TDMS Study 05706-02 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: 02 TIME: 23:58:51
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: ROUTE: DOSED FEED NTP C#: C60162
PATHOLOGIST: W. HALL 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: 02 TIME: 23:58:51
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: ROUTE: DOSED FEED NTP C#: C60162
PATHOLOGIST: W. HALL S. EUSTIS CAS: 81-11-8
RATS(FISCHER344)
----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
----------------
Adrenal Gland
Bone Marrow
Brain
Clitoral Gland
Epididymis
Heart
Islets, Pancreatic
Kidney
Larynx
Liver
Lung
Nose
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Preputial Gland
Prostate
Salivary Glands
Spleen
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: IRDC 4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID DATE: 09/18/94
EXPERIMENT: 05706 TEST: 02 TIME: 23:58:51
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: ROUTE: DOSED FEED NTP C#: C60162
PATHOLOGIST: W. HALL 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 RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Malignant
Clitoral/Preputial Gland Carcinoma
Carcinoma or Adenoma
Liver Hepatocellular Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
All Organs Malignant Tumors
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Clitoral/Preputial Gland Adenoma
Carcinoma or Adenoma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Thyroid Gland: C-Cell Carcinoma
Carcinoma or Adenoma
All Organs Benign Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 09/19/94 EXPERIMENT: 05706 TEST: 02 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 12500PPM 25000PPM | CONTROL 12500PPM 25000PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) | 0/49 (0%) 0/50 (0%) 2/49 (4%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% | 0.0% 0.0% 5.9% |
|TERMINAL (d) | 0/22 (0%) 0/19 (0%) 0/24 (0%) | 0/30 (0%) 0/33 (0%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | --- --- --- | --- --- 722 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.104 (e) P=0.261 |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.120 (e) P=0.268 |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.109 (e) P=0.268 |
|COCHRAN-ARMITAGE | (e) | P=0.095 |
|FISHER EXACT | (e) (e) | (e) P=0.247 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 16/48 (33%) 18/50 (36%) 19/50 (38%) | 2/49 (4%) 4/50 (8%) 5/49 (10%) |
|ADJUSTED (b) | 50.5% 56.0% 59.6% | 6.7% 12.1% 14.0% |
|TERMINAL (d) | 7/21 (33%) 7/20 (35%) 12/24 (50%) | 2/30 (7%) 4/33 (12%) 4/33 (12%) |
|FIRST INCIDENCE (DAYS) | 540 583 520 | 729 (T) 729 (T) 671 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.441 P=0.405 P=0.477 | P=0.204 P=0.380 P=0.261 |
|INCIDENTAL TUMOR | P=0.389 P=0.575 P=0.438 | P=0.206 P=0.380 P=0.260 |
|LOGISTIC REGRESSION | P=0.396 P=0.491 P=0.438 | P=0.219 P=0.380 P=0.265 |
|COCHRAN-ARMITAGE | P=0.354 | P=0.168 |
|FISHER EXACT | P=0.474 P=0.393 | P=0.349 P=0.218 |
|=================================================================================================================================|
DATE: 09/19/94 EXPERIMENT: 05706 TEST: 02 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 12500PPM 25000PPM | CONTROL 12500PPM 25000PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 4/50 (8%) 8/50 (16%) | 0/49 (0%) 2/50 (4%) 0/49 (0%) |
|ADJUSTED (b) | 8.9% 16.1% 27.6% | 0.0% 5.7% 0.0% |
|TERMINAL (d) | 1/21 (5%) 2/20 (10%) 4/24 (17%) | 0/30 (0%) 1/33 (3%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 713 663 658 | --- 706 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.049 * P=0.339 P=0.074 | P=0.641N P=0.263 (e) |
|INCIDENTAL TUMOR | P=0.031 * P=0.420 P=0.054 | P=0.633N P=0.191 (e) |
|LOGISTIC REGRESSION | P=0.037 * P=0.358 P=0.059 | P=0.647N P=0.243 (e) |
|COCHRAN-ARMITAGE | P=0.033 * | P=0.669 |
|FISHER EXACT | P=0.359 P=0.053 | P=0.253 (e) |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 17/48 (35%) 21/50 (42%) 26/50 (52%) | 2/49 (4%) 6/50 (12%) 5/49 (10%) |
|ADJUSTED (b) | 52.7% 63.9% 73.6% | 6.7% 17.4% 14.0% |
|TERMINAL (d) | 7/21 (33%) 9/20 (45%) 15/24 (63%) | 2/30 (7%) 5/33 (15%) 4/33 (12%) |
