TDMS Study 05057-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Mason HC YELLOW 4 DATE: 09/08/94
EXPERIMENT: 05057 TEST: 02 TIME: 06:32:57
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01ES9561901 ROUTE: DOSED FEED NTP C#: 56019
PATHOLOGIST: R. FLEISCHMAN S. EUSTIS CAS: 5982043-8
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Mason HC YELLOW 4 DATE: 09/08/94
EXPERIMENT: 05057 TEST: 02 TIME: 06:32:57
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01ES9561901 ROUTE: DOSED FEED NTP C#: 56019
PATHOLOGIST: R. FLEISCHMAN S. EUSTIS CAS: 5982043-8
MICE(B6C3F1)
----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
----------------
Adrenal Gland
Bone Marrow
Brain
Epididymis
Gallbladder
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Nose
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Preputial Gland
Prostate
Salivary Glands
Spleen
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Mason HC YELLOW 4 DATE: 09/08/94
EXPERIMENT: 05057 TEST: 02 TIME: 06:32:57
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01ES9561901 ROUTE: DOSED FEED NTP C#: 56019
PATHOLOGIST: R. FLEISCHMAN S. EUSTIS CAS: 5982043-8
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF HC YELLOW 4
====================================================================================================
MALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
All Organs Hemangiosarcoma or Hemangioma
Benign Tumors
Malignant and Benign Tumors
====================================================================================================
FEMALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
All Organs Benign Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 02 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.5% 1.O% | UNTREATE 0.5% 1.0% |
| | D 61UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/17 (0%) 0/48 (0%) | 0/50 (0%) 0/3 (0%) 0/50 (0%) |
|ADJUSTED (b) | 7.1% 0.0% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/28 (7%) 0/1 (0%) 0/35 (0%) | 0/43 (0%) 0/0 0/43 (0%) |
|FIRST INCIDENCE (DAYS) | 730 (T) --- --- | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.107N P=0.956N P=0.190N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.107N P=0.956N P=0.190N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.107N P=0.956N P=0.190N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.129N | (e) |
|FISHER EXACT | P=0.554N P=0.258N | (e) (e) |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/49 (0%) 3/50 (6%) | 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 3.6% 0.0% 8.6% | 2.3% 2.6% 2.3% |
|TERMINAL (d) | 1/28 (4%) 0/29 (0%) 3/35 (9%) | 1/43 (2%) 1/38 (3%) 1/43 (2%) |
|FIRST INCIDENCE (DAYS) | 730 (T) --- 730 (T) | 730 (T) 730 (T) 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.230 P=0.493N P=0.387 | P=0.637 P=0.734 P=0.762 |
|INCIDENTAL TUMOR | P=0.230 P=0.493N P=0.387 | P=0.637 P=0.734 P=0.762 |
|LOGISTIC REGRESSION | P=0.230 P=0.493N P=0.387 | P=0.637 P=0.734 P=0.762 |
|COCHRAN-ARMITAGE | P=0.177 | P=0.640 |
|FISHER EXACT | P=0.505N P=0.309 | P=0.753N P=0.753N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 02 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.5% 1.O% | UNTREATE 0.5% 1.0% |
| | D 61UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/49 (0%) 3/50 (6%) | 2/50 (4%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 3.6% 0.0% 8.6% | 4.4% 2.6% 2.3% |
|TERMINAL (d) | 1/28 (4%) 0/29 (0%) 3/35 (9%) | 1/43 (2%) 1/38 (3%) 1/43 (2%) |
