TDMS Study 05108-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Mason PROMETHAZINE HYDROCHLORIDE DATE: 09/14/94
EXPERIMENT: 05108 TEST: 02 TIME: 00:32:03
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: 09/14/94
EXPERIMENT: 05108 TEST: 02 TIME: 00:32:03
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
MICE(B6C3F1)
----------------------------
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
Gallbladder
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: 09/14/94
EXPERIMENT: 05108 TEST: 02 TIME: 00:32:03
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 MICE
-------------
ORGAN MORPHOLOGY
------- ------------
All Organs Malignant Tumors
====================================================================================================
FEMALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
All Organs Malignant Lymphoma And Histiocytic Sarcoma
====================================================================================================
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 02 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 11.25 22.5 45.0 | VEHICLE 3.75 7.5 15.0 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/58 (3%) 2/60 (3%) 5/58 (9%) 0/59 (0%) | 2/60 (3%) 0/60 (0%) 1/60 (2%) 0/60 (0%) |
|ADJUSTED (b) | 4.9% 4.5% 12.4% 0.0% | 5.1% 0.0% 2.6% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 1/37 (3%) 2/44 (5%) 4/39 (10%) 0/43 (0%) | 2/39 (5%) 0/42 (0%) 1/39 (3%) 0/41 (0%) |
|FIRST INCIDENCE (DAYS) | 627 729 (T) 725 --- | 736 (T) --- 736 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.232N P=0.644N P=0.237 P=0.214N | P=0.184N P=0.222N P=0.500N P=0.227N |
|INCIDENTAL TUMOR | P=0.272N P=0.683 P=0.104 P=0.294N | P=0.184N P=0.222N P=0.500N P=0.227N |
|LOGISTIC REGRESSION | P=0.234N P=0.669N P=0.221 P=0.228N | P=0.184N P=0.222N P=0.500N P=0.227N |
|COCHRAN-ARMITAGE | P=0.261N | P=0.188N |
|FISHER EXACT | P=0.678N P=0.219 P=0.244N | P=0.248N P=0.500N P=0.248N |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/60 (3%) 2/60 (3%) 2/60 (3%) | 2/60 (3%) 4/60 (7%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 4.4% 5.0% 4.4% | 5.1% 9.0% 0.0% 2.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/39 (0%) 1/44 (2%) 2/40 (5%) 1/44 (2%) | 2/39 (5%) 3/42 (7%) 0/39 (0%) 1/41 (2%) |
|FIRST INCIDENCE (DAYS) | --- 649 729 (T) 703 | 736 (T) 554 --- 736 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.271 P=0.261 P=0.244 P=0.269 | P=0.194N P=0.370 P=0.238N P=0.483N |
|INCIDENTAL TUMOR | P=0.281 P=0.177 P=0.244 P=0.253 | P=0.182N P=0.287 P=0.238N P=0.483N |
|LOGISTIC REGRESSION | P=0.263 P=0.241 P=0.244 P=0.256 | P=0.205N P=0.351 P=0.238N P=0.483N |
|COCHRAN-ARMITAGE | P=0.242 | P=0.200N |
|FISHER EXACT | P=0.248 P=0.248 P=0.248 | P=0.340 P=0.248N P=0.500N |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 02 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 11.25 22.5 45.0 | VEHICLE 3.75 7.5 15.0 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 2/60 (3%) 2/60 (3%) 2/60 (3%) | 3/60 (5%) 4/60 (7%) 1/60 (2%) 1/60 (2%) |
|ADJUSTED (b) | 2.5% 4.4% 5.0% 4.4% | 7.4% 9.0% 2.3% 2.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/39 (0%) 1/44 (2%) 2/40 (5%) 1/44 (2%) | 2/39 (5%) 3/42 (7%) 0/39 (0%) 1/41 (2%) |
|FIRST INCIDENCE (DAYS) | 722 649 729 (T) 703 | 720 554 707 736 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.458 P=0.533 P=0.509 P=0.541 | P=0.136N P=0.539 P=0.308N P=0.289N |
|INCIDENTAL TUMOR | P=0.475 P=0.348 P=0.506 P=0.515 | P=0.147N P=0.463 P=0.337N P=0.328N |
|LOGISTIC REGRESSION | P=0.449 P=0.509 P=0.508 P=0.531 | P=0.142N P=0.517 P=0.305N P=0.304N |
|COCHRAN-ARMITAGE | P=0.423 | P=0.138N |
|FISHER EXACT | P=0.500 P=0.500 P=0.500 | P=0.500 P=0.309N P=0.309N |
|=================================================================================================================================|
| |
