TDMS Study 05092-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst O-NITROANISOLE DATE: 04/08/97
EXPERIMENT: 05092 TEST: 03 TIME: 12:42:45
TEST TYPE: SPECIAL STUDY CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-45038 ROUTE: DOSED FEED NTP C#: 60388B
PATHOLOGIST: R. THOMPSON S. EUSTIS CAS: 0091-23-6
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst O-NITROANISOLE DATE: 04/08/97
EXPERIMENT: 05092 TEST: 03 TIME: 12:42:45
TEST TYPE: SPECIAL STUDY CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-45038 ROUTE: DOSED FEED NTP C#: 60388B
PATHOLOGIST: R. THOMPSON S. EUSTIS CAS: 0091-23-6
RATS(FISCHER 344)
----------------------------
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
Adrenal Medulla
Brain
Clitoral Gland
Clitoral/Preputial Gland
Epididymis
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Nose
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Preputial Gland
Prostate
Spleen
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst O-NITROANISOLE DATE: 04/08/97
EXPERIMENT: 05092 TEST: 03 TIME: 12:42:45
TEST TYPE: SPECIAL STUDY CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-45038 ROUTE: DOSED FEED NTP C#: 60388B
PATHOLOGIST: R. THOMPSON S. EUSTIS CAS: 0091-23-6
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF O-NITROANISOLE
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Intestine Large: Colon/Rectum Carcinoma
Polyp Adenomatous
Kidney: Pelvis and Transitional Epithelium
Carcinoma
Papilloma
Stomach, Forestomach Squamous Cell Papilloma
Testes Adenoma
Urinary Bladder Carcinoma
Carcinoma or Papilloma
Papilloma
Sarcoma
Squamous Cell Carcinoma
Squamous Cell Papilloma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Mesothelioma: Benign, Malignant, NOS
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Intestine Large: Colon/Rectum Carcinoma
Polyp Adenomatous
Kidney: Pelvis and Transitional Epithelium
Papilloma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Stomach, Forestomach Squamous Cell Papilloma
Urinary Bladder Carcinoma
Carcinoma or Papilloma
Leiomyosarcoma
Sarcoma
Squamous Cell Papilloma
All Organs Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 04/08/97 EXPERIMENT: 05092 TEST: 03 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER 344) -- O-NITROANISOLE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0.0% 0.600% 1.80% | 0.0% 0.600% 1.80% |
| | 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/2 (50%) 2/2 (100%) 0/0 (0%) | 0/2 (0%) 0/0 (0%) 0/1 (0%) |
|ADJUSTED (b) | 100.0% 66.7% 0.0% | 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 | 0/0 0/0 0/0 |
|INTERIM SACRIFICE 2 (c)| 0/0 0/0 0/0 | 0/0 0/0 0/0 |
|INTERIM SACRIFICE 3 (c)| 0/0 0/0 0/0 | 0/0 0/0 0/0 |
|INTERIM SACRIFICE 4 (c)| 0/0 0/0 0/0 | 0/0 0/0 0/0 |
|TERMINAL (d) | 1/1 (100%) 0/0 0/0 | 0/1 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 728 (T) 648 --- | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.073 P=0.007 ** (e) | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.760 P=0.362 (e) | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.760 P=0.362 (e) | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.876 | (e) |
|FISHER EXACT | P=0.500 P=1.000N | (e) (e) |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/7 (14%) 1/7 (14%) 0/0 (0%) | 2/5 (40%) 0/6 (0%) 0/1 (0%) |
|ADJUSTED (b) | 25.0% 8.3% 0.0% | 36.4% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 | 0/0 0/0 0/0 |
|INTERIM SACRIFICE 2 (c)| 0/0 0/0 0/0 | 0/0 0/0 0/0 |
|INTERIM SACRIFICE 3 (c)| 0/1 (0%) 0/1 (0%) 0/0 | 0/0 0/0 0/0 |
|INTERIM SACRIFICE 4 (c)| 0/0 0/0 0/0 | 1/2 (50%) 0/1 (0%) 0/0 |
|TERMINAL (d) | 1/4 (25%) 0/0 0/0 | 1/3 (33%) 0/2 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 728 (T) 480 --- | 455 (I) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.781 P=0.398 (e) | P=0.653N P=0.366N (e) |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.653N P=0.366N (e) |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.341N P=0.177N P=0.688N |
|COCHRAN-ARMITAGE | P=0.937 | P=0.320N |
|FISHER EXACT | P=0.769N P=1.000N | P=0.182N P=0.667N |
|=================================================================================================================================|
DATE: 04/08/97 EXPERIMENT: 05092 TEST: 03 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER 344) -- O-NITROANISOLE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0.0% 0.600% 1.80% | 0.0% 0.600% 1.80% |
| | 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/7 (29%) 1/7 (14%) 0/0 (0%) | 2/5 (40%) 1/6 (17%) 0/1 (0%) |
|ADJUSTED (b) | 50.0% 16.7% 0.0% | 66.7% 50.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 | 0/0 0/0 0/0 |
|INTERIM SACRIFICE 2 (c)| 0/0 0/0 0/0 | 0/0 0/0 0/0 |