|FIRST INCIDENCE (DAYS) | 730 (T) --- 730 (T) | 532 730 (T) 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.230 P=0.493N P=0.387 | P=0.376N P=0.526N P=0.493N |
|INCIDENTAL TUMOR | P=0.230 P=0.493N P=0.387 | P=0.580N P=0.673N P=0.762 |
|LOGISTIC REGRESSION | P=0.230 P=0.493N P=0.387 | P=0.400N P=0.508N P=0.558N |
|COCHRAN-ARMITAGE | P=0.177 | P=0.378N |
|FISHER EXACT | P=0.505N P=0.309 | P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 0/22 (0%) 0/48 (0%) | 0/50 (0%) 0/18 (0%) 0/50 (0%) |
|ADJUSTED (b) | 5.8% 0.0% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/28 (0%) 0/4 (0%) 0/35 (0%) | 0/43 (0%) 0/10 (0%) 0/43 (0%) |
|FIRST INCIDENCE (DAYS) | 519 --- --- | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.088N P=0.251N P=0.211N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.164N P=0.446N P=0.328N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.115N P=0.491N P=0.242N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.121N | (e) |
|FISHER EXACT | P=0.473N P=0.253N | (e) (e) |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 02 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.5% 1.O% | UNTREATE 0.5% 1.0% |
| | D 61UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/49 (16%) 7/22 (32%) 4/48 (8%) | 5/50 (10%) 8/18 (44%) 4/50 (8%) |
|ADJUSTED (b) | 28.6% 100.0% 11.4% | 11.6% 80.0% 9.3% |
|TERMINAL (d) | 8/28 (29%) 4/4 (100%) 4/35 (11%) | 5/43 (12%) 8/10 (80%) 4/43 (9%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 512 730 (T) | 730 (T) 730 (T) 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.073N P=0.003 ** P=0.083N | P=0.444N P<0.001 ** P=0.500N |
|INCIDENTAL TUMOR | P=0.063N P=0.005 ** P=0.083N | P=0.444N P<0.001 ** P=0.500N |
|LOGISTIC REGRESSION | P=0.098N P=0.001 ** P=0.083N | P=0.444N P<0.001 ** P=0.500N |
|COCHRAN-ARMITAGE | P=0.177N | P=0.443N |
|FISHER EXACT | P=0.123 P=0.188N | P=0.003 ** P=0.500N |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/49 (10%) 7/22 (32%) 9/48 (19%) | 1/50 (2%) 0/18 (0%) 0/50 (0%) |
|ADJUSTED (b) | 16.2% 56.8% 24.7% | 2.3% 0.0% 0.0% |
|TERMINAL (d) | 3/28 (11%) 2/4 (50%) 8/35 (23%) | 1/43 (2%) 0/10 (0%) 0/43 (0%) |
|FIRST INCIDENCE (DAYS) | 694 512 617 | 730 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.332 P=0.051 P=0.326 | P=0.299N P=0.787N P=0.500N |
|INCIDENTAL TUMOR | P=0.329 P=0.010 ** P=0.330 | P=0.299N P=0.787N P=0.500N |
|LOGISTIC REGRESSION | P=0.370 P<0.001 ** P=0.279 | P=0.299N P=0.787N P=0.500N |
|COCHRAN-ARMITAGE | P=0.164 | P=0.293N |
|FISHER EXACT | P=0.031 * P=0.182 | P=0.735N P=0.500N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 02 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.5% 1.O% | UNTREATE 0.5% 1.0% |
| | D 61UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/49 (27%) 10/22 (45%) 12/48 (25%) | 6/50 (12%) 8/18 (44%) 4/50 (8%) |
|ADJUSTED (b) | 43.0% 100.0% 33.1% | 14.0% 80.0% 9.3% |
|TERMINAL (d) | 11/28 (39%) 4/4 (100%) 11/35 (31%) | 6/43 (14%) 8/10 (80%) 4/43 (9%) |
|FIRST INCIDENCE (DAYS) | 694 512 617 | 730 (T) 730 (T) 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.211N P=0.015 * P=0.262N | P=0.340N P<0.001 ** P=0.369N |
|INCIDENTAL TUMOR | P=0.179N P=0.002 ** P=0.254N | P=0.340N P<0.001 ** P=0.369N |
|LOGISTIC REGRESSION | P=0.263N P<0.001 ** P=0.327N | P=0.340N P<0.001 ** P=0.369N |
|COCHRAN-ARMITAGE | P=0.482N | P=0.338N |
|FISHER EXACT | P=0.098 P=0.524N | P=0.007 ** P=0.370N |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/49 (27%) 10/22 (45%) 12/48 (25%) | 6/50 (12%) 8/18 (44%) 4/50 (8%) |