|Intestine Small |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) 2/60 (3%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 2.3% 4.8% 2.3% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/39 (0%) 1/44 (2%) 1/40 (3%) 1/44 (2%) | 0/39 (0%) 0/42 (0%) 0/39 (0%) 0/41 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) 710 729 (T) | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.392 P=0.524 P=0.248 P=0.524 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.401 P=0.524 P=0.243 P=0.524 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.391 P=0.524 P=0.240 P=0.524 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.367 | (e) |
|FISHER EXACT | P=0.500 P=0.248 P=0.500 | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 02 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 11.25 22.5 45.0 | VEHICLE 3.75 7.5 15.0 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Intestine Small, Jejunum |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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% 4.8% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/39 (0%) 0/44 (0%) 1/40 (3%) 0/44 (0%) | 0/39 (0%) 0/42 (0%) 0/39 (0%) 0/41 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 710 --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.611 (e) P=0.248 (e) | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.619 (e) P=0.243 (e) | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.610 (e) P=0.240 (e) | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.595 | (e) |
|FISHER EXACT | (e) P=0.248 (e) | (e) (e) (e) |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/60 (0%) 0/59 (0%) 3/60 (5%) | 1/59 (2%) 0/59 (0%) 0/60 (0%) 0/59 (0%) |
|ADJUSTED (b) | 2.2% 0.0% 0.0% 6.8% | 2.4% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/39 (0%) 0/44 (0%) 0/40 (0%) 3/44 (7%) | 0/38 (0%) 0/42 (0%) 0/39 (0%) 0/41 (0%) |
|FIRST INCIDENCE (DAYS) | 627 --- --- 729 (T) | 718 --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.099 P=0.496N P=0.504N P=0.347 | P=0.306N P=0.486N P=0.500N P=0.495N |
|INCIDENTAL TUMOR | P=0.076 P=0.638N (e) P=0.277 | P=0.354N P=0.500N P=0.536N P=0.581N |
|LOGISTIC REGRESSION | P=0.094 P=0.499N P=0.505N P=0.327 | P=0.306N P=0.490N P=0.496N P=0.500N |
|COCHRAN-ARMITAGE | P=0.087 | P=0.305N |
|FISHER EXACT | P=0.500N P=0.504N P=0.309 | P=0.500N P=0.496N P=0.500N |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 02 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 11.25 22.5 45.0 | VEHICLE 3.75 7.5 15.0 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/59 (0%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 4.5% 0.0% 2.3% | 0.0% 0.0% 2.1% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/39 (0%) 2/44 (5%) 0/40 (0%) 1/44 (2%) | 0/39 (0%) 0/42 (0%) 0/39 (0%) 0/41 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) --- 729 (T) | --- --- 626 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.560 P=0.265 (e) P=0.524 | P=0.696 (e) P=0.513 (e) |
|INCIDENTAL TUMOR | P=0.560 P=0.265 (e) P=0.524 | P=0.738 (e) P=0.602 (e) |
|LOGISTIC REGRESSION | P=0.560 P=0.265 (e) P=0.524 | P=0.707 (e) P=0.502 (e) |
|COCHRAN-ARMITAGE | P=0.539 | P=0.694 |
|FISHER EXACT | P=0.248 (e) P=0.500 | (e) P=0.500 (e) |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 17/60 (28%) 15/60 (25%) 15/59 (25%) 21/60 (35%) | 3/60 (5%) 4/60 (7%) 6/60 (10%) 9/60 (15%) |
|ADJUSTED (b) | 36.5% 30.1% 33.9% 43.6% | 7.7% 9.3% 14.7% 20.9% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 3/10 (30%) 1/10 (10%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 1/9 (11%) |
|TERMINAL (d) | 10/39 (26%) 10/44 (23%) 12/40 (30%) 17/44 (39%) | 3/39 (8%) 3/42 (7%) 5/39 (13%) 8/41 (20%) |
|FIRST INCIDENCE (DAYS) | 458 (I) 458 (I) 444 460 (I) | 736 (T) 725 629 462 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.284 P=0.319N P=0.400N P=0.433 | P=0.031 * P=0.542 P=0.246 P=0.071 |
|INCIDENTAL TUMOR | P=0.213 P=0.540N P=0.563N P=0.313 | P=0.030 * P=0.546 P=0.271 P=0.071 |
|LOGISTIC REGRESSION | P=0.226 P=0.523N P=0.504N P=0.283 | P=0.025 * P=0.540 P=0.243 P=0.060 |
|COCHRAN-ARMITAGE | P=0.190 | P=0.029 * |
|FISHER EXACT | P=0.418N P=0.440N P=0.278 | P=0.500 P=0.245 P=0.063 |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 02 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 11.25 22.5 45.0 | VEHICLE 3.75 7.5 15.0 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/60 (13%) 9/60 (15%) 5/59 (8%) 9/60 (15%) | 1/60 (2%) 1/60 (2%) 1/60 (2%) 2/60 (3%) |
