TDMS Study 05091-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: American Biogenics DIHYDROCOUMARIN DATE: 09/12/94
EXPERIMENT: 05091 TEST: 01 TIME: 08:31:40
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-45039 ROUTE: GAVAGE NTP C#: 55890B
PATHOLOGIST: R. DAHLGREN S. EUSTIS CAS: 119-84-6
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: American Biogenics DIHYDROCOUMARIN DATE: 09/12/94
EXPERIMENT: 05091 TEST: 01 TIME: 08:31:40
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-45039 ROUTE: GAVAGE NTP C#: 55890B
PATHOLOGIST: R. DAHLGREN S. EUSTIS CAS: 119-84-6
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
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 DIHYDROCOUMARIN DATE: 09/12/94
EXPERIMENT: 05091 TEST: 01 TIME: 08:31:40
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-45039 ROUTE: GAVAGE NTP C#: 55890B
PATHOLOGIST: R. DAHLGREN S. EUSTIS CAS: 119-84-6
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF DIHYDROCOUMARIN
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Clitoral/Preputial Gland Adenoma
Carcinoma
Carcinoma or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Skin Basal Cell Adenoma
Fibroma
Keratoacanthoma
Testes Adenoma
All Organs Benign Tumors
Malignant and Benign Tumors
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Skin Fibroma
Squamous Cell Papilloma
Stomach, Forestomach Squamous Cell Carcinoma or Papilloma Squamous
All Organs Benign Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 09/12/94 EXPERIMENT: 05091 TEST: 01 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIHYDROCOUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 150MG/KG 300MG/KG 600MG/KG | VEHICLE 150MG/KG 300MG/KG 600MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 17/89 (19%) 10/59 (17%) 12/59 (20%) 17/130 (13%)| 1/60 (2%) 7/58 (12%) 6/59 (10%) 4/59 (7%) |
|ADJUSTED (b) | 52.5% 48.2% 55.3% 57.9% | 3.0% 31.0% 17.2% 16.7% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 13/28 (46%) 4/13 (31%) 2/8 (25%) 5/12 (42%) | 0/31 (0%) 6/21 (29%) 3/26 (12%) 3/23 (13%) |
|FIRST INCIDENCE (DAYS) | 634 668 615 529 | 716 710 580 717 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.080 P=0.474 P=0.123 P=0.110 | P=0.234 P=0.009 ** P=0.052 P=0.105 |
|INCIDENTAL TUMOR | P=0.335N P=0.273N P=0.351N P=0.408N | P=0.308 P=0.013 * P=0.109 P=0.097 |
|LOGISTIC REGRESSION | P=0.394N P=0.370N P=0.457N P=0.357N | P=0.259 P=0.012 * P=0.057 P=0.109 |
|COCHRAN-ARMITAGE | P=0.130N | P=0.335 |
|FISHER EXACT | P=0.458N P=0.507 P=0.154N | P=0.027 * P=0.054 P=0.177 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 18/89 (20%) 11/59 (19%) 12/59 (20%) 17/130 (13%)| 2/60 (3%) 7/58 (12%) 6/59 (10%) 4/59 (7%) |
|ADJUSTED (b) | 53.8% 50.9% 55.3% 57.9% | 6.2% 31.0% 17.2% 16.7% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 13/28 (46%) 4/13 (31%) 2/8 (25%) 5/12 (42%) | 1/31 (3%) 6/21 (29%) 3/26 (12%) 3/23 (13%) |
|FIRST INCIDENCE (DAYS) | 634 668 615 529 | 716 710 580 717 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.127 P=0.443 P=0.180 P=0.164 | P=0.329 P=0.024 * P=0.115 P=0.213 |
|INCIDENTAL TUMOR | P=0.207N P=0.238N P=0.228N P=0.276N | P=0.413 P=0.035 * P=0.211 P=0.204 |
|LOGISTIC REGRESSION | P=0.283N P=0.378N P=0.357N P=0.265N | P=0.360 P=0.032 * P=0.129 P=0.224 |
|COCHRAN-ARMITAGE | P=0.083N | P=0.447 |
|FISHER EXACT | P=0.493N P=0.573 P=0.110N | P=0.074 P=0.131 P=0.332 |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05091 TEST: 01 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIHYDROCOUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 150MG/KG 300MG/KG 600MG/KG | VEHICLE 150MG/KG 300MG/KG 600MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/86 (9%) 1/59 (2%) 1/58 (2%) 1/129 (1%) | 3/57 (5%) 1/57 (2%) 2/60 (3%) 1/59 (2%) |
|ADJUSTED (b) | 27.3% 7.7% 12.5% 3.3% | 9.0% 2.9% 7.2% 4.3% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 7/28 (25%) 1/13 (8%) 1/8 (13%) 0/12 (0%) | 2/30 (7%) 0/20 (0%) 1/26 (4%) 1/23 (4%) |
|FIRST INCIDENCE (DAYS) | 704 729 (T) 729 (T) 681 | 652 657 717 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.082N P=0.141N P=0.298N P=0.133N | P=0.346N P=0.409N P=0.550N P=0.407N |
|INCIDENTAL TUMOR | P=0.038N* P=0.089N P=0.179N P=0.034N* | P=0.338N P=0.287N P=0.452N P=0.392N |
|LOGISTIC REGRESSION | P=0.027N* P=0.082N P=0.140N P=0.034N* | P=0.301N P=0.343N P=0.484N P=0.352N |
|COCHRAN-ARMITAGE | P=0.003N** | P=0.266N |
|FISHER EXACT | P=0.059N P=0.062N P=0.003N** | P=0.309N P=0.476N P=0.296N |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/86 (5%) 3/59 (5%) 0/58 (0%) 1/129 (1%) | 2/57 (4%) 4/57 (7%) 0/60 (0%) 1/59 (2%) |
|ADJUSTED (b) | 10.5% 7.7% 0.0% 1.5% | 5.3% 16.5% 0.0% 3.3% |
|INTERIM SACRIFICE 1 (c)| 1/19 (5%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 2/28 (7%) 0/13 (0%) 0/8 (0%) 0/12 (0%) | 1/30 (3%) 2/20 (10%) 0/26 (0%) 0/23 (0%) |
|FIRST INCIDENCE (DAYS) | 275 (I) 576 --- 577 | 506 682 --- 678 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.074N P=0.481 P=0.291N P=0.238N | P=0.249N P=0.217 P=0.253N P=0.562N |
