TDMS Study 05706-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: IRDC 4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID DATE: 09/18/94
EXPERIMENT: 05706 TEST: 01 TIME: 22:57:56
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: ROUTE: DOSED FEED NTP C#: 60162
PATHOLOGIST: M. STEDHAM S. EUSTIS CAS: 81-11-8
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: IRDC 4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID DATE: 09/18/94
EXPERIMENT: 05706 TEST: 01 TIME: 22:57:56
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: ROUTE: DOSED FEED NTP C#: 60162
PATHOLOGIST: M. STEDHAM S. EUSTIS CAS: 81-11-8
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
Larynx
Liver
Lung
Nose
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Preputial Gland
Prostate
Salivary Glands
Spleen
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: IRDC 4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID DATE: 09/18/94
EXPERIMENT: 05706 TEST: 01 TIME: 22:57:56
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: ROUTE: DOSED FEED NTP C#: 60162
PATHOLOGIST: M. STEDHAM S. EUSTIS CAS: 81-11-8
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
====================================================================================================
MALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
Liver Hepatocellular Adenoma
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
====================================================================================================
FEMALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
All Organs Malignant Lymphoma And Histiocytic Sarcoma
Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,
NOS, or Undifferentiated Cell Type
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 09/18/94 EXPERIMENT: 05706 TEST: 01 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 6250PPM 12500PPM | CONTROL 6250PPM 12500PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/7 (0%) 2/48 (4%) | 1/49 (2%) 0/6 (0%) 0/47 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 5.0% | 2.3% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/1 (0%) 0/0 | 1/43 (2%) 0/0 0/38 (0%) |
|TERMINAL (d) | 0/43 (0%) 0/0 2/40 (5%) | 729 (T) --- --- |
|FIRST INCIDENCE (DAYS) | --- --- 729 (T) | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | P=0.330N (e) P=0.525N |
|LIFE TABLE | P=0.131 (e) P=0.223 | P=0.330N (e) P=0.525N |
|INCIDENTAL TUMOR | P=0.131 (e) P=0.223 | P=0.330N (e) P=0.525N |
|LOGISTIC REGRESSION | P=0.131 (e) P=0.223 | P=0.309N |
|COCHRAN-ARMITAGE | P=0.128 | P=0.891N P=0.510N |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) 2/49 (4%) |
|ADJUSTED (b) | 2.3% 2.5% 0.0% | 0.0% 2.3% 5.3% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/1 (0%) 0/0 | 0/43 (0%) 1/43 (2%) 2/38 (5%) |
|TERMINAL (d) | 1/43 (2%) 1/40 (3%) 0/42 (0%) | --- 729 (T) 729 (T) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) --- | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | P=0.121 P=0.500 P=0.212 |
|LIFE TABLE | P=0.338N P=0.746 P=0.505N | P=0.121 P=0.500 P=0.212 |
|INCIDENTAL TUMOR | P=0.338N P=0.746 P=0.505N | P=0.121 P=0.500 P=0.212 |
|LOGISTIC REGRESSION | P=0.338N P=0.746 P=0.505N | P=0.138 |
|COCHRAN-ARMITAGE | P=0.331N | P=0.500 P=0.242 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05706 TEST: 01 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 6250PPM 12500PPM | CONTROL 6250PPM 12500PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 9/50 (18%) 6/50 (12%) | 3/50 (6%) 0/17 (0%) 2/49 (4%) |
