TDMS Study 05057-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Mason HC YELLOW 4 DATE: 09/08/94
EXPERIMENT: 05057 TEST: 01 TIME: 04:40:13
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01ES9561901 ROUTE: DOSED FEED NTP C#: 56019
PATHOLOGIST: K. MURTHY S. EUSTIS CAS: 5982043-8
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Mason HC YELLOW 4 DATE: 09/08/94
EXPERIMENT: 05057 TEST: 01 TIME: 04:40:13
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01ES9561901 ROUTE: DOSED FEED NTP C#: 56019
PATHOLOGIST: K. MURTHY S. EUSTIS CAS: 5982043-8
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
Liver
Lung
Nose
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Preputial Gland
Prostate
Salivary Glands
Spleen
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Mason HC YELLOW 4 DATE: 09/08/94
EXPERIMENT: 05057 TEST: 01 TIME: 04:40:13
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01ES9561901 ROUTE: DOSED FEED NTP C#: 56019
PATHOLOGIST: K. MURTHY S. EUSTIS CAS: 5982043-8
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF HC YELLOW 4
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Mammary Gland Fibroadenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Skin: Subcutaneous Tissue Fibroma
Testes Adenoma
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Clitoral/Preputial Gland Adenoma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Uterus Polyp Stromal
Sarcoma Stromal or Polyp Stromal
====================================================================================================
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 01 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.25% 0.5% | UNTREATE 0.5% 1.0% |
| | D 61 UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 19/50 (38%) 17/49 (35%) 16/48 (33%) | 1/49 (2%) 3/46 (7%) 2/49 (4%) |
|ADJUSTED (b) | 58.9% 51.1% 45.6% | 3.7% 10.0% 5.9% |
|TERMINAL (d) | 9/21 (43%) 13/29 (45%) 10/28 (36%) | 1/27 (4%) 3/30 (10%) 2/34 (6%) |
|FIRST INCIDENCE (DAYS) | 637 658 570 | 729 (T) 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.108N P=0.132N P=0.143N | P=0.492 P=0.342 P=0.581 |
|INCIDENTAL TUMOR | P=0.251N P=0.381N P=0.323N | P=0.492 P=0.342 P=0.581 |
|LOGISTIC REGRESSION | P=0.253N P=0.321N P=0.317N | P=0.492 P=0.342 P=0.581 |
|COCHRAN-ARMITAGE | P=0.352N | P=0.400 |
|FISHER EXACT | P=0.447N P=0.393N | P=0.285 P=0.500 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/49 (2%) 0/48 (0%) | 1/49 (2%) 0/46 (0%) 0/49 (0%) |
|ADJUSTED (b) | 7.1% 3.4% 0.0% | 3.7% 0.0% 0.0% |
|TERMINAL (d) | 1/21 (5%) 1/29 (3%) 0/28 (0%) | 1/27 (4%) 0/30 (0%) 0/34 (0%) |
|FIRST INCIDENCE (DAYS) | 637 729 (T) --- | 729 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.111N P=0.428N P=0.208N | P=0.240N P=0.479N P=0.454N |
|INCIDENTAL TUMOR | P=0.144N P=0.492N P=0.267N | P=0.240N P=0.479N P=0.454N |
|LOGISTIC REGRESSION | P=0.143N P=0.498N P=0.246N | P=0.240N P=0.479N P=0.454N |
|COCHRAN-ARMITAGE | P=0.149N | P=0.272N |
|FISHER EXACT | P=0.508N P=0.258N | P=0.516N P=0.500N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 01 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.25% 0.5% | UNTREATE 0.5% 1.0% |
| | D 61 UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 19/50 (38%) 18/49 (37%) 16/48 (33%) | 2/49 (4%) 3/46 (7%) 2/49 (4%) |
|ADJUSTED (b) | 58.9% 54.1% 45.6% | 7.4% 10.0% 5.9% |
|TERMINAL (d) | 9/21 (43%) 14/29 (48%) 10/28 (36%) | 2/27 (7%) 3/30 (10%) 2/34 (6%) |
|FIRST INCIDENCE (DAYS) | 637 658 570 | 729 (T) 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.105N P=0.171N P=0.143N | P=0.493N P=0.549 P=0.610N |
|INCIDENTAL TUMOR | P=0.245N P=0.453N P=0.323N | P=0.493N P=0.549 P=0.610N |
