TR 380 Rat Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest EPINEPHRINE HCL DATE: 09/12/94
EXPERIMENT: 05095 TEST: 01 TIME: 23:40:57
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-38061 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 55663
PATHOLOGIST: R. RENNE CAS: 55-31-2
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest EPINEPHRINE HCL DATE: 09/12/94
EXPERIMENT: 05095 TEST: 01 TIME: 23:40:57
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-38061 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 55663
PATHOLOGIST: R. RENNE CAS: 55-31-2
RATS(FISCHER344)
----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
----------------
Adrenal Gland
Bone Marrow
Brain
Clitoral Gland
Epididymis
Heart
Islets, Pancreatic
Kidney
Larynx
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 Northwest EPINEPHRINE HCL DATE: 09/12/94
EXPERIMENT: 05095 TEST: 01 TIME: 23:40:57
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-38061 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 55663
PATHOLOGIST: R. RENNE CAS: 55-31-2
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF EPINEPHRINE HCL
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Skin Fibroma
Thyroid Gland: C-Cell Carcinoma
Carcinoma or Adenoma
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Clitoral/Preputial Gland Adenoma
Carcinoma or Adenoma
Islets, Pancreatic Adenoma
Carcinoma or Adenoma
All Organs Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 09/13/94 EXPERIMENT: 05095 TEST: 01 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- EPINEPHRINE HCL
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1.5MG/M3 5.0MG/M3 | CONTROL 1.5MG/M3 5.0MG/M3 |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 3/25 (12%) 16/48 (33%) | 1/50 (2%) 1/22 (5%) 4/47 (9%) |
|ADJUSTED (b) | 29.6% 37.9% 43.1% | 2.9% 2.7% 11.0% |
|TERMINAL (d) | 8/33 (24%) 1/3 (33%) 11/31 (35%) | 0/32 (0%) 0/2 (0%) 2/30 (7%) |
|FIRST INCIDENCE (DAYS) | 661 717 556 | 715 714 581 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.110 P=0.638 P=0.142 | P=0.125 P=0.754N P=0.180 |
|INCIDENTAL TUMOR | P=0.094 P=0.553N P=0.167 | P=0.136 P=0.700N P=0.198 |
|LOGISTIC REGRESSION | P=0.074 P=0.597 P=0.143 | P=0.126 P=0.472 P=0.143 |
|COCHRAN-ARMITAGE | P=0.081 | P=0.126 |
|FISHER EXACT | P=0.236N P=0.152 | P=0.521 P=0.162 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 4/25 (16%) 17/48 (35%) | 1/50 (2%) 1/22 (5%) 4/47 (9%) |
|ADJUSTED (b) | 29.6% 69.0% 44.6% | 2.9% 2.7% 11.0% |
|TERMINAL (d) | 8/33 (24%) 2/3 (67%) 11/31 (35%) | 0/32 (0%) 0/2 (0%) 2/30 (7%) |
|FIRST INCIDENCE (DAYS) | 661 717 556 | 715 714 581 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.086 P=0.369 P=0.102 | P=0.125 P=0.754N P=0.180 |
|INCIDENTAL TUMOR | P=0.066 P=0.473 P=0.106 | P=0.136 P=0.700N P=0.198 |
|LOGISTIC REGRESSION | P=0.055 P=0.307 P=0.100 | P=0.126 P=0.472 P=0.143 |
|COCHRAN-ARMITAGE | P=0.061 | P=0.126 |
|FISHER EXACT | P=0.388N P=0.106 | P=0.521 P=0.162 |
|=================================================================================================================================|
DATE: 09/13/94 EXPERIMENT: 05095 TEST: 01 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- EPINEPHRINE HCL
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1.5MG/M3 5.0MG/M3 | CONTROL 1.5MG/M3 5.0MG/M3 |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Brain |
| Oligodendroglioma, Glioma, or Astrocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/24 (4%) 0/50 (0%) | 0/50 (0%) 1/21 (5%) 2/49 (4%) |
|ADJUSTED (b) | 2.1% 2.9% 0.0% | 0.0% 0.0% 5.8% |
|TERMINAL (d) | 0/33 (0%) 0/1 (0%) 0/32 (0%) | 0/32 (0%) 0/0 1/30 (3%) |
|FIRST INCIDENCE (DAYS) | 653 693 --- | --- 651 662 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.388N P=0.720 P=0.536N | P=0.222 P=0.500 P=0.233 |
