TDMS Study 05024-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus N-METHYLOLACRYLAMIDE DATE: 09/04/94
EXPERIMENT: 05024 TEST: 01 TIME: 03:30:40
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1CP9565302 ROUTE: GAVAGE NTP C#: 60333
PATHOLOGIST: J. TOFT S. EUSTIS CAS: 924-42-5
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus N-METHYLOLACRYLAMIDE DATE: 09/04/94
EXPERIMENT: 05024 TEST: 01 TIME: 03:30:40
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1CP9565302 ROUTE: GAVAGE NTP C#: 60333
PATHOLOGIST: J. TOFT S. EUSTIS CAS: 924-42-5
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: Battelle Columbus N-METHYLOLACRYLAMIDE DATE: 09/04/94
EXPERIMENT: 05024 TEST: 01 TIME: 03:30:40
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1CP9565302 ROUTE: GAVAGE NTP C#: 60333
PATHOLOGIST: J. TOFT S. EUSTIS CAS: 924-42-5
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF N-METHYLOLACRYLAMIDE
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Skin Keratoacanthoma
Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,
Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma
Testes Adenoma
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
All Organs Benign Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 09/04/94 EXPERIMENT: 05024 TEST: 01 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 6 MG/KG 12 MG/KG | VEHICLE 6 MG/KG 12 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) | 3/50 (6%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 9.1% 2.2% | 8.6% 4.0% 3.0% |
|TERMINAL (d) | 0/28 (0%) 2/22 (9%) 0/27 (0%) | 3/35 (9%) 0/22 (0%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | --- 731 (T) 573 | 731 (T) 711 731 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.358 P=0.186 P=0.500 | P=0.229N P=0.475N P=0.326N |
|INCIDENTAL TUMOR | P=0.340 P=0.186 P=0.464 | P=0.227N P=0.424N P=0.326N |
|LOGISTIC REGRESSION | P=0.361 P=0.186 P=0.510 | P=0.227N P=0.452N P=0.326N |
|COCHRAN-ARMITAGE | P=0.360 | P=0.202N |
|FISHER EXACT | P=0.247 P=0.500 | P=0.309N P=0.309N |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 18/49 (37%) 7/50 (14%) 13/50 (26%) | 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|ADJUSTED (b) | 50.7% 26.2% 36.9% | 2.9% 4.2% 5.3% |
|TERMINAL (d) | 10/27 (37%) 4/22 (18%) 6/27 (22%) | 1/35 (3%) 0/22 (0%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | 637 608 654 | 731 (T) 715 625 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.161N P=0.051N P=0.198N | P=0.370 P=0.657 P=0.481 |
|INCIDENTAL TUMOR | P=0.091N P=0.023N* P=0.107N | P=0.408 P=0.723 P=0.565 |
|LOGISTIC REGRESSION | P=0.115N P=0.022N* P=0.143N | P=0.376 P=0.683 P=0.500 |
|COCHRAN-ARMITAGE | P=0.136N | P=0.378 |
|FISHER EXACT | P=0.008N** P=0.175N | P=0.753N P=0.500 |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05024 TEST: 01 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 6 MG/KG 12 MG/KG | VEHICLE 6 MG/KG 12 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 4.7% 9.1% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/27 (0%) 2/22 (9%) 0/27 (0%) | 0/35 (0%) 0/22 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 422 731 (T) --- | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.181N P=0.638 P=0.234N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.176N P=0.691 P=0.245N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.167N P=0.653N P=0.212N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.171N | (e) |