|FIRST INCIDENCE (DAYS) | 540 583 520 | 729 (T) 706 671 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.134 P=0.280 P=0.150 | P=0.232 P=0.167 P=0.261 |
|INCIDENTAL TUMOR | P=0.062 P=0.431 P=0.080 | P=0.235 P=0.138 P=0.260 |
|LOGISTIC REGRESSION | P=0.067 P=0.334 P=0.084 | P=0.244 P=0.151 P=0.265 |
|COCHRAN-ARMITAGE | P=0.060 | P=0.186 |
|FISHER EXACT | P=0.323 P=0.073 | P=0.141 P=0.218 |
|=================================================================================================================================|
DATE: 09/19/94 EXPERIMENT: 05706 TEST: 02 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 12500PPM 25000PPM | CONTROL 12500PPM 25000PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 4/20 (20%) 4/49 (8%) | 4/47 (9%) 5/13 (38%) 4/46 (9%) |
|ADJUSTED (b) | 28.7% 38.5% 14.5% | 13.8% 69.3% 11.1% |
|TERMINAL (d) | 5/22 (23%) 1/3 (33%) 3/24 (13%) | 4/29 (14%) 2/3 (67%) 2/30 (7%) |
|FIRST INCIDENCE (DAYS) | 540 580 561 | 729 (T) 663 671 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.129N P=0.566 P=0.156N | P=0.514N P=0.014 * P=0.603N |
|INCIDENTAL TUMOR | P=0.147N P=0.307 P=0.169N | P=0.454N P<0.001 ** P=0.583N |
|LOGISTIC REGRESSION | P=0.147N P=0.340 P=0.169N | P=0.493N P<0.001 ** P=0.587N |
|COCHRAN-ARMITAGE | P=0.161N | P=0.547 |
|FISHER EXACT | P=0.466 P=0.188N | P=0.018 * P=0.631 |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/20 (15%) 4/49 (8%) | 0/47 (0%) 0/13 (0%) 0/46 (0%) |
|ADJUSTED (b) | 12.5% 38.1% 13.9% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/22 (9%) 1/3 (33%) 1/24 (4%) | 0/29 (0%) 0/3 (0%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | 696 676 676 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.478 P=0.259 P=0.548 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.451 P=0.046 * P=0.521 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.396 P=0.032 * P=0.526 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.416 | (e) |
|FISHER EXACT | P=0.222 P=0.489 | (e) (e) |
|=================================================================================================================================|
DATE: 09/19/94 EXPERIMENT: 05706 TEST: 02 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 12500PPM 25000PPM | CONTROL 12500PPM 25000PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 7/20 (35%) 8/49 (16%) | 4/47 (9%) 5/13 (38%) 4/46 (9%) |
|ADJUSTED (b) | 39.4% 71.4% 26.9% | 13.8% 69.3% 11.1% |
|TERMINAL (d) | 7/22 (32%) 2/3 (67%) 4/24 (17%) | 4/29 (14%) 2/3 (67%) 2/30 (7%) |
|FIRST INCIDENCE (DAYS) | 540 580 561 | 729 (T) 663 671 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.223N P=0.293 P=0.258N | P=0.514N P=0.014 * P=0.603N |
|INCIDENTAL TUMOR | P=0.249N P=0.037 * P=0.283N | P=0.454N P<0.001 ** P=0.583N |
|LOGISTIC REGRESSION | P=0.247N P=0.045 * P=0.279N | P=0.493N P<0.001 ** P=0.587N |
|COCHRAN-ARMITAGE | P=0.289N | P=0.547 |
|FISHER EXACT | P=0.204 P=0.323N | P=0.018 * P=0.631 |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/16 (0%) 2/49 (4%) | 0/49 (0%) 0/8 (0%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 8.3% | 0.0% 0.0% 3.0% |
|TERMINAL (d) | 0/22 (0%) 0/1 (0%) 2/24 (8%) | 0/30 (0%) 0/0 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | --- --- 729 (T) | --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.153 (e) P=0.257 | P=0.325 (e) P=0.519 |
|INCIDENTAL TUMOR | P=0.153 (e) P=0.257 | P=0.325 (e) P=0.519 |
|LOGISTIC REGRESSION | P=0.153 (e) P=0.257 | P=0.325 (e) P=0.519 |
|COCHRAN-ARMITAGE | P=0.124 | P=0.304 |
|FISHER EXACT | (e) P=0.247 | (e) P=0.505 |
|=================================================================================================================================|
DATE: 09/19/94 EXPERIMENT: 05706 TEST: 02 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 12500PPM 25000PPM | CONTROL 12500PPM 25000PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 0/16 (0%) 2/49 (4%) | 0/49 (0%) 0/8 (0%) 0/50 (0%) |
