TDMS Study 05212-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus OXAZEPAM DATE: 10/24/96
EXPERIMENT: 05212 TEST: 05 TIME: 12:01:17
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
------------------------------------------------------------------------------------------------------------------------------------
CONTROL VS 10,000 PPM STOP
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 0 PPM
INCLUDE 002 0 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: 10/24/96
EXPERIMENT: 05212 TEST: 05 TIME: 12:01:17
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: 10/24/96
EXPERIMENT: 05212 TEST: 05 TIME: 12:01:17
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
Clitoral/Preputial Gland Adenoma
Carcinoma or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Testes Adenoma
Thyroid Gland: C-Cell Adenoma
Carcinoma or Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Clitoral/Preputial Gland Adenoma
Carcinoma or Adenoma
All Organs Benign Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 10/24/96 EXPERIMENT: 05212 TEST: 05 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 10,000 | 0 PPM 10,000 |
| | PPM STOP | PPM STOP |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 0/1 (0%) | 1/50 (2%) 0/0 (0%) |
|ADJUSTED (b) | 44.1% 0.0% | 3.1% 0.0% |
|TERMINAL (d) | 3/17 (18%) 0/0 | 1/32 (3%) 0/0 |
|FIRST INCIDENCE (DAYS) | 571 --- | 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.045N* | (e) (e) |
|INCIDENTAL TUMOR | P=0.521N | (e) (e) |
|LOGISTIC REGRESSION | P=0.675N | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.725N | P=1.000N |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 1/1 (100%) | 3/50 (6%) 0/0 (0%) |
|ADJUSTED (b) | 44.1% 10.0% | 8.9% 0.0% |
|TERMINAL (d) | 3/17 (18%) 0/0 | 2/32 (6%) 0/0 |
|FIRST INCIDENCE (DAYS) | 571 690 | 700 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.132N | P=0.512N |
|INCIDENTAL TUMOR | P=0.521 | (e) (e) |
|LOGISTIC REGRESSION | P=0.345 | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.294 | P=1.000N |
|=================================================================================================================================|
DATE: 10/24/96 EXPERIMENT: 05212 TEST: 05 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 10,000 | 0 PPM 10,000 |
| | PPM STOP | PPM STOP |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/48 (15%) 10/14 (71%) | 7/49 (14%) 7/11 (64%) |
|ADJUSTED (b) | 29.8% 73.6% | 19.4% 65.1% |
|TERMINAL (d) | 3/17 (18%) 0/0 | 4/31 (13%) 5/8 (63%) |
|FIRST INCIDENCE (DAYS) | 601 584 | 550 718 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.001 ** | P=0.077 |
|INCIDENTAL TUMOR | P<0.001 ** | P=0.004 ** |
|LOGISTIC REGRESSION | P<0.001 ** | P=0.002 ** |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P<0.001 ** | P=0.002 ** |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/48 (17%) 10/14 (71%) | 8/49 (16%) 7/11 (64%) |
|ADJUSTED (b) | 31.5% 73.6% | 22.4% 65.1% |
|TERMINAL (d) | 3/17 (18%) 0/0 | 5/31 (16%) 5/8 (63%) |
|FIRST INCIDENCE (DAYS) | 541 584 | 550 718 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.004 ** | P=0.101 |
|INCIDENTAL TUMOR | P<0.001 ** | P=0.008 ** |
|LOGISTIC REGRESSION | P<0.001 ** | P=0.004 ** |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P<0.001 ** | P=0.003 ** |
|=================================================================================================================================|
DATE: 10/24/96 EXPERIMENT: 05212 TEST: 05 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 10,000 | 0 PPM 10,000 |
| | PPM STOP | PPM STOP |
|=================================================================================================================================|
| |
|Intestine Small: Jejunum |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 9.1% 0.0% | 0.0% 0.0% |
|TERMINAL (d) | 1/17 (6%) 0/0 | 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 690 --- | --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.712N | (e) (e) |
|INCIDENTAL TUMOR | P=0.511N | (e) (e) |
|LOGISTIC REGRESSION | P=0.506N | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.247N | (e) |
|=================================================================================================================================|
| |
