TDMS Study 05090-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: American Biogenics COUMARIN DATE: 09/12/94
EXPERIMENT: 05090 TEST: 01 TIME: 03:29:00
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01ES45039 ROUTE: GAVAGE NTP C#: 07103B
PATHOLOGIST: R. DAHLGREN CAS: 000091645
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: American Biogenics COUMARIN DATE: 09/12/94
EXPERIMENT: 05090 TEST: 01 TIME: 03:29:00
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01ES45039 ROUTE: GAVAGE NTP C#: 07103B
PATHOLOGIST: R. DAHLGREN CAS: 000091645
RATS(FISCHER344)
----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
----------------
Adrenal Gland
Bone Marrow
Brain
Clitoral Gland
Epididymis
Heart
Islets, Pancreatic
Kidney
Larynx
Liver
Lung
Nose
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Preputial Gland
Prostate
Salivary Glands
Spleen
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: American Biogenics COUMARIN DATE: 09/12/94
EXPERIMENT: 05090 TEST: 01 TIME: 03:29:00
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01ES45039 ROUTE: GAVAGE NTP C#: 07103B
PATHOLOGIST: R. DAHLGREN CAS: 000091645
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF COUMARIN
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Kidney: Renal Tubule Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Testes Adenoma
Thyroid Gland: Follicular Cell
Carcinoma or Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear,
or Undifferentiated
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Clitoral/Preputial Gland Adenoma
Carcinoma or Adenoma
Kidney: Renal Tubule Adenoma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)
Papilloma Squamous or Papilloma
Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma
Pharynx Squamous Cell Papilloma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Thyroid Gland: C-Cell Carcinoma or Adenoma
====================================================================================================
DATE: 09/12/94 EXPERIMENT: 05090 TEST: 01 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- COUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 25 MG/KG 50 MG/KG 100MG/KG | VEHICLE 25 MG/KG 50 MG/KG 100MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/89 (10%) 5/60 (8%) 5/59 (8%) 5/130 (4%) | 3/60 (5%) 2/60 (3%) 2/58 (3%) 1/59 (2%) |
|ADJUSTED (b) | 27.2% 29.9% 61.1% 40.1% | 9.1% 5.3% 5.7% 3.3% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/17 (0%) 0/10 (0%) 0/9 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 5/28 (18%) 2/9 (22%) 1/2 (50%) 4/11 (36%) | 2/29 (7%) 2/38 (5%) 2/35 (6%) 1/30 (3%) |
|FIRST INCIDENCE (DAYS) | 573 503 506 680 | 607 729 (T) 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.412 P=0.468 P=0.055 P=0.449 | P=0.235N P=0.401N P=0.434N P=0.295N |
|INCIDENTAL TUMOR | P=0.314N P=0.286N P=0.566N P=0.443N | P=0.216N P=0.525N P=0.432N P=0.281N |
|LOGISTIC REGRESSION | P=0.315N P=0.404N P=0.491 P=0.536N | P=0.238N P=0.469N P=0.506N P=0.301N |
|COCHRAN-ARMITAGE | P=0.042N* | P=0.240N |
|FISHER EXACT | P=0.475N P=0.488N P=0.058N | P=0.500N P=0.516N P=0.316N |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/85 (2%) 1/59 (2%) 1/59 (2%) 1/126 (1%) | 0/58 (0%) 6/57 (11%) 0/58 (0%) 2/59 (3%) |
|ADJUSTED (b) | 7.1% 5.0% 3.6% 9.1% | 0.0% 15.9% 0.0% 6.3% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/17 (0%) 0/10 (0%) 0/9 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/28 (7%) 0/9 (0%) 0/2 (0%) 1/11 (9%) | 0/29 (0%) 5/36 (14%) 0/34 (0%) 1/30 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 666 580 729 (T) | --- 659 --- 693 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.564 P=0.679 P=0.526 P=0.676 | P=0.580 P=0.031 * (e) P=0.234 |
|INCIDENTAL TUMOR | P=0.526N P=0.625N P=0.799 P=0.676 | P=0.588 P=0.020 * (e) P=0.233 |
|LOGISTIC REGRESSION | P=0.509N P=0.675N P=0.727 P=0.676 | P=0.593 P=0.019 * (e) P=0.238 |
|COCHRAN-ARMITAGE | P=0.261N | P=0.586N |
|FISHER EXACT | P=0.635N P=0.635N P=0.355N | P=0.013 * (e) P=0.252 |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05090 TEST: 01 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- COUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 25 MG/KG 50 MG/KG 100MG/KG | VEHICLE 25 MG/KG 50 MG/KG 100MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/85 (1%) 1/59 (2%) 0/59 (0%) 2/126 (2%) | 0/58 (0%) 1/57 (2%) 1/58 (2%) 2/59 (3%) |
|ADJUSTED (b) | 3.6% 2.9% 0.0% 10.5% | 0.0% 2.8% 2.9% 5.7% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/17 (0%) 0/10 (0%) 0/9 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/28 (4%) 0/9 (0%) 0/2 (0%) 1/11 (9%) | 0/29 (0%) 1/36 (3%) 1/34 (3%) 1/30 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 615 --- 525 | --- 729 (T) 729 (T) 642 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.262 P=0.632 P=0.959N P=0.334 | P=0.144 P=0.543 P=0.532 P=0.246 |
|INCIDENTAL TUMOR | P=0.419 P=0.769 P=0.959N P=0.428 | P=0.174 P=0.543 P=0.532 P=0.264 |
|LOGISTIC REGRESSION | P=0.396 P=0.710 P=0.959N P=0.507 | P=0.154 P=0.543 P=0.532 P=0.243 |
|COCHRAN-ARMITAGE | P=0.534 | P=0.158 |
|FISHER EXACT | P=0.653 P=0.590N P=0.645 | P=0.496 P=0.500 P=0.252 |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/85 (4%) 2/59 (3%) 1/59 (2%) 3/126 (2%) | 0/58 (0%) 7/57 (12%) 1/58 (2%) 4/59 (7%) |