|ADJUSTED (b) | 17.3% 18.9% 10.9% 19.4% | 2.6% 2.4% 2.0% 4.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 3/39 (8%) 6/44 (14%) 2/40 (5%) 7/44 (16%) | 1/39 (3%) 1/42 (2%) 0/39 (0%) 1/41 (2%) |
|FIRST INCIDENCE (DAYS) | 362 460 (I) 522 631 | 736 (T) 736 (T) 569 734 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.523N P=0.570 P=0.283N P=0.589 | P=0.357 P=0.745N P=0.758N P=0.520 |
|INCIDENTAL TUMOR | P=0.398 P=0.345 P=0.367N P=0.347 | P=0.345 P=0.745N P=0.705N P=0.465 |
|LOGISTIC REGRESSION | P=0.475 P=0.501 P=0.293N P=0.522 | P=0.343 P=0.745N P=0.762N P=0.510 |
|COCHRAN-ARMITAGE | P=0.511 | P=0.351 |
|FISHER EXACT | P=0.500 P=0.290N P=0.500 | P=0.752N P=0.752N P=0.500 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/60 (13%) 9/60 (15%) 5/59 (8%) 10/60 (17%) | 1/60 (2%) 1/60 (2%) 1/60 (2%) 2/60 (3%) |
|ADJUSTED (b) | 17.3% 18.9% 10.9% 21.6% | 2.6% 2.4% 2.0% 4.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 3/39 (8%) 6/44 (14%) 2/40 (5%) 8/44 (18%) | 1/39 (3%) 1/42 (2%) 0/39 (0%) 1/41 (2%) |
|FIRST INCIDENCE (DAYS) | 362 460 (I) 522 631 | 736 (T) 736 (T) 569 734 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.468 P=0.570 P=0.283N P=0.496 | P=0.357 P=0.745N P=0.758N P=0.520 |
|INCIDENTAL TUMOR | P=0.290 P=0.345 P=0.367N P=0.261 | P=0.345 P=0.745N P=0.705N P=0.465 |
|LOGISTIC REGRESSION | P=0.365 P=0.501 P=0.293N P=0.425 | P=0.343 P=0.745N P=0.762N P=0.510 |
|COCHRAN-ARMITAGE | P=0.397 | P=0.351 |
|FISHER EXACT | P=0.500 P=0.290N P=0.399 | P=0.752N P=0.752N P=0.500 |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 02 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 11.25 22.5 45.0 | VEHICLE 3.75 7.5 15.0 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 19/60 (32%) 22/60 (37%) 18/59 (31%) 26/60 (43%) | 4/60 (7%) 4/60 (7%) 7/60 (12%) 11/60 (18%) |
|ADJUSTED (b) | 39.7% 43.6% 38.9% 52.9% | 10.3% 9.3% 16.4% 25.1% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 4/10 (40%) 1/10 (10%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 1/9 (11%) |
|TERMINAL (d) | 11/39 (28%) 16/44 (36%) 13/40 (33%) 21/44 (48%) | 4/39 (10%) 3/42 (7%) 5/39 (13%) 9/41 (22%) |
|FIRST INCIDENCE (DAYS) | 362 458 (I) 444 460 (I) | 736 (T) 725 569 462 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.227 P=0.489 P=0.477N P=0.267 | P=0.016 * P=0.600N P=0.268 P=0.057 |
|INCIDENTAL TUMOR | P=0.119 P=0.276 P=0.562 P=0.099 | P=0.014 * P=0.596N P=0.315 P=0.050 * |
|LOGISTIC REGRESSION | P=0.156 P=0.355 P=0.522N P=0.170 | P=0.012 * P=0.604N P=0.262 P=0.045 * |
|COCHRAN-ARMITAGE | P=0.130 | P=0.015 * |
|FISHER EXACT | P=0.350 P=0.525N P=0.129 | P=0.641N P=0.264 P=0.048 * |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 19/60 (32%) 22/60 (37%) 18/59 (31%) 26/60 (43%) | 4/60 (7%) 4/60 (7%) 7/60 (12%) 11/60 (18%) |
|ADJUSTED (b) | 39.7% 43.6% 38.9% 52.9% | 10.3% 9.3% 16.4% 25.1% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 4/10 (40%) 1/10 (10%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 1/9 (11%) |
|TERMINAL (d) | 11/39 (28%) 16/44 (36%) 13/40 (33%) 21/44 (48%) | 4/39 (10%) 3/42 (7%) 5/39 (13%) 9/41 (22%) |
|FIRST INCIDENCE (DAYS) | 362 458 (I) 444 460 (I) | 736 (T) 725 569 462 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.227 P=0.489 P=0.477N P=0.267 | P=0.016 * P=0.600N P=0.268 P=0.057 |
|INCIDENTAL TUMOR | P=0.119 P=0.276 P=0.562 P=0.099 | P=0.014 * P=0.596N P=0.315 P=0.050 * |
|LOGISTIC REGRESSION | P=0.156 P=0.355 P=0.522N P=0.170 | P=0.012 * P=0.604N P=0.262 P=0.045 * |
|COCHRAN-ARMITAGE | P=0.130 | P=0.015 * |
|FISHER EXACT | P=0.350 P=0.525N P=0.129 | P=0.641N P=0.264 P=0.048 * |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 02 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 11.25 22.5 45.0 | VEHICLE 3.75 7.5 15.0 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/60 (15%) 6/60 (10%) 6/60 (10%) 7/60 (12%) | 8/60 (13%) 2/60 (3%) 0/59 (0%) 2/60 (3%) |