|Intestine Small: Site Unspecified |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 9.1% 0.0% | 0.0% 0.0% |
|TERMINAL (d) | 1/17 (6%) 0/0 | 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 690 --- | --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.712N | (e) (e) |
|INCIDENTAL TUMOR | P=0.511N | (e) (e) |
|LOGISTIC REGRESSION | P=0.506N | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.247N | (e) |
|=================================================================================================================================|
DATE: 10/24/96 EXPERIMENT: 05212 TEST: 05 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 10,000 | 0 PPM 10,000 |
| | PPM STOP | PPM STOP |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/0 (0%) | 0/50 (0%) 0/0 (0%) |
|ADJUSTED (b) | 6.7% 0.0% | 0.0% 0.0% |
|TERMINAL (d) | 0/17 (0%) 0/0 | 0/32 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 682 --- | --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.547N | (e) (e) |
|INCIDENTAL TUMOR | (e) (e) | (e) (e) |
|LOGISTIC REGRESSION | (e) (e) | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=1.000N | (e) |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/0 (0%) | 1/50 (2%) 0/0 (0%) |
|ADJUSTED (b) | 9.9% 0.0% | 3.1% 0.0% |
|TERMINAL (d) | 0/17 (0%) 0/0 | 1/32 (3%) 0/0 |
|FIRST INCIDENCE (DAYS) | 682 --- | 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.407N | (e) (e) |
|INCIDENTAL TUMOR | (e) (e) | (e) (e) |
|LOGISTIC REGRESSION | (e) (e) | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=1.000N | P=1.000N |
|=================================================================================================================================|
DATE: 10/24/96 EXPERIMENT: 05212 TEST: 05 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 10,000 | 0 PPM 10,000 |
| | PPM STOP | PPM STOP |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/49 (0%) |
|ADJUSTED (b) | 8.4% 2.6% | 0.0% 0.0% |
|TERMINAL (d) | 1/17 (6%) 0/0 | 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 608 585 | --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.741 | (e) (e) |
|INCIDENTAL TUMOR | P=0.438N | (e) (e) |
|LOGISTIC REGRESSION | P=0.504N | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500N | (e) |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/49 (0%) |
|ADJUSTED (b) | 8.4% 2.6% | 0.0% 0.0% |
|TERMINAL (d) | 1/17 (6%) 0/0 | 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 608 585 | --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.741 | (e) (e) |
|INCIDENTAL TUMOR | P=0.438N | (e) (e) |
|LOGISTIC REGRESSION | P=0.504N | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500N | (e) |
|=================================================================================================================================|
DATE: 10/24/96 EXPERIMENT: 05212 TEST: 05 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 10,000 | 0 PPM 10,000 |
| | PPM STOP | PPM STOP |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) | 2/50 (4%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 3.4% | 5.1% 2.1% |
|TERMINAL (d) | 0/17 (0%) 0/0 | 1/32 (3%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- 614 | 228 562 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.457 | P=0.519N |
|INCIDENTAL TUMOR | P=0.767 | P=0.761N |
|LOGISTIC REGRESSION | P=0.530 | P=0.713N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500 | P=0.500N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) | 3/50 (6%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 13.1% | 7.4% 2.1% |
|TERMINAL (d) | 0/17 (0%) 0/0 | 1/32 (3%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- 614 | 228 562 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.114 | P=0.327N |
|INCIDENTAL TUMOR | P=0.366 | P=0.470N |
|LOGISTIC REGRESSION | P=0.204 | P=0.466N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.247 | P=0.309N |
|=================================================================================================================================|
DATE: 10/24/96 EXPERIMENT: 05212 TEST: 05 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 10,000 | 0 PPM 10,000 |
| | PPM STOP | PPM STOP |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) | 25/50 (50%) 23/50 (46%) |
|ADJUSTED (b) | 18.2% 0.0% | 67.0% 66.7% |