|ADJUSTED (b) | 10.7% 7.8% 3.6% 19.5% | 0.0% 18.6% 2.9% 11.7% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/17 (0%) 0/10 (0%) 0/9 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 3/28 (11%) 0/9 (0%) 0/2 (0%) 2/11 (18%) | 0/29 (0%) 6/36 (17%) 1/34 (3%) 2/30 (7%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 615 580 525 | --- 659 729 (T) 642 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.299 P=0.531 P=0.565 P=0.322 | P=0.252 P=0.018 * P=0.532 P=0.066 |
|INCIDENTAL TUMOR | P=0.515 P=0.614N P=0.805N P=0.389 | P=0.290 P=0.011 * P=0.532 P=0.071 |
|LOGISTIC REGRESSION | P=0.522 P=0.653N P=0.720N P=0.542 | P=0.271 P=0.010 * P=0.532 P=0.065 |
|COCHRAN-ARMITAGE | P=0.370N | P=0.285 |
|FISHER EXACT | P=0.668N P=0.457N P=0.462N | P=0.006 ** P=0.500 P=0.061 |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05090 TEST: 01 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- COUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 25 MG/KG 50 MG/KG 100MG/KG | VEHICLE 25 MG/KG 50 MG/KG 100MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/86 (5%) 1/60 (2%) 2/59 (3%) 1/128 (1%) | 1/59 (2%) 0/59 (0%) 1/58 (2%) 2/57 (4%) |
|ADJUSTED (b) | 13.3% 11.1% 27.9% 2.2% | 3.3% 0.0% 2.9% 6.7% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/17 (0%) 0/10 (0%) 0/9 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 3/28 (11%) 1/9 (11%) 0/2 (0%) 0/11 (0%) | 0/29 (0%) 0/38 (0%) 1/35 (3%) 2/30 (7%) |
|FIRST INCIDENCE (DAYS) | 660 729 (T) 588 588 | 719 --- 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.426N P=0.554N P=0.207 P=0.415N | P=0.227 P=0.453N P=0.719N P=0.508 |
|INCIDENTAL TUMOR | P=0.222N P=0.405N P=0.705 P=0.199N | P=0.242 P=0.621N P=0.657 P=0.497 |
|LOGISTIC REGRESSION | P=0.238N P=0.406N P=0.586 P=0.228N | P=0.222 P=0.479N P=0.751N P=0.491 |
|COCHRAN-ARMITAGE | P=0.078N | P=0.238 |
|FISHER EXACT | P=0.315N P=0.530N P=0.086N | P=0.500N P=0.748 P=0.487 |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/88 (1%) 2/60 (3%) 3/60 (5%) 4/130 (3%) | 0/59 (0%) 0/60 (0%) 0/60 (0%) 2/59 (3%) |
|ADJUSTED (b) | 3.6% 6.4% 13.8% 20.4% | 0.0% 0.0% 0.0% 6.4% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/17 (0%) 0/10 (0%) 1/9 (11%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/28 (4%) 0/9 (0%) 0/2 (0%) 2/11 (18%) | 0/29 (0%) 0/38 (0%) 0/36 (0%) 1/30 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 583 455 (I) 496 | --- --- --- 699 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.082 P=0.337 P=0.041 * P=0.086 | P=0.037 * (e) (e) P=0.234 |
|INCIDENTAL TUMOR | P=0.252 P=0.559 P=0.238 P=0.135 | P=0.055 (e) (e) P=0.233 |
|LOGISTIC REGRESSION | P=0.222 P=0.407 P=0.175 P=0.207 | P=0.043 * (e) (e) P=0.237 |
|COCHRAN-ARMITAGE | P=0.329 | P=0.046 * |
|FISHER EXACT | P=0.359 P=0.182 P=0.328 | (e) (e) P=0.248 |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05090 TEST: 01 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- COUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 25 MG/KG 50 MG/KG 100MG/KG | VEHICLE 25 MG/KG 50 MG/KG 100MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Oncocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/88 (0%) 0/60 (0%) 0/60 (0%) 2/130 (2%) | 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/59 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 4.1% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/17 (0%) 0/10 (0%) 0/9 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/28 (0%) 0/9 (0%) 0/2 (0%) 0/11 (0%) | 0/29 (0%) 0/38 (0%) 0/36 (0%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 565 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.068 (e) (e) P=0.275 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.170 (e) (e) P=0.619 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.093 (e) (e) P=0.301 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.111 | (e) |
|FISHER EXACT | (e) (e) P=0.355 | (e) (e) (e) |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/89 (0%) 0/60 (0%) 0/60 (0%) 2/130 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 3.8% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/17 (0%) 0/10 (0%) 0/9 (0%) 1/20 (5%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/28 (0%) 0/9 (0%) 0/2 (0%) 0/11 (0%) | 0/29 (0%) 0/38 (0%) 0/36 (0%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 453 (I) | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.072 (e) (e) P=0.251 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.125 (e) (e) P=0.418 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.106 (e) (e) P=0.318 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.110 | (e) |
|FISHER EXACT | (e) (e) P=0.351 | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05090 TEST: 01 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- COUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 25 MG/KG 50 MG/KG 100MG/KG | VEHICLE 25 MG/KG 50 MG/KG 100MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/89 (2%) 0/60 (0%) 0/60 (0%) 0/130 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 6.8% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/17 (0%) 0/10 (0%) 0/9 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/28 (4%) 0/9 (0%) 0/2 (0%) 0/11 (0%) | 0/29 (0%) 0/38 (0%) 0/36 (0%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | 720 --- --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.285N P=0.517N P=0.857N P=0.458N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.194N P=0.228N P=0.480N P=0.289N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.265N P=0.460N P=0.800N P=0.425N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.091N | (e) |
