TDMS Study 05075-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus DIPHENYLHYDANTOIN DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 TIME: 09:34:49 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-82151 ROUTE: DOSED FEED NTP C#: 55765 PATHOLOGIST: M. RYAN S. EUSTIS CAS: 57-41-0 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus DIPHENYLHYDANTOIN DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 TIME: 09:34:49 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-82151 ROUTE: DOSED FEED NTP C#: 55765 PATHOLOGIST: M. RYAN S. EUSTIS CAS: 57-41-0 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 DIPHENYLHYDANTOIN DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 TIME: 09:34:49 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-82151 ROUTE: DOSED FEED NTP C#: 55765 PATHOLOGIST: M. RYAN S. EUSTIS CAS: 57-41-0 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF DIPHENYLHYDANTOIN ==================================================================================================== MALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Cortex Adenoma Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma: Benign, Complex, Malignant, NOS Clitoral/Preputial Gland Carcinoma or Adenoma Islets, Pancreatic Adenoma Carcinoma or Adenoma Liver Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Alveolar/Bronchiolar Carcinoma Mammary Gland Fibroma, Fibroadenoma, Carcinoma, or Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma Skin: Subcutaneous Tissue Neurofibrosarcoma, Fibrosarcoma, Sarcoma, Neurofibroma, or Fibroma Testes Adenoma Thyroid Gland: C-Cell Carcinoma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus DIPHENYLHYDANTOIN DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 TIME: 09:34:49 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-82151 ROUTE: DOSED FEED NTP C#: 55765 PATHOLOGIST: M. RYAN S. EUSTIS CAS: 57-41-0 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF DIPHENYLHYDANTOIN ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Clitoral/Preputial Gland Adenoma Carcinoma or Adenoma Mammary Gland Carcinoma Carcinoma or Adenoma Fibroadenoma Fibroma, Fibroadenoma or Adenoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma Thyroid Gland: C-Cell Adenoma Carcinoma or Adenoma Uterus Polyp Stromal Sarcoma Stromal or Polyp Stromal All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/100 (0%) 0/48 (0%) 0/145 (0%) 3/99 (3%) | 2/71 (3%) 0/23 (0%) 0/50 (0%) 0/100 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 5.2% | 6.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/50 (0%) 0/32 (0%) 0/70 (0%) 1/52 (2%) | 2/32 (6%) 0/0 0/0 0/69 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 697 | 729 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.012 * (e) (e) P=0.137 | P=0.057N (e) (e) P=0.093N | |INCIDENTAL TUMOR | P=0.009 ** (e) (e) P=0.108 | P=0.057N (e) (e) P=0.093N | |LOGISTIC REGRESSION | P=0.010 * (e) (e) P=0.124 | P=0.057N (e) (e) P=0.093N | |COCHRAN-ARMITAGE | P=0.011 * | P=0.152N | |FISHER EXACT | (e) (e) P=0.121 | P=0.569N P=0.342N P=0.171N | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 31/100 (31%) 16/50 (32%) 56/146 (38%) 52/98 (53%) | 5/70 (7%) 0/23 (0%) 2/52 (4%) 5/100 (5%) | |ADJUSTED (b) | 47.7% 43.9% 56.7% 69.5% | 12.1% 0.0% 50.4% 6.9% | |TERMINAL (d) | 18/50 (36%) 13/33 (39%) 32/71 (45%) 30/52 (58%) | 3/31 (10%) 0/0 1/2 (50%) 3/69 (4%) | |FIRST INCIDENCE (DAYS) | 627 549 501 494 | 627 --- 648 671 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.001 ** P=0.281N P=0.164 P=0.009 ** | P=0.300N P=0.413N P=0.678N P=0.317N | |INCIDENTAL TUMOR | P<0.001 ** P=0.574N P=0.144 P<0.001 ** | P=0.396N P=0.326N P=0.673 P=0.444N | |LOGISTIC REGRESSION | P<0.001 ** P=0.501N P=0.155 P<0.001 ** | P=0.344N P=0.316N P=0.606N P=0.330N | |COCHRAN-ARMITAGE | P<0.001 ** | P=0.538N | |FISHER EXACT | P=0.522 P=0.147 P=0.001 ** | P=0.233N P=0.359N P=0.394N | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/100 (1%) 2/50 (4%) 7/146 (5%) 3/98 (3%) | 1/70 (1%) 0/23 (0%) 0/52 (0%) 0/100 (0%) | |ADJUSTED (b) | 1.2% 4.3% 7.2% 4.6% | 3.2% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/50 (0%) 0/33 (0%) 2/71 (3%) 1/52 (2%) | 1/31 (3%) 0/0 0/2 (0%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | 632 340 307 399 | 729 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.450 P=0.273 P=0.109 P=0.320 | P=0.224N (e) P=0.967N P=0.341N | |INCIDENTAL TUMOR | P=0.430 P=0.601 P=0.148 P=0.297 | P=0.224N (e) P=0.967N P=0.341N | |LOGISTIC REGRESSION | P=0.529 P=0.413 P=0.111 P=0.345 | P=0.224N (e) P=0.967N P=0.341N | |COCHRAN-ARMITAGE | P=0.442 | P=0.362N | |FISHER EXACT | P=0.258 P=0.096 P=0.303 | P=0.753N P=0.574N P=0.412N | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 32/100 (32%) 18/50 (36%) 62/146 (42%) 54/98 (55%) | 6/70 (9%) 0/23 (0%) 2/52 (4%) 5/100 (5%) | |ADJUSTED (b) | 48.4% 46.3% 60.5% 71.1% | 15.2% 0.0% 50.4% 6.9% | |TERMINAL (d) | 18/50 (36%) 13/33 (39%) 34/71 (48%) 31/52 (60%) | 4/31 (13%) 0/0 1/2 (50%) 3/69 (4%) | |FIRST INCIDENCE (DAYS) | 627 340 307 399 | 627 --- 648 671 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.002 ** P=0.409N P=0.084 P=0.007 ** | P=0.170N P=0.413N P=0.652N P=0.183N | |INCIDENTAL TUMOR | P<0.001 ** P=0.528 P=0.076 P<0.001 ** | P=0.237N P=0.326N P=0.692 P=0.278N | |LOGISTIC REGRESSION | P<0.001 ** P=0.427 P=0.065 P<0.001 ** | P=0.216N P=0.287N P=0.536N P=0.199N | |COCHRAN-ARMITAGE | P<0.001 ** | P=0.411N | |FISHER EXACT | P=0.377 P=0.063 P<0.001 ** | P=0.172N P=0.255N P=0.267N | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Bone | | Osteosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/100 (0%) 0/50 (0%) 2/150 (1%) 1/100 (1%) | 0/100 (0%) 0/50 (0%) 0/150 (0%) 0/100 (0%) | |ADJUSTED (b) | 0.0% 0.0% 1.8% 1.2% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/50 (0%) 0/33 (0%) 0/71 (0%) 0/53 (0%) | 0/60 (0%) 0/27 (0%) 0/99 (0%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 652 609 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.392 (e) P=0.339 P=0.495 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.378 (e) P=0.355 P=0.485 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.416 (e) P=0.338 P=0.537 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.397 | (e) | |FISHER EXACT | (e) P=0.359 P=0.500 | (e) (e) (e) | |=================================================================================================================================| | | |Brain | | Oligodendroglioma, Glioma, or Astrocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/77 (3%) 0/17 (0%) 0/82 (0%) 1/100 (1%) | 0/71 (0%) 0/23 (0%) 0/52 (0%) 0/100 (0%) | |ADJUSTED (b) | 3.2% 0.0% 0.0% 1.7% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/0 0/3 (0%) 0/53 (0%) | 0/31 (0%) 0/0 0/1 (0%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | 662 --- --- 715 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.601N P=0.359N P=0.160N P=0.483N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.622N P=0.547N P=0.136N P=0.552N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.401N P=0.678N P=0.265N P=0.388N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.462N | (e) | |FISHER EXACT | P=0.669N P=0.233N P=0.403N | (e) (e) (e) | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/76 (4%) 1/18 (6%) 3/86 (3%) 2/99 (2%) | 4/66 (6%) 4/24 (17%) 6/58 (10%) 1/99 (1%) | |ADJUSTED (b) | 6.6% 50.0% 14.2% 3.8% | 12.9% 100.0% 31.5% 1.5% | |TERMINAL (d) | 1/26 (4%) 1/2 (50%) 1/8 (13%) 2/53 (4%) | 4/31 (13%) 1/1 (100%) 3/10 (30%) 1/68 (1%) | |FIRST INCIDENCE (DAYS) | 613 732 (T) 626 732 (T) | 729 (T) 634 439 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.159N P=0.682 P=0.632 