TDMS Study 05108-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Mason PROMETHAZINE HYDROCHLORIDE DATE: 09/13/94
EXPERIMENT: 05108 TEST: 01 TIME: 21:49:52
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-45069 ROUTE: GAVAGE NTP C#: C60673
PATHOLOGIST: R. FLEISCHMAN K. MURTHY CAS: 58-33-3
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Mason PROMETHAZINE HYDROCHLORIDE DATE: 09/13/94
EXPERIMENT: 05108 TEST: 01 TIME: 21:49:52
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-45069 ROUTE: GAVAGE NTP C#: C60673
PATHOLOGIST: R. FLEISCHMAN K. MURTHY CAS: 58-33-3
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
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: Mason PROMETHAZINE HYDROCHLORIDE DATE: 09/13/94
EXPERIMENT: 05108 TEST: 01 TIME: 21:49:52
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-45069 ROUTE: GAVAGE NTP C#: C60673
PATHOLOGIST: R. FLEISCHMAN K. MURTHY CAS: 58-33-3
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF PROMETHAZINE HYDROCHLORIDE
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Skin Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma
Testes Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear,
or Undifferentiated
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Mammary Gland Adenoma
Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Uterus Polyp Stromal
Sarcoma Stromal or Polyp Stromal
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear,
or Undifferentiated
Benign Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 01 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 103 WEEKS
FEMALE TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 8.3 16.6 33.3 | VEHICLE 8.3 16.6 33.3 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 14/60 (23%) 11/60 (18%) 9/59 (15%) 2/59 (3%) | 4/60 (7%) 1/59 (2%) 2/60 (3%) 3/58 (5%) |
|ADJUSTED (b) | 42.3% 43.5% 33.2% 7.9% | 12.5% 2.6% 5.7% 12.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 6/23 (26%) 5/18 (28%) 0/11 (0%) 0/10 (0%) | 4/32 (13%) 0/34 (0%) 1/31 (3%) 3/24 (13%) |
|FIRST INCIDENCE (DAYS) | 570 568 462 (I) 565 | 729 (T) 676 643 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.065N P=0.578 P=0.582 P=0.050N | P=0.487 P=0.162N P=0.348N P=0.657 |
|INCIDENTAL TUMOR | P=0.002N** P=0.510N P=0.192N P=0.002N** | P=0.533 P=0.177N P=0.298N P=0.657 |
|LOGISTIC REGRESSION | P=0.006N** P=0.542N P=0.306N P=0.007N** | P=0.496 P=0.159N P=0.347N P=0.657 |
|COCHRAN-ARMITAGE | P=0.001N** | P=0.558N |
|FISHER EXACT | P=0.327N P=0.189N P=0.001N** | P=0.187N P=0.340N P=0.519N |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 1/60 (2%) 1/59 (2%) 1/59 (2%) | 0/60 (0%) 0/59 (0%) 0/60 (0%) 0/58 (0%) |
|ADJUSTED (b) | 8.4% 5.6% 5.0% 4.8% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 0/23 (0%) 1/18 (6%) 0/11 (0%) 0/10 (0%) | 0/32 (0%) 0/34 (0%) 0/31 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 570 717 (T) 691 657 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.448N P=0.416N P=0.432N P=0.541N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.263N P=0.361N P=0.243N P=0.295N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.323N P=0.354N P=0.352N P=0.370N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.248N | (e) |
|FISHER EXACT | P=0.309N P=0.316N P=0.316N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 01 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 103 WEEKS
FEMALE TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 8.3 16.6 33.3 | VEHICLE 8.3 16.6 33.3 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 16/60 (27%) 12/60 (20%) 10/59 (17%) 4/59 (7%) | 4/60 (7%) 1/59 (2%) 2/60 (3%) 3/58 (5%) |
|ADJUSTED (b) | 46.0% 47.9% 36.5% 15.2% | 12.5% 2.6% 5.7% 12.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 6/23 (26%) 6/18 (33%) 0/11 (0%) 0/10 (0%) | 4/32 (13%) 0/34 (0%) 1/31 (3%) 3/24 (13%) |
|FIRST INCIDENCE (DAYS) | 570 568 462 (I) 565 | 729 (T) 676 643 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.134N P=0.544N P=0.553N P=0.124N | P=0.487 P=0.162N P=0.348N P=0.657 |
|INCIDENTAL TUMOR | P=0.004N** P=0.450N P=0.130N P=0.005N** | P=0.533 P=0.177N P=0.298N P=0.657 |
|LOGISTIC REGRESSION | P=0.005N** P=0.482N P=0.262N P=0.017N* | P=0.496 P=0.159N P=0.347N P=0.657 |
|COCHRAN-ARMITAGE | P=0.003N** | P=0.558N |
|FISHER EXACT | P=0.259N P=0.144N P=0.003N** | P=0.187N P=0.340N P=0.519N |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/58 (3%) 5/60 (8%) 2/58 (3%) 3/59 (5%) | 3/56 (5%) 9/55 (16%) 1/58 (2%) 2/57 (4%) |
|ADJUSTED (b) | 8.3% 16.6% 11.8% 22.1% | 10.7% 24.6% 3.1% 6.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 1/23 (4%) 1/18 (6%) 1/11 (9%) 2/10 (20%) | 3/28 (11%) 5/30 (17%) 0/29 (0%) 1/24 (4%) |
