TR 373 Rat Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Microbiological Assoc. SUCCINIC ANHYDRIDE DATE: 09/05/94 EXPERIMENT: 05041 TEST: 01 TIME: 13:27:41 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01ES2802601 ROUTE: GAVAGE NTP C#: 55696B PATHOLOGIST: W. HALL CAS: 108-30-5 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Microbiological Assoc. SUCCINIC ANHYDRIDE DATE: 09/05/94 EXPERIMENT: 05041 TEST: 01 TIME: 13:27:41 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES2802601 ROUTE: GAVAGE NTP C#: 55696B PATHOLOGIST: W. HALL CAS: 108-30-5 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 Larynx Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Microbiological Assoc. SUCCINIC ANHYDRIDE DATE: 09/05/94 EXPERIMENT: 05041 TEST: 01 TIME: 13:27:41 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES2802601 ROUTE: GAVAGE NTP C#: 55696B PATHOLOGIST: W. HALL CAS: 108-30-5 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF SUCCINIC ANHYDRIDE ==================================================================================================== MALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma: Benign, Complex, Malignant, NOS Clitoral/Preputial Gland Adenoma Carcinoma or Adenoma Skin Keratoacanthoma Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma Testes Adenoma All Organs Benign Tumors Malignant and Benign Tumors ==================================================================================================== 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: 09/05/94 EXPERIMENT: 05041 TEST: 01 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SUCCINIC ANHYDRIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 50MG/KG 100MG/KG | CONTROL 50MG/KG 100MG/KG | | | MALE LOW MALE HIGHMALE | FEMALE LOW FEM HIGHFEM | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 17/58 (29%) 9/58 (16%) 12/58 (21%) | 3/59 (5%) 1/43 (2%) 3/54 (6%) | |ADJUSTED (b) | 38.3% 23.2% 31.9% | 9.4% 8.3% 11.5% | |TERMINAL (d) | 10/36 (28%) 3/31 (10%) 7/32 (22%) | 2/31 (6%) 1/12 (8%) 3/26 (12%) | |FIRST INCIDENCE (DAYS) | 590 641 625 | 726 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.266N P=0.129N P=0.321N | P=0.505 P=0.589N P=0.586 | |INCIDENTAL TUMOR | P=0.318N P=0.092N P=0.390N | P=0.499 P=0.593N P=0.577 | |LOGISTIC REGRESSION | P=0.272N P=0.096N P=0.334N | P=0.504 P=0.654N P=0.584 | |COCHRAN-ARMITAGE | P=0.156N | P=0.550 | |FISHER EXACT | P=0.059N P=0.196N | P=0.436N P=0.617 | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/58 (9%) 5/58 (9%) 2/58 (3%) | 1/59 (2%) 0/43 (0%) 0/54 (0%) | |ADJUSTED (b) | 13.5% 12.9% 6.3% | 3.2% 0.0% 0.0% | |TERMINAL (d) | 4/36 (11%) 2/31 (6%) 2/32 (6%) | 1/31 (3%) 0/12 (0%) 0/26 (0%) | |FIRST INCIDENCE (DAYS) | 716 620 729 (T) | 729 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.233N P=0.556 P=0.267N | P=0.319N P=0.689N P=0.535N | |INCIDENTAL TUMOR | P=0.255N P=0.557 P=0.278N | P=0.319N P=0.689N P=0.535N | |LOGISTIC REGRESSION | P=0.241N P=0.564 P=0.266N | P=0.319N P=0.689N P=0.535N | |COCHRAN-ARMITAGE | P=0.180N | P=0.290N | |FISHER EXACT | P=0.629N P=0.219N | P=0.578N P=0.522N | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05041 TEST: 01 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SUCCINIC ANHYDRIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 50MG/KG 100MG/KG | CONTROL 50MG/KG 100MG/KG | | | MALE LOW MALE HIGHMALE | FEMALE LOW FEM HIGHFEM | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 22/58 (38%) 14/58 (24%) 13/58 (22%) | 4/59 (7%) 1/43 (2%) 3/54 (6%) | |ADJUSTED (b) | 49.1% 33.6% 34.6% | 12.5% 8.3% 11.5% | |TERMINAL (d) | 14/36 (39%) 5/31 (16%) 8/32 (25%) | 3/31 (10%) 1/12 (8%) 3/26 (12%) | |FIRST INCIDENCE (DAYS) | 590 620 625 | 726 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.108N P=0.187N P=0.130N | P=0.507N P=0.470N P=0.590N | |INCIDENTAL TUMOR | P=0.123N P=0.136N P=0.158N | P=0.512N P=0.474N P=0.598N | |LOGISTIC REGRESSION | P=0.120N P=0.141N P=0.127N | P=0.507N P=0.525N P=0.593N | |COCHRAN-ARMITAGE | P=0.040N* | P=0.459N | |FISHER EXACT | P=0.080N P=0.052N | P=0.295N P=0.550N | |=================================================================================================================================| | | |Brain | | Glioma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/60 (3%) 0/27 (0%) 0/60 (0%) | 0/60 (0%) 0/45 (0%) 0/60 (0%) | |ADJUSTED (b) | 4.1% 0.0% 0.0% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/36 (0%) 0/1 (0%) 0/32 (0%) | 0/31 (0%) 0/12 (0%) 0/27 (0%) | |FIRST INCIDENCE (DAYS) | 481 --- --- | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.111N P=0.260N P=0.268N | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.074N