|FISHER EXACT | P=0.355N P=0.355N P=0.164N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/89 (2%) 0/60 (0%) 0/60 (0%) 2/130 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 6.8% 0.0% 0.0% 3.8% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/17 (0%) 0/10 (0%) 0/9 (0%) 1/20 (5%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/28 (4%) 0/9 (0%) 0/2 (0%) 0/11 (0%) | 0/29 (0%) 0/38 (0%) 0/36 (0%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | 720 --- --- 453 (I) | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.369 P=0.517N P=0.857N P=0.540 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.541 P=0.228N P=0.480N P=0.612N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.553 P=0.460N P=0.800N P=0.651N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.589N | (e) |
|FISHER EXACT | P=0.355N P=0.355N P=0.537N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05090 TEST: 01 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- COUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 25 MG/KG 50 MG/KG 100MG/KG | VEHICLE 25 MG/KG 50 MG/KG 100MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/89 (2%) 0/60 (0%) 0/60 (0%) 2/130 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 6.8% 0.0% 0.0% 3.8% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/17 (0%) 0/10 (0%) 0/9 (0%) 1/20 (5%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/28 (4%) 0/9 (0%) 0/2 (0%) 0/11 (0%) | 0/29 (0%) 0/38 (0%) 0/36 (0%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | 720 --- --- 453 (I) | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.369 P=0.517N P=0.857N P=0.540 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.541 P=0.228N P=0.480N P=0.612N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.553 P=0.460N P=0.800N P=0.651N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.589N | (e) |
|FISHER EXACT | P=0.355N P=0.355N P=0.537N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/89 (1%) 2/59 (3%) 1/59 (2%) 1/130 (1%) | 0/60 (0%) 1/59 (2%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 3.6% 10.0% 2.0% 1.3% | 0.0% 2.6% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/17 (0%) 0/10 (0%) 1/9 (11%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/28 (4%) 0/9 (0%) 0/2 (0%) 0/11 (0%) | 0/29 (0%) 1/38 (3%) 0/36 (0%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 652 455 (I) 496 | --- 729 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.590 P=0.262 P=0.436 P=0.734 | P=0.576N P=0.554 (e) (e) |
|INCIDENTAL TUMOR | P=0.490N P=0.596 P=0.436 P=0.751N | P=0.576N P=0.554 (e) (e) |
|LOGISTIC REGRESSION | P=0.419N P=0.374 P=0.671 P=0.723N | P=0.576N P=0.554 (e) (e) |
|COCHRAN-ARMITAGE | P=0.358N | P=0.566N |
|FISHER EXACT | P=0.349 P=0.640 P=0.649N | P=0.496 (e) (e) |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05090 TEST: 01 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- COUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 25 MG/KG 50 MG/KG 100MG/KG | VEHICLE 25 MG/KG 50 MG/KG 100MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/89 (0%) 0/60 (0%) 0/60 (0%) 1/130 (1%) | 1/60 (2%) 2/60 (3%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 4.0% | 3.4% 5.3% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/17 (0%) 0/10 (0%) 0/9 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/28 (0%) 0/9 (0%) 0/2 (0%) 0/11 (0%) | 1/29 (3%) 2/38 (5%) 0/36 (0%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 638 | 729 (T) 729 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.173 (e) (e) P=0.433 | P=0.183N P=0.594 P=0.457N P=0.493N |
|INCIDENTAL TUMOR | P=0.374 (e) (e) P=0.810 | P=0.183N P=0.594 P=0.457N P=0.493N |
|LOGISTIC REGRESSION | P=0.227 (e) (e) P=0.520 | P=0.183N P=0.594 P=0.457N P=0.493N |
|COCHRAN-ARMITAGE | P=0.286 | P=0.188N |
|FISHER EXACT | (e) (e) P=0.594 | P=0.500 P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/89 (0%) 0/60 (0%) 0/60 (0%) 1/130 (1%) | 2/60 (3%) 2/60 (3%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 4.0% | 6.9% 5.3% 0.0% 3.3% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/17 (0%) 0/10 (0%) 0/9 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/28 (0%) 0/9 (0%) 0/2 (0%) 0/11 (0%) | 2/29 (7%) 2/38 (5%) 0/36 (0%) 1/30 (3%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 638 | 729 (T) 729 (T) --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.173 (e) (e) P=0.433 | P=0.298N P=0.594N P=0.192N P=0.488N |
|INCIDENTAL TUMOR | P=0.374 (e) (e) P=0.810 | P=0.298N P=0.594N P=0.192N P=0.488N |
|LOGISTIC REGRESSION | P=0.227 (e) (e) P=0.520 | P=0.298N P=0.594N P=0.192N P=0.488N |
|COCHRAN-ARMITAGE | P=0.286 | P=0.296N |
|FISHER EXACT | (e) (e) P=0.594 | P=0.691N P=0.248N P=0.500N |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05090 TEST: 01 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- COUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 25 MG/KG 50 MG/KG 100MG/KG | VEHICLE 25 MG/KG 50 MG/KG 100MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/89 (4%) 1/60 (2%) 2/60 (3%) 2/130 (2%) | 17/60 (28%) 24/60 (40%) 22/60 (37%) 11/60 (18%) |
