TDMS Study 05121-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus SCOPOLAMINE HYDROBROMIDE TRIHYDRATE DATE: 04/03/96
EXPERIMENT: 05121 TEST: 05 TIME: 21:36:18
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01 ES 85227 ROUTE: GAVAGE NTP C#: 03098C
PATHOLOGIST: M. RYAN CAS: 6533-68-2
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus SCOPOLAMINE HYDROBROMIDE TRIHYDRATE DATE: 04/03/96
EXPERIMENT: 05121 TEST: 05 TIME: 21:36:18
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01 ES 85227 ROUTE: GAVAGE NTP C#: 03098C
PATHOLOGIST: M. RYAN CAS: 6533-68-2
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 Cortex
Adrenal Medulla
Bone Marrow
Brain
Clitoral Gland
Clitoral/Preputial 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 SCOPOLAMINE HYDROBROMIDE TRIHYDRATE DATE: 04/03/96
EXPERIMENT: 05121 TEST: 05 TIME: 21:36:18
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01 ES 85227 ROUTE: GAVAGE NTP C#: 03098C
PATHOLOGIST: M. RYAN CAS: 6533-68-2
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Islets, Pancreatic Carcinoma or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Testes Adenoma
Thyroid Gland: Follicular Cell
Carcinoma or Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Thyroid Gland: Follicular Cell
Adenoma
Carcinoma or Adenoma
Uterus Polyp Stromal
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 05 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 1/60 (2%) |
|ADJUSTED (b) | 3.2% 0.0% 0.0% 0.0% | 0.0% 0.0% 6.8% 4.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/0 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/20 (0%) 0/14 (0%) 0/22 (0%) 0/28 (0%) | 0/34 (0%) 0/17 (0%) 1/26 (4%) 1/22 (5%) |
|FIRST INCIDENCE (DAYS) | 671 --- --- --- | --- --- 680 726 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.547N P=0.535N P=0.507N P=0.470N | P=0.402 (e) P=0.201 P=0.413 |
|INCIDENTAL TUMOR | P=0.689N P=0.500N P=0.550N P=0.617N | P=0.365 (e) P=0.262 P=0.413 |
|LOGISTIC REGRESSION | P=0.581N P=0.517N P=0.496N P=0.498N | P=0.396 (e) P=0.216 P=0.413 |
|COCHRAN-ARMITAGE | P=0.588N | P=0.460 |
|FISHER EXACT | P=0.500N P=0.500N P=0.500N | (e) P=0.248 P=0.500 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/60 (18%) 13/60 (22%) 12/60 (20%) 10/60 (17%) | 1/60 (2%) 0/60 (0%) 1/60 (2%) 1/60 (2%) |
|ADJUSTED (b) | 41.4% 57.0% 37.7% 30.3% | 2.4% 0.0% 3.8% 3.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/0 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 5/20 (25%) 6/14 (43%) 4/22 (18%) 7/28 (25%) | 0/34 (0%) 0/17 (0%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 673 585 589 456 (I) | 627 --- 726 (T) 499 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.096N P=0.156 P=0.532 P=0.268N | P=0.517 P=0.633N P=0.722 P=0.666 |
|INCIDENTAL TUMOR | P=0.344N P=0.308 P=0.476 P=0.529N | P=0.570 P=0.398N P=0.760N P=0.664N |
|LOGISTIC REGRESSION | P=0.246N P=0.233 P=0.522 P=0.451N | P=0.558 P=0.565N P=0.750 P=0.752N |
|COCHRAN-ARMITAGE | P=0.352N | P=0.574 |
|FISHER EXACT | P=0.410 P=0.500 P=0.500N | P=0.500N P=0.752N P=0.752N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 05 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/60 (18%) 13/60 (22%) 12/60 (20%) 10/60 (17%) | 1/60 (2%) 0/60 (0%) 1/60 (2%) 2/60 (3%) |
|ADJUSTED (b) | 41.4% 57.0% 37.7% 30.3% | 2.4% 0.0% 3.8% 7.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/0 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 5/20 (25%) 6/14 (43%) 4/22 (18%) 7/28 (25%) | 0/34 (0%) 0/17 (0%) 1/26 (4%) 1/22 (5%) |
|FIRST INCIDENCE (DAYS) | 673 585 589 456 (I) | 627 --- 726 (T) 499 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.096N P=0.156 P=0.532 P=0.268N | P=0.185 P=0.633N P=0.722 P=0.357 |
|INCIDENTAL TUMOR | P=0.344N P=0.308 P=0.476 P=0.529N | P=0.229 P=0.398N P=0.760N P=0.551 |
|LOGISTIC REGRESSION | P=0.246N P=0.233 P=0.522 P=0.451N | P=0.210 P=0.565N P=0.750 P=0.462 |
|COCHRAN-ARMITAGE | P=0.352N | P=0.243 |
|FISHER EXACT | P=0.410 P=0.500 P=0.500N | P=0.500N P=0.752N P=0.500 |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 1/60 (2%) 4/58 (7%) 2/60 (3%) | 3/59 (5%) 2/60 (3%) 3/58 (5%) 1/60 (2%) |
|ADJUSTED (b) | 11.1% 7.1% 11.1% 7.1% | 9.1% 11.8% 10.4% 4.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/9 (11%) 0/10 (0%) | 0/10 (0%) 0/0 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/20 (5%) 1/14 (7%) 0/21 (0%) 2/28 (7%) | 3/33 (9%) 2/17 (12%) 2/24 (8%) 1/22 (5%) |
