TDMS Study 05043-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Mason 2,4-DIAMINOPHENOL DIHYDROCHLORIDE DATE: 09/05/94
EXPERIMENT: 05043 TEST: 01 TIME: 17:53:48
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01CP9561903 ROUTE: GAVAGE NTP C#: 60026
PATHOLOGIST: S. WYAND S. EUSTIS CAS: 137-09-7
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Mason 2,4-DIAMINOPHENOL DIHYDROCHLORIDE DATE: 09/05/94
EXPERIMENT: 05043 TEST: 01 TIME: 17:53:48
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01CP9561903 ROUTE: GAVAGE NTP C#: 60026
PATHOLOGIST: S. WYAND S. EUSTIS CAS: 137-09-7
RATS(FISCHER344)
----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
----------------
Adrenal Gland
Bone Marrow
Brain
Clitoral Gland
Epididymis
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Nose
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Preputial Gland
Prostate
Salivary Glands
Spleen
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Mason 2,4-DIAMINOPHENOL DIHYDROCHLORIDE DATE: 09/05/94
EXPERIMENT: 05043 TEST: 01 TIME: 17:53:48
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01CP9561903 ROUTE: GAVAGE NTP C#: 60026
PATHOLOGIST: S. WYAND S. EUSTIS CAS: 137-09-7
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Islets, Pancreatic Adenoma
Carcinoma or Adenoma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Testes Adenoma
Thyroid Gland: C-Cell Adenoma
Carcinoma or Adenoma
All Organs Benign Tumors
Malignant and Benign Tumors
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Islets, Pancreatic Adenoma
Carcinoma or Adenoma
Mammary Gland Carcinoma
Pancreas Adenoma
Skin: Subcutaneous Tissue Fibrosarcoma
Neurofibrosarcoma, Fibrosarcoma, Sarcoma,
Neurofibroma, or Fibroma
Neurofibrosarcoma, Fibrosarcoma, or Sarcoma
Uterus Polyp Stromal
All Organs Malignant Tumors
====================================================================================================
DATE: 09/05/94 EXPERIMENT: 05043 TEST: 01 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE .0125 G/ .025G/KG | VEHICLE .0125 G/ .025G/KG |
| | 72 VM KG 72LM 72HM | 72VF KG 72LF 72HF |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/49 (20%) 8/50 (16%) 7/50 (14%) | 2/48 (4%) 1/15 (7%) 3/48 (6%) |
|ADJUSTED (b) | 35.2% 36.2% 33.5% | 6.9% 50.0% 8.4% |
|TERMINAL (d) | 7/24 (29%) 7/21 (33%) 4/16 (25%) | 2/29 (7%) 1/2 (50%) 1/31 (3%) |
|FIRST INCIDENCE (DAYS) | 570 687 468 | 729 (T) 729 (T) 645 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.547N P=0.532N P=0.596N | P=0.441 P=0.228 P=0.528 |
|INCIDENTAL TUMOR | P=0.470N P=0.557N P=0.492N | P=0.437 P=0.228 P=0.518 |
|LOGISTIC REGRESSION | P=0.421N P=0.563N P=0.442N | P=0.427 P=0.228 P=0.514 |
|COCHRAN-ARMITAGE | P=0.237N | P=0.411 |
|FISHER EXACT | P=0.379N P=0.282N | P=0.564 P=0.500 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/49 (14%) 2/50 (4%) 3/50 (6%) | 0/48 (0%) 0/15 (0%) 0/48 (0%) |
|ADJUSTED (b) | 24.8% 9.5% 15.6% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 5/24 (21%) 2/21 (10%) 2/16 (13%) | 0/29 (0%) 0/2 (0%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | 525 729 (T) 644 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.217N P=0.120N P=0.336N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.165N P=0.114N P=0.247N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.155N P=0.117N P=0.229N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.093N | (e) |
|FISHER EXACT | P=0.075N P=0.151N | (e) (e) |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05043 TEST: 01 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE .0125 G/ .025G/KG | VEHICLE .0125 G/ .025G/KG |
| | 72 VM KG 72LM 72HM | 72VF KG 72LF 72HF |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 15/49 (31%) 9/50 (18%) 9/50 (18%) | 2/48 (4%) 1/15 (7%) 3/48 (6%) |
|ADJUSTED (b) | 49.4% 40.8% 41.2% | 6.9% 50.0% 8.4% |