|INCIDENTAL TUMOR | P=0.470N P=0.750N P=0.602N | P=0.248 P=0.557 P=0.264 |
|LOGISTIC REGRESSION | P=0.322N P=0.658 P=0.475N | P=0.236 P=0.334 P=0.234 |
|COCHRAN-ARMITAGE | P=0.335N | P=0.235 |
|FISHER EXACT | P=0.546 P=0.500N | P=0.296 P=0.242 |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 0/25 (0%) 2/49 (4%) | 5/48 (10%) 1/21 (5%) 0/47 (0%) |
|ADJUSTED (b) | 7.9% 0.0% 5.3% | 13.6% 33.3% 0.0% |
|TERMINAL (d) | 1/33 (3%) 0/3 (0%) 1/32 (3%) | 3/31 (10%) 1/3 (33%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 707 --- 630 | 577 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.545N P=0.280N P=0.533N | P=0.030N* P=0.583N P=0.039N* |
|INCIDENTAL TUMOR | P=0.476N P=0.192N P=0.392N | P=0.025N* P=0.683N P=0.030N* |
|LOGISTIC REGRESSION | P=0.523N P=0.386N P=0.494N | P=0.026N* P=0.425N P=0.036N* |
|COCHRAN-ARMITAGE | P=0.521N | P=0.027N* |
|FISHER EXACT | P=0.284N P=0.500N | P=0.402N P=0.030N* |
|=================================================================================================================================|
DATE: 09/13/94 EXPERIMENT: 05095 TEST: 01 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- EPINEPHRINE HCL
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1.5MG/M3 5.0MG/M3 | CONTROL 1.5MG/M3 5.0MG/M3 |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/25 (4%) 2/49 (4%) | 2/48 (4%) 1/21 (5%) 0/47 (0%) |
|ADJUSTED (b) | 0.0% 2.5% 5.5% | 5.8% 33.3% 0.0% |
|TERMINAL (d) | 0/33 (0%) 0/3 (0%) 1/32 (3%) | 1/31 (3%) 1/3 (33%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | --- 672 672 | 682 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.204 P=0.477 P=0.224 | P=0.184N P=0.609 P=0.253N |
|INCIDENTAL TUMOR | P=0.146 P=0.527 P=0.189 | P=0.171N P=0.625 P=0.225N |
|LOGISTIC REGRESSION | P=0.230 P=0.409 P=0.241 | P=0.169N P=0.613 P=0.239N |
|COCHRAN-ARMITAGE | P=0.231 | P=0.176N |
|FISHER EXACT | P=0.338 P=0.247 | P=0.670 P=0.253N |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 1/25 (4%) 4/49 (8%) | 7/48 (15%) 2/21 (10%) 0/47 (0%) |
|ADJUSTED (b) | 7.9% 2.5% 10.6% | 18.9% 66.7% 0.0% |
|TERMINAL (d) | 1/33 (3%) 0/3 (0%) 2/32 (6%) | 4/31 (13%) 2/3 (67%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 707 672 630 | 577 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.376 P=0.540N P=0.461 | P=0.009N** P=0.675 P=0.012N* |
|INCIDENTAL TUMOR | P=0.380 P=0.417N P=0.551 | P=0.007N** P=0.617 P=0.008N** |
|LOGISTIC REGRESSION | P=0.413 P=0.637N P=0.508 | P=0.007N** P=0.526N P=0.010N* |
|COCHRAN-ARMITAGE | P=0.412 | P=0.008N** |
|FISHER EXACT | P=0.584N P=0.500 | P=0.442N P=0.007N** |
|=================================================================================================================================|
DATE: 09/13/94 EXPERIMENT: 05095 TEST: 01 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- EPINEPHRINE HCL
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1.5MG/M3 5.0MG/M3 | CONTROL 1.5MG/M3 5.0MG/M3 |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 1/24 (4%) 1/49 (2%) | 1/49 (2%) 1/22 (5%) 0/47 (0%) |
|ADJUSTED (b) | 14.4% 3.6% 2.9% | 3.1% 100.0% 0.0% |
|TERMINAL (d) | 4/33 (12%) 0/1 (0%) 0/32 (0%) | 1/32 (3%) 1/1 (100%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | 714 720 714 | 729 (T) 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.096N P=0.740N P=0.120N | P=0.327N P=0.033 * P=0.513N |
|INCIDENTAL TUMOR | P=0.124N P=0.676N P=0.152N | P=0.327N P=0.033 * P=0.513N |
|LOGISTIC REGRESSION | P=0.098N P=0.566 P=0.126N | P=0.327N P=0.033 * P=0.513N |
|COCHRAN-ARMITAGE | P=0.093N | P=0.343N |
|FISHER EXACT | P=0.360N P=0.107N | P=0.527 P=0.510N |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 2/24 (8%) 1/49 (2%) | 1/49 (2%) 1/22 (5%) 0/47 (0%) |
|ADJUSTED (b) | 16.4% 6.1% 2.9% | 3.1% 100.0% 0.0% |