|ADJUSTED (b) | 3.3% 0.0% 6.7% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/1 (0%) 1/24 (4%) | 0/30 (0%) 0/0 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 687 --- 624 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.380 P=0.529N P=0.506 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.371 P=0.923N P=0.489 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.386 P=0.853N P=0.506 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.376 | (e) |
|FISHER EXACT | P=0.754N P=0.500 | (e) (e) |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 0/16 (0%) 4/49 (8%) | 0/49 (0%) 0/8 (0%) 1/50 (2%) |
|ADJUSTED (b) | 3.3% 0.0% 14.8% | 0.0% 0.0% 3.0% |
|TERMINAL (d) | 0/22 (0%) 0/1 (0%) 3/24 (13%) | 0/30 (0%) 0/0 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | 687 --- 624 | --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.122 P=0.529N P=0.196 | P=0.325 (e) P=0.519 |
|INCIDENTAL TUMOR | P=0.124 P=0.923N P=0.187 | P=0.325 (e) P=0.519 |
|LOGISTIC REGRESSION | P=0.122 P=0.853N P=0.186 | P=0.325 (e) P=0.519 |
|COCHRAN-ARMITAGE | P=0.109 | P=0.304 |
|FISHER EXACT | P=0.754N P=0.181 | (e) P=0.505 |
|=================================================================================================================================|
DATE: 09/19/94 EXPERIMENT: 05706 TEST: 02 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 12500PPM 25000PPM | CONTROL 12500PPM 25000PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/49 (2%) 5/50 (10%) | 3/50 (6%) 0/42 (0%) 1/50 (2%) |
|ADJUSTED (b) | 4.5% 5.3% 20.0% | 10.0% 0.0% 3.0% |
|TERMINAL (d) | 1/22 (5%) 1/19 (5%) 4/24 (17%) | 3/30 (10%) 0/27 (0%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 720 | 729 (T) --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.063 P=0.730 P=0.124 | P=0.160N P=0.139N P=0.271N |
|INCIDENTAL TUMOR | P=0.059 P=0.730 P=0.119 | P=0.160N P=0.139N P=0.271N |
|LOGISTIC REGRESSION | P=0.058 P=0.730 P=0.118 | P=0.160N P=0.139N P=0.271N |
|COCHRAN-ARMITAGE | P=0.049 * | P=0.182N |
|FISHER EXACT | P=0.747 P=0.102 | P=0.156N P=0.309N |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/30 (3%) 2/50 (4%) | 0/50 (0%) 1/29 (3%) 1/50 (2%) |
|ADJUSTED (b) | 4.5% 10.0% 7.2% | 0.0% 5.3% 3.0% |
|TERMINAL (d) | 1/22 (5%) 1/10 (10%) 1/24 (4%) | 0/30 (0%) 1/19 (5%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 676 | --- 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.416 P=0.577 P=0.528 | P=0.364 P=0.409 P=0.519 |
|INCIDENTAL TUMOR | P=0.412 P=0.577 P=0.520 | P=0.364 P=0.409 P=0.519 |
|LOGISTIC REGRESSION | P=0.408 P=0.577 P=0.517 | P=0.364 P=0.409 P=0.519 |
|COCHRAN-ARMITAGE | P=0.386 | P=0.343 |
|FISHER EXACT | P=0.612 P=0.500 | P=0.367 P=0.500 |
|=================================================================================================================================|
DATE: 09/19/94 EXPERIMENT: 05706 TEST: 02 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 12500PPM 25000PPM | CONTROL 12500PPM 25000PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/30 (7%) 3/50 (6%) | 0/50 (0%) 1/29 (3%) 1/50 (2%) |
|ADJUSTED (b) | 9.1% 13.6% 11.2% | 0.0% 5.3% 3.0% |
|TERMINAL (d) | 2/22 (9%) 1/10 (10%) 2/24 (8%) | 0/30 (0%) 1/19 (5%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 697 676 | --- 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.454 P=0.469 P=0.538 | P=0.364 P=0.409 P=0.519 |
|INCIDENTAL TUMOR | P=0.444 P=0.419 P=0.532 | P=0.364 P=0.409 P=0.519 |
|LOGISTIC REGRESSION | P=0.441 P=0.399 P=0.527 | P=0.364 P=0.409 P=0.519 |
|COCHRAN-ARMITAGE | P=0.412 | P=0.343 |
|FISHER EXACT | P=0.483 P=0.500 | P=0.367 P=0.500 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 1/50 (2%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% | 6.7% 3.0% 6.1% |
|TERMINAL (d) | 0/22 (0%) 0/20 (0%) 0/24 (0%) | 2/30 (7%) 1/33 (3%) 2/33 (6%) |
|FIRST INCIDENCE (DAYS) | --- --- --- | 729 (T) 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.577N P=0.467N P=0.661N |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.577N P=0.467N P=0.661N |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.577N P=0.467N P=0.661N |
|COCHRAN-ARMITAGE | (e) | P=0.610 |
|FISHER EXACT | (e) (e) | P=0.500N P=0.691N |
|=================================================================================================================================|