|TERMINAL (d) | 10/24 (42%) 8/21 (38%) 5/16 (31%) | 2/29 (7%) 1/2 (50%) 1/31 (3%) |
|FIRST INCIDENCE (DAYS) | 525 687 468 | 729 (T) 729 (T) 645 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.338N P=0.217N P=0.413N | P=0.441 P=0.228 P=0.528 |
|INCIDENTAL TUMOR | P=0.233N P=0.222N P=0.258N | P=0.437 P=0.228 P=0.518 |
|LOGISTIC REGRESSION | P=0.198N P=0.222N P=0.219N | P=0.427 P=0.228 P=0.514 |
|COCHRAN-ARMITAGE | P=0.083N | P=0.411 |
|FISHER EXACT | P=0.109N P=0.109N | P=0.564 P=0.500 |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/17 (6%) 2/24 (8%) 2/26 (8%) | 2/12 (17%) 1/17 (6%) 1/9 (11%) |
|ADJUSTED (b) | 50.0% 5.9% 36.0% | 66.7% 14.3% 50.0% |
|TERMINAL (d) | 1/2 (50%) 0/2 (0%) 1/3 (33%) | 2/3 (67%) 1/7 (14%) 1/2 (50%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 488 653 | 729 (T) 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.405 P=0.453 P=0.563 | P=0.439N P=0.196N P=0.691N |
|INCIDENTAL TUMOR | P=0.498 P=0.562 P=0.601 | P=0.439N P=0.196N P=0.691N |
|LOGISTIC REGRESSION | P=0.509 P=0.534 P=0.628 | P=0.439N P=0.196N P=0.691N |
|COCHRAN-ARMITAGE | P=0.540 | P=0.448N |
|FISHER EXACT | P=0.630 P=0.658 | P=0.367N P=0.612N |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05043 TEST: 01 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE .0125 G/ .025G/KG | VEHICLE .0125 G/ .025G/KG |
| | 72 VM KG 72LM 72HM | 72VF KG 72LF 72HF |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/17 (12%) 3/24 (13%) 2/26 (8%) | 1/12 (8%) 5/17 (29%) 1/9 (11%) |
|ADJUSTED (b) | 4.8% 53.2% 8.3% | 33.3% 45.6% 2.6% |
|TERMINAL (d) | 0/2 (0%) 1/2 (50%) 0/3 (0%) | 1/3 (33%) 3/7 (43%) 0/2 (0%) |
|FIRST INCIDENCE (DAYS) | 525 581 632 | 729 (T) 540 676 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.531 P=0.445 P=0.611 | P=0.539 P=0.244 P=0.716 |
|INCIDENTAL TUMOR | P=0.529N P=0.514 P=0.642N | P=0.424N P=0.443 P=0.581N |
|LOGISTIC REGRESSION | P=0.446N P=0.549 P=0.570N | P=0.546 P=0.378 P=0.732 |
|COCHRAN-ARMITAGE | P=0.412N | P=0.488 |
|FISHER EXACT | P=0.665 P=0.521N | P=0.182 P=0.686 |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/17 (18%) 5/24 (21%) 4/26 (15%) | 3/12 (25%) 6/17 (35%) 2/9 (22%) |
|ADJUSTED (b) | 52.4% 56.0% 41.3% | 100.0% 59.2% 51.3% |
|TERMINAL (d) | 1/2 (50%) 1/2 (50%) 1/3 (33%) | 3/3 (100%) 4/7 (57%) 1/2 (50%) |
|FIRST INCIDENCE (DAYS) | 525 488 632 | 729 (T) 540 676 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.391 P=0.287 P=0.470 | P=0.536N P=0.651 P=0.716N |
|INCIDENTAL TUMOR | P=0.556 P=0.399 P=0.617 | P=0.247N P=0.513N P=0.419N |
|LOGISTIC REGRESSION | P=0.542N P=0.397 P=0.674N | P=0.518N P=0.557N P=0.708N |
|COCHRAN-ARMITAGE | P=0.482N | P=0.571N |
|FISHER EXACT | P=0.563 P=0.581N | P=0.432 P=0.647N |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05043 TEST: 01 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE .0125 G/ .025G/KG | VEHICLE .0125 G/ .025G/KG |
| | 72 VM KG 72LM 72HM | 72VF KG 72LF 72HF |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/22 (14%) 2/50 (4%) | 0/49 (0%) 1/14 (7%) 0/50 (0%) |
|ADJUSTED (b) | 10.1% 100.0% 12.5% | 0.0% 100.0% 0.0% |
|TERMINAL (d) | 1/24 (4%) 2/2 (100%) 2/16 (13%) | 0/29 (0%) 1/1 (100%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | 570 653 729 (T) | --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.543 P=0.169 P=0.655N | P=0.681N P=0.005 ** (e) |
|INCIDENTAL TUMOR | P=0.575N P=0.017 * P=0.605N | P=0.681N P=0.005 ** (e) |
|LOGISTIC REGRESSION | P=0.548N P=0.017 * P=0.588N | P=0.681N P=0.005 ** (e) |
|COCHRAN-ARMITAGE | P=0.420N | P=0.701N |
|FISHER EXACT | P=0.259 P=0.500N | P=0.222 (e) |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/22 (14%) 2/50 (4%) | 0/49 (0%) 2/14 (14%) 0/50 (0%) |
|ADJUSTED (b) | 14.0% 100.0% 12.5% | 0.0% 100.0% 0.0% |