P=0.271N P=0.174N | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.098N P=0.347N P=0.195N | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.119N | (e) | |FISHER EXACT | P=0.473N P=0.248N | (e) (e) | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05041 TEST: 01 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SUCCINIC ANHYDRIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 50MG/KG 100MG/KG | CONTROL 50MG/KG 100MG/KG | | | MALE LOW MALE HIGHMALE | FEMALE LOW FEM HIGHFEM | |=================================================================================================================================| | | |Brain | | Oligodendroglioma, Glioma, or Astrocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/60 (3%) 1/27 (4%) 0/60 (0%) | 1/60 (2%) 0/45 (0%) 1/60 (2%) | |ADJUSTED (b) | 4.1% 2.7% 0.0% | 2.7% 0.0% 2.8% | |TERMINAL (d) | 0/36 (0%) 0/1 (0%) 0/32 (0%) | 0/31 (0%) 0/12 (0%) 0/27 (0%) | |FIRST INCIDENCE (DAYS) | 481 714 --- | 711 --- 663 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.167N P=0.527N P=0.268N | P=0.631 P=0.535N P=0.724 | |INCIDENTAL TUMOR | P=0.121N P=0.567N P=0.174N | P=0.606 P=0.536N P=0.700 | |LOGISTIC REGRESSION | P=0.160N P=0.744 P=0.195N | P=0.621 P=0.635N P=0.729 | |COCHRAN-ARMITAGE | P=0.166N | P=0.662N | |FISHER EXACT | P=0.677 P=0.248N | P=0.571N P=0.752N | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 4/23 (17%) 1/51 (2%) | 2/39 (5%) 2/27 (7%) 3/53 (6%) | |ADJUSTED (b) | 0.0% 52.5% 3.3% | 7.1% 5.1% 10.0% | |TERMINAL (d) | 0/31 (0%) 2/4 (50%) 1/30 (3%) | 1/20 (5%) 0/11 (0%) 1/24 (4%) | |FIRST INCIDENCE (DAYS) | --- 641 729 (T) | 641 590 642 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.380 P=0.003 ** P=0.493 | P=0.386 P=0.594 P=0.493 | |INCIDENTAL TUMOR | P=0.375 P=0.003 ** P=0.493 | P=0.420 P=0.590 P=0.521 | |LOGISTIC REGRESSION | P=0.385 P=0.001 ** P=0.493 | P=0.482 P=0.556 P=0.554 | |COCHRAN-ARMITAGE | P=0.424 | P=0.558 | |FISHER EXACT | P=0.009 ** P=0.515 | P=0.544 P=0.644 | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05041 TEST: 01 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SUCCINIC ANHYDRIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 50MG/KG 100MG/KG | CONTROL 50MG/KG 100MG/KG | | | MALE LOW MALE HIGHMALE | FEMALE LOW FEM HIGHFEM | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 4/23 (17%) 1/51 (2%) | 2/39 (5%) 2/27 (7%) 3/53 (6%) | |ADJUSTED (b) | 0.0% 52.5% 3.3% | 7.1% 5.1% 10.0% | |TERMINAL (d) | 0/31 (0%) 2/4 (50%) 1/30 (3%) | 1/20 (5%) 0/11 (0%) 1/24 (4%) | |FIRST INCIDENCE (DAYS) | --- 641 729 (T) | 641 590 642 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.380 P=0.003 ** P=0.493 | P=0.386 P=0.594 P=0.493 | |INCIDENTAL TUMOR | P=0.375 P=0.003 ** P=0.493 | P=0.420 P=0.590 P=0.521 | |LOGISTIC REGRESSION | P=0.385 P=0.001 ** P=0.493 | P=0.482 P=0.556 P=0.554 | |COCHRAN-ARMITAGE | P=0.424 | P=0.558 | |FISHER EXACT | P=0.009 ** P=0.515 | P=0.544 P=0.644 | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/59 (2%) 2/27 (7%) 1/60 (2%) | 0/60 (0%) 0/44 (0%) 0/60 (0%) | |ADJUSTED (b) | 2.8% 51.2% 3.1% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/36 (3%) 1/2 (50%) 1/32 (3%) | 0/31 (0%) 0/12 (0%) 0/27 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 676 729 (T) | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.562 P=0.060 P=0.736 | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.563 P=0.055 P=0.736 | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.565 P=0.082 P=0.736 | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.605N | (e) | |FISHER EXACT | P=0.231 P=0.748N | (e) (e) | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05041 TEST: 01 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SUCCINIC ANHYDRIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 50MG/KG 100MG/KG | CONTROL 50MG/KG 100MG/KG | | | MALE LOW MALE HIGHMALE | FEMALE LOW FEM HIGHFEM | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/59 (3%) 2/27 (7%) 1/60 (2%) | 0/60 (0%) 0/44 (0%) 0/60 (0%) | |ADJUSTED (b) | 4.9% 51.2% 3.1% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/36 (3%) 1/2 (50%) 1/32 (3%) | 0/31 (0%) 0/12 (0%) 0/27 (0%) | |FIRST INCIDENCE (DAYS) | 681 676 729 (T) | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.453N P=0.279 P=0.543N | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.448N P=0.260 P=0.537N | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.449N P=0.222 P=0.538N | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.394N | (e) | |FISHER EXACT | P=0.372 P=0.494N | (e) (e) | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Nephroblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/59 (0%) | 0/60 (0%) 2/59 (3%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% | 0.0% 4.0% 0.0% | |TERMINAL (d) | 0/36 (0%) 0/33 (0%) 0/32 (0%) | 0/31 (0%) 0/27 (0%) 0/27 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- | --- 169 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.637 P=0.205 (e) | |INCIDENTAL TUMOR | (e) (e) (e) | P=0.630N P=0.335 (e) | |LOGISTIC REGRESSION | (e) (e) (e) | P=0.579N P=0.402 (e) | |COCHRAN-ARMITAGE | (e) | P=0.668 | |FISHER EXACT | (e) (e) | P=0.244 (e) | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05041 TEST: 01 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SUCCINIC ANHYDRIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 50MG/KG 100MG/KG | CONTROL 50MG/KG 100MG/KG | | | MALE LOW MALE HIGHMALE | FEMALE LOW FEM HIGHFEM | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/47 (0%) 0/60 (0%) | 2/60 (3%) 1/51 (2%) 3/60 (5%) | |ADJUSTED (b) | 2.8% 0.0% 0.0% | 6.5% 5.6% 11.1% | |TERMINAL (d) | 1/36 (3%) 0/20 (0%) 0/32 (0%) | 2/31 (6%) 1/18 (6%) 3/27 (11%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- --- | 729 (T) 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.302N P=0.617N P=0.523N | P=0.346 P=0.687N P=0.436 | |INCIDENTAL TUMOR | P=0.302N P=0.617N P=0.523N | P=0.346 P=0.687N P=0.436 | |LOGISTIC REGRESSION | P=0.302N P=0.618N P=0.524N | P=0.346 P=0.687N P=0.436 | |COCHRAN-ARMITAGE | P=0.277N | P=0.402 | |FISHER EXACT | P=0.561N P=0.500N | P=0.561N P=0.500 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/60 (3%) 0/60 (0%) 1/60 (2%) | 3/60 (5%) 1/49 (2%) 0/60 (0%) | |ADJUSTED (b) | 5.6% 0.0% 3.1% | 9.1% 6.3% 0.0% | |TERMINAL (d) | 2/36 (6%) 0/33 (0%) 1/32 (3%) | 2/31 (6%) 1/16 (6%) 0/27 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- 729 (T) | 719 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.393N P=0.258N P=0.541N | P=0.091N P=0.504N P=0.147N | |INCIDENTAL TUMOR | P=0.393N P=0.258N P=0.541N | P=0.096N P=0.510N P=0.158N | |LOGISTIC REGRESSION | P=0.393N P=0.258N P=0.541N | P=0.094N P=0.532N P=0.150N | |COCHRAN-ARMITAGE | P=0.361N | P=0.067N | |FISHER EXACT | P=0.248N P=0.500N | P=0.389N P=0.122N | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05041 TEST: 01 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SUCCINIC ANHYDRIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 50MG/KG 100MG/KG | CONTROL 50MG/KG 100MG/KG | | | MALE LOW MALE HIGHMALE | FEMALE LOW FEM HIGHFEM | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/60 (3%) 1/60 (2%) 1/60 (2%) | 3/60 (5%) 1/49 (2%) 0/60 (0%) | |ADJUSTED (b) | 5.6% 2.6% 3.1% | 9.1% 6.3% 0.0% | |TERMINAL (d) | 2/36 (6%) 0/33 (0%) 1/32 (3%) | 2/31 (6%) 1/16 (6%) 0/27 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 705 729 (T) | 719 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.418N P=0.532N P=0.541N | P=0.091N P=0.504N P=0.147N | |INCIDENTAL TUMOR | P=0.415N P=0.541N P=0.541N | P=0.096N P=0.510N P=0.158N | |LOGISTIC REGRESSION | P=0.414N P=0.529N P=0.541N | P=0.094N P=0.532N P=0.150N | |COCHRAN-ARMITAGE | P=0.378N | P=0.067N | |FISHER EXACT | P=0.500N P=0.500N | P=0.389N P=0.122N | |=================================================================================================================================| | | |Mammary Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/60 (0%) 0/60 (0%) | 1/60 (2%) 2/60 (3%) 0/60 (0%) | |ADJUSTED (b) | 2.8% 0.0% 0.0% | 1.8% 4.9% 0.0% | |TERMINAL (d) | 1/36 (3%) 0/33 (0%) 0/32 (0%) | 0/31 (0%) 0/27 (0%) 0/27 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- --- | 507 606 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.287N P=0.517N P=0.523N | P=0.415N P=0.443 P=0.545N | |INCIDENTAL TUMOR | P=0.287N P=0.517N P=0.523N | P=0.465N P=0.414 P=0.638N | |LOGISTIC REGRESSION | P=0.287N P=0.517N P=0.524N | P=0.354N P=0.516 P=0.453N | |COCHRAN-ARMITAGE | P=0.270N | P=0.361N | |FISHER EXACT | P=0.500N P=0.500N | P=0.500 P=0.500N | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05041 TEST: 01 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SUCCINIC ANHYDRIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 50MG/KG 100MG/KG | CONTROL 50MG/KG 100MG/KG | | | MALE LOW MALE HIGHMALE | FEMALE LOW FEM HIGHFEM | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 2/60 (3%) 2/60 (3%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% | 0.0% 5.7% 7.4% | |TERMINAL (d) | 0/36 (0%) 0/33 (0%) 0/32 (0%) | 0/31 (0%) 0/27 (0%) 2/27 (7%) | |FIRST INCIDENCE (DAYS) | --- --- --- | --- 620 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.149 P=0.210 P=0.208 | |INCIDENTAL TUMOR | (e) (e) (e) | P=0.141 P=0.196 P=0.208 | |LOGISTIC REGRESSION | (e) (e) (e) | P=0.143 P=0.210 P=0.208 | |COCHRAN-ARMITAGE | (e) | P=0.176 | |FISHER EXACT | (e) (e) | P=0.248 P=0.248 | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/60 (0%) 0/60 (0%) | 1/60 (2%) 4/60 (7%) 2/60 (3%) | |ADJUSTED (b) | 2.8% 0.0% 0.0% | 1.8% 10.4% 7.4% | |TERMINAL (d) | 1/36 (3%) 0/33 (0%) 0/32 (0%) | 0/31 (0%) 0/27 (0%) 2/27 (7%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- --- | 507 606 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.287N P=0.517N P=0.523N | P=0.339 P=0.142 P=0.442 | |INCIDENTAL TUMOR | P=0.287N P=0.517N P=0.523N | P=0.295 P=0.115 P=0.390 | |LOGISTIC REGRESSION | P=0.287N P=0.517N P=0.524N | P=0.367 P=0.168 P=0.469 | |COCHRAN-ARMITAGE | P=0.270N | P=0.407 | |FISHER EXACT | P=0.500N P=0.500N | P=0.182 P=0.500 | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05041 TEST: 01 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SUCCINIC ANHYDRIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 50MG/KG 100MG/KG | CONTROL 50MG/KG 100MG/KG | | | MALE LOW MALE HIGHMALE | FEMALE LOW FEM HIGHFEM | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 2/60 (3%) 1/60 (2%) | 25/60 (42%) 23/60 (38%) 12/60 (20%) | |ADJUSTED (b) | 2.5% 6.1% 3.1% | 57.0% 61.0% 35.8% | |TERMINAL (d) | 0/36 (0%) 2/33 (6%) 1/32 (3%) | 13/31 (42%) 13/27 (48%) 6/27 (22%) | |FIRST INCIDENCE (DAYS) | 711 729 (T) 729 (T) | 553 603 663 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.586 P=0.471 P=0.739 | P=0.049N* P=0.470 P=0.047N* | |INCIDENTAL TUMOR | P=0.585 P=0.459 P=0.737 | P=0.039N* P=0.422 P=0.038N* | |LOGISTIC REGRESSION | P=0.587 P=0.470 P=0.738 | P=0.036N* P=0.429 P=0.035N* | |COCHRAN-ARMITAGE | P=0.622N | P=0.008N** | |FISHER EXACT | P=0.500 P=0.752N | P=0.426N P=0.009N** | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 2/60 (3%) 1/60 (2%) | 26/60 (43%) 25/60 (42%) 12/60 (20%) | |ADJUSTED (b) | 5.2% 6.1% 3.1% | 57.8% 63.0% 35.8% | |TERMINAL (d) | 1/36 (3%) 2/33 (6%) 1/32 (3%) | 13/31 (42%) 13/27 (48%) 6/27 (22%) | |FIRST INCIDENCE (DAYS) | 711 729 (T) 729 (T) | 507 603 663 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.431N P=0.663 P=0.536N | P=0.041N* P=0.392 P=0.035N* | |INCIDENTAL TUMOR | P=0.432N P=0.653 P=0.537N | P=0.032N* P=0.322 P=0.030N* | |LOGISTIC REGRESSION | P=0.430N P=0.664 P=0.538N | P=0.025N* P=0.346 P=0.023N* | |COCHRAN-ARMITAGE | P=0.391N | P=0.005N** | |FISHER EXACT | P=0.691N P=0.500N | P=0.500N P=0.005N** | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05041 TEST: 01 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SUCCINIC ANHYDRIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 50MG/KG 100MG/KG | CONTROL 50MG/KG 100MG/KG | | | MALE LOW MALE HIGHMALE | FEMALE LOW FEM HIGHFEM | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 2/60 (3%) 1/60 (2%) | 26/60 (43%) 25/60 (42%) 14/60 (23%) | |ADJUSTED (b) | 5.2% 6.1% 3.1% | 57.8% 63.0% 42.0% | |TERMINAL (d) | 1/36 (3%) 2/33 (6%) 1/32 (3%) | 13/31 (42%) 13/27 (48%) 8/27 (30%) | |FIRST INCIDENCE (DAYS) | 711 729 (T) 729 (T) | 507 603 663 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.431N P=0.663 P=0.536N | P=0.084N P=0.392 P=0.079N | |INCIDENTAL TUMOR | P=0.432N P=0.653 P=0.537N | P=0.078N P=0.322 P=0.079N | |LOGISTIC REGRESSION | P=0.430N P=0.664 P=0.538N | P=0.063N P=0.346 P=0.064N | |COCHRAN-ARMITAGE | P=0.391N | P=0.014N* | |FISHER EXACT | P=0.691N P=0.500N | P=0.500N P=0.016N* | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 20/57 (35%) 16/59 (27%) 13/60 (22%) | 30/60 (50%) 26/55 (47%) 20/60 (33%) | |ADJUSTED (b) | 48.5% 37.8% 34.0% | 65.8% 72.6% 55.8% | |TERMINAL (d) | 14/34 (41%) 9/33 (27%) 8/32 (25%) | 16/31 (52%) 14/23 (61%) 12/27 (44%) | |FIRST INCIDENCE (DAYS) | 599 451 533 | 553 471 337 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.156N P=0.340N P=0.177N | P=0.188N P=0.407 P=0.193N | |INCIDENTAL TUMOR | P=0.098N P=0.301N P=0.139N | P=0.175N P=0.292 P=0.160N | |LOGISTIC REGRESSION | P=0.107N P=0.271N P=0.137N | P=0.171N P=0.280 P=0.176N | |COCHRAN-ARMITAGE | P=0.065N | P=0.040N* | |FISHER EXACT | P=0.234N P=0.080N | P=0.458N P=0.048N* | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05041 TEST: 01 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SUCCINIC ANHYDRIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 50MG/KG 100MG/KG | CONTROL 50MG/KG 100MG/KG | | | MALE LOW MALE HIGHMALE | FEMALE LOW FEM HIGHFEM | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 20/57 (35%) 16/59 (27%) 14/60 (23%) | 31/60 (52%) 26/55 (47%) 21/60 (35%) | |ADJUSTED (b) | 48.5% 37.8% 35.4% | 68.0% 72.6% 57.1% | |TERMINAL (d) | 14/34 (41%) 9/33 (27%) 8/32 (25%) | 17/31 (55%) 14/23 (61%) 12/27 (44%) | |FIRST