|INTERIM SACRIFICE 3 (c)| 0/1 (0%) 0/1 (0%) 0/0 | 0/0 0/0 0/0 |
|INTERIM SACRIFICE 4 (c)| 0/0 0/0 0/0 | 0/2 (0%) 0/1 (0%) 0/0 |
|TERMINAL (d) | 2/4 (50%) 0/0 0/0 | 2/3 (67%) 1/2 (50%) 0/0 |
|FIRST INCIDENCE (DAYS) | 728 (T) 636 --- | 728 (T) 728 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.724 P=0.293 (e) | P=0.909N P=0.691N (e) |
|INCIDENTAL TUMOR | P=0.921 P=0.638 (e) | P=0.909N P=0.691N (e) |
|LOGISTIC REGRESSION | P=0.921 P=0.638 (e) | P=0.909N P=0.691N (e) |
|COCHRAN-ARMITAGE | P=0.743N | P=0.420N |
|FISHER EXACT | P=0.500N P=1.000N | P=0.424N P=0.667N |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/7 (43%) 2/7 (29%) 0/0 (0%) | 4/5 (80%) 1/6 (17%) 0/1 (0%) |
|ADJUSTED (b) | 75.0% 23.6% 0.0% | 100.0% 50.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 | 0/0 0/0 0/0 |
|INTERIM SACRIFICE 2 (c)| 0/0 0/0 0/0 | 0/0 0/0 0/0 |
|INTERIM SACRIFICE 3 (c)| 0/1 (0%) 0/1 (0%) 0/0 | 0/0 0/0 0/0 |
|INTERIM SACRIFICE 4 (c)| 0/0 0/0 0/0 | 1/2 (50%) 0/1 (0%) 0/0 |
|TERMINAL (d) | 3/4 (75%) 0/0 0/0 | 3/3 (100%) 1/2 (50%) 0/0 |
|FIRST INCIDENCE (DAYS) | 728 (T) 480 --- | 455 (I) 728 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.289 P=0.093 (e) | P=0.539N P=0.262N (e) |
|INCIDENTAL TUMOR | P=0.921 P=0.638 (e) | P=0.539N P=0.262N (e) |
|LOGISTIC REGRESSION | P=0.921 P=0.638 (e) | P=0.276N P=0.103N (e) |
|COCHRAN-ARMITAGE | P=0.712N | P=0.108N |
|FISHER EXACT | P=0.500N P=1.000N | P=0.067N P=0.333N |
|=================================================================================================================================|
DATE: 04/08/97 EXPERIMENT: 05092 TEST: 03 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER 344) -- O-NITROANISOLE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0.0% 0.600% 1.80% | 0.0% 0.600% 1.80% |
| | 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC |
|=================================================================================================================================|
| |
|Intestine Large: Colon/Rectum |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 5/60 (8%) | 0/60 (0%) 0/60 (0%) 2/60 (3%) |
|ADJUSTED (b) | 0.0% 0.0% 39.3% | 0.0% 0.0% 19.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (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%) |
|INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 1/6 (17%) | 0/10 (0%) 0/10 (0%) 0/6 (0%) |
|INTERIM SACRIFICE 4 (c)| 0/9 (0%) 0/3 (0%) 0/0 | 0/8 (0%) 0/10 (0%) 0/0 |
|TERMINAL (d) | 0/13 (0%) 0/1 (0%) 0/0 | 0/14 (0%) 0/4 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- 249 | --- --- 317 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** (e) P<0.001 ** | P=0.010 * (e) P=0.053 |
|INCIDENTAL TUMOR | P=0.107 (e) P=0.398 | P=0.741 (e) P=0.967 |
|LOGISTIC REGRESSION | P=0.005 ** (e) P=0.036 * | P=0.079 (e) P=0.202 |
|COCHRAN-ARMITAGE | P=0.004 ** | P=0.092 |
|FISHER EXACT | (e) P=0.029 * | (e) P=0.248 |
|=================================================================================================================================|
| |
|Intestine Large: Colon/Rectum |
| Polyp Adenomatous |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 25/60 (42%) 30/60 (50%) | 0/60 (0%) 8/60 (13%) 18/60 (30%) |
|ADJUSTED (b) | 0.0% 94.1% 95.5% | 0.0% 51.4% 100.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 2/10 (20%) | 0/10 (0%) 1/10 (10%) 0/10 (0%) |
|INTERIM SACRIFICE 3 (c)| 0/10 (0%) 2/10 (20%) 4/6 (67%) | 0/10 (0%) 0/10 (0%) 1/6 (17%) |
|INTERIM SACRIFICE 4 (c)| 0/9 (0%) 3/3 (100%) 0/0 | 0/8 (0%) 2/10 (20%) 0/0 |
|TERMINAL (d) | 0/13 (0%) 0/1 (0%) 0/0 | 0/14 (0%) 0/4 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 274 (I) 190 (I) | --- 190 (I) 233 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P=0.003 ** | P=0.024 * P=0.012 * P=0.078 |
|LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.003 ** P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** |
|FISHER EXACT | P<0.001 ** P<0.001 ** | P=0.003 ** P<0.001 ** |
|=================================================================================================================================|
DATE: 04/08/97 EXPERIMENT: 05092 TEST: 03 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER 344) -- O-NITROANISOLE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0.0% 0.600% 1.80% | 0.0% 0.600% 1.80% |
| | 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC |
|=================================================================================================================================|
| |
|Kidney: Pelvis and Transitional Epithelium |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) 8/60 (13%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 33.3% 30.9% | 0.0% 0.0% 6.3% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (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%) |
|INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 2/6 (33%) | 0/10 (0%) 0/10 (0%) 0/6 (0%) |
|INTERIM SACRIFICE 4 (c)| 0/9 (0%) 0/3 (0%) 0/0 | 0/8 (0%) 0/10 (0%) 0/0 |
|TERMINAL (d) | 0/13 (0%) 0/1 (0%) 0/0 | 0/14 (0%) 0/4 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 648 217 | --- --- 307 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.174 P<0.001 ** | P=0.194 (e) P=0.381 |
|INCIDENTAL TUMOR | P=0.012 * P=0.500 P=0.128 | P=0.885 (e) P=0.997 |
|LOGISTIC REGRESSION | P<0.001 ** P=0.313 P=0.010 ** | P=0.299 (e) P=0.504 |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.296 |
|FISHER EXACT | P=0.500 P=0.003 ** | (e) P=0.500 |
|=================================================================================================================================|
| |
|Kidney: Pelvis and Transitional Epithelium |
| Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 4/60 (7%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 23.1% | 0.0% 0.0% 33.3% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (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%) |
|INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 1/6 (17%) | 0/10 (0%) 0/10 (0%) 0/6 (0%) |
|INTERIM SACRIFICE 4 (c)| 0/9 (0%) 0/3 (0%) 0/0 | 0/8 (0%) 0/10 (0%) 0/0 |
|TERMINAL (d) | 0/13 (0%) 0/1 (0%) 0/0 | 0/14 (0%) 0/4 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- 228 | --- --- 346 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.001 ** (e) P=0.016 * | P=0.029 * (e) P=0.082 |
|INCIDENTAL TUMOR | P=0.127 (e) P=0.398 | P=0.885 (e) P=0.997 |
|LOGISTIC REGRESSION | P=0.017 * (e) P=0.084 | P=0.268 (e) P=0.468 |
|COCHRAN-ARMITAGE | P=0.011 * | P=0.296 |
|FISHER EXACT | (e) P=0.059 | (e) P=0.500 |
|=================================================================================================================================|
DATE: 04/08/97 EXPERIMENT: 05092 TEST: 03 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER 344) -- O-NITROANISOLE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0.0% 0.600% 1.80% | 0.0% 0.600% 1.80% |
| | 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/8 (25%) 0/7 (0%) 1/3 (33%) | 0/3 (0%) 0/3 (0%) 0/2 (0%) |
|ADJUSTED (b) | 28.0% 0.0% 5.0% | 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/1 (0%) | 0/0 0/0 0/0 |
|INTERIM SACRIFICE 2 (c)| 0/0 0/2 (0%) 0/0 | 0/0 0/2 (0%) 0/0 |
|INTERIM SACRIFICE 3 (c)| 0/0 0/2 (0%) 0/0 | 0/0 0/0 0/0 |
|INTERIM SACRIFICE 4 (c)| 1/1 (100%) 0/0 0/0 | 0/0 0/0 0/0 |
|TERMINAL (d) | 1/4 (25%) 0/0 0/0 | 0/1 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 455 (I) --- 263 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.182 (e) P=0.362 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.638 (e) (e) | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.642 P=0.399N P=0.925N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.656 | (e) |
|FISHER EXACT | P=0.267N P=0.661 | (e) (e) |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/60 (0%) 0/60 (0%) | 8/60 (13%) 3/60 (5%) 0/60 (0%) |
|ADJUSTED (b) | 7.7% 0.0% 0.0% | 48.3% 58.3% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (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%) |
|INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/6 (0%) | 0/10 (0%) 0/10 (0%) 0/6 (0%) |
|INTERIM SACRIFICE 4 (c)| 0/9 (0%) 0/3 (0%) 0/0 | 0/8 (0%) 0/10 (0%) 0/0 |
|TERMINAL (d) | 1/13 (8%) 0/1 (0%) 0/0 | 6/14 (43%) 2/4 (50%) 0/0 |
|FIRST INCIDENCE (DAYS) | 728 (T) --- --- | 413 662 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=1.000N P=0.952N (e) | P=0.757 P=0.606 P=0.995N |
|INCIDENTAL TUMOR | P=1.000N P=0.952N (e) | P=0.593N P=0.575N P=0.581N |
|LOGISTIC REGRESSION | P=1.000N P=0.952N (e) | P=0.510N P=0.448N P=0.640N |
|COCHRAN-ARMITAGE | P=0.394N | P=0.004N** |
|FISHER EXACT | P=0.500N P=0.500N | P=0.102N P=0.003N** |
|=================================================================================================================================|
DATE: 04/08/97 EXPERIMENT: 05092 TEST: 03 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER 344) -- O-NITROANISOLE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0.0% 0.600% 1.80% | 0.0% 0.600% 1.80% |
| | 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/60 (0%) 0/60 (0%) | 8/60 (13%) 3/60 (5%) 0/60 (0%) |
|ADJUSTED (b) | 7.7% 0.0% 0.0% | 48.3% 58.3% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (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%) |
|INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/6 (0%) | 0/10 (0%) 0/10 (0%) 0/6 (0%) |
|INTERIM SACRIFICE 4 (c)| 0/9 (0%) 0/3 (0%) 0/0 | 0/8 (0%) 0/10 (0%) 0/0 |
|TERMINAL (d) | 1/13 (8%) 0/1 (0%) 0/0 | 6/14 (43%) 2/4 (50%) 0/0 |