|LOGISTIC REGRESSION | P=0.251N P=0.398N P=0.317N | P=0.493N P=0.549 P=0.610N |
|COCHRAN-ARMITAGE | P=0.354N | P=0.593 |
|FISHER EXACT | P=0.531N P=0.393N | P=0.470 P=0.691N |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/48 (19%) 13/50 (26%) 8/49 (16%) | 7/47 (15%) 5/47 (11%) 2/44 (5%) |
|ADJUSTED (b) | 37.9% 36.6% 23.9% | 20.6% 15.2% 6.7% |
|TERMINAL (d) | 7/21 (33%) 8/29 (28%) 5/28 (18%) | 3/25 (12%) 3/29 (10%) 2/30 (7%) |
|FIRST INCIDENCE (DAYS) | 639 481 553 | 625 710 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.261N P=0.485 P=0.310N | P=0.039N* P=0.303N P=0.059N |
|INCIDENTAL TUMOR | P=0.365N P=0.376 P=0.422N | P=0.087N P=0.400N P=0.106N |
|LOGISTIC REGRESSION | P=0.410N P=0.295 P=0.451N | P=0.063N P=0.357N P=0.091N |
|COCHRAN-ARMITAGE | P=0.430N | P=0.073N |
|FISHER EXACT | P=0.269 P=0.481N | P=0.379N P=0.095N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 01 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.25% 0.5% | UNTREATE 0.5% 1.0% |
| | D 61 UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 0/50 (0%) 0/49 (0%) | 0/47 (0%) 0/47 (0%) 2/44 (5%) |
|ADJUSTED (b) | 2.1% 0.0% 0.0% | 0.0% 0.0% 6.7% |
|TERMINAL (d) | 0/21 (0%) 0/29 (0%) 0/28 (0%) | 0/25 (0%) 0/29 (0%) 2/30 (7%) |
|FIRST INCIDENCE (DAYS) | 508 --- --- | --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.277N P=0.508N P=0.508N | P=0.112 (e) P=0.279 |
|INCIDENTAL TUMOR | P=0.204N P=0.362N P=0.419N | P=0.112 (e) P=0.279 |
|LOGISTIC REGRESSION | P=0.282N P=0.511N P=0.522N | P=0.112 (e) P=0.279 |
|COCHRAN-ARMITAGE | P=0.266N | P=0.088 |
|FISHER EXACT | P=0.490N P=0.495N | (e) P=0.231 |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/48 (21%) 13/50 (26%) 8/49 (16%) | 7/47 (15%) 5/47 (11%) 4/44 (9%) |
|ADJUSTED (b) | 39.2% 36.6% 23.9% | 20.6% 15.2% 13.3% |
|TERMINAL (d) | 7/21 (33%) 8/29 (28%) 5/28 (18%) | 3/25 (12%) 3/29 (10%) 4/30 (13%) |
|FIRST INCIDENCE (DAYS) | 508 481 553 | 625 710 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.192N P=0.576 P=0.232N | P=0.144N P=0.303N P=0.193N |
|INCIDENTAL TUMOR | P=0.267N P=0.505 P=0.306N | P=0.256N P=0.400N P=0.292N |
|LOGISTIC REGRESSION | P=0.325N P=0.373 P=0.367N | P=0.212N P=0.357N P=0.277N |
|COCHRAN-ARMITAGE | P=0.335N | P=0.240N |
|FISHER EXACT | P=0.358 P=0.379N | P=0.379N P=0.301N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 01 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.25% 0.5% | UNTREATE 0.5% 1.0% |
| | D 61 UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 4/47 (9%) 3/48 (6%) | 1/50 (2%) 0/50 (0%) 1/48 (2%) |
|ADJUSTED (b) | 5.0% 13.4% 8.8% | 3.7% 0.0% 2.5% |
|TERMINAL (d) | 1/20 (5%) 3/28 (11%) 1/28 (4%) | 1/27 (4%) 0/31 (0%) 0/34 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 723 570 | 729 (T) --- 686 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.339 P=0.295 P=0.368 | P=0.632N P=0.472N P=0.723N |
|INCIDENTAL TUMOR | P=0.267 P=0.228 P=0.292 | P=0.630 P=0.472N P=0.722 |
|LOGISTIC REGRESSION | P=0.264 P=0.266 P=0.305 | P=0.666N P=0.472N P=0.760N |
|COCHRAN-ARMITAGE | P=0.253 | P=0.661 |
|FISHER EXACT | P=0.174 P=0.308 | P=0.500N P=0.742 |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 3/49 (6%) | 2/50 (4%) 1/50 (2%) 2/50 (4%) |
|ADJUSTED (b) | 7.6% 3.4% 10.7% | 5.3% 2.1% 5.6% |
|TERMINAL (d) | 1/21 (5%) 1/29 (3%) 3/28 (11%) | 0/27 (0%) 0/31 (0%) 1/34 (3%) |
|FIRST INCIDENCE (DAYS) | 666 729 (T) 729 (T) | 658 545 715 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.501 P=0.412N P=0.619 | P=0.562N P=0.477N P=0.637N |
|INCIDENTAL TUMOR | P=0.469 P=0.475N P=0.580 | P=0.495 P=0.585N P=0.577 |