DATE: 09/19/94 EXPERIMENT: 05706 TEST: 02 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 12500PPM 25000PPM | CONTROL 12500PPM 25000PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) | 1/50 (2%) 2/50 (4%) 3/50 (6%) |
|ADJUSTED (b) | 0.0% 4.3% 0.0% | 3.3% 5.1% 7.9% |
|TERMINAL (d) | 0/22 (0%) 0/20 (0%) 0/24 (0%) | 1/30 (3%) 1/33 (3%) 2/33 (6%) |
|FIRST INCIDENCE (DAYS) | --- 725 --- | 729 (T) 565 351 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.718N P=0.509 (e) | P=0.246 P=0.524 P=0.334 |
|INCIDENTAL TUMOR | P=0.746 P=0.581 (e) | P=0.199 P=0.569 P=0.332 |
|LOGISTIC REGRESSION | P=0.719N P=0.500 (e) | P=0.175 P=0.499 P=0.235 |
|COCHRAN-ARMITAGE | P=0.731 | P=0.222 |
|FISHER EXACT | P=0.500 (e) | P=0.500 P=0.309 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) | 3/50 (6%) 3/50 (6%) 5/50 (10%) |
|ADJUSTED (b) | 0.0% 4.3% 0.0% | 10.0% 8.0% 13.9% |
|TERMINAL (d) | 0/22 (0%) 0/20 (0%) 0/24 (0%) | 3/30 (10%) 2/33 (6%) 4/33 (12%) |
|FIRST INCIDENCE (DAYS) | --- 725 --- | 729 (T) 565 351 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.718N P=0.509 (e) | P=0.322 P=0.624N P=0.404 |
|INCIDENTAL TUMOR | P=0.746 P=0.581 (e) | P=0.284 P=0.594N P=0.403 |
|LOGISTIC REGRESSION | P=0.719N P=0.500 (e) | P=0.261 P=0.661N P=0.326 |
|COCHRAN-ARMITAGE | P=0.731 | P=0.283 |
|FISHER EXACT | P=0.500 (e) | P=0.661N P=0.357 |
|=================================================================================================================================|
DATE: 09/19/94 EXPERIMENT: 05706 TEST: 02 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 12500PPM 25000PPM | CONTROL 12500PPM 25000PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 4/50 (8%) | 11/50 (22%) 21/50 (42%) 21/50 (42%) |
|ADJUSTED (b) | 9.1% 10.0% 15.1% | 29.0% 53.1% 49.9% |
|TERMINAL (d) | 1/22 (5%) 2/20 (10%) 2/24 (8%) | 5/30 (17%) 15/33 (45%) 13/33 (39%) |
|FIRST INCIDENCE (DAYS) | 67 729 (T) 700 | 528 583 638 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.456 P=0.526N P=0.537 | P=0.074 P=0.061 P=0.082 |
|INCIDENTAL TUMOR | P=0.379 P=0.489N P=0.352 | P=0.017 * P=0.014 * P=0.016 * |
|LOGISTIC REGRESSION | P=0.311 P=0.518N P=0.437 | P=0.029 * P=0.027 * P=0.029 * |
|COCHRAN-ARMITAGE | P=0.417 | P=0.023 * |
|FISHER EXACT | P=0.500N P=0.500 | P=0.026 * P=0.026 * |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 4/50 (8%) | 13/50 (26%) 21/50 (42%) 23/50 (46%) |
|ADJUSTED (b) | 9.1% 10.0% 15.1% | 34.7% 53.1% 54.9% |
|TERMINAL (d) | 1/22 (5%) 2/20 (10%) 2/24 (8%) | 7/30 (23%) 15/33 (45%) 15/33 (45%) |
|FIRST INCIDENCE (DAYS) | 67 729 (T) 700 | 528 583 638 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.456 P=0.526N P=0.537 | P=0.080 P=0.131 P=0.093 |
|INCIDENTAL TUMOR | P=0.379 P=0.489N P=0.352 | P=0.019 * P=0.044 * P=0.021 * |
|LOGISTIC REGRESSION | P=0.311 P=0.518N P=0.437 | P=0.033 * P=0.071 P=0.037 * |
|COCHRAN-ARMITAGE | P=0.417 | P=0.025 * |
|FISHER EXACT | P=0.500N P=0.500 | P=0.069 P=0.030 * |
|=================================================================================================================================|
DATE: 09/19/94 EXPERIMENT: 05706 TEST: 02 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 12500PPM 25000PPM | CONTROL 12500PPM 25000PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 4/50 (8%) | 14/50 (28%) 22/50 (44%) 26/50 (52%) |
|ADJUSTED (b) | 9.1% 13.9% 15.1% | 37.5% 54.1% 60.7% |
|TERMINAL (d) | 1/22 (5%) 2/20 (10%) 2/24 (8%) | 8/30 (27%) 15/33 (45%) 17/33 (52%) |
|FIRST INCIDENCE (DAYS) | 67 725 700 | 528 565 351 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.463 P=0.642 P=0.537 | P=0.044 * P=0.139 P=0.053 |
|INCIDENTAL TUMOR | P=0.384 P=0.622N P=0.352 | P=0.007 ** P=0.052 P=0.010 ** |
|LOGISTIC REGRESSION | P=0.323 P=0.653 P=0.437 | P=0.011 * P=0.073 P=0.012 * |
|COCHRAN-ARMITAGE | P=0.421 | P=0.010 ** |
|FISHER EXACT | P=0.661N P=0.500 | P=0.072 P=0.012 * |
|=================================================================================================================================|
| |
|Ovary |
| Granulosa Cell Tumor Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 0/50 (0%) 0/8 (0%) 2/50 (4%) |