|ADJUSTED (b) | 22.2% 13.6% 14.5% 15.9% | 17.7% 4.8% 0.0% 4.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 2/10 (20%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 8/39 (21%) 6/44 (14%) 5/40 (13%) 7/44 (16%) | 4/39 (10%) 2/42 (5%) 0/38 (0%) 2/41 (5%) |
|FIRST INCIDENCE (DAYS) | 580 729 (T) 693 729 (T) | 464 (I) 736 (T) --- 736 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.326N P=0.213N P=0.275N P=0.299N | P=0.024N* P=0.043N* P=0.007N** P=0.051N |
|INCIDENTAL TUMOR | P=0.351N P=0.240N P=0.368N P=0.333N | P=0.028N* P=0.039N* P=0.008N** P=0.063N |
|LOGISTIC REGRESSION | P=0.329N P=0.250N P=0.281N P=0.318N | P=0.024N* P=0.049N* P=0.006N** P=0.051N |
|COCHRAN-ARMITAGE | P=0.393N | P=0.023N* |
|FISHER EXACT | P=0.291N P=0.291N P=0.395N | P=0.047N* P=0.003N** P=0.047N* |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 6/60 (10%) 1/60 (2%) 1/60 (2%) | 2/60 (3%) 0/60 (0%) 0/59 (0%) 0/60 (0%) |
|ADJUSTED (b) | 4.9% 12.9% 2.5% 2.3% | 4.7% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 1/39 (3%) 5/44 (11%) 1/40 (3%) 1/44 (2%) | 0/39 (0%) 0/42 (0%) 0/38 (0%) 0/41 (0%) |
|FIRST INCIDENCE (DAYS) | 676 458 (I) 729 (T) 729 (T) | 693 --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.143N P=0.173 P=0.491N P=0.459N | P=0.117N P=0.225N P=0.239N P=0.239N |
|INCIDENTAL TUMOR | P=0.142N P=0.139 P=0.494N P=0.472N | P=0.146N P=0.196N P=0.270N P=0.323N |
|LOGISTIC REGRESSION | P=0.150N P=0.140 P=0.498N P=0.474N | P=0.117N P=0.230N P=0.242N P=0.241N |
|COCHRAN-ARMITAGE | P=0.163N | P=0.116N |
|FISHER EXACT | P=0.136 P=0.500N P=0.500N | P=0.248N P=0.252N P=0.248N |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 02 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 11.25 22.5 45.0 | VEHICLE 3.75 7.5 15.0 |
| | 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) | 11/60 (18%) 10/60 (17%) 7/60 (12%) 8/60 (13%) | 10/60 (17%) 2/60 (3%) 0/59 (0%) 2/60 (3%) |
|ADJUSTED (b) | 26.5% 21.8% 17.0% 18.2% | 21.5% 4.8% 0.0% 4.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | 2/10 (20%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 9/39 (23%) 9/44 (20%) 6/40 (15%) 8/44 (18%) | 4/39 (10%) 2/42 (5%) 0/38 (0%) 2/41 (5%) |
|FIRST INCIDENCE (DAYS) | 580 458 (I) 693 729 (T) | 464 (I) 736 (T) --- 736 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.175N P=0.394N P=0.207N P=0.216N | P=0.007N** P=0.015N* P=0.002N** P=0.019N* |
|INCIDENTAL TUMOR | P=0.189N P=0.460N P=0.279N P=0.247N | P=0.009N** P=0.010N* P=0.002N** P=0.024N* |
|LOGISTIC REGRESSION | P=0.181N P=0.468N P=0.211N P=0.234N | P=0.006N** P=0.016N* P=0.002N** P=0.017N* |
|COCHRAN-ARMITAGE | P=0.232N | P=0.006N** |
|FISHER EXACT | P=0.500N P=0.222N P=0.309N | P=0.015N* P<0.001N** P=0.015N* |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 0/59 (0%) 2/59 (3%) 2/58 (3%) 1/58 (2%) |
|ADJUSTED (b) | | 0.0% 4.5% 5.4% 2.4% |
|INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | | 0/38 (0%) 1/41 (2%) 2/37 (5%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | | --- 693 736 (T) 734 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.473 P=0.255 P=0.232 P=0.515 |
|INCIDENTAL TUMOR | | P=0.412 P=0.265 P=0.232 P=0.419 |
|LOGISTIC REGRESSION | | P=0.459 P=0.247 P=0.232 P=0.502 |
|COCHRAN-ARMITAGE | | P=0.463 |
|FISHER EXACT | | P=0.248 P=0.244 P=0.496 |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 02 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 11.25 22.5 45.0 | VEHICLE 3.75 7.5 15.0 |
| | 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) | 0/58 (0%) 0/60 (0%) 0/55 (0%) 0/56 (0%) | 5/56 (9%) 3/59 (5%) 4/59 (7%) 3/58 (5%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 13.4% 7.3% 9.3% 7.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/38 (0%) 0/44 (0%) 0/35 (0%) 0/40 (0%) | 4/35 (11%) 3/41 (7%) 2/38 (5%) 3/39 (8%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 622 736 (T) 629 736 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.316N P=0.280N P=0.461N P=0.306N |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.279N P=0.347N P=0.359N P=0.306N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.339N P=0.293N P=0.462N P=0.335N |
|COCHRAN-ARMITAGE | (e) | P=0.329N |