|LOGISTIC REGRESSION | P=0.429 P=0.481N P=0.535 | P=0.571 P=0.579N P=0.686N |
|COCHRAN-ARMITAGE | P=0.391 | P=0.610 |
|FISHER EXACT | P=0.500N P=0.490 | P=0.500N P=0.691N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 01 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.25% 0.5% | UNTREATE 0.5% 1.0% |
| | D 61 UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 4/49 (8%) | 2/50 (4%) 1/50 (2%) 2/50 (4%) |
|ADJUSTED (b) | 7.6% 3.4% 12.9% | 5.3% 2.1% 5.6% |
|TERMINAL (d) | 1/21 (5%) 1/29 (3%) 3/28 (11%) | 0/27 (0%) 0/31 (0%) 1/34 (3%) |
|FIRST INCIDENCE (DAYS) | 666 729 (T) 654 | 658 545 715 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.321 P=0.412N P=0.451 | P=0.562N P=0.477N P=0.637N |
|INCIDENTAL TUMOR | P=0.275 P=0.475N P=0.384 | P=0.495 P=0.585N P=0.577 |
|LOGISTIC REGRESSION | P=0.246 P=0.481N P=0.347 | P=0.571 P=0.579N P=0.686N |
|COCHRAN-ARMITAGE | P=0.231 | P=0.610 |
|FISHER EXACT | P=0.500N P=0.329 | P=0.500N P=0.691N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/49 (2%) | 3/50 (6%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 3.6% 0.0% 3.6% | 10.1% 0.0% 5.9% |
|TERMINAL (d) | 0/21 (0%) 0/29 (0%) 1/28 (4%) | 2/27 (7%) 0/31 (0%) 2/34 (6%) |
|FIRST INCIDENCE (DAYS) | 710 --- 729 (T) | 700 --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.636N P=0.461N P=0.721N | P=0.319N P=0.102N P=0.407N |
|INCIDENTAL TUMOR | P=0.665 P=0.587N P=0.760N | P=0.360N P=0.119N P=0.462N |
|LOGISTIC REGRESSION | P=0.653N P=0.487N P=0.742N | P=0.345N P=0.107N P=0.442N |
|COCHRAN-ARMITAGE | P=0.665 | P=0.390N |
|FISHER EXACT | P=0.500N P=0.747 | P=0.121N P=0.500N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 01 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.25% 0.5% | UNTREATE 0.5% 1.0% |
| | D 61 UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/49 (2%) | 4/50 (8%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 3.6% 0.0% 3.6% | 11.9% 0.0% 5.9% |
|TERMINAL (d) | 0/21 (0%) 0/29 (0%) 1/28 (4%) | 2/27 (7%) 0/31 (0%) 2/34 (6%) |
|FIRST INCIDENCE (DAYS) | 710 --- 729 (T) | 409 --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.636N P=0.461N P=0.721N | P=0.175N P=0.055N P=0.264N |
|INCIDENTAL TUMOR | P=0.665 P=0.587N P=0.760N | P=0.217N P=0.073N P=0.327N |
|LOGISTIC REGRESSION | P=0.653N P=0.487N P=0.742N | P=0.252N P=0.081N P=0.371N |
|COCHRAN-ARMITAGE | P=0.665 | P=0.222N |
|FISHER EXACT | P=0.500N P=0.747 | P=0.059N P=0.339N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/49 (0%) | 28/50 (56%) 19/50 (38%) 18/50 (36%) |
|ADJUSTED (b) | 13.6% 3.4% 0.0% | 74.5% 47.7% 49.6% |
|TERMINAL (d) | 2/21 (10%) 1/29 (3%) 0/28 (0%) | 18/27 (67%) 11/31 (35%) 16/34 (47%) |
|FIRST INCIDENCE (DAYS) | 725 729 (T) --- | 582 612 650 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.034N* P=0.198N P=0.079N | P=0.005N** P=0.030N* P=0.005N** |
|INCIDENTAL TUMOR | P=0.047N* P=0.257N P=0.103N | P=0.015N* P=0.040N* P=0.013N* |
|LOGISTIC REGRESSION | P=0.039N* P=0.207N P=0.090N | P=0.013N* P=0.034N* P=0.015N* |
|COCHRAN-ARMITAGE | P=0.062N | P=0.028N* |
|FISHER EXACT | P=0.309N P=0.125N | P=0.054N P=0.035N* |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 01 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.25% 0.5% | UNTREATE 0.5% 1.0% |
| | D 61 UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 1/49 (2%) | 29/50 (58%) 19/50 (38%) 20/50 (40%) |
|ADJUSTED (b) | 16.7% 3.4% 3.6% | 75.3% 47.7% 55.2% |
|TERMINAL (d) | 2/21 (10%) 1/29 (3%) 1/28 (4%) | 18/27 (67%) 11/31 (35%) 18/34 (53%) |
|FIRST INCIDENCE (DAYS) | 710 729 (T) 729 (T) | 582 612 650 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.060N P=0.104N P=0.119N | P=0.009N** P=0.021N* P=0.008N** |