|TERMINAL (d) | 1/17 (6%) 0/0 | 20/32 (63%) 14/25 (56%) |
|FIRST INCIDENCE (DAYS) | 698 --- | 529 562 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.537N | P=0.394 |
|INCIDENTAL TUMOR | P=0.127N | P=0.455N |
|LOGISTIC REGRESSION | P=0.214N | P=0.428N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.059N | P=0.421N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) | 26/50 (52%) 23/50 (46%) |
|ADJUSTED (b) | 18.2% 10.0% | 67.8% 66.7% |
|TERMINAL (d) | 1/17 (6%) 0/0 | 20/32 (63%) 14/25 (56%) |
|FIRST INCIDENCE (DAYS) | 698 690 | 529 562 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.608 | P=0.468 |
|INCIDENTAL TUMOR | P=0.321N | P=0.364N |
|LOGISTIC REGRESSION | P=0.515N | P=0.340N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.181N | P=0.345N |
|=================================================================================================================================|
DATE: 10/24/96 EXPERIMENT: 05212 TEST: 05 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 10,000 | 0 PPM 10,000 |
| | PPM STOP | PPM STOP |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) | 27/50 (54%) 23/50 (46%) |
|ADJUSTED (b) | 18.2% 13.1% | 68.4% 66.7% |
|TERMINAL (d) | 1/17 (6%) 0/0 | 20/32 (63%) 14/25 (56%) |
|FIRST INCIDENCE (DAYS) | 698 614 | 228 562 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.345 | P=0.542 |
|INCIDENTAL TUMOR | P=0.410N | P=0.364N |
|LOGISTIC REGRESSION | P=0.614N | P=0.346N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.339N | P=0.274N |
|=================================================================================================================================|
| |
|Pancreas |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/0 (0%) | 0/50 (0%) 0/0 (0%) |
|ADJUSTED (b) | 11.8% 0.0% | 0.0% 0.0% |
|TERMINAL (d) | 2/17 (12%) 0/0 | 0/32 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 730 (T) --- | --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) | (e) (e) |
|INCIDENTAL TUMOR | (e) (e) | (e) (e) |
|LOGISTIC REGRESSION | (e) (e) | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=1.000N | (e) |
|=================================================================================================================================|
DATE: 10/24/96 EXPERIMENT: 05212 TEST: 05 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 10,000 | 0 PPM 10,000 |
| | PPM STOP | PPM STOP |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 17/49 (35%) 5/5 (100%) | 31/50 (62%) 23/35 (66%) |
|ADJUSTED (b) | 61.7% 49.7% | 73.6% 67.3% |
|TERMINAL (d) | 8/17 (47%) 0/0 | 21/32 (66%) 8/16 (50%) |
|FIRST INCIDENCE (DAYS) | 471 627 | 529 562 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.310 | P=0.438 |
|INCIDENTAL TUMOR | P=0.009 ** | P=0.486N |
|LOGISTIC REGRESSION | P=0.010 ** | P=0.507 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.008 ** | 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) | 5/50 (10%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 14.6% 4.8% | 0.0% 2.1% |
|TERMINAL (d) | 0/17 (0%) 0/0 | 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 517 542 | --- 562 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.458N | P=0.513 |
|INCIDENTAL TUMOR | P=0.138N | P=0.550 |
|LOGISTIC REGRESSION | P=0.157N | P=0.424 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.218N | P=0.500 |
|=================================================================================================================================|
DATE: 10/24/96 EXPERIMENT: 05212 TEST: 05 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 10,000 | 0 PPM 10,000 |
| | PPM STOP | PPM STOP |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) | 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 16.2% 34.8% | 0.0% 6.1% |
|TERMINAL (d) | 2/17 (12%) 0/0 | 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 711 558 | --- 703 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.154 | P=0.240 |
|INCIDENTAL TUMOR | P=0.629 | P=0.399 |
|LOGISTIC REGRESSION | P=0.629 | P=0.235 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500N | P=0.247 |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 3/50 (6%) | 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 21.5% 47.9% | 0.0% 6.1% |