|ADJUSTED (b) | 43.0% 100.0% 33.1% | 14.0% 80.0% 9.3% |
|TERMINAL (d) | 11/28 (39%) 4/4 (100%) 11/35 (31%) | 6/43 (14%) 8/10 (80%) 4/43 (9%) |
|FIRST INCIDENCE (DAYS) | 694 512 617 | 730 (T) 730 (T) 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.211N P=0.015 * P=0.262N | P=0.340N P<0.001 ** P=0.369N |
|INCIDENTAL TUMOR | P=0.179N P=0.002 ** P=0.254N | P=0.340N P<0.001 ** P=0.369N |
|LOGISTIC REGRESSION | P=0.263N P<0.001 ** P=0.327N | P=0.340N P<0.001 ** P=0.369N |
|COCHRAN-ARMITAGE | P=0.482N | P=0.338N |
|FISHER EXACT | P=0.098 P=0.524N | P=0.007 ** P=0.370N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 02 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.5% 1.O% | UNTREATE 0.5% 1.0% |
| | D 61UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 8/29 (28%) 6/49 (12%) | 3/50 (6%) 2/8 (25%) 1/50 (2%) |
|ADJUSTED (b) | 23.0% 72.7% 17.1% | 7.0% 51.1% 2.3% |
|TERMINAL (d) | 5/28 (18%) 8/11 (73%) 6/35 (17%) | 3/43 (7%) 1/2 (50%) 1/43 (2%) |
|FIRST INCIDENCE (DAYS) | 721 730 (T) 730 (T) | 730 (T) 682 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.259N P=0.029 * P=0.345N | P=0.257N P=0.101 P=0.305N |
|INCIDENTAL TUMOR | P=0.283N P=0.006 ** P=0.376N | P=0.195N P=0.209 P=0.305N |
|LOGISTIC REGRESSION | P=0.318N P=0.005 ** P=0.395N | P=0.245N P=0.065 P=0.305N |
|COCHRAN-ARMITAGE | P=0.464N | P=0.256N |
|FISHER EXACT | P=0.119 P=0.516N | P=0.136 P=0.309N |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/29 (3%) 1/49 (2%) | 1/50 (2%) 0/8 (0%) 1/50 (2%) |
|ADJUSTED (b) | 7.1% 3.3% 2.9% | 2.3% 0.0% 2.1% |
|TERMINAL (d) | 2/28 (7%) 0/11 (0%) 1/35 (3%) | 1/43 (2%) 0/2 (0%) 0/43 (0%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 687 730 (T) | 730 (T) --- 610 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.324N P=0.720N P=0.422N | P=0.648N P=0.986N P=0.755N |
|INCIDENTAL TUMOR | P=0.351N P=0.613 P=0.422N | P=0.538N P=0.986N P=0.664N |
|LOGISTIC REGRESSION | P=0.339N P=0.678 P=0.422N | P=0.632 P=0.986N P=0.739 |
|COCHRAN-ARMITAGE | P=0.393N | P=0.645N |
|FISHER EXACT | P=0.697N P=0.508N | P=0.862N P=0.753N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 02 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.5% 1.O% | UNTREATE 0.5% 1.0% |
| | D 61UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 9/29 (31%) 7/49 (14%) | 4/50 (8%) 2/8 (25%) 2/50 (4%) |
|ADJUSTED (b) | 26.3% 73.6% 20.0% | 9.3% 51.1% 4.4% |
|TERMINAL (d) | 6/28 (21%) 8/11 (73%) 7/35 (20%) | 4/43 (9%) 1/2 (50%) 1/43 (2%) |
|FIRST INCIDENCE (DAYS) | 721 687 730 (T) | 730 (T) 682 610 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.251N P=0.027 * P=0.330N | P=0.280N P=0.123 P=0.335N |
|INCIDENTAL TUMOR | P=0.282N P=0.002 ** P=0.359N | P=0.186N P=0.264 P=0.273N |
|LOGISTIC REGRESSION | P=0.314N P=0.003 ** P=0.385N | P=0.275N P=0.100 P=0.331N |
|COCHRAN-ARMITAGE | P=0.468N | P=0.283N |
|FISHER EXACT | P=0.101 P=0.517N | P=0.189 P=0.339N |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 2/50 (4%) 0/47 (0%) 3/50 (6%) |
|ADJUSTED (b) | | 4.7% 0.0% 7.0% |
|TERMINAL (d) | | 2/43 (5%) 0/36 (0%) 3/43 (7%) |
|FIRST INCIDENCE (DAYS) | | 730 (T) --- 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.393 P=0.278N P=0.500 |
|INCIDENTAL TUMOR | | P=0.393 P=0.278N P=0.500 |
|LOGISTIC REGRESSION | | P=0.393 P=0.278N P=0.500 |
|COCHRAN-ARMITAGE | | P=0.391 |
|FISHER EXACT | | P=0.263N P=0.500 |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 02 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.5% 1.O% | UNTREATE 0.5% 1.0% |