|TERMINAL (d) | 2/24 (8%) 2/2 (100%) 2/16 (13%) | 0/29 (0%) 1/1 (100%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | 570 653 729 (T) | --- 653 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.489N P=0.197 P=0.511N | P=0.641N P=0.032 * (e) |
|INCIDENTAL TUMOR | P=0.453N P=0.026 * P=0.462N | P=0.620N P<0.001 ** (e) |
|LOGISTIC REGRESSION | P=0.419N P=0.025 * P=0.436N | P=0.633N P=0.002 ** (e) |
|COCHRAN-ARMITAGE | P=0.283N | P=0.643N |
|FISHER EXACT | P=0.363 P=0.339N | P=0.047 * (e) |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05043 TEST: 01 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE .0125 G/ .025G/KG | VEHICLE .0125 G/ .025G/KG |
| | 72 VM KG 72LM 72HM | 72VF KG 72LF 72HF |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/30 (0%) 3/50 (6%) | 1/50 (2%) 1/17 (6%) 0/50 (0%) |
|ADJUSTED (b) | 8.3% 0.0% 14.2% | 3.3% 2.6% 0.0% |
|TERMINAL (d) | 2/24 (8%) 0/5 (0%) 1/16 (6%) | 1/30 (3%) 0/3 (0%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- 632 | 729 (T) 625 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.270 P=0.616N P=0.350 | P=0.341N P=0.550 P=0.493N |
|INCIDENTAL TUMOR | P=0.303 P=0.616N P=0.395 | P=0.331N P=0.716 P=0.493N |
|LOGISTIC REGRESSION | P=0.303 P=0.616N P=0.391 | P=0.347N P=0.449 P=0.493N |
|COCHRAN-ARMITAGE | P=0.397 | P=0.350N |
|FISHER EXACT | P=0.388N P=0.500 | P=0.446 P=0.500N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 3/50 (6%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% | 7.4% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/21 (0%) 0/16 (0%) | 1/30 (3%) 0/32 (0%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- | 199 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.036N* P=0.115N P=0.120N |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.058N P=0.133N P=0.168N |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.077N P=0.202N P=0.201N |
|COCHRAN-ARMITAGE | (e) | P=0.037N* |
|FISHER EXACT | (e) (e) | P=0.121N P=0.121N |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05043 TEST: 01 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE .0125 G/ .025G/KG | VEHICLE .0125 G/ .025G/KG |
| | 72 VM KG 72LM 72HM | 72VF KG 72LF 72HF |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 0/50 (0%) | 17/50 (34%) 21/50 (42%) 13/50 (26%) |
|ADJUSTED (b) | 14.4% 0.0% 0.0% | 46.7% 56.0% 38.1% |
|TERMINAL (d) | 2/24 (8%) 0/21 (0%) 0/16 (0%) | 11/30 (37%) 16/32 (50%) 10/31 (32%) |
|FIRST INCIDENCE (DAYS) | 653 --- --- | 680 443 695 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.030N* P=0.092N P=0.120N | P=0.216N P=0.338 P=0.251N |
|INCIDENTAL TUMOR | P=0.028N* P=0.112N P=0.098N | P=0.168N P=0.186 P=0.200N |
|LOGISTIC REGRESSION | P=0.024N* P=0.085N P=0.094N | P=0.198N P=0.264 P=0.292N |
|COCHRAN-ARMITAGE | P=0.015N* | P=0.230N |
|FISHER EXACT | P=0.059N P=0.059N | P=0.268 P=0.257N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 0/50 (0%) | 19/50 (38%) 21/50 (42%) 13/50 (26%) |
|ADJUSTED (b) | 14.4% 0.0% 0.0% | 48.9% 56.0% 38.1% |
|TERMINAL (d) | 2/24 (8%) 0/21 (0%) 0/16 (0%) | 11/30 (37%) 16/32 (50%) 10/31 (32%) |
|FIRST INCIDENCE (DAYS) | 653 --- --- | 199 443 695 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.030N* P=0.092N P=0.120N | P=0.122N P=0.492 P=0.147N |
|INCIDENTAL TUMOR | P=0.028N* P=0.112N P=0.098N | P=0.101N P=0.307 P=0.127N |
|LOGISTIC REGRESSION | P=0.024N* P=0.085N P=0.094N | P=0.103N P=0.438 P=0.122N |
|COCHRAN-ARMITAGE | P=0.015N* | P=0.125N |
|FISHER EXACT | P=0.059N P=0.059N | P=0.419 P=0.142N |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05043 TEST: 01 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE .0125 G/ .025G/KG | VEHICLE .0125 G/ .025G/KG |
| | 72 VM KG 72LM 72HM | 72VF KG 72LF 72HF |
|=================================================================================================================================|