|INCIDENTAL TUMOR | P=0.025N* P=0.469N P=0.197N P=0.103N | P=0.237N P=0.330 P=0.355N P=0.525N |
|LOGISTIC REGRESSION | P=0.031N* P=0.641 P=0.106N P=0.082N | P=0.204N P=0.295 P=0.230N P=0.494N |
|COCHRAN-ARMITAGE | P=0.031N* | P=0.188N |
|FISHER EXACT | P=0.598 P=0.124N P=0.085N | P=0.339 P=0.235N P=0.487N |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05091 TEST: 01 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIHYDROCOUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 150MG/KG 300MG/KG 600MG/KG | VEHICLE 150MG/KG 300MG/KG 600MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/86 (14%) 4/59 (7%) 1/58 (2%) 2/129 (2%) | 5/57 (9%) 5/57 (9%) 2/60 (3%) 2/59 (3%) |
|ADJUSTED (b) | 36.6% 14.8% 12.5% 4.8% | 14.1% 19.0% 7.2% 7.5% |
|INTERIM SACRIFICE 1 (c)| 1/19 (5%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 9/28 (32%) 1/13 (8%) 1/8 (13%) 0/12 (0%) | 3/30 (10%) 2/20 (10%) 1/26 (4%) 1/23 (4%) |
|FIRST INCIDENCE (DAYS) | 275 (I) 576 729 (T) 577 | 506 657 717 678 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.014N* P=0.313N P=0.124N P=0.050N* | P=0.171N P=0.445 P=0.261N P=0.322N |
|INCIDENTAL TUMOR | P=0.002N** P=0.073N P=0.047N* P=0.004N** | P=0.154N P=0.628N P=0.243N P=0.288N |
|LOGISTIC REGRESSION | P<0.001N** P=0.066N P=0.003N** P<0.001N** | P=0.121N P=0.568 P=0.195N P=0.240N |
|COCHRAN-ARMITAGE | P<0.001N** | P=0.102N |
|FISHER EXACT | P=0.138N P=0.009N** P<0.001N** | P=0.629N P=0.199N P=0.205N |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/88 (6%) 2/57 (4%) 4/58 (7%) 3/120 (3%) | 2/60 (3%) 0/53 (0%) 1/60 (2%) 1/58 (2%) |
|ADJUSTED (b) | 15.5% 11.0% 24.8% 12.8% | 6.5% 0.0% 2.7% 4.3% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 1/19 (5%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 4/28 (14%) 1/13 (8%) 1/8 (13%) 1/12 (8%) | 2/31 (6%) 0/21 (0%) 0/26 (0%) 1/23 (4%) |
|FIRST INCIDENCE (DAYS) | 457 (I) 668 662 661 | 729 (T) --- 678 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.523 P=0.541N P=0.260 P=0.623N | P=0.560N P=0.327N P=0.544N P=0.604N |
|INCIDENTAL TUMOR | P=0.377N P=0.483N P=0.520 P=0.489N | P=0.575N P=0.327N P=0.510N P=0.604N |
|LOGISTIC REGRESSION | P=0.291N P=0.331N P=0.621N P=0.272N | P=0.550N P=0.327N P=0.510N P=0.604N |
|COCHRAN-ARMITAGE | P=0.191N | P=0.498N |
|FISHER EXACT | P=0.432N P=0.512 P=0.207N | P=0.280N P=0.500N P=0.513N |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05091 TEST: 01 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIHYDROCOUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 150MG/KG 300MG/KG 600MG/KG | VEHICLE 150MG/KG 300MG/KG 600MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Kidney: Pelvis and Transitional Epithelium |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/89 (0%) 0/58 (0%) 0/57 (0%) 2/130 (2%) | 0/60 (0%) 0/56 (0%) 0/59 (0%) 0/58 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 2.2% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/28 (0%) 0/13 (0%) 0/8 (0%) 0/12 (0%) | 0/31 (0%) 0/21 (0%) 0/26 (0%) 0/23 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 444 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.102 (e) (e) P=0.348 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.205 (e) (e) P=0.464 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.129 (e) (e) P=0.325 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.113 | (e) |
|FISHER EXACT | (e) (e) P=0.351 | (e) (e) (e) |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/89 (0%) 1/58 (2%) 0/57 (0%) 2/130 (2%) | 1/60 (2%) 1/56 (2%) 1/59 (2%) 0/58 (0%) |
|ADJUSTED (b) | 0.0% 3.6% 0.0% 5.7% | 3.2% 3.4% 3.8% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/28 (0%) 0/13 (0%) 0/8 (0%) 0/12 (0%) | 1/31 (3%) 0/21 (0%) 1/26 (4%) 0/23 (0%) |
|FIRST INCIDENCE (DAYS) | --- 668 --- 605 | 729 (T) 710 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.178 P=0.455 (e) P=0.245 | P=0.359N P=0.702 P=0.723 P=0.560N |
|INCIDENTAL TUMOR | P=0.374 P=0.581 (e) P=0.556 | P=0.369N P=0.749 P=0.723 P=0.560N |
|LOGISTIC REGRESSION | P=0.228 P=0.446 (e) P=0.304 | P=0.354N P=0.718 P=0.723 P=0.560N |
|COCHRAN-ARMITAGE | P=0.268 | P=0.315N |
|FISHER EXACT | P=0.395 (e) P=0.351 | P=0.735 P=0.748 P=0.508N |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05091 TEST: 01 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIHYDROCOUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 150MG/KG 300MG/KG 600MG/KG | VEHICLE 150MG/KG 300MG/KG 600MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/89 (0%) 1/58 (2%) 0/57 (0%) 2/130 (2%) | 1/60 (2%) 1/56 (2%) 2/59 (3%) 0/58 (0%) |
|ADJUSTED (b) | 0.0% 3.6% 0.0% 5.7% | 3.2% 3.4% 6.1% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/28 (0%) 0/13 (0%) 0/8 (0%) 0/12 (0%) | 1/31 (3%) 0/21 (0%) 1/26 (4%) 0/23 (0%) |
|FIRST INCIDENCE (DAYS) | --- 668 --- 605 | 729 (T) 710 624 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.178 P=0.455 (e) P=0.245 | P=0.420N P=0.702 P=0.459 P=0.560N |