|ADJUSTED (b) | 4.7% 22.5% 14.3% | 7.0% 0.0% 5.3% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/1 (0%) 0/0 | 3/43 (7%) 0/11 (0%) 2/38 (5%) |
|TERMINAL (d) | 2/43 (5%) 9/40 (23%) 6/42 (14%) | 729 (T) --- 729 (T) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | P=0.456N P=0.436N P=0.556N |
|LIFE TABLE | P=0.126 P=0.020 * P=0.127 | P=0.456N P=0.436N P=0.556N |
|INCIDENTAL TUMOR | P=0.126 P=0.020 * P=0.127 | P=0.456N P=0.436N P=0.556N |
|LOGISTIC REGRESSION | P=0.126 P=0.019 * P=0.127 | P=0.411N |
|COCHRAN-ARMITAGE | P=0.135 | P=0.409N P=0.510N |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 3/50 (6%) | 2/50 (4%) 0/17 (0%) 0/49 (0%) |
|ADJUSTED (b) | 7.0% 7.5% 7.1% | 4.7% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/1 (0%) 0/0 | 2/43 (5%) 0/11 (0%) 0/38 (0%) |
|TERMINAL (d) | 3/43 (7%) 3/40 (8%) 3/42 (7%) | 729 (T) --- --- |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | P=0.145N P=0.565N P=0.266N |
|LIFE TABLE | P=0.571 P=0.629 P=0.652 | P=0.145N P=0.565N P=0.266N |
|INCIDENTAL TUMOR | P=0.571 P=0.629 P=0.652 | P=0.145N P=0.565N P=0.266N |
|LOGISTIC REGRESSION | P=0.571 P=0.629 P=0.652 | P=0.126N |
|COCHRAN-ARMITAGE | P=0.583 | P=0.554N P=0.253N |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05706 TEST: 01 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 6250PPM 12500PPM | CONTROL 6250PPM 12500PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 11/50 (22%) 8/50 (16%) | 5/50 (10%) 0/17 (0%) 2/49 (4%) |
|ADJUSTED (b) | 11.6% 27.5% 19.0% | 11.6% 0.0% 5.3% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/1 (0%) 0/0 | 5/43 (12%) 0/11 (0%) 2/38 (5%) |
|TERMINAL (d) | 5/43 (12%) 11/40 (28%) 8/42 (19%) | 729 (T) --- 729 (T) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | P=0.188N P=0.275N P=0.269N |
|LIFE TABLE | P=0.230 P=0.061 P=0.259 | P=0.188N P=0.275N P=0.269N |
|INCIDENTAL TUMOR | P=0.230 P=0.061 P=0.259 | P=0.188N P=0.275N P=0.269N |
|LOGISTIC REGRESSION | P=0.230 P=0.061 P=0.259 | P=0.152N |
|COCHRAN-ARMITAGE | P=0.248 | P=0.219N P=0.226N |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 11/50 (22%) 8/50 (16%) | 5/50 (10%) 0/17 (0%) 2/49 (4%) |
|ADJUSTED (b) | 11.6% 27.5% 19.0% | 11.6% 0.0% 5.3% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/1 (0%) 0/0 | 5/43 (12%) 0/11 (0%) 2/38 (5%) |
|TERMINAL (d) | 5/43 (12%) 11/40 (28%) 8/42 (19%) | 729 (T) --- 729 (T) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | P=0.188N P=0.275N P=0.269N |
|LIFE TABLE | P=0.230 P=0.061 P=0.259 | P=0.188N P=0.275N P=0.269N |
|INCIDENTAL TUMOR | P=0.230 P=0.061 P=0.259 | P=0.188N P=0.275N P=0.269N |
|LOGISTIC REGRESSION | P=0.230 P=0.061 P=0.259 | P=0.152N |
|COCHRAN-ARMITAGE | P=0.248 | P=0.219N P=0.226N |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05706 TEST: 01 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 6250PPM 12500PPM | CONTROL 6250PPM 12500PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 3/49 (6%) 7/50 (14%) | 12/50 (24%) 3/49 (6%) 5/49 (10%) |
|ADJUSTED (b) | 27.9% 7.5% 16.7% | 27.3% 7.0% 12.5% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/1 (0%) 0/0 | 11/43 (26%) 3/43 (7%) 3/38 (8%) |
|TERMINAL (d) | 12/43 (28%) 3/40 (8%) 7/42 (17%) | 714 729 (T) 718 |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | P=0.046N* P=0.013N* P=0.096N |
|LIFE TABLE | P=0.110N P=0.017N* P=0.164N | P=0.022N* P=0.015N* P=0.043N* |