| | D 61UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/38 (0%) 0/13 (0%) 0/40 (0%) | 5/42 (12%) 0/0 (0%) 1/45 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% | 12.9% 0.0% 2.6% |
|TERMINAL (d) | 0/22 (0%) 0/0 0/32 (0%) | 4/36 (11%) 0/0 1/38 (3%) |
|FIRST INCIDENCE (DAYS) | --- --- --- | 463 --- 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.058N P=0.500N P=0.094N |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.113N (e) P=0.163N |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.113N (e) P=0.163N |
|COCHRAN-ARMITAGE | (e) | P=0.058N |
|FISHER EXACT | (e) (e) | P=1.000N P=0.086N |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibrosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 2/49 (4%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 18.4% 4.8% 7.1% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/28 (7%) 0/29 (0%) 0/35 (0%) | 0/43 (0%) 0/38 (0%) 0/43 (0%) |
|FIRST INCIDENCE (DAYS) | 508 291 484 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.129N P=0.149N P=0.179N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.239N P=0.256N P=0.249N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.182N P=0.141N P=0.116N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.170N | (e) |
|FISHER EXACT | P=0.141N P=0.243N | (e) (e) |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 02 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.5% 1.O% | UNTREATE 0.5% 1.0% |
| | D 61UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, Sarcoma, |
| Neurofibroma, or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 3/49 (6%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 18.4% 8.1% 7.1% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/28 (7%) 1/29 (3%) 0/35 (0%) | 0/43 (0%) 0/38 (0%) 0/43 (0%) |
|FIRST INCIDENCE (DAYS) | 508 291 484 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.134N P=0.256N P=0.179N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.241N P=0.397N P=0.249N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.185N P=0.252N P=0.116N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.179N | (e) |
|FISHER EXACT | P=0.254N P=0.243N | (e) (e) |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/49 (4%) 1/50 (2%) | 3/50 (6%) 2/50 (4%) 1/50 (2%) |
|ADJUSTED (b) | 10.7% 6.9% 2.9% | 7.0% 5.1% 2.3% |
|TERMINAL (d) | 3/28 (11%) 2/29 (7%) 1/35 (3%) | 3/43 (7%) 1/38 (3%) 1/43 (2%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 730 (T) 730 (T) | 730 (T) 718 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.159N P=0.484N P=0.228N | P=0.227N P=0.551N P=0.305N |
|INCIDENTAL TUMOR | P=0.159N P=0.484N P=0.228N | P=0.184N P=0.350N P=0.305N |
|LOGISTIC REGRESSION | P=0.159N P=0.484N P=0.228N | P=0.214N P=0.505N P=0.305N |
|COCHRAN-ARMITAGE | P=0.223N | P=0.222N |
|FISHER EXACT | P=0.510N P=0.309N | P=0.500N P=0.309N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 02 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.5% 1.O% | UNTREATE 0.5% 1.0% |
| | D 61UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/47 (2%) 0/48 (0%) 2/49 (4%) | 0/48 (0%) 0/49 (0%) 0/50 (0%) |
|ADJUSTED (b) | 2.7% 0.0% 5.7% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/26 (0%) 0/29 (0%) 2/35 (6%) | 0/42 (0%) 0/37 (0%) 0/43 (0%) |
|FIRST INCIDENCE (DAYS) | 508 --- 730 (T) | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.430 P=0.500N P=0.586 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.364 P=0.567N P=0.505 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.390 P=0.500N P=0.534 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.372 | (e) |