|FIRST INCIDENCE (DAYS) | 716 491 616 583 | 729 (T) 597 689 550 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.280 P=0.146 P=0.467 P=0.206 | P=0.201N P=0.085 P=0.302N P=0.563N |
|INCIDENTAL TUMOR | P=0.454 P=0.327 P=0.618 P=0.334 | P=0.132N P=0.099 P=0.297N P=0.477N |
|LOGISTIC REGRESSION | P=0.485 P=0.204 P=0.594 P=0.298 | P=0.164N P=0.077 P=0.294N P=0.554N |
|COCHRAN-ARMITAGE | P=0.577N | P=0.121N |
|FISHER EXACT | P=0.234 P=0.691N P=0.508 | P=0.058 P=0.296N P=0.492N |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 01 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 103 WEEKS
FEMALE TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 8.3 16.6 33.3 | VEHICLE 8.3 16.6 33.3 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/58 (3%) 5/60 (8%) 2/58 (3%) 3/59 (5%) | 3/56 (5%) 9/55 (16%) 1/58 (2%) 3/57 (5%) |
|ADJUSTED (b) | 8.3% 16.6% 11.8% 22.1% | 10.7% 24.6% 3.1% 10.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 1/23 (4%) 1/18 (6%) 1/11 (9%) 2/10 (20%) | 3/28 (11%) 5/30 (17%) 0/29 (0%) 2/24 (8%) |
|FIRST INCIDENCE (DAYS) | 716 491 616 583 | 729 (T) 597 689 550 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.280 P=0.146 P=0.467 P=0.206 | P=0.349N P=0.085 P=0.302N P=0.597 |
|INCIDENTAL TUMOR | P=0.454 P=0.327 P=0.618 P=0.334 | P=0.256N P=0.099 P=0.297N P=0.660N |
|LOGISTIC REGRESSION | P=0.485 P=0.204 P=0.594 P=0.298 | P=0.302N P=0.077 P=0.294N P=0.605 |
|COCHRAN-ARMITAGE | P=0.577N | P=0.229N |
|FISHER EXACT | P=0.234 P=0.691N P=0.508 | P=0.058 P=0.296N P=0.652N |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/60 (8%) 2/60 (3%) 2/59 (3%) 1/58 (2%) | 2/60 (3%) 1/59 (2%) 0/60 (0%) 0/55 (0%) |
|ADJUSTED (b) | 17.0% 11.1% 8.5% 4.5% | 6.3% 2.9% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 3/23 (13%) 2/18 (11%) 0/11 (0%) 0/10 (0%) | 2/32 (6%) 1/34 (3%) 0/31 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 462 (I) 717 (T) 666 656 | 729 (T) 729 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.273N P=0.321N P=0.462N P=0.321N | P=0.126N P=0.479N P=0.245N P=0.303N |
|INCIDENTAL TUMOR | P=0.187N P=0.307N P=0.326N P=0.251N | P=0.126N P=0.479N P=0.245N P=0.303N |
|LOGISTIC REGRESSION | P=0.139N P=0.288N P=0.276N P=0.162N | P=0.126N P=0.479N P=0.245N P=0.303N |
|COCHRAN-ARMITAGE | P=0.084N | P=0.108N |
|FISHER EXACT | P=0.219N P=0.226N P=0.111N | P=0.506N P=0.248N P=0.270N |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 01 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 103 WEEKS
FEMALE TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 8.3 16.6 33.3 | VEHICLE 8.3 16.6 33.3 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/59 (0%) 0/57 (0%) |
|ADJUSTED (b) | 8.7% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 2/23 (9%) 0/18 (0%) 0/11 (0%) 0/10 (0%) | 0/32 (0%) 0/34 (0%) 0/31 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 717 (T) --- --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.209N P=0.293N P=0.411N P=0.434N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.209N P=0.293N P=0.411N P=0.434N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.209N P=0.293N P=0.411N P=0.434N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.116N | (e) |
|FISHER EXACT | P=0.248N P=0.248N P=0.248N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 1/60 (2%) 1/60 (2%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/59 (0%) 0/57 (0%) |
|ADJUSTED (b) | 8.7% 4.5% 9.1% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 2/23 (9%) 0/18 (0%) 1/11 (9%) 0/10 (0%) | 0/32 (0%) 0/34 (0%) 0/31 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 717 (T) 696 717 (T) --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.328N P=0.580N P=0.725 P=0.434N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.287N P=0.582N P=0.725 P=0.434N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.298N P=0.596N P=0.725 P=0.434N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.153N | (e) |
|FISHER EXACT | P=0.500N P=0.500N P=0.248N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 01 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 103 WEEKS
FEMALE TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 8.3 16.6 33.3 | VEHICLE 8.3 16.6 33.3 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/60 (7%) 2/60 (3%) 2/60 (3%) 1/60 (2%) | 0/60 (0%) 0/59 (0%) 1/60 (2%) 1/59 (2%) |
