TDMS Study 05212-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus OXAZEPAM DATE: 07/19/96
EXPERIMENT: 05212 TEST: 05 TIME: 16:29:30
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-15322 ROUTE: DOSED FEED NTP C#: 62453B
PATHOLOGIST: RYAN, M. CAS: 604-75-1
------------------------------------------------------------------------------------------------------------------------------------
CORE STUDY
REASONS FOR REMOVAL: 25022 Accidently Killed
25019 Moribund Sacrifice
25020 Natural Death
25021 Terminal Sacrifice
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 0 PPM
INCLUDE 002 0 PPM
INCLUDE 003 625 PPM
INCLUDE 004 625 PPM
INCLUDE 007 2500 PPM
INCLUDE 008 2500 PPM
INCLUDE 009 5000 PPM
INCLUDE 010 5000 PPM
INCLUDE 011 10,000 PPM STOP
INCLUDE 012 10,000 PPM STOP
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus OXAZEPAM DATE: 07/19/96
EXPERIMENT: 05212 TEST: 05 TIME: 16:29:30
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-15322 ROUTE: DOSED FEED NTP C#: 62453B
PATHOLOGIST: RYAN, M. CAS: 604-75-1
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 OXAZEPAM DATE: 07/19/96
EXPERIMENT: 05212 TEST: 05 TIME: 16:29:30
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-15322 ROUTE: DOSED FEED NTP C#: 62453B
PATHOLOGIST: RYAN, M. CAS: 604-75-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF OXAZEPAM
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Clitoral/Preputial Gland Adenoma
Carcinoma or Adenoma
Mammary Gland Carcinoma or Adenoma
Fibroadenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Skin Fibroma
Skin: Sebaceous Gland Adenoma
Testes Adenoma
Thyroid Gland: C-Cell Adenoma
Carcinoma or Adenoma
Thyroid Gland: Follicular Cell
Carcinoma or Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus OXAZEPAM DATE: 07/19/96
EXPERIMENT: 05212 TEST: 05 TIME: 16:29:30
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-15322 ROUTE: DOSED FEED NTP C#: 62453B
PATHOLOGIST: RYAN, M. CAS: 604-75-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF OXAZEPAM
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Clitoral/Preputial Gland Adenoma
Carcinoma or Adenoma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Skin Fibroma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 14/50 (28%) 9/50 (18%) 6/50 (12%) 3/50 (6%) 0/1 (0%) |
|ADJUSTED (b) | 44.1% 42.4% 38.8% 8.8% 0.0% |
|TERMINAL (d) | 3/17 (18%) 2/11 (18%) 1/6 (17%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 571 557 655 452 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.040N* P=0.562N P=0.529N P=0.543 P=0.045N* |
|INCIDENTAL TUMOR | P=0.030N* P=0.300N P=0.041N* P=0.059N P=0.521N |
|LOGISTIC REGRESSION | P=0.049N* P=0.259N P=0.022N* P=0.049N* P=0.675N |
|COCHRAN-ARMITAGE | P=0.004N** |
|FISHER EXACT | P=0.171N P=0.039N* P=0.003N** P=0.725N |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 14/50 (28%) 9/50 (18%) 6/50 (12%) 3/50 (6%) 1/1 (100%) |
|ADJUSTED (b) | 44.1% 42.4% 38.8% 8.8% 10.0% |
|TERMINAL (d) | 3/17 (18%) 2/11 (18%) 1/6 (17%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 571 557 655 452 690 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.101N P=0.562N P=0.529N P=0.543 P=0.132N |
|INCIDENTAL TUMOR | P=0.170N P=0.300N P=0.041N* P=0.059N P=0.521 |
|LOGISTIC REGRESSION | P=0.246N P=0.259N P=0.022N* P=0.049N* P=0.345 |
|COCHRAN-ARMITAGE | P=0.028N* |
|FISHER EXACT | P=0.171N P=0.039N* P=0.003N** P=0.294 |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Brain |
| Oligodendroglioma, Glioma, or Astrocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/2 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 15.3% 0.0% 0.0% |
|TERMINAL (d) | 0/17 (0%) 0/11 (0%) 0/6 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- 662 --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.626 (e) P=0.112 (e) (e) |
|INCIDENTAL TUMOR | P=0.595 (e) P=0.249 (e) (e) |
|LOGISTIC REGRESSION | P=0.560 (e) P=0.174 (e) (e) |
|COCHRAN-ARMITAGE | P=0.721 |
|FISHER EXACT | (e) P=0.247 (e) (e) |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 7/48 (15%) 9/50 (18%) 5/50 (10%) 4/49 (8%) 10/14 (71%) |
|ADJUSTED (b) | 29.8% 38.8% 30.2% 17.7% 73.6% |
|TERMINAL (d) | 3/17 (18%) 3/11 (27%) 1/6 (17%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 601 523 613 529 584 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.004 ** P=0.178 P=0.371 P=0.069 P=0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.432 P=0.420N P=0.592N P<0.001 ** |
|LOGISTIC REGRESSION | P<0.001 ** P=0.362 P=0.558N P=0.656N P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** |
|FISHER EXACT | P=0.428 P=0.351N P=0.250N P<0.001 ** |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 8/48 (17%) 9/50 (18%) 5/50 (10%) 4/49 (8%) 10/14 (71%) |
|ADJUSTED (b) | 31.5% 38.8% 30.2% 17.7% 73.6% |
|TERMINAL (d) | 3/17 (18%) 3/11 (27%) 1/6 (17%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 541 523 613 529 584 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.008 ** P=0.257 P=0.494 P=0.143 P=0.004 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.572 P=0.301N P=0.333N P<0.001 ** |
|LOGISTIC REGRESSION | P<0.001 ** P=0.507 P=0.377N P=0.432N P<0.001 ** |
|COCHRAN-ARMITAGE | P=0.002 ** |
|FISHER EXACT | P=0.537 P=0.250N P=0.168N P<0.001 ** |
|=================================================================================================================================|
| |
|Intestine Large: Colon/Rectum |
| Polyp Adenomatous |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 11.6% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/17 (0%) 1/11 (9%) 0/6 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | --- 571 --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.457N P=0.180 (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.336N P=0.275 (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.286N P=0.218 (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.247N |
|FISHER EXACT | P=0.247 (e) (e) (e) |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Intestine Small: Jejunum |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 9.1% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/17 (6%) 0/11 (0%) 0/6 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 690 --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.463N P=0.351N P=0.477N P=0.918N P=0.712N |
|INCIDENTAL TUMOR | P=0.331N P=0.357N P=0.340N P=0.753N P=0.511N |
|LOGISTIC REGRESSION | P=0.345N P=0.328N P=0.374N P=0.729N P=0.506N |
|COCHRAN-ARMITAGE | P=0.177N |
|FISHER EXACT | P=0.247N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
| |
|Intestine Small: Site Unspecified |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 9.1% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/17 (6%) 0/11 (0%) 0/6 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 690 --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.463N P=0.351N P=0.477N P=0.918N P=0.712N |
|INCIDENTAL TUMOR | P=0.331N P=0.357N P=0.340N P=0.753N P=0.511N |
|LOGISTIC REGRESSION | P=0.345N P=0.328N P=0.374N P=0.729N P=0.506N |
|COCHRAN-ARMITAGE | P=0.177N |