|INCIDENTAL TUMOR | P=0.086N P=0.170N P=0.160N | P=0.025N* P=0.026N* P=0.022N* |
|LOGISTIC REGRESSION | P=0.073N P=0.124N P=0.137N | P=0.022N* P=0.021N* P=0.023N* |
|COCHRAN-ARMITAGE | P=0.104N | P=0.044N* |
|FISHER EXACT | P=0.181N P=0.187N | P=0.036N* P=0.055N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 1/49 (2%) | 30/50 (60%) 19/50 (38%) 20/50 (40%) |
|ADJUSTED (b) | 16.7% 3.4% 3.6% | 75.8% 47.7% 55.2% |
|TERMINAL (d) | 2/21 (10%) 1/29 (3%) 1/28 (4%) | 18/27 (67%) 11/31 (35%) 18/34 (53%) |
|FIRST INCIDENCE (DAYS) | 710 729 (T) 729 (T) | 409 612 650 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.060N P=0.104N P=0.119N | P=0.006N** P=0.015N* P=0.005N** |
|INCIDENTAL TUMOR | P=0.086N P=0.170N P=0.160N | P=0.018N* P=0.019N* P=0.015N* |
|LOGISTIC REGRESSION | P=0.073N P=0.124N P=0.137N | P=0.016N* P=0.016N* P=0.019N* |
|COCHRAN-ARMITAGE | P=0.104N | P=0.028N* |
|FISHER EXACT | P=0.181N P=0.187N | P=0.022N* P=0.036N* |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 01 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.25% 0.5% | UNTREATE 0.5% 1.0% |
| | D 61 UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) |
| Papilloma Squamous or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/49 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 2.4% 0.0% 6.9% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/21 (0%) 0/29 (0%) 1/28 (4%) | 0/27 (0%) 0/31 (0%) 0/34 (0%) |
|FIRST INCIDENCE (DAYS) | 625 --- 715 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.393 P=0.500N P=0.547 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.308 P=0.581N P=0.435 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.357 P=0.503N P=0.496 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.355 | (e) |
|FISHER EXACT | P=0.500N P=0.492 | (e) (e) |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/49 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 2.4% 0.0% 6.9% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/21 (0%) 0/29 (0%) 1/28 (4%) | 0/27 (0%) 0/31 (0%) 0/34 (0%) |
|FIRST INCIDENCE (DAYS) | 625 --- 715 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.393 P=0.500N P=0.547 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.308 P=0.581N P=0.435 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.357 P=0.503N P=0.496 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.355 | (e) |
|FISHER EXACT | P=0.500N P=0.492 | (e) (e) |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 01 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.25% 0.5% | UNTREATE 0.5% 1.0% |
| | D 61 UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|Pancreas |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/48 (8%) 2/48 (4%) | 2/49 (4%) 2/50 (4%) 0/49 (0%) |
|ADJUSTED (b) | 8.7% 13.8% 6.0% | 7.1% 6.5% 0.0% |
|TERMINAL (d) | 1/21 (5%) 4/29 (14%) 1/28 (4%) | 1/27 (4%) 2/31 (6%) 0/34 (0%) |
|FIRST INCIDENCE (DAYS) | 722 729 (T) 658 | 728 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.478N P=0.493 P=0.616N | P=0.133N P=0.647N P=0.194N |
|INCIDENTAL TUMOR | P=0.539N P=0.422 P=0.686 | P=0.169N P=0.677N P=0.278N |
|LOGISTIC REGRESSION | P=0.556N P=0.464 P=0.689N | P=0.134N P=0.661N P=0.195N |
|COCHRAN-ARMITAGE | P=0.569 | P=0.175N |
|FISHER EXACT | P=0.319 P=0.676 | P=0.684N P=0.247N |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 0/44 (0%) 2/37 (5%) | 1/46 (2%) 1/39 (3%) 0/45 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 10.0% | 3.6% 2.6% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/27 (0%) 2/20 (10%) | 0/24 (0%) 0/24 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 729 (T) | 728 685 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.083 (e) P=0.237 | P=0.301N P=0.740N P=0.461N |
