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). --multipart-boundary Content-type: text/plain Range: bytes 126282-126282/126282 --multipart-boundary--