|TERMINAL (d) | 4/33 (12%) 0/1 (0%) 0/32 (0%) | 1/32 (3%) 1/1 (100%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | 702 677 714 | 729 (T) 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.060N P=0.644 P=0.074N | P=0.327N P=0.033 * P=0.513N |
|INCIDENTAL TUMOR | P=0.084N P=0.625N P=0.103N | P=0.327N P=0.033 * P=0.513N |
|LOGISTIC REGRESSION | P=0.056N P=0.556 P=0.073N | P=0.327N P=0.033 * P=0.513N |
|COCHRAN-ARMITAGE | P=0.050N | P=0.343N |
|FISHER EXACT | P=0.486N P=0.059N | P=0.527 P=0.510N |
|=================================================================================================================================|
DATE: 09/13/94 EXPERIMENT: 05095 TEST: 01 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- EPINEPHRINE HCL
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1.5MG/M3 5.0MG/M3 | CONTROL 1.5MG/M3 5.0MG/M3 |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/33 (3%) 0/49 (0%) | 2/50 (4%) 0/31 (0%) 1/47 (2%) |
|ADJUSTED (b) | 3.0% 2.9% 0.0% | 6.3% 0.0% 3.3% |
|TERMINAL (d) | 1/33 (3%) 0/11 (0%) 0/32 (0%) | 2/32 (6%) 0/10 (0%) 1/30 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 693 --- | 729 (T) --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.358N P=0.615 P=0.506N | P=0.488N P=0.516N P=0.523N |
|INCIDENTAL TUMOR | P=0.395N P=0.656 P=0.506N | P=0.488N P=0.516N P=0.523N |
|LOGISTIC REGRESSION | P=0.353N P=0.640 P=0.506N | P=0.488N P=0.516N P=0.523N |
|COCHRAN-ARMITAGE | P=0.348N | P=0.516N |
|FISHER EXACT | P=0.640 P=0.505N | P=0.378N P=0.523N |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/29 (3%) 2/49 (4%) | 0/50 (0%) 1/23 (4%) 0/48 (0%) |
|ADJUSTED (b) | 10.7% 14.3% 5.8% | 0.0% 2.7% 0.0% |
|TERMINAL (d) | 2/33 (6%) 1/7 (14%) 1/32 (3%) | 0/32 (0%) 0/2 (0%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | 702 729 (T) 707 | --- 714 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.335N P=0.549N P=0.376N | P=0.701N P=0.511 (e) |
|INCIDENTAL TUMOR | P=0.402N P=0.476N P=0.465N | P=0.665N P=0.557 (e) |
|LOGISTIC REGRESSION | P=0.343N P=0.605N P=0.373N | P=0.646N P=0.254 (e) |
|COCHRAN-ARMITAGE | P=0.330N | P=0.667N |
|FISHER EXACT | P=0.390N P=0.349N | P=0.315 (e) |
|=================================================================================================================================|
DATE: 09/13/94 EXPERIMENT: 05095 TEST: 01 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- EPINEPHRINE HCL
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1.5MG/M3 5.0MG/M3 | CONTROL 1.5MG/M3 5.0MG/M3 |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 1/29 (3%) 2/49 (4%) | 0/50 (0%) 1/23 (4%) 0/48 (0%) |
|ADJUSTED (b) | 13.6% 14.3% 5.8% | 0.0% 2.7% 0.0% |
|TERMINAL (d) | 3/33 (9%) 1/7 (14%) 1/32 (3%) | 0/32 (0%) 0/2 (0%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | 702 729 (T) 707 | --- 714 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.221N P=0.477N P=0.251N | P=0.701N P=0.511 (e) |
|INCIDENTAL TUMOR | P=0.268N P=0.409N P=0.319N | P=0.665N P=0.557 (e) |
|LOGISTIC REGRESSION | P=0.230N P=0.521N P=0.251N | P=0.646N P=0.254 (e) |
|COCHRAN-ARMITAGE | P=0.217N | P=0.667N |
|FISHER EXACT | P=0.278N P=0.226N | P=0.315 (e) |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 3/50 (6%) 4/50 (8%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% | 6.3% 8.8% 11.4% |
|TERMINAL (d) | 0/33 (0%) 0/27 (0%) 0/32 (0%) | 2/32 (6%) 1/29 (3%) 2/30 (7%) |
|FIRST INCIDENCE (DAYS) | --- --- --- | 729 (T) 714 637 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.293 P=0.484 P=0.323 |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.336 P=0.525 P=0.353 |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.307 P=0.497 P=0.344 |
|COCHRAN-ARMITAGE | (e) | P=0.297 |
|FISHER EXACT | (e) (e) | P=0.500 P=0.339 |
|=================================================================================================================================|