| |
|Pancreas |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/22 (5%) 3/50 (6%) | 0/49 (0%) 1/13 (8%) 0/50 (0%) |
|ADJUSTED (b) | 4.2% 33.3% 18.8% | 0.0% 100.0% 0.0% |
|TERMINAL (d) | 1/24 (4%) 1/3 (33%) 3/16 (19%) | 0/30 (0%) 1/1 (100%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) | --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.114 P=0.262 P=0.170 | P=0.687N P=0.004 ** (e) |
|INCIDENTAL TUMOR | P=0.114 P=0.262 P=0.170 | P=0.687N P=0.004 ** (e) |
|LOGISTIC REGRESSION | P=0.114 P=0.262 P=0.170 | P=0.687N P=0.004 ** (e) |
|COCHRAN-ARMITAGE | P=0.225 | P=0.700N |
|FISHER EXACT | P=0.521 P=0.309 | P=0.210 (e) |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 17/50 (34%) 14/49 (29%) | 22/50 (44%) 26/50 (52%) 25/50 (50%) |
|ADJUSTED (b) | 60.3% 54.2% 56.3% | 63.9% 64.8% 67.0% |
|TERMINAL (d) | 10/24 (42%) 8/21 (38%) 7/16 (44%) | 18/30 (60%) 18/32 (56%) 19/31 (61%) |
|FIRST INCIDENCE (DAYS) | 426 463 512 | 481 540 498 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.286N P=0.366N P=0.337N | P=0.360 P=0.362 P=0.395 |
|INCIDENTAL TUMOR | P=0.088N P=0.265N P=0.105N | P=0.393 P=0.341 P=0.429 |
|LOGISTIC REGRESSION | P=0.080N P=0.223N P=0.094N | P=0.347 P=0.262 P=0.387 |
|COCHRAN-ARMITAGE | P=0.044N* | P=0.308 |
|FISHER EXACT | P=0.154N P=0.056N | P=0.274 P=0.344 |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05043 TEST: 01 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE .0125 G/ .025G/KG | VEHICLE .0125 G/ .025G/KG |
| | 72 VM KG 72LM 72HM | 72VF KG 72LF 72HF |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/49 (2%) | 2/50 (4%) 0/50 (0%) 3/50 (6%) |
|ADJUSTED (b) | 3.3% 0.0% 2.8% | 5.5% 0.0% 8.2% |
|TERMINAL (d) | 0/24 (0%) 0/21 (0%) 0/16 (0%) | 1/30 (3%) 0/32 (0%) 1/31 (3%) |
|FIRST INCIDENCE (DAYS) | 681 --- 546 | 536 --- 669 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.610 P=0.536N P=0.700 | P=0.402 P=0.233N P=0.513 |
|INCIDENTAL TUMOR | P=0.608N P=0.607N P=0.705N | P=0.428 P=0.160N P=0.547 |
|LOGISTIC REGRESSION | P=0.665N P=0.524N P=0.750N | P=0.389 P=0.245N P=0.500 |
|COCHRAN-ARMITAGE | P=0.665 | P=0.390 |
|FISHER EXACT | P=0.500N P=0.747 | P=0.247N P=0.500 |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 24/50 (48%) 17/50 (34%) 15/49 (31%) | 24/50 (48%) 26/50 (52%) 28/50 (56%) |
|ADJUSTED (b) | 61.6% 54.2% 57.5% | 67.7% 64.8% 71.3% |
|TERMINAL (d) | 10/24 (42%) 8/21 (38%) 7/16 (44%) | 19/30 (63%) 18/32 (56%) 20/31 (65%) |
|FIRST INCIDENCE (DAYS) | 426 463 512 | 481 540 498 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.301N P=0.311N P=0.360N | P=0.299 P=0.514 P=0.333 |
|INCIDENTAL TUMOR | P=0.084N P=0.218N P=0.097N | P=0.329 P=0.535 P=0.371 |
|LOGISTIC REGRESSION | P=0.081N P=0.170N P=0.094N | P=0.280 P=0.427 P=0.319 |
|COCHRAN-ARMITAGE | P=0.046N* | P=0.242 |
|FISHER EXACT | P=0.111N P=0.059N | P=0.421 P=0.274 |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05043 TEST: 01 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE .0125 G/ .025G/KG | VEHICLE .0125 G/ .025G/KG |
| | 72 VM KG 72LM 72HM | 72VF KG 72LF 72HF |
|=================================================================================================================================|
| |
|Prostate |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 0/19 (0%) 1/50 (2%) | |
|ADJUSTED (b) | 8.3% 0.0% 5.3% | |
|TERMINAL (d) | 2/24 (8%) 0/0 0/16 (0%) | |
|FIRST INCIDENCE (DAYS) | 729 (T) --- 725 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.495N (e) P=0.620N | |
|INCIDENTAL TUMOR | P=0.487N (e) P=0.603N | |
|LOGISTIC REGRESSION | P=0.484N (e) P=0.603N | |
|COCHRAN-ARMITAGE | P=0.369N | |