INCIDENCE (DAYS) | 599 451 533 | 553 471 337 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.213N P=0.340N P=0.240N | P=0.195N P=0.460 P=0.202N | |INCIDENTAL TUMOR | P=0.144N P=0.301N P=0.201N | P=0.181N P=0.355 P=0.169N | |LOGISTIC REGRESSION | P=0.150N P=0.271N P=0.190N | P=0.179N P=0.341 P=0.187N | |COCHRAN-ARMITAGE | P=0.096N | P=0.041N* | |FISHER EXACT | P=0.234N P=0.116N | P=0.388N P=0.048N* | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 0/60 (0%) 6/60 (10%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 4.7% 0.0% 17.8% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/36 (0%) 0/33 (0%) 5/32 (16%) | 0/31 (0%) 0/27 (0%) 0/27 (0%) | |FIRST INCIDENCE (DAYS) | 691 --- 703 | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.049 * P=0.264N P=0.107 | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.048 * P=0.276N P=0.104 | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.046 * P=0.249N P=0.101 | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.061 | (e) | |FISHER EXACT | P=0.248N P=0.136 | (e) (e) | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05041 TEST: 01 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SUCCINIC ANHYDRIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 50MG/KG 100MG/KG | CONTROL 50MG/KG 100MG/KG | | | MALE LOW MALE HIGHMALE | FEMALE LOW FEM HIGHFEM | |=================================================================================================================================| | | |Skin | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 1/60 (2%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 5.6% 3.0% 0.0% | 0.0% 0.0% 2.4% | |TERMINAL (d) | 2/36 (6%) 1/33 (3%) 0/32 (0%) | 0/31 (0%) 0/27 (0%) 0/27 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) --- | --- --- 606 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.163N P=0.530N P=0.264N | P=0.249 (e) P=0.465 | |INCIDENTAL TUMOR | P=0.163N P=0.530N P=0.264N | P=0.243 (e) P=0.455 | |LOGISTIC REGRESSION | P=0.163N P=0.530N P=0.264N | P=0.265 (e) P=0.504 | |COCHRAN-ARMITAGE | P=0.142N | P=0.270 | |FISHER EXACT | P=0.500N P=0.248N | (e) P=0.500 | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 1/60 (2%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 5.6% 3.0% 0.0% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/36 (6%) 1/33 (3%) 0/32 (0%) | 0/31 (0%) 0/27 (0%) 0/27 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) --- | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.163N P=0.530N P=0.264N | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.163N P=0.530N P=0.264N | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.163N P=0.530N P=0.264N | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.142N | (e) | |FISHER EXACT | P=0.500N P=0.248N | (e) (e) | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05041 TEST: 01 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SUCCINIC ANHYDRIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 50MG/KG 100MG/KG | CONTROL 50MG/KG 100MG/KG | | | MALE LOW MALE HIGHMALE | FEMALE LOW FEM HIGHFEM | |=================================================================================================================================| | | |Skin | | Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 5.4% 0.0% 0.0% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/36 (3%) 0/33 (0%) 0/32 (0%) | 0/31 (0%) 0/27 (0%) 0/27 (0%) | |FIRST INCIDENCE (DAYS) | 723 --- --- | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.110N P=0.259N P=0.266N | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.111N P=0.270N P=0.263N | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.107N P=0.257N P=0.261N | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.096N | (e) | |FISHER EXACT | P=0.248N P=0.248N | (e) (e) | |=================================================================================================================================| | | |Skin | | Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 0/60 (0%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 8.1% 0.0% 3.1% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/36 (6%) 0/33 (0%) 1/32 (3%) | 0/31 (0%) 0/27 (0%) 0/27 (0%) | |FIRST INCIDENCE (DAYS) | 723 --- 729 (T) | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.205N P=0.139N P=0.349N | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.204N P=0.145N P=0.346N | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.200N P=0.136N P=0.343N | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.176N | (e) | |FISHER EXACT | P=0.122N P=0.309N | (e) (e) | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05041 TEST: 01 