|FISHER EXACT | (e) (e) (e) | P=0.329N P=0.467N P=0.339N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/58 (0%) 0/60 (0%) 0/55 (0%) 0/56 (0%) | 5/56 (9%) 3/59 (5%) 5/59 (8%) 3/58 (5%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 13.4% 7.3% 11.3% 7.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/38 (0%) 0/44 (0%) 0/35 (0%) 0/40 (0%) | 4/35 (11%) 3/41 (7%) 2/38 (5%) 3/39 (8%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 622 736 (T) 629 736 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.337N P=0.280N P=0.589N P=0.306N |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.287N P=0.347N P=0.465N P=0.306N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.360N P=0.293N P=0.593N P=0.335N |
|COCHRAN-ARMITAGE | (e) | P=0.349N |
|FISHER EXACT | (e) (e) (e) | P=0.329N P=0.595N P=0.339N |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 02 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 11.25 22.5 45.0 | VEHICLE 3.75 7.5 15.0 |
| | 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) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 2/60 (3%) 2/60 (3%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 4.6% 4.6% 0.0% 2.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/39 (0%) 0/44 (0%) 0/40 (0%) 0/44 (0%) | 1/39 (3%) 1/42 (2%) 0/39 (0%) 0/41 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 582 722 --- 734 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.293N P=0.666N P=0.240N P=0.491N |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.324N P=0.632 P=0.185N P=0.541N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.302N P=0.689N P=0.238N P=0.504N |
|COCHRAN-ARMITAGE | (e) | P=0.296N |
|FISHER EXACT | (e) (e) (e) | P=0.691N P=0.248N P=0.500N |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, or Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 2/60 (3%) 2/60 (3%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 4.6% 4.6% 0.0% 2.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/39 (0%) 0/44 (0%) 0/40 (0%) 0/44 (0%) | 1/39 (3%) 1/42 (2%) 0/39 (0%) 0/41 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 582 722 --- 734 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.293N P=0.666N P=0.240N P=0.491N |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.324N P=0.632 P=0.185N P=0.541N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.302N P=0.689N P=0.238N P=0.504N |
|COCHRAN-ARMITAGE | (e) | P=0.296N |
|FISHER EXACT | (e) (e) (e) | P=0.691N P=0.248N P=0.500N |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 02 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 11.25 22.5 45.0 | VEHICLE 3.75 7.5 15.0 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 1/60 (2%) 2/60 (3%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 2.6% 4.6% 0.0% 2.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/39 (0%) 0/44 (0%) 0/40 (0%) 0/44 (0%) | 1/39 (3%) 1/42 (2%) 0/39 (0%) 0/41 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 736 (T) 722 --- 734 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.490N P=0.531 P=0.500N P=0.747N |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.566N P=0.535 P=0.500N P=0.722 |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.506N P=0.523 P=0.500N P=0.759N |
|COCHRAN-ARMITAGE | (e) | P=0.500N |
|FISHER EXACT | (e) (e) (e) | P=0.500 P=0.500N P=0.752N |
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/59 (0%) 1/58 (2%) 0/60 (0%) 2/60 (3%) | 0/59 (0%) 0/59 (0%) 0/59 (0%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 2.4% 0.0% 4.3% | 0.0% 0.0% 0.0% 2.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/38 (0%) 1/42 (2%) 0/40 (0%) 1/44 (2%) | 0/38 (0%) 0/42 (0%) 0/38 (0%) 1/41 (2%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) --- 669 | --- --- --- 736 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.161 P=0.520 (e) P=0.268 | P=0.204 (e) (e) P=0.515 |
|INCIDENTAL TUMOR | P=0.168 P=0.520 (e) P=0.256 | P=0.204 (e) (e) P=0.515 |
|LOGISTIC REGRESSION | P=0.156 P=0.520 (e) P=0.254 | P=0.204 (e) (e) P=0.515 |
|COCHRAN-ARMITAGE | P=0.144 | P=0.201 |