|ADJUSTED (b) | 16.0% 9.8% 11.6% 5.9% | 0.0% 0.0% 3.2% 3.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 3/23 (13%) 1/18 (6%) 1/11 (9%) 0/10 (0%) | 0/32 (0%) 0/34 (0%) 1/31 (3%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 687 696 598 667 | --- --- 729 (T) 640 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.389N P=0.454N P=0.619N P=0.487N | P=0.181 (e) P=0.494 P=0.446 |
|INCIDENTAL TUMOR | P=0.259N P=0.451N P=0.526N P=0.387N | P=0.257 (e) P=0.494 P=0.682 |
|LOGISTIC REGRESSION | P=0.273N P=0.467N P=0.481N P=0.390N | P=0.196 (e) P=0.494 P=0.480 |
|COCHRAN-ARMITAGE | P=0.138N | P=0.234 |
|FISHER EXACT | P=0.340N P=0.340N P=0.182N | (e) P=0.500 P=0.496 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/60 (7%) 2/60 (3%) 3/60 (5%) 1/60 (2%) | 0/60 (0%) 0/59 (0%) 1/60 (2%) 1/59 (2%) |
|ADJUSTED (b) | 16.0% 9.8% 13.5% 5.9% | 0.0% 0.0% 3.2% 3.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 3/23 (13%) 1/18 (6%) 1/11 (9%) 0/10 (0%) | 0/32 (0%) 0/34 (0%) 1/31 (3%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 687 696 479 667 | --- --- 729 (T) 640 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.422N P=0.454N P=0.549 P=0.487N | P=0.181 (e) P=0.494 P=0.446 |
|INCIDENTAL TUMOR | P=0.286N P=0.451N P=0.573N P=0.387N | P=0.257 (e) P=0.494 P=0.682 |
|LOGISTIC REGRESSION | P=0.256N P=0.467N P=0.575N P=0.390N | P=0.196 (e) P=0.494 P=0.480 |
|COCHRAN-ARMITAGE | P=0.163N | P=0.234 |
|FISHER EXACT | P=0.340N P=0.500N P=0.182N | (e) P=0.500 P=0.496 |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 01 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 103 WEEKS
FEMALE TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 8.3 16.6 33.3 | VEHICLE 8.3 16.6 33.3 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/60 (7%) 2/60 (3%) 3/60 (5%) 1/60 (2%) | 0/60 (0%) 0/59 (0%) 1/60 (2%) 1/59 (2%) |
|ADJUSTED (b) | 16.0% 9.8% 13.5% 5.9% | 0.0% 0.0% 3.2% 3.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 3/23 (13%) 1/18 (6%) 1/11 (9%) 0/10 (0%) | 0/32 (0%) 0/34 (0%) 1/31 (3%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 687 696 479 667 | --- --- 729 (T) 640 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.422N P=0.454N P=0.549 P=0.487N | P=0.181 (e) P=0.494 P=0.446 |
|INCIDENTAL TUMOR | P=0.286N P=0.451N P=0.573N P=0.387N | P=0.257 (e) P=0.494 P=0.682 |
|LOGISTIC REGRESSION | P=0.256N P=0.467N P=0.575N P=0.390N | P=0.196 (e) P=0.494 P=0.480 |
|COCHRAN-ARMITAGE | P=0.163N | P=0.234 |
|FISHER EXACT | P=0.340N P=0.500N P=0.182N | (e) P=0.500 P=0.496 |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/60 (0%) 0/59 (0%) 1/60 (2%) | 2/60 (3%) 1/59 (2%) 0/60 (0%) 0/59 (0%) |
|ADJUSTED (b) | 4.3% 0.0% 0.0% 1.9% | 5.1% 2.9% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/9 (11%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 1/23 (4%) 0/18 (0%) 0/11 (0%) 0/10 (0%) | 1/32 (3%) 1/34 (3%) 0/31 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 717 (T) --- --- 462 (I) | 451 (I) 729 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.496 P=0.549N P=0.647N P=0.658 | P=0.128N P=0.486N P=0.243N P=0.313N |
|INCIDENTAL TUMOR | P=0.496 P=0.549N P=0.647N P=0.658 | P=0.128N P=0.486N P=0.243N P=0.313N |
|LOGISTIC REGRESSION | P=0.603 P=0.549N P=0.647N P=0.759N | P=0.103N P=0.510N P=0.242N P=0.233N |
|COCHRAN-ARMITAGE | P=0.594 | P=0.102N |
|FISHER EXACT | P=0.500N P=0.504N P=0.752N | P=0.506N P=0.248N P=0.252N |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 01 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 103 WEEKS
FEMALE TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 8.3 16.6 33.3 | VEHICLE 8.3 16.6 33.3 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/60 (0%) 1/59 (2%) 1/60 (2%) | 2/60 (3%) 1/59 (2%) 1/60 (2%) 0/59 (0%) |
|ADJUSTED (b) | 4.3% 0.0% 9.1% 1.9% | 5.1% 2.9% 3.2% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/9 (11%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 1/23 (4%) 0/18 (0%) 1/11 (9%) 0/10 (0%) | 1/32 (3%) 1/34 (3%) 1/31 (3%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 717 (T) --- 717 (T) 462 (I) | 451 (I) 729 (T) 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.383 P=0.549N P=0.589 P=0.658 | P=0.201N P=0.486N P=0.507N P=0.313N |
|INCIDENTAL TUMOR | P=0.383 P=0.549N P=0.589 P=0.658 | P=0.201N P=0.486N P=0.507N P=0.313N |
|LOGISTIC REGRESSION | P=0.511 P=0.549N P=0.589 P=0.759N | P=0.169N P=0.510N P=0.500N P=0.233N |
|COCHRAN-ARMITAGE | P=0.539 | P=0.155N |
|FISHER EXACT | P=0.500N P=0.748 P=0.752N | P=0.506N P=0.500N P=0.252N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 1/60 (2%) | 3/60 (5%) 3/60 (5%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 4.3% 5.6% 0.0% 10.0% | 8.4% 8.5% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 1/23 (4%) 1/18 (6%) 0/11 (0%) 1/10 (10%) | 2/32 (6%) 2/34 (6%) 0/31 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 717 (T) 717 (T) --- 717 (T) | 513 704 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.478 P=0.707 P=0.647N P=0.566 | P=0.052N P=0.629N P=0.125N P=0.168N |