|FIRST INCIDENCE (DAYS) | 471 726 (T) 456 (I) 726 (T) | 726 (T) 726 (T) 547 726 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.395N P=0.406N P=0.492 P=0.391N | P=0.337N P=0.578 P=0.532 P=0.458N |
|INCIDENTAL TUMOR | P=0.567N P=0.344N P=0.307 P=0.497N | P=0.338N P=0.578 P=0.560 P=0.458N |
|LOGISTIC REGRESSION | P=0.532N P=0.326N P=0.480 P=0.495N | P=0.347N P=0.578 P=0.609 P=0.458N |
|COCHRAN-ARMITAGE | P=0.541N | P=0.271N |
|FISHER EXACT | P=0.309N P=0.481 P=0.500N | P=0.492N P=0.652 P=0.303N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 05 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 2/60 (3%) 4/58 (7%) 2/60 (3%) | 3/59 (5%) 2/60 (3%) 3/58 (5%) 1/60 (2%) |
|ADJUSTED (b) | 11.1% 9.1% 11.1% 7.1% | 9.1% 11.8% 10.4% 4.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/9 (11%) 0/10 (0%) | 0/10 (0%) 0/0 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/20 (5%) 1/14 (7%) 0/21 (0%) 2/28 (7%) | 3/33 (9%) 2/17 (12%) 2/24 (8%) 1/22 (5%) |
|FIRST INCIDENCE (DAYS) | 471 492 456 (I) 726 (T) | 726 (T) 726 (T) 547 726 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.328N P=0.594N P=0.492 P=0.391N | P=0.337N P=0.578 P=0.532 P=0.458N |
|INCIDENTAL TUMOR | P=0.503N P=0.512N P=0.307 P=0.497N | P=0.338N P=0.578 P=0.560 P=0.458N |
|LOGISTIC REGRESSION | P=0.455N P=0.504N P=0.480 P=0.495N | P=0.347N P=0.578 P=0.609 P=0.458N |
|COCHRAN-ARMITAGE | P=0.458N | P=0.271N |
|FISHER EXACT | P=0.500N P=0.481 P=0.500N | P=0.492N P=0.652 P=0.303N |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 2/60 (3%) 1/60 (2%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/59 (0%) 1/60 (2%) |
|ADJUSTED (b) | 15.0% 10.9% 4.5% 0.0% | 0.0% 0.0% 0.0% 4.2% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/0 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 3/20 (15%) 1/14 (7%) 1/22 (5%) 0/28 (0%) | 0/34 (0%) 0/17 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 726 (T) 678 726 (T) --- | --- --- --- 647 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.059N P=0.643N P=0.268N P=0.067N | P=0.195 (e) (e) P=0.398 |
|INCIDENTAL TUMOR | P=0.069N P=0.630N P=0.268N P=0.067N | P=0.096 (e) (e) P=0.282 |
|LOGISTIC REGRESSION | P=0.076N P=0.622N P=0.268N P=0.067N | P=0.217 (e) (e) P=0.455 |
|COCHRAN-ARMITAGE | P=0.114N | P=0.237 |
|FISHER EXACT | P=0.500N P=0.309N P=0.122N | (e) (e) P=0.500 |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 05 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 3/60 (5%) 1/60 (2%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/59 (0%) 1/60 (2%) |
|ADJUSTED (b) | 15.0% 17.7% 4.5% 0.0% | 0.0% 0.0% 0.0% 4.2% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/0 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 3/20 (15%) 2/14 (14%) 1/22 (5%) 0/28 (0%) | 0/34 (0%) 0/17 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 726 (T) 678 726 (T) --- | --- --- --- 647 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.038N* P=0.508 P=0.268N P=0.067N | P=0.195 (e) (e) P=0.398 |
|INCIDENTAL TUMOR | P=0.045N* P=0.520 P=0.268N P=0.067N | P=0.096 (e) (e) P=0.282 |
|LOGISTIC REGRESSION | P=0.051N P=0.530 P=0.268N P=0.067N | P=0.217 (e) (e) P=0.455 |
|COCHRAN-ARMITAGE | P=0.085N | P=0.237 |
|FISHER EXACT | P=0.660N P=0.309N P=0.122N | (e) (e) P=0.500 |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 10.0% 0.0% 2.1% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/0 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/20 (10%) 0/14 (0%) 0/22 (0%) 0/28 (0%) | 0/34 (0%) 0/17 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 726 (T) --- 576 --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.251N P=0.318N P=0.465N P=0.167N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.267N P=0.318N P=0.380N P=0.167N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.306N P=0.318N P=0.492N P=0.167N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.318N | (e) |
|FISHER EXACT | P=0.248N P=0.500N P=0.248N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 05 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 2/60 (3%) 2/60 (3%) 2/60 (3%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 4.5% 7.7% 6.7% 6.7% | 2.9% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/0 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/20 (0%) 0/14 (0%) 1/22 (5%) 1/28 (4%) | 1/34 (3%) 0/17 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 720 660 596 686 | 726 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.634N P=0.414 P=0.519 P=0.574 | P=0.619N P=0.638N P=0.553N P=0.587N |