|FISHER EXACT | P=0.247N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/0 (0%) |
|ADJUSTED (b) | 6.7% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/17 (0%) 0/11 (0%) 0/6 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 682 --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.371N P=0.362N P=0.445N P=0.750N P=0.547N |
|INCIDENTAL TUMOR | P=0.405N P=0.374N P=0.225N P=0.546N (e) |
|LOGISTIC REGRESSION | P=0.405N P=0.374N P=0.225N P=0.546N (e) |
|COCHRAN-ARMITAGE | P=0.282N |
|FISHER EXACT | P=0.258N P=0.253N P=0.247N P=1.000N |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/0 (0%) |
|ADJUSTED (b) | 9.9% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/17 (0%) 0/11 (0%) 0/6 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 682 --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.262N P=0.232N P=0.321N P=0.648N P=0.407N |
|INCIDENTAL TUMOR | P=0.222N P=0.237N P=0.108N P=0.412N (e) |
|LOGISTIC REGRESSION | P=0.222N P=0.237N P=0.108N P=0.412N (e) |
|COCHRAN-ARMITAGE | P=0.140N |
|FISHER EXACT | P=0.129N P=0.125N P=0.121N P=1.000N |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 3/50 (6%) 1/50 (2%) 0/42 (0%) |
|ADJUSTED (b) | 5.6% 0.0% 23.8% 16.7% 0.0% |
|TERMINAL (d) | 0/17 (0%) 0/11 (0%) 1/6 (17%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 723 --- 641 634 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.454 P=0.598N P=0.099 P=0.159 (e) |
|INCIDENTAL TUMOR | P=0.410N P=0.617N P=0.296 P=0.748 P=0.523N |
|LOGISTIC REGRESSION | P=0.559N P=0.588N P=0.188 P=0.503 P=0.918N |
|COCHRAN-ARMITAGE | P=0.395N |
|FISHER EXACT | P=0.500N P=0.309 P=0.753N P=0.543N |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/49 (0%) 3/50 (6%) 1/50 (2%) |
|ADJUSTED (b) | 5.9% 0.0% 0.0% 8.9% 2.6% |
|TERMINAL (d) | 1/17 (6%) 0/11 (0%) 0/6 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 730 (T) --- --- 451 585 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.165 P=0.587N P=0.707N P=0.073 P=0.495 |
|INCIDENTAL TUMOR | P=0.153 P=0.587N P=0.707N P=0.386 P=0.767 |
|LOGISTIC REGRESSION | P=0.333 P=0.587N P=0.707N P=0.419 P=0.742 |
|COCHRAN-ARMITAGE | P=0.294 |
|FISHER EXACT | P=0.500N P=0.505N P=0.309 P=0.753N |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/49 (0%) 3/50 (6%) 1/50 (2%) |
|ADJUSTED (b) | 8.4% 0.0% 0.0% 8.9% 2.6% |
|TERMINAL (d) | 1/17 (6%) 0/11 (0%) 0/6 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 608 --- --- 451 585 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.318 P=0.325N P=0.368N P=0.144 P=0.741 |
|INCIDENTAL TUMOR | P=0.411 P=0.184N P=0.229N P=0.718 P=0.438N |
|LOGISTIC REGRESSION | P=0.517 P=0.269N P=0.268N P=0.637 P=0.504N |
|COCHRAN-ARMITAGE | P=0.467 |
|FISHER EXACT | P=0.247N P=0.253N P=0.500 P=0.500N |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/49 (0%) 3/50 (6%) 1/50 (2%) |
|ADJUSTED (b) | 8.4% 0.0% 0.0% 8.9% 2.6% |
|TERMINAL (d) | 1/17 (6%) 0/11 (0%) 0/6 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 608 --- --- 451 585 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.318 P=0.325N P=0.368N P=0.144 P=0.741 |
|INCIDENTAL TUMOR | P=0.411 P=0.184N P=0.229N P=0.718 P=0.438N |
|LOGISTIC REGRESSION | P=0.517 P=0.269N P=0.268N P=0.637 P=0.504N |
|COCHRAN-ARMITAGE | P=0.467 |
|FISHER EXACT | P=0.247N P=0.253N P=0.500 P=0.500N |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/3 (0%) |
|ADJUSTED (b) | 2.2% 0.0% 16.7% 0.0% 0.0% |
|TERMINAL (d) | 0/17 (0%) 0/11 (0%) 1/6 (17%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 517 --- 730 (T) --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.580N P=0.518N P=0.643 P=0.566N P=0.504N |
|INCIDENTAL TUMOR | P=0.733N P=0.419N P=0.652 P=0.266N (e) |
|LOGISTIC REGRESSION | P=0.629N P=0.353N P=0.749N P=0.341N P=0.999N |
|COCHRAN-ARMITAGE | P=0.591N |
|FISHER EXACT | P=0.500N P=0.753N P=0.500N P=0.943N |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/3 (0%) |
|ADJUSTED (b) | 2.2% 9.1% 23.6% 0.0% 0.0% |
|TERMINAL (d) | 0/17 (0%) 1/11 (9%) 1/6 (17%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 517 730 (T) 689 --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.581N P=0.702 P=0.283 P=0.566N P=0.504N |
|INCIDENTAL TUMOR | P=0.735N P=0.762 P=0.393 P=0.266N (e) |
|LOGISTIC REGRESSION | P=0.647N P=0.751N P=0.493 P=0.341N P=0.999N |
|COCHRAN-ARMITAGE | P=0.456N |
|FISHER EXACT | P=0.753N P=0.500 P=0.500N P=0.943N |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Mammary Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% 10.0% |
|TERMINAL (d) | 0/17 (0%) 0/11 (0%) 0/6 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- --- --- 690 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.060 (e) (e) (e) P=0.288 |
|INCIDENTAL TUMOR | P=0.159 (e) (e) (e) P=0.489 |
|LOGISTIC REGRESSION | P=0.073 (e) (e) (e) P=0.368 |
|COCHRAN-ARMITAGE | P=0.142 |
|FISHER EXACT | (e) (e) (e) P=0.500 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 2.5% 3.4% |
|TERMINAL (d) | 0/17 (0%) 0/11 (0%) 0/6 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- --- 452 614 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.146 (e) (e) P=0.455 P=0.457 |
|INCIDENTAL TUMOR | P=0.193 (e) (e) P=0.734 P=0.767 |
|LOGISTIC REGRESSION | P=0.162 (e) (e) P=0.766 P=0.530 |
|COCHRAN-ARMITAGE | P=0.152 |
|FISHER EXACT | (e) (e) P=0.500 P=0.500 |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 2.5% 13.1% |
|TERMINAL (d) | 0/17 (0%) 0/11 (0%) 0/6 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- --- 452 614 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.017 * (e) (e) P=0.455 P=0.114 |
|INCIDENTAL TUMOR | P=0.044 * (e) (e) P=0.734 P=0.366 |
|LOGISTIC REGRESSION | P=0.032 * (e) (e) P=0.766 P=0.204 |
|COCHRAN-ARMITAGE | P=0.031 * |
|FISHER EXACT | (e) (e) P=0.500 P=0.247 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 4/50 (8%) 5/50 (10%) 4/50 (8%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 18.2% 32.9% 38.9% 7.4% 0.0% |
|TERMINAL (d) | 1/17 (6%) 3/11 (27%) 2/6 (33%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 698 481 655 452 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.465N P=0.280 P=0.213 P=0.330 P=0.537N |
|INCIDENTAL TUMOR | P=0.143N P=0.257 P=0.453 P=0.662N P=0.127N |
|LOGISTIC REGRESSION | P=0.052N P=0.336 P=0.384 P=0.592N P=0.214N |
|COCHRAN-ARMITAGE | P=0.017N* |
|FISHER EXACT | P=0.500 P=0.643N P=0.339N P=0.059N |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 4/50 (8%) 5/50 (10%) 4/50 (8%) 2/50 (4%) 1/50 (2%) |
|ADJUSTED (b) | 18.2% 32.9% 38.9% 7.4% 10.0% |
|TERMINAL (d) | 1/17 (6%) 3/11 (27%) 2/6 (33%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 698 481 655 452 690 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.428 P=0.280 P=0.213 P=0.330 P=0.608 |
|INCIDENTAL TUMOR | P=0.322N P=0.257 P=0.453 P=0.662N P=0.321N |
|LOGISTIC REGRESSION | P=0.148N P=0.336 P=0.384 P=0.592N P=0.515N |
|COCHRAN-ARMITAGE | P=0.056N |
|FISHER EXACT | P=0.500 P=0.643N P=0.339N P=0.181N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 4/50 (8%) 5/50 (10%) 4/50 (8%) 2/50 (4%) 2/50 (4%) |
|ADJUSTED (b) | 18.2% 32.9% 38.9% 7.4% 13.1% |