|INCIDENTAL TUMOR | P=0.478 P=0.707 P=0.647N P=0.566 | P=0.048N* P=0.549 P=0.175N P=0.149N |
|LOGISTIC REGRESSION | P=0.478 P=0.707 P=0.647N P=0.566 | P=0.045N* P=0.634N P=0.120N P=0.143N |
|COCHRAN-ARMITAGE | P=0.617N | P=0.035N* |
|FISHER EXACT | P=0.752N P=0.500N P=0.752N | P=0.660N P=0.122N P=0.122N |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 01 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 103 WEEKS
FEMALE TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 8.3 16.6 33.3 | VEHICLE 8.3 16.6 33.3 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/60 (7%) 2/60 (3%) 0/60 (0%) 0/60 (0%) | 14/60 (23%) 13/60 (22%) 10/60 (17%) 6/60 (10%) |
|ADJUSTED (b) | 16.0% 11.1% 0.0% 0.0% | 42.0% 36.1% 29.0% 19.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 3/23 (13%) 2/18 (11%) 0/11 (0%) 0/10 (0%) | 13/32 (41%) 11/34 (32%) 7/31 (23%) 3/24 (13%) |
|FIRST INCIDENCE (DAYS) | 687 717 (T) --- --- | 547 692 652 421 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.072N P=0.457N P=0.171N P=0.212N | P=0.101N P=0.421N P=0.260N P=0.133N |
|INCIDENTAL TUMOR | P=0.061N P=0.452N P=0.141N P=0.176N | P=0.075N P=0.409N P=0.234N P=0.079N |
|LOGISTIC REGRESSION | P=0.059N P=0.466N P=0.134N P=0.181N | P=0.080N P=0.415N P=0.251N P=0.104N |
|COCHRAN-ARMITAGE | P=0.018N* | P=0.025N* |
|FISHER EXACT | P=0.340N P=0.059N P=0.059N | P=0.500N P=0.247N P=0.042N* |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 5/60 (8%) 3/60 (5%) 0/60 (0%) 1/60 (2%) | 15/60 (25%) 15/60 (25%) 10/60 (17%) 6/60 (10%) |
|ADJUSTED (b) | 20.2% 16.7% 0.0% 10.0% | 43.4% 40.5% 29.0% 19.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 4/23 (17%) 3/18 (17%) 0/11 (0%) 1/10 (10%) | 13/32 (41%) 12/34 (35%) 7/31 (23%) 3/24 (13%) |
|FIRST INCIDENCE (DAYS) | 687 717 (T) --- 717 (T) | 513 692 652 421 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.175N P=0.499N P=0.119N P=0.380N | P=0.059N P=0.502N P=0.195N P=0.095N |
|INCIDENTAL TUMOR | P=0.156N P=0.495N P=0.097N P=0.336N | P=0.038N* P=0.575N P=0.197N P=0.050N |
|LOGISTIC REGRESSION | P=0.149N P=0.509N P=0.088N P=0.345N | P=0.041N* P=0.488N P=0.181N P=0.066N |
|COCHRAN-ARMITAGE | P=0.038N* | P=0.012N* |
|FISHER EXACT | P=0.359N P=0.029N* P=0.103N | P=0.583N P=0.184N P=0.026N* |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 01 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 103 WEEKS
FEMALE TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 8.3 16.6 33.3 | VEHICLE 8.3 16.6 33.3 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 5/60 (8%) 3/60 (5%) 0/60 (0%) 1/60 (2%) | 15/60 (25%) 15/60 (25%) 10/60 (17%) 6/60 (10%) |
|ADJUSTED (b) | 20.2% 16.7% 0.0% 10.0% | 43.4% 40.5% 29.0% 19.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 4/23 (17%) 3/18 (17%) 0/11 (0%) 1/10 (10%) | 13/32 (41%) 12/34 (35%) 7/31 (23%) 3/24 (13%) |
|FIRST INCIDENCE (DAYS) | 687 717 (T) --- 717 (T) | 513 692 652 421 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.175N P=0.499N P=0.119N P=0.380N | P=0.059N P=0.502N P=0.195N P=0.095N |
|INCIDENTAL TUMOR | P=0.156N P=0.495N P=0.097N P=0.336N | P=0.038N* P=0.575N P=0.197N P=0.050N |
|LOGISTIC REGRESSION | P=0.149N P=0.509N P=0.088N P=0.345N | P=0.041N* P=0.488N P=0.181N P=0.066N |
|COCHRAN-ARMITAGE | P=0.038N* | P=0.012N* |
|FISHER EXACT | P=0.359N P=0.029N* P=0.103N | P=0.583N P=0.184N P=0.026N* |
|=================================================================================================================================|
| |
|Pancreas |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 2/60 (3%) 1/59 (2%) 0/60 (0%) | 0/60 (0%) 0/59 (0%) 0/60 (0%) 0/56 (0%) |
|ADJUSTED (b) | 7.9% 10.5% 7.7% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 1/23 (4%) 1/18 (6%) 0/11 (0%) 0/10 (0%) | 0/32 (0%) 0/34 (0%) 0/31 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 697 716 704 --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.307N P=0.603 P=0.696N P=0.433N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.200N P=0.608 P=0.554N P=0.357N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.269N P=0.596 P=0.652N P=0.395N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.127N | (e) |
|FISHER EXACT | P=0.691N P=0.506N P=0.248N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 01 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 103 WEEKS