|FISHER EXACT | P=0.684N P=0.242N | (e) (e) |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 20/49 (41%) 9/50 (18%) 13/50 (26%) | 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|ADJUSTED (b) | 53.0% 34.4% 36.9% | 2.9% 4.2% 5.3% |
|TERMINAL (d) | 10/27 (37%) 6/22 (27%) 6/27 (22%) | 1/35 (3%) 0/22 (0%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | 422 608 654 | 731 (T) 715 625 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.088N P=0.070N P=0.115N | P=0.370 P=0.657 P=0.481 |
|INCIDENTAL TUMOR | P=0.040N* P=0.029N* P=0.049N* | P=0.408 P=0.723 P=0.565 |
|LOGISTIC REGRESSION | P=0.055N P=0.024N* P=0.078N | P=0.376 P=0.683 P=0.500 |
|COCHRAN-ARMITAGE | P=0.065N | P=0.378 |
|FISHER EXACT | P=0.011N* P=0.088N | P=0.753N P=0.500 |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05024 TEST: 01 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 6 MG/KG 12 MG/KG | VEHICLE 6 MG/KG 12 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 2/17 (12%) 3/48 (6%) | 2/45 (4%) 2/17 (12%) 4/50 (8%) |
|ADJUSTED (b) | 5.7% 0.0% 8.9% | 6.3% 100.0% 11.8% |
|TERMINAL (d) | 0/27 (0%) 0/0 1/27 (4%) | 2/32 (6%) 1/1 (100%) 3/33 (9%) |
|FIRST INCIDENCE (DAYS) | 688 600 548 | 731 (T) 423 726 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.429 P=0.615 P=0.517 | P=0.295 P=0.057 P=0.347 |
|INCIDENTAL TUMOR | P=0.429 P=0.150 P=0.506 | P=0.302 P=0.106 P=0.358 |
|LOGISTIC REGRESSION | P=0.410 P=0.070 P=0.488 | P=0.326 P=0.221 P=0.355 |
|COCHRAN-ARMITAGE | P=0.406 | P=0.324 |
|FISHER EXACT | P=0.271 P=0.490 | P=0.300 P=0.390 |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 2/17 (12%) 3/48 (6%) | 2/45 (4%) 2/17 (12%) 4/50 (8%) |
|ADJUSTED (b) | 5.7% 0.0% 8.9% | 6.3% 100.0% 11.8% |
|TERMINAL (d) | 0/27 (0%) 0/0 1/27 (4%) | 2/32 (6%) 1/1 (100%) 3/33 (9%) |
|FIRST INCIDENCE (DAYS) | 688 600 548 | 731 (T) 423 726 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.429 P=0.615 P=0.517 | P=0.295 P=0.057 P=0.347 |
|INCIDENTAL TUMOR | P=0.429 P=0.150 P=0.506 | P=0.302 P=0.106 P=0.358 |
|LOGISTIC REGRESSION | P=0.410 P=0.070 P=0.488 | P=0.326 P=0.221 P=0.355 |
|COCHRAN-ARMITAGE | P=0.406 | P=0.324 |
|FISHER EXACT | P=0.271 P=0.490 | P=0.300 P=0.390 |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05024 TEST: 01 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 6 MG/KG 12 MG/KG | VEHICLE 6 MG/KG 12 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/14 (0%) 2/50 (4%) | 0/50 (0%) 0/16 (0%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 0.0% 5.6% | 0.0% 0.0% 6.1% |
|TERMINAL (d) | 0/28 (0%) 0/0 0/27 (0%) | 0/35 (0%) 0/0 2/33 (6%) |
|FIRST INCIDENCE (DAYS) | --- --- 654 | --- --- 731 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.109 (e) P=0.249 | P=0.133 (e) P=0.225 |
|INCIDENTAL TUMOR | P=0.177 (e) P=0.286 | P=0.133 (e) P=0.225 |
|LOGISTIC REGRESSION | P=0.133 (e) P=0.238 | P=0.133 (e) P=0.225 |
|COCHRAN-ARMITAGE | P=0.127 | P=0.125 |
|FISHER EXACT | (e) P=0.247 | (e) P=0.247 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 0/21 (0%) 0/50 (0%) |