|INCIDENTAL TUMOR | P=0.083 (e) P=0.237 | P=0.424N P=0.730 P=0.588N |
|LOGISTIC REGRESSION | P=0.083 (e) P=0.237 | P=0.324N P=0.745 P=0.451N |
|COCHRAN-ARMITAGE | P=0.072 | P=0.340N |
|FISHER EXACT | (e) P=0.191 | P=0.710 P=0.505N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 01 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.25% 0.5% | UNTREATE 0.5% 1.0% |
| | D 61 UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 17/45 (38%) 20/49 (41%) 28/49 (57%) | 33/49 (67%) 35/48 (73%) 30/49 (61%) |
|ADJUSTED (b) | 59.1% 53.0% 67.4% | 77.8% 89.2% 69.2% |
|TERMINAL (d) | 10/20 (50%) 12/29 (41%) 15/28 (54%) | 18/27 (67%) 25/29 (86%) 20/33 (61%) |
|FIRST INCIDENCE (DAYS) | 598 626 367 | 447 478 557 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.140 P=0.434N P=0.176 | P=0.091N P=0.526N P=0.131N |
|INCIDENTAL TUMOR | P=0.031 * P=0.455 P=0.048 * | P=0.259N P=0.383 P=0.355N |
|LOGISTIC REGRESSION | P=0.034 * P=0.489 P=0.047 * | P=0.248N P=0.390 P=0.295N |
|COCHRAN-ARMITAGE | P=0.036 * | P=0.295N |
|FISHER EXACT | P=0.464 P=0.047 * | P=0.353 P=0.337N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 17/45 (38%) 20/49 (41%) 28/49 (57%) | 34/49 (69%) 35/48 (73%) 30/49 (61%) |
|ADJUSTED (b) | 59.1% 53.0% 67.4% | 78.5% 89.2% 69.2% |
|TERMINAL (d) | 10/20 (50%) 12/29 (41%) 15/28 (54%) | 18/27 (67%) 25/29 (86%) 20/33 (61%) |
|FIRST INCIDENCE (DAYS) | 598 626 367 | 447 478 557 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.140 P=0.434N P=0.176 | P=0.067N P=0.453N P=0.100N |
|INCIDENTAL TUMOR | P=0.031 * P=0.455 P=0.048 * | P=0.203N P=0.459 P=0.295N |
|LOGISTIC REGRESSION | P=0.034 * P=0.489 P=0.047 * | P=0.182N P=0.479 P=0.222N |
|COCHRAN-ARMITAGE | P=0.036 * | P=0.225N |
|FISHER EXACT | P=0.464 P=0.047 * | P=0.437 P=0.262N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 01 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.25% 0.5% | UNTREATE 0.5% 1.0% |
| | D 61 UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, |
| Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/49 (4%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 4.3% 6.6% 5.6% | 3.7% 3.2% 0.0% |
|TERMINAL (d) | 0/21 (0%) 1/29 (3%) 1/28 (4%) | 1/27 (4%) 1/31 (3%) 0/34 (0%) |
|FIRST INCIDENCE (DAYS) | 724 728 436 | 729 (T) 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.458 P=0.615 P=0.551 | P=0.284N P=0.731N P=0.454N |
|INCIDENTAL TUMOR | P=0.410 P=0.436 P=0.549 | P=0.284N P=0.731N P=0.454N |
|LOGISTIC REGRESSION | P=0.381 P=0.430 P=0.486 | P=0.284N P=0.731N P=0.454N |
|COCHRAN-ARMITAGE | P=0.383 | P=0.331N |
|FISHER EXACT | P=0.500 P=0.492 | P=0.753N P=0.500N |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 5/50 (10%) 0/49 (0%) | 1/50 (2%) 3/50 (6%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 15.6% 0.0% | 3.2% 6.9% 2.2% |
|TERMINAL (d) | 0/21 (0%) 3/29 (10%) 0/28 (0%) | 0/27 (0%) 0/31 (0%) 0/34 (0%) |
|FIRST INCIDENCE (DAYS) | --- 672 --- | 710 544 632 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.520N P=0.067 (e) | P=0.568N P=0.349 P=0.727N |
|INCIDENTAL TUMOR | P=0.594N P=0.033 * (e) | P=0.478 P=0.222 P=0.705 |
|LOGISTIC REGRESSION | P=0.585N P=0.041 * (e) | P=0.533 P=0.250 P=0.749 |
|COCHRAN-ARMITAGE | P=0.603 | P=0.610 |
|FISHER EXACT | P=0.028 * (e) | P=0.309 P=0.753N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 01 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.25% 0.5% | UNTREATE 0.5% 1.0% |