DATE: 09/13/94 EXPERIMENT: 05095 TEST: 01 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- EPINEPHRINE HCL
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1.5MG/M3 5.0MG/M3 | CONTROL 1.5MG/M3 5.0MG/M3 |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) | 10/50 (20%) 11/50 (22%) 11/50 (22%) |
|ADJUSTED (b) | 5.6% 0.0% 3.1% | 26.9% 31.2% 30.2% |
|TERMINAL (d) | 1/33 (3%) 0/27 (0%) 1/32 (3%) | 7/32 (22%) 6/29 (21%) 6/30 (20%) |
|FIRST INCIDENCE (DAYS) | 717 --- 729 (T) | 476 679 622 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.530N P=0.293N P=0.520N | P=0.465 P=0.446 P=0.468 |
|INCIDENTAL TUMOR | P=0.574N P=0.254N P=0.565N | P=0.506 P=0.501 P=0.439 |
|LOGISTIC REGRESSION | P=0.545N P=0.277N P=0.535N | P=0.504 P=0.487 P=0.504 |
|COCHRAN-ARMITAGE | P=0.528N | P=0.484 |
|FISHER EXACT | P=0.247N P=0.500N | P=0.500 P=0.500 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) | 11/50 (22%) 13/50 (26%) 14/50 (28%) |
|ADJUSTED (b) | 5.6% 0.0% 3.1% | 29.8% 36.2% 37.5% |
|TERMINAL (d) | 1/33 (3%) 0/27 (0%) 1/32 (3%) | 8/32 (25%) 7/29 (24%) 8/30 (27%) |
|FIRST INCIDENCE (DAYS) | 717 --- 729 (T) | 476 679 622 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.530N P=0.293N P=0.520N | P=0.305 P=0.358 P=0.298 |
|INCIDENTAL TUMOR | P=0.574N P=0.254N P=0.565N | P=0.342 P=0.413 P=0.269 |
|LOGISTIC REGRESSION | P=0.545N P=0.277N P=0.535N | P=0.335 P=0.392 P=0.328 |
|COCHRAN-ARMITAGE | P=0.528N | P=0.314 |
|FISHER EXACT | P=0.247N P=0.500N | P=0.408 P=0.322 |
|=================================================================================================================================|
DATE: 09/13/94 EXPERIMENT: 05095 TEST: 01 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- EPINEPHRINE HCL
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1.5MG/M3 5.0MG/M3 | CONTROL 1.5MG/M3 5.0MG/M3 |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Ovary |
| Granulosa Cell Tumor Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 2/50 (4%) 0/22 (0%) 0/47 (0%) |
|ADJUSTED (b) | | 5.9% 0.0% 0.0% |
|TERMINAL (d) | | 1/32 (3%) 0/1 (0%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | | 714 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.193N P=0.467N P=0.247N |
|INCIDENTAL TUMOR | | P=0.181N P=0.423N P=0.224N |
|LOGISTIC REGRESSION | | P=0.182N P=0.600N P=0.238N |
|COCHRAN-ARMITAGE | | P=0.195N |
|FISHER EXACT | | P=0.479N P=0.263N |
|=================================================================================================================================|
| |
|Ovary |
| Granulosa Cell Tumor, Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 2/50 (4%) 1/22 (5%) 0/47 (0%) |
|ADJUSTED (b) | | 5.9% 100.0% 0.0% |
|TERMINAL (d) | | 1/32 (3%) 1/1 (100%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | | 714 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.180N P=0.553 P=0.247N |
|INCIDENTAL TUMOR | | P=0.171N P=0.595 P=0.224N |
|LOGISTIC REGRESSION | | P=0.166N P=0.503 P=0.238N |
|COCHRAN-ARMITAGE | | P=0.185N |
|FISHER EXACT | | P=0.671 P=0.263N |
|=================================================================================================================================|
DATE: 09/13/94 EXPERIMENT: 05095 TEST: 01 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- EPINEPHRINE HCL
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1.5MG/M3 5.0MG/M3 | CONTROL 1.5MG/M3 5.0MG/M3 |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 34/50 (68%) 29/36 (81%) 25/48 (52%) | 30/49 (61%) 25/38 (66%) 32/47 (68%) |
|ADJUSTED (b) | 76.8% 100.0% 61.2% | 74.8% 86.9% 83.8% |
|TERMINAL (d) | 23/33 (70%) 14/14 (100%) 16/31 (52%) | 22/32 (69%) 14/17 (82%) 23/29 (79%) |
|FIRST INCIDENCE (DAYS) | 540 601 560 | 582 430 622 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.074N P=0.021 * P=0.168N | P=0.343 P=0.170 P=0.278 |