|ADJUSTED (b) | 10.5% 3.1% 10.8% 18.2% | 48.2% 57.0% 59.5% 29.8% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 1/17 (6%) 0/10 (0%) 0/9 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/28 (4%) 0/9 (0%) 0/2 (0%) 2/11 (18%) | 12/29 (41%) 20/38 (53%) 21/36 (58%) 6/30 (20%) |
|FIRST INCIDENCE (DAYS) | 455 (I) 625 533 729 (T) | 491 659 709 551 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.553N P=0.335N P=0.535 P=0.616N | P=0.065N P=0.393 P=0.470 P=0.131N |
|INCIDENTAL TUMOR | P=0.233N P=0.134N P=0.261N P=0.391N | P=0.044N* P=0.155 P=0.252 P=0.101N |
|LOGISTIC REGRESSION | P=0.290N P=0.270N P=0.535N P=0.321N | P=0.050N P=0.165 P=0.236 P=0.121N |
|COCHRAN-ARMITAGE | P=0.175N | P=0.059N |
|FISHER EXACT | P=0.329N P=0.539N P=0.185N | P=0.124 P=0.218 P=0.140N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/89 (4%) 1/60 (2%) 2/60 (3%) 3/130 (2%) | 18/60 (30%) 25/60 (42%) 22/60 (37%) 11/60 (18%) |
|ADJUSTED (b) | 10.5% 3.1% 10.8% 21.5% | 51.3% 59.4% 59.5% 29.8% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 1/17 (6%) 0/10 (0%) 0/9 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/28 (4%) 0/9 (0%) 0/2 (0%) 2/11 (18%) | 13/29 (45%) 21/38 (55%) 21/36 (58%) 6/30 (20%) |
|FIRST INCIDENCE (DAYS) | 455 (I) 625 533 638 | 491 659 709 551 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.411 P=0.335N P=0.535 P=0.526 | P=0.039N* P=0.414 P=0.564 P=0.093N |
|INCIDENTAL TUMOR | P=0.350N P=0.134N P=0.261N P=0.454N | P=0.025N* P=0.169 P=0.337 P=0.068N |
|LOGISTIC REGRESSION | P=0.468N P=0.270N P=0.535N P=0.481N | P=0.029N* P=0.170 P=0.310 P=0.084N |
|COCHRAN-ARMITAGE | P=0.304N | P=0.037N* |
|FISHER EXACT | P=0.329N P=0.539N P=0.300N | P=0.127 P=0.281 P=0.100N |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05090 TEST: 01 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- COUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 25 MG/KG 50 MG/KG 100MG/KG | VEHICLE 25 MG/KG 50 MG/KG 100MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/89 (4%) 1/60 (2%) 2/60 (3%) 3/130 (2%) | 19/60 (32%) 25/60 (42%) 22/60 (37%) 12/60 (20%) |
|ADJUSTED (b) | 10.5% 3.1% 10.8% 21.5% | 54.3% 59.4% 59.5% 32.7% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 1/17 (6%) 0/10 (0%) 0/9 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/28 (4%) 0/9 (0%) 0/2 (0%) 2/11 (18%) | 14/29 (48%) 21/38 (55%) 21/36 (58%) 7/30 (23%) |
|FIRST INCIDENCE (DAYS) | 455 (I) 625 533 638 | 491 659 709 551 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.411 P=0.335N P=0.535 P=0.526 | P=0.044N* P=0.502 P=0.512N P=0.095N |
|INCIDENTAL TUMOR | P=0.350N P=0.134N P=0.261N P=0.454N | P=0.029N* P=0.236 P=0.432 P=0.070N |
|LOGISTIC REGRESSION | P=0.468N P=0.270N P=0.535N P=0.481N | P=0.034N* P=0.230 P=0.391 P=0.087N |
|COCHRAN-ARMITAGE | P=0.304N | P=0.042N* |
|FISHER EXACT | P=0.329N P=0.539N P=0.300N | P=0.172 P=0.350 P=0.105N |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) |
| Papilloma Squamous or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/89 (1%) 1/60 (2%) 1/60 (2%) 1/130 (1%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 2/60 (3%) |
|ADJUSTED (b) | 3.6% 5.9% 9.1% 9.1% | 0.0% 0.0% 0.0% 6.7% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/17 (0%) 0/10 (0%) 0/9 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/28 (4%) 0/9 (0%) 0/2 (0%) 1/11 (9%) | 0/29 (0%) 0/38 (0%) 0/36 (0%) 2/30 (7%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 673 631 729 (T) | --- --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.395 P=0.552 P=0.347 P=0.541 | P=0.037 * (e) (e) P=0.245 |
|INCIDENTAL TUMOR | P=0.570 P=0.772 P=0.743 P=0.541 | P=0.037 * (e) (e) P=0.245 |
|LOGISTIC REGRESSION | P=0.514 P=0.663 P=0.558 P=0.541 | P=0.037 * (e) (e) P=0.245 |
|COCHRAN-ARMITAGE | P=0.469N | P=0.046 * |
|FISHER EXACT | P=0.645 P=0.645 P=0.649N | (e) (e) P=0.248 |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05090 TEST: 01 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- COUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 25 MG/KG 50 MG/KG 100MG/KG | VEHICLE 25 MG/KG 50 MG/KG 100MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/89 (1%) 1/60 (2%) 1/60 (2%) 1/130 (1%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 2/60 (3%) |
|ADJUSTED (b) | 3.6% 5.9% 9.1% 9.1% | 0.0% 0.0% 0.0% 6.7% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/17 (0%) 0/10 (0%) 0/9 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/28 (4%) 0/9 (0%) 0/2 (0%) 1/11 (9%) | 0/29 (0%) 0/38 (0%) 0/36 (0%) 2/30 (7%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 673 631 729 (T) | --- --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.395 P=0.552 P=0.347 P=0.541 | P=0.037 * (e) (e) P=0.245 |
|INCIDENTAL TUMOR | P=0.570 P=0.772 P=0.743 P=0.541 | P=0.037 * (e) (e) P=0.245 |
|LOGISTIC REGRESSION | P=0.514 P=0.663 P=0.558 P=0.541 | P=0.037 * (e) (e) P=0.245 |
|COCHRAN-ARMITAGE | P=0.469N | P=0.046 * |
|FISHER EXACT | P=0.645 P=0.645 P=0.649N | (e) (e) P=0.248 |
|=================================================================================================================================|
| |
|Pancreas |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/86 (1%) 2/59 (3%) 3/59 (5%) 1/128 (1%) | 0/59 (0%) 0/59 (0%) 0/58 (0%) 0/56 (0%) |