|TERMINAL (d) | 2/17 (12%) 0/0 | 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 491 558 | --- 703 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.187 | P=0.240 |
|INCIDENTAL TUMOR | P=0.629N | P=0.399 |
|LOGISTIC REGRESSION | P=0.492N | P=0.235 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.357N | P=0.247 |
|=================================================================================================================================|
DATE: 10/24/96 EXPERIMENT: 05212 TEST: 05 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 10,000 | 0 PPM 10,000 |
| | PPM STOP | PPM STOP |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 6.3% 20.0% | 0.0% 0.0% |
|TERMINAL (d) | 0/17 (0%) 0/0 | 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 491 697 | --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.669 | (e) (e) |
|INCIDENTAL TUMOR | P=0.567N | (e) (e) |
|LOGISTIC REGRESSION | P=0.476N | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500N | (e) |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 11.0% 20.0% | 0.0% 0.0% |
|TERMINAL (d) | 0/17 (0%) 0/0 | 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 491 697 | --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.712 | (e) (e) |
|INCIDENTAL TUMOR | P=0.362N | (e) (e) |
|LOGISTIC REGRESSION | P=0.323N | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.309N | (e) |
|=================================================================================================================================|
DATE: 10/24/96 EXPERIMENT: 05212 TEST: 05 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 10,000 | 0 PPM 10,000 |
| | PPM STOP | PPM STOP |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 10.1% 4.8% | 0.0% 0.0% |
|TERMINAL (d) | 0/17 (0%) 0/0 | 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 585 542 | --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.645 | (e) (e) |
|INCIDENTAL TUMOR | P=0.331N | (e) (e) |
|LOGISTIC REGRESSION | P=0.449N | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500N | (e) |
|=================================================================================================================================|
| |
|Skin |
| Schwannoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 11.6% 0.0% | 0.0% 0.0% |
|TERMINAL (d) | 1/17 (6%) 0/0 | 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 480 --- | --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.377N | (e) (e) |
|INCIDENTAL TUMOR | P=0.298N | (e) (e) |
|LOGISTIC REGRESSION | P=0.107N | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.121N | (e) |
|=================================================================================================================================|
DATE: 10/24/96 EXPERIMENT: 05212 TEST: 05 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 10,000 | 0 PPM 10,000 |
| | PPM STOP | PPM STOP |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 5.0% 0.0% | 0.0% 0.0% |
|TERMINAL (d) | 0/17 (0%) 0/0 | 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 517 --- | --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.353N | (e) (e) |
|INCIDENTAL TUMOR | P=0.298N | (e) (e) |
|LOGISTIC REGRESSION | P=0.186N | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.247N | (e) |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 14.6% 4.8% | 0.0% 2.1% |
|TERMINAL (d) | 0/17 (0%) 0/0 | 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 517 542 | --- 562 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.458N | P=0.513 |
|INCIDENTAL TUMOR | P=0.138N | P=0.550 |
|LOGISTIC REGRESSION | P=0.157N | P=0.424 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.218N | P=0.500 |
|=================================================================================================================================|
DATE: 10/24/96 EXPERIMENT: 05212 TEST: 05 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 10,000 | 0 PPM 10,000 |
| | PPM STOP | PPM STOP |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 14.6% 4.8% | 0.0% 0.0% |
|TERMINAL (d) | 0/17 (0%) 0/0 | 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 517 542 | --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.458N | (e) (e) |
|INCIDENTAL TUMOR | P=0.138N | (e) (e) |
|LOGISTIC REGRESSION | P=0.157N | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.218N | (e) |