|TERMINAL (d) | 1/17 (6%) 3/11 (27%) 2/6 (33%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 698 481 655 452 614 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.222 P=0.280 P=0.213 P=0.330 P=0.345 |
|INCIDENTAL TUMOR | P=0.497N P=0.257 P=0.453 P=0.662N P=0.410N |
|LOGISTIC REGRESSION | P=0.283N P=0.336 P=0.384 P=0.592N P=0.614N |
|COCHRAN-ARMITAGE | P=0.134N |
|FISHER EXACT | P=0.500 P=0.643N P=0.339N P=0.339N |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Pancreas |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/48 (2%) 1/49 (2%) 0/50 (0%) 0/0 (0%) |
|ADJUSTED (b) | 11.8% 4.5% 3.7% 0.0% 0.0% |
|TERMINAL (d) | 2/17 (12%) 0/11 (0%) 0/6 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 730 (T) 642 641 --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.432N P=0.653N P=0.720 (e) (e) |
|INCIDENTAL TUMOR | P=0.455N P=0.503N P=0.639N (e) (e) |
|LOGISTIC REGRESSION | P=0.455N P=0.503N P=0.639N (e) (e) |
|COCHRAN-ARMITAGE | P=0.255N |
|FISHER EXACT | P=0.515N P=0.508N P=0.247N P=1.000N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 17/49 (35%) 12/50 (24%) 10/50 (20%) 2/48 (4%) 5/5 (100%) |
|ADJUSTED (b) | 61.7% 41.5% 56.7% 10.9% 49.7% |
|TERMINAL (d) | 8/17 (47%) 1/11 (9%) 1/6 (17%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 471 481 600 529 627 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.444N P=0.577N P=0.330 P=0.573N P=0.310 |
|INCIDENTAL TUMOR | P=0.490 P=0.254N P=0.261N P=0.055N P=0.009 ** |
|LOGISTIC REGRESSION | P=0.377 P=0.246N P=0.246N P=0.030N* P=0.010 ** |
|COCHRAN-ARMITAGE | P=0.313N |
|FISHER EXACT | P=0.172N P=0.078N P<0.001N** P=0.008 ** |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 17/49 (35%) 12/50 (24%) 10/50 (20%) 2/48 (4%) 5/5 (100%) |
|ADJUSTED (b) | 61.7% 41.5% 56.7% 10.9% 49.7% |
|TERMINAL (d) | 8/17 (47%) 1/11 (9%) 1/6 (17%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 471 481 600 529 627 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.444N P=0.577N P=0.330 P=0.573N P=0.310 |
|INCIDENTAL TUMOR | P=0.490 P=0.254N P=0.261N P=0.055N P=0.009 ** |
|LOGISTIC REGRESSION | P=0.377 P=0.246N P=0.246N P=0.030N* P=0.010 ** |
|COCHRAN-ARMITAGE | P=0.313N |
|FISHER EXACT | P=0.172N P=0.078N P<0.001N** P=0.008 ** |
|=================================================================================================================================|
| |
|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) | 5/50 (10%) 5/50 (10%) 2/50 (4%) 3/50 (6%) 2/50 (4%) |
|ADJUSTED (b) | 14.6% 23.5% 12.9% 17.5% 4.8% |
|TERMINAL (d) | 0/17 (0%) 1/11 (9%) 0/6 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 517 524 663 507 542 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.450N P=0.422 P=0.512N P=0.292 P=0.458N |
|INCIDENTAL TUMOR | P=0.085N P=0.597N P=0.154N P=0.257N P=0.138N |
|LOGISTIC REGRESSION | P=0.146N P=0.616N P=0.222N P=0.411N P=0.157N |
|COCHRAN-ARMITAGE | P=0.134N |
|FISHER EXACT | P=0.630N P=0.218N P=0.357N P=0.218N |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |
|ADJUSTED (b) | 16.2% 2.9% 3.1% 100.0% 34.8% |
|TERMINAL (d) | 2/17 (12%) 0/11 (0%) 0/6 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 711 572 613 585 558 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.111 P=0.433N P=0.609N P=0.016 * P=0.154 |
|INCIDENTAL TUMOR | P=0.526 P=0.355N P=0.394N P=0.307 P=0.629 |
|LOGISTIC REGRESSION | P=0.432 P=0.398N P=0.452N P=0.230 P=0.629 |
|COCHRAN-ARMITAGE | P=0.574 |
|FISHER EXACT | P=0.309N P=0.309N P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 5/50 (10%) 4/50 (8%) 1/50 (2%) 2/50 (4%) 3/50 (6%) |
|ADJUSTED (b) | 21.5% 12.9% 3.1% 100.0% 47.9% |
|TERMINAL (d) | 2/17 (12%) 0/11 (0%) 0/6 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 491 536 613 585 558 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.298 P=0.594 P=0.318N P=0.231 P=0.187 |
|INCIDENTAL TUMOR | P=0.282N P=0.407N P=0.136N P=0.662N P=0.629N |
|LOGISTIC REGRESSION | P=0.397N P=0.489N P=0.124N P=0.670N P=0.492N |
|COCHRAN-ARMITAGE | P=0.307N |
|FISHER EXACT | P=0.500N P=0.102N P=0.218N P=0.357N |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 6.3% 10.4% 0.0% 0.0% 20.0% |
|TERMINAL (d) | 0/17 (0%) 0/11 (0%) 0/6 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 491 536 --- --- 697 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.405N P=0.389 P=0.339N P=0.461N P=0.669 |
|INCIDENTAL TUMOR | P=0.139N P=0.676 P=0.234N P=0.208N P=0.567N |
|LOGISTIC REGRESSION | P=0.202N P=0.607 P=0.182N P=0.188N P=0.476N |
|COCHRAN-ARMITAGE | P=0.201N |
|FISHER EXACT | P=0.500 P=0.247N P=0.247N P=0.500N |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 11.0% 10.4% 0.0% 0.0% 20.0% |
|TERMINAL (d) | 0/17 (0%) 0/11 (0%) 0/6 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 491 536 --- --- 697 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.350N P=0.533 P=0.252N P=0.434N P=0.712 |
|INCIDENTAL TUMOR | P=0.084N P=0.559N P=0.116N P=0.162N P=0.362N |
|LOGISTIC REGRESSION | P=0.139N P=0.608N P=0.107N P=0.149N P=0.323N |
|COCHRAN-ARMITAGE | P=0.123N |
|FISHER EXACT | P=0.661N P=0.121N P=0.121N P=0.309N |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 1/50 (2%) 3/50 (6%) 2/50 (4%) |
|ADJUSTED (b) | 10.1% 23.5% 5.0% 17.5% 4.8% |
|TERMINAL (d) | 0/17 (0%) 1/11 (9%) 0/6 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 585 524 663 507 542 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.539 P=0.210 P=0.547N P=0.121 P=0.645 |
|INCIDENTAL TUMOR | P=0.192N P=0.405 P=0.217N P=0.581N P=0.331N |
|LOGISTIC REGRESSION | P=0.294N P=0.343 P=0.338N P=0.606 P=0.449N |
|COCHRAN-ARMITAGE | P=0.282N |
|FISHER EXACT | P=0.357 P=0.309N P=0.661N P=0.500N |
|=================================================================================================================================|
| |
|Skin |
| Schwannoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 11.6% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/17 (6%) 0/11 (0%) 0/6 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 480 --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.229N P=0.181N P=0.256N P=0.467N P=0.377N |
|INCIDENTAL TUMOR | P=0.142N P=0.156N P=0.176N P=0.208N P=0.298N |
|LOGISTIC REGRESSION | P=0.103N P=0.110N P=0.109N P=0.155N P=0.107N |
|COCHRAN-ARMITAGE | P=0.090N |
|FISHER EXACT | P=0.121N P=0.121N P=0.121N P=0.121N |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 5.0% 0.0% 8.3% 0.0% 0.0% |
|TERMINAL (d) | 0/17 (0%) 0/11 (0%) 0/6 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 517 --- 689 --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.310N P=0.323N P=0.698N P=0.486N P=0.353N |
|INCIDENTAL TUMOR | P=0.177N P=0.252N P=0.487N P=0.208N P=0.298N |
|LOGISTIC REGRESSION | P=0.188N P=0.183N P=0.478N P=0.198N P=0.186N |
|COCHRAN-ARMITAGE | P=0.174N |
|FISHER EXACT | P=0.247N P=0.500N P=0.247N P=0.247N |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 5/50 (10%) 5/50 (10%) 2/50 (4%) 3/50 (6%) 2/50 (4%) |
|ADJUSTED (b) | 14.6% 23.5% 12.9% 17.5% 4.8% |
|TERMINAL (d) | 0/17 (0%) 1/11 (9%) 0/6 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 517 524 663 507 542 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.450N P=0.422 P=0.512N P=0.292 P=0.458N |