|ADJUSTED (b) | | 0.0% 0.0% 6.1% |
|TERMINAL (d) | | 0/30 (0%) 0/0 2/33 (6%) |
|FIRST INCIDENCE (DAYS) | | --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.158 (e) P=0.259 |
|INCIDENTAL TUMOR | | P=0.158 (e) P=0.259 |
|LOGISTIC REGRESSION | | P=0.158 (e) P=0.259 |
|COCHRAN-ARMITAGE | | P=0.133 |
|FISHER EXACT | | (e) P=0.247 |
|=================================================================================================================================|
DATE: 09/19/94 EXPERIMENT: 05706 TEST: 02 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 12500PPM 25000PPM | CONTROL 12500PPM 25000PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 17/50 (34%) 8/49 (16%) 10/50 (20%) | 15/50 (30%) 20/37 (54%) 14/49 (29%) |
|ADJUSTED (b) | 51.2% 24.6% 32.5% | 38.1% 64.1% 39.4% |
|TERMINAL (d) | 8/22 (36%) 2/20 (10%) 5/24 (21%) | 8/30 (27%) 14/24 (58%) 12/33 (36%) |
|FIRST INCIDENCE (DAYS) | 443 327 624 | 528 558 686 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.059N P=0.056N P=0.076N | P=0.329N P=0.107 P=0.380N |
|INCIDENTAL TUMOR | P=0.068N P=0.044N* P=0.081N | P=0.498N P=0.011 * P=0.552N |
|LOGISTIC REGRESSION | P=0.061N P=0.037N* P=0.077N | P=0.446N P=0.019 * P=0.511N |
|COCHRAN-ARMITAGE | P=0.063N | P=0.488N |
|FISHER EXACT | P=0.036N* P=0.088N | P=0.021 * P=0.526N |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 7.3% 7.8% 6.8% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/22 (5%) 1/20 (5%) 1/24 (4%) | 0/30 (0%) 0/33 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 630 658 635 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.566N P=0.686 P=0.664N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.592N P=0.689 P=0.693N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.589N P=0.691N P=0.686N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.601 | (e) |
|FISHER EXACT | P=0.691N P=0.691N | (e) (e) |
|=================================================================================================================================|
DATE: 09/19/94 EXPERIMENT: 05706 TEST: 02 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 12500PPM 25000PPM | CONTROL 12500PPM 25000PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 9.1% 5.0% 4.2% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/22 (9%) 1/20 (5%) 1/24 (4%) | 0/30 (0%) 0/33 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.352N P=0.534N P=0.469N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.352N P=0.534N P=0.469N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.352N P=0.534N P=0.469N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.378N | (e) |
|FISHER EXACT | P=0.500N P=0.500N | (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 5.5% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/20 (0%) 0/24 (0%) | 0/30 (0%) 0/33 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 588 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.101 (e) P=0.250 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.089 (e) P=0.231 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.087 (e) P=0.218 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.095 | (e) |
|FISHER EXACT | (e) P=0.247 | (e) (e) |
|=================================================================================================================================|
DATE: 09/19/94 EXPERIMENT: 05706 TEST: 02 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 12500PPM 25000PPM | CONTROL 12500PPM 25000PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, |
| Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 5/50 (10%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 16.1% 12.6% 15.7% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/22 (14%) 2/20 (10%) 2/24 (8%) | 0/30 (0%) 0/33 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 630 658 588 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.474 P=0.528N P=0.545 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.446 P=0.526N P=0.513 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.447 P=0.492N P=0.520 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.427 | (e) |