FEMALE TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 8.3 16.6 33.3 | VEHICLE 8.3 16.6 33.3 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 21/60 (35%) 18/60 (30%) 17/58 (29%) 8/59 (14%) | 28/59 (47%) 26/58 (45%) 23/58 (40%) 18/58 (31%) |
|ADJUSTED (b) | 49.7% 57.3% 56.8% 48.6% | 70.8% 60.7% 55.4% 54.0% |
|INTERIM SACRIFICE 1 (c)| 5/10 (50%) 2/10 (20%) 1/10 (10%) 0/9 (0%) | 2/10 (20%) 2/10 (20%) 1/10 (10%) 1/7 (14%) |
|TERMINAL (d) | 5/23 (22%) 7/18 (39%) 2/11 (18%) 4/10 (40%) | 20/31 (65%) 18/34 (53%) 13/31 (42%) 10/24 (42%) |
|FIRST INCIDENCE (DAYS) | 462 (I) 462 (I) 401 565 | 450 (I) 451 (I) 451 (I) 442 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.238N P=0.486 P=0.356 P=0.226N | P=0.271N P=0.277N P=0.245N P=0.282N |
|INCIDENTAL TUMOR | P=0.011N* P=0.505N P=0.256N P=0.023N* | P=0.060N P=0.155N P=0.128N P=0.076N |
|LOGISTIC REGRESSION | P=0.012N* P=0.424N P=0.360N P=0.014N* | P=0.087N P=0.303N P=0.167N P=0.124N |
|COCHRAN-ARMITAGE | P=0.005N** | P=0.032N* |
|FISHER EXACT | P=0.348N P=0.322N P=0.006N** | P=0.460N P=0.253N P=0.051N |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 16.1% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 0/23 (0%) 0/18 (0%) 1/11 (9%) 0/10 (0%) | 0/32 (0%) 0/34 (0%) 0/31 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 704 --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.432 (e) P=0.109 (e) | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.496 (e) P=0.173 (e) | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.449 (e) P=0.133 (e) | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.597 | (e) |
|FISHER EXACT | (e) P=0.248 (e) | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 01 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 103 WEEKS
FEMALE TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 8.3 16.6 33.3 | VEHICLE 8.3 16.6 33.3 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 1/60 (2%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 13.0% 5.6% 0.0% 0.0% | 0.0% 2.1% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 3/23 (13%) 1/18 (6%) 0/11 (0%) 0/10 (0%) | 0/32 (0%) 0/34 (0%) 0/31 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 717 (T) 717 (T) --- --- | --- 597 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.121N P=0.394N P=0.275N P=0.298N | P=0.622N P=0.532 (e) (e) |
|INCIDENTAL TUMOR | P=0.121N P=0.394N P=0.275N P=0.298N | P=0.483N P=0.682 (e) (e) |
|LOGISTIC REGRESSION | P=0.121N P=0.394N P=0.275N P=0.298N | P=0.557N P=0.482 (e) (e) |
|COCHRAN-ARMITAGE | P=0.044N* | P=0.568N |
|FISHER EXACT | P=0.309N P=0.122N P=0.122N | P=0.500 (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 1/60 (2%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 8.7% 5.6% 0.0% 0.0% | 0.0% 2.1% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 2/23 (9%) 1/18 (6%) 0/11 (0%) 0/10 (0%) | 0/32 (0%) 0/34 (0%) 0/31 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 717 (T) 717 (T) --- --- | --- 597 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.214N P=0.586N P=0.411N P=0.434N | P=0.622N P=0.532 (e) (e) |
|INCIDENTAL TUMOR | P=0.214N P=0.586N P=0.411N P=0.434N | P=0.483N P=0.682 (e) (e) |
|LOGISTIC REGRESSION | P=0.214N P=0.586N P=0.411N P=0.434N | P=0.557N P=0.482 (e) (e) |
|COCHRAN-ARMITAGE | P=0.101N | P=0.568N |
|FISHER EXACT | P=0.500N P=0.248N P=0.248N | P=0.500 (e) (e) |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 01 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 103 WEEKS
FEMALE TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 8.3 16.6 33.3 | VEHICLE 8.3 16.6 33.3 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, |
| Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/60 (7%) 1/60 (2%) 2/60 (3%) 0/60 (0%) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 14.5% 5.6% 16.1% 0.0% | 0.0% 5.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 3/23 (13%) 1/18 (6%) 1/11 (9%) 0/10 (0%) | 0/32 (0%) 1/34 (3%) 0/31 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 462 (I) 717 (T) 704 --- | --- 597 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.166N P=0.241N P=0.623N P=0.168N | P=0.467N P=0.264 (e) (e) |
|INCIDENTAL TUMOR | P=0.146N P=0.241N P=0.561N P=0.168N | P=0.373N P=0.344 (e) (e) |
|LOGISTIC REGRESSION | P=0.092N P=0.222N P=0.423N P=0.086N | P=0.431N P=0.245 (e) (e) |
|COCHRAN-ARMITAGE | P=0.053N | P=0.405N |