|INCIDENTAL TUMOR | P=0.085N P=0.597N P=0.154N P=0.257N P=0.138N |
|LOGISTIC REGRESSION | P=0.146N P=0.616N P=0.222N P=0.411N P=0.157N |
|COCHRAN-ARMITAGE | P=0.134N |
|FISHER EXACT | P=0.630N P=0.218N P=0.357N P=0.218N |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 5/50 (10%) 5/50 (10%) 2/50 (4%) 3/50 (6%) 2/50 (4%) |
|ADJUSTED (b) | 14.6% 23.5% 12.9% 17.5% 4.8% |
|TERMINAL (d) | 0/17 (0%) 1/11 (9%) 0/6 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 517 524 663 507 542 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.450N P=0.422 P=0.512N P=0.292 P=0.458N |
|INCIDENTAL TUMOR | P=0.085N P=0.597N P=0.154N P=0.257N P=0.138N |
|LOGISTIC REGRESSION | P=0.146N P=0.616N P=0.222N P=0.411N P=0.157N |
|COCHRAN-ARMITAGE | P=0.134N |
|FISHER EXACT | P=0.630N P=0.218N P=0.357N P=0.218N |
|=================================================================================================================================|
| |
|Skin: Sebaceous Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 2.9% 0.0% 0.0% 0.0% 19.5% |
|TERMINAL (d) | 0/17 (0%) 0/11 (0%) 0/6 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 682 --- --- --- 614 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.042 * P=0.627N P=0.677N P=0.901N P=0.214 |
|INCIDENTAL TUMOR | P=0.207 P=0.617N P=0.489N P=0.753N P=0.629 |
|LOGISTIC REGRESSION | P=0.091 P=0.548N P=0.554N P=0.776N P=0.421 |
|COCHRAN-ARMITAGE | P=0.145 |
|FISHER EXACT | P=0.500N P=0.500N P=0.500N P=0.500 |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 45/50 (90%) 48/50 (96%) 49/50 (98%) 47/50 (94%) 48/48 (100%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 17/17 (100%) 11/11 (100%) 6/6 (100%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 517 386 381 422 480 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.014 * P<0.001 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.004 ** P=0.092 P=0.053 P<0.001 ** P=0.055 |
|LOGISTIC REGRESSION | P=0.011 * P=0.054 P=0.012 * P<0.001 ** P=0.014 * |
|COCHRAN-ARMITAGE | P=0.061 |
|FISHER EXACT | P=0.218 P=0.102 P=0.357 P=0.031 * |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 10/50 (20%) 5/49 (10%) 6/50 (12%) 2/50 (4%) 1/50 (2%) |
|ADJUSTED (b) | 35.5% 34.6% 31.7% 8.6% 9.1% |
|TERMINAL (d) | 3/17 (18%) 3/11 (27%) 0/6 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 571 614 558 452 687 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.298N P=0.400N P=0.444 P=0.564 P=0.320N |
|INCIDENTAL TUMOR | P=0.013N* P=0.328N P=0.185N P=0.206N P=0.017N* |
|LOGISTIC REGRESSION | P=0.019N* P=0.312N P=0.351N P=0.145N P=0.030N* |
|COCHRAN-ARMITAGE | P=0.003N** |
|FISHER EXACT | P=0.140N P=0.207N P=0.014N* P=0.004N** |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 10/50 (20%) 5/49 (10%) 6/50 (12%) 2/50 (4%) 2/50 (4%) |
|ADJUSTED (b) | 35.5% 34.6% 31.7% 8.6% 13.2% |
|TERMINAL (d) | 3/17 (18%) 3/11 (27%) 0/6 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 571 614 558 452 634 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.484N P=0.400N P=0.444 P=0.564 P=0.516N |
|INCIDENTAL TUMOR | P=0.033N* P=0.328N P=0.185N P=0.206N P=0.030N* |
|LOGISTIC REGRESSION | P=0.051N P=0.312N P=0.351N P=0.145N P=0.068N |
|COCHRAN-ARMITAGE | P=0.010N** |
|FISHER EXACT | P=0.140N P=0.207N P=0.014N* P=0.014N* |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/49 (0%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |
|ADJUSTED (b) | 2.4% 0.0% 3.1% 52.9% 9.5% |
|TERMINAL (d) | 0/17 (0%) 0/11 (0%) 0/6 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 554 --- 613 575 638 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.083 P=0.525N P=0.747 P=0.135 P=0.384 |
|INCIDENTAL TUMOR | P=0.409 P=0.335N P=0.553N P=0.557 P=0.569N |
|LOGISTIC REGRESSION | P=0.161 P=0.408N P=0.707N P=0.426 P=0.557 |
|COCHRAN-ARMITAGE | P=0.176 |
|FISHER EXACT | P=0.505N P=0.753N P=0.500 P=0.500 |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 21
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 3/49 (6%) 3/50 (6%) 4/50 (8%) 1/50 (2%) |
|ADJUSTED (b) | 12.5% 16.3% 12.6% 13.4% 4.8% |
|TERMINAL (d) | 1/17 (6%) 1/11 (9%) 0/6 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 688 614 424 442 638 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.506 P=0.456 P=0.339 P=0.057 P=0.660 |
|INCIDENTAL TUMOR | P=0.275N P=0.634 P=0.606 P=0.471 P=0.371N |
|LOGISTIC REGRESSION | P=0.245N P=0.546 P=0.656 P=0.516 P=0.513N |
|COCHRAN-ARMITAGE | P=0.247N |
|FISHER EXACT | P=0.651 P=0.661N P=0.500 P=0.309N |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 3/49 (6%) 4/50 (8%) 6/50 (12%) 2/50 (4%) |
|ADJUSTED (b) | 14.6% 16.3% 15.4% 59.2% 9.5% |
|TERMINAL (d) | 1/17 (6%) 1/11 (9%) 0/6 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 554 614 424 442 638 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.308 P=0.603 P=0.354 P=0.010 * P=0.573 |
|INCIDENTAL TUMOR | P=0.297N P=0.471N P=0.580N P=0.354 P=0.190N |
|LOGISTIC REGRESSION | P=0.384N P=0.582N P=0.617N P=0.318 P=0.400N |
|COCHRAN-ARMITAGE | P=0.378N |
|FISHER EXACT | P=0.511N P=0.643N P=0.370 P=0.339N |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 22
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | |
|ADJUSTED (b) | |
|TERMINAL (d) | |
|FIRST INCIDENCE (DAYS) | |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | |
|INCIDENTAL TUMOR | |
|LOGISTIC REGRESSION | |
|COCHRAN-ARMITAGE | |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | |
|ADJUSTED (b) | |
|TERMINAL (d) | |
|FIRST INCIDENCE (DAYS) | |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | |
|INCIDENTAL TUMOR | |
|LOGISTIC REGRESSION | |
|COCHRAN-ARMITAGE | |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 23
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 2.7% 0.0% 5.0% 7.7% |
|TERMINAL (d) | 0/17 (0%) 0/11 (0%) 0/6 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | --- 557 --- 562 670 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.293 P=0.480 (e) P=0.357 P=0.303 |
|INCIDENTAL TUMOR | P=0.505 P=0.677 (e) P=0.665 P=0.489 |
|LOGISTIC REGRESSION | P=0.369 P=0.592 (e) P=0.575 P=0.439 |
|COCHRAN-ARMITAGE | P=0.359 |
|FISHER EXACT | P=0.500 (e) P=0.500 P=0.500 |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 27/50 (54%) 36/50 (72%) 33/50 (66%) 19/50 (38%) 33/50 (66%) |
|ADJUSTED (b) | 72.4% 91.4% 86.0% 100.0% 100.0% |
|TERMINAL (d) | 8/17 (47%) 8/11 (73%) 3/6 (50%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 498 426 381 442 480 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.005 ** P=0.002 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.397N P=0.033 * P=0.294 P=0.379N P=0.188 |
|LOGISTIC REGRESSION | P=0.502 P=0.020 * P=0.187 P=0.459N P=0.110 |
|COCHRAN-ARMITAGE | P=0.444N |
|FISHER EXACT | P=0.048 * P=0.154 P=0.080N P=0.154 |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 24
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 5.4% 8.6% 3.7% 2.1% 3.1% |
|TERMINAL (d) | 0/17 (0%) 0/11 (0%) 0/6 (0%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 592 586 641 237 613 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.503N P=0.522 P=0.637N P=0.682 P=0.647N |