|FISHER EXACT | P=0.496 (e) P=0.252 | (e) (e) P=0.504 |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 02 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 11.25 22.5 45.0 | VEHICLE 3.75 7.5 15.0 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 1/60 (2%) 1/60 (2%) 1/60 (2%) 2/60 (3%) |
|ADJUSTED (b) | 2.6% 0.0% 0.0% 0.0% | 2.6% 2.4% 2.6% 4.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 1/39 (3%) 0/44 (0%) 0/40 (0%) 0/44 (0%) | 1/39 (3%) 1/42 (2%) 1/39 (3%) 2/41 (5%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- --- --- | 736 (T) 736 (T) 736 (T) 736 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.296N P=0.476N P=0.495N P=0.476N | P=0.359 P=0.745N P=0.762 P=0.517 |
|INCIDENTAL TUMOR | P=0.296N P=0.476N P=0.495N P=0.476N | P=0.359 P=0.745N P=0.762 P=0.517 |
|LOGISTIC REGRESSION | P=0.296N P=0.476N P=0.495N P=0.476N | P=0.359 P=0.745N P=0.762 P=0.517 |
|COCHRAN-ARMITAGE | P=0.306N | P=0.351 |
|FISHER EXACT | P=0.500N P=0.500N P=0.500N | P=0.752N P=0.752N P=0.500 |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/58 (0%) 1/60 (2%) 0/58 (0%) 0/60 (0%) | 4/60 (7%) 2/60 (3%) 1/57 (2%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 2.3% 0.0% 0.0% | 9.6% 4.8% 2.7% 2.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/37 (0%) 1/44 (2%) 0/38 (0%) 0/44 (0%) | 3/39 (8%) 2/42 (5%) 1/37 (3%) 1/41 (2%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) --- --- | 582 736 (T) 736 (T) 736 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.549N P=0.535 (e) (e) | P=0.111N P=0.309N P=0.194N P=0.172N |
|INCIDENTAL TUMOR | P=0.549N P=0.535 (e) (e) | P=0.103N P=0.385N P=0.177N P=0.170N |
|LOGISTIC REGRESSION | P=0.549N P=0.535 (e) (e) | P=0.118N P=0.322N P=0.197N P=0.184N |
|COCHRAN-ARMITAGE | P=0.564N | P=0.115N |
|FISHER EXACT | P=0.508 (e) (e) | P=0.340N P=0.198N P=0.182N |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 02 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 11.25 22.5 45.0 | VEHICLE 3.75 7.5 15.0 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/58 (0%) 1/60 (2%) 1/58 (2%) 0/60 (0%) | 4/60 (7%) 2/60 (3%) 1/57 (2%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 2.3% 2.4% 0.0% | 9.6% 4.8% 2.7% 2.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/37 (0%) 1/44 (2%) 0/38 (0%) 0/44 (0%) | 3/39 (8%) 2/42 (5%) 1/37 (3%) 1/41 (2%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) 725 --- | 582 736 (T) 736 (T) 736 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.573N P=0.535 P=0.510 (e) | P=0.111N P=0.309N P=0.194N P=0.172N |
|INCIDENTAL TUMOR | P=0.560N P=0.535 P=0.500 (e) | P=0.103N P=0.385N P=0.177N P=0.170N |
|LOGISTIC REGRESSION | P=0.569N P=0.535 P=0.504 (e) | P=0.118N P=0.322N P=0.197N P=0.184N |
|COCHRAN-ARMITAGE | P=0.590N | P=0.115N |
|FISHER EXACT | P=0.508 P=0.500 (e) | P=0.340N P=0.198N P=0.182N |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 1/60 (2%) 3/60 (5%) 3/60 (5%) 2/60 (3%) |
|ADJUSTED (b) | | 2.6% 6.9% 6.9% 3.5% |
|INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 1/9 (11%) 2/9 (22%) |
|TERMINAL (d) | | 1/39 (3%) 2/42 (5%) 2/39 (5%) 0/41 (0%) |
|FIRST INCIDENCE (DAYS) | | 736 (T) 725 464 (I) 462 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.466 P=0.335 P=0.297 P=0.481 |
|INCIDENTAL TUMOR | | P=0.442 P=0.341 P=0.297 P=0.481 |
|LOGISTIC REGRESSION | | P=0.500 P=0.330 P=0.306 P=0.569 |
|COCHRAN-ARMITAGE | | P=0.477 |
|FISHER EXACT | | P=0.309 P=0.309 P=0.500 |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 02 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 11.25 22.5 45.0 | VEHICLE 3.75 7.5 15.0 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Hemangioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) 1/60 (2%) 2/60 (3%) | 0/60 (0%) 1/60 (2%) 2/60 (3%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 2.3% 2.3% 4.5% | 0.0% 2.4% 4.8% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/39 (0%) 1/44 (2%) 0/40 (0%) 2/44 (5%) | 0/39 (0%) 1/42 (2%) 1/39 (3%) 0/41 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) 666 729 (T) | --- 736 (T) 701 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.172 P=0.524 P=0.505 P=0.265 | P=0.615N P=0.515 P=0.240 (e) |