|FISHER EXACT | P=0.516N P=0.492N | |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 4/50 (8%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 6.2% 0.0% 18.3% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/24 (4%) 0/21 (0%) 2/16 (13%) | 0/30 (0%) 0/32 (0%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | 522 --- 561 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.140 P=0.279N P=0.207 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.197 P=0.226N P=0.295 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.203 P=0.224N P=0.315 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.222 | (e) |
|FISHER EXACT | P=0.247N P=0.339 | (e) (e) |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05043 TEST: 01 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE .0125 G/ .025G/KG | VEHICLE .0125 G/ .025G/KG |
| | 72 VM KG 72LM 72HM | 72VF KG 72LF 72HF |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 4.2% 4.8% 8.8% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/24 (4%) 1/21 (5%) 1/16 (6%) | 0/30 (0%) 0/32 (0%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 541 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.276 P=0.733 P=0.390 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.332 P=0.733 P=0.476 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.332 P=0.733 P=0.469 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.378 | (e) |
|FISHER EXACT | P=0.753N P=0.500 | (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 4.2% 8.7% 6.3% | 0.0% 0.0% 3.2% |
|TERMINAL (d) | 1/24 (4%) 1/21 (5%) 1/16 (6%) | 0/30 (0%) 0/32 (0%) 1/31 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 686 729 (T) | --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.503 P=0.451 P=0.670 | P=0.273 (e) P=0.507 |
|INCIDENTAL TUMOR | P=0.518 P=0.408 P=0.670 | P=0.273 (e) P=0.507 |
|LOGISTIC REGRESSION | P=0.535 P=0.435 P=0.670 | P=0.273 (e) P=0.507 |
|COCHRAN-ARMITAGE | P=0.622N | P=0.269 |
|FISHER EXACT | P=0.500 P=0.753N | (e) P=0.500 |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05043 TEST: 01 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE .0125 G/ .025G/KG | VEHICLE .0125 G/ .025G/KG |
| | 72 VM KG 72LM 72HM | 72VF KG 72LF 72HF |
|=================================================================================================================================|
| |
|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%) 6/50 (12%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 14.4% 13.3% 26.2% | 0.0% 0.0% 3.2% |
|TERMINAL (d) | 3/24 (13%) 2/21 (10%) 3/16 (19%) | 0/30 (0%) 0/32 (0%) 1/31 (3%) |
|FIRST INCIDENCE (DAYS) | 522 686 541 | --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.148 P=0.581N P=0.191 | P=0.273 (e) P=0.507 |
|INCIDENTAL TUMOR | P=0.220 P=0.574N P=0.297 | P=0.273 (e) P=0.507 |
|LOGISTIC REGRESSION | P=0.230 P=0.581N P=0.316 | P=0.273 (e) P=0.507 |
|COCHRAN-ARMITAGE | P=0.297 | P=0.269 |
|FISHER EXACT | P=0.500N P=0.370 | (e) P=0.500 |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibrosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) | 3/50 (6%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 4.2% 4.8% 5.9% | 8.8% 0.0% 0.0% |
|TERMINAL (d) | 1/24 (4%) 1/21 (5%) 0/16 (0%) | 2/30 (7%) 0/32 (0%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 728 | 536 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.536 P=0.733 P=0.675 | P=0.036N* P=0.115N P=0.118N |
|INCIDENTAL TUMOR | P=0.557 P=0.733 P=0.706 | P=0.027N* P=0.078N P=0.102N |
|LOGISTIC REGRESSION | P=0.558 P=0.733 P=0.697 | P=0.037N* P=0.121N P=0.121N |
|COCHRAN-ARMITAGE | P=0.640 | P=0.037N* |
|FISHER EXACT | P=0.753N P=0.753N | P=0.121N P=0.121N |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05043 TEST: 01 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE .0125 G/ .025G/KG | VEHICLE .0125 G/ .025G/KG |
| | 72 VM KG 72LM 72HM | 72VF KG 72LF 72HF |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, Sarcoma, |