|=================================================================================================================================|
| |
|Skin: Sebaceous Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 2.9% 19.5% | 0.0% 0.0% |
|TERMINAL (d) | 0/17 (0%) 0/0 | 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 682 614 | --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.214 | (e) (e) |
|INCIDENTAL TUMOR | P=0.629 | (e) (e) |
|LOGISTIC REGRESSION | P=0.421 | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500 | (e) |
|=================================================================================================================================|
DATE: 10/24/96 EXPERIMENT: 05212 TEST: 05 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 10,000 | 0 PPM 10,000 |
| | PPM STOP | PPM STOP |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 45/50 (90%) 48/48 (100%) | |
|ADJUSTED (b) | 100.0% 100.0% | |
|TERMINAL (d) | 17/17 (100%) 0/0 | |
|FIRST INCIDENCE (DAYS) | 517 480 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** | |
|INCIDENTAL TUMOR | P=0.055 | |
|LOGISTIC REGRESSION | P=0.014 * | |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.031 * | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 1/50 (2%) | 6/50 (12%) 4/50 (8%) |
|ADJUSTED (b) | 35.5% 9.1% | 16.5% 13.8% |
|TERMINAL (d) | 3/17 (18%) 0/0 | 3/32 (9%) 3/25 (12%) |
|FIRST INCIDENCE (DAYS) | 571 687 | 647 562 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.320N | P=0.472N |
|INCIDENTAL TUMOR | P=0.017N* | P=0.320N |
|LOGISTIC REGRESSION | P=0.030N* | P=0.365N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.004N** | P=0.370N |
|=================================================================================================================================|
DATE: 10/24/96 EXPERIMENT: 05212 TEST: 05 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 10,000 | 0 PPM 10,000 |
| | PPM STOP | PPM STOP |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 2/50 (4%) | 7/50 (14%) 4/50 (8%) |
|ADJUSTED (b) | 35.5% 13.2% | 19.4% 13.8% |
|TERMINAL (d) | 3/17 (18%) 0/0 | 4/32 (13%) 3/25 (12%) |
|FIRST INCIDENCE (DAYS) | 571 634 | 647 562 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.516N | P=0.366N |
|INCIDENTAL TUMOR | P=0.030N* | P=0.232N |
|LOGISTIC REGRESSION | P=0.068N | P=0.258N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.014N* | P=0.262N |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) | 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 2.4% 9.5% | 3.1% 0.0% |
|TERMINAL (d) | 0/17 (0%) 0/0 | 1/32 (3%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 554 638 | 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.384 | P=0.549N |
|INCIDENTAL TUMOR | P=0.569N | P=0.549N |
|LOGISTIC REGRESSION | P=0.557 | P=0.549N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500 | P=0.500N |
|=================================================================================================================================|
DATE: 10/24/96 EXPERIMENT: 05212 TEST: 05 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 10,000 | 0 PPM 10,000 |
| | PPM STOP | PPM STOP |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) | 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 12.5% 4.8% | 2.5% 0.0% |
|TERMINAL (d) | 1/17 (6%) 0/0 | 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 688 638 | 641 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.660 | P=0.505N |
|INCIDENTAL TUMOR | P=0.371N | P=0.450N |
|LOGISTIC REGRESSION | P=0.513N | P=0.517N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.309N | P=0.500N |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) | 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 14.6% 9.5% | 5.5% 0.0% |
|TERMINAL (d) | 1/17 (6%) 0/0 | 1/32 (3%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 554 638 | 641 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.573 | P=0.270N |
|INCIDENTAL TUMOR | P=0.190N | P=0.238N |
|LOGISTIC REGRESSION | P=0.400N | P=0.237N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.339N | P=0.247N |
|=================================================================================================================================|
DATE: 10/24/96 EXPERIMENT: 05212 TEST: 05 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 10,000 | 0 PPM 10,000 |