|INCIDENTAL TUMOR | P=0.179 P=0.524 P=0.500 P=0.265 | P=0.651N P=0.515 P=0.220 (e) |
|LOGISTIC REGRESSION | P=0.167 P=0.524 P=0.500 P=0.265 | P=0.623N P=0.515 P=0.238 (e) |
|COCHRAN-ARMITAGE | P=0.153 | P=0.616N |
|FISHER EXACT | P=0.500 P=0.500 P=0.248 | P=0.500 P=0.248 (e) |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 3/60 (5%) 0/60 (0%) 3/60 (5%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 6.8% 0.0% 6.5% | 0.0% 0.0% 2.1% 2.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/39 (0%) 3/44 (7%) 0/40 (0%) 2/44 (5%) | 0/39 (0%) 0/42 (0%) 0/39 (0%) 1/41 (2%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) --- 669 | --- --- 626 736 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.187 P=0.143 (e) P=0.145 | P=0.237 (e) P=0.513 P=0.510 |
|INCIDENTAL TUMOR | P=0.192 P=0.143 (e) P=0.138 | P=0.262 (e) P=0.602 P=0.510 |
|LOGISTIC REGRESSION | P=0.183 P=0.143 (e) P=0.133 | P=0.233 (e) P=0.502 P=0.510 |
|COCHRAN-ARMITAGE | P=0.164 | P=0.236 |
|FISHER EXACT | P=0.122 (e) P=0.122 | (e) P=0.500 P=0.500 |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 02 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 11.25 22.5 45.0 | VEHICLE 3.75 7.5 15.0 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 3/60 (5%) 1/60 (2%) 4/60 (7%) | 0/60 (0%) 1/60 (2%) 3/60 (5%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 6.8% 2.3% 8.8% | 0.0% 2.4% 6.8% 2.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/39 (0%) 3/44 (7%) 0/40 (0%) 3/44 (7%) | 0/39 (0%) 1/42 (2%) 1/39 (3%) 1/41 (2%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) 666 669 | --- 736 (T) 626 736 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.089 P=0.143 P=0.505 P=0.081 | P=0.354 P=0.515 P=0.128 P=0.510 |
|INCIDENTAL TUMOR | P=0.093 P=0.143 P=0.500 P=0.077 | P=0.345 P=0.515 P=0.141 P=0.510 |
|LOGISTIC REGRESSION | P=0.084 P=0.143 P=0.500 P=0.073 | P=0.343 P=0.515 P=0.121 P=0.510 |
|COCHRAN-ARMITAGE | P=0.072 | P=0.351 |
|FISHER EXACT | P=0.122 P=0.500 P=0.059 | P=0.500 P=0.122 P=0.500 |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | 0/60 (0%) 2/60 (3%) 1/60 (2%) 2/60 (3%) |
|ADJUSTED (b) | 2.4% 0.0% 2.4% 0.0% | 0.0% 4.3% 2.3% 4.3% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/39 (0%) 0/44 (0%) 0/40 (0%) 0/44 (0%) | 0/39 (0%) 0/42 (0%) 0/39 (0%) 0/41 (0%) |
|FIRST INCIDENCE (DAYS) | 698 --- 725 --- | --- 677 701 643 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.388N P=0.481N P=0.752N P=0.477N | P=0.242 P=0.260 P=0.500 P=0.242 |
|INCIDENTAL TUMOR | P=0.367N P=0.638N P=0.777 P=0.500N | P=0.146 P=0.265 P=0.464 P=0.196 |
|LOGISTIC REGRESSION | P=0.393N P=0.495N P=0.761N P=0.490N | P=0.306 P=0.244 P=0.500 P=0.241 |
|COCHRAN-ARMITAGE | P=0.405N | P=0.246 |
|FISHER EXACT | P=0.500N P=0.752N P=0.500N | P=0.248 P=0.500 P=0.248 |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 02 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 11.25 22.5 45.0 | VEHICLE 3.75 7.5 15.0 |
| | 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) | 4/60 (7%) 8/60 (13%) 7/60 (12%) 4/60 (7%) | 8/60 (13%) 18/60 (30%) 15/60 (25%) 12/60 (20%) |
|ADJUSTED (b) | 9.9% 16.5% 16.2% 8.5% | 19.9% 38.1% 35.4% 27.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 3/39 (8%) 6/44 (14%) 4/40 (10%) 2/44 (5%) | 7/39 (18%) 13/42 (31%) 12/39 (31%) 9/41 (22%) |
|FIRST INCIDENCE (DAYS) | 698 128 666 568 | 718 677 626 643 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.373N P=0.234 P=0.285 P=0.577N | P=0.426 P=0.041 * P=0.083 P=0.265 |
|INCIDENTAL TUMOR | P=0.532N P=0.192 P=0.259 P=0.640 | P=0.336 P=0.036 * P=0.077 P=0.213 |
|LOGISTIC REGRESSION | P=0.474N P=0.180 P=0.265 P=0.611N | P=0.335 P=0.030 * P=0.075 P=0.220 |
|COCHRAN-ARMITAGE | P=0.426N | P=0.406 |
|FISHER EXACT | P=0.181 P=0.264 P=0.641N | P=0.022 * P=0.082 P=0.232 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 8/60 (13%) 6/60 (10%) 4/60 (7%) | 8/60 (13%) 16/60 (27%) 14/60 (23%) 10/60 (17%) |
|ADJUSTED (b) | 7.7% 16.5% 14.1% 8.5% | 19.9% 35.3% 33.9% 23.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 3/39 (8%) 6/44 (14%) 4/40 (10%) 2/44 (5%) | 7/39 (18%) 13/42 (31%) 12/39 (31%) 9/41 (22%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 128 666 568 | 718 693 626 679 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.461N P=0.138 P=0.259 P=0.562 | P=0.522N P=0.081 P=0.118 P=0.438 |