|INCIDENTAL TUMOR | P=0.119N P=0.657N P=0.296N P=0.252N P=0.223N |
|LOGISTIC REGRESSION | P=0.285N P=0.694N P=0.494N P=0.203N P=0.476N |
|COCHRAN-ARMITAGE | P=0.332N |
|FISHER EXACT | P=0.691N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 47/50 (94%) 50/50 (100%) 50/50 (100%) 47/50 (94%) 48/50 (96%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 17/17 (100%) 11/11 (100%) 6/6 (100%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 471 386 381 422 480 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.014 * P<0.001 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.323 P=0.053 P=0.107 P=0.006 ** P=0.303 |
|LOGISTIC REGRESSION | P=0.643 P=0.011 * P=0.014 * P=0.001 ** P=0.331 |
|COCHRAN-ARMITAGE | P=0.365N |
|FISHER EXACT | P=0.121 P=0.121 P=0.661N P=0.500 |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 25
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 38/50 (76%) 43/50 (86%) 40/50 (80%) 25/50 (50%) 35/50 (70%) |
|ADJUSTED (b) | 85.6% 93.5% 96.5% 100.0% 100.0% |
|TERMINAL (d) | 11/17 (65%) 8/11 (73%) 5/6 (83%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 480 426 381 237 480 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.003 ** P=0.016 * P=0.003 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.014N* P=0.181 P=0.549 P=0.024N* P=0.288N |
|LOGISTIC REGRESSION | P=0.035N* P=0.083 P=0.477 P=0.025N* P=0.363N |
|COCHRAN-ARMITAGE | P=0.022N* |
|FISHER EXACT | P=0.154 P=0.405 P=0.006N** P=0.326N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 50/50 (100%) 50/50 (100%) 50/50 (100%) 48/50 (96%) 48/50 (96%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 17/17 (100%) 11/11 (100%) 6/6 (100%) 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | 471 386 381 237 480 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.035 * P=0.001 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.188N (e) (e) (e) P=0.767N |
|LOGISTIC REGRESSION | P=0.022N* (e) (e) (e) P=0.423N |
|COCHRAN-ARMITAGE | P=0.036N* |
|FISHER EXACT | P=1.000N P=1.000N P=0.247N P=0.247N |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 26
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 0/50 (0%) 1/50 (2%) 0/0 (0%) |
|ADJUSTED (b) | 3.1% 9.4% 0.0% 3.2% 0.0% |
|TERMINAL (d) | 1/32 (3%) 1/26 (4%) 0/20 (0%) 1/31 (3%) 0/0 |
|FIRST INCIDENCE (DAYS) | 729 (T) 550 --- 729 (T) --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.265N P=0.258 P=0.594N P=0.755 (e) |
|INCIDENTAL TUMOR | P=0.417N P=0.322 P=0.594N P=0.755 (e) |
|LOGISTIC REGRESSION | P=0.417N P=0.322 P=0.594N P=0.755 (e) |
|COCHRAN-ARMITAGE | P=0.428N |
|FISHER EXACT | P=0.309 P=0.500N P=0.753N P=1.000N |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 0/50 (0%) 1/50 (2%) 0/0 (0%) |
|ADJUSTED (b) | 8.9% 9.4% 0.0% 3.2% 0.0% |
|TERMINAL (d) | 2/32 (6%) 1/26 (4%) 0/20 (0%) 1/31 (3%) 0/0 |
|FIRST INCIDENCE (DAYS) | 700 550 --- 729 (T) --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.101N P=0.596 P=0.204N P=0.312N P=0.512N |
|INCIDENTAL TUMOR | P=0.164N P=0.618N P=0.147N P=0.283N (e) |
|LOGISTIC REGRESSION | P=0.164N P=0.618N P=0.147N P=0.283N (e) |
|COCHRAN-ARMITAGE | P=0.169N |
|FISHER EXACT | P=0.661N P=0.121N P=0.309N P=1.000N |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 27
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Brain |
| Oligodendroglioma, Glioma, or Astrocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/0 (0%) |
|ADJUSTED (b) | 2.0% 3.8% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 1/26 (4%) 0/20 (0%) 0/31 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 223 729 (T) --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.273N P=0.738 P=0.500N P=0.504N P=0.500N |
|INCIDENTAL TUMOR | P=0.458N P=0.659 (e) P=0.638N (e) |
|LOGISTIC REGRESSION | P=0.458N P=0.659 (e) P=0.638N (e) |
|COCHRAN-ARMITAGE | P=0.366N |
|FISHER EXACT | P=0.753N P=0.500N P=0.500N P=1.000N |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 7/49 (14%) 3/50 (6%) 3/50 (6%) 4/50 (8%) 7/11 (64%) |
|ADJUSTED (b) | 19.4% 10.1% 9.6% 11.5% 65.1% |
|TERMINAL (d) | 4/31 (13%) 2/26 (8%) 1/20 (5%) 2/31 (6%) 5/8 (63%) |
|FIRST INCIDENCE (DAYS) | 550 654 565 679 718 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.059 P=0.210N P=0.309N P=0.259N P=0.077 |
|INCIDENTAL TUMOR | P=0.002 ** P=0.129N P=0.133N P=0.192N P=0.004 ** |
|LOGISTIC REGRESSION | P=0.001 ** P=0.149N P=0.153N P=0.239N P=0.002 ** |
|COCHRAN-ARMITAGE | P<0.001 ** |
|FISHER EXACT | P=0.151N P=0.151N P=0.251N P=0.002 ** |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 28
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 8/49 (16%) 3/50 (6%) 4/50 (8%) 4/50 (8%) 7/11 (64%) |
|ADJUSTED (b) | 22.4% 10.1% 12.5% 11.5% 65.1% |
|TERMINAL (d) | 5/31 (16%) 2/26 (8%) 1/20 (5%) 2/31 (6%) 5/8 (63%) |
|FIRST INCIDENCE (DAYS) | 550 654 565 679 718 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.103 P=0.145N P=0.360N P=0.179N P=0.101 |
|INCIDENTAL TUMOR | P=0.005 ** P=0.084N P=0.152N P=0.126N P=0.008 ** |
|LOGISTIC REGRESSION | P=0.004 ** P=0.093N P=0.174N P=0.157N P=0.004 ** |
|COCHRAN-ARMITAGE | P=0.002 ** |
|FISHER EXACT | P=0.094N P=0.168N P=0.168N P=0.003 ** |
|=================================================================================================================================|
| |
|Intestine Large: Colon/Rectum |
| Polyp Adenomatous |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 2.6% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/26 (0%) 0/20 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 647 --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.377N P=0.500N P=0.552N P=0.495N P=0.505N |
|INCIDENTAL TUMOR | P=0.337N P=0.377N P=0.410N P=0.429N P=0.362N |
|LOGISTIC REGRESSION | P=0.383N P=0.503N P=0.495N P=0.503N P=0.513N |
|COCHRAN-ARMITAGE | P=0.378N |
|FISHER EXACT | P=0.500N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 29
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Intestine Small: Jejunum |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/26 (0%) 0/20 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | (e) |
|FISHER EXACT | (e) (e) (e) (e) |
|=================================================================================================================================|
| |
|Intestine Small: Site Unspecified |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/26 (0%) 0/20 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | (e) |
|FISHER EXACT | (e) (e) (e) (e) |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 30
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/0 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/26 (0%) 0/20 (0%) 0/31 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | (e) |
|FISHER EXACT | (e) (e) (e) (e) |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/0 (0%) |
|ADJUSTED (b) | 3.1% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/32 (3%) 0/26 (0%) 0/20 (0%) 0/31 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 729 (T) --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.590N P=0.541N P=0.594N P=0.506N (e) |