|INCIDENTAL TUMOR | P=0.374 P=0.581 (e) P=0.556 | P=0.351N P=0.749 P=0.550 P=0.560N |
|LOGISTIC REGRESSION | P=0.228 P=0.446 (e) P=0.304 | P=0.398N P=0.718 P=0.496 P=0.560N |
|COCHRAN-ARMITAGE | P=0.268 | P=0.371N |
|FISHER EXACT | P=0.395 (e) P=0.351 | P=0.735 P=0.494 P=0.508N |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/88 (0%) 1/57 (2%) 2/59 (3%) 3/128 (2%) | 0/60 (0%) 0/58 (0%) 0/60 (0%) 1/59 (2%) |
|ADJUSTED (b) | 0.0% 7.7% 6.3% 12.3% | 0.0% 0.0% 0.0% 4.3% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/19 (0%) 0/10 (0%) 1/10 (10%) 0/20 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/28 (0%) 1/13 (8%) 0/8 (0%) 1/12 (8%) | 0/31 (0%) 0/21 (0%) 0/26 (0%) 1/23 (4%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) 459 (I) 640 | --- --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.053 P=0.347 P=0.137 P=0.095 | P=0.179 (e) (e) P=0.440 |
|INCIDENTAL TUMOR | P=0.115 P=0.347 P=0.257 P=0.206 | P=0.179 (e) (e) P=0.440 |
|LOGISTIC REGRESSION | P=0.144 P=0.347 P=0.148 P=0.155 | P=0.179 (e) (e) P=0.440 |
|COCHRAN-ARMITAGE | P=0.187 | P=0.198 |
|FISHER EXACT | P=0.393 P=0.159 P=0.206 | (e) (e) P=0.496 |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05091 TEST: 01 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIHYDROCOUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 150MG/KG 300MG/KG 600MG/KG | VEHICLE 150MG/KG 300MG/KG 600MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/88 (0%) 1/57 (2%) 3/59 (5%) 3/128 (2%) | 0/60 (0%) 0/58 (0%) 0/60 (0%) 1/59 (2%) |
|ADJUSTED (b) | 0.0% 7.7% 9.4% 12.3% | 0.0% 0.0% 0.0% 4.3% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/19 (0%) 0/10 (0%) 1/10 (10%) 0/20 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/28 (0%) 1/13 (8%) 0/8 (0%) 1/12 (8%) | 0/31 (0%) 0/21 (0%) 0/26 (0%) 1/23 (4%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) 459 (I) 640 | --- --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.062 P=0.347 P=0.066 P=0.095 | P=0.179 (e) (e) P=0.440 |
|INCIDENTAL TUMOR | P=0.153 P=0.347 P=0.186 P=0.206 | P=0.179 (e) (e) P=0.440 |
|LOGISTIC REGRESSION | P=0.159 P=0.347 P=0.072 P=0.155 | P=0.179 (e) (e) P=0.440 |
|COCHRAN-ARMITAGE | P=0.210 | P=0.198 |
|FISHER EXACT | P=0.393 P=0.063 P=0.206 | (e) (e) P=0.496 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/88 (0%) 1/57 (2%) 3/59 (5%) 3/128 (2%) | 0/60 (0%) 0/58 (0%) 0/60 (0%) 1/59 (2%) |
|ADJUSTED (b) | 0.0% 7.7% 9.4% 12.3% | 0.0% 0.0% 0.0% 4.3% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/19 (0%) 0/10 (0%) 1/10 (10%) 0/20 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/28 (0%) 1/13 (8%) 0/8 (0%) 1/12 (8%) | 0/31 (0%) 0/21 (0%) 0/26 (0%) 1/23 (4%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) 459 (I) 640 | --- --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.062 P=0.347 P=0.066 P=0.095 | P=0.179 (e) (e) P=0.440 |
|INCIDENTAL TUMOR | P=0.153 P=0.347 P=0.186 P=0.206 | P=0.179 (e) (e) P=0.440 |
|LOGISTIC REGRESSION | P=0.159 P=0.347 P=0.072 P=0.155 | P=0.179 (e) (e) P=0.440 |
|COCHRAN-ARMITAGE | P=0.210 | P=0.198 |
|FISHER EXACT | P=0.393 P=0.063 P=0.206 | (e) (e) P=0.496 |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05091 TEST: 01 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIHYDROCOUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 150MG/KG 300MG/KG 600MG/KG | VEHICLE 150MG/KG 300MG/KG 600MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/89 (3%) 1/60 (2%) 1/60 (2%) 1/130 (1%) | 1/60 (2%) 0/58 (0%) 0/60 (0%) 0/59 (0%) |
|ADJUSTED (b) | 8.5% 7.7% 12.5% 2.3% | 3.2% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 1/19 (5%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 2/28 (7%) 1/13 (8%) 1/8 (13%) 0/12 (0%) | 1/31 (3%) 0/21 (0%) 0/26 (0%) 0/23 (0%) |
|FIRST INCIDENCE (DAYS) | 457 (I) 729 (T) 729 (T) 661 | 729 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.413N P=0.588N P=0.718N P=0.432N | P=0.335N P=0.578N P=0.535N P=0.560N |
|INCIDENTAL TUMOR | P=0.363N P=0.588N P=0.718N P=0.335N | P=0.335N P=0.578N P=0.535N P=0.560N |
|LOGISTIC REGRESSION | P=0.166N P=0.391N P=0.365N P=0.199N | P=0.335N P=0.578N P=0.535N P=0.560N |
|COCHRAN-ARMITAGE | P=0.138N | P=0.306N |
|FISHER EXACT | P=0.469N P=0.469N P=0.185N | P=0.508N P=0.500N P=0.504N |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/89 (3%) 1/60 (2%) 1/60 (2%) 1/130 (1%) | 1/60 (2%) 0/58 (0%) 1/60 (2%) 0/59 (0%) |
|ADJUSTED (b) | 8.5% 7.7% 12.5% 2.3% | 3.2% 0.0% 3.8% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 1/19 (5%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 2/28 (7%) 1/13 (8%) 1/8 (13%) 0/12 (0%) | 1/31 (3%) 0/21 (0%) 1/26 (4%) 0/23 (0%) |
|FIRST INCIDENCE (DAYS) | 457 (I) 729 (T) 729 (T) 661 | 729 (T) --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.413N P=0.588N P=0.718N P=0.432N | P=0.449N P=0.578N P=0.723 P=0.560N |