|INCIDENTAL TUMOR | P=0.028N* P=0.039 * P=0.057N | P=0.392 P=0.243 P=0.412 |
|LOGISTIC REGRESSION | P=0.031N* P=0.049 * P=0.084N | P=0.447 P=0.258 P=0.405 |
|COCHRAN-ARMITAGE | P=0.028N* | P=0.302 |
|FISHER EXACT | P=0.147 P=0.080N | P=0.416 P=0.313 |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 34/50 (68%) 30/36 (83%) 25/48 (52%) | 31/49 (63%) 26/38 (68%) 33/47 (70%) |
|ADJUSTED (b) | 76.8% 100.0% 61.2% | 75.4% 87.2% 84.2% |
|TERMINAL (d) | 23/33 (70%) 14/14 (100%) 16/31 (52%) | 22/32 (69%) 14/17 (82%) 23/29 (79%) |
|FIRST INCIDENCE (DAYS) | 540 598 560 | 582 430 622 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.070N P=0.015 * P=0.168N | P=0.348 P=0.178 P=0.286 |
|INCIDENTAL TUMOR | P=0.018N* P=0.039 * P=0.057N | P=0.412 P=0.244 P=0.432 |
|LOGISTIC REGRESSION | P=0.026N* P=0.035 * P=0.084N | P=0.451 P=0.238 P=0.407 |
|COCHRAN-ARMITAGE | P=0.024N* | P=0.301 |
|FISHER EXACT | P=0.086 P=0.080N | P=0.393 P=0.307 |
|=================================================================================================================================|
DATE: 09/13/94 EXPERIMENT: 05095 TEST: 01 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- EPINEPHRINE HCL
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1.5MG/M3 5.0MG/M3 | CONTROL 1.5MG/M3 5.0MG/M3 |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 0/50 (0%) 1/50 (2%) | 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 13.0% 0.0% 2.6% | 2.1% 3.4% 2.6% |
|TERMINAL (d) | 2/33 (6%) 0/27 (0%) 0/32 (0%) | 0/32 (0%) 1/29 (3%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | 693 --- 674 | 577 729 (T) 679 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.126N P=0.061N P=0.132N | P=0.683N P=0.739 P=0.755N |
|INCIDENTAL TUMOR | P=0.169N P=0.037N* P=0.195N | P=0.642N P=0.704 P=0.711N |
|LOGISTIC REGRESSION | P=0.113N P=0.041N* P=0.108N | P=0.678 P=0.756N P=0.739 |
|COCHRAN-ARMITAGE | P=0.107N | P=0.687 |
|FISHER EXACT | P=0.028N* P=0.102N | P=0.753N P=0.753N |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 5.6% 0.0% 2.9% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/33 (3%) 0/27 (0%) 0/32 (0%) | 0/32 (0%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | 717 --- 717 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.537N P=0.293N P=0.529N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.629N P=0.254N P=0.621N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.547N P=0.277N P=0.531N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.528N | (e) |
|FISHER EXACT | P=0.247N P=0.500N | (e) (e) |
|=================================================================================================================================|
DATE: 09/13/94 EXPERIMENT: 05095 TEST: 01 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- EPINEPHRINE HCL
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1.5MG/M3 5.0MG/M3 | CONTROL 1.5MG/M3 5.0MG/M3 |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Skin |
| Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 5.5% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/33 (0%) 0/27 (0%) 1/32 (3%) | 0/32 (0%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 672 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.092 (e) P=0.224 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.064 (e) P=0.182 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.092 (e) P=0.240 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.092 | (e) |
|FISHER EXACT | (e) P=0.247 | (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 5.5% | 3.1% 0.0% 0.0% |
|TERMINAL (d) | 0/33 (0%) 0/27 (0%) 1/32 (3%) | 1/32 (3%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 672 | 729 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.092 (e) P=0.224 | P=0.429N P=0.520N P=0.513N |
|INCIDENTAL TUMOR | P=0.064 (e) P=0.182 | P=0.429N P=0.520N P=0.513N |