| | D 61 UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibrosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/49 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 7.0% 0.0% 2.6% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/21 (5%) 0/29 (0%) 0/28 (0%) | 0/27 (0%) 0/31 (0%) 0/34 (0%) |
|FIRST INCIDENCE (DAYS) | 619 --- 676 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.322N P=0.200N P=0.449N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.418N P=0.245N P=0.565N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.367N P=0.238N P=0.508N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.366N | (e) |
|FISHER EXACT | P=0.247N P=0.508N | (e) (e) |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, Sarcoma, |
| Neurofibroma, or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 5/50 (10%) 1/49 (2%) | 1/50 (2%) 3/50 (6%) 1/50 (2%) |
|ADJUSTED (b) | 7.0% 15.6% 2.6% | 3.2% 6.9% 2.2% |
|TERMINAL (d) | 1/21 (5%) 3/29 (10%) 0/28 (0%) | 0/27 (0%) 0/31 (0%) 0/34 (0%) |
|FIRST INCIDENCE (DAYS) | 619 672 676 | 710 544 632 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.318N P=0.336 P=0.449N | P=0.568N P=0.349 P=0.727N |
|INCIDENTAL TUMOR | P=0.436N P=0.217 P=0.565N | P=0.478 P=0.222 P=0.705 |
|LOGISTIC REGRESSION | P=0.408N P=0.232 P=0.508N | P=0.533 P=0.250 P=0.749 |
|COCHRAN-ARMITAGE | P=0.421N | P=0.610 |
|FISHER EXACT | P=0.218 P=0.508N | P=0.309 P=0.753N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 01 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.25% 0.5% | UNTREATE 0.5% 1.0% |
| | D 61 UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 47/50 (94%) 43/50 (86%) 41/49 (84%) | |
|ADJUSTED (b) | 100.0% 100.0% 97.5% | |
|TERMINAL (d) | 21/21 (100%) 29/29 (100%) 27/28 (96%) | |
|FIRST INCIDENCE (DAYS) | 508 467 436 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.011N* P=0.018N* P=0.018N* | |
|INCIDENTAL TUMOR | P=0.016N* P=0.063N P=0.026N* | |
|LOGISTIC REGRESSION | P=0.056N P=0.140N P=0.075N | |
|COCHRAN-ARMITAGE | P=0.077N | |
|FISHER EXACT | P=0.159N P=0.094N | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/49 (14%) 5/49 (10%) 6/48 (13%) | 9/50 (18%) 7/50 (14%) 8/50 (16%) |
|ADJUSTED (b) | 30.3% 14.7% 21.4% | 27.0% 18.5% 20.5% |
|TERMINAL (d) | 6/21 (29%) 3/29 (10%) 6/28 (21%) | 5/27 (19%) 4/31 (13%) 5/34 (15%) |
|FIRST INCIDENCE (DAYS) | 637 588 729 (T) | 645 611 531 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.272N P=0.220N P=0.294N | P=0.317N P=0.310N P=0.356N |
|INCIDENTAL TUMOR | P=0.332N P=0.280N P=0.326N | P=0.450N P=0.374N P=0.553N |
|LOGISTIC REGRESSION | P=0.407N P=0.344N P=0.410N | P=0.454N P=0.390N P=0.485N |
|COCHRAN-ARMITAGE | P=0.454N | P=0.446N |
|FISHER EXACT | P=0.380N P=0.516N | P=0.393N P=0.500N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 01 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.25% 0.5% | UNTREATE 0.5% 1.0% |
| | D 61 UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/49 (14%) 5/49 (10%) 6/48 (13%) | 10/50 (20%) 7/50 (14%) 8/50 (16%) |
|ADJUSTED (b) | 30.3% 14.7% 21.4% | 28.6% 18.5% 20.5% |
|TERMINAL (d) | 6/21 (29%) 3/29 (10%) 6/28 (21%) | 5/27 (19%) 4/31 (13%) 5/34 (15%) |
|FIRST INCIDENCE (DAYS) | 637 588 729 (T) | 600 611 531 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.272N P=0.220N P=0.294N | P=0.234N P=0.230N P=0.271N |
|INCIDENTAL TUMOR | P=0.332N P=0.280N P=0.326N | P=0.347N P=0.277N P=0.448N |
|LOGISTIC REGRESSION | P=0.407N P=0.344N P=0.410N | P=0.363N P=0.308N P=0.399N |
|COCHRAN-ARMITAGE | P=0.454N | P=0.344N |
|FISHER EXACT | P=0.380N P=0.516N | P=0.298N P=0.398N |
|=================================================================================================================================|
| |