|INCIDENTAL TUMOR | P=0.363N P=0.588N P=0.718N P=0.335N | P=0.449N P=0.578N P=0.723 P=0.560N |
|LOGISTIC REGRESSION | P=0.166N P=0.391N P=0.365N P=0.199N | P=0.449N P=0.578N P=0.723 P=0.560N |
|COCHRAN-ARMITAGE | P=0.138N | P=0.406N |
|FISHER EXACT | P=0.469N P=0.469N P=0.185N | P=0.508N P=0.752N P=0.504N |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05091 TEST: 01 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIHYDROCOUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 150MG/KG 300MG/KG 600MG/KG | VEHICLE 150MG/KG 300MG/KG 600MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/90 (3%) 2/60 (3%) 0/60 (0%) 2/130 (2%) | 15/60 (25%) 10/58 (17%) 22/60 (37%) 6/60 (10%) |
|ADJUSTED (b) | 9.3% 5.7% 0.0% 16.7% | 39.5% 36.7% 59.2% 19.5% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 1/10 (10%) 1/7 (14%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 2/28 (7%) 0/13 (0%) 0/8 (0%) 2/12 (17%) | 9/31 (29%) 5/21 (24%) 12/26 (46%) 3/23 (13%) |
|FIRST INCIDENCE (DAYS) | 619 584 --- 729 (T) | 462 (I) 462 (I) 611 521 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.503N P=0.661 P=0.291N P=0.601 | P=0.198N P=0.516N P=0.066 P=0.103N |
|INCIDENTAL TUMOR | P=0.369N P=0.361N P=0.197N P=0.691N | P=0.089N P=0.303N P=0.182 P=0.041N* |
|LOGISTIC REGRESSION | P=0.275N P=0.612N P=0.157N P=0.516N | P=0.110N P=0.302N P=0.104 P=0.047N* |
|COCHRAN-ARMITAGE | P=0.216N | P=0.070N |
|FISHER EXACT | P=0.685N P=0.213N P=0.332N | P=0.210N P=0.118 P=0.026N* |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/90 (4%) 2/60 (3%) 0/60 (0%) 2/130 (2%) | 15/60 (25%) 10/58 (17%) 22/60 (37%) 6/60 (10%) |
|ADJUSTED (b) | 12.7% 5.7% 0.0% 16.7% | 39.5% 36.7% 59.2% 19.5% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 1/10 (10%) 1/7 (14%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 3/28 (11%) 0/13 (0%) 0/8 (0%) 2/12 (17%) | 9/31 (29%) 5/21 (24%) 12/26 (46%) 3/23 (13%) |
|FIRST INCIDENCE (DAYS) | 619 584 --- 729 (T) | 462 (I) 462 (I) 611 521 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.386N P=0.580N P=0.227N P=0.657N | P=0.198N P=0.516N P=0.066 P=0.103N |
|INCIDENTAL TUMOR | P=0.268N P=0.267N P=0.154N P=0.568N | P=0.089N P=0.303N P=0.182 P=0.041N* |
|LOGISTIC REGRESSION | P=0.167N P=0.457N P=0.094N P=0.372N | P=0.110N P=0.302N P=0.104 P=0.047N* |
|COCHRAN-ARMITAGE | P=0.119N | P=0.070N |
|FISHER EXACT | P=0.544N P=0.126N P=0.189N | P=0.210N P=0.118 P=0.026N* |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05091 TEST: 01 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIHYDROCOUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 150MG/KG 300MG/KG 600MG/KG | VEHICLE 150MG/KG 300MG/KG 600MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/90 (4%) 2/60 (3%) 0/60 (0%) 2/130 (2%) | 15/60 (25%) 10/58 (17%) 22/60 (37%) 6/60 (10%) |
|ADJUSTED (b) | 12.7% 5.7% 0.0% 16.7% | 39.5% 36.7% 59.2% 19.5% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 1/10 (10%) 1/7 (14%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 3/28 (11%) 0/13 (0%) 0/8 (0%) 2/12 (17%) | 9/31 (29%) 5/21 (24%) 12/26 (46%) 3/23 (13%) |
|FIRST INCIDENCE (DAYS) | 619 584 --- 729 (T) | 462 (I) 462 (I) 611 521 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.386N P=0.580N P=0.227N P=0.657N | P=0.198N P=0.516N P=0.066 P=0.103N |
|INCIDENTAL TUMOR | P=0.268N P=0.267N P=0.154N P=0.568N | P=0.089N P=0.303N P=0.182 P=0.041N* |
|LOGISTIC REGRESSION | P=0.167N P=0.457N P=0.094N P=0.372N | P=0.110N P=0.302N P=0.104 P=0.047N* |
|COCHRAN-ARMITAGE | P=0.119N | P=0.070N |
|FISHER EXACT | P=0.544N P=0.126N P=0.189N | P=0.210N P=0.118 P=0.026N* |
|=================================================================================================================================|
| |
|Pancreas |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/88 (2%) 5/57 (9%) 4/58 (7%) 2/117 (2%) | 0/58 (0%) 0/53 (0%) 1/59 (2%) 0/58 (0%) |
|ADJUSTED (b) | 7.1% 24.2% 18.7% 6.5% | 0.0% 0.0% 3.8% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 2/28 (7%) 2/13 (15%) 0/8 (0%) 0/12 (0%) | 0/31 (0%) 0/21 (0%) 1/26 (4%) 0/23 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 549 662 537 | --- --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.565 P=0.063 P=0.102 P=0.543 | P=0.665 (e) P=0.465 (e) |
|INCIDENTAL TUMOR | P=0.218N P=0.144 P=0.408 P=0.691N | P=0.665 (e) P=0.465 (e) |
|LOGISTIC REGRESSION | P=0.325N P=0.119 P=0.220 P=0.641N | P=0.665 (e) P=0.465 (e) |
|COCHRAN-ARMITAGE | P=0.245N | P=0.697 |
|FISHER EXACT | P=0.084 P=0.171 P=0.576N | (e) P=0.504 (e) |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05091 TEST: 01 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIHYDROCOUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 150MG/KG 300MG/KG 600MG/KG | VEHICLE 150MG/KG 300MG/KG 600MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 26/88 (30%) 21/57 (37%) 14/56 (25%) 18/122 (15%)| 36/59 (61%) 21/55 (38%) 28/59 (47%) 20/59 (34%) |
|ADJUSTED (b) | 64.4% 74.2% 51.6% 65.8% | 75.3% 68.7% 68.1% 56.0% |