| Neurofibroma, or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 2/50 (4%) | 4/50 (8%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 10.5% 4.8% 11.8% | 11.5% 5.5% 0.0% |
|TERMINAL (d) | 2/24 (8%) 1/21 (5%) 1/16 (6%) | 2/30 (7%) 1/32 (3%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | 549 729 (T) 728 | 536 617 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.543N P=0.356N P=0.657N | P=0.037N* P=0.328N P=0.064N |
|INCIDENTAL TUMOR | P=0.503N P=0.318N P=0.605N | P=0.029N* P=0.253N P=0.053N |
|LOGISTIC REGRESSION | P=0.482N P=0.350N P=0.583N | P=0.036N* P=0.334N P=0.062N |
|COCHRAN-ARMITAGE | P=0.399N | P=0.037N* |
|FISHER EXACT | P=0.309N P=0.500N | P=0.339N P=0.059N |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, or Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) | 3/50 (6%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 6.4% 4.8% 5.9% | 8.8% 2.4% 0.0% |
|TERMINAL (d) | 1/24 (4%) 1/21 (5%) 0/16 (0%) | 2/30 (7%) 0/32 (0%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | 549 729 (T) 728 | 536 617 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.486N P=0.548N P=0.609N | P=0.059N P=0.299N P=0.118N |
|INCIDENTAL TUMOR | P=0.440N P=0.502N P=0.541N | P=0.042N* P=0.170N P=0.102N |
|LOGISTIC REGRESSION | P=0.428N P=0.532N P=0.534N | P=0.063N P=0.310N P=0.121N |
|COCHRAN-ARMITAGE | P=0.378N | P=0.060N |
|FISHER EXACT | P=0.500N P=0.500N | P=0.309N P=0.121N |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05043 TEST: 01 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE .0125 G/ .025G/KG | VEHICLE .0125 G/ .025G/KG |
| | 72 VM KG 72LM 72HM | 72VF KG 72LF 72HF |
|=================================================================================================================================|
| |
|Spleen |
| Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/29 (7%) 1/50 (2%) | 0/50 (0%) 0/20 (0%) 0/50 (0%) |
|ADJUSTED (b) | 6.2% 19.5% 6.3% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/24 (4%) 1/6 (17%) 1/16 (6%) | 0/30 (0%) 0/3 (0%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | 440 639 729 (T) | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.526N P=0.422 P=0.596N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.453N P=0.498 P=0.524N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.435N P=0.434 P=0.489N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.398N | (e) |
|FISHER EXACT | P=0.468 P=0.500N | (e) (e) |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 42/50 (84%) 42/50 (84%) 46/50 (92%) | |
|ADJUSTED (b) | 100.0% 100.0% 100.0% | |
|TERMINAL (d) | 24/24 (100%) 21/21 (100%) 16/16 (100%) | |
|FIRST INCIDENCE (DAYS) | 481 450 433 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.008 ** P=0.193 P=0.010 ** | |
|INCIDENTAL TUMOR | P=0.004 ** P=0.091 P=0.008 ** | |
|LOGISTIC REGRESSION | P=0.010 ** P=0.083 P=0.023 * | |
|COCHRAN-ARMITAGE | P=0.152 | |
|FISHER EXACT | P=0.607N P=0.178 | |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05043 TEST: 01 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE .0125 G/ .025G/KG | VEHICLE .0125 G/ .025G/KG |
| | 72 VM KG 72LM 72HM | 72VF KG 72LF 72HF |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 4/20 (20%) 3/50 (6%) | 7/50 (14%) 0/12 (0%) 7/50 (14%) |
|ADJUSTED (b) | 13.8% 100.0% 13.3% | 21.8% 0.0% 22.6% |
|TERMINAL (d) | 2/24 (8%) 1/1 (100%) 1/16 (6%) | 6/30 (20%) 0/0 7/31 (23%) |
|FIRST INCIDENCE (DAYS) | 647 561 610 | 481 --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.520 P=0.170 P=0.632 | P=0.533N P=0.500N P=0.590N |
|INCIDENTAL TUMOR | P=0.531N P=0.014 * P=0.603N | P=0.525N P=0.362N P=0.576N |
|LOGISTIC REGRESSION | P=0.512N P=0.008 ** P=0.584N | P=0.545N P=0.367N P=0.597N |
|COCHRAN-ARMITAGE | P=0.431N | P=0.560 |
|FISHER EXACT | P=0.156 P=0.500N | P=0.203N P=0.613N |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/20 (0%) 2/50 (4%) | 2/50 (4%) 1/12 (8%) 3/50 (6%) |