|Tongue |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/49 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 6.9% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/21 (0%) 0/29 (0%) 1/28 (4%) | 0/27 (0%) 0/31 (0%) 0/34 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 715 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.109 (e) P=0.289 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.097 (e) P=0.240 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.101 (e) P=0.262 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.093 | (e) |
|FISHER EXACT | (e) P=0.242 | (e) (e) |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 01 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.25% 0.5% | UNTREATE 0.5% 1.0% |
| | D 61 UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 4/50 (8%) 8/50 (16%) 12/50 (24%) |
|ADJUSTED (b) | | 11.4% 23.6% 31.3% |
|TERMINAL (d) | | 0/27 (0%) 6/31 (19%) 9/34 (26%) |
|FIRST INCIDENCE (DAYS) | | 625 686 632 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.056 P=0.246 P=0.071 |
|INCIDENTAL TUMOR | | P=0.024 * P=0.168 P=0.029 * |
|LOGISTIC REGRESSION | | P=0.025 * P=0.201 P=0.031 * |
|COCHRAN-ARMITAGE | | P=0.020 * |
|FISHER EXACT | | P=0.178 P=0.027 * |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 4/50 (8%) 9/50 (18%) 12/50 (24%) |
|ADJUSTED (b) | | 11.4% 26.7% 31.3% |
|TERMINAL (d) | | 0/27 (0%) 7/31 (23%) 9/34 (26%) |
|FIRST INCIDENCE (DAYS) | | 625 686 632 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.061 P=0.176 P=0.071 |
|INCIDENTAL TUMOR | | P=0.027 * P=0.114 P=0.029 * |
|LOGISTIC REGRESSION | | P=0.028 * P=0.137 P=0.031 * |
|COCHRAN-ARMITAGE | | P=0.022 * |
|FISHER EXACT | | P=0.117 P=0.027 * |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 01 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.25% 0.5% | UNTREATE 0.5% 1.0% |
| | D 61 UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, |
| or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 19/50 (38%) 21/50 (42%) 16/49 (33%) | 14/50 (28%) 15/50 (30%) 10/50 (20%) |
|ADJUSTED (b) | 46.1% 51.1% 40.5% | 37.1% 34.6% 23.2% |
|TERMINAL (d) | 2/21 (10%) 10/29 (34%) 6/28 (21%) | 6/27 (22%) 5/31 (16%) 4/34 (12%) |
|FIRST INCIDENCE (DAYS) | 485 467 570 | 447 544 497 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.192N P=0.466N P=0.238N | P=0.135N P=0.534N P=0.159N |
|INCIDENTAL TUMOR | P=0.536N P=0.199 P=0.561 | P=0.343N P=0.411 P=0.361N |
|LOGISTIC REGRESSION | P=0.515N P=0.251 P=0.575 | P=0.257N P=0.443 P=0.321N |
|COCHRAN-ARMITAGE | P=0.330N | P=0.212N |
|FISHER EXACT | P=0.419 P=0.365N | P=0.500 P=0.241N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma And Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/49 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 4.1% 2.3% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/21 (0%) 0/29 (0%) 0/28 (0%) | 0/27 (0%) 0/31 (0%) 0/34 (0%) |
|FIRST INCIDENCE (DAYS) | --- 367 588 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.349 P=0.242 P=0.487 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.278 P=0.262 P=0.383 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.329 P=0.207 P=0.488 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.355 | (e) |
|FISHER EXACT | P=0.247 P=0.495 | (e) (e) |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 01 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.25% 0.5% | UNTREATE 0.5% 1.0% |
| | D 61 UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/49 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 4.1% 2.3% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/21 (0%) 0/29 (0%) 0/28 (0%) | 0/27 (0%) 0/31 (0%) 0/34 (0%) |