|FISHER EXACT | P=0.182N P=0.340N P=0.059N | P=0.248 (e) (e) |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 3/60 (5%) 4/60 (7%) 2/60 (3%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 8.5% 7.7% 12.4% 9.0% | 3.1% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 0/23 (0%) 0/18 (0%) 0/11 (0%) 0/10 (0%) | 1/32 (3%) 0/34 (0%) 0/31 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 595 529 520 617 | 729 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.540 P=0.543 P=0.348 P=0.601 | P=0.339N P=0.488N P=0.506N P=0.557N |
|INCIDENTAL TUMOR | P=0.275N P=0.564N P=0.603N P=0.429N | P=0.339N P=0.488N P=0.506N P=0.557N |
|LOGISTIC REGRESSION | P=0.202N P=0.591N P=0.487 P=0.587N | P=0.339N P=0.488N P=0.506N P=0.557N |
|COCHRAN-ARMITAGE | P=0.420N | P=0.307N |
|FISHER EXACT | P=0.660N P=0.500 P=0.500N | P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 01 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 103 WEEKS
FEMALE TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 8.3 16.6 33.3 | VEHICLE 8.3 16.6 33.3 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, Sarcoma, |
| Neurofibroma, or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 3/60 (5%) 5/60 (8%) 2/60 (3%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 8.5% 7.7% 14.4% 9.0% | 3.1% 0.0% 0.0% 3.3% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 0/23 (0%) 0/18 (0%) 0/11 (0%) 0/10 (0%) | 1/32 (3%) 0/34 (0%) 0/31 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 595 529 520 617 | 729 (T) --- --- 629 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.517 P=0.543 P=0.229 P=0.601 | P=0.535 P=0.488N P=0.506N P=0.695 |
|INCIDENTAL TUMOR | P=0.270N P=0.564N P=0.586 P=0.429N | P=0.627 P=0.488N P=0.506N P=0.703N |
|LOGISTIC REGRESSION | P=0.204N P=0.591N P=0.534 P=0.587N | P=0.559 P=0.488N P=0.506N P=0.723 |
|COCHRAN-ARMITAGE | P=0.442N | P=0.595 |
|FISHER EXACT | P=0.660N P=0.359 P=0.500N | P=0.500N P=0.500N P=0.752N |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 52/60 (87%) 48/60 (80%) 50/60 (83%) 50/60 (83%) | |
|ADJUSTED (b) | 100.0% 97.9% 100.0% 98.0% | |
|INTERIM SACRIFICE 1 (c)| 5/10 (50%) 4/10 (40%) 6/10 (60%) 7/9 (78%) | |
|TERMINAL (d) | 23/23 (100%) 17/18 (94%) 11/11 (100%) 9/10 (90%) | |
|FIRST INCIDENCE (DAYS) | 462 (I) 462 (I) 462 (I) 458 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.200 P=0.009 ** P<0.001 ** | |
|INCIDENTAL TUMOR | P=0.139 P=0.446N P=0.525 P=0.260 | |
|LOGISTIC REGRESSION | P=0.143 P=0.599N P=0.589 P=0.243 | |
|COCHRAN-ARMITAGE | P=0.454N | |
|FISHER EXACT | P=0.232N P=0.399N P=0.399N | |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 01 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 103 WEEKS
FEMALE TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 8.3 16.6 33.3 | VEHICLE 8.3 16.6 33.3 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/59 (7%) 5/59 (8%) 3/54 (6%) 2/50 (4%) | 4/59 (7%) 4/59 (7%) 10/55 (18%) 2/54 (4%) |
|ADJUSTED (b) | 11.6% 21.0% 15.6% 11.7% | 12.5% 11.3% 32.3% 8.3% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/9 (11%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 1/23 (4%) 2/18 (11%) 1/11 (9%) 1/10 (10%) | 4/32 (13%) 3/34 (9%) 10/31 (32%) 2/24 (8%) |
|FIRST INCIDENCE (DAYS) | 602 563 625 462 (I) | 729 (T) 692 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.503N P=0.346 P=0.580 P=0.590N | P=0.551 P=0.608N P=0.058 P=0.475N |
|INCIDENTAL TUMOR | P=0.315N P=0.423 P=0.561N P=0.431N | P=0.557 P=0.614N P=0.058 P=0.475N |
|LOGISTIC REGRESSION | P=0.358N P=0.414 P=0.626N P=0.450N | P=0.539 P=0.606N P=0.057 P=0.475N |
|COCHRAN-ARMITAGE | P=0.275N | P=0.440N |
|FISHER EXACT | P=0.500 P=0.550N P=0.421N | P=0.642N P=0.058 P=0.383N |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/59 (7%) 5/59 (8%) 3/54 (6%) 2/50 (4%) | 4/59 (7%) 4/59 (7%) 10/55 (18%) 3/54 (6%) |
|ADJUSTED (b) | 11.6% 21.0% 15.6% 11.7% | 12.5% 11.3% 32.3% 12.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/9 (11%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 1/23 (4%) 2/18 (11%) 1/11 (9%) 1/10 (10%) | 4/32 (13%) 3/34 (9%) 10/31 (32%) 3/24 (13%) |
|FIRST INCIDENCE (DAYS) | 602 563 625 462 (I) | 729 (T) 692 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.503N P=0.346 P=0.580 P=0.590N | P=0.389 P=0.608N P=0.058 P=0.657 |
|INCIDENTAL TUMOR | P=0.315N P=0.423 P=0.561N P=0.431N | P=0.394 P=0.614N P=0.058 P=0.657 |
|LOGISTIC REGRESSION | P=0.358N P=0.414 P=0.626N P=0.450N | P=0.375 P=0.606N P=0.057 P=0.657 |
|COCHRAN-ARMITAGE | P=0.275N | P=0.540 |
|FISHER EXACT | P=0.500 P=0.550N P=0.421N | P=0.642N P=0.058 P=0.550N |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 01 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 103 WEEKS
FEMALE TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 8.3 16.6 33.3 | VEHICLE 8.3 16.6 33.3 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/59 (2%) 1/59 (2%) 1/54 (2%) 0/50 (0%) | 2/59 (3%) 2/59 (3%) 2/55 (4%) 0/54 (0%) |