|INTERIM SACRIFICE 1 (c)| 1/19 (5%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 1/19 (5%) 1/10 (10%) 1/10 (10%) 0/20 (0%) | 5/10 (50%) 0/7 (0%) 1/10 (10%) 1/9 (11%) |
|TERMINAL (d) | 15/28 (54%) 7/13 (54%) 1/8 (13%) 5/11 (45%) | 20/31 (65%) 12/21 (57%) 14/26 (54%) 10/23 (43%) |
|FIRST INCIDENCE (DAYS) | 275 (I) 458 (I) 459 (I) 483 | 385 471 462 (I) 455 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.410N P=0.098 P=0.447 P=0.532 | P=0.099N P=0.194N P=0.279N P=0.077N |
|INCIDENTAL TUMOR | P=0.002N** P=0.425N P=0.045N* P=0.012N* | P=0.016N* P=0.027N* P=0.117N P=0.004N** |
|LOGISTIC REGRESSION | P=0.002N** P=0.533 P=0.078N P=0.010N** | P=0.015N* P=0.017N* P=0.094N P=0.005N** |
|COCHRAN-ARMITAGE | P=0.001N** | P=0.008N** |
|FISHER EXACT | P=0.231 P=0.346N P=0.008N** | P=0.012N* P=0.098N P=0.003N** |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/90 (0%) 0/60 (0%) 0/60 (0%) 3/130 (2%) | 0/60 (0%) 0/58 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 12.6% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/28 (0%) 0/13 (0%) 0/8 (0%) 0/12 (0%) | 0/31 (0%) 0/21 (0%) 0/26 (0%) 0/23 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 661 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.012 * (e) (e) P=0.083 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.058 (e) (e) P=0.381 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.022 * (e) (e) P=0.136 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.046 * | (e) |
|FISHER EXACT | (e) (e) P=0.204 | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05091 TEST: 01 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIHYDROCOUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 150MG/KG 300MG/KG 600MG/KG | VEHICLE 150MG/KG 300MG/KG 600MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/90 (1%) 4/60 (7%) 0/60 (0%) 3/130 (2%) | 0/60 (0%) 0/58 (0%) 1/60 (2%) 2/60 (3%) |
|ADJUSTED (b) | 3.6% 22.1% 0.0% 16.1% | 0.0% 0.0% 3.8% 8.3% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 1/28 (4%) 2/13 (15%) 0/8 (0%) 1/12 (8%) | 0/31 (0%) 0/21 (0%) 1/26 (4%) 1/23 (4%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 599 --- 661 | --- --- 729 (T) 717 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.243 P=0.049 * P=0.748N P=0.148 | P=0.055 (e) P=0.465 P=0.178 |
|INCIDENTAL TUMOR | P=0.455 P=0.119 P=0.748N P=0.332 | P=0.045 * (e) P=0.465 P=0.171 |
|LOGISTIC REGRESSION | P=0.469 P=0.101 P=0.748N P=0.271 | P=0.052 (e) P=0.465 P=0.184 |
|COCHRAN-ARMITAGE | P=0.545N | P=0.072 |
|FISHER EXACT | P=0.083 P=0.600N P=0.459 | (e) P=0.500 P=0.248 |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/90 (3%) 3/60 (5%) 2/60 (3%) 0/130 (0%) | 0/60 (0%) 0/58 (0%) 2/60 (3%) 0/60 (0%) |
|ADJUSTED (b) | 8.5% 11.5% 16.0% 0.0% | 0.0% 0.0% 7.7% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 1/19 (5%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 2/28 (7%) 0/13 (0%) 1/8 (13%) 0/12 (0%) | 0/31 (0%) 0/21 (0%) 2/26 (8%) 0/23 (0%) |
|FIRST INCIDENCE (DAYS) | 457 (I) 634 684 --- | --- --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.136N P=0.408 P=0.477 P=0.225N | P=0.551 (e) P=0.200 (e) |
|INCIDENTAL TUMOR | P=0.046N* P=0.642 P=0.587 P=0.225N | P=0.551 (e) P=0.200 (e) |
|LOGISTIC REGRESSION | P=0.041N* P=0.542 P=0.581N P=0.072N | P=0.551 (e) P=0.200 (e) |
|COCHRAN-ARMITAGE | P=0.034N* | P=0.597 |
|FISHER EXACT | P=0.456 P=0.685N P=0.067N | (e) P=0.248 (e) |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05091 TEST: 01 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIHYDROCOUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 150MG/KG 300MG/KG 600MG/KG | VEHICLE 150MG/KG 300MG/KG 600MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/90 (2%) 1/60 (2%) 1/60 (2%) 1/130 (1%) | 0/60 (0%) 0/58 (0%) 0/60 (0%) 2/60 (3%) |
|ADJUSTED (b) | 5.4% 4.3% 6.7% 8.3% | 0.0% 0.0% 0.0% 8.7% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/28 (0%) 0/13 (0%) 0/8 (0%) 1/12 (8%) | 0/31 (0%) 0/21 (0%) 0/26 (0%) 2/23 (9%) |
|FIRST INCIDENCE (DAYS) | 655 681 709 729 (T) | --- --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.455N P=0.586N P=0.587N P=0.543N | P=0.037 * (e) (e) P=0.175 |
|INCIDENTAL TUMOR | P=0.205N P=0.357N P=0.219N P=0.335N | P=0.037 * (e) (e) P=0.175 |
|LOGISTIC REGRESSION | P=0.334N P=0.587N P=0.561N P=0.432N | P=0.037 * (e) (e) P=0.175 |
|COCHRAN-ARMITAGE | P=0.267N | P=0.048 * |
|FISHER EXACT | P=0.649N P=0.649N P=0.365N | (e) (e) P=0.248 |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, |
| Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 5/90 (6%) 3/60 (5%) 3/60 (5%) 4/130 (3%) | 0/60 (0%) 0/58 (0%) 2/60 (3%) 2/60 (3%) |
|ADJUSTED (b) | 13.5% 11.5% 21.6% 19.9% | 0.0% 0.0% 7.7% 8.7% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 1/19 (5%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 2/28 (7%) 0/13 (0%) 1/8 (13%) 1/12 (8%) | 0/31 (0%) 0/21 (0%) 2/26 (8%) 2/23 (9%) |