|ADJUSTED (b) | 8.3% 0.0% 6.6% | 5.9% 0.0% 7.9% |
|TERMINAL (d) | 2/24 (8%) 0/1 (0%) 0/16 (0%) | 1/30 (3%) 0/0 1/31 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- 468 | 682 568 645 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.500 P=0.939N P=0.588 | P=0.420 P=0.760 P=0.510 |
|INCIDENTAL TUMOR | P=0.558 P=0.939N P=0.670 | P=0.441 P=0.682 P=0.530 |
|LOGISTIC REGRESSION | P=0.574 P=0.939N P=0.685 | P=0.420 P=0.489 P=0.510 |
|COCHRAN-ARMITAGE | P=0.610 | P=0.412 |
|FISHER EXACT | P=0.507N P=0.691N | P=0.482 P=0.500 |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05043 TEST: 01 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE .0125 G/ .025G/KG | VEHICLE .0125 G/ .025G/KG |
| | 72 VM KG 72LM 72HM | 72VF KG 72LF 72HF |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 4/20 (20%) 5/50 (10%) | 9/50 (18%) 1/12 (8%) 10/50 (20%) |
|ADJUSTED (b) | 21.6% 100.0% 19.1% | 27.1% 0.0% 29.4% |
|TERMINAL (d) | 4/24 (17%) 1/1 (100%) 1/16 (6%) | 7/30 (23%) 0/0 8/31 (26%) |
|FIRST INCIDENCE (DAYS) | 647 561 468 | 481 568 645 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.457 P=0.192 P=0.538 | P=0.479 P=0.500N P=0.530 |
|INCIDENTAL TUMOR | P=0.554N P=0.022 * P=0.602N | P=0.495 P=0.572N P=0.553 |
|LOGISTIC REGRESSION | P=0.532N P=0.012 * P=0.577N | P=0.473 P=0.629N P=0.525 |
|COCHRAN-ARMITAGE | P=0.440N | P=0.448 |
|FISHER EXACT | P=0.304 P=0.500N | P=0.375N P=0.500 |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/20 (0%) 0/50 (0%) | 0/50 (0%) 0/12 (0%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% | 0.0% 0.0% 6.0% |
|TERMINAL (d) | 0/24 (0%) 0/1 (0%) 0/16 (0%) | 0/30 (0%) 0/0 1/31 (3%) |
|FIRST INCIDENCE (DAYS) | --- --- --- | --- --- 695 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.124 (e) P=0.240 |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.154 (e) P=0.253 |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.141 (e) P=0.242 |
|COCHRAN-ARMITAGE | (e) | P=0.129 |
|FISHER EXACT | (e) (e) | (e) P=0.247 |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05043 TEST: 01 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE .0125 G/ .025G/KG | VEHICLE .0125 G/ .025G/KG |
| | 72 VM KG 72LM 72HM | 72VF KG 72LF 72HF |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/20 (0%) 0/50 (0%) | 0/50 (0%) 0/12 (0%) 3/50 (6%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% | 0.0% 0.0% 9.1% |
|TERMINAL (d) | 0/24 (0%) 0/1 (0%) 0/16 (0%) | 0/30 (0%) 0/0 2/31 (6%) |
|FIRST INCIDENCE (DAYS) | --- --- --- | --- --- 695 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.064 (e) P=0.125 |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.080 (e) P=0.132 |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.070 (e) P=0.122 |
|COCHRAN-ARMITAGE | (e) | P=0.061 |
|FISHER EXACT | (e) (e) | (e) P=0.121 |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 12/50 (24%) 4/50 (8%) 9/50 (18%) |
|ADJUSTED (b) | | 34.4% 10.9% 26.2% |
|TERMINAL (d) | | 8/30 (27%) 2/32 (6%) 7/31 (23%) |
|FIRST INCIDENCE (DAYS) | | 680 617 411 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.242N P=0.029N* P=0.298N |
|INCIDENTAL TUMOR | | P=0.216N P=0.025N* P=0.261N |
|LOGISTIC REGRESSION | | P=0.232N P=0.027N* P=0.287N |
|COCHRAN-ARMITAGE | | P=0.251N |
|FISHER EXACT | | P=0.027N* P=0.312N |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05043 TEST: 01 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE .0125 G/ .025G/KG | VEHICLE .0125 G/ .025G/KG |
| | 72 VM KG 72LM 72HM | 72VF KG 72LF 72HF |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, |
| or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 4/50 (8%) 5/50 (10%) | 13/50 (26%) 7/50 (14%) 11/50 (22%) |
|ADJUSTED (b) | 23.1% 14.8% 18.5% | 37.5% 18.1% 26.2% |