|ADJUSTED (b) | 14.3% 4.5% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 4/28 (14%) 1/22 (5%) 0/27 (0%) | 0/35 (0%) 0/1 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 731 (T) 731 (T) --- | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.031N* P=0.255N P=0.066N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.031N* P=0.255N P=0.066N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.031N* P=0.255N P=0.066N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.026N* | (e) |
|FISHER EXACT | P=0.181N P=0.059N | (e) (e) |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05024 TEST: 01 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 6 MG/KG 12 MG/KG | VEHICLE 6 MG/KG 12 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/21 (0%) 0/50 (0%) |
|ADJUSTED (b) | 14.3% 8.4% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 4/28 (14%) 1/22 (5%) 0/27 (0%) | 0/35 (0%) 0/1 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 731 (T) 722 --- | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.044N* P=0.445N P=0.066N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.041N* P=0.448N P=0.066N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.038N* P=0.436N P=0.066N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.037N* | (e) |
|FISHER EXACT | P=0.339N P=0.059N | (e) (e) |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/21 (0%) 0/50 (0%) |
|ADJUSTED (b) | 14.3% 8.4% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 4/28 (14%) 1/22 (5%) 0/27 (0%) | 0/35 (0%) 0/1 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 731 (T) 722 --- | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.044N* P=0.445N P=0.066N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.041N* P=0.448N P=0.066N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.038N* P=0.436N P=0.066N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.037N* | (e) |
|FISHER EXACT | P=0.339N P=0.059N | (e) (e) |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05024 TEST: 01 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 6 MG/KG 12 MG/KG | VEHICLE 6 MG/KG 12 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/17 (0%) 0/49 (0%) | 0/50 (0%) 0/17 (0%) 1/50 (2%) |
|ADJUSTED (b) | 5.8% 0.0% 0.0% | 0.0% 0.0% 3.0% |
|TERMINAL (d) | 1/28 (4%) 0/0 0/27 (0%) | 0/35 (0%) 0/0 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | 593 --- --- | --- --- 731 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.127N P=0.524N P=0.244N | P=0.298 (e) P=0.488 |
|INCIDENTAL TUMOR | P=0.125N P=0.419N P=0.264N | P=0.298 (e) P=0.488 |
|LOGISTIC REGRESSION | P=0.125N P=0.555N P=0.242N | P=0.298 (e) P=0.488 |
|COCHRAN-ARMITAGE | P=0.126N | P=0.294 |
|FISHER EXACT | P=0.554N P=0.253N | (e) P=0.500 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) | 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 6.0% | 2.9% 3.8% 3.0% |
|TERMINAL (d) | 0/28 (0%) 0/22 (0%) 0/27 (0%) | 1/35 (3%) 0/22 (0%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | --- --- 708 | 731 (T) 698 731 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.111 (e) P=0.253 | P=0.612 P=0.655 P=0.749 |
|INCIDENTAL TUMOR | P=0.130 (e) P=0.286 | P=0.622 P=0.723 P=0.749 |
|LOGISTIC REGRESSION | P=0.104 (e) P=0.242 | P=0.623 P=0.704 P=0.749 |
|COCHRAN-ARMITAGE | P=0.095 | P=0.640 |