|INCIDENTAL TUMOR | P=0.485 P=0.130 P=0.252 P=0.495 | P=0.511 P=0.082 P=0.118 P=0.397 |
|LOGISTIC REGRESSION | P=0.553 P=0.103 P=0.246 P=0.532 | P=0.516 P=0.070 P=0.112 P=0.396 |
|COCHRAN-ARMITAGE | P=0.515N | P=0.543N |
|FISHER EXACT | P=0.102 P=0.245 P=0.500 | P=0.054 P=0.119 P=0.399 |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 02 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 11.25 22.5 45.0 | VEHICLE 3.75 7.5 15.0 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 26/60 (43%) 25/60 (42%) 24/60 (40%) 30/60 (50%) | 26/60 (43%) 20/60 (33%) 17/60 (28%) 18/60 (30%) |
|ADJUSTED (b) | 55.0% 49.7% 50.5% 62.4% | 54.6% 44.2% 38.8% 39.1% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 3/10 (30%) 1/10 (10%) 1/10 (10%) | 2/10 (20%) 0/10 (0%) 1/9 (11%) 3/9 (33%) |
|TERMINAL (d) | 18/39 (46%) 19/44 (43%) 17/40 (43%) 26/44 (59%) | 18/39 (46%) 17/42 (40%) 13/39 (33%) 14/41 (34%) |
|FIRST INCIDENCE (DAYS) | 458 (I) 458 (I) 444 460 (I) | 442 554 464 (I) 462 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.379 P=0.335N P=0.402N P=0.509 | P=0.087N P=0.120N P=0.077N P=0.085N |
|INCIDENTAL TUMOR | P=0.291 P=0.570 P=0.533N P=0.370 | P=0.092N P=0.206N P=0.053N P=0.115N |
|LOGISTIC REGRESSION | P=0.271 P=0.556 P=0.493N P=0.345 | P=0.100N P=0.140N P=0.062N P=0.101N |
|COCHRAN-ARMITAGE | P=0.234 | P=0.087N |
|FISHER EXACT | P=0.500N P=0.427N P=0.292 | P=0.174N P=0.064N P=0.092N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 15/60 (25%) 23/60 (38%) 14/60 (23%) 19/60 (32%) | 16/60 (27%) 21/60 (35%) 19/60 (32%) 17/60 (28%) |
|ADJUSTED (b) | 31.2% 44.4% 29.7% 38.6% | 34.7% 43.6% 40.9% 36.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 2/10 (20%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 7/39 (18%) 16/44 (36%) 7/40 (18%) 14/44 (32%) | 9/39 (23%) 15/42 (36%) 12/39 (31%) 12/41 (29%) |
|FIRST INCIDENCE (DAYS) | 283 128 522 568 | 582 677 569 561 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.526N P=0.169 P=0.479N P=0.414 | P=0.493N P=0.314 P=0.359 P=0.542 |
|INCIDENTAL TUMOR | P=0.241 P=0.030 * P=0.536 P=0.118 | P=0.461 P=0.268 P=0.361 P=0.383 |
|LOGISTIC REGRESSION | P=0.446 P=0.084 P=0.499N P=0.301 | P=0.456 P=0.196 P=0.390 P=0.381 |
|COCHRAN-ARMITAGE | P=0.434 | P=0.509N |
|FISHER EXACT | P=0.085 P=0.500N P=0.272 | P=0.215 P=0.344 P=0.500 |
|=================================================================================================================================|
DATE: 09/14/94 EXPERIMENT: 05108 TEST: 02 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PROMETHAZINE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 11.25 22.5 45.0 | VEHICLE 3.75 7.5 15.0 |
| | MALE MG/KG MG/KG MG/KG | FEMALE MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 32/60 (53%) 40/60 (67%) 30/60 (50%) 38/60 (63%) | 34/60 (57%) 33/60 (55%) 30/60 (50%) 29/60 (48%) |
|ADJUSTED (b) | 63.6% 72.5% 59.8% 74.5% | 67.8% 66.0% 62.1% 58.7% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 5/10 (50%) 1/10 (10%) 1/10 (10%) | 2/10 (20%) 0/10 (0%) 1/9 (11%) 3/9 (33%) |
|TERMINAL (d) | 21/39 (54%) 29/44 (66%) 20/40 (50%) 31/44 (70%) | 23/39 (59%) 25/42 (60%) 21/39 (54%) 21/41 (51%) |
|FIRST INCIDENCE (DAYS) | 283 128 444 460 (I) | 442 554 464 (I) 462 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.495 P=0.280 P=0.403N P=0.424 | P=0.193N P=0.354N P=0.321N P=0.215N |
|INCIDENTAL TUMOR | P=0.189 P=0.053 P=0.576N P=0.103 | P=0.219N P=0.477N P=0.229N P=0.303N |
|LOGISTIC REGRESSION | P=0.361 P=0.097 P=0.419N P=0.255 | P=0.192N P=0.479N P=0.282N P=0.258N |
|COCHRAN-ARMITAGE | P=0.298 | P=0.179N |
|FISHER EXACT | P=0.096 P=0.428N P=0.177 | P=0.500N P=0.292N P=0.232N |
|=================================================================================================================================|
(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): 458
Female interim sacrifices(days): 462
(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).