|INCIDENTAL TUMOR | P=0.110N P=0.017N* P=0.164N | P=0.038N* P=0.014N* P=0.077N |
|LOGISTIC REGRESSION | P=0.110N P=0.017N* P=0.164N | P=0.031N* |
|COCHRAN-ARMITAGE | P=0.102N | P=0.013N* P=0.059N |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/49 (2%) 4/50 (8%) | 2/50 (4%) 0/49 (0%) 0/49 (0%) |
|ADJUSTED (b) | 7.0% 2.5% 9.5% | 4.7% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/1 (0%) 0/0 | 2/43 (5%) 0/43 (0%) 0/38 (0%) |
|TERMINAL (d) | 3/43 (7%) 1/40 (3%) 4/42 (10%) | 729 (T) --- --- |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | P=0.106N P=0.238N P=0.266N |
|LIFE TABLE | P=0.402 P=0.331N P=0.487 | P=0.106N P=0.238N P=0.266N |
|INCIDENTAL TUMOR | P=0.402 P=0.331N P=0.487 | P=0.106N P=0.238N P=0.266N |
|LOGISTIC REGRESSION | P=0.402 P=0.331N P=0.487 | P=0.098N |
|COCHRAN-ARMITAGE | P=0.412 | P=0.253N P=0.253N |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05706 TEST: 01 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 6250PPM 12500PPM | CONTROL 6250PPM 12500PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 4/49 (8%) 10/50 (20%) | 13/50 (26%) 3/49 (6%) 5/49 (10%) |
|ADJUSTED (b) | 34.9% 10.0% 23.8% | 29.5% 7.0% 12.5% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/1 (0%) 0/0 | 12/43 (28%) 3/43 (7%) 3/38 (8%) |
|TERMINAL (d) | 15/43 (35%) 4/40 (10%) 10/42 (24%) | 714 729 (T) 718 |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | P=0.027N* P=0.007N** P=0.065N |
|LIFE TABLE | P=0.137N P=0.008N** P=0.190N | P=0.012N* P=0.008N** P=0.027N* |
|INCIDENTAL TUMOR | P=0.137N P=0.008N** P=0.190N | P=0.022N* P=0.008N** P=0.050N* |
|LOGISTIC REGRESSION | P=0.137N P=0.008N** P=0.190N | P=0.017N* |
|COCHRAN-ARMITAGE | P=0.128N | P=0.007N** P=0.037N* |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/8 (0%) 0/44 (0%) | 7/50 (14%) 2/7 (29%) 6/48 (13%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% | 16.3% 100.0% 15.1% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/1 (0%) 0/0 | 7/43 (16%) 2/2 (100%) 5/38 (13%) |
|TERMINAL (d) | 0/42 (0%) 0/0 0/38 (0%) | 729 (T) 729 (T) 660 |
|FIRST INCIDENCE (DAYS) | --- --- --- | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | P=0.540N P=0.025 * P=0.588N |
|LIFE TABLE | (e) (e) (e) | P=0.498N P=0.025 * P=0.541N |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.501N P=0.025 * P=0.546N |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.475N |
|COCHRAN-ARMITAGE | (e) | P=0.304 P=0.532N |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05706 TEST: 01 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 6250PPM 12500PPM | CONTROL 6250PPM 12500PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/8 (0%) 0/44 (0%) | 8/50 (16%) 2/7 (29%) 7/48 (15%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% | 18.6% 100.0% 17.7% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/1 (0%) 0/0 | 8/43 (19%) 2/2 (100%) 6/38 (16%) |
|TERMINAL (d) | 0/42 (0%) 0/0 0/38 (0%) | 729 (T) 729 (T) 660 |
|FIRST INCIDENCE (DAYS) | --- --- --- | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | P=0.551N P=0.035 * P=0.597N |
|LIFE TABLE | (e) (e) (e) | P=0.511N P=0.035 * P=0.552N |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.511N P=0.035 * P=0.553N |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.481N |
|COCHRAN-ARMITAGE | (e) | P=0.356 P=0.535N |
|=================================================================================================================================|