|INCIDENTAL TUMOR | P=0.442 P=0.500 P=0.579 P=0.403 | P=0.619N P=0.638N P=0.554N P=0.587N |
|LOGISTIC REGRESSION | P=0.566 P=0.453 P=0.508 P=0.530 | P=0.619N P=0.638N P=0.554N P=0.587N |
|COCHRAN-ARMITAGE | P=0.534 | P=0.588N |
|FISHER EXACT | P=0.500 P=0.500 P=0.500 | P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 3/60 (5%) 2/60 (3%) 2/60 (3%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 9.3% 14.3% 6.7% 6.7% | 2.9% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/0 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/20 (5%) 1/14 (7%) 1/22 (5%) 1/28 (4%) | 1/34 (3%) 0/17 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 720 660 596 686 | 726 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.388N P=0.371 P=0.669N P=0.603N | P=0.619N P=0.638N P=0.553N P=0.587N |
|INCIDENTAL TUMOR | P=0.569N P=0.435 P=0.625N P=0.655 | P=0.619N P=0.638N P=0.554N P=0.587N |
|LOGISTIC REGRESSION | P=0.492N P=0.414 P=0.688N P=0.659N | P=0.619N P=0.638N P=0.554N P=0.587N |
|COCHRAN-ARMITAGE | P=0.543N | P=0.588N |
|FISHER EXACT | P=0.500 P=0.691N P=0.691N | P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 05 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 3/60 (5%) 2/60 (3%) 2/60 (3%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 9.3% 14.3% 6.7% 6.7% | 2.9% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/0 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/20 (5%) 1/14 (7%) 1/22 (5%) 1/28 (4%) | 1/34 (3%) 0/17 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 720 660 596 686 | 726 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.388N P=0.371 P=0.669N P=0.603N | P=0.619N P=0.638N P=0.553N P=0.587N |
|INCIDENTAL TUMOR | P=0.569N P=0.435 P=0.625N P=0.655 | P=0.619N P=0.638N P=0.554N P=0.587N |
|LOGISTIC REGRESSION | P=0.492N P=0.414 P=0.688N P=0.659N | P=0.619N P=0.638N P=0.554N P=0.587N |
|COCHRAN-ARMITAGE | P=0.543N | P=0.588N |
|FISHER EXACT | P=0.500 P=0.691N P=0.691N | P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 1/60 (2%) 1/60 (2%) 2/60 (3%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 2.9% 5.9% 7.7% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/0 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/20 (0%) 0/14 (0%) 0/22 (0%) 0/28 (0%) | 1/34 (3%) 1/17 (6%) 2/26 (8%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 726 (T) 726 (T) 726 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.355N P=0.600 P=0.406 P=0.587N |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.355N P=0.600 P=0.406 P=0.587N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.355N P=0.600 P=0.406 P=0.587N |
|COCHRAN-ARMITAGE | (e) | P=0.309N |
|FISHER EXACT | (e) (e) (e) | P=0.752N P=0.500 P=0.500N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 05 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 8/60 (13%) 3/60 (5%) 3/60 (5%) | 29/60 (48%) 10/60 (17%) 19/60 (32%) 16/60 (27%) |
|ADJUSTED (b) | 11.7% 31.5% 11.6% 10.7% | 70.4% 46.1% 59.8% 58.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/0 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 1/20 (5%) 3/14 (21%) 2/22 (9%) 3/28 (11%) | 22/34 (65%) 6/17 (35%) 14/26 (54%) 11/22 (50%) |
|FIRST INCIDENCE (DAYS) | 673 404 646 726 (T) | 562 562 404 457 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.142N P=0.059 P=0.644N P=0.532N | P=0.476N P=0.134N P=0.242N P=0.322N |
|INCIDENTAL TUMOR | P=0.252N P=0.088 P=0.627 P=0.651N | P=0.517N P=0.026N* P=0.092N P=0.251N |
|LOGISTIC REGRESSION | P=0.264N P=0.097 P=0.656N P=0.620N | P=0.484N P=0.052N P=0.071N P=0.235N |
|COCHRAN-ARMITAGE | P=0.278N | P=0.210N |
|FISHER EXACT | P=0.102 P=0.660N P=0.660N | P<0.001N** P=0.047N* P=0.012N* |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 8/60 (13%) 3/60 (5%) 3/60 (5%) | 29/60 (48%) 10/60 (17%) 20/60 (33%) 16/60 (27%) |
|ADJUSTED (b) | 11.7% 31.5% 11.6% 10.7% | 70.4% 46.1% 63.1% 58.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/0 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 1/20 (5%) 3/14 (21%) 2/22 (9%) 3/28 (11%) | 22/34 (65%) 6/17 (35%) 15/26 (58%) 11/22 (50%) |