|FIRST INCIDENCE (DAYS) | --- 367 588 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.349 P=0.242 P=0.487 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.278 P=0.262 P=0.383 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.329 P=0.207 P=0.488 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.355 | (e) |
|FISHER EXACT | P=0.247 P=0.495 | (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/49 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 7.6% 2.4% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/21 (5%) 0/29 (0%) 0/28 (0%) | 0/27 (0%) 0/31 (0%) 0/34 (0%) |
|FIRST INCIDENCE (DAYS) | 666 626 --- | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.119N P=0.447N P=0.191N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.181N P=0.559N P=0.236N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.146N P=0.501N P=0.237N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.145N | (e) |
|FISHER EXACT | P=0.500N P=0.253N | (e) (e) |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 01 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.25% 0.5% | UNTREATE 0.5% 1.0% |
| | D 61 UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 49/50 (98%) 48/49 (98%) | 43/50 (86%) 48/50 (96%) 43/50 (86%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% | 95.4% 96.0% 91.4% |
|TERMINAL (d) | 21/21 (100%) 29/29 (100%) 28/28 (100%) | 25/27 (93%) 29/31 (94%) 30/34 (88%) |
|FIRST INCIDENCE (DAYS) | 485 367 367 | 447 478 531 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.085N P=0.084N P=0.104N | P=0.106N P=0.540N P=0.131N |
|INCIDENTAL TUMOR | P=0.388N P=0.638N P=0.581N | P=0.527N P=0.096 P=0.544N |
|LOGISTIC REGRESSION | P=0.694N P=0.962 P=0.887N | P=0.441N P=0.122 P=0.470N |
|COCHRAN-ARMITAGE | P=0.634N | P=0.564N |
|FISHER EXACT | P=0.753N P=0.747N | P=0.080 P=0.613N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 27/50 (54%) 27/50 (54%) 19/49 (39%) | 19/50 (38%) 18/50 (36%) 13/50 (26%) |
|ADJUSTED (b) | 59.9% 59.8% 44.7% | 44.6% 39.9% 30.2% |
|TERMINAL (d) | 4/21 (19%) 12/29 (41%) 6/28 (21%) | 6/27 (22%) 6/31 (19%) 6/34 (18%) |
|FIRST INCIDENCE (DAYS) | 485 367 436 | 409 544 497 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.054N P=0.307N P=0.070N | P=0.078N P=0.373N P=0.093N |
|INCIDENTAL TUMOR | P=0.177N P=0.352 P=0.230N | P=0.244N P=0.527 P=0.263N |
|LOGISTIC REGRESSION | P=0.131N P=0.443 P=0.226N | P=0.205N P=0.533 P=0.233N |
|COCHRAN-ARMITAGE | P=0.079N | P=0.122N |
|FISHER EXACT | P=0.579N P=0.094N | P=0.500N P=0.142N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05057 TEST: 01 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- HC YELLOW 4
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATE 0.25% 0.5% | UNTREATE 0.5% 1.0% |
| | D 61 UM 61LM 61HM | D 61UF 61LF 61HF |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 50/50 (100%) 48/49 (98%) | 49/50 (98%) 49/50 (98%) 48/50 (96%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% | 98.0% 98.0% 96.0% |
|TERMINAL (d) | 21/21 (100%) 29/29 (100%) 28/28 (100%) | 26/27 (96%) 30/31 (97%) 32/34 (94%) |
|FIRST INCIDENCE (DAYS) | 485 367 367 | 409 478 497 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.087N P=0.111N P=0.104N | P=0.074N P=0.238N P=0.095N |
|INCIDENTAL TUMOR | P=0.299N (e) P=0.581N | P=0.451N P=0.731 P=0.581N |
|LOGISTIC REGRESSION | P=0.608N (e) P=0.887N | P=0.451N P=0.731 P=0.581N |
|COCHRAN-ARMITAGE | P=0.665N | P=0.378N |
|FISHER EXACT | P=0.500 P=0.747N | P=0.753N P=0.500N |
|=================================================================================================================================|
(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).