| |
|Skin |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|ADJUSTED (b) | 2.3% 5.0% 0.0% | 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/1 (0%) 0/0 | 0/43 (0%) 0/43 (0%) 0/38 (0%) |
|TERMINAL (d) | 1/43 (2%) 2/40 (5%) 0/42 (0%) | --- --- --- |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) --- | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | (e) (e) (e) |
|LIFE TABLE | P=0.368N P=0.475 P=0.505N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.368N P=0.475 P=0.505N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.368N P=0.475 P=0.505N | (e) |
|COCHRAN-ARMITAGE | P=0.360N | (e) (e) |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05706 TEST: 01 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 6250PPM 12500PPM | CONTROL 6250PPM 12500PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|ADJUSTED (b) | 4.7% 2.5% 2.4% | 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/1 (0%) 0/0 | 0/43 (0%) 0/43 (0%) 0/38 (0%) |
|TERMINAL (d) | 2/43 (5%) 1/40 (3%) 1/42 (2%) | --- --- --- |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | (e) (e) (e) |
|LIFE TABLE | P=0.387N P=0.525N P=0.508N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.387N P=0.525N P=0.508N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.387N P=0.525N P=0.508N | (e) |
|COCHRAN-ARMITAGE | P=0.378N | (e) (e) |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibrosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 1/49 (2%) |
|ADJUSTED (b) | 4.7% 2.2% 4.8% | 0.0% 0.0% 2.5% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/1 (0%) 0/0 | 0/43 (0%) 0/43 (0%) 0/38 (0%) |
|TERMINAL (d) | 2/43 (5%) 0/40 (0%) 2/42 (5%) | --- --- 718 |
|FIRST INCIDENCE (DAYS) | 729 (T) 607 729 (T) | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | P=0.259 (e) P=0.486 |
|LIFE TABLE | P=0.601 P=0.511N P=0.686 | P=0.422 (e) P=0.669 |
|INCIDENTAL TUMOR | P=0.606 P=0.398N P=0.686 | P=0.266 (e) P=0.495 |
|LOGISTIC REGRESSION | P=0.609 P=0.494N P=0.686 | P=0.266 |
|COCHRAN-ARMITAGE | P=0.610 | (e) P=0.495 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05706 TEST: 01 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 6250PPM 12500PPM | CONTROL 6250PPM 12500PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, Sarcoma, |
| Neurofibroma, or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 3/50 (6%) 5/50 (10%) | 0/50 (0%) 0/50 (0%) 1/49 (2%) |
|ADJUSTED (b) | 11.6% 6.7% 11.9% | 0.0% 0.0% 2.5% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/1 (0%) 0/0 | 0/43 (0%) 0/43 (0%) 0/38 (0%) |
|TERMINAL (d) | 5/43 (12%) 1/40 (3%) 5/42 (12%) | --- --- 718 |
|FIRST INCIDENCE (DAYS) | 729 (T) 605 729 (T) | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | P=0.259 (e) P=0.486 |
|LIFE TABLE | P=0.557 P=0.381N P=0.616 | P=0.422 (e) P=0.669 |
|INCIDENTAL TUMOR | P=0.560 P=0.244N P=0.616 | P=0.266 (e) P=0.495 |
|LOGISTIC REGRESSION | P=0.568 P=0.341N P=0.616 | P=0.266 |
|COCHRAN-ARMITAGE | P=0.571N | (e) P=0.495 |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, or Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 4/50 (8%) | 0/50 (0%) 0/50 (0%) 1/49 (2%) |
|ADJUSTED (b) | 7.0% 4.3% 9.5% | 0.0% 0.0% 2.5% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/1 (0%) 0/0 | 0/43 (0%) 0/43 (0%) 0/38 (0%) |
|TERMINAL (d) | 3/43 (7%) 0/40 (0%) 4/42 (10%) | --- --- 718 |