|FISHER EXACT | (e) P=0.247 | P=0.753N P=0.753N |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05024 TEST: 01 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 6 MG/KG 12 MG/KG | VEHICLE 6 MG/KG 12 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) | 19/50 (38%) 9/50 (18%) 17/50 (34%) |
|ADJUSTED (b) | 7.1% 4.5% 3.7% | 46.7% 26.6% 48.1% |
|TERMINAL (d) | 2/28 (7%) 1/22 (5%) 1/27 (4%) | 14/35 (40%) 2/22 (9%) 15/33 (45%) |
|FIRST INCIDENCE (DAYS) | 731 (T) 731 (T) 731 (T) | 529 443 443 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.393N P=0.585N P=0.513N | P=0.447N P=0.217N P=0.495N |
|INCIDENTAL TUMOR | P=0.393N P=0.585N P=0.513N | P=0.388N P=0.021N* P=0.432N |
|LOGISTIC REGRESSION | P=0.393N P=0.585N P=0.513N | P=0.381N P=0.027N* P=0.432N |
|COCHRAN-ARMITAGE | P=0.378N | P=0.372N |
|FISHER EXACT | P=0.500N P=0.500N | P=0.022N* P=0.418N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) | 19/50 (38%) 9/50 (18%) 17/50 (34%) |
|ADJUSTED (b) | 7.1% 4.5% 6.9% | 46.7% 26.6% 48.1% |
|TERMINAL (d) | 2/28 (7%) 1/22 (5%) 1/27 (4%) | 14/35 (40%) 2/22 (9%) 15/33 (45%) |
|FIRST INCIDENCE (DAYS) | 731 (T) 731 (T) 722 | 529 443 443 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.598 P=0.585N P=0.687 | P=0.447N P=0.217N P=0.495N |
|INCIDENTAL TUMOR | P=0.600N P=0.585N P=0.684N | P=0.388N P=0.021N* P=0.432N |
|LOGISTIC REGRESSION | P=0.598N P=0.585N P=0.687N | P=0.381N P=0.027N* P=0.432N |
|COCHRAN-ARMITAGE | P=0.610 | P=0.372N |
|FISHER EXACT | P=0.500N P=0.691N | P=0.022N* P=0.418N |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05024 TEST: 01 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 6 MG/KG 12 MG/KG | VEHICLE 6 MG/KG 12 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 3/50 (6%) | 19/50 (38%) 10/50 (20%) 17/50 (34%) |
|ADJUSTED (b) | 7.1% 4.5% 9.5% | 46.7% 29.4% 48.1% |
|TERMINAL (d) | 2/28 (7%) 1/22 (5%) 1/27 (4%) | 14/35 (40%) 2/22 (9%) 15/33 (45%) |
|FIRST INCIDENCE (DAYS) | 731 (T) 731 (T) 708 | 529 443 443 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.402 P=0.585N P=0.501 | P=0.450N P=0.303N P=0.495N |
|INCIDENTAL TUMOR | P=0.424 P=0.585N P=0.531 | P=0.389N P=0.036N* P=0.432N |
|LOGISTIC REGRESSION | P=0.417 P=0.585N P=0.516 | P=0.382N P=0.048N* P=0.432N |
|COCHRAN-ARMITAGE | P=0.399 | P=0.372N |
|FISHER EXACT | P=0.500N P=0.500 | P=0.038N* P=0.418N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 19/50 (38%) 14/23 (61%) 13/50 (26%) | 19/49 (39%) 19/40 (48%) 14/50 (28%) |
|ADJUSTED (b) | 49.1% 63.9% 35.4% | 43.4% 63.2% 32.1% |
|TERMINAL (d) | 10/28 (36%) 3/6 (50%) 6/27 (22%) | 11/35 (31%) 7/15 (47%) 6/33 (18%) |
|FIRST INCIDENCE (DAYS) | 410 421 425 | 529 458 443 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.161N P=0.224 P=0.172N | P=0.273N P=0.045 * P=0.275N |
|INCIDENTAL TUMOR | P=0.120N P=0.099 P=0.139N | P=0.101N P=0.342 P=0.107N |
|LOGISTIC REGRESSION | P=0.128N P=0.084 P=0.143N | P=0.094N P=0.362 P=0.083N |
|COCHRAN-ARMITAGE | P=0.128N | P=0.156N |
|FISHER EXACT | P=0.058 P=0.142N | P=0.270 P=0.178N |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05024 TEST: 01 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 6 MG/KG 12 MG/KG | VEHICLE 6 MG/KG 12 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 19/50 (38%) 14/23 (61%) 14/50 (28%) | 19/49 (39%) 19/40 (48%) 14/50 (28%) |
|ADJUSTED (b) | 49.1% 63.9% 37.1% | 43.4% 63.2% 32.1% |
|TERMINAL (d) | 10/28 (36%) 3/6 (50%) 6/27 (22%) | 11/35 (31%) 7/15 (47%) 6/33 (18%) |