|INCIDENTAL TUMOR | P=0.590N P=0.541N P=0.594N P=0.506N (e) |
|LOGISTIC REGRESSION | P=0.590N P=0.541N P=0.594N P=0.506N (e) |
|COCHRAN-ARMITAGE | P=0.599N |
|FISHER EXACT | P=0.500N P=0.505N P=0.505N P=1.000N |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 31
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/1 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/26 (0%) 0/20 (0%) 0/31 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | (e) |
|FISHER EXACT | (e) (e) (e) (e) |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/26 (0%) 0/20 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | (e) |
|FISHER EXACT | (e) (e) (e) (e) |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 32
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/26 (0%) 0/20 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | (e) |
|FISHER EXACT | (e) (e) (e) (e) |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/26 (0%) 0/20 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | (e) |
|FISHER EXACT | (e) (e) (e) (e) |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 33
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 2/49 (4%) 0/0 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 6.5% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/26 (0%) 0/20 (0%) 2/31 (6%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- --- 729 (T) --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.117 (e) (e) P=0.231 (e) |
|INCIDENTAL TUMOR | P=0.117 (e) (e) P=0.231 (e) |
|LOGISTIC REGRESSION | P=0.117 (e) (e) P=0.231 (e) |
|COCHRAN-ARMITAGE | P=0.102 |
|FISHER EXACT | (e) (e) P=0.242 (e) |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/49 (0%) 2/49 (4%) 0/0 (0%) |
|ADJUSTED (b) | 0.0% 3.2% 0.0% 6.5% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/26 (0%) 0/20 (0%) 2/31 (6%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 718 --- 729 (T) --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.456 P=0.494 (e) P=0.231 (e) |
|INCIDENTAL TUMOR | P=0.283 P=0.623 (e) P=0.231 (e) |
|LOGISTIC REGRESSION | P=0.283 P=0.623 (e) P=0.231 (e) |
|COCHRAN-ARMITAGE | P=0.266 |
|FISHER EXACT | P=0.500 (e) P=0.242 (e) |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 34
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Mammary Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 2.4% 6.9% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 1/26 (4%) 0/20 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 613 718 --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.133N P=0.475 P=0.537N P=0.473N P=0.510N |
|INCIDENTAL TUMOR | P=0.115N P=0.546 P=0.377N P=0.500N P=0.450N |
|LOGISTIC REGRESSION | P=0.126N P=0.500 P=0.497N P=0.502N P=0.535N |
|COCHRAN-ARMITAGE | P=0.127N |
|FISHER EXACT | P=0.500 P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 5.1% 10.3% 0.0% 0.0% 2.1% |
|TERMINAL (d) | 1/32 (3%) 2/26 (8%) 0/20 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 228 697 --- --- 562 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.209N P=0.443 P=0.288N P=0.243N P=0.519N |
|INCIDENTAL TUMOR | P=0.258N P=0.437 P=0.594N P=0.318N P=0.761N |
|LOGISTIC REGRESSION | P=0.218N P=0.483 P=0.288N P=0.213N P=0.713N |
|COCHRAN-ARMITAGE | P=0.201N |
|FISHER EXACT | P=0.500 P=0.247N P=0.247N P=0.500N |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 35
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 7.4% 16.8% 0.0% 0.0% 2.1% |
|TERMINAL (d) | 1/32 (3%) 3/26 (12%) 0/20 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 228 697 --- --- 562 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.062N P=0.305 P=0.163N P=0.118N P=0.327N |
|INCIDENTAL TUMOR | P=0.068N P=0.336 P=0.216N P=0.166N P=0.470N |
|LOGISTIC REGRESSION | P=0.060N P=0.347 P=0.130N P=0.109N P=0.466N |
|COCHRAN-ARMITAGE | P=0.056N |
|FISHER EXACT | P=0.357 P=0.121N P=0.121N P=0.309N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 25/50 (50%) 19/50 (38%) 9/50 (18%) 13/50 (26%) 23/50 (46%) |
|ADJUSTED (b) | 67.0% 52.8% 33.2% 35.1% 66.7% |
|TERMINAL (d) | 20/32 (63%) 10/26 (38%) 4/20 (20%) 8/31 (26%) 14/25 (56%) |
|FIRST INCIDENCE (DAYS) | 529 612 589 550 562 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.375 P=0.363N P=0.039N* P=0.017N* P=0.394 |
|INCIDENTAL TUMOR | P=0.524 P=0.143N P=0.003N** P=0.010N** P=0.455N |
|LOGISTIC REGRESSION | P=0.489 P=0.152N P=0.003N** P=0.007N** P=0.428N |
|COCHRAN-ARMITAGE | P=0.439 |
|FISHER EXACT | P=0.157N P<0.001N** P=0.011N* P=0.421N |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 36
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 26/50 (52%) 20/50 (40%) 9/50 (18%) 13/50 (26%) 23/50 (46%) |
|ADJUSTED (b) | 67.8% 55.7% 33.2% 35.1% 66.7% |
|TERMINAL (d) | 20/32 (63%) 11/26 (42%) 4/20 (20%) 8/31 (26%) 14/25 (56%) |
|FIRST INCIDENCE (DAYS) | 529 612 589 550 562 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.461 P=0.372N P=0.028N* P=0.011N* P=0.468 |
|INCIDENTAL TUMOR | P=0.452N P=0.151N P=0.001N** P=0.006N** P=0.364N |
|LOGISTIC REGRESSION | P=0.486N P=0.153N P=0.001N** P=0.004N** P=0.340N |
|COCHRAN-ARMITAGE | P=0.534 |
|FISHER EXACT | P=0.158N P<0.001N** P=0.007N** P=0.345N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 27/50 (54%) 23/50 (46%) 9/50 (18%) 13/50 (26%) 23/50 (46%) |
|ADJUSTED (b) | 68.4% 62.7% 33.2% 35.1% 66.7% |
|TERMINAL (d) | 20/32 (63%) 13/26 (50%) 4/20 (20%) 8/31 (26%) 14/25 (56%) |
|FIRST INCIDENCE (DAYS) | 228 612 589 550 562 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.440N P=0.531N P=0.019N* P=0.007N** P=0.542 |
|INCIDENTAL TUMOR | P=0.305N P=0.287N P=0.001N** P=0.005N** P=0.364N |
|LOGISTIC REGRESSION | P=0.310N P=0.268N P<0.001N** P=0.003N** P=0.346N |
|COCHRAN-ARMITAGE | P=0.360N |
|FISHER EXACT | P=0.274N P<0.001N** P=0.004N** P=0.274N |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 37
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Pancreas |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/49 (2%) 0/0 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 3.2% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/26 (0%) 0/20 (0%) 1/31 (3%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- --- 729 (T) --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.410 (e) (e) P=0.494 (e) |
|INCIDENTAL TUMOR | P=0.410 (e) (e) P=0.494 (e) |
|LOGISTIC REGRESSION | P=0.410 (e) (e) P=0.494 (e) |
|COCHRAN-ARMITAGE | P=0.401 |
|FISHER EXACT | (e) (e) P=0.495 (e) |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 31/50 (62%) 28/50 (56%) 21/50 (42%) 12/50 (24%) 23/35 (66%) |
|ADJUSTED (b) | 73.6% 79.6% 62.0% 31.8% 67.3% |
|TERMINAL (d) | 21/32 (66%) 19/26 (73%) 9/20 (45%) 6/31 (19%) 8/16 (50%) |
|FIRST INCIDENCE (DAYS) | 529 475 506 646 562 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.268N P=0.479 P=0.504N P<0.001N** P=0.438 |
|INCIDENTAL TUMOR | P=0.218N P=0.320N P=0.040N* P<0.001N** P=0.486N |
|LOGISTIC REGRESSION | P=0.302N P=0.338N P=0.058N P<0.001N** P=0.507 |
|COCHRAN-ARMITAGE | P=0.384N |
|FISHER EXACT | P=0.342N P=0.036N* P<0.001N** P=0.453 |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 38
