.707 P=0.448 P=0.495 | (e) P=0.222 P=0.500 |
|=================================================================================================================================|
| |
|Uterus |
| Leiomyoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 0/70 (0%) 0/61 (0%) 0/63 (0%) 2/70 (3%) |
|ADJUSTED (b) | | 0.0% 0.0% 0.0% 5.6% |
|INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | | 0/29 (0%) 0/34 (0%) 0/34 (0%) 1/29 (3%) |
|FIRST INCIDENCE (DAYS) | | --- --- --- 619 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.043 * (e) (e) P=0.240 |
|INCIDENTAL TUMOR | | P=0.055 (e) (e) P=0.264 |
|LOGISTIC REGRESSION | | P=0.045 * (e) (e) P=0.232 |
|COCHRAN-ARMITAGE | | P=0.053 |
|FISHER EXACT | | (e) (e) P=0.248 |
|=================================================================================================================================|
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 01 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 150 PPM 300 PPM 600 PPM | 0 PPM 150 PPM 300 PPM 600 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 5/70 (7%) 7/61 (11%) 5/63 (8%) 5/70 (7%) |
|ADJUSTED (b) | | 12.9% 18.4% 14.3% 16.1% |
|INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| | 1/10 (10%) 1/10 (10%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | | 2/29 (7%) 5/34 (15%) 4/34 (12%) 4/29 (14%) |
|FIRST INCIDENCE (DAYS) | | 456 (I) 456 (I) 723 685 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.499N P=0.463 P=0.556N P=0.617 |
|INCIDENTAL TUMOR | | P=0.515N P=0.400 P=0.620 P=0.604 |
|LOGISTIC REGRESSION | | P=0.498N P=0.362 P=0.625 P=0.613 |
|COCHRAN-ARMITAGE | | P=0.446N |
|FISHER EXACT | | P=0.289 P=0.560 P=0.628N |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/70 (0%) 0/60 (0%) 2/61 (3%) 0/70 (0%) | 0/70 (0%) 0/61 (0%) 0/63 (0%) 0/70 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 8.1% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/25 (0%) 0/25 (0%) 1/19 (5%) 0/27 (0%) | 0/29 (0%) 0/34 (0%) 0/34 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 688 --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.605 (e) P=0.216 (e) | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.611 (e) P=0.266 (e) | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.607 (e) P=0.242 (e) | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.599 | (e) |
|FISHER EXACT | (e) P=0.215 (e) | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 01 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 150 PPM 300 PPM 600 PPM | 0 PPM 150 PPM 300 PPM 600 PPM |
| | | |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/70 (0%) 1/60 (2%) 2/61 (3%) 0/70 (0%) | 0/70 (0%) 0/61 (0%) 0/63 (0%) 0/70 (0%) |
|ADJUSTED (b) | 0.0% 2.3% 8.1% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/25 (0%) 0/25 (0%) 1/19 (5%) 0/27 (0%) | 0/29 (0%) 0/34 (0%) 0/34 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | --- 611 688 --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.600N P=0.524 P=0.216 (e) | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.590N P=0.669 P=0.266 (e) | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.602N P=0.483 P=0.242 (e) | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.604N | (e) |
|FISHER EXACT | P=0.462 P=0.215 (e) | (e) (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, |
| or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 22/70 (31%) 23/60 (38%) 19/61 (31%) 18/70 (26%) | 8/70 (11%) 11/61 (18%) 7/63 (11%) 9/70 (13%) |
|ADJUSTED (b) | 57.6% 55.9% 50.0% 49.1% | 19.8% 23.8% 16.2% 24.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 10/25 (40%) 9/25 (36%) 4/19 (21%) 11/27 (41%) | 1/29 (3%) 2/34 (6%) 1/34 (3%) 3/29 (10%) |
|FIRST INCIDENCE (DAYS) | 508 539 541 368 | 534 522 619 589 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.163N P=0.552 P=0.463N P=0.209N | P=0.499 P=0.392 P=0.454N P=0.471 |
|INCIDENTAL TUMOR | P=0.095N P=0.421N P=0.079N P=0.140N | P=0.525 P=0.131 P=0.509 P=0.401 |
|LOGISTIC REGRESSION | P=0.091N P=0.294N P=0.043N* P=0.194N | P=0.428N P=0.168 P=0.576N P=0.538 |
|COCHRAN-ARMITAGE | P=0.165N | P=0.504N |
|FISHER EXACT | P=0.261 P=0.562N P=0.287N | P=0.205 P=0.587N P=0.500 |
|=================================================================================================================================|
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 01 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 150 PPM 300 PPM 600 PPM | 0 PPM 150 PPM 300 PPM 600 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/70 (0%) 2/60 (3%) 0/61 (0%) 1/70 (1%) | 1/70 (1%) 0/61 (0%) 0/63 (0%) 0/70 (0%) |