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SUCCINIC ANHYDRIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 50MG/KG 100MG/KG | CONTROL 50MG/KG 100MG/KG | | | MALE LOW MALE HIGHMALE | FEMALE LOW FEM HIGHFEM | |=================================================================================================================================| | | |Skin | | Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, | | Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 7/60 (12%) 1/60 (2%) 7/60 (12%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 17.5% 3.0% 20.9% | 0.0% 0.0% 2.4% | |TERMINAL (d) | 4/36 (11%) 1/33 (3%) 6/32 (19%) | 0/31 (0%) 0/27 (0%) 0/27 (0%) | |FIRST INCIDENCE (DAYS) | 691 729 (T) 703 | --- --- 606 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.490 P=0.047N* P=0.523 | P=0.249 (e) P=0.465 | |INCIDENTAL TUMOR | P=0.493 P=0.049N* P=0.527 | P=0.243 (e) P=0.455 | |LOGISTIC REGRESSION | P=0.493 P=0.042N* P=0.527 | P=0.265 (e) P=0.504 | |COCHRAN-ARMITAGE | P=0.566 | P=0.270 | |FISHER EXACT | P=0.031N* P=0.611N | (e) P=0.500 | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 3/60 (5%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 6.6% 7.4% 6.3% | 0.0% 0.0% 2.9% | |TERMINAL (d) | 1/36 (3%) 1/33 (3%) 2/32 (6%) | 0/31 (0%) 0/27 (0%) 0/27 (0%) | |FIRST INCIDENCE (DAYS) | 542 451 729 (T) | --- --- 678 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.469N P=0.624 P=0.556N | P=0.246 (e) P=0.463 | |INCIDENTAL TUMOR | P=0.365N P=0.626 P=0.479N | P=0.233 (e) P=0.443 | |LOGISTIC REGRESSION | P=0.421N P=0.643N P=0.530N | P=0.252 (e) P=0.473 | |COCHRAN-ARMITAGE | P=0.412N | P=0.270 | |FISHER EXACT | P=0.660N P=0.500N | (e) P=0.500 | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05041 TEST: 01 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SUCCINIC ANHYDRIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 50MG/KG 100MG/KG | CONTROL 50MG/KG 100MG/KG | | | MALE LOW MALE HIGHMALE | FEMALE LOW FEM HIGHFEM | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibroma or Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 4/60 (7%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 6.6% 9.1% 6.3% | 0.0% 0.0% 2.9% | |TERMINAL (d) | 1/36 (3%) 1/33 (3%) 2/32 (6%) | 0/31 (0%) 0/27 (0%) 0/27 (0%) | |FIRST INCIDENCE (DAYS) | 542 451 729 (T) | --- --- 678 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.477N P=0.463 P=0.556N | P=0.246 (e) P=0.463 | |INCIDENTAL TUMOR | P=0.329N P=0.451 P=0.479N | P=0.233 (e) P=0.443 | |LOGISTIC REGRESSION | P=0.403N P=0.544 P=0.530N | P=0.252 (e) P=0.473 | |COCHRAN-ARMITAGE | P=0.417N | P=0.270 | |FISHER EXACT | P=0.500 P=0.500N | (e) P=0.500 | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, Sarcoma, | | Neurofibroma, or Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 4/60 (7%) 4/60 (7%) | 0/60 (0%) 0/60 (0%) 2/60 (3%) | |ADJUSTED (b) | 6.6% 9.1% 12.5% | 0.0% 0.0% 6.1% | |TERMINAL (d) | 1/36 (3%) 1/33 (3%) 4/32 (13%) | 0/31 (0%) 0/27 (0%) 0/27 (0%) | |FIRST INCIDENCE (DAYS) | 542 451 729 (T) | --- --- 678 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.363 P=0.463 P=0.434 | P=0.085 (e) P=0.210 | |INCIDENTAL TUMOR | P=0.493 P=0.451 P=0.499 | P=0.068 (e) P=0.173 | |LOGISTIC REGRESSION | P=0.417 P=0.544 P=0.450 | P=0.081 (e) P=0.200 | |COCHRAN-ARMITAGE | P=0.424 | P=0.096 | |FISHER EXACT | P=0.500 P=0.500 | (e) P=0.248 | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05041 TEST: 01 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SUCCINIC ANHYDRIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 50MG/KG 100MG/KG | CONTROL 50MG/KG 100MG/KG | | | MALE LOW MALE HIGHMALE | FEMALE LOW FEM HIGHFEM | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, or Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 0.0% 6.3% | 0.0% 0.0% 3.2% | |TERMINAL (d) | 0/36 (0%) 0/33 (0%) 2/32 (6%) | 0/31 (0%) 0/27 (0%) 0/27 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 729 (T) | --- --- 720 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.085 (e) P=0.213 | P=0.259 (e) P=0.482 | |INCIDENTAL TUMOR | P=0.085 (e) P=0.213 | P=0.233 (e) P=0.443 | |LOGISTIC REGRESSION | P=0.085 (e) P=0.213 | P=0.247 (e) P=0.464 | |COCHRAN-ARMITAGE | P=0.096 | P=0.270 | |FISHER EXACT | (e) P=0.248 | (e) P=0.500 | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 56/60 (93%) 48/58 (83%) 48/60 (80%) | | |ADJUSTED (b) | 100.0% 97.9% 97.9% | | |TERMINAL (d) | 36/36 (100%) 30/31 (97%) 31/32 (97%) | | |FIRST INCIDENCE (DAYS) | 364 575 431 | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.406N P=0.465N P=0.436N | | |INCIDENTAL TUMOR | P=0.189N P=0.153N P=0.196N | | |LOGISTIC REGRESSION | P=0.248N P=0.161N