| | PPM STOP | PPM STOP |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # |
|----------- | | |
|OVERALL (a) | | 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | | 6.3% 0.0% |
|TERMINAL (d) | | 2/32 (6%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | | 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.294N |
|INCIDENTAL TUMOR | | P=0.294N |
|LOGISTIC REGRESSION | | P=0.294N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | | P=0.247N |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # |
|----------- | | |
|OVERALL (a) | | 3/50 (6%) 1/50 (2%) |
|ADJUSTED (b) | | 9.4% 4.0% |
|TERMINAL (d) | | 3/32 (9%) 1/25 (4%) |
|FIRST INCIDENCE (DAYS) | | 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.396N |
|INCIDENTAL TUMOR | | P=0.396N |
|LOGISTIC REGRESSION | | P=0.396N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | | P=0.309N |
|=================================================================================================================================|
DATE: 10/24/96 EXPERIMENT: 05212 TEST: 05 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 10,000 | 0 PPM 10,000 |
| | PPM STOP | PPM STOP |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 27/50 (54%) 34/50 (68%) | 14/50 (28%) 15/50 (30%) |
|ADJUSTED (b) | 72.4% 100.0% | 37.7% 40.5% |
|TERMINAL (d) | 8/17 (47%) 0/0 | 10/32 (31%) 6/25 (24%) |
|FIRST INCIDENCE (DAYS) | 498 480 | 522 506 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** | P=0.336 |
|INCIDENTAL TUMOR | P=0.161 | P=0.576 |
|LOGISTIC REGRESSION | P=0.075 | P=0.507 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.109 | P=0.500 |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 5.4% 3.1% | 0.0% 0.0% |
|TERMINAL (d) | 0/17 (0%) 0/0 | 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 592 613 | --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.647N | (e) (e) |
|INCIDENTAL TUMOR | P=0.223N | (e) (e) |
|LOGISTIC REGRESSION | P=0.476N | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500N | (e) |
|=================================================================================================================================|
DATE: 10/24/96 EXPERIMENT: 05212 TEST: 05 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 10,000 | 0 PPM 10,000 |
| | PPM STOP | PPM STOP |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 47/50 (94%) 48/50 (96%) | 43/50 (86%) 38/50 (76%) |
|ADJUSTED (b) | 100.0% 100.0% | 95.5% 84.3% |
|TERMINAL (d) | 17/17 (100%) 0/0 | 30/32 (94%) 18/25 (72%) |
|FIRST INCIDENCE (DAYS) | 471 480 | 529 562 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** | P=0.482 |
|INCIDENTAL TUMOR | P=0.303 | P=0.039N* |
|LOGISTIC REGRESSION | P=0.331 | P=0.092N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500 | P=0.154N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 38/50 (76%) 35/50 (70%) | 21/50 (42%) 17/50 (34%) |
|ADJUSTED (b) | 85.6% 100.0% | 51.1% 43.0% |
|TERMINAL (d) | 11/17 (65%) 0/0 | 13/32 (41%) 6/25 (24%) |
|FIRST INCIDENCE (DAYS) | 480 480 | 223 506 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** | P=0.460N |
|INCIDENTAL TUMOR | P=0.288N | P=0.322N |
|LOGISTIC REGRESSION | P=0.363N | P=0.293N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.326N | P=0.268N |
|=================================================================================================================================|
DATE: 10/24/96 EXPERIMENT: 05212 TEST: 05 PAGE 21
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OXAZEPAM
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 10,000 | 0 PPM 10,000 |
| | PPM STOP | PPM STOP |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 48/50 (96%) | 49/50 (98%) 43/50 (86%) |
|ADJUSTED (b) | 100.0% 100.0% | 100.0% 89.5% |
|TERMINAL (d) | 17/17 (100%) 0/0 | 32/32 (100%) 20/25 (80%) |
|FIRST INCIDENCE (DAYS) | 471 480 | 223 506 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** | P=0.515 |
|INCIDENTAL TUMOR | P=0.767N | P=0.024N* |
|LOGISTIC REGRESSION | P=0.423N | P=0.030N* |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.247N | P=0.030N* |
|=================================================================================================================================|
(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).