|LOGISTIC REGRESSION | P=0.092 (e) P=0.240 | P=0.429N P=0.520N P=0.513N |
|COCHRAN-ARMITAGE | P=0.092 | P=0.421N |
|FISHER EXACT | (e) P=0.247 | P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 09/13/94 EXPERIMENT: 05095 TEST: 01 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- EPINEPHRINE HCL
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1.5MG/M3 5.0MG/M3 | CONTROL 1.5MG/M3 5.0MG/M3 |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, |
| Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 4/50 (8%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 8.5% 0.0% 11.3% | 3.1% 0.0% 0.0% |
|TERMINAL (d) | 2/33 (6%) 0/27 (0%) 2/32 (6%) | 1/32 (3%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | 717 --- 672 | 729 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.282 P=0.165N P=0.465 | P=0.429N P=0.520N P=0.513N |
|INCIDENTAL TUMOR | P=0.205 P=0.143N P=0.374 | P=0.429N P=0.520N P=0.513N |
|LOGISTIC REGRESSION | P=0.262 P=0.158N P=0.462 | P=0.429N P=0.520N P=0.513N |
|COCHRAN-ARMITAGE | P=0.284 | P=0.421N |
|FISHER EXACT | P=0.121N P=0.500 | P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 39/50 (78%) 32/47 (68%) 42/50 (84%) | |
|ADJUSTED (b) | 86.6% 96.8% 93.2% | |
|TERMINAL (d) | 27/33 (82%) 23/24 (96%) 29/32 (91%) | |
|FIRST INCIDENCE (DAYS) | 653 535 500 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.224 P=0.345 P=0.235 | |
|INCIDENTAL TUMOR | P=0.085 P=0.564N P=0.204 | |
|LOGISTIC REGRESSION | P=0.051 P=0.561 P=0.192 | |
|COCHRAN-ARMITAGE | P=0.180 | |
|FISHER EXACT | P=0.192N P=0.306 | |
|=================================================================================================================================|
DATE: 09/13/94 EXPERIMENT: 05095 TEST: 01 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- EPINEPHRINE HCL
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1.5MG/M3 5.0MG/M3 | CONTROL 1.5MG/M3 5.0MG/M3 |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 3/24 (13%) 5/49 (10%) | 4/50 (8%) 3/21 (14%) 5/47 (11%) |
|ADJUSTED (b) | 24.4% 8.8% 15.6% | 12.5% 0.0% 15.8% |
|TERMINAL (d) | 7/33 (21%) 0/2 (0%) 5/32 (16%) | 4/32 (13%) 0/0 4/30 (13%) |
|FIRST INCIDENCE (DAYS) | 463 681 729 (T) | 729 (T) 623 715 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.178N P=0.563 P=0.215N | P=0.516 P=0.128 P=0.466 |
|INCIDENTAL TUMOR | P=0.268N P=0.598 P=0.317N | P=0.536 P=0.127 P=0.478 |
|LOGISTIC REGRESSION | P=0.239N P=0.340N P=0.201N | P=0.539 P=0.180 P=0.497 |
|COCHRAN-ARMITAGE | P=0.192N | P=0.466 |
|FISHER EXACT | P=0.407N P=0.205N | P=0.339 P=0.460 |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/24 (8%) 0/49 (0%) | 2/50 (4%) 0/21 (0%) 2/47 (4%) |
|ADJUSTED (b) | 9.9% 100.0% 0.0% | 6.3% 0.0% 6.7% |
|TERMINAL (d) | 1/33 (3%) 2/2 (100%) 0/32 (0%) | 2/32 (6%) 0/0 2/30 (7%) |
|FIRST INCIDENCE (DAYS) | 540 729 (T) --- | 729 (T) --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.055N P=0.513 P=0.075N | P=0.615 (e) P=0.673 |
|INCIDENTAL TUMOR | P=0.097N P=0.516 P=0.187N | P=0.615 (e) P=0.673 |
|LOGISTIC REGRESSION | P=0.048N* P=0.674N P=0.058N | P=0.615 (e) P=0.673 |
|COCHRAN-ARMITAGE | P=0.050N* | P=0.569 |
|FISHER EXACT | P=0.640 P=0.061N | P=0.493N P=0.668 |
|=================================================================================================================================|
DATE: 09/13/94 EXPERIMENT: 05095 TEST: 01 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- EPINEPHRINE HCL
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1.5MG/M3 5.0MG/M3 | CONTROL 1.5MG/M3 5.0MG/M3 |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 5/24 (21%) 5/49 (10%) | 5/50 (10%) 3/21 (14%) 7/47 (15%) |
|ADJUSTED (b) | 32.4% 100.0% 15.6% | 15.6% 0.0% 22.3% |
|TERMINAL (d) | 8/33 (24%) 2/2 (100%) 5/32 (16%) | 5/32 (16%) 0/0 6/30 (20%) |