|FIRST INCIDENCE (DAYS) | 728 (T) --- --- | 413 662 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=1.000N P=0.952N (e) | P=0.757 P=0.606 P=0.995N |
|INCIDENTAL TUMOR | P=1.000N P=0.952N (e) | P=0.593N P=0.575N P=0.581N |
|LOGISTIC REGRESSION | P=1.000N P=0.952N (e) | P=0.510N P=0.448N P=0.640N |
|COCHRAN-ARMITAGE | P=0.394N | P=0.004N** |
|FISHER EXACT | P=0.500N P=0.500N | P=0.102N P=0.003N** |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/60 (0%) 0/60 (0%) | 8/60 (13%) 3/60 (5%) 0/60 (0%) |
|ADJUSTED (b) | 7.7% 0.0% 0.0% | 48.3% 58.3% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (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%) |
|INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/6 (0%) | 0/10 (0%) 0/10 (0%) 0/6 (0%) |
|INTERIM SACRIFICE 4 (c)| 0/9 (0%) 0/3 (0%) 0/0 | 0/8 (0%) 0/10 (0%) 0/0 |
|TERMINAL (d) | 1/13 (8%) 0/1 (0%) 0/0 | 6/14 (43%) 2/4 (50%) 0/0 |
|FIRST INCIDENCE (DAYS) | 728 (T) --- --- | 413 662 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=1.000N P=0.952N (e) | P=0.757 P=0.606 P=0.995N |
|INCIDENTAL TUMOR | P=1.000N P=0.952N (e) | P=0.593N P=0.575N P=0.581N |
|LOGISTIC REGRESSION | P=1.000N P=0.952N (e) | P=0.510N P=0.448N P=0.640N |
|COCHRAN-ARMITAGE | P=0.394N | P=0.004N** |
|FISHER EXACT | P=0.500N P=0.500N | P=0.102N P=0.003N** |
|=================================================================================================================================|
DATE: 04/08/97 EXPERIMENT: 05092 TEST: 03 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER 344) -- O-NITROANISOLE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0.0% 0.600% 1.80% | 0.0% 0.600% 1.80% |
| | 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/8 (88%) 0/0 (0%) 0/0 (0%) | 12/13 (92%) 5/9 (56%) 0/0 (0%) |
|ADJUSTED (b) | 83.1% 0.0% 0.0% | 100.0% 77.4% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 | 0/0 0/0 0/0 |
|INTERIM SACRIFICE 2 (c)| 0/0 0/0 0/0 | 0/0 0/0 0/0 |
|INTERIM SACRIFICE 3 (c)| 0/0 0/0 0/0 | 0/0 0/0 0/0 |
|INTERIM SACRIFICE 4 (c)| 1/1 (100%) 0/0 0/0 | 0/0 1/1 (100%) 0/0 |
|TERMINAL (d) | 4/5 (80%) 0/0 0/0 | 9/9 (100%) 2/3 (67%) 0/0 |
|FIRST INCIDENCE (DAYS) | 455 (I) --- --- | 648 455 (I) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.876N P=0.584N (e) | P=0.812N P=0.661N (e) |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.296N P=0.097N (e) |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.296N P=0.097N (e) |
|COCHRAN-ARMITAGE | (e) | P=0.162N |
|FISHER EXACT | P=1.000N P=1.000N | P=0.067N P=1.000N |
|=================================================================================================================================|
| |
|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) | 3/60 (5%) 0/60 (0%) 0/60 (0%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 16.8% 0.0% 0.0% | 5.6% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (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%) |
|INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/6 (0%) | 0/10 (0%) 0/10 (0%) 0/6 (0%) |
|INTERIM SACRIFICE 4 (c)| 1/9 (11%) 0/3 (0%) 0/0 | 0/8 (0%) 0/10 (0%) 0/0 |
|TERMINAL (d) | 1/13 (8%) 0/1 (0%) 0/0 | 0/14 (0%) 0/4 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 455 (I) --- --- | 590 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.865N P=0.582N (e) | P=0.910N P=0.617N (e) |
|INCIDENTAL TUMOR | P=0.599N P=0.325N (e) | P=0.673N P=0.186N (e) |
|LOGISTIC REGRESSION | P=0.381N P=0.260N P=0.730N | P=0.686N P=0.571N P=0.897N |
|COCHRAN-ARMITAGE | P=0.081N | P=0.394N |
|FISHER EXACT | P=0.122N P=0.122N | P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 04/08/97 EXPERIMENT: 05092 TEST: 03 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER 344) -- O-NITROANISOLE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0.0% 0.600% 1.80% | 0.0% 0.600% 1.80% |
| | 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 13.8% 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%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/6 (0%) | 0/10 (0%) 0/10 (0%) 0/6 (0%) |
|INTERIM SACRIFICE 4 (c)| 0/9 (0%) 0/3 (0%) 0/0 | 0/8 (0%) 0/10 (0%) 0/0 |
|TERMINAL (d) | 1/13 (8%) 0/1 (0%) 0/0 | 0/14 (0%) 0/4 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 701 --- --- | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.993N P=0.850N (e) | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.777N P=0.449N (e) | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.953N P=0.687N (e) | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.171N | (e) |
|FISHER EXACT | P=0.248N P=0.248N | (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 10.9% 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%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/6 (0%) | 0/10 (0%) 0/10 (0%) 0/6 (0%) |