|ADJUSTED (b) | 3.6% 13.2% 13.5% 9.1% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/17 (0%) 0/10 (0%) 0/9 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/28 (4%) 1/9 (11%) 0/2 (0%) 1/11 (9%) | 0/29 (0%) 0/38 (0%) 0/35 (0%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 518 548 729 (T) | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.470 P=0.255 P=0.060 P=0.541 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.423N P=0.255 P=0.452 P=0.541 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.518N P=0.411 P=0.154 P=0.541 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.363N | (e) |
|FISHER EXACT | P=0.361 P=0.184 P=0.643N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05090 TEST: 01 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- COUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 25 MG/KG 50 MG/KG 100MG/KG | VEHICLE 25 MG/KG 50 MG/KG 100MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Pharynx |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/89 (1%) 1/60 (2%) 1/60 (2%) 0/130 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 2/60 (3%) |
|ADJUSTED (b) | 3.6% 5.9% 9.1% 0.0% | 0.0% 0.0% 0.0% 6.7% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/17 (0%) 0/10 (0%) 0/9 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/28 (4%) 0/9 (0%) 0/2 (0%) 0/11 (0%) | 0/29 (0%) 0/38 (0%) 0/36 (0%) 2/30 (7%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 673 631 --- | --- --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.498N P=0.552 P=0.347 P=0.686N | P=0.037 * (e) (e) P=0.245 |
|INCIDENTAL TUMOR | P=0.295N P=0.772 P=0.743 P=0.686N | P=0.037 * (e) (e) P=0.245 |
|LOGISTIC REGRESSION | P=0.373N P=0.663 P=0.558 P=0.688N | P=0.037 * (e) (e) P=0.245 |
|COCHRAN-ARMITAGE | P=0.222N | P=0.046 * |
|FISHER EXACT | P=0.645 P=0.645 P=0.406N | (e) (e) P=0.248 |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 21/88 (24%) 12/58 (21%) 18/58 (31%) 19/130 (15%)| 30/59 (51%) 26/57 (46%) 23/58 (40%) 28/59 (47%) |
|ADJUSTED (b) | 52.8% 56.2% 100.0% 54.2% | 74.2% 61.6% 60.2% 69.1% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 1/17 (6%) 0/10 (0%) 2/9 (22%) 4/20 (20%) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 11/28 (39%) 3/9 (33%) 2/2 (100%) 4/11 (36%) | 19/29 (66%) 21/37 (57%) 20/35 (57%) 18/30 (60%) |
|FIRST INCIDENCE (DAYS) | 337 577 455 (I) 453 (I) | 435 456 (I) 622 463 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.120 P=0.432 P<0.001 ** P=0.275 | P=0.485N P=0.064N P=0.033N* P=0.393N |
|INCIDENTAL TUMOR | P=0.108N P=0.101N P=0.540 P=0.115N | P=0.347N P=0.380N P=0.184N P=0.342N |
|LOGISTIC REGRESSION | P=0.211N P=0.222N P=0.208 P=0.171N | P=0.364N P=0.250N P=0.125N P=0.407N |
|COCHRAN-ARMITAGE | P=0.050N* | P=0.401N |
|FISHER EXACT | P=0.406N P=0.221 P=0.061N | P=0.353N P=0.151N P=0.427N |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05090 TEST: 01 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- COUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 25 MG/KG 50 MG/KG 100MG/KG | VEHICLE 25 MG/KG 50 MG/KG 100MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 21/88 (24%) 12/58 (21%) 18/58 (31%) 19/130 (15%)| 31/59 (53%) 26/57 (46%) 23/58 (40%) 28/59 (47%) |
|ADJUSTED (b) | 52.8% 56.2% 100.0% 54.2% | 75.0% 61.6% 60.2% 69.1% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 1/17 (6%) 0/10 (0%) 2/9 (22%) 4/20 (20%) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 11/28 (39%) 3/9 (33%) 2/2 (100%) 4/11 (36%) | 19/29 (66%) 21/37 (57%) 20/35 (57%) 18/30 (60%) |
|FIRST INCIDENCE (DAYS) | 337 577 455 (I) 453 (I) | 435 456 (I) 622 463 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.120 P=0.432 P<0.001 ** P=0.275 | P=0.427N P=0.046N* P=0.023N* P=0.336N |
|INCIDENTAL TUMOR | P=0.108N P=0.101N P=0.540 P=0.115N | P=0.288N P=0.330N P=0.159N P=0.276N |
|LOGISTIC REGRESSION | P=0.211N P=0.222N P=0.208 P=0.171N | P=0.298N P=0.189N P=0.087N P=0.329N |
|COCHRAN-ARMITAGE | P=0.050N* | P=0.343N |
|FISHER EXACT | P=0.406N P=0.221 P=0.061N | P=0.288N P=0.113N P=0.356N |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/89 (1%) 4/60 (7%) 1/60 (2%) 1/130 (1%) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 2.6% 28.1% 50.0% 1.4% | 2.8% 2.6% 0.0% 3.3% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/17 (0%) 0/10 (0%) 0/9 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/28 (0%) 2/9 (22%) 1/2 (50%) 0/11 (0%) | 0/29 (0%) 1/38 (3%) 0/36 (0%) 1/30 (3%) |
|FIRST INCIDENCE (DAYS) | 609 569 729 (T) 511 | 693 729 (T) --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.565N P=0.053 P=0.421 P=0.711N | P=0.636N P=0.718N P=0.489N P=0.755 |
|INCIDENTAL TUMOR | P=0.323N P=0.160 P=0.743 P=0.395N | P=0.621N P=0.729 P=0.757N P=0.754 |
|LOGISTIC REGRESSION | P=0.362N P=0.107 P=0.591 P=0.691N | P=0.625N P=0.745N P=0.498N P=0.762N |
|COCHRAN-ARMITAGE | P=0.213N | P=0.616N |
|FISHER EXACT | P=0.085 P=0.645 P=0.649N | P=0.752N P=0.500N P=0.752N |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05090 TEST: 01 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- COUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 25 MG/KG 50 MG/KG 100MG/KG | VEHICLE 25 MG/KG 50 MG/KG 100MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/89 (1%) 4/60 (7%) 0/60 (0%) 1/130 (1%) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 2.6% 28.1% 0.0% 1.4% | 0.0% 2.6% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/17 (0%) 0/10 (0%) 0/9 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/28 (0%) 2/9 (22%) 0/2 (0%) 0/11 (0%) | 0/29 (0%) 1/38 (3%) 0/36 (0%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | 609 569 --- 511 | --- 729 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.481N P=0.053 P=0.643N P=0.711N | P=0.576N P=0.554 (e) (e) |