|FIRST INCIDENCE (DAYS) | 410 421 425 | 529 458 443 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.210N P=0.224 P=0.226N | P=0.273N P=0.045 * P=0.275N |
|INCIDENTAL TUMOR | P=0.162N P=0.099 P=0.187N | P=0.101N P=0.342 P=0.107N |
|LOGISTIC REGRESSION | P=0.178N P=0.084 P=0.199N | P=0.094N P=0.362 P=0.083N |
|COCHRAN-ARMITAGE | P=0.177N | P=0.156N |
|FISHER EXACT | P=0.058 P=0.198N | P=0.270 P=0.178N |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 6/50 (12%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 3.6% 23.1% 8.4% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/28 (4%) 3/22 (14%) 0/27 (0%) | 0/35 (0%) 0/22 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 731 (T) 608 695 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.291 P=0.033 * P=0.323 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.319 P=0.043 * P=0.362 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.287 P=0.035 * P=0.311 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.274 | (e) |
|FISHER EXACT | P=0.056 P=0.309 | (e) (e) |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05024 TEST: 01 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 6 MG/KG 12 MG/KG | VEHICLE 6 MG/KG 12 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 3.6% 9.1% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/28 (4%) 2/22 (9%) 0/27 (0%) | 0/35 (0%) 0/22 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 731 (T) 731 (T) --- | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.375N P=0.415 P=0.507N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.375N P=0.415 P=0.507N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.375N P=0.415 P=0.507N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.360N | (e) |
|FISHER EXACT | P=0.500 P=0.500N | (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, |
| Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 8/50 (16%) 4/50 (8%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 10.7% 31.2% 11.8% | 2.9% 0.0% 0.0% |
|TERMINAL (d) | 3/28 (11%) 5/22 (23%) 1/27 (4%) | 1/35 (3%) 0/22 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 731 (T) 608 695 | 731 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.435 P=0.047 * P=0.504 | P=0.291N P=0.593N P=0.512N |
|INCIDENTAL TUMOR | P=0.467 P=0.058 P=0.541 | P=0.291N P=0.593N P=0.512N |
|LOGISTIC REGRESSION | P=0.454 P=0.051 P=0.517 | P=0.291N P=0.593N P=0.512N |
|COCHRAN-ARMITAGE | P=0.434 | P=0.269N |
|FISHER EXACT | P=0.100 P=0.500 | P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05024 TEST: 01 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 6 MG/KG 12 MG/KG | VEHICLE 6 MG/KG 12 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 7.3% 5.5% 5.8% | 0.0% 3.0% 0.0% |
|TERMINAL (d) | 0/28 (0%) 0/22 (0%) 1/27 (4%) | 0/35 (0%) 0/22 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 624 549 573 | --- 644 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.403N P=0.570N P=0.496N | P=0.715 P=0.443 (e) |
|INCIDENTAL TUMOR | P=0.406N P=0.368N P=0.534N | P=0.686N P=0.718 (e) |
|LOGISTIC REGRESSION | P=0.466N P=0.420N P=0.501N | P=0.736N P=0.524 (e) |
|COCHRAN-ARMITAGE | P=0.406N | P=0.731 |
|FISHER EXACT | P=0.500N P=0.500N | P=0.500 (e) |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, Sarcoma, |