|INTERIM SACRIFICE 4 (c)| 1/9 (11%) 0/3 (0%) 0/0 | 0/8 (0%) 0/10 (0%) 0/0 |
|TERMINAL (d) | 1/13 (8%) 0/1 (0%) 0/0 | 0/14 (0%) 0/4 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 455 (I) --- --- | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.911N P=0.638N (e) | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.911N P=0.638N (e) | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.464N P=0.362N P=0.738N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.171N | (e) |
|FISHER EXACT | P=0.248N P=0.248N | (e) (e) |
|=================================================================================================================================|
DATE: 04/08/97 EXPERIMENT: 05092 TEST: 03 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER 344) -- O-NITROANISOLE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0.0% 0.600% 1.80% | 0.0% 0.600% 1.80% |
| | 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 0/60 (0%) 0/60 (0%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 16.8% 0.0% 0.0% | 5.6% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (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%) |
|INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/6 (0%) | 0/10 (0%) 0/10 (0%) 0/6 (0%) |
|INTERIM SACRIFICE 4 (c)| 1/9 (11%) 0/3 (0%) 0/0 | 0/8 (0%) 0/10 (0%) 0/0 |
|TERMINAL (d) | 1/13 (8%) 0/1 (0%) 0/0 | 0/14 (0%) 0/4 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 455 (I) --- --- | 590 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.865N P=0.582N (e) | P=0.910N P=0.617N (e) |
|INCIDENTAL TUMOR | P=0.599N P=0.325N (e) | P=0.673N P=0.186N (e) |
|LOGISTIC REGRESSION | P=0.381N P=0.260N P=0.730N | P=0.686N P=0.571N P=0.897N |
|COCHRAN-ARMITAGE | P=0.081N | P=0.394N |
|FISHER EXACT | P=0.122N P=0.122N | P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 16.8% 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%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/6 (0%) | 0/10 (0%) 0/10 (0%) 0/6 (0%) |
|INTERIM SACRIFICE 4 (c)| 1/9 (11%) 0/3 (0%) 0/0 | 0/8 (0%) 0/10 (0%) 0/0 |
|TERMINAL (d) | 1/13 (8%) 0/1 (0%) 0/0 | 0/14 (0%) 0/4 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 455 (I) --- --- | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.865N P=0.582N (e) | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.599N P=0.325N (e) | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.381N P=0.260N P=0.730N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.081N | (e) |
|FISHER EXACT | P=0.122N P=0.122N | (e) (e) |
|=================================================================================================================================|
DATE: 04/08/97 EXPERIMENT: 05092 TEST: 03 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER 344) -- O-NITROANISOLE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0.0% 0.600% 1.80% | 0.0% 0.600% 1.80% |
| | 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 4/60 (7%) 1/60 (2%) | 1/60 (2%) 4/60 (7%) 4/60 (7%) |
|ADJUSTED (b) | 0.0% 29.7% 16.7% | 7.1% 48.1% 100.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (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%) |
|INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/6 (0%) | 0/10 (0%) 0/10 (0%) 0/6 (0%) |
|INTERIM SACRIFICE 4 (c)| 0/9 (0%) 0/3 (0%) 0/0 | 0/8 (0%) 0/10 (0%) 0/0 |
|TERMINAL (d) | 0/13 (0%) 0/1 (0%) 0/0 | 1/14 (7%) 1/4 (25%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 190 (I) 298 | 728 (T) 424 245 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.045 * P=0.018 * P=0.186 | P<0.001 ** P=0.026 * P<0.001 ** |
|INCIDENTAL TUMOR | P=0.602 P=0.233 (e) | P=0.074 P=0.120 P=0.368 |
|LOGISTIC REGRESSION | P=0.427 P=0.048 * P=0.510 | P=0.005 ** P=0.059 P=0.040 * |
|COCHRAN-ARMITAGE | P=0.596 | P=0.205 |
|FISHER EXACT | P=0.059 P=0.500 | P=0.182 P=0.182 |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 26/60 (43%) 23/60 (38%) 0/60 (0%) | |
|ADJUSTED (b) | 100.0% 100.0% 0.0% | |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | |
|INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/6 (0%) | |
|INTERIM SACRIFICE 4 (c)| 6/9 (67%) 3/3 (100%) 0/0 | |
|TERMINAL (d) | 13/13 (100%) 1/1 (100%) 0/0 | |
|FIRST INCIDENCE (DAYS) | 455 (I) 329 --- | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** (e) | |
|INCIDENTAL TUMOR | P=0.799N P=0.086 (e) | |
|LOGISTIC REGRESSION | P=0.436 P=0.050 * (e) | |
|COCHRAN-ARMITAGE | P<0.001N** | |
|FISHER EXACT | P=0.355N P<0.001N** | |
|=================================================================================================================================|