|ADJUSTED (b) | 4.3% 2.1% 5.0% 0.0% | 6.3% 5.9% 6.5% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 1/23 (4%) 0/18 (0%) 0/11 (0%) 0/10 (0%) | 2/32 (6%) 2/34 (6%) 2/31 (6%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 717 (T) 491 691 --- | 729 (T) 729 (T) 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.441N P=0.729 P=0.638 P=0.666N | P=0.226N P=0.674N P=0.684 P=0.303N |
|INCIDENTAL TUMOR | P=0.455N P=0.631N P=0.673 P=0.666N | P=0.226N P=0.674N P=0.684 P=0.303N |
|LOGISTIC REGRESSION | P=0.370N P=0.753N P=0.652 P=0.666N | P=0.226N P=0.674N P=0.684 P=0.303N |
|COCHRAN-ARMITAGE | P=0.351N | P=0.185N |
|FISHER EXACT | P=0.752N P=0.730 P=0.541N | P=0.691N P=0.664 P=0.270N |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/59 (2%) 1/59 (2%) 1/54 (2%) 0/50 (0%) | 2/59 (3%) 2/59 (3%) 3/55 (5%) 0/54 (0%) |
|ADJUSTED (b) | 4.3% 2.1% 5.0% 0.0% | 6.3% 5.9% 9.7% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 1/23 (4%) 0/18 (0%) 0/11 (0%) 0/10 (0%) | 2/32 (6%) 2/34 (6%) 3/31 (10%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 717 (T) 491 691 --- | 729 (T) 729 (T) 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.441N P=0.729 P=0.638 P=0.666N | P=0.279N P=0.674N P=0.485 P=0.303N |
|INCIDENTAL TUMOR | P=0.455N P=0.631N P=0.673 P=0.666N | P=0.279N P=0.674N P=0.485 P=0.303N |
|LOGISTIC REGRESSION | P=0.370N P=0.753N P=0.652 P=0.666N | P=0.279N P=0.674N P=0.485 P=0.303N |
|COCHRAN-ARMITAGE | P=0.351N | P=0.226N |
|FISHER EXACT | P=0.752N P=0.730 P=0.541N | P=0.691N P=0.467 P=0.270N |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 01 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 103 WEEKS
FEMALE TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 8.3 16.6 33.3 | VEHICLE 8.3 16.6 33.3 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 12/60 (20%) 7/60 (12%) 5/60 (8%) 1/60 (2%) |
|ADJUSTED (b) | | 28.5% 17.6% 14.4% 4.2% |
|INTERIM SACRIFICE 1 (c)| | 2/10 (20%) 1/10 (10%) 1/10 (10%) 0/7 (0%) |
|TERMINAL (d) | | 5/32 (16%) 4/34 (12%) 4/31 (13%) 1/24 (4%) |
|FIRST INCIDENCE (DAYS) | | 450 (I) 451 (I) 450 (I) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.004N** P=0.135N P=0.068N P=0.009N** |
|INCIDENTAL TUMOR | | P=0.002N** P=0.124N P=0.056N P=0.003N** |
|LOGISTIC REGRESSION | | P=0.001N** P=0.157N P=0.057N P=0.002N** |
|COCHRAN-ARMITAGE | | P<0.001N** |
|FISHER EXACT | | P=0.159N P=0.057N P=0.001N** |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 13/60 (22%) 7/60 (12%) 5/60 (8%) 1/60 (2%) |
|ADJUSTED (b) | | 29.8% 17.6% 14.4% 4.2% |
|INTERIM SACRIFICE 1 (c)| | 2/10 (20%) 1/10 (10%) 1/10 (10%) 0/7 (0%) |
|TERMINAL (d) | | 5/32 (16%) 4/34 (12%) 4/31 (13%) 1/24 (4%) |
|FIRST INCIDENCE (DAYS) | | 413 451 (I) 450 (I) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.002N** P=0.095N P=0.046N* P=0.006N** |
|INCIDENTAL TUMOR | | P=0.001N** P=0.114N P=0.044N* P=0.001N** |
|LOGISTIC REGRESSION | | P<0.001N** P=0.118N P=0.037N* P=0.001N** |
|COCHRAN-ARMITAGE | | P<0.001N** |
|FISHER EXACT | | P=0.110N P=0.036N* P<0.001N** |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 01 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 103 WEEKS
FEMALE TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 8.3 16.6 33.3 | VEHICLE 8.3 16.6 33.3 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 5.8% 4.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 0/23 (0%) 0/18 (0%) 0/11 (0%) 0/10 (0%) | 0/32 (0%) 0/34 (0%) 0/31 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 184 625 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.173 (e) P=0.194 P=0.406 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.426 (e) P=0.253 P=0.648 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.328 (e) P=0.258 P=0.484 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.247 | (e) |
|FISHER EXACT | (e) P=0.248 P=0.500 | (e) (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, |
| or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 22/60 (37%) 31/60 (52%) 24/60 (40%) 19/60 (32%) | 17/60 (28%) 18/60 (30%) 13/60 (22%) 9/60 (15%) |
|ADJUSTED (b) | 58.6% 82.1% 72.3% 64.9% | 40.2% 41.8% 36.4% 30.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 9/23 (39%) 12/18 (67%) 5/11 (45%) 3/10 (30%) | 8/32 (25%) 10/34 (29%) 9/31 (29%) 5/24 (21%) |
|FIRST INCIDENCE (DAYS) | 512 501 479 365 | 412 479 643 499 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.145 P=0.013 * P=0.044 * P=0.097 | P=0.158N P=0.558N P=0.299N P=0.222N |