|FIRST INCIDENCE (DAYS) | 673 404 646 726 (T) | 562 562 404 457 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.142N P=0.059 P=0.644N P=0.532N | P=0.463N P=0.134N P=0.315N P=0.322N |
|INCIDENTAL TUMOR | P=0.252N P=0.088 P=0.627 P=0.651N | P=0.503N P=0.026N* P=0.136N P=0.251N |
|LOGISTIC REGRESSION | P=0.264N P=0.097 P=0.656N P=0.620N | P=0.473N P=0.052N P=0.105N P=0.235N |
|COCHRAN-ARMITAGE | P=0.278N | P=0.200N |
|FISHER EXACT | P=0.102 P=0.660N P=0.660N | P<0.001N** P=0.068N P=0.012N* |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 05 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 8/60 (13%) 3/60 (5%) 3/60 (5%) | 29/60 (48%) 10/60 (17%) 21/60 (35%) 16/60 (27%) |
|ADJUSTED (b) | 11.7% 31.5% 11.6% 10.7% | 70.4% 46.1% 66.5% 58.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/0 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 1/20 (5%) 3/14 (21%) 2/22 (9%) 3/28 (11%) | 22/34 (65%) 6/17 (35%) 16/26 (62%) 11/22 (50%) |
|FIRST INCIDENCE (DAYS) | 673 404 646 726 (T) | 562 562 404 457 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.142N P=0.059 P=0.644N P=0.532N | P=0.451N P=0.134N P=0.398N P=0.322N |
|INCIDENTAL TUMOR | P=0.252N P=0.088 P=0.627 P=0.651N | P=0.489N P=0.026N* P=0.194N P=0.251N |
|LOGISTIC REGRESSION | P=0.264N P=0.097 P=0.656N P=0.620N | P=0.462N P=0.052N P=0.149N P=0.235N |
|COCHRAN-ARMITAGE | P=0.278N | P=0.190N |
|FISHER EXACT | P=0.102 P=0.660N P=0.660N | P<0.001N** P=0.097N P=0.012N* |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 4.5% 3.6% | 0.0% 0.0% 6.4% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/0 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/20 (0%) 0/14 (0%) 1/22 (5%) 1/28 (4%) | 0/34 (0%) 0/17 (0%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 726 (T) 726 (T) | --- --- 631 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.490 (e) P=0.519 P=0.567 | P=0.678N (e) P=0.205 (e) |
|INCIDENTAL TUMOR | P=0.490 (e) P=0.519 P=0.567 | P=0.679N (e) P=0.240 (e) |
|LOGISTIC REGRESSION | P=0.490 (e) P=0.519 P=0.567 | P=0.665N (e) P=0.224 (e) |
|COCHRAN-ARMITAGE | P=0.376 | P=0.624N |
|FISHER EXACT | (e) P=0.500 P=0.500 | (e) P=0.248 (e) |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 05 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) 1/60 (2%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 4.0% 4.5% 3.6% | 0.0% 0.0% 6.4% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/0 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/20 (0%) 0/14 (0%) 1/22 (5%) 1/28 (4%) | 0/34 (0%) 0/17 (0%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | --- 678 726 (T) 726 (T) | --- --- 631 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.653 P=0.470 P=0.519 P=0.567 | P=0.678N (e) P=0.205 (e) |
|INCIDENTAL TUMOR | P=0.595 P=0.500 P=0.519 P=0.567 | P=0.679N (e) P=0.240 (e) |
|LOGISTIC REGRESSION | P=0.600 P=0.480 P=0.519 P=0.567 | P=0.665N (e) P=0.224 (e) |
|COCHRAN-ARMITAGE | P=0.551 | P=0.624N |
|FISHER EXACT | P=0.500 P=0.500 P=0.500 | (e) P=0.248 (e) |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 19/59 (32%) 17/58 (29%) 14/60 (23%) 11/60 (18%) | 21/60 (35%) 13/60 (22%) 15/60 (25%) 10/60 (17%) |
|ADJUSTED (b) | 57.6% 51.9% 43.7% 27.9% | 51.4% 51.0% 39.2% 38.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 1/10 (10%) 1/10 (10%) | 1/10 (10%) 0/0 1/10 (10%) 0/10 (0%) |
|TERMINAL (d) | 7/19 (37%) 2/14 (14%) 6/22 (27%) 5/28 (18%) | 15/34 (44%) 6/17 (35%) 5/26 (19%) 7/22 (32%) |
|FIRST INCIDENCE (DAYS) | 471 446 456 (I) 351 | 457 (I) 408 457 (I) 520 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.016N* P=0.445 P=0.181N P=0.029N* | P=0.153N P=0.314 P=0.385N P=0.217N |
|INCIDENTAL TUMOR | P=0.112N P=0.405N P=0.256N P=0.075N | P=0.123N P=0.548N P=0.158N P=0.125N |
|LOGISTIC REGRESSION | P=0.051N P=0.415N P=0.155N P=0.061N | P=0.105N P=0.558N P=0.201N P=0.137N |
|COCHRAN-ARMITAGE | P=0.060N | P=0.053N |
|FISHER EXACT | P=0.445N P=0.191N P=0.063N | P=0.078N P=0.160N P=0.018N* |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 05 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal |
| Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/60 (7%) 5/60 (8%) 3/60 (5%) 5/60 (8%) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 18.7% 27.4% 12.0% 15.2% | 2.9% 3.3% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/0 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 3/20 (15%) 3/14 (21%) 2/22 (9%) 3/28 (11%) | 1/34 (3%) 0/17 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 713 589 666 456 (I) | 726 (T) 519 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.463N P=0.306 P=0.459N P=0.614N | P=0.418N P=0.632 P=0.553N P=0.587N |