| Neurofibroma, or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 2/50 (4%) | 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 7.3% 5.5% 5.8% | 2.0% 5.9% 0.0% |
|TERMINAL (d) | 0/28 (0%) 0/22 (0%) 1/27 (4%) | 0/35 (0%) 0/22 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 624 549 573 | 351 641 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.403N P=0.570N P=0.496N | P=0.374N P=0.433 P=0.500N |
|INCIDENTAL TUMOR | P=0.406N P=0.368N P=0.534N | P=0.318N P=0.672N (e) |
|LOGISTIC REGRESSION | P=0.466N P=0.420N P=0.501N | P=0.347N P=0.675 (e) |
|COCHRAN-ARMITAGE | P=0.406N | P=0.360N |
|FISHER EXACT | P=0.500N P=0.500N | P=0.500 P=0.500N |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05024 TEST: 01 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 6 MG/KG 12 MG/KG | VEHICLE 6 MG/KG 12 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 40/50 (80%) 41/48 (85%) 46/50 (92%) | |
|ADJUSTED (b) | 90.9% 100.0% 100.0% | |
|TERMINAL (d) | 24/28 (86%) 22/22 (100%) 27/27 (100%) | |
|FIRST INCIDENCE (DAYS) | 593 492 487 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.186 P=0.087 P=0.201 | |
|INCIDENTAL TUMOR | P=0.040 * P=0.057 P=0.079 | |
|LOGISTIC REGRESSION | P=0.021 * P=0.041 * P=0.044 * | |
|COCHRAN-ARMITAGE | P=0.057 | |
|FISHER EXACT | P=0.330 P=0.074 | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 4/17 (24%) 9/50 (18%) | 11/50 (22%) 2/17 (12%) 7/50 (14%) |
|ADJUSTED (b) | 19.5% 100.0% 24.4% | 30.2% 100.0% 19.4% |
|TERMINAL (d) | 3/28 (11%) 3/3 (100%) 4/27 (15%) | 10/35 (29%) 1/1 (100%) 5/33 (15%) |
|FIRST INCIDENCE (DAYS) | 593 608 425 | 639 575 625 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.344 P=0.309 P=0.402 | P=0.221N P=0.356 P=0.258N |
|INCIDENTAL TUMOR | P=0.334 P=0.146 P=0.369 | P=0.174N P=0.606 P=0.198N |
|LOGISTIC REGRESSION | P=0.345 P=0.074 P=0.388 | P=0.203N P=0.262 P=0.236N |
|COCHRAN-ARMITAGE | P=0.345 | P=0.176N |
|FISHER EXACT | P=0.286 P=0.393 | P=0.296N P=0.218N |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05024 TEST: 01 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 6 MG/KG 12 MG/KG | VEHICLE 6 MG/KG 12 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 4/17 (24%) 10/50 (20%) | 12/50 (24%) 2/17 (12%) 7/50 (14%) |
|ADJUSTED (b) | 22.7% 100.0% 27.7% | 33.0% 100.0% 19.4% |
|TERMINAL (d) | 4/28 (14%) 3/3 (100%) 5/27 (19%) | 11/35 (31%) 1/1 (100%) 5/33 (15%) |
|FIRST INCIDENCE (DAYS) | 593 608 425 | 639 575 625 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.346 P=0.338 P=0.402 | P=0.158N P=0.369 P=0.188N |
|INCIDENTAL TUMOR | P=0.337 P=0.172 P=0.371 | P=0.120N P=0.619 P=0.139N |
|LOGISTIC REGRESSION | P=0.352 P=0.090 P=0.393 | P=0.144N P=0.271 P=0.170N |
|COCHRAN-ARMITAGE | P=0.351 | P=0.120N |
|FISHER EXACT | P=0.357 P=0.398 | P=0.240N P=0.154N |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/17 (0%) 0/50 (0%) | 2/50 (4%) 0/17 (0%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% | 5.0% 0.0% 5.3% |
|TERMINAL (d) | 0/28 (0%) 0/3 (0%) 0/27 (0%) | 1/35 (3%) 0/1 (0%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | --- --- --- | 639 --- 652 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.586 P=0.532N P=0.671 |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.579N P=0.320N P=0.644N |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.603 P=0.671N P=0.694N |