|FISHER EXACT | P=0.500N P=0.500 | (e) (e) |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibrosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 2.9% 0.0% 6.5% | 0.0% 0.0% 5.6% |
|TERMINAL (d) | 0/22 (0%) 0/20 (0%) 1/24 (4%) | 0/30 (0%) 0/33 (0%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | 630 --- 588 | --- --- 718 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.378 P=0.494N P=0.519 | P=0.111 (e) P=0.273 |
|INCIDENTAL TUMOR | P=0.357 P=0.552N P=0.491 | P=0.120 (e) P=0.268 |
|LOGISTIC REGRESSION | P=0.353 P=0.502N P=0.490 | P=0.109 (e) P=0.266 |
|COCHRAN-ARMITAGE | P=0.360 | P=0.095 |
|FISHER EXACT | P=0.500N P=0.500 | (e) P=0.247 |
|=================================================================================================================================|
DATE: 09/19/94 EXPERIMENT: 05706 TEST: 02 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 12500PPM 25000PPM | CONTROL 12500PPM 25000PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, Sarcoma, |
| Neurofibroma, or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 4/50 (8%) | 1/50 (2%) 0/50 (0%) 3/50 (6%) |
|ADJUSTED (b) | 2.9% 7.6% 11.5% | 2.4% 0.0% 7.5% |
|TERMINAL (d) | 0/22 (0%) 0/20 (0%) 1/24 (4%) | 0/30 (0%) 0/33 (0%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | 630 595 491 | 653 --- 638 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.153 P=0.326 P=0.208 | P=0.209 P=0.510N P=0.355 |
|INCIDENTAL TUMOR | P=0.127 P=0.266 P=0.179 | P=0.163 P=0.607N P=0.249 |
|LOGISTIC REGRESSION | P=0.111 P=0.299 P=0.151 | P=0.168 P=0.501N P=0.287 |
|COCHRAN-ARMITAGE | P=0.133 | P=0.176 |
|FISHER EXACT | P=0.309 P=0.181 | P=0.500N P=0.309 |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, or Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 2.9% 5.4% 8.4% | 0.0% 0.0% 5.6% |
|TERMINAL (d) | 0/22 (0%) 0/20 (0%) 1/24 (4%) | 0/30 (0%) 0/33 (0%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | 630 615 491 | --- --- 718 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.243 P=0.517 P=0.331 | P=0.111 (e) P=0.273 |
|INCIDENTAL TUMOR | P=0.219 P=0.486 P=0.300 | P=0.120 (e) P=0.268 |
|LOGISTIC REGRESSION | P=0.191 P=0.497 P=0.253 | P=0.109 (e) P=0.266 |
|COCHRAN-ARMITAGE | P=0.222 | P=0.095 |
|FISHER EXACT | P=0.500 P=0.309 | (e) P=0.247 |
|=================================================================================================================================|
DATE: 09/19/94 EXPERIMENT: 05706 TEST: 02 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 12500PPM 25000PPM | CONTROL 12500PPM 25000PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 5.4% 2.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/20 (0%) 0/24 (0%) | 0/30 (0%) 0/33 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | --- 615 491 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.374 P=0.253 P=0.517 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.355 P=0.252 P=0.500 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.309 P=0.235 P=0.384 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.360 | (e) |
|FISHER EXACT | P=0.247 P=0.500 | (e) (e) |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 42/50 (84%) 40/50 (80%) 46/50 (92%) | |
|ADJUSTED (b) | 97.6% 97.5% 100.0% | |
|TERMINAL (d) | 21/22 (95%) 19/20 (95%) 24/24 (100%) | |
|FIRST INCIDENCE (DAYS) | 446 510 508 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.466 P=0.538N P=0.491 | |
|INCIDENTAL TUMOR | P=0.235 P=0.322N P=0.262 | |
|LOGISTIC REGRESSION | P=0.252 P=0.293N P=0.307 | |
|COCHRAN-ARMITAGE | P=0.161 | |
|FISHER EXACT | P=0.398N P=0.178 | |
|=================================================================================================================================|
DATE: 09/19/94 EXPERIMENT: 05706 TEST: 02 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 12500PPM 25000PPM | CONTROL 12500PPM 25000PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 1/18 (6%) 0/50 (0%) | 2/49 (4%) 0/10 (0%) 3/49 (6%) |
|ADJUSTED (b) | 8.1% 33.3% 0.0% | 6.3% 0.0% 9.1% |
|TERMINAL (d) | 1/22 (5%) 1/3 (33%) 0/24 (0%) | 1/30 (3%) 0/2 (0%) 3/33 (9%) |
|FIRST INCIDENCE (DAYS) | 696 729 (T) --- | 713 --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.156N P=0.634 P=0.223N | P=0.449 P=0.445N P=0.547 |