|FIRST INCIDENCE (DAYS) | 463 681 729 (T) | 729 (T) 623 715 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.033N* P=0.430 P=0.047N* | P=0.389 P=0.128 P=0.337 |
|INCIDENTAL TUMOR | P=0.077N P=0.452 P=0.132N | P=0.406 P=0.127 P=0.347 |
|LOGISTIC REGRESSION | P=0.032N* P=0.353N P=0.032N* | P=0.407 P=0.236 P=0.372 |
|COCHRAN-ARMITAGE | P=0.032N* | P=0.320 |
|FISHER EXACT | P=0.430N P=0.037N* | P=0.439 P=0.336 |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/24 (0%) 0/49 (0%) | 0/50 (0%) 0/21 (0%) 0/47 (0%) |
|ADJUSTED (b) | 5.6% 0.0% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/33 (3%) 0/2 (0%) 0/32 (0%) | 0/32 (0%) 0/0 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | 717 --- --- | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.196N P=0.507N P=0.255N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.219N P=0.447N P=0.299N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.198N P=0.681N P=0.259N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.189N | (e) |
|FISHER EXACT | P=0.454N P=0.253N | (e) (e) |
|=================================================================================================================================|
DATE: 09/13/94 EXPERIMENT: 05095 TEST: 01 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- EPINEPHRINE HCL
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1.5MG/M3 5.0MG/M3 | CONTROL 1.5MG/M3 5.0MG/M3 |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/22 (0%) 0/49 (0%) | 2/49 (4%) 0/21 (0%) 0/47 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% | 6.3% 0.0% 0.0% |
|TERMINAL (d) | 0/33 (0%) 0/1 (0%) 0/32 (0%) | 2/32 (6%) 0/0 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- | 729 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.189N (e) P=0.252N |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.189N (e) P=0.252N |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.189N (e) P=0.252N |
|COCHRAN-ARMITAGE | (e) | P=0.191N |
|FISHER EXACT | (e) (e) | P=0.487N P=0.258N |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 10/50 (20%) 4/50 (8%) 4/50 (8%) |
|ADJUSTED (b) | | 28.4% 12.8% 13.3% |
|TERMINAL (d) | | 7/32 (22%) 3/29 (10%) 4/30 (13%) |
|FIRST INCIDENCE (DAYS) | | 693 714 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.102N P=0.097N P=0.092N |
|INCIDENTAL TUMOR | | P=0.083N P=0.070N P=0.070N |
|LOGISTIC REGRESSION | | P=0.083N P=0.072N P=0.069N |
|COCHRAN-ARMITAGE | | P=0.089N |
|FISHER EXACT | | P=0.074N P=0.074N |
|=================================================================================================================================|
DATE: 09/13/94 EXPERIMENT: 05095 TEST: 01 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- EPINEPHRINE HCL
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1.5MG/M3 5.0MG/M3 | CONTROL 1.5MG/M3 5.0MG/M3 |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 10/50 (20%) 4/50 (8%) 4/50 (8%) |
|ADJUSTED (b) | | 28.4% 12.8% 13.3% |
|TERMINAL (d) | | 7/32 (22%) 3/29 (10%) 4/30 (13%) |
|FIRST INCIDENCE (DAYS) | | 693 714 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.102N P=0.097N P=0.092N |
|INCIDENTAL TUMOR | | P=0.083N P=0.070N P=0.070N |
|LOGISTIC REGRESSION | | P=0.083N P=0.072N P=0.069N |
|COCHRAN-ARMITAGE | | P=0.089N |
|FISHER EXACT | | P=0.074N P=0.074N |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, |
| or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 19/50 (38%) 21/50 (42%) 22/50 (44%) | 24/50 (48%) 18/50 (36%) 16/50 (32%) |
|ADJUSTED (b) | 47.4% 50.4% 50.3% | 52.6% 40.9% 41.4% |
|TERMINAL (d) | 13/33 (39%) 8/27 (30%) 11/32 (34%) | 11/32 (34%) 4/29 (14%) 9/30 (30%) |
|FIRST INCIDENCE (DAYS) | 463 535 556 | 258 126 615 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.325 P=0.215 P=0.288 | P=0.136N P=0.245N P=0.131N |
|INCIDENTAL TUMOR | P=0.364 P=0.474 P=0.462 | P=0.059N P=0.063N P=0.094N |