|INCIDENTAL TUMOR | P=0.593 P=0.391 P=0.502N P=0.560 | P=0.357N P=0.742N P=0.554N P=0.587N |
|LOGISTIC REGRESSION | P=0.537 P=0.374 P=0.499N P=0.521 | P=0.389N P=0.708 P=0.554N P=0.587N |
|COCHRAN-ARMITAGE | P=0.468 | P=0.376N |
|FISHER EXACT | P=0.500 P=0.500N P=0.500 | P=0.752N P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 5/60 (8%) 3/60 (5%) 3/60 (5%) 3/60 (5%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 15.7% 13.0% 11.8% 10.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/0 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/20 (5%) 1/14 (7%) 2/22 (9%) 2/28 (7%) | 0/34 (0%) 0/17 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 649 656 656 685 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.278N P=0.454N P=0.359N P=0.267N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.489N P=0.404N P=0.423N P=0.489N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.390N P=0.407N P=0.344N P=0.341N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.441N | (e) |
|FISHER EXACT | P=0.359N P=0.359N P=0.359N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 05 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 6/60 (10%) 3/60 (5%) 4/60 (7%) 3/60 (5%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 17.8% 13.0% 14.3% 10.0% | 2.9% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/0 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/20 (5%) 1/14 (7%) 2/22 (9%) 2/28 (7%) | 1/34 (3%) 0/17 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 642 656 646 685 | 726 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.206N P=0.340N P=0.378N P=0.179N | P=0.619N P=0.638N P=0.553N P=0.587N |
|INCIDENTAL TUMOR | P=0.416N P=0.246N P=0.392N P=0.350N | P=0.619N P=0.638N P=0.554N P=0.587N |
|LOGISTIC REGRESSION | P=0.507N P=0.226N P=0.356N P=0.232N | P=0.619N P=0.638N P=0.554N P=0.587N |
|COCHRAN-ARMITAGE | P=0.341N | P=0.588N |
|FISHER EXACT | P=0.245N P=0.372N P=0.245N | P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/60 (7%) 3/60 (5%) 3/60 (5%) 2/60 (3%) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 18.7% 18.6% 12.0% 6.8% | 2.9% 3.3% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/0 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 3/20 (15%) 2/14 (14%) 2/22 (9%) 1/28 (4%) | 1/34 (3%) 0/17 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 713 702 666 692 | 726 (T) 519 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.161N P=0.627 P=0.459N P=0.220N | P=0.418N P=0.632 P=0.553N P=0.587N |
|INCIDENTAL TUMOR | P=0.250N P=0.638N P=0.502N P=0.319N | P=0.357N P=0.742N P=0.554N P=0.587N |
|LOGISTIC REGRESSION | P=0.223N P=0.651 P=0.499N P=0.274N | P=0.389N P=0.708 P=0.554N P=0.587N |
|COCHRAN-ARMITAGE | P=0.331N | P=0.376N |
|FISHER EXACT | P=0.500N P=0.500N P=0.340N | P=0.752N P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 05 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 3/60 (5%) 0/60 (0%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 16.6% 0.0% 5.3% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/0 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/20 (0%) 2/14 (14%) 0/22 (0%) 1/28 (4%) | 0/34 (0%) 0/17 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | --- 589 --- 456 (I) | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.533 P=0.078 (e) P=0.276 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.508 P=0.108 (e) P=0.276 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.428 P=0.101 (e) P=0.242 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.425 | (e) |
|FISHER EXACT | P=0.122 (e) P=0.248 | (e) (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/60 (7%) 5/60 (8%) 3/60 (5%) 4/60 (7%) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 18.7% 27.4% 12.0% 11.8% | 2.9% 3.3% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/0 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 3/20 (15%) 3/14 (21%) 2/22 (9%) 2/28 (7%) | 1/34 (3%) 0/17 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 713 589 666 456 (I) | 726 (T) 519 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.322N P=0.306 P=0.459N P=0.500N | P=0.418N P=0.632 P=0.553N P=0.587N |