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 31/50 (62%) 28/50 (56%) 22/50 (44%) 12/50 (24%) 23/35 (66%) |
|ADJUSTED (b) | 73.6% 79.6% 65.4% 31.8% 67.3% |
|TERMINAL (d) | 21/32 (66%) 19/26 (73%) 10/20 (50%) 6/31 (19%) 8/16 (50%) |
|FIRST INCIDENCE (DAYS) | 529 475 506 646 562 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.263N P=0.479 P=0.548 P<0.001N** P=0.438 |
|INCIDENTAL TUMOR | P=0.211N P=0.320N P=0.067N P<0.001N** P=0.486N |
|LOGISTIC REGRESSION | P=0.290N P=0.338N P=0.089N P<0.001N** P=0.507 |
|COCHRAN-ARMITAGE | P=0.374N |
|FISHER EXACT | P=0.342N P=0.054N P<0.001N** P=0.453 |
|=================================================================================================================================|
| |
|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) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 3.8% 5.0% 2.9% 2.1% |
|TERMINAL (d) | 0/32 (0%) 1/26 (4%) 1/20 (5%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) 729 (T) 715 562 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.435 P=0.459 P=0.406 P=0.512 P=0.513 |
|INCIDENTAL TUMOR | P=0.460 P=0.459 P=0.406 P=0.571 P=0.550 |
|LOGISTIC REGRESSION | P=0.441 P=0.459 P=0.406 P=0.508 P=0.424 |
|COCHRAN-ARMITAGE | P=0.438 |
|FISHER EXACT | P=0.500 P=0.500 P=0.500 P=0.500 |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 39
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 3.2% 6.1% |
|TERMINAL (d) | 0/32 (0%) 0/26 (0%) 0/20 (0%) 1/31 (3%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 729 (T) 703 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.035 * (e) (e) P=0.494 P=0.240 |
|INCIDENTAL TUMOR | P=0.047 * (e) (e) P=0.494 P=0.399 |
|LOGISTIC REGRESSION | P=0.034 * (e) (e) P=0.494 P=0.235 |
|COCHRAN-ARMITAGE | P=0.031 * |
|FISHER EXACT | (e) (e) P=0.500 P=0.247 |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 6.9% 0.0% 3.2% 6.1% |
|TERMINAL (d) | 0/32 (0%) 1/26 (4%) 0/20 (0%) 1/31 (3%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- 717 --- 729 (T) 703 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.242 P=0.217 (e) P=0.494 P=0.240 |
|INCIDENTAL TUMOR | P=0.296 P=0.280 (e) P=0.494 P=0.399 |
|LOGISTIC REGRESSION | P=0.249 P=0.228 (e) P=0.494 P=0.235 |
|COCHRAN-ARMITAGE | P=0.242 |
|FISHER EXACT | P=0.247 (e) P=0.500 P=0.247 |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 40
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 6.9% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 1/26 (4%) 0/20 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- 717 --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.258N P=0.217 (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.231N P=0.280 (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.247N P=0.228 (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.247N |
|FISHER EXACT | P=0.247 (e) (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 6.9% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 1/26 (4%) 0/20 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- 717 --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.258N P=0.217 (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.231N P=0.280 (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.247N P=0.228 (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.247N |
|FISHER EXACT | P=0.247 (e) (e) (e) |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 41
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 2.9% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/26 (0%) 0/20 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 715 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.623 (e) (e) P=0.512 (e) |
|INCIDENTAL TUMOR | P=0.663 (e) (e) P=0.571 (e) |
|LOGISTIC REGRESSION | P=0.624 (e) (e) P=0.508 (e) |
|COCHRAN-ARMITAGE | P=0.622 |
|FISHER EXACT | (e) (e) P=0.500 (e) |
|=================================================================================================================================|
| |
|Skin |
| Schwannoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/26 (0%) 0/20 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | (e) |
|FISHER EXACT | (e) (e) (e) (e) |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 42
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/26 (0%) 0/20 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | (e) |
|FISHER EXACT | (e) (e) (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 2.9% 2.1% |
|TERMINAL (d) | 0/32 (0%) 0/26 (0%) 0/20 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 715 562 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.164 (e) (e) P=0.512 P=0.513 |
|INCIDENTAL TUMOR | P=0.188 (e) (e) P=0.571 P=0.550 |
|LOGISTIC REGRESSION | P=0.142 (e) (e) P=0.508 P=0.424 |
|COCHRAN-ARMITAGE | P=0.152 |
|FISHER EXACT | (e) (e) P=0.500 P=0.500 |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 43
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 2.9% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/26 (0%) 0/20 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 715 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.623 (e) (e) P=0.512 (e) |
|INCIDENTAL TUMOR | P=0.663 (e) (e) P=0.571 (e) |
|LOGISTIC REGRESSION | P=0.624 (e) (e) P=0.508 (e) |
|COCHRAN-ARMITAGE | P=0.622 |
|FISHER EXACT | (e) (e) P=0.500 (e) |
|=================================================================================================================================|
| |
|Skin: Sebaceous Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 2.7% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/26 (0%) 0/20 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- 666 --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.440N P=0.495 (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.399N P=0.623 (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.447N P=0.499 (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.445N |
|FISHER EXACT | P=0.500 (e) (e) (e) |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 44
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | |
|ADJUSTED (b) | |
|TERMINAL (d) | |
|FIRST INCIDENCE (DAYS) | |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | |
|INCIDENTAL TUMOR | |
|LOGISTIC REGRESSION | |
|COCHRAN-ARMITAGE | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 6/50 (12%) 3/50 (6%) 6/48 (13%) 2/49 (4%) 4/50 (8%) |
|ADJUSTED (b) | 16.5% 11.5% 23.4% 5.8% 13.8% |
|TERMINAL (d) | 3/32 (9%) 3/26 (12%) 3/20 (15%) 1/31 (3%) 3/25 (12%) |
|FIRST INCIDENCE (DAYS) | 647 729 (T) 578 679 562 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.363N P=0.324N P=0.364 P=0.147N P=0.472N |
|INCIDENTAL TUMOR | P=0.295N P=0.208N P=0.601 P=0.084N P=0.320N |
|LOGISTIC REGRESSION | P=0.317N P=0.247N P=0.519 P=0.126N P=0.365N |
|COCHRAN-ARMITAGE | P=0.335N |
|FISHER EXACT | P=0.243N P=0.591 P=0.141N P=0.370N |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 45
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 7/50 (14%) 3/50 (6%) 7/48 (15%) 3/49 (6%) 4/50 (8%) |
|ADJUSTED (b) | 19.4% 11.5% 27.9% 8.5% 13.8% |