|INCIDENTAL TUMOR | P=0.172N P=0.376 P=0.230N | P=0.457 P=0.965N P=0.550 |
|LOGISTIC REGRESSION | P=0.165N P=0.446 P=0.225N | P=0.470 P=0.865N P=0.565 |
|COCHRAN-ARMITAGE | P=0.166N | P=0.405 |
|FISHER EXACT | P=0.615 P=0.242N | P=0.687N P=0.500 |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 1/18 (6%) 3/50 (6%) | 2/49 (4%) 2/10 (20%) 5/49 (10%) |
|ADJUSTED (b) | 8.2% 33.3% 12.5% | 6.7% 100.0% 14.5% |
|TERMINAL (d) | 1/22 (5%) 1/3 (33%) 3/24 (13%) | 2/30 (7%) 2/2 (100%) 4/33 (12%) |
|FIRST INCIDENCE (DAYS) | 704 729 (T) 729 (T) | 729 (T) 729 (T) 719 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.450 P=0.628 P=0.535 | P=0.225 P=0.003 ** P=0.262 |
|INCIDENTAL TUMOR | P=0.449 P=0.376 P=0.532 | P=0.233 P=0.003 ** P=0.261 |
|LOGISTIC REGRESSION | P=0.449 P=0.439 P=0.534 | P=0.243 P=0.003 ** P=0.271 |
|COCHRAN-ARMITAGE | P=0.419 | P=0.180 |
|FISHER EXACT | P=0.615 P=0.510 | P=0.130 P=0.218 |
|=================================================================================================================================|
DATE: 09/19/94 EXPERIMENT: 05706 TEST: 02 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 12500PPM 25000PPM | CONTROL 12500PPM 25000PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/49 (8%) 2/18 (11%) 3/50 (6%) | 4/49 (8%) 2/10 (20%) 8/49 (16%) |
|ADJUSTED (b) | 15.8% 66.7% 12.5% | 12.7% 100.0% 23.3% |
|TERMINAL (d) | 2/22 (9%) 2/3 (67%) 3/24 (13%) | 3/30 (10%) 2/2 (100%) 7/33 (21%) |
|FIRST INCIDENCE (DAYS) | 696 729 (T) 729 (T) | 713 729 (T) 719 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.379N P=0.479 P=0.458N | P=0.195 P=0.172 P=0.233 |
|INCIDENTAL TUMOR | P=0.387N P=0.122 P=0.466N | P=0.206 P=0.009 ** P=0.233 |
|LOGISTIC REGRESSION | P=0.384N P=0.193 P=0.464N | P=0.221 P=0.014 * P=0.248 |
|COCHRAN-ARMITAGE | P=0.414N | P=0.146 |
|FISHER EXACT | P=0.516 P=0.489N | P=0.266 P=0.178 |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 9/50 (18%) 8/50 (16%) 11/50 (22%) |
|ADJUSTED (b) | | 28.2% 22.7% 28.3% |
|TERMINAL (d) | | 8/30 (27%) 6/33 (18%) 7/33 (21%) |
|FIRST INCIDENCE (DAYS) | | 578 706 351 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.444 P=0.419N P=0.502 |
|INCIDENTAL TUMOR | | P=0.422 P=0.463N P=0.445 |
|LOGISTIC REGRESSION | | P=0.379 P=0.479N P=0.398 |
|COCHRAN-ARMITAGE | | P=0.350 |
|FISHER EXACT | | P=0.500N P=0.402 |
|=================================================================================================================================|
DATE: 09/19/94 EXPERIMENT: 05706 TEST: 02 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 12500PPM 25000PPM | CONTROL 12500PPM 25000PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 9/50 (18%) 9/50 (18%) 11/50 (22%) |
|ADJUSTED (b) | | 28.2% 24.6% 28.3% |
|TERMINAL (d) | | 8/30 (27%) 6/33 (18%) 7/33 (21%) |
|FIRST INCIDENCE (DAYS) | | 578 643 351 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.448 P=0.525N P=0.502 |
|INCIDENTAL TUMOR | | P=0.399 P=0.548N P=0.445 |
|LOGISTIC REGRESSION | | P=0.375 P=0.591N P=0.398 |
|COCHRAN-ARMITAGE | | P=0.352 |
|FISHER EXACT | | P=0.602N P=0.402 |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 2.4% 0.0% | 4.4% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/20 (0%) 0/24 (0%) | 0/30 (0%) 0/33 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | --- 609 --- | 603 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.732 P=0.510 (e) | P=0.090N P=0.247N P=0.219N |
|INCIDENTAL TUMOR | P=0.712 P=0.448 (e) | P=0.122N P=0.147N P=0.500N |
|LOGISTIC REGRESSION | P=0.719 P=0.495 (e) | P=0.106N P=0.239N P=0.279N |
|COCHRAN-ARMITAGE | P=0.731 | P=0.095N |
|FISHER EXACT | P=0.500 (e) | P=0.247N P=0.247N |
|=================================================================================================================================|
DATE: 09/19/94 EXPERIMENT: 05706 TEST: 02 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 12500PPM 25000PPM | CONTROL 12500PPM 25000PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, |
| or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 29/50 (58%) 28/50 (56%) | 16/50 (32%) 14/50 (28%) 15/50 (30%) |