|INCIDENTAL TUMOR | P=0.231N P=0.160 P=0.274N P=0.395N | P=0.576N P=0.554 (e) (e) |
|LOGISTIC REGRESSION | P=0.300N P=0.107 P=0.586N P=0.691N | P=0.576N P=0.554 (e) (e) |
|COCHRAN-ARMITAGE | P=0.200N | P=0.567N |
|FISHER EXACT | P=0.085 P=0.597N P=0.649N | P=0.500 (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, |
| Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/89 (2%) 5/60 (8%) 1/60 (2%) 2/130 (2%) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 6.0% 29.6% 50.0% 2.4% | 2.8% 2.6% 0.0% 3.3% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/17 (0%) 0/10 (0%) 0/9 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/28 (4%) 2/9 (22%) 1/2 (50%) 0/11 (0%) | 0/29 (0%) 1/38 (3%) 0/36 (0%) 1/30 (3%) |
|FIRST INCIDENCE (DAYS) | 609 482 729 (T) 380 | 693 729 (T) --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.530N P=0.058 P=0.473 P=0.696N | P=0.636N P=0.718N P=0.489N P=0.755 |
|INCIDENTAL TUMOR | P=0.249N P=0.147 P=0.761 P=0.381N | P=0.621N P=0.729 P=0.757N P=0.754 |
|LOGISTIC REGRESSION | P=0.267N P=0.127 P=0.676 P=0.575N | P=0.625N P=0.745N P=0.498N P=0.762N |
|COCHRAN-ARMITAGE | P=0.184N | P=0.616N |
|FISHER EXACT | P=0.094 P=0.645N P=0.537N | P=0.752N P=0.500N P=0.752N |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05090 TEST: 01 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- COUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 25 MG/KG 50 MG/KG 100MG/KG | VEHICLE 25 MG/KG 50 MG/KG 100MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/89 (2%) 0/60 (0%) 1/60 (2%) 0/130 (0%) | 0/60 (0%) 1/60 (2%) 1/60 (2%) 1/60 (2%) |
|ADJUSTED (b) | 6.0% 0.0% 2.8% 0.0% | 0.0% 2.6% 2.8% 2.8% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/17 (0%) 0/10 (0%) 0/9 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/28 (4%) 0/9 (0%) 0/2 (0%) 0/11 (0%) | 0/29 (0%) 1/38 (3%) 1/36 (3%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | 609 --- 539 --- | --- 729 (T) 729 (T) 679 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.254N P=0.367N P=0.685 P=0.338N | P=0.371 P=0.554 P=0.543 P=0.500 |
|INCIDENTAL TUMOR | P=0.101N P=0.269N P=0.441N P=0.148N | P=0.379 P=0.554 P=0.543 P=0.481 |
|LOGISTIC REGRESSION | P=0.169N P=0.303N P=0.667N P=0.244N | P=0.378 P=0.554 P=0.543 P=0.504 |
|COCHRAN-ARMITAGE | P=0.132N | P=0.384 |
|FISHER EXACT | P=0.355N P=0.645N P=0.164N | P=0.500 P=0.500 P=0.500 |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, Sarcoma, |
| Neurofibroma, or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/89 (3%) 0/60 (0%) 1/60 (2%) 0/130 (0%) | 0/60 (0%) 1/60 (2%) 1/60 (2%) 1/60 (2%) |
|ADJUSTED (b) | 9.5% 0.0% 2.8% 0.0% | 0.0% 2.6% 2.8% 2.8% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/17 (0%) 0/10 (0%) 0/9 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/28 (7%) 0/9 (0%) 0/2 (0%) 0/11 (0%) | 0/29 (0%) 1/38 (3%) 1/36 (3%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | 609 --- 539 --- | --- 729 (T) 729 (T) 679 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.175N P=0.275N P=0.706 P=0.241N | P=0.371 P=0.554 P=0.543 P=0.500 |
|INCIDENTAL TUMOR | P=0.071N P=0.202N P=0.407N P=0.111N | P=0.379 P=0.554 P=0.543 P=0.481 |
|LOGISTIC REGRESSION | P=0.095N P=0.187N P=0.542N P=0.151N | P=0.378 P=0.554 P=0.543 P=0.504 |
|COCHRAN-ARMITAGE | P=0.056N | P=0.384 |
|FISHER EXACT | P=0.210N P=0.469N P=0.066N | P=0.500 P=0.500 P=0.500 |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05090 TEST: 01 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- COUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 25 MG/KG 50 MG/KG 100MG/KG | VEHICLE 25 MG/KG 50 MG/KG 100MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/89 (0%) 2/60 (3%) 0/60 (0%) 2/130 (2%) | 1/60 (2%) 3/60 (5%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 12.8% 0.0% 3.0% | 3.4% 7.9% 0.0% 2.1% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/17 (0%) 1/10 (10%) 0/9 (0%) 1/20 (5%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/28 (0%) 1/9 (11%) 0/2 (0%) 0/11 (0%) | 1/29 (3%) 3/38 (8%) 0/36 (0%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | --- 455 (I) --- 453 (I) | 729 (T) 729 (T) --- 543 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.255 P=0.085 (e) P=0.280 | P=0.413N P=0.406 P=0.457N P=0.752N |
|INCIDENTAL TUMOR | P=0.323 P=0.085 (e) P=0.418 | P=0.362N P=0.406 P=0.457N P=0.682N |
|LOGISTIC REGRESSION | P=0.393 P=0.172 (e) P=0.323 | P=0.408N P=0.406 P=0.457N P=0.762 |
|COCHRAN-ARMITAGE | P=0.411 | P=0.409N |
|FISHER EXACT | P=0.161 (e) P=0.351 | P=0.309 P=0.500N P=0.752N |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 53/85 (62%) 52/59 (88%) 50/55 (91%) 98/130 (75%)| |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 1/18 (6%) | |
|INTERIM SACRIFICE 2 (c)| 15/17 (88%) 9/10 (90%) 8/9 (89%) 18/20 (90%) | |
|TERMINAL (d) | 28/28 (100%) 9/9 (100%) 2/2 (100%) 11/11 (100%)| |
|FIRST INCIDENCE (DAYS) | 408 453 (I) 428 275 (I) | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |
|INCIDENTAL TUMOR | P=0.002 ** P=0.091 P=0.008 ** P=0.001 ** | |
|LOGISTIC REGRESSION | P=0.029 * P=0.306 P=0.171 P=0.037 * | |
|COCHRAN-ARMITAGE | P=0.151 | |
|FISHER EXACT | P<0.001 ** P<0.001 ** P=0.030 * | |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05090 TEST: 01 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- COUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 25 MG/KG 50 MG/KG 100MG/KG | VEHICLE 25 MG/KG 50 MG/KG 100MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/87 (2%) 1/59 (2%) 1/58 (2%) 0/130 (0%) | 0/59 (0%) 0/60 (0%) 0/59 (0%) 2/59 (3%) |
|ADJUSTED (b) | 6.3% 3.3% 5.3% 0.0% | 0.0% 0.0% 0.0% 6.7% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/17 (0%) 0/10 (0%) 0/9 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/28 (4%) 0/9 (0%) 0/2 (0%) 0/11 (0%) | 0/29 (0%) 0/38 (0%) 0/35 (0%) 2/30 (7%) |
|FIRST INCIDENCE (DAYS) | 660 631 615 --- | --- --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.294N P=0.687N P=0.532 P=0.426N | P=0.038 * (e) (e) P=0.245 |
|INCIDENTAL TUMOR | P=0.081N P=0.418N P=0.587N P=0.269N | P=0.038 * (e) (e) P=0.245 |
|LOGISTIC REGRESSION | P=0.166N P=0.600N P=0.743 P=0.289N | P=0.038 * (e) (e) P=0.245 |
|COCHRAN-ARMITAGE | P=0.096N | P=0.046 * |
|FISHER EXACT | P=0.643N P=0.649N P=0.160N | (e) (e) P=0.248 |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/87 (1%) 3/59 (5%) 0/58 (0%) 0/130 (0%) | 0/59 (0%) 0/60 (0%) 0/59 (0%) 1/59 (2%) |
|ADJUSTED (b) | 1.2% 13.6% 0.0% 0.0% | 0.0% 0.0% 0.0% 2.5% |
|INTERIM SACRIFICE 1 (c)| 1/17 (6%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/17 (0%) 0/10 (0%) 0/9 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/28 (0%) 0/9 (0%) 0/2 (0%) 0/11 (0%) | 0/29 (0%) 0/38 (0%) 0/35 (0%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | 274 (I) 645 --- --- | --- --- --- 651 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.268N P=0.055 (e) P=0.489N | P=0.195 (e) (e) P=0.505 |
|INCIDENTAL TUMOR | P=0.144N P=0.364 (e) P=0.489N | P=0.230 (e) (e) P=0.481 |
|LOGISTIC REGRESSION | P=0.101N P=0.189 P=0.751N P=0.403N | P=0.199 (e) (e) P=0.501 |
|COCHRAN-ARMITAGE | P=0.096N | P=0.198 |
|FISHER EXACT | P=0.181 P=0.600N P=0.401N | (e) (e) P=0.500 |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05090 TEST: 01 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- COUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 25 MG/KG 50 MG/KG 100MG/KG | VEHICLE 25 MG/KG 50 MG/KG 100MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/87 (2%) 4/59 (7%) 0/58 (0%) 1/130 (1%) | 1/59 (2%) 1/60 (2%) 1/59 (2%) 2/59 (3%) |
|ADJUSTED (b) | 4.7% 22.3% 0.0% 2.2% | 2.3% 2.6% 2.9% 5.8% |
|INTERIM SACRIFICE 1 (c)| 1/17 (6%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/17 (0%) 0/10 (0%) 0/9 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/28 (4%) 0/9 (0%) 0/2 (0%) 0/11 (0%) | 0/29 (0%) 1/38 (3%) 1/35 (3%) 1/30 (3%) |
|FIRST INCIDENCE (DAYS) | 274 (I) 645 --- 588 | 607 729 (T) 729 (T) 651 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.392N P=0.037 * P=0.959N P=0.580N | P=0.340 P=0.728N P=0.742N P=0.509 |
|INCIDENTAL TUMOR | P=0.171N P=0.389 P=0.959N P=0.425N | P=0.380 P=0.647 P=0.719N P=0.514 |
|LOGISTIC REGRESSION | P=0.140N P=0.227 P=0.342N P=0.369N | P=0.350 P=0.756N P=0.757 P=0.504 |
|COCHRAN-ARMITAGE | P=0.101N | P=0.349 |
|FISHER EXACT | P=0.180 P=0.358N P=0.353N | P=0.748N P=0.752N P=0.500 |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 8/60 (13%) 14/60 (23%) 6/60 (10%) 7/60 (12%) |
|ADJUSTED (b) | | 23.7% 34.4% 14.4% 18.6% |
|INTERIM SACRIFICE 1 (c)| | |
|INTERIM SACRIFICE 2 (c)| | 1/10 (10%) 1/10 (10%) 2/10 (20%) 2/10 (20%) |
|TERMINAL (d) | | 5/29 (17%) 12/38 (32%) 4/36 (11%) 3/30 (10%) |
|FIRST INCIDENCE (DAYS) | | 455 (I) 456 (I) 455 (I) 456 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.241N P=0.275 P=0.276N P=0.500N |
|INCIDENTAL TUMOR | | P=0.238N P=0.191 P=0.405N P=0.506N |
|LOGISTIC REGRESSION | | P=0.213N P=0.144 P=0.394N P=0.485N |
|COCHRAN-ARMITAGE | | P=0.220N |
|FISHER EXACT | | P=0.119 P=0.389N P=0.500N |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05090 TEST: 01 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- COUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 25 MG/KG 50 MG/KG 100MG/KG | VEHICLE 25 MG/KG 50 MG/KG 100MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/89 (0%) 2/60 (3%) 0/60 (0%) 1/130 (1%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 6.8% 0.0% 1.5% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/17 (0%) 0/10 (0%) 0/9 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/28 (0%) 0/9 (0%) 0/2 (0%) 0/11 (0%) | 0/29 (0%) 0/38 (0%) 0/36 (0%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | --- 482 --- 512 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.561 P=0.192 (e) P=0.587 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.518N P=0.338 (e) P=0.791 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.626N P=0.164 (e) P=0.575 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.611N | (e) |
|FISHER EXACT | P=0.161 (e) P=0.594 | (e) (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, |
| or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 8/89 (9%) 10/60 (17%) 1/60 (2%) 10/130 (8%) | 6/60 (10%) 5/60 (8%) 6/60 (10%) 4/60 (7%) |