|INCIDENTAL TUMOR | P=0.164N P=0.035 * P=0.544N P=0.347N | P=0.042N* P=0.351 P=0.318N P=0.110N |
|LOGISTIC REGRESSION | P=0.152N P=0.016 * P=0.447 P=0.502 | P=0.058N P=0.498N P=0.257N P=0.118N |
|COCHRAN-ARMITAGE | P=0.142N | P=0.027N* |
|FISHER EXACT | P=0.071 P=0.426 P=0.350N | P=0.500 P=0.264N P=0.060N |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 01 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 103 WEEKS
FEMALE TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 8.3 16.6 33.3 | VEHICLE 8.3 16.6 33.3 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma And Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 5.8% 4.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 0/23 (0%) 0/18 (0%) 0/11 (0%) 0/10 (0%) | 0/32 (0%) 0/34 (0%) 0/31 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 184 625 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.173 (e) P=0.194 P=0.406 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.426 (e) P=0.253 P=0.648 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.328 (e) P=0.258 P=0.484 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.247 | (e) |
|FISHER EXACT | (e) P=0.248 P=0.500 | (e) (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 57/60 (95%) 52/60 (87%) 54/60 (90%) 52/60 (87%) | 43/60 (72%) 37/60 (62%) 40/60 (67%) 24/60 (40%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 93.3% 80.0% 90.8% 66.8% |
|INTERIM SACRIFICE 1 (c)| 9/10 (90%) 5/10 (50%) 7/10 (70%) 8/9 (89%) | 4/10 (40%) 2/10 (20%) 2/10 (20%) 1/7 (14%) |
|TERMINAL (d) | 23/23 (100%) 18/18 (100%) 11/11 (100%) 10/10 (100%)| 29/32 (91%) 25/34 (74%) 27/31 (87%) 13/24 (54%) |
|FIRST INCIDENCE (DAYS) | 462 (I) 462 (I) 401 458 | 450 (I) 451 (I) 450 (I) 421 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.001 ** P=0.228 P=0.013 * P=0.002 ** | P=0.099N P=0.098N P=0.424N P=0.063N |
|INCIDENTAL TUMOR | P=0.477 P=0.182N P=0.412N P=0.672 | P=0.004N** P=0.026N* P=0.267N P=0.002N** |
|LOGISTIC REGRESSION | P=0.524 P=0.284N P=0.343N P=0.548N | P=0.007N** P=0.046N* P=0.279N P=0.003N** |
|COCHRAN-ARMITAGE | P=0.150N | P<0.001N** |
|FISHER EXACT | P=0.102N P=0.245N P=0.102N | P=0.166N P=0.346N P<0.001N** |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 01 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 103 WEEKS
FEMALE TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 8.3 16.6 33.3 | VEHICLE 8.3 16.6 33.3 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 28/60 (47%) 32/60 (53%) 29/60 (48%) 23/60 (38%) | 19/60 (32%) 18/60 (30%) 16/60 (27%) 16/60 (27%) |
|ADJUSTED (b) | 69.9% 85.1% 80.2% 70.9% | 43.6% 41.8% 44.0% 47.3% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/7 (0%) |
|TERMINAL (d) | 12/23 (52%) 13/18 (72%) 6/11 (55%) 3/10 (30%) | 9/32 (28%) 10/34 (29%) 11/31 (35%) 8/24 (33%) |
|FIRST INCIDENCE (DAYS) | 512 501 184 365 | 412 479 643 371 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.102 P=0.060 P=0.040 * P=0.094 | P=0.394 P=0.412N P=0.384N P=0.474 |
|INCIDENTAL TUMOR | P=0.131N P=0.182 P=0.512N P=0.212N | P=0.368N P=0.463 P=0.442N P=0.446N |
|LOGISTIC REGRESSION | P=0.352N P=0.113 P=0.352 P=0.343N | P=0.501N P=0.449N P=0.337N P=0.484N |
|COCHRAN-ARMITAGE | P=0.127N | P=0.290N |
|FISHER EXACT | P=0.292 P=0.500 P=0.230N | P=0.500N P=0.344N P=0.344N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 57/60 (95%) 52/60 (87%) 57/60 (95%) 54/60 (90%) | 50/60 (83%) 44/60 (73%) 41/60 (68%) 33/60 (55%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 96.1% 86.2% 93.1% 81.6% |
|INTERIM SACRIFICE 1 (c)| 9/10 (90%) 5/10 (50%) 7/10 (70%) 8/9 (89%) | 4/10 (40%) 2/10 (20%) 2/10 (20%) 1/7 (14%) |
|TERMINAL (d) | 23/23 (100%) 18/18 (100%) 11/11 (100%) 10/10 (100%)| 30/32 (94%) 27/34 (79%) 28/31 (90%) 17/24 (71%) |
|FIRST INCIDENCE (DAYS) | 462 (I) 462 (I) 184 365 | 412 451 (I) 450 (I) 371 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.228 P=0.005 ** P<0.001 ** | P=0.246N P=0.110N P=0.122N P=0.214N |
|INCIDENTAL TUMOR | P=0.241 P=0.182N P=0.657 P=0.485 | P=0.002N** P=0.050N P=0.030N* P=0.002N** |
|LOGISTIC REGRESSION | P=0.192 P=0.284N P=0.584 P=0.509 | P=0.012N* P=0.017N* P=0.013N* P=0.006N** |
|COCHRAN-ARMITAGE | P=0.376N | P<0.001N** |
|FISHER EXACT | P=0.102N P=0.660N P=0.245N | P=0.134N P=0.043N* P<0.001N** |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 01 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 103 WEEKS
FEMALE 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.
(c) Observed incidence at interim kill.
Male interim sacrifices(days): 462
Female interim sacrifices(days): 450
(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).