|ADJUSTED (b) | 60.6% 71.1% 64.7% | 43.9% 35.3% 34.1% |
|TERMINAL (d) | 8/22 (36%) 9/20 (45%) 10/24 (42%) | 10/30 (33%) 8/33 (24%) 5/33 (15%) |
|FIRST INCIDENCE (DAYS) | 561 510 508 | 644 630 638 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.335 P=0.207 P=0.350 | P=0.326N P=0.337N P=0.354N |
|INCIDENTAL TUMOR | P=0.185 P=0.191 P=0.212 | P=0.378N P=0.492N P=0.429N |
|LOGISTIC REGRESSION | P=0.240 P=0.184 P=0.268 | P=0.333N P=0.399N P=0.427N |
|COCHRAN-ARMITAGE | P=0.184 | P=0.457N |
|FISHER EXACT | P=0.158 P=0.212 | P=0.414N P=0.500N |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 13.6% 2.4% 11.6% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/22 (14%) 0/20 (0%) 2/24 (8%) | 0/30 (0%) 0/33 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 595 700 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.561N P=0.327N P=0.624N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.570N P=0.355N P=0.630N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.575N P=0.299N P=0.631N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.594 | (e) |
|FISHER EXACT | P=0.309N P=0.661N | (e) (e) |
|=================================================================================================================================|
DATE: 09/19/94 EXPERIMENT: 05706 TEST: 02 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 12500PPM 25000PPM | CONTROL 12500PPM 25000PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 47/50 (94%) 44/50 (88%) 48/50 (96%) | 32/50 (64%) 36/50 (72%) 44/50 (88%) |
|ADJUSTED (b) | 100.0% 97.7% 100.0% | 77.3% 81.5% 97.7% |
|TERMINAL (d) | 22/22 (100%) 19/20 (95%) 24/24 (100%) | 21/30 (70%) 25/33 (76%) 32/33 (97%) |
|FIRST INCIDENCE (DAYS) | 67 327 508 | 528 558 351 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.416N P=0.474N P=0.446N | P=0.087 P=0.458 P=0.103 |
|INCIDENTAL TUMOR | P=0.487 P=0.204N P=0.516 | P=0.004 ** P=0.243 P=0.005 ** |
|LOGISTIC REGRESSION | P=0.521 P=0.205N P=0.682 | P=0.007 ** P=0.263 P=0.008 ** |
|COCHRAN-ARMITAGE | P=0.424 | P=0.004 ** |
|FISHER EXACT | P=0.243N P=0.500 | P=0.260 P=0.005 ** |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 32/50 (64%) 38/50 (76%) 42/50 (84%) | 23/50 (46%) 21/50 (42%) 22/50 (44%) |
|ADJUSTED (b) | 77.6% 82.4% 85.6% | 55.3% 49.4% 49.2% |
|TERMINAL (d) | 13/22 (59%) 12/20 (60%) 17/24 (71%) | 12/30 (40%) 12/33 (36%) 11/33 (33%) |
|FIRST INCIDENCE (DAYS) | 379 134 491 | 559 565 351 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.170 P=0.214 P=0.179 | P=0.309N P=0.341N P=0.334N |
|INCIDENTAL TUMOR | P=0.013 * P=0.196 P=0.022 * | P=0.439N P=0.452N P=0.514N |
|LOGISTIC REGRESSION | P=0.017 * P=0.143 P=0.025 * | P=0.441N P=0.414N P=0.501N |
|COCHRAN-ARMITAGE | P=0.014 * | P=0.460N |
|FISHER EXACT | P=0.138 P=0.020 * | P=0.420N P=0.500N |
|=================================================================================================================================|
DATE: 09/19/94 EXPERIMENT: 05706 TEST: 02 PAGE 21
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 4,4-DIAMINO-2,2-STILBENEDISULFONIC AC
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 12500PPM 25000PPM | CONTROL 12500PPM 25000PPM |
| | MALE MALE MALE | FEMALE FEMALE FEMALE |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 50/50 (100%) 50/50 (100%) | 45/50 (90%) 44/50 (88%) 50/50 (100%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% | 93.7% 91.6% 100.0% |
|TERMINAL (d) | 22/22 (100%) 20/20 (100%) 24/24 (100%) | 27/30 (90%) 29/33 (88%) 33/33 (100%) |
|FIRST INCIDENCE (DAYS) | 67 134 491 | 528 558 351 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.364N P=0.473 P=0.392N | P=0.522 P=0.318N P=0.562N |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.034 * P=0.538N P=0.028 * |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.063 P=0.491N P=0.051 |
|COCHRAN-ARMITAGE | (e) | P=0.042 * |
|FISHER EXACT | P=1.000N P=1.000N | P=0.500N P=0.028 * |
|=================================================================================================================================|
(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).