|INCIDENTAL TUMOR | P=0.453N P=0.391 P=0.502N P=0.608N | P=0.357N P=0.742N P=0.554N P=0.587N |
|LOGISTIC REGRESSION | P=0.498N P=0.374 P=0.499N P=0.630N | P=0.389N P=0.708 P=0.554N P=0.587N |
|COCHRAN-ARMITAGE | P=0.561N | P=0.376N |
|FISHER EXACT | P=0.500 P=0.500N P=0.641N | P=0.752N P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 05 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/60 (7%) 5/60 (8%) 3/60 (5%) 4/60 (7%) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 18.7% 27.4% 12.0% 11.8% | 2.9% 3.3% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/0 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 3/20 (15%) 3/14 (21%) 2/22 (9%) 2/28 (7%) | 1/34 (3%) 0/17 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 713 589 666 456 (I) | 726 (T) 519 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.322N P=0.306 P=0.459N P=0.500N | P=0.418N P=0.632 P=0.553N P=0.587N |
|INCIDENTAL TUMOR | P=0.453N P=0.391 P=0.502N P=0.608N | P=0.357N P=0.742N P=0.554N P=0.587N |
|LOGISTIC REGRESSION | P=0.498N P=0.374 P=0.499N P=0.630N | P=0.389N P=0.708 P=0.554N P=0.587N |
|COCHRAN-ARMITAGE | P=0.561N | P=0.376N |
|FISHER EXACT | P=0.500 P=0.500N P=0.641N | P=0.752N P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 52/60 (87%) 50/60 (83%) 55/60 (92%) 53/60 (88%) | |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | |
|INTERIM SACRIFICE 1 (c)| 9/10 (90%) 8/10 (80%) 9/10 (90%) 9/10 (90%) | |
|TERMINAL (d) | 20/20 (100%) 14/14 (100%) 22/22 (100%) 28/28 (100%)| |
|FIRST INCIDENCE (DAYS) | 443 404 456 (I) 456 (I) | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.028N* P=0.167 P=0.499 P=0.115N | |
|INCIDENTAL TUMOR | P=0.385 P=0.563N P=0.561 P=0.374 | |
|LOGISTIC REGRESSION | P=0.278 P=0.460N P=0.321 P=0.362 | |
|COCHRAN-ARMITAGE | P=0.405 | |
|FISHER EXACT | P=0.399N P=0.279 P=0.500 | |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 05 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 4/60 (7%) 3/60 (5%) 2/60 (3%) | 3/60 (5%) 1/60 (2%) 2/60 (3%) 1/60 (2%) |
|ADJUSTED (b) | 3.1% 16.1% 9.9% 5.3% | 8.8% 5.9% 7.7% 4.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/0 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/20 (0%) 1/14 (7%) 0/22 (0%) 1/28 (4%) | 3/34 (9%) 1/17 (6%) 2/26 (8%) 1/22 (5%) |
|FIRST INCIDENCE (DAYS) | 663 504 646 456 (I) | 726 (T) 726 (T) 726 (T) 726 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.398N P=0.141 P=0.307 P=0.555 | P=0.448N P=0.572N P=0.622N P=0.470N |
|INCIDENTAL TUMOR | P=0.609 P=0.176 P=0.213 P=0.472 | P=0.448N P=0.572N P=0.622N P=0.470N |
|LOGISTIC REGRESSION | P=0.515N P=0.167 P=0.313 P=0.501 | P=0.448N P=0.572N P=0.622N P=0.470N |
|COCHRAN-ARMITAGE | P=0.519N | P=0.377N |
|FISHER EXACT | P=0.182 P=0.309 P=0.500 | P=0.309N P=0.500N P=0.309N |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/60 (0%) 3/60 (5%) 0/60 (0%) | 2/60 (3%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 5.0% 0.0% 13.6% 0.0% | 5.9% 5.9% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/0 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/20 (5%) 0/14 (0%) 3/22 (14%) 0/28 (0%) | 2/34 (6%) 1/17 (6%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 726 (T) --- 726 (T) --- | 726 (T) 726 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.253N P=0.571N P=0.337 P=0.433N | P=0.273N P=0.734 P=0.299N P=0.338N |
|INCIDENTAL TUMOR | P=0.253N P=0.571N P=0.337 P=0.433N | P=0.273N P=0.734 P=0.299N P=0.338N |
|LOGISTIC REGRESSION | P=0.253N P=0.571N P=0.337 P=0.433N | P=0.273N P=0.734 P=0.299N P=0.338N |
|COCHRAN-ARMITAGE | P=0.383N | P=0.241N |
|FISHER EXACT | P=0.500N P=0.309 P=0.500N | P=0.500N P=0.248N P=0.248N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 05 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 4/60 (7%) 6/60 (10%) 2/60 (3%) | 5/60 (8%) 2/60 (3%) 2/60 (3%) 1/60 (2%) |
|ADJUSTED (b) | 8.0% 16.1% 22.2% 5.3% | 14.7% 11.8% 7.7% 4.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/0 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/20 (5%) 1/14 (7%) 3/22 (14%) 1/28 (4%) | 5/34 (15%) 2/17 (12%) 2/26 (8%) 1/22 (5%) |
|FIRST INCIDENCE (DAYS) | 663 504 646 456 (I) | 726 (T) 726 (T) 726 (T) 726 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.202N P=0.258 P=0.155 P=0.618N | P=0.214N P=0.557N P=0.334N P=0.226N |