|FISHER EXACT | P=0.495N P=0.516 | (e) (e) |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | | 4.7% 2.6% 0.0% |
|TERMINAL (d) | | 2/43 (5%) 1/38 (3%) 0/43 (0%) |
|FIRST INCIDENCE (DAYS) | | 730 (T) 730 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.147N P=0.543N P=0.238N |
|INCIDENTAL TUMOR | | P=0.147N P=0.543N P=0.238N |
|LOGISTIC REGRESSION | | P=0.147N P=0.543N P=0.238N |
|COCHRAN-ARMITAGE | | P=0.142N |
|FISHER EXACT | | P=0.500N P=0.247N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 02 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.5% 1.O% | UNTREATE 0.5% 1.0% |
| | D 61UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 2/50 (4%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | | 4.7% 2.6% 2.3% |
|TERMINAL (d) | | 2/43 (5%) 1/38 (3%) 1/43 (2%) |
|FIRST INCIDENCE (DAYS) | | 730 (T) 730 (T) 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.381N P=0.543N P=0.500N |
|INCIDENTAL TUMOR | | P=0.381N P=0.543N P=0.500N |
|LOGISTIC REGRESSION | | P=0.381N P=0.543N P=0.500N |
|COCHRAN-ARMITAGE | | P=0.378N |
|FISHER EXACT | | P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/49 (0%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 5.8% 0.0% 0.0% | 0.0% 2.1% 0.0% |
|TERMINAL (d) | 0/28 (0%) 0/29 (0%) 0/35 (0%) | 0/43 (0%) 0/38 (0%) 0/43 (0%) |
|FIRST INCIDENCE (DAYS) | 519 --- --- | --- 592 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.088N P=0.251N P=0.211N | P=0.726N P=0.513 (e) |
|INCIDENTAL TUMOR | P=0.150N P=0.357N P=0.323N | P=0.558N P=0.362 (e) |
|LOGISTIC REGRESSION | P=0.093N P=0.242N P=0.237N | P=0.698 P=0.497 (e) |
|COCHRAN-ARMITAGE | P=0.096N | P=0.731 |
|FISHER EXACT | P=0.253N P=0.247N | P=0.500 (e) |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 02 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.5% 1.O% | UNTREATE 0.5% 1.0% |
| | D 61UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/49 (0%) 0/50 (0%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 9.2% 0.0% 0.0% | 2.3% 2.1% 0.0% |
|TERMINAL (d) | 1/28 (4%) 0/29 (0%) 0/35 (0%) | 0/43 (0%) 0/38 (0%) 0/43 (0%) |
|FIRST INCIDENCE (DAYS) | 519 --- --- | 634 592 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.031N* P=0.128N P=0.097N | P=0.324N P=0.746N P=0.496N |
|INCIDENTAL TUMOR | P=0.055N P=0.185N P=0.153N | P=0.133N P=0.638 P=0.318N |
|LOGISTIC REGRESSION | P=0.033N* P=0.124N P=0.108N | P=0.383N P=0.759 P=0.562N |
|COCHRAN-ARMITAGE | P=0.038N* | P=0.331N |
|FISHER EXACT | P=0.125N P=0.121N | P=0.753N P=0.500N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma And Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/49 (2%) 1/50 (2%) | 9/50 (18%) 14/50 (28%) 8/50 (16%) |
|ADJUSTED (b) | 6.1% 3.4% 2.9% | 19.4% 30.6% 16.6% |
|TERMINAL (d) | 1/28 (4%) 1/29 (3%) 1/35 (3%) | 6/43 (14%) 7/38 (18%) 3/43 (7%) |
|FIRST INCIDENCE (DAYS) | 449 730 (T) 730 (T) | 466 519 554 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.317N P=0.495N P=0.432N | P=0.437N P=0.151 P=0.481N |
|INCIDENTAL TUMOR | P=0.370N P=0.531N P=0.512N | P=0.380N P=0.397 P=0.292N |
|LOGISTIC REGRESSION | P=0.354N P=0.507N P=0.495N | P=0.356N P=0.160 P=0.594 |
|COCHRAN-ARMITAGE | P=0.379N | P=0.451N |
|FISHER EXACT | P=0.508N P=0.500N | P=0.171 P=0.500N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 02 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.5% 1.O% | UNTREATE 0.5% 1.0% |