|COCHRAN-ARMITAGE | (e) | P=0.608 |
|FISHER EXACT | (e) (e) | P=0.554N P=0.691N |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05024 TEST: 01 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 6 MG/KG 12 MG/KG | VEHICLE 6 MG/KG 12 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/17 (6%) 0/50 (0%) | 2/50 (4%) 0/17 (0%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 3.6% 0.0% | 5.0% 0.0% 5.3% |
|TERMINAL (d) | 0/28 (0%) 0/3 (0%) 0/27 (0%) | 1/35 (3%) 0/1 (0%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | --- 695 --- | 639 --- 652 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.706N P=0.461 (e) | P=0.586 P=0.532N P=0.671 |
|INCIDENTAL TUMOR | P=0.656N P=0.056 (e) | P=0.579N P=0.320N P=0.644N |
|LOGISTIC REGRESSION | P=0.701N P=0.160 (e) | P=0.603 P=0.671N P=0.694N |
|COCHRAN-ARMITAGE | P=0.706 | P=0.608 |
|FISHER EXACT | P=0.254 (e) | P=0.554N P=0.691N |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 8/50 (16%) 2/50 (4%) 9/50 (18%) |
|ADJUSTED (b) | | 20.3% 6.6% 25.7% |
|TERMINAL (d) | | 5/35 (14%) 0/22 (0%) 7/33 (21%) |
|FIRST INCIDENCE (DAYS) | | 656 575 715 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.404 P=0.166N P=0.449 |
|INCIDENTAL TUMOR | | P=0.430 P=0.058N P=0.462 |
|LOGISTIC REGRESSION | | P=0.419 P=0.074N P=0.466 |
|COCHRAN-ARMITAGE | | P=0.440 |
|FISHER EXACT | | P=0.046N* P=0.500 |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05024 TEST: 01 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 6 MG/KG 12 MG/KG | VEHICLE 6 MG/KG 12 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 0/50 (0%) 3/50 (6%) 0/50 (0%) |
|ADJUSTED (b) | | 0.0% 8.9% 0.0% |
|TERMINAL (d) | | 0/35 (0%) 1/22 (5%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | | --- 458 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.630 P=0.088 (e) |
|INCIDENTAL TUMOR | | P=0.656 P=0.224 (e) |
|LOGISTIC REGRESSION | | P=0.651 P=0.179 (e) |
|COCHRAN-ARMITAGE | | P=0.640 |
|FISHER EXACT | | P=0.121 (e) |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 8/50 (16%) 5/50 (10%) 9/50 (18%) |
|ADJUSTED (b) | | 20.3% 14.9% 25.7% |
|TERMINAL (d) | | 5/35 (14%) 1/22 (5%) 7/33 (21%) |
|FIRST INCIDENCE (DAYS) | | 656 458 715 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.409 P=0.543N P=0.449 |
|INCIDENTAL TUMOR | | P=0.431 P=0.224N P=0.462 |
|LOGISTIC REGRESSION | | P=0.437 P=0.272N P=0.466 |
|COCHRAN-ARMITAGE | | P=0.444 |
|FISHER EXACT | | P=0.277N P=0.500 |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05024 TEST: 01 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 6 MG/KG 12 MG/KG | VEHICLE 6 MG/KG 12 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, |
| or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 18/50 (36%) 18/50 (36%) 24/50 (48%) | 14/50 (28%) 11/50 (22%) 15/50 (30%) |
|ADJUSTED (b) | 46.1% 49.2% 60.3% | 35.2% 31.1% 37.6% |
|TERMINAL (d) | 8/28 (29%) 6/22 (27%) 12/27 (44%) | 10/35 (29%) 1/22 (5%) 9/33 (27%) |
|FIRST INCIDENCE (DAYS) | 554 509 548 | 676 508 595 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.185 P=0.333 P=0.200 | P=0.406 P=0.428 P=0.437 |
|INCIDENTAL TUMOR | P=0.160 P=0.564 P=0.193 | P=0.490 P=0.267N P=0.480 |
|LOGISTIC REGRESSION | P=0.108 P=0.576 P=0.159 | P=0.445 P=0.411N P=0.477 |