|FIRST INCIDENCE (DAYS) | 457 (I) 634 684 661 | --- --- 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.525 P=0.607N P=0.578 P=0.595 | P=0.064 (e) P=0.200 P=0.175 |
|INCIDENTAL TUMOR | P=0.210N P=0.318N P=0.399N P=0.291N | P=0.064 (e) P=0.200 P=0.175 |
|LOGISTIC REGRESSION | P=0.308N P=0.499N P=0.455N P=0.353N | P=0.064 (e) P=0.200 P=0.175 |
|COCHRAN-ARMITAGE | P=0.219N | P=0.088 |
|FISHER EXACT | P=0.596N P=0.596N P=0.282N | (e) P=0.248 P=0.248 |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05091 TEST: 01 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIHYDROCOUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 150MG/KG 300MG/KG 600MG/KG | VEHICLE 150MG/KG 300MG/KG 600MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/90 (0%) 0/60 (0%) 0/60 (0%) 0/130 (0%) | 0/60 (0%) 0/58 (0%) 0/60 (0%) 2/60 (3%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 8.7% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/28 (0%) 0/13 (0%) 0/8 (0%) 0/12 (0%) | 0/31 (0%) 0/21 (0%) 0/26 (0%) 2/23 (9%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.037 * (e) (e) P=0.175 |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.037 * (e) (e) P=0.175 |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.037 * (e) (e) P=0.175 |
|COCHRAN-ARMITAGE | (e) | P=0.048 * |
|FISHER EXACT | (e) (e) (e) | (e) (e) P=0.248 |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 56/88 (64%) 41/59 (69%) 41/59 (69%) 85/126 (67%)| |
|ADJUSTED (b) | 100.0% 97.4% 100.0% 98.7% | |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 13/19 (68%) 2/10 (20%) 2/10 (20%) 11/20 (55%) | |
|TERMINAL (d) | 28/28 (100%) 12/13 (92%) 8/8 (100%) 11/12 (92%) | |
|FIRST INCIDENCE (DAYS) | 457 (I) 458 (I) 458 (I) 457 (I) | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.099 P=0.016 * P<0.001 ** | |
|INCIDENTAL TUMOR | P=0.157 P=0.063N P=0.055N P=0.554 | |
|LOGISTIC REGRESSION | P=0.231 P=0.050N P=0.008N** P=0.413N | |
|COCHRAN-ARMITAGE | P=0.373 | |
|FISHER EXACT | P=0.290 P=0.290 P=0.331 | |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05091 TEST: 01 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIHYDROCOUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 150MG/KG 300MG/KG 600MG/KG | VEHICLE 150MG/KG 300MG/KG 600MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/89 (1%) 1/58 (2%) 0/59 (0%) 1/116 (1%) | 1/59 (2%) 4/55 (7%) 1/59 (2%) 2/59 (3%) |
|ADJUSTED (b) | 2.1% 7.7% 0.0% 3.4% | 3.2% 17.9% 1.9% 8.7% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/7 (0%) 1/10 (10%) 0/9 (0%) |
|TERMINAL (d) | 0/28 (0%) 1/13 (8%) 0/8 (0%) 0/12 (0%) | 1/31 (3%) 3/21 (14%) 0/26 (0%) 2/23 (9%) |
|FIRST INCIDENCE (DAYS) | 534 729 (T) --- 687 | 729 (T) 716 461 (I) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.640N P=0.673 P=0.504N P=0.728N | P=0.516 P=0.086 P=0.741 P=0.396 |
|INCIDENTAL TUMOR | P=0.516N P=0.650 P=0.682N P=0.545N | P=0.516 P=0.110 P=0.741 P=0.396 |
|LOGISTIC REGRESSION | P=0.535N P=0.697 P=0.621N P=0.708N | P=0.562 P=0.105 P=0.752 P=0.396 |
|COCHRAN-ARMITAGE | P=0.505N | P=0.586N |
|FISHER EXACT | P=0.635 P=0.601N P=0.681N | P=0.161 P=0.752N P=0.500 |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/89 (1%) 2/58 (3%) 1/59 (2%) 3/116 (3%) | 0/59 (0%) 1/55 (2%) 0/59 (0%) 0/59 (0%) |
|ADJUSTED (b) | 3.6% 13.5% 5.9% 5.4% | 0.0% 4.8% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 1/20 (5%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 1/28 (4%) 1/13 (8%) 0/8 (0%) 0/12 (0%) | 0/31 (0%) 1/21 (5%) 0/26 (0%) 0/23 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 721 701 457 (I) | --- 729 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.167 P=0.267 P=0.544 P=0.266 | P=0.597N P=0.422 (e) (e) |
|INCIDENTAL TUMOR | P=0.362 P=0.375 P=0.764 P=0.428 | P=0.597N P=0.422 (e) (e) |
|LOGISTIC REGRESSION | P=0.341 P=0.300 P=0.680 P=0.392 | P=0.597N P=0.422 (e) (e) |
|COCHRAN-ARMITAGE | P=0.401 | P=0.563N |
|FISHER EXACT | P=0.343 P=0.640 P=0.416 | P=0.482 (e) (e) |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05091 TEST: 01 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIHYDROCOUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 150MG/KG 300MG/KG 600MG/KG | VEHICLE 150MG/KG 300MG/KG 600MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/89 (2%) 3/58 (5%) 1/59 (2%) 3/116 (3%) | 0/59 (0%) 1/55 (2%) 1/59 (2%) 1/59 (2%) |
|ADJUSTED (b) | 7.1% 20.7% 5.9% 5.4% | 0.0% 4.8% 3.8% 3.1% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 1/20 (5%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 2/28 (7%) 2/13 (15%) 0/8 (0%) 0/12 (0%) | 0/31 (0%) 1/21 (5%) 1/26 (4%) 0/23 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 721 701 457 (I) | --- 729 (T) 729 (T) 639 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.298 P=0.196 P=0.651 P=0.386 | P=0.334 P=0.422 P=0.465 P=0.451 |
|INCIDENTAL TUMOR | P=0.512 P=0.270 P=0.677N P=0.553 | P=0.428 P=0.422 P=0.465 P=0.701 |
|LOGISTIC REGRESSION | P=0.575 P=0.231 P=0.686N P=0.593 | P=0.359 P=0.422 P=0.465 P=0.496 |