|FIRST INCIDENCE (DAYS) | 729 (T) 605 729 (T) | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | P=0.259 (e) P=0.486 |
|LIFE TABLE | P=0.409 P=0.509N P=0.487 | P=0.422 (e) P=0.669 |
|INCIDENTAL TUMOR | P=0.403 P=0.326N P=0.487 | P=0.266 (e) P=0.495 |
|LOGISTIC REGRESSION | P=0.414 P=0.496N P=0.487 | P=0.266 |
|COCHRAN-ARMITAGE | P=0.417 | (e) P=0.495 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05706 TEST: 01 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 6250PPM 12500PPM | CONTROL 6250PPM 12500PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|ADJUSTED (b) | 2.3% 2.2% 4.8% | 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/1 (0%) 0/0 | 0/43 (0%) 0/43 (0%) 0/38 (0%) |
|TERMINAL (d) | 1/43 (2%) 0/40 (0%) 2/42 (5%) | --- --- --- |
|FIRST INCIDENCE (DAYS) | 729 (T) 605 729 (T) | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | (e) (e) (e) |
|LIFE TABLE | P=0.374 P=0.760 P=0.492 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.368 P=0.657N P=0.492 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.376 P=0.762 P=0.492 | (e) |
|COCHRAN-ARMITAGE | P=0.378 | (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) | 1/50 (2%) 1/50 (2%) 1/49 (2%) |
|ADJUSTED (b) | 2.3% 4.8% 0.0% | 2.3% 2.3% 2.6% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/1 (0%) 0/0 | 1/43 (2%) 1/43 (2%) 1/38 (3%) |
|TERMINAL (d) | 1/43 (2%) 1/40 (3%) 0/42 (0%) | 729 (T) 729 (T) 729 (T) |
|FIRST INCIDENCE (DAYS) | 729 (T) 711 --- | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | P=0.608 P=0.762 P=0.734 |
|LIFE TABLE | P=0.369N P=0.481 P=0.505N | P=0.608 P=0.762 P=0.734 |
|INCIDENTAL TUMOR | P=0.277N P=0.746 P=0.505N | P=0.608 P=0.762 P=0.734 |
|LOGISTIC REGRESSION | P=0.362N P=0.507 P=0.505N | P=0.634 |
|COCHRAN-ARMITAGE | P=0.360N | P=0.753N P=0.747 |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05706 TEST: 01 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 6250PPM 12500PPM | CONTROL 6250PPM 12500PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) | 1/50 (2%) 1/50 (2%) 2/49 (4%) |
|ADJUSTED (b) | 4.7% 4.8% 2.4% | 2.3% 2.3% 5.3% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/1 (0%) 0/0 | 1/43 (2%) 1/43 (2%) 2/38 (5%) |
|TERMINAL (d) | 2/43 (5%) 1/40 (3%) 1/42 (2%) | 729 (T) 729 (T) 729 (T) |
|FIRST INCIDENCE (DAYS) | 729 (T) 711 729 (T) | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | P=0.339 P=0.762 P=0.457 |
|LIFE TABLE | P=0.400N P=0.672 P=0.508N | P=0.339 P=0.762 P=0.457 |
|INCIDENTAL TUMOR | P=0.335N P=0.525N P=0.508N | P=0.339 P=0.762 P=0.457 |
|LOGISTIC REGRESSION | P=0.393N P=0.690N P=0.508N | P=0.372 |
|COCHRAN-ARMITAGE | P=0.390N | P=0.753N P=0.492 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma And Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 6/50 (12%) 6/50 (12%) | 19/50 (38%) 10/50 (20%) 11/49 (22%) |
|ADJUSTED (b) | 4.7% 13.9% 13.6% | 39.6% 22.1% 25.3% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/1 (0%) 0/0 | 14/43 (33%) 8/43 (19%) 6/38 (16%) |
|TERMINAL (d) | 2/43 (5%) 3/40 (8%) 4/42 (10%) | 587 601 639 |
|FIRST INCIDENCE (DAYS) | 729 (T) 628 438 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | P=0.097N P=0.052N P=0.140N |
|LIFE TABLE | P=0.117 P=0.126 P=0.134 | P=0.017N* P=0.051N P=0.025N* |
|INCIDENTAL TUMOR | P=0.182 P=0.386 P=0.326 | P=0.051N P=0.040N* P=0.071N |
|LOGISTIC REGRESSION | P=0.112 P=0.491 P=0.133 | P=0.050N |