|ADJUSTED (b) | 0.0% 6.0% 0.0% 3.7% | 3.3% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/25 (0%) 1/25 (4%) 0/19 (0%) 1/27 (4%) | 0/29 (0%) 0/34 (0%) 0/34 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | --- 542 --- 729 (T) | 725 --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.556 P=0.257 (e) P=0.515 | P=0.308N P=0.475N P=0.475N P=0.507N |
|INCIDENTAL TUMOR | P=0.539 P=0.166 (e) P=0.515 | P=0.345N P=0.581N P=0.581N P=0.562N |
|LOGISTIC REGRESSION | P=0.553 P=0.229 (e) P=0.515 | P=0.311N P=0.481N P=0.486N P=0.511N |
|COCHRAN-ARMITAGE | P=0.547 | P=0.306N |
|FISHER EXACT | P=0.211 (e) P=0.500 | P=0.534N P=0.526N P=0.500N |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 54/70 (77%) 50/60 (83%) 58/61 (95%) 58/70 (83%) | 43/70 (61%) 39/61 (64%) 40/63 (63%) 37/70 (53%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 89.2% 86.2% 88.7% 83.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 10/10 (100%) 2/10 (20%) 8/10 (80%) 10/10 (100%)| 3/10 (30%) 2/10 (20%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 25/25 (100%) 25/25 (100%) 19/19 (100%) 27/27 (100%)| 24/29 (83%) 28/34 (82%) 29/34 (85%) 22/29 (76%) |
|FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 456 (I) 456 (I) | 451 456 (I) 383 466 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.344 P=0.280N P=0.108 P=0.529 | P=0.313N P=0.099N P=0.139N P=0.266N |
|INCIDENTAL TUMOR | P=0.215 P=0.004N** P=0.571N P=0.662N | P=0.187N P=0.233N P=0.332N P=0.192N |
|LOGISTIC REGRESSION | P=0.151 P=0.007N** P=0.689N P=0.562 | P=0.219N P=0.223N P=0.335N P=0.188N |
|COCHRAN-ARMITAGE | P=0.199 | P=0.136N |
|FISHER EXACT | P=0.256 P=0.003 ** P=0.263 | P=0.455 P=0.474 P=0.197N |
|=================================================================================================================================|
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 01 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 150 PPM 300 PPM 600 PPM | 0 PPM 150 PPM 300 PPM 600 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 26/70 (37%) 30/60 (50%) 24/61 (39%) 23/70 (33%) | 16/70 (23%) 13/61 (21%) 9/63 (14%) 10/70 (14%) |
|ADJUSTED (b) | 67.0% 67.4% 59.0% 58.9% | 36.5% 28.6% 21.3% 25.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 13/25 (52%) 12/25 (48%) 5/19 (26%) 13/27 (48%) | 3/29 (10%) 4/34 (12%) 3/34 (9%) 3/29 (10%) |
|FIRST INCIDENCE (DAYS) | 508 366 541 368 | 534 522 619 456 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.176N P=0.375 P=0.560N P=0.257N | P=0.146N P=0.264N P=0.081N P=0.183N |
|INCIDENTAL TUMOR | P=0.092N P=0.487 P=0.081N P=0.171N | P=0.090N P=0.525N P=0.187N P=0.162N |
|LOGISTIC REGRESSION | P=0.094N P=0.542 P=0.038N* P=0.187N | P=0.045N* P=0.500N P=0.143N P=0.092N |
|COCHRAN-ARMITAGE | P=0.173N | P=0.087N |
|FISHER EXACT | P=0.097 P=0.468 P=0.362N | P=0.500N P=0.149N P=0.139N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 55/70 (79%) 52/60 (87%) 58/61 (95%) 60/70 (86%) | 49/70 (70%) 45/61 (74%) 42/63 (67%) 42/70 (60%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 94.1% 88.1% 89.3% 87.3% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/1 (0%) 0/10 (0%) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 10/10 (100%) 3/10 (30%) 8/10 (80%) 10/10 (100%)| 3/10 (30%) 2/10 (20%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 25/25 (100%) 25/25 (100%) 19/19 (100%) 27/27 (100%)| 26/29 (90%) 28/34 (82%) 29/34 (85%) 23/29 (79%) |
|FIRST INCIDENCE (DAYS) | 456 (I) 366 456 (I) 368 | 451 456 (I) 383 456 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.320 P=0.329N P=0.141 P=0.474 | P=0.260N P=0.106N P=0.047N* P=0.237N |
|INCIDENTAL TUMOR | P=0.101 P=0.013N* P=0.421N P=0.536 | P=0.061N P=0.233N P=0.068N P=0.075N |
|LOGISTIC REGRESSION | P=0.064 P=0.019N* P=0.465N P=0.275 | P=0.063N P=0.228N P=0.074N P=0.066N |
|COCHRAN-ARMITAGE | P=0.152 | P=0.072N |
|FISHER EXACT | P=0.165 P=0.005 ** P=0.189 | P=0.389 P=0.410N P=0.144N |
|=================================================================================================================================|
DATE: 09/11/94 EXPERIMENT: 05087 TEST: 01 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRIAMTERENE
TERMINAL SACRIFICE AT 105 WEEKS
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for
intercurrent mortality.
(c) Observed incidence at interim kill.
Male interim sacrifices(days): 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).