|COCHRAN-ARMITAGE | P=0.509N | P=0.391 |
|FISHER EXACT | P=0.306 P=0.651N P=0.623 | P=0.482 P=0.500 P=0.500 |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 11/60 (18%) 13/58 (22%) 9/60 (15%) 8/60 (13%) |
|ADJUSTED (b) | | 31.6% 42.9% 25.9% 26.4% |
|INTERIM SACRIFICE 1 (c)| | |
|INTERIM SACRIFICE 2 (c)| | 2/10 (20%) 2/7 (29%) 3/10 (30%) 0/9 (0%) |
|TERMINAL (d) | | 9/31 (29%) 7/21 (33%) 5/26 (19%) 4/23 (17%) |
|FIRST INCIDENCE (DAYS) | | 461 (I) 461 (I) 461 (I) 504 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.311N P=0.118 P=0.528N P=0.536N |
|INCIDENTAL TUMOR | | P=0.257N P=0.151 P=0.510N P=0.409N |
|LOGISTIC REGRESSION | | P=0.206N P=0.304 P=0.462N P=0.394N |
|COCHRAN-ARMITAGE | | P=0.177N |
|FISHER EXACT | | P=0.374 P=0.404N P=0.309N |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05091 TEST: 01 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIHYDROCOUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 150MG/KG 300MG/KG 600MG/KG | VEHICLE 150MG/KG 300MG/KG 600MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 11/60 (18%) 13/58 (22%) 9/60 (15%) 9/60 (15%) |
|ADJUSTED (b) | | 31.6% 42.9% 25.9% 27.7% |
|INTERIM SACRIFICE 1 (c)| | |
|INTERIM SACRIFICE 2 (c)| | 2/10 (20%) 2/7 (29%) 3/10 (30%) 0/9 (0%) |
|TERMINAL (d) | | 9/31 (29%) 7/21 (33%) 5/26 (19%) 4/23 (17%) |
|FIRST INCIDENCE (DAYS) | | 461 (I) 461 (I) 461 (I) 455 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.409N P=0.118 P=0.528N P=0.561 |
|INCIDENTAL TUMOR | | P=0.344N P=0.151 P=0.510N P=0.494N |
|LOGISTIC REGRESSION | | P=0.284N P=0.304 P=0.462N P=0.477N |
|COCHRAN-ARMITAGE | | P=0.254N |
|FISHER EXACT | | P=0.374 P=0.404N P=0.404N |
|=================================================================================================================================|
| |
|Vagina |
| Leiomyosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 0/60 (0%) 2/58 (3%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | | 0.0% 5.1% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| | |
|INTERIM SACRIFICE 2 (c)| | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | | 0/31 (0%) 0/21 (0%) 0/26 (0%) 0/23 (0%) |
|FIRST INCIDENCE (DAYS) | | --- 508 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.428N P=0.218 (e) (e) |
|INCIDENTAL TUMOR | | P=0.413N P=0.290 (e) (e) |
|LOGISTIC REGRESSION | | P=0.392N P=0.247 (e) (e) |
|COCHRAN-ARMITAGE | | P=0.403N |
|FISHER EXACT | | P=0.239 (e) (e) |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05091 TEST: 01 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIHYDROCOUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 150MG/KG 300MG/KG 600MG/KG | VEHICLE 150MG/KG 300MG/KG 600MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, |
| or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 10/90 (11%) 5/60 (8%) 8/60 (13%) 12/130 (9%) | 10/60 (17%) 10/58 (17%) 12/60 (20%) 12/60 (20%) |
|ADJUSTED (b) | 25.5% 21.2% 46.0% 44.1% | 25.0% 27.0% 30.3% 34.9% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 2/28 (7%) 1/13 (8%) 3/8 (38%) 4/12 (33%) | 4/31 (13%) 2/21 (10%) 3/26 (12%) 3/23 (13%) |
|FIRST INCIDENCE (DAYS) | 526 550 603 604 | 589 357 580 531 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.159 P=0.388N P=0.382 P=0.286 | P=0.206 P=0.397 P=0.353 P=0.217 |
|INCIDENTAL TUMOR | P=0.394N P=0.053N P=0.281N P=0.191N | P=0.447 P=0.401N P=0.514N P=0.383 |
|LOGISTIC REGRESSION | P=0.298N P=0.094N P=0.238N P=0.185N | P=0.431 P=0.535 P=0.524N P=0.464 |
|COCHRAN-ARMITAGE | P=0.413N | P=0.338 |
|FISHER EXACT | P=0.397N P=0.434 P=0.406N | P=0.564 P=0.407 P=0.407 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma And Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/90 (0%) 2/60 (3%) 0/60 (0%) 0/130 (0%) | 1/60 (2%) 0/58 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 4.9% 0.0% 0.0% | 3.2% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/28 (0%) 0/13 (0%) 0/8 (0%) 0/12 (0%) | 1/31 (3%) 0/21 (0%) 0/26 (0%) 0/23 (0%) |
|FIRST INCIDENCE (DAYS) | --- 462 --- --- | 729 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.309N P=0.213 (e) (e) | P=0.335N P=0.578N P=0.535N P=0.560N |
|INCIDENTAL TUMOR | P=0.199N P=0.316 (e) (e) | P=0.335N P=0.578N P=0.535N P=0.560N |
|LOGISTIC REGRESSION | P=0.315N P=0.126 (e) (e) | P=0.335N P=0.578N P=0.535N P=0.560N |
|COCHRAN-ARMITAGE | P=0.317N | P=0.305N |
|FISHER EXACT | P=0.158 (e) (e) | P=0.508N P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05091 TEST: 01 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIHYDROCOUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 150MG/KG 300MG/KG 600MG/KG | VEHICLE 150MG/KG 300MG/KG 600MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/90 (0%) 2/60 (3%) 0/60 (0%) 0/130 (0%) | 0/60 (0%) 0/58 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 4.9% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/28 (0%) 0/13 (0%) 0/8 (0%) 0/12 (0%) | 0/31 (0%) 0/21 (0%) 0/26 (0%) 0/23 (0%) |