|ADJUSTED (b) | 21.9% 46.4% 3.6% 43.7% | 15.5% 11.6% 14.4% 9.1% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/17 (0%) 0/10 (0%) 0/9 (0%) 1/20 (5%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 3/28 (11%) 2/9 (22%) 0/2 (0%) 3/11 (27%) | 1/29 (3%) 3/38 (8%) 2/36 (6%) 1/30 (3%) |
|FIRST INCIDENCE (DAYS) | 420 503 580 453 (I) | 554 439 554 375 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.157 P=0.057 P=0.404N P=0.095 | P=0.355N P=0.401N P=0.559N P=0.371N |
|INCIDENTAL TUMOR | P=0.377N P=0.566 P=0.020N* P=0.586N | P=0.187N P=0.504 P=0.428 P=0.265N |
|LOGISTIC REGRESSION | P=0.520N P=0.199 P=0.093N P=0.468 | P=0.241N P=0.619 P=0.456 P=0.378N |
|COCHRAN-ARMITAGE | P=0.210N | P=0.336N |
|FISHER EXACT | P=0.125 P=0.062N P=0.458N | P=0.500N P=0.619N P=0.372N |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05090 TEST: 01 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- COUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 25 MG/KG 50 MG/KG 100MG/KG | VEHICLE 25 MG/KG 50 MG/KG 100MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/89 (1%) 0/60 (0%) 1/60 (2%) 2/130 (2%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 2.7% 0.0% 5.9% 7.5% | 2.6% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/17 (0%) 0/10 (0%) 0/9 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/28 (0%) 0/9 (0%) 0/2 (0%) 0/11 (0%) | 0/29 (0%) 0/38 (0%) 0/36 (0%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | 622 --- 622 583 | 662 --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.191 P=0.523N P=0.579 P=0.415 | P=0.310N P=0.485N P=0.495N P=0.505N |
|INCIDENTAL TUMOR | P=0.546 P=0.375N P=0.490N P=0.637N | P=0.334N P=0.621N P=0.757N P=0.519N |
|LOGISTIC REGRESSION | P=0.320 P=0.554N P=0.659 P=0.558 | P=0.305N P=0.496N P=0.502N P=0.497N |
|COCHRAN-ARMITAGE | P=0.411 | P=0.306N |
|FISHER EXACT | P=0.597N P=0.645 P=0.639 | P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 63/89 (71%) 55/60 (92%) 54/60 (90%) 101/130 (78%)| 38/60 (63%) 45/60 (75%) 38/60 (63%) 42/60 (70%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 86.0% 93.7% 90.3% 87.3% |
|INTERIM SACRIFICE 1 (c)| 1/17 (6%) 0/0 0/0 1/18 (6%) | |
|INTERIM SACRIFICE 2 (c)| 16/17 (94%) 9/10 (90%) 8/9 (89%) 19/20 (95%) | 1/10 (10%) 2/10 (20%) 2/10 (20%) 2/10 (20%) |
|TERMINAL (d) | 28/28 (100%) 9/9 (100%) 2/2 (100%) 11/11 (100%)| 23/29 (79%) 35/38 (92%) 32/36 (89%) 24/30 (80%) |
|FIRST INCIDENCE (DAYS) | 274 (I) 453 (I) 428 275 (I) | 435 456 (I) 455 (I) 456 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P=0.303 P=0.443N P=0.161N P=0.358 |
|INCIDENTAL TUMOR | P=0.102 P=0.469 P=0.355 P=0.156 | P=0.524 P=0.079 P=0.410 P=0.431 |
|LOGISTIC REGRESSION | P=0.231 P=0.605N P=0.414N P=0.280 | P=0.450 P=0.113 P=0.594 P=0.339 |
|COCHRAN-ARMITAGE | P=0.425 | P=0.399 |
|FISHER EXACT | P=0.001 ** P=0.004 ** P=0.159 | P=0.118 P=0.575N P=0.281 |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05090 TEST: 01 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- COUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 25 MG/KG 50 MG/KG 100MG/KG | VEHICLE 25 MG/KG 50 MG/KG 100MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 17/89 (19%) 13/60 (22%) 4/60 (7%) 19/130 (15%)| 10/60 (17%) 7/60 (12%) 10/60 (17%) 11/60 (18%) |
|ADJUSTED (b) | 45.6% 51.5% 53.8% 68.2% | 24.9% 16.7% 24.4% 29.7% |
|INTERIM SACRIFICE 1 (c)| 0/17 (0%) 0/0 0/0 0/18 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/17 (0%) 0/10 (0%) 0/9 (0%) 1/20 (5%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 9/28 (32%) 2/9 (22%) 1/2 (50%) 6/11 (55%) | 2/29 (7%) 5/38 (13%) 6/36 (17%) 7/30 (23%) |
|FIRST INCIDENCE (DAYS) | 420 482 408 253 | 554 439 554 375 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.063 P=0.198 P=0.614 P=0.050 * | P=0.310 P=0.202N P=0.491N P=0.507 |
|INCIDENTAL TUMOR | P=0.396N P=0.216N P=0.014N* P=0.479N | P=0.496 P=0.594N P=0.386 P=0.595N |
|LOGISTIC REGRESSION | P=0.481N P=0.555N P=0.057N P=0.580N | P=0.434 P=0.448N P=0.420 P=0.518 |
|COCHRAN-ARMITAGE | P=0.151N | P=0.338 |
|FISHER EXACT | P=0.428 P=0.026N* P=0.243N | P=0.301N P=0.596N P=0.500 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 64/89 (72%) 55/60 (92%) 55/60 (92%) 103/130 (79%)| 42/60 (70%) 46/60 (77%) 42/60 (70%) 45/60 (75%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 89.2% 93.8% 91.2% 89.8% |
|INTERIM SACRIFICE 1 (c)| 1/17 (6%) 0/0 0/0 1/18 (6%) | |
|INTERIM SACRIFICE 2 (c)| 16/17 (94%) 9/10 (90%) 8/9 (89%) 20/20 (100%)| 1/10 (10%) 2/10 (20%) 2/10 (20%) 2/10 (20%) |
|TERMINAL (d) | 28/28 (100%) 9/9 (100%) 2/2 (100%) 11/11 (100%)| 24/29 (83%) 35/38 (92%) 32/36 (89%) 25/30 (83%) |
|FIRST INCIDENCE (DAYS) | 274 (I) 453 (I) 408 253 | 435 439 455 (I) 375 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P=0.313 P=0.250N P=0.176N P=0.427 |
|INCIDENTAL TUMOR | P=0.076 P=0.638 P=0.529 P=0.137 | P=0.431N P=0.123 P=0.335 P=0.588 |
|LOGISTIC REGRESSION | P=0.147 P=0.489N P=0.514N P=0.195 | P=0.541N P=0.164 P=0.495 P=0.435 |
|COCHRAN-ARMITAGE | P=0.367 | P=0.394 |
|FISHER EXACT | P=0.002 ** P=0.002 ** P=0.138 | P=0.268 P=0.579N P=0.342 |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05090 TEST: 01 PAGE 21
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- COUMARIN
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): 274 453
Female interim sacrifices(days): 455
(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).