P=0.265N | | |COCHRAN-ARMITAGE | P=0.026N* | | |FISHER EXACT | P=0.067N P=0.029N* | | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05041 TEST: 01 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SUCCINIC ANHYDRIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 50MG/KG 100MG/KG | CONTROL 50MG/KG 100MG/KG | | | MALE LOW MALE HIGHMALE | FEMALE LOW FEM HIGHFEM | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/60 (12%) 7/60 (12%) 5/58 (9%) | 5/59 (8%) 2/45 (4%) 5/60 (8%) | |ADJUSTED (b) | 19.4% 16.7% 15.1% | 14.5% 10.7% 17.2% | |TERMINAL (d) | 7/36 (19%) 3/33 (9%) 4/32 (13%) | 4/31 (13%) 1/13 (8%) 4/27 (15%) | |FIRST INCIDENCE (DAYS) | 729 (T) 598 719 | 494 723 663 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.411N P=0.548 P=0.461N | P=0.473 P=0.531N P=0.533 | |INCIDENTAL TUMOR | P=0.439N P=0.607 P=0.474N | P=0.442 P=0.546N P=0.496 | |LOGISTIC REGRESSION | P=0.427N P=0.573 P=0.457N | P=0.454 P=0.495N P=0.519 | |COCHRAN-ARMITAGE | P=0.351N | P=0.560N | |FISHER EXACT | P=0.611N P=0.405N | P=0.345N P=0.618N | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/60 (10%) 2/60 (3%) 2/58 (3%) | 4/59 (7%) 2/45 (4%) 3/60 (5%) | |ADJUSTED (b) | 15.5% 5.9% 6.3% | 12.9% 10.7% 11.1% | |TERMINAL (d) | 4/36 (11%) 1/33 (3%) 2/32 (6%) | 4/31 (13%) 1/13 (8%) 3/27 (11%) | |FIRST INCIDENCE (DAYS) | 706 723 729 (T) | 729 (T) 723 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.111N P=0.170N P=0.178N | P=0.501N P=0.661 P=0.577N | |INCIDENTAL TUMOR | P=0.121N P=0.178N P=0.193N | P=0.507N P=0.654 P=0.577N | |LOGISTIC REGRESSION | P=0.107N P=0.163N P=0.175N | P=0.499N P=0.637 P=0.577N | |COCHRAN-ARMITAGE | P=0.088N | P=0.412N | |FISHER EXACT | P=0.136N P=0.147N | P=0.475N P=0.491N | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05041 TEST: 01 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SUCCINIC ANHYDRIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 50MG/KG 100MG/KG | CONTROL 50MG/KG 100MG/KG | | | MALE LOW MALE HIGHMALE | FEMALE LOW FEM HIGHFEM | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/60 (22%) 9/60 (15%) 6/58 (10%) | 9/59 (15%) 3/45 (7%) 8/60 (13%) | |ADJUSTED (b) | 34.0% 21.8% 18.1% | 27.1% 18.1% 28.0% | |TERMINAL (d) | 11/36 (31%) 4/33 (12%) 5/32 (16%) | 8/31 (26%) 2/13 (15%) 7/27 (26%) | |FIRST INCIDENCE (DAYS) | 706 598 719 | 494 723 663 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.090N P=0.316N P=0.106N | P=0.540 P=0.397N P=0.584 | |INCIDENTAL TUMOR | P=0.101N P=0.281N P=0.116N | P=0.514 P=0.409N P=0.554 | |LOGISTIC REGRESSION | P=0.092N P=0.292N P=0.098N | P=0.509 P=0.326N P=0.547 | |COCHRAN-ARMITAGE | P=0.059N | P=0.431N | |FISHER EXACT | P=0.240N P=0.077N | P=0.147N P=0.485N | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # | |----------- | | | |OVERALL (a) | | 11/60 (18%) 8/60 (13%) 9/60 (15%) | |ADJUSTED (b) | | 32.8% 22.7% 28.7% | |TERMINAL (d) | | 9/31 (29%) 3/27 (11%) 6/27 (22%) | |FIRST INCIDENCE (DAYS) | | 663 541 606 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.489N P=0.429N P=0.539N | |INCIDENTAL TUMOR | | P=0.541N P=0.453N P=0.572N | |LOGISTIC REGRESSION | | P=0.524N P=0.453N P=0.584N | |COCHRAN-ARMITAGE | | P=0.353N | |FISHER EXACT | | P=0.309N P=0.404N | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05041 TEST: 01 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SUCCINIC ANHYDRIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 50MG/KG 100MG/KG | CONTROL 50MG/KG 100MG/KG | | | MALE LOW MALE HIGHMALE | FEMALE LOW FEM HIGHFEM | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # | |----------- | | | |OVERALL (a) | | 0/60 (0%) 1/60 (2%) 2/60 (3%) | |ADJUSTED (b) | | 0.0% 3.0% 7.4% | |TERMINAL (d) | | 0/31 (0%) 0/27 (0%) 2/27 (7%) | |FIRST INCIDENCE (DAYS) | | --- 695 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.121 P=0.457 P=0.208 | |INCIDENTAL TUMOR | | P=0.117 P=0.464 P=0.208 | |LOGISTIC REGRESSION | | P=0.116 P=0.469 P=0.208 | |COCHRAN-ARMITAGE | | P=0.142 | |FISHER EXACT | | P=0.500 P=0.248 | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # | |----------- | | | |OVERALL (a) | | 11/60 (18%) 9/60 (15%) 11/60 (18%) | |ADJUSTED (b) | | 32.8% 25.0% 35.5% | |TERMINAL (d) | | 9/31 (29%) 3/27 (11%) 8/27 (30%) | |FIRST INCIDENCE (DAYS) | | 663 541 606 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.401 P=0.536N P=0.448 | |INCIDENTAL TUMOR | | P=0.348 P=0.562N P=0.417 | |LOGISTIC REGRESSION | | P=0.362 P=0.562N P=0.402 | |COCHRAN-ARMITAGE | | P=0.548 | |FISHER EXACT | | P=0.404N P=0.593N | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05041 TEST: 01 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SUCCINIC ANHYDRIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 50MG/KG 100MG/KG | CONTROL 50MG/KG 100MG/KG | | | MALE LOW MALE HIGHMALE | FEMALE LOW FEM HIGHFEM | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, | | or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 13/60 (22%) 11/60 (18%) 12/60 (20%) | 11/60 (18%) 6/60 (10%) 8/60 (13%) | |ADJUSTED (b) | 27.8% 28.1% 28.8% | 26.6% 19.4% 24.5% | |TERMINAL (d) | 6/36 (17%) 6/33 (18%) 5/32 (16%) | 5/31 (16%) 4/27 (15%) 4/27 (15%) | |FIRST INCIDENCE (DAYS) | 549 641 515 | 494 599 606 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.508 P=0.506N P=0.547 | P=0.384N P=0.252N P=0.450N | |INCIDENTAL TUMOR | P=0.522 P=0.442N P=0.557 | P=0.427N P=0.254N P=0.511N | |LOGISTIC REGRESSION | P=0.544N P=0.448N P=0.570N | P=0.381N P=0.229N P=0.442N | |COCHRAN-ARMITAGE | P=0.455N | P=0.255N | |FISHER EXACT | P=0.410N P=0.500N | P=0.148N P=0.309N | |=================================================================================================================================| | | |All Organs | | Mesothelioma Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 3/60 (5%) 4/60 (7%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 4.6% 7.5% 10.5% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/36 (3%) 1/33 (3%) 2/32 (6%) | 0/31 (0%) 0/27 (0%) 0/27 (0%) | |FIRST INCIDENCE (DAYS) | 603 634 570 | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.226 P=0.463 P=0.292 | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.201 P=0.525 P=0.264 | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.243 P=0.497 P=0.314 | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.265 | (e) | |FISHER EXACT | P=0.500 P=0.340 | (e) (e) | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05041 TEST: 01 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SUCCINIC ANHYDRIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 50MG/KG 100MG/KG | CONTROL 50MG/KG 100MG/KG | | | MALE LOW MALE HIGHMALE | FEMALE LOW FEM HIGHFEM | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 59/60 (98%) 56/60 (93%) 51/60 (85%) | 52/60 (87%) 42/60 (70%) 34/60 (57%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% | 98.1% 91.2% 82.8% | |TERMINAL (d) | 36/36 (100%) 33/33 (100%) 32/32 (100%) | 30/31 (97%) 23/27 (85%) 20/27 (74%) | |FIRST INCIDENCE (DAYS) | 364 451 431 | 479 471 337 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.440N P=0.455 P=0.461N | P=0.052N P=0.377N P=0.053N | |INCIDENTAL TUMOR | P=0.027N* P=0.362N P=0.079N | P=0.008N** P=0.372N P=0.009N** | |LOGISTIC REGRESSION | P=0.065N P=0.490N P=0.142N | P=0.004N** P=0.355N P=0.007N** | |COCHRAN-ARMITAGE | P=0.005N** | P<0.001N** | |FISHER EXACT | P=0.182N P=0.008N** | P=0.022N* P<0.001N** | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 30/60 (50%) 28/60 (47%) 21/60 (35%) | 21/60 (35%) 15/60 (25%) 18/60 (30%) | |ADJUSTED (b) | 57.4% 56.0% 49.5% | 47.2% 40.1% 52.0% | |TERMINAL (d) | 15/36 (42%) 12/33 (36%) 12/32 (38%) | 10/31 (32%) 7/27 (26%) 11/27 (41%) | |FIRST INCIDENCE (DAYS) | 145 365 515 | 494 169 606 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.204N P=0.536 P=0.212N | P=0.524N P=0.348N P=0.568N | |INCIDENTAL TUMOR | P=0.108N P=0.386N P=0.126N | P=0.507 P=0.303N P=0.504 | |LOGISTIC REGRESSION | P=0.108N P=0.425N P=0.101N | P=0.512N P=0.272N P=0.562 | |COCHRAN-ARMITAGE | P=0.059N | P=0.309N | |FISHER EXACT | P=0.428N P=0.070N | P=0.160N P=0.348N | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05041 TEST: 01 PAGE 22 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SUCCINIC ANHYDRIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 50MG/KG 100MG/KG | CONTROL 50MG/KG 100MG/KG | | | MALE LOW MALE HIGHMALE | FEMALE LOW FEM HIGHFEM | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 60/60 (100%) 57/60 (95%) 52/60 (87%) | 55/60 (92%) 47/60 (78%) 39/60 (65%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% | 98.2% 95.9% 90.6% | |TERMINAL (d) | 36/36 (100%) 33/33 (100%) 32/32 (100%) | 30/31 (97%) 25/27 (93%) 23/27 (85%) | |FIRST INCIDENCE (DAYS) | 145 365 431 | 479 169 337 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.446N P=0.455 P=0.466N | P=0.118N P=0.534N P=0.120N | |INCIDENTAL TUMOR | P=0.009N** P=0.215N P=0.028N* | P=0.012N* P=0.673 P=0.017N* | |LOGISTIC REGRESSION | P=0.013N* P=0.176N P=0.041N* | P=0.005N** P=0.659 P=0.016N* | |COCHRAN-ARMITAGE | P=0.002N** | P<0.001N** | |FISHER EXACT | P=0.122N P=0.003N** | P=0.036N* P<0.001N** | |=================================================================================================================================| (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 152335-152335/152335 --multipart-boundary--