DATE: 04/08/97 EXPERIMENT: 05092 TEST: 03 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER 344) -- O-NITROANISOLE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0.0% 0.600% 1.80% | 0.0% 0.600% 1.80% |
| | 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/59 (0%) 27/59 (46%) 50/60 (83%) | 0/58 (0%) 28/59 (47%) 48/60 (80%) |
|ADJUSTED (b) | 0.0% 100.0% 100.0% | 0.0% 100.0% 100.0% |
|INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/9 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 10/10 (100%) | 0/10 (0%) 0/10 (0%) 10/10 (100%) |
|INTERIM SACRIFICE 3 (c)| 0/10 (0%) 3/10 (30%) 6/6 (100%) | 0/10 (0%) 1/9 (11%) 6/6 (100%) |
|INTERIM SACRIFICE 4 (c)| 0/9 (0%) 1/3 (33%) 0/0 | 0/8 (0%) 9/10 (90%) 0/0 |
|TERMINAL (d) | 0/13 (0%) 1/1 (100%) 0/0 | 0/12 (0%) 4/4 (100%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 274 (I) 87 (I) | --- 274 (I) 190 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** |
|FISHER EXACT | P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Carcinoma or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/59 (0%) 36/59 (61%) 50/60 (83%) | 0/58 (0%) 30/59 (51%) 48/60 (80%) |
|ADJUSTED (b) | 0.0% 100.0% 100.0% | 0.0% 100.0% 100.0% |
|INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/9 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 2/10 (20%) 10/10 (100%) | 0/10 (0%) 0/10 (0%) 10/10 (100%) |
|INTERIM SACRIFICE 3 (c)| 0/10 (0%) 5/10 (50%) 6/6 (100%) | 0/10 (0%) 1/9 (11%) 6/6 (100%) |
|INTERIM SACRIFICE 4 (c)| 0/9 (0%) 3/3 (100%) 0/0 | 0/8 (0%) 10/10 (100%) 0/0 |
|TERMINAL (d) | 0/13 (0%) 1/1 (100%) 0/0 | 0/12 (0%) 4/4 (100%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 190 (I) 87 (I) | --- 274 (I) 190 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** |
|FISHER EXACT | P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
DATE: 04/08/97 EXPERIMENT: 05092 TEST: 03 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER 344) -- O-NITROANISOLE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0.0% 0.600% 1.80% | 0.0% 0.600% 1.80% |
| | 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Leiomyosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/59 (0%) 0/59 (0%) 0/60 (0%) | 0/58 (0%) 1/59 (2%) 2/60 (3%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% | 0.0% 7.1% 22.2% |
|INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (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%) |
|INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/6 (0%) |
|INTERIM SACRIFICE 4 (c)| 0/9 (0%) 0/3 (0%) 0/0 | 0/8 (0%) 0/10 (0%) 0/0 |
|TERMINAL (d) | 0/13 (0%) 0/1 (0%) 0/0 | 0/12 (0%) 0/4 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- --- | --- 476 333 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.003 ** P=0.450 P=0.038 * |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.696 P=0.669 P=0.967 |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.108 P=0.485 P=0.194 |
|COCHRAN-ARMITAGE | (e) | P=0.182 |
|FISHER EXACT | (e) (e) | P=0.504 P=0.256 |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/59 (0%) 9/59 (15%) 1/60 (2%) | 0/58 (0%) 2/59 (3%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 53.8% 3.3% | 0.0% 12.2% 3.4% |
|INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 2/10 (20%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 3 (c)| 0/10 (0%) 2/10 (20%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/6 (0%) |
|INTERIM SACRIFICE 4 (c)| 0/9 (0%) 2/3 (67%) 0/0 | 0/8 (0%) 1/10 (10%) 0/0 |
|TERMINAL (d) | 0/13 (0%) 0/1 (0%) 0/0 | 0/12 (0%) 0/4 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 190 (I) 236 | --- 455 (I) 265 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.101 P<0.001 ** P=0.443 | P=0.087 P=0.218 P=0.441 |
|INCIDENTAL TUMOR | P=0.394 P=0.002 ** (e) | P=0.636 P=0.359 P=0.997 |
|LOGISTIC REGRESSION | P=0.586N P=0.002 ** P=0.570 | P=0.384 P=0.219 P=0.536 |
|COCHRAN-ARMITAGE | P=0.456N | P=0.509 |
|FISHER EXACT | P=0.001 ** P=0.504 | P=0.252 P=0.508 |
|=================================================================================================================================|
DATE: 04/08/97 EXPERIMENT: 05092 TEST: 03 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER 344) -- O-NITROANISOLE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0.0% 0.600% 1.80% | 0.0% 0.600% 1.80% |
| | 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/59 (0%) 2/59 (3%) 9/60 (15%) | 0/58 (0%) 1/59 (2%) 11/60 (18%) |
|ADJUSTED (b) | 0.0% 9.6% 68.0% | 0.0% 8.3% 100.0% |
|INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 2/10 (20%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 2/6 (33%) |
|INTERIM SACRIFICE 4 (c)| 0/9 (0%) 1/3 (33%) 0/0 | 0/8 (0%) 0/10 (0%) 0/0 |