| | D 61UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/49 (2%) 1/50 (2%) | 9/50 (18%) 14/50 (28%) 8/50 (16%) |
|ADJUSTED (b) | 6.1% 3.4% 2.9% | 19.4% 30.6% 16.6% |
|TERMINAL (d) | 1/28 (4%) 1/29 (3%) 1/35 (3%) | 6/43 (14%) 7/38 (18%) 3/43 (7%) |
|FIRST INCIDENCE (DAYS) | 449 730 (T) 730 (T) | 466 519 554 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.317N P=0.495N P=0.432N | P=0.437N P=0.151 P=0.481N |
|INCIDENTAL TUMOR | P=0.370N P=0.531N P=0.512N | P=0.380N P=0.397 P=0.292N |
|LOGISTIC REGRESSION | P=0.354N P=0.507N P=0.495N | P=0.356N P=0.160 P=0.594 |
|COCHRAN-ARMITAGE | P=0.379N | P=0.451N |
|FISHER EXACT | P=0.508N P=0.500N | P=0.171 P=0.500N |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 19/50 (38%) 17/49 (35%) 13/50 (26%) | 21/50 (42%) 13/50 (26%) 11/50 (22%) |
|ADJUSTED (b) | 60.9% 52.6% 37.1% | 46.6% 32.3% 25.6% |
|TERMINAL (d) | 16/28 (57%) 14/29 (48%) 13/35 (37%) | 19/43 (44%) 11/38 (29%) 11/43 (26%) |
|FIRST INCIDENCE (DAYS) | 508 512 730 (T) | 463 682 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.021N* P=0.374N P=0.026N* | P=0.021N* P=0.141N P=0.027N* |
|INCIDENTAL TUMOR | P=0.023N* P=0.345N P=0.035N* | P=0.018N* P=0.085N P=0.032N* |
|LOGISTIC REGRESSION | P=0.034N* P=0.465N P=0.044N* | P=0.014N* P=0.060N P=0.020N* |
|COCHRAN-ARMITAGE | P=0.121N | P=0.019N* |
|FISHER EXACT | P=0.447N P=0.142N | P=0.069N P=0.026N* |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 02 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.5% 1.O% | UNTREATE 0.5% 1.0% |
| | D 61UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 12/49 (24%) 16/50 (32%) | 14/50 (28%) 15/50 (30%) 12/50 (24%) |
|ADJUSTED (b) | 44.2% 30.9% 37.3% | 29.2% 32.0% 24.0% |
|TERMINAL (d) | 8/28 (29%) 3/29 (10%) 9/35 (26%) | 9/43 (21%) 7/38 (18%) 5/43 (12%) |
|FIRST INCIDENCE (DAYS) | 449 291 308 | 466 519 554 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.335N P=0.288N P=0.354N | P=0.362N P=0.435 P=0.395N |
|INCIDENTAL TUMOR | P=0.496N P=0.268N P=0.551N | P=0.220N P=0.542N P=0.192N |
|LOGISTIC REGRESSION | P=0.375N P=0.192N P=0.396N | P=0.239N P=0.528N P=0.544N |
|COCHRAN-ARMITAGE | P=0.544 | P=0.368N |
|FISHER EXACT | P=0.272N P=0.585N | P=0.500 P=0.410N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 28/50 (56%) 23/49 (47%) 23/50 (46%) | 30/50 (60%) 24/50 (48%) 21/50 (42%) |
|ADJUSTED (b) | 77.7% 60.1% 54.1% | 61.2% 50.7% 42.0% |
|TERMINAL (d) | 20/28 (71%) 14/29 (48%) 16/35 (46%) | 24/43 (56%) 15/38 (39%) 14/43 (33%) |
|FIRST INCIDENCE (DAYS) | 449 291 308 | 463 519 554 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.047N* P=0.222N P=0.050N* | P=0.071N P=0.321N P=0.078N |
|INCIDENTAL TUMOR | P=0.063N P=0.197N P=0.085N | P=0.024N* P=0.108N P=0.026N* |
|LOGISTIC REGRESSION | P=0.046N* P=0.222N P=0.066N | P=0.057N P=0.163N P=0.072N |
|COCHRAN-ARMITAGE | P=0.184N | P=0.045N* |
|FISHER EXACT | P=0.242N P=0.212N | P=0.158N P=0.055N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 02 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for
intercurrent mortality.
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death. The incidental tumor
test regards these lesions as non-fatal. Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fisher's exact tests compare directly the overall incidence rates.
For all tests, a negative trend is indicated by "N".
(e) Value of Statistic cannot be computed.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).