|TERMINAL (d) | 4/32 (13%) 3/26 (12%) 4/20 (20%) 1/31 (3%) 3/25 (12%) |
|FIRST INCIDENCE (DAYS) | 647 729 (T) 578 679 562 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.304N P=0.232N P=0.324 P=0.171N P=0.366N |
|INCIDENTAL TUMOR | P=0.235N P=0.140N P=0.540 P=0.094N P=0.232N |
|LOGISTIC REGRESSION | P=0.256N P=0.162N P=0.480 P=0.096N P=0.258N |
|COCHRAN-ARMITAGE | P=0.274N |
|FISHER EXACT | P=0.159N P=0.581 P=0.167N P=0.262N |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/48 (0%) 2/49 (4%) 0/50 (0%) |
|ADJUSTED (b) | 3.1% 0.0% 0.0% 6.5% 0.0% |
|TERMINAL (d) | 1/32 (3%) 0/26 (0%) 0/20 (0%) 2/31 (6%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- --- 729 (T) --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.623N P=0.541N P=0.594N P=0.489 P=0.549N |
|INCIDENTAL TUMOR | P=0.623N P=0.541N P=0.594N P=0.489 P=0.549N |
|LOGISTIC REGRESSION | P=0.623N P=0.541N P=0.594N P=0.489 P=0.549N |
|COCHRAN-ARMITAGE | P=0.601N |
|FISHER EXACT | P=0.500N P=0.510N P=0.492 P=0.500N |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 46
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 3/48 (6%) 1/49 (2%) 0/50 (0%) |
|ADJUSTED (b) | 2.5% 0.0% 12.4% 3.2% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/26 (0%) 2/20 (10%) 1/31 (3%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 641 --- 589 729 (T) --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.360N P=0.505N P=0.201 P=0.758N P=0.505N |
|INCIDENTAL TUMOR | P=0.350N P=0.500N P=0.324 P=0.757 P=0.450N |
|LOGISTIC REGRESSION | P=0.346N P=0.504N P=0.285 P=0.759 P=0.517N |
|COCHRAN-ARMITAGE | P=0.349N |
|FISHER EXACT | P=0.500N P=0.293 P=0.747 P=0.500N |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 3/48 (6%) 3/49 (6%) 0/50 (0%) |
|ADJUSTED (b) | 5.5% 0.0% 12.4% 9.7% 0.0% |
|TERMINAL (d) | 1/32 (3%) 0/26 (0%) 2/20 (10%) 3/31 (10%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 641 --- 589 729 (T) --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.367N P=0.265N P=0.344 P=0.493 P=0.270N |
|INCIDENTAL TUMOR | P=0.359N P=0.262N P=0.483 P=0.488 P=0.238N |
|LOGISTIC REGRESSION | P=0.335N P=0.237N P=0.461 P=0.517 P=0.237N |
|COCHRAN-ARMITAGE | P=0.346N |
|FISHER EXACT | P=0.247N P=0.480 P=0.490 P=0.247N |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 47
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 3/50 (6%) 4/50 (8%) 0/50 (0%) |
|ADJUSTED (b) | 6.3% 13.6% 13.9% 10.9% 0.0% |
|TERMINAL (d) | 2/32 (6%) 2/26 (8%) 2/20 (10%) 2/31 (6%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 718 703 631 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.142N P=0.273 P=0.302 P=0.340 P=0.294N |
|INCIDENTAL TUMOR | P=0.110N P=0.364 P=0.371 P=0.356 P=0.294N |
|LOGISTIC REGRESSION | P=0.120N P=0.311 P=0.349 P=0.349 P=0.294N |
|COCHRAN-ARMITAGE | P=0.126N |
|FISHER EXACT | P=0.339 P=0.500 P=0.339 P=0.247N |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 3/50 (6%) 5/50 (10%) 1/50 (2%) |
|ADJUSTED (b) | 9.4% 13.6% 13.9% 12.9% 4.0% |
|TERMINAL (d) | 3/32 (9%) 2/26 (8%) 2/20 (10%) 2/31 (6%) 1/25 (4%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 718 703 631 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.252N P=0.415 P=0.443 P=0.364 P=0.396N |
|INCIDENTAL TUMOR | P=0.207N P=0.513 P=0.512 P=0.371 P=0.396N |
|LOGISTIC REGRESSION | P=0.216N P=0.469 P=0.497 P=0.366 P=0.396N |
|COCHRAN-ARMITAGE | P=0.227N |
|FISHER EXACT | P=0.500 P=0.661N P=0.357 P=0.309N |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 48
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 6.1% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/26 (0%) 0/20 (0%) 1/31 (3%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 715 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.475 (e) (e) P=0.243 (e) |
|INCIDENTAL TUMOR | P=0.509 (e) (e) P=0.275 (e) |
|LOGISTIC REGRESSION | P=0.484 (e) (e) P=0.244 (e) |
|COCHRAN-ARMITAGE | P=0.481 |
|FISHER EXACT | (e) (e) P=0.247 (e) |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 14/50 (28%) 19/50 (38%) 29/50 (58%) 18/50 (36%) 15/50 (30%) |
|ADJUSTED (b) | 37.7% 46.9% 67.4% 43.8% 40.5% |
|TERMINAL (d) | 10/32 (31%) 7/26 (27%) 7/20 (35%) 9/31 (29%) 6/25 (24%) |
|FIRST INCIDENCE (DAYS) | 522 400 414 613 506 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.325N P=0.136 P<0.001 ** P=0.277 P=0.336 |
|INCIDENTAL TUMOR | P=0.197N P=0.255 P=0.017 * P=0.317 P=0.576 |
|LOGISTIC REGRESSION | P=0.221N P=0.198 P=0.003 ** P=0.279 P=0.507 |
|COCHRAN-ARMITAGE | P=0.265N |
|FISHER EXACT | P=0.198 P=0.002 ** P=0.260 P=0.500 |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 49
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/26 (0%) 0/20 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | (e) |
|FISHER EXACT | (e) (e) (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 43/50 (86%) 39/50 (78%) 30/50 (60%) 26/50 (52%) 38/50 (76%) |
|ADJUSTED (b) | 95.5% 95.0% 81.9% 66.1% 84.3% |
|TERMINAL (d) | 30/32 (94%) 24/26 (92%) 14/20 (70%) 18/31 (58%) 18/25 (72%) |
|FIRST INCIDENCE (DAYS) | 529 475 506 550 562 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.312N P=0.446 P=0.563 P=0.003N** P=0.482 |
|INCIDENTAL TUMOR | P=0.063N P=0.162N P=0.006N** P<0.001N** P=0.039N* |
|LOGISTIC REGRESSION | P=0.090N P=0.174N P=0.007N** P<0.001N** P=0.092N |
|COCHRAN-ARMITAGE | P=0.159N |
|FISHER EXACT | P=0.218N P=0.003N** P<0.001N** P=0.154N |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 50
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|DOSE | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 |
| | PPM STOP |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 21/50 (42%) 26/50 (52%) 34/50 (68%) 22/50 (44%) 17/50 (34%) |
|ADJUSTED (b) | 51.1% 60.1% 76.4% 51.6% 43.0% |
|TERMINAL (d) | 13/32 (41%) 10/26 (38%) 10/20 (50%) 11/31 (35%) 6/25 (24%) |
|FIRST INCIDENCE (DAYS) | 223 288 414 613 506 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.095N P=0.146 P=0.001 ** P=0.498 P=0.460N |
|INCIDENTAL TUMOR | P=0.030N* P=0.238 P=0.016 * P=0.531 P=0.322N |
|LOGISTIC REGRESSION | P=0.045N* P=0.205 P=0.013 * P=0.496 P=0.293N |
|COCHRAN-ARMITAGE | P=0.037N* |
|FISHER EXACT | P=0.212 P=0.008 ** P=0.500 P=0.268N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 49/50 (98%) 49/50 (98%) 45/50 (90%) 38/50 (76%) 43/50 (86%) |
|ADJUSTED (b) | 100.0% 98.0% 90.0% 82.5% 89.5% |
|TERMINAL (d) | 32/32 (100%) 25/26 (96%) 15/20 (75%) 23/31 (74%) 20/25 (80%) |
|FIRST INCIDENCE (DAYS) | 223 288 414 550 506 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.178N P=0.220 P=0.085 P=0.058N P=0.515 |
|INCIDENTAL TUMOR | P=0.001N** P=0.738N P=0.047N* P<0.001N** P=0.024N* |
|LOGISTIC REGRESSION | P=0.004N** P=0.761N P=0.063N P=0.001N** P=0.030N* |
|COCHRAN-ARMITAGE | P=0.004N** |
|FISHER EXACT | P=0.753N P=0.102N P<0.001N** P=0.030N* |
|=================================================================================================================================|
DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 PAGE 51
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for
intercurrent mortality.
(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).