|TERMINAL (d) | 0/13 (0%) 0/1 (0%) 0/0 | 0/12 (0%) 0/4 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 305 158 | --- 504 248 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.123 P<0.001 ** | P<0.001 ** P=0.419 P<0.001 ** |
|INCIDENTAL TUMOR | P=0.074 P=0.282 P=0.234 | P=0.009 ** P=0.669 P=0.043 * |
|LOGISTIC REGRESSION | P=0.001 ** P=0.231 P=0.009 ** | P<0.001 ** P=0.478 P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** |
|FISHER EXACT | P=0.248 P=0.002 ** | P=0.504 P<0.001 ** |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/59 (0%) 0/59 (0%) 6/60 (10%) | 0/58 (0%) 0/59 (0%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 67.5% | 0.0% 0.0% 9.1% |
|INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (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%) |
|INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 1/6 (17%) | 0/10 (0%) 0/9 (0%) 0/6 (0%) |
|INTERIM SACRIFICE 4 (c)| 0/9 (0%) 0/3 (0%) 0/0 | 0/8 (0%) 0/10 (0%) 0/0 |
|TERMINAL (d) | 0/13 (0%) 0/1 (0%) 0/0 | 0/12 (0%) 0/4 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- 242 | --- --- 324 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** (e) P<0.001 ** | P=0.141 (e) P=0.307 |
|INCIDENTAL TUMOR | P=0.090 (e) P=0.398 | P=0.885 (e) P=0.997 |
|LOGISTIC REGRESSION | P=0.002 ** (e) P=0.020 * | P=0.289 (e) P=0.490 |
|COCHRAN-ARMITAGE | P=0.001 ** | P=0.301 |
|FISHER EXACT | (e) P=0.014 * | (e) P=0.508 |
|=================================================================================================================================|
DATE: 04/08/97 EXPERIMENT: 05092 TEST: 03 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER 344) -- O-NITROANISOLE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0.0% 0.600% 1.80% | 0.0% 0.600% 1.80% |
| | 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/59 (0%) 0/59 (0%) 4/60 (7%) | 0/58 (0%) 0/59 (0%) 4/60 (7%) |
|ADJUSTED (b) | 0.0% 0.0% 63.1% | 0.0% 0.0% 34.2% |
|INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (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%) |
|INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/6 (0%) | 0/10 (0%) 0/9 (0%) 0/6 (0%) |
|INTERIM SACRIFICE 4 (c)| 0/9 (0%) 0/3 (0%) 0/0 | 0/8 (0%) 0/10 (0%) 0/0 |
|TERMINAL (d) | 0/13 (0%) 0/1 (0%) 0/0 | 0/12 (0%) 0/4 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- 254 | --- --- 221 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** (e) P<0.001 ** | P<0.001 ** (e) P=0.006 ** |
|INCIDENTAL TUMOR | P=0.400 (e) (e) | P=0.562 (e) P=0.877 |
|LOGISTIC REGRESSION | P=0.012 * (e) P=0.062 | P=0.013 * (e) P=0.062 |
|COCHRAN-ARMITAGE | P=0.011 * | P=0.012 * |
|FISHER EXACT | (e) P=0.061 | (e) P=0.064 |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 3/60 (5%) 3/60 (5%) 0/60 (0%) |
|ADJUSTED (b) | | 17.6% 22.1% 0.0% |
|INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 3 (c)| | 0/10 (0%) 0/10 (0%) 0/6 (0%) |
|INTERIM SACRIFICE 4 (c)| | 1/8 (13%) 1/10 (10%) 0/0 |
|TERMINAL (d) | | 2/14 (14%) 0/4 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | | 455 (I) 455 (I) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.610 P=0.434 (e) |
|INCIDENTAL TUMOR | | P=0.651N P=0.650N (e) |
|LOGISTIC REGRESSION | | P=0.487N P=0.515 P=0.700N |
|COCHRAN-ARMITAGE | | P=0.091N |
|FISHER EXACT | | P=0.660N P=0.122N |
|=================================================================================================================================|
DATE: 04/08/97 EXPERIMENT: 05092 TEST: 03 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER 344) -- O-NITROANISOLE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0.0% 0.600% 1.80% | 0.0% 0.600% 1.80% |
| | 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 16.7% 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%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/6 (0%) | 0/10 (0%) 0/10 (0%) 0/6 (0%) |
|INTERIM SACRIFICE 4 (c)| 0/9 (0%) 0/3 (0%) 0/0 | 0/8 (0%) 0/10 (0%) 0/0 |
|TERMINAL (d) | 0/13 (0%) 0/1 (0%) 0/0 | 0/14 (0%) 0/4 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 275 --- | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.561 P=0.150 (e) | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.387N P=0.581 (e) | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.763 P=0.199 (e) | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.575N | (e) |
|FISHER EXACT | P=0.248 (e) | (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 12/60 (20%) 2/60 (3%) 0/60 (0%) | 3/60 (5%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 62.9% 41.7% 0.0% | 20.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/6 (0%) | 0/10 (0%) 0/10 (0%) 0/6 (0%) |
|INTERIM SACRIFICE 4 (c)| 0/9 (0%) 0/3 (0%) 0/0 | 0/8 (0%) 0/10 (0%) 0/0 |
|TERMINAL (d) | 6/13 (46%) 0/1 (0%) 0/0 | 2/14 (14%) 0/4 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 564 617 --- | 679 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.772N P=0.630N (e) | P=0.689N P=0.413N (e) |