|LOGISTIC REGRESSION | P=0.384 P=0.500 P=0.382 | P=0.102N P=0.131N P=0.086N |
|COCHRAN-ARMITAGE | P=0.334 | P=0.088N |
|FISHER EXACT | P=0.419 P=0.342 | P=0.156N P=0.076N |
|=================================================================================================================================|
DATE: 09/13/94 EXPERIMENT: 05095 TEST: 01 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- EPINEPHRINE HCL
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1.5MG/M3 5.0MG/M3 | CONTROL 1.5MG/M3 5.0MG/M3 |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 3.0% 5.9% 8.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/33 (3%) 1/27 (4%) 1/32 (3%) | 0/32 (0%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 644 556 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.264 P=0.444 P=0.304 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.418 P=0.717 P=0.435 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.281 P=0.506 P=0.331 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.259 | (e) |
|FISHER EXACT | P=0.500 P=0.309 | (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 47/50 (94%) 50/50 (100%) | 43/50 (86%) 35/50 (70%) 38/50 (76%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% | 95.5% 77.6% 88.2% |
|TERMINAL (d) | 33/33 (100%) 27/27 (100%) 32/32 (100%) | 30/32 (94%) 19/29 (66%) 25/30 (83%) |
|FIRST INCIDENCE (DAYS) | 463 535 500 | 476 430 581 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.433 P=0.186 P=0.386 | P=0.380N P=0.230N P=0.339N |
|INCIDENTAL TUMOR | P=0.062 (e) (e) | P=0.279N P=0.035N* P=0.198N |
|LOGISTIC REGRESSION | P=0.417 P=0.094N (e) | P=0.189N P=0.050N P=0.098N |
|COCHRAN-ARMITAGE | P=0.472 | P=0.255N |
|FISHER EXACT | P=0.121N P=1.000N | P=0.045N* P=0.154N |
|=================================================================================================================================|
DATE: 09/13/94 EXPERIMENT: 05095 TEST: 01 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- EPINEPHRINE HCL
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 1.5MG/M3 5.0MG/M3 | CONTROL 1.5MG/M3 5.0MG/M3 |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 25/50 (50%) 27/50 (54%) 26/50 (52%) | 29/50 (58%) 22/50 (44%) 23/50 (46%) |
|ADJUSTED (b) | 58.4% 61.2% 58.7% | 62.6% 48.5% 56.2% |
|TERMINAL (d) | 16/33 (48%) 11/27 (41%) 14/32 (44%) | 15/32 (47%) 6/29 (21%) 13/30 (43%) |
|FIRST INCIDENCE (DAYS) | 463 535 556 | 258 126 615 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.465 P=0.189 P=0.410 | P=0.273N P=0.224N P=0.249N |
|INCIDENTAL TUMOR | P=0.503 P=0.490 P=0.531 | P=0.169N P=0.036N* P=0.171N |
|LOGISTIC REGRESSION | P=0.543N P=0.567 P=0.543 | P=0.224N P=0.098N P=0.167N |
|COCHRAN-ARMITAGE | P=0.508 | P=0.205N |
|FISHER EXACT | P=0.421 P=0.500 | P=0.115N P=0.158N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 49/50 (98%) 50/50 (100%) | 49/50 (98%) 41/50 (82%) 43/50 (86%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% | 98.0% 82.0% 91.5% |
|TERMINAL (d) | 33/33 (100%) 27/27 (100%) 32/32 (100%) | 31/32 (97%) 20/29 (69%) 26/30 (87%) |
|FIRST INCIDENCE (DAYS) | 463 535 500 | 258 126 581 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.464 P=0.115 P=0.386 | P=0.325N P=0.261N P=0.296N |
|INCIDENTAL TUMOR | P=0.443 (e) (e) | P=0.111N P=0.005N** P=0.034N* |
|LOGISTIC REGRESSION | P=0.676 P=0.465N (e) | P=0.113N P=0.005N** P=0.023N* |
|COCHRAN-ARMITAGE | P=0.698 | P=0.111N |
|FISHER EXACT | P=0.500N P=1.000N | P=0.008N** P=0.030N* |
|=================================================================================================================================|
DATE: 09/13/94 EXPERIMENT: 05095 TEST: 01 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- EPINEPHRINE HCL
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).
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