|TERMINAL (d) | 4/24 (17%) 2/21 (10%) 0/16 (0%) | 9/30 (30%) 1/32 (3%) 3/31 (10%) |
|FIRST INCIDENCE (DAYS) | 522 463 595 | 246 620 526 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.504N P=0.357N P=0.588N | P=0.344N P=0.106N P=0.383N |
|INCIDENTAL TUMOR | P=0.364N P=0.322N P=0.435N | P=0.339N P=0.178N P=0.399N |
|LOGISTIC REGRESSION | P=0.359N P=0.297N P=0.433N | P=0.351N P=0.101N P=0.404N |
|COCHRAN-ARMITAGE | P=0.314N | P=0.356N |
|FISHER EXACT | P=0.262N P=0.380N | P=0.105N P=0.408N |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 8.3% 10.4% 0.0% | 0.0% 0.0% 2.2% |
|TERMINAL (d) | 2/24 (8%) 1/21 (5%) 0/16 (0%) | 0/30 (0%) 0/32 (0%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 561 --- | --- --- 570 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.298N P=0.434 P=0.330N | P=0.278 (e) P=0.509 |
|INCIDENTAL TUMOR | P=0.248N P=0.509 P=0.330N | P=0.227 (e) P=0.500 |
|LOGISTIC REGRESSION | P=0.238N P=0.449 P=0.330N | P=0.232 (e) P=0.460 |
|COCHRAN-ARMITAGE | P=0.202N | P=0.269 |
|FISHER EXACT | P=0.500 P=0.247N | (e) P=0.500 |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05043 TEST: 01 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE .0125 G/ .025G/KG | VEHICLE .0125 G/ .025G/KG |
| | 72 VM KG 72LM 72HM | 72VF KG 72LF 72HF |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 47/50 (94%) 45/50 (90%) 48/50 (96%) | 32/50 (64%) 38/50 (76%) 39/50 (78%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% | 81.8% 84.4% 95.0% |
|TERMINAL (d) | 24/24 (100%) 21/21 (100%) 16/16 (100%) | 23/30 (77%) 25/32 (78%) 29/31 (94%) |
|FIRST INCIDENCE (DAYS) | 426 450 433 | 481 443 411 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.028 * P=0.282 P=0.030 * | P=0.154 P=0.268 P=0.162 |
|INCIDENTAL TUMOR | P=0.014 * P=0.199 P=0.032 * | P=0.135 P=0.182 P=0.158 |
|LOGISTIC REGRESSION | P=0.087 P=0.272 P=0.160 | P=0.092 P=0.138 P=0.111 |
|COCHRAN-ARMITAGE | P=0.421 | P=0.072 |
|FISHER EXACT | P=0.357N P=0.500 | P=0.138 P=0.093 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 24/50 (48%) 16/50 (32%) 19/50 (38%) | 23/50 (46%) 13/50 (26%) 19/50 (38%) |
|ADJUSTED (b) | 65.7% 49.0% 57.0% | 59.0% 31.1% 41.8% |
|TERMINAL (d) | 13/24 (54%) 7/21 (33%) 4/16 (25%) | 15/30 (50%) 4/32 (13%) 6/31 (19%) |
|FIRST INCIDENCE (DAYS) | 440 360 327 | 193 540 379 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.497 P=0.234N P=0.490 | P=0.239N P=0.039N* P=0.269N |
|INCIDENTAL TUMOR | P=0.214N P=0.082N P=0.230N | P=0.246N P=0.035N* P=0.296N |
|LOGISTIC REGRESSION | P=0.209N P=0.097N P=0.236N | P=0.268N P=0.034N* P=0.312N |
|COCHRAN-ARMITAGE | P=0.178N | P=0.234N |
|FISHER EXACT | P=0.076N P=0.210N | P=0.030N* P=0.272N |
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05043 TEST: 01 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE .0125 G/ .025G/KG | VEHICLE .0125 G/ .025G/KG |
| | 72 VM KG 72LM 72HM | 72VF KG 72LF 72HF |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 46/50 (92%) 49/50 (98%) | 41/50 (82%) 41/50 (82%) 47/50 (94%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% | 89.0% 87.2% 95.9% |
|TERMINAL (d) | 24/24 (100%) 21/21 (100%) 16/16 (100%) | 25/30 (83%) 26/32 (81%) 29/31 (94%) |
|FIRST INCIDENCE (DAYS) | 426 360 327 | 193 443 379 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.041 * P=0.330 P=0.044 * | P=0.244 P=0.459N P=0.270 |
|INCIDENTAL TUMOR | P=0.162 P=0.710 P=0.377 | P=0.098 P=0.570N P=0.105 |
|LOGISTIC REGRESSION | P=0.331 P=0.741 P=0.520 | P=0.074 P=0.569N P=0.073 |
|COCHRAN-ARMITAGE | P=0.601 | P=0.056 |
|FISHER EXACT | P=0.181N P=0.753N | P=0.602N P=0.061 |
|=================================================================================================================================|
(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).
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