|INCIDENTAL TUMOR | P=0.053N P=0.020N* (e) | P=0.582N P=0.323N (e) |
|LOGISTIC REGRESSION | P=0.212N P=0.140N P=0.724N | P=0.581N P=0.314N P=1.000N |
|COCHRAN-ARMITAGE | P<0.001N** | P=0.081N |
|FISHER EXACT | P=0.004N** P<0.001N** | P=0.122N P=0.122N |
|=================================================================================================================================|
DATE: 04/08/97 EXPERIMENT: 05092 TEST: 03 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER 344) -- O-NITROANISOLE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0.0% 0.600% 1.80% | 0.0% 0.600% 1.80% |
| | 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 6/60 (10%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 46.9% 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%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 3 (c)| 0/10 (0%) 0/10 (0%) 0/6 (0%) | 0/10 (0%) 0/10 (0%) 0/6 (0%) |
|INTERIM SACRIFICE 4 (c)| 0/9 (0%) 2/3 (67%) 0/0 | 0/8 (0%) 0/10 (0%) 0/0 |
|TERMINAL (d) | 0/13 (0%) 0/1 (0%) 0/0 | 0/14 (0%) 0/4 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 423 --- | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.002 ** P<0.001 ** (e) | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.055 P=0.018 * (e) | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.084 P=0.005 ** (e) | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.370N | (e) |
|FISHER EXACT | P=0.014 * (e) | (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 26/60 (43%) 35/60 (58%) 32/60 (53%) | 18/60 (30%) 18/60 (30%) 22/60 (37%) |
|ADJUSTED (b) | 100.0% 100.0% 96.4% | 89.5% 93.6% 100.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 3/10 (30%) 2/10 (20%) | 0/10 (0%) 1/10 (10%) 0/10 (0%) |
|INTERIM SACRIFICE 3 (c)| 0/10 (0%) 4/10 (40%) 4/6 (67%) | 0/10 (0%) 0/10 (0%) 1/6 (17%) |
|INTERIM SACRIFICE 4 (c)| 6/9 (67%) 3/3 (100%) 0/0 | 2/8 (25%) 3/10 (30%) 0/0 |
|TERMINAL (d) | 13/13 (100%) 1/1 (100%) 0/0 | 12/14 (86%) 3/4 (75%) 0/0 |
|FIRST INCIDENCE (DAYS) | 455 (I) 190 (I) 190 (I) | 413 190 (I) 221 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.007 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.006 ** P<0.001 ** P=0.003 ** | P=0.126 P=0.198 P=0.154 |
|LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.166 P<0.001 ** |
|COCHRAN-ARMITAGE | P=0.237 | P=0.234 |
|FISHER EXACT | P=0.072 P=0.181 | P=0.579N P=0.281 |
|=================================================================================================================================|
DATE: 04/08/97 EXPERIMENT: 05092 TEST: 03 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER 344) -- O-NITROANISOLE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0.0% 0.600% 1.80% | 0.0% 0.600% 1.80% |
| | 15 SSAC 15 SSAC 15 SSAC | 15 SSAC 15 SSAC 15 SSAC |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 15/60 (25%) 32/60 (53%) 51/60 (85%) | 10/60 (17%) 30/60 (50%) 48/60 (80%) |
|ADJUSTED (b) | 75.0% 100.0% 100.0% | 53.2% 100.0% 100.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 10/10 (100%) | 0/10 (0%) 0/10 (0%) 10/10 (100%) |
|INTERIM SACRIFICE 3 (c)| 0/10 (0%) 3/10 (30%) 6/6 (100%) | 0/10 (0%) 1/10 (10%) 6/6 (100%) |
|INTERIM SACRIFICE 4 (c)| 0/9 (0%) 3/3 (100%) 0/0 | 0/8 (0%) 9/10 (90%) 0/0 |
|TERMINAL (d) | 8/13 (62%) 1/1 (100%) 0/0 | 6/14 (43%) 4/4 (100%) 0/0 |
|FIRST INCIDENCE (DAYS) | 564 207 87 (I) | 408 274 (I) 190 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** |
|FISHER EXACT | P=0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 26/60 (43%) 39/60 (65%) 51/60 (85%) | 22/60 (37%) 32/60 (53%) 48/60 (80%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% | 95.4% 100.0% 100.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 3/10 (30%) 10/10 (100%) | 0/10 (0%) 1/10 (10%) 10/10 (100%) |
|INTERIM SACRIFICE 3 (c)| 0/10 (0%) 6/10 (60%) 6/6 (100%) | 0/10 (0%) 1/10 (10%) 6/6 (100%) |
|INTERIM SACRIFICE 4 (c)| 6/9 (67%) 3/3 (100%) 0/0 | 2/8 (25%) 10/10 (100%) 0/0 |
|TERMINAL (d) | 13/13 (100%) 1/1 (100%) 0/0 | 13/14 (93%) 4/4 (100%) 0/0 |
|FIRST INCIDENCE (DAYS) | 455 (I) 190 (I) 87 (I) | 408 190 (I) 190 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** |
|FISHER EXACT | P=0.014 * P<0.001 ** | P=0.049 * P<0.001 ** |
|=================================================================================================================================|
DATE: 04/08/97 EXPERIMENT: 05092 TEST: 03 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER 344) -- O-NITROANISOLE
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): 87 190 274 455
Female interim sacrifices(days): 87 190 274 455
(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).