|COCHRAN-ARMITAGE | P=0.131 | P=0.455 |
|FISHER EXACT | P=0.582N P=0.156 | P=0.322N P=0.500 |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 2.5% 2.1% 7.4% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/28 (0%) 0/22 (0%) 2/27 (7%) | 0/35 (0%) 0/22 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 655 492 731 (T) | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.375 P=0.733 P=0.492 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.375 P=0.723N P=0.517 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.375 P=0.695N P=0.504 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.378 | (e) |
|FISHER EXACT | P=0.753N P=0.500 | (e) (e) |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05024 TEST: 01 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 6 MG/KG 12 MG/KG | VEHICLE 6 MG/KG 12 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 48/50 (96%) 48/50 (96%) 49/50 (98%) | 39/50 (78%) 28/50 (56%) 36/50 (72%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% | 82.9% 67.8% 79.7% |
|TERMINAL (d) | 28/28 (100%) 22/22 (100%) 27/27 (100%) | 27/35 (77%) 10/22 (45%) 24/33 (73%) |
|FIRST INCIDENCE (DAYS) | 410 421 425 | 529 423 443 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.461 P=0.105 P=0.485 | P=0.462N P=0.463 P=0.500N |
|INCIDENTAL TUMOR | P=0.457 P=0.477 P=0.620 | P=0.258N P=0.009N** P=0.255N |
|LOGISTIC REGRESSION | P=0.244 P=0.443 P=0.425 | P=0.300N P=0.008N** P=0.333N |
|COCHRAN-ARMITAGE | P=0.390 | P=0.295N |
|FISHER EXACT | P=0.691N P=0.500 | P=0.016N* P=0.322N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 23/50 (46%) 29/50 (58%) | 18/50 (36%) 16/50 (32%) 18/50 (36%) |
|ADJUSTED (b) | 54.8% 57.2% 69.7% | 43.2% 42.0% 44.0% |
|TERMINAL (d) | 10/28 (36%) 7/22 (32%) 15/27 (56%) | 12/35 (34%) 3/22 (14%) 11/33 (33%) |
|FIRST INCIDENCE (DAYS) | 422 379 487 | 351 458 383 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.206 P=0.313 P=0.218 | P=0.476 P=0.279 P=0.507 |
|INCIDENTAL TUMOR | P=0.156 P=0.533N P=0.188 | P=0.535N P=0.282N P=0.471 |
|LOGISTIC REGRESSION | P=0.135 P=0.517N P=0.159 | P=0.541N P=0.402N P=0.582N |
|COCHRAN-ARMITAGE | P=0.136 | P=0.542N |
|FISHER EXACT | P=0.579N P=0.158 | P=0.417N P=0.582N |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05024 TEST: 01 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 6 MG/KG 12 MG/KG | VEHICLE 6 MG/KG 12 MG/KG |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 49/50 (98%) 49/50 (98%) | 45/50 (90%) 36/50 (72%) 42/50 (84%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% | 91.8% 77.6% 87.4% |
|TERMINAL (d) | 28/28 (100%) 22/22 (100%) 27/27 (100%) | 31/35 (89%) 12/22 (55%) 27/33 (82%) |
|FIRST INCIDENCE (DAYS) | 410 379 425 | 351 423 383 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.519 P=0.110 P=0.546 | P=0.480N P=0.235 P=0.515N |
|INCIDENTAL TUMOR | P=0.601N P=0.638 P=0.712N | P=0.195N P=0.005N** P=0.282N |
|LOGISTIC REGRESSION | P=0.604 P=0.633 P=0.749 | P=0.198N P=0.003N** P=0.278N |
|COCHRAN-ARMITAGE | P=0.640 | P=0.258N |
|FISHER EXACT | P=0.753N P=0.753N | P=0.020N* P=0.277N |
|=================================================================================================================================|
(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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