|INCIDENTAL TUMOR | P=0.366N P=0.306 P=0.110 P=0.687N | P=0.214N P=0.557N P=0.334N P=0.226N |
|LOGISTIC REGRESSION | P=0.326N P=0.307 P=0.138 P=0.694 | P=0.214N P=0.557N P=0.334N P=0.226N |
|COCHRAN-ARMITAGE | P=0.347N | P=0.165N |
|FISHER EXACT | P=0.340 P=0.136 P=0.691N | P=0.219N P=0.219N P=0.103N |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 2/60 (3%) 1/60 (2%) 0/60 (0%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 3/60 (5%) |
|ADJUSTED (b) | 8.9% 10.9% 4.2% 0.0% | 2.9% 0.0% 0.0% 13.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/0 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/20 (5%) 1/14 (7%) 0/22 (0%) 0/28 (0%) | 1/34 (3%) 0/17 (0%) 0/26 (0%) 3/22 (14%) |
|FIRST INCIDENCE (DAYS) | 430 678 713 --- | 726 (T) --- --- 726 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.081N P=0.598N P=0.303N P=0.110N | P=0.028 * P=0.638N P=0.553N P=0.164 |
|INCIDENTAL TUMOR | P=0.135N P=0.486N P=0.366N P=0.125N | P=0.028 * P=0.638N P=0.554N P=0.164 |
|LOGISTIC REGRESSION | P=0.112N P=0.513N P=0.306N P=0.118N | P=0.028 * P=0.638N P=0.554N P=0.164 |
|COCHRAN-ARMITAGE | P=0.114N | P=0.045 * |
|FISHER EXACT | P=0.500N P=0.309N P=0.122N | P=0.500N P=0.500N P=0.309 |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 05 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/60 (7%) 2/60 (3%) 1/60 (2%) 0/60 (0%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 3/60 (5%) |
|ADJUSTED (b) | 13.7% 10.9% 4.2% 0.0% | 2.9% 0.0% 0.0% 13.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/0 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/20 (10%) 1/14 (7%) 0/22 (0%) 0/28 (0%) | 1/34 (3%) 0/17 (0%) 0/26 (0%) 3/22 (14%) |
|FIRST INCIDENCE (DAYS) | 430 678 713 --- | 726 (T) --- --- 726 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.050N* P=0.454N P=0.175N P=0.048N* | P=0.028 * P=0.638N P=0.553N P=0.164 |
|INCIDENTAL TUMOR | P=0.083N P=0.352N P=0.209N P=0.055N | P=0.028 * P=0.638N P=0.554N P=0.164 |
|LOGISTIC REGRESSION | P=0.075N P=0.361N P=0.177N P=0.064N | P=0.028 * P=0.638N P=0.554N P=0.164 |
|COCHRAN-ARMITAGE | P=0.079N | P=0.045 * |
|FISHER EXACT | P=0.340N P=0.182N P=0.059N | P=0.500N P=0.500N P=0.309 |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 7/60 (12%) 1/60 (2%) 4/60 (7%) 4/60 (7%) |
|ADJUSTED (b) | | 19.1% 2.6% 13.5% 12.8% |
|INTERIM SACRIFICE 1 (c)| | 1/10 (10%) 0/0 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | | 6/34 (18%) 0/17 (0%) 3/26 (12%) 1/22 (5%) |
|FIRST INCIDENCE (DAYS) | | 457 (I) 379 471 457 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.583 P=0.229N P=0.400N P=0.486N |
|INCIDENTAL TUMOR | | P=0.558N P=0.144N P=0.398N P=0.383N |
|LOGISTIC REGRESSION | | P=0.580 P=0.091N P=0.297N P=0.389N |
|COCHRAN-ARMITAGE | | P=0.571N |
|FISHER EXACT | | P=0.031N* P=0.264N P=0.264N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 05 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/60 (3%) 2/60 (3%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 5.3% 7.5% 4.9% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/0 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/20 (0%) 0/14 (0%) 1/22 (5%) 0/28 (0%) | 0/34 (0%) 0/17 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | --- 583 660 516 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.473 P=0.220 P=0.247 P=0.262 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.291 P=0.371 P=0.222 P=0.139 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.290 P=0.244 P=0.242 P=0.241 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.411 | (e) |
|FISHER EXACT | P=0.248 P=0.248 P=0.248 | (e) (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 34/60 (57%) 21/60 (35%) 26/60 (43%) 24/60 (40%) | 20/60 (33%) 6/60 (10%) 13/60 (22%) 4/60 (7%) |
|ADJUSTED (b) | 86.2% 73.3% 66.5% 59.3% | 47.3% 26.9% 38.8% 13.5% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/0 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 15/20 (75%) 8/14 (57%) 10/22 (45%) 12/28 (43%) | 13/34 (38%) 2/17 (12%) 7/26 (27%) 2/22 (9%) |
|FIRST INCIDENCE (DAYS) | 443 533 463 504 | 374 519 555 392 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.029N* P=0.195N P=0.111N P=0.013N* | P=0.021N* P=0.147N P=0.306N P=0.010N* |
|INCIDENTAL TUMOR | P=0.313N P=0.014N* P=0.092N P=0.067N | P=0.014N* P=0.023N* P=0.114N P=0.002N** |