|COCHRAN-ARMITAGE | P=0.114 | P=0.038N* P=0.071N |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05706 TEST: 01 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 6250PPM 12500PPM | CONTROL 6250PPM 12500PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 6/50 (12%) 6/50 (12%) | 19/50 (38%) 10/50 (20%) 11/49 (22%) |
|ADJUSTED (b) | 4.7% 13.9% 13.6% | 39.6% 22.1% 25.3% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/1 (0%) 0/0 | 14/43 (33%) 8/43 (19%) 6/38 (16%) |
|TERMINAL (d) | 2/43 (5%) 3/40 (8%) 4/42 (10%) | 587 601 639 |
|FIRST INCIDENCE (DAYS) | 729 (T) 628 438 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | P=0.097N P=0.052N P=0.140N |
|LIFE TABLE | P=0.117 P=0.126 P=0.134 | P=0.017N* P=0.051N P=0.025N* |
|INCIDENTAL TUMOR | P=0.182 P=0.386 P=0.326 | P=0.051N P=0.040N* P=0.071N |
|LOGISTIC REGRESSION | P=0.112 P=0.491 P=0.133 | P=0.050N |
|COCHRAN-ARMITAGE | P=0.114 | P=0.038N* P=0.071N |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 10/50 (20%) 15/50 (30%) | 21/50 (42%) 9/50 (18%) 12/49 (24%) |
|ADJUSTED (b) | 34.9% 25.0% 35.7% | 46.5% 19.9% 29.1% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/1 (0%) 0/0 | 19/43 (44%) 7/43 (16%) 9/38 (24%) |
|TERMINAL (d) | 15/43 (35%) 10/40 (25%) 15/42 (36%) | 410 601 660 |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | P=0.065N P=0.010N* P=0.103N |
|LIFE TABLE | P=0.517 P=0.231N P=0.558 | P=0.026N* P=0.012N* P=0.046N* |
|INCIDENTAL TUMOR | P=0.517 P=0.231N P=0.558 | P=0.034N* P=0.009N** P=0.052N |
|LOGISTIC REGRESSION | P=0.517 P=0.231N P=0.558 | P=0.033N* |
|COCHRAN-ARMITAGE | P=0.545 | P=0.008N** P=0.051N |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05706 TEST: 01 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 6250PPM 12500PPM | CONTROL 6250PPM 12500PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 15/50 (30%) 16/50 (32%) | 24/50 (48%) 12/50 (24%) 15/49 (31%) |
|ADJUSTED (b) | 25.6% 32.6% 36.3% | 49.0% 26.0% 33.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/1 (0%) 0/0 | 18/43 (42%) 9/43 (21%) 8/38 (21%) |
|TERMINAL (d) | 11/43 (26%) 9/40 (23%) 14/42 (33%) | 587 601 602 |
|FIRST INCIDENCE (DAYS) | 729 (T) 605 438 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | P=0.094N P=0.020N* P=0.137N |
|LIFE TABLE | P=0.155 P=0.212 P=0.168 | P=0.013N* P=0.012N* P=0.019N* |
|INCIDENTAL TUMOR | P=0.219 P=0.577 P=0.294 | P=0.010N** P=0.011N* P=0.016N* |
|LOGISTIC REGRESSION | P=0.150 P=0.279 P=0.175 | P=0.042N* |
|COCHRAN-ARMITAGE | P=0.158 | P=0.011N* P=0.059N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 24/50 (48%) 25/50 (50%) | 34/50 (68%) 17/50 (34%) 24/49 (49%) |
|ADJUSTED (b) | 53.5% 52.2% 56.8% | 68.0% 36.9% 51.9% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/1 (0%) 0/0 | 27/43 (63%) 14/43 (33%) 16/38 (42%) |
|TERMINAL (d) | 23/43 (53%) 18/40 (45%) 23/42 (55%) | 410 601 602 |
|FIRST INCIDENCE (DAYS) | 729 (T) 605 438 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | P=0.110N P=0.002N** P=0.157N |
|LIFE TABLE | P=0.347 P=0.390 P=0.376 | P=0.017N* P=0.001N** P=0.023N* |
|INCIDENTAL TUMOR | P=0.457 P=0.414N P=0.540 | P=0.017N* P<0.001N** P=0.035N* |
|LOGISTIC REGRESSION | P=0.367 P=0.568 P=0.407 | P=0.035N* |
|COCHRAN-ARMITAGE | P=0.382 | P<0.001N** P=0.043N* |
|=================================================================================================================================|
DATE: 09/18/94 EXPERIMENT: 05706 TEST: 01 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
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).