|FIRST INCIDENCE (DAYS) | --- 462 --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.309N P=0.213 (e) (e) | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.199N P=0.316 (e) (e) | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.315N P=0.126 (e) (e) | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.317N | (e) |
|FISHER EXACT | P=0.158 (e) (e) | (e) (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/90 (0%) 2/60 (3%) 1/60 (2%) 0/130 (0%) | 0/60 (0%) 0/58 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 7.5% 4.5% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/28 (0%) 0/13 (0%) 0/8 (0%) 0/12 (0%) | 0/31 (0%) 0/21 (0%) 0/26 (0%) 0/23 (0%) |
|FIRST INCIDENCE (DAYS) | --- 556 694 --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.459N P=0.177 P=0.425 (e) | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.202N P=0.402 P=0.669 (e) | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.363N P=0.178 P=0.458 (e) | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.341N | (e) |
|FISHER EXACT | P=0.158 P=0.400 (e) | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05091 TEST: 01 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIHYDROCOUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 150MG/KG 300MG/KG 600MG/KG | VEHICLE 150MG/KG 300MG/KG 600MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 64/90 (71%) 48/60 (80%) 50/60 (83%) 90/130 (69%)| 46/60 (77%) 38/58 (66%) 50/60 (83%) 32/60 (53%) |
|ADJUSTED (b) | 100.0% 97.9% 100.0% 100.0% | 93.6% 94.8% 96.0% 85.1% |
|INTERIM SACRIFICE 1 (c)| 1/19 (5%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 15/19 (79%) 3/10 (30%) 4/10 (40%) 11/20 (55%) | 5/10 (50%) 3/7 (43%) 5/10 (50%) 1/9 (11%) |
|TERMINAL (d) | 28/28 (100%) 12/13 (92%) 8/8 (100%) 12/12 (100%)| 28/31 (90%) 19/21 (90%) 24/26 (92%) 18/23 (78%) |
|FIRST INCIDENCE (DAYS) | 275 (I) 458 (I) 458 (I) 457 (I) | 385 461 (I) 461 (I) 455 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.069 P=0.007 ** P<0.001 ** | P=0.265N P=0.254 P=0.113 P=0.268N |
|INCIDENTAL TUMOR | P=0.205N P=0.013N* P=0.064N P=0.102N | P=0.021N* P=0.469N P=0.223 P=0.019N* |
|LOGISTIC REGRESSION | P=0.183N P=0.031N* P=0.032N* P=0.046N* | P=0.017N* P=0.295N P=0.253 P=0.018N* |
|COCHRAN-ARMITAGE | P=0.232N | P=0.010N** |
|FISHER EXACT | P=0.150 P=0.062 P=0.442N | P=0.128N P=0.247 P=0.006N** |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 17/90 (19%) 12/60 (20%) 11/60 (18%) 17/130 (13%)| 15/60 (25%) 20/58 (34%) 15/60 (25%) 16/60 (27%) |
|ADJUSTED (b) | 40.8% 39.9% 51.9% 48.7% | 36.5% 49.8% 38.6% 42.5% |
|INTERIM SACRIFICE 1 (c)| 1/19 (5%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 6/28 (21%) 2/13 (15%) 3/8 (38%) 4/12 (33%) | 7/31 (23%) 4/21 (19%) 5/26 (19%) 4/23 (17%) |
|FIRST INCIDENCE (DAYS) | 275 (I) 462 603 444 | 506 357 580 455 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.403 P=0.450 P=0.430 P=0.420 | P=0.386 P=0.083 P=0.482 P=0.255 |
|INCIDENTAL TUMOR | P=0.056N P=0.104N P=0.118N P=0.052N | P=0.389N P=0.344 P=0.387N P=0.507 |
|LOGISTIC REGRESSION | P=0.154N P=0.469N P=0.282N P=0.191N | P=0.362N P=0.166 P=0.375N P=0.586N |
|COCHRAN-ARMITAGE | P=0.105N | P=0.464N |
|FISHER EXACT | P=0.513 P=0.554N P=0.163N | P=0.177 P=0.583N P=0.500 |
|=================================================================================================================================|
DATE: 09/12/94 EXPERIMENT: 05091 TEST: 01 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIHYDROCOUMARIN
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 150MG/KG 300MG/KG 600MG/KG | VEHICLE 150MG/KG 300MG/KG 600MG/KG |
| | 65 KILL 65 STOP | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 65/90 (72%) 49/60 (82%) 51/60 (85%) 93/130 (72%)| 51/60 (85%) 46/58 (79%) 53/60 (88%) 40/60 (67%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 94.3% 95.7% 98.1% 90.5% |
|INTERIM SACRIFICE 1 (c)| 2/19 (11%) 0/0 0/0 0/19 (0%) | |
|INTERIM SACRIFICE 2 (c)| 15/19 (79%) 3/10 (30%) 4/10 (40%) 11/20 (55%) | 5/10 (50%) 3/7 (43%) 5/10 (50%) 1/9 (11%) |
|TERMINAL (d) | 28/28 (100%) 13/13 (100%) 8/8 (100%) 12/12 (100%)| 28/31 (90%) 19/21 (90%) 25/26 (96%) 19/23 (83%) |
|FIRST INCIDENCE (DAYS) | 275 (I) 458 (I) 458 (I) 444 | 385 357 461 (I) 455 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.047 * P=0.005 ** P<0.001 ** | P=0.428N P=0.133 P=0.191 P=0.528N |
|INCIDENTAL TUMOR | P=0.267N P=0.030N* P=0.083N P=0.124N | P=0.010N** P=0.477N P=0.458 P=0.027N* |
|LOGISTIC REGRESSION | P=0.247N P=0.031N* P=0.046N* P=0.112N | P=0.019N* P=0.585N P=0.424 P=0.046N* |
|COCHRAN-ARMITAGE | P=0.292N | P=0.012N* |
|FISHER EXACT | P=0.128 P=0.050 * P=0.518N | P=0.286N P=0.395 P=0.016N* |
|=================================================================================================================================|
(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): 274 457
Female interim sacrifices(days): 461
(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).