|LOGISTIC REGRESSION | P=0.290N P=0.021N* P=0.061N P=0.049N* | P=0.011N* P=0.040N* P=0.144N P=0.002N** |
|COCHRAN-ARMITAGE | P=0.249N | P=0.006N** |
|FISHER EXACT | P=0.014N* P=0.101N P=0.050N* | P=0.002N** P=0.110N P<0.001N** |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 05 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 1/60 (2%) 4/60 (7%) 3/60 (5%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 3.7% 3.6% 10.9% 10.7% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/0 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/20 (0%) 0/14 (0%) 1/22 (5%) 3/28 (11%) | 0/34 (0%) 0/17 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 698 666 565 726 (T) | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.422 P=0.715 P=0.201 P=0.406 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.279 P=0.763 P=0.340 P=0.342 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.313 P=0.739 P=0.183 P=0.354 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.293 | (e) |
|FISHER EXACT | P=0.752N P=0.182 P=0.309 | (e) (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 57/60 (95%) 57/60 (95%) 58/60 (97%) 57/60 (95%) | 39/60 (65%) 19/60 (32%) 33/60 (55%) 30/60 (50%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 84.4% 65.7% 83.8% 87.9% |
|INTERIM SACRIFICE 1 (c)| 9/10 (90%) 8/10 (80%) 10/10 (100%) 9/10 (90%) | 2/10 (20%) 0/0 1/10 (10%) 2/10 (20%) |
|TERMINAL (d) | 20/20 (100%) 14/14 (100%) 22/22 (100%) 28/28 (100%)| 27/34 (79%) 8/17 (47%) 20/26 (77%) 18/22 (82%) |
|FIRST INCIDENCE (DAYS) | 430 404 456 (I) 351 | 457 (I) 379 404 457 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.020N* P=0.115 P=0.498N P=0.110N | P=0.207 P=0.547N P=0.479 P=0.235 |
|INCIDENTAL TUMOR | P=0.313 P=0.647 P=0.579 P=0.397 | P=0.206 P=0.037N* P=0.316N P=0.454 |
|LOGISTIC REGRESSION | P=0.311 P=0.666 P=0.545 P=0.408 | P=0.218 P=0.088N P=0.264N P=0.442 |
|COCHRAN-ARMITAGE | P=0.587N | P=0.532N |
|FISHER EXACT | P=0.660N P=0.500 P=0.660N | P<0.001N** P=0.176N P=0.070N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 05 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | O MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 39/60 (65%) 27/60 (45%) 31/60 (52%) 29/60 (48%) | 23/60 (38%) 9/60 (15%) 16/60 (27%) 6/60 (10%) |
|ADJUSTED (b) | 92.4% 84.1% 76.1% 65.2% | 54.8% 41.5% 45.7% 19.5% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/0 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 17/20 (85%) 10/14 (71%) 13/22 (59%) 13/28 (46%) | 16/34 (47%) 5/17 (29%) 8/26 (31%) 3/22 (14%) |
|FIRST INCIDENCE (DAYS) | 443 492 463 456 (I) | 374 519 555 391 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.020N* P=0.310N P=0.113N P=0.014N* | P=0.022N* P=0.283N P=0.361N P=0.014N* |
|INCIDENTAL TUMOR | P=0.303N P=0.014N* P=0.057N P=0.082N | P=0.014N* P=0.079N P=0.128N P=0.002N** |
|LOGISTIC REGRESSION | P=0.299N P=0.013N* P=0.027N* P=0.050N* | P=0.010N* P=0.118N P=0.166N P=0.003N** |
|COCHRAN-ARMITAGE | P=0.224N | P=0.005N** |
|FISHER EXACT | P=0.022N* P=0.097N P=0.048N* | P=0.003N** P=0.121N P<0.001N** |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 58/60 (97%) 57/60 (95%) 59/60 (98%) 57/60 (95%) | 50/60 (83%) 23/60 (38%) 40/60 (67%) 33/60 (55%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 96.1% 78.4% 92.8% 88.7% |
|INTERIM SACRIFICE 1 (c)| 9/10 (90%) 8/10 (80%) 10/10 (100%) 9/10 (90%) | 2/10 (20%) 0/0 1/10 (10%) 2/10 (20%) |
|TERMINAL (d) | 20/20 (100%) 14/14 (100%) 22/22 (100%) 28/28 (100%)| 32/34 (94%) 11/17 (65%) 23/26 (88%) 18/22 (82%) |
|FIRST INCIDENCE (DAYS) | 430 404 456 (I) 351 | 374 379 404 391 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.017N* P=0.142 P=0.495N P=0.088N | P=0.488 P=0.391N P=0.490N P=0.537N |
|INCIDENTAL TUMOR | P=0.404 P=0.500N P=0.500 P=0.621 | P=0.556N P<0.001N** P=0.026N* P=0.054N |
|LOGISTIC REGRESSION | P=0.433 P=0.530N P=0.570 P=0.630 | P=0.476N P=0.006N** P=0.040N* P=0.093N |
|COCHRAN-ARMITAGE | P=0.457N | P=0.169N |
|FISHER EXACT | P=0.500N P=0.500 P=0.500N | P<0.001N** P=0.028N* P<0.001N** |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 05 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for
intercurrent mortality.
(c) Observed incidence at interim kill.
Male interim sacrifices(days): 456
Female interim sacrifices(days): 457
(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).