P=0.311N | P=0.003N** P=0.004 ** P=0.071 P=0.028N* | |INCIDENTAL TUMOR | P=0.167N P=0.595 P=0.636 P=0.341N | P=0.004N** P=0.019 * P=0.063 P=0.028N* | |LOGISTIC REGRESSION | P=0.192N P=0.568 P=0.654N P=0.347N | P=0.012N* P=0.030 * P=0.270 P=0.028N* | |COCHRAN-ARMITAGE | P=0.273N | P=0.014N* | |FISHER EXACT | P=0.579 P=0.599N P=0.377N | P=0.128 P=0.293 P=0.084N | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/76 (4%) 0/18 (0%) 2/86 (2%) 0/99 (0%) | 2/66 (3%) 0/24 (0%) 1/58 (2%) 2/99 (2%) | |ADJUSTED (b) | 6.3% 0.0% 13.2% 0.0% | 4.7% 0.0% 10.0% 2.8% | |TERMINAL (d) | 1/26 (4%) 0/2 (0%) 1/8 (13%) 0/53 (0%) | 1/31 (3%) 0/1 (0%) 1/10 (10%) 1/68 (1%) | |FIRST INCIDENCE (DAYS) | 634 --- 623 --- | 700 --- 729 (T) 693 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.063N P=0.361N P=0.587N P=0.085N | P=0.463N P=0.624N P=0.696N P=0.533N | |INCIDENTAL TUMOR | P=0.065N P=0.441N P=0.588N P=0.098N | P=0.541N P=0.597N P=0.724N P=0.663N | |LOGISTIC REGRESSION | P=0.071N P=0.481N P=0.473N P=0.080N | P=0.434N P=0.669N P=0.729 P=0.498N | |COCHRAN-ARMITAGE | P=0.077N | P=0.592N | |FISHER EXACT | P=0.524N P=0.442N P=0.080N | P=0.536N P=0.549N P=0.526N | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/76 (8%) 1/18 (6%) 5/86 (6%) 2/99 (2%) | 6/66 (9%) 4/24 (17%) 7/58 (12%) 3/99 (3%) | |ADJUSTED (b) | 12.6% 50.0% 27.1% 3.8% | 17.4% 100.0% 41.2% 4.2% | |TERMINAL (d) | 2/26 (8%) 1/2 (50%) 2/8 (25%) 2/53 (4%) | 5/31 (16%) 1/1 (100%) 4/10 (40%) 2/68 (3%) | |FIRST INCIDENCE (DAYS) | 613 732 (T) 623 732 (T) | 700 634 439 693 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.026N* P=0.455N P=0.589N P=0.053N | P=0.004N** P=0.023 * P=0.108 P=0.044N* | |INCIDENTAL TUMOR | P=0.027N* P=0.595N P=0.589N P=0.066N | P=0.006N** P=0.070 P=0.091 P=0.067N | |LOGISTIC REGRESSION | P=0.037N* P=0.647N P=0.473N P=0.062N | P=0.016N* P=0.075 P=0.334 P=0.046N* | |COCHRAN-ARMITAGE | P=0.058N | P=0.023N* | |FISHER EXACT | P=0.598N P=0.414N P=0.070N | P=0.255 P=0.401 P=0.093N | |=================================================================================================================================| | | |Ear | | Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/100 (0%) 0/50 (0%) 0/150 (0%) 0/100 (0%) | 0/100 (0%) 0/50 (0%) 2/150 (1%) 0/100 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 1.9% 0.0% | |TERMINAL (d) | 0/50 (0%) 0/33 (0%) 0/71 (0%) 0/53 (0%) | 0/60 (0%) 0/27 (0%) 1/99 (1%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- 699 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.634N (e) P=0.352 (e) | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.712N (e) P=0.310 (e) | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.658N (e) P=0.340 (e) | |COCHRAN-ARMITAGE | (e) | P=0.664N | |FISHER EXACT | (e) (e) (e) | (e) P=0.359 (e) | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/77 (5%) 0/15 (0%) 1/76 (1%) 0/97 (0%) | 2/70 (3%) 1/23 (4%) 1/48 (2%) 0/100 (0%) | |ADJUSTED (b) | 9.9% 0.0% 0.9% 0.0% | 4.4% 0.0% 1.0% 0.0% | |TERMINAL (d) | 2/27 (7%) 0/0 0/3 (0%) 0/52 (0%) | 1/31 (3%) 0/0 0/1 (0%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | 543 --- 652 --- | 652 681 711 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.027N* P=0.382N P=0.293N P=0.030N* | P=0.083N P=0.588 P=0.635N P=0.156N | |INCIDENTAL TUMOR | P=0.025N* P=0.755N P=0.345N P=0.033N* | P=0.130N P=0.600 P=0.711N P=0.206N | |LOGISTIC REGRESSION | P=0.036N* P=0.438N P=0.199N P=0.039N* | P=0.064N P=0.581 P=0.717 P=0.156N | |COCHRAN-ARMITAGE | P=0.038N* | P=0.087N | |FISHER EXACT | P=0.484N P=0.187N P=0.037N* | P=0.578 P=0.639N P=0.168N | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/77 (1%) 0/15 (0%) 2/76 (3%) 0/97 (0%) | 0/70 (0%) 0/23 (0%) 0/48 (0%) 0/100 (0%) | |ADJUSTED (b) | 3.7% 0.0% 33.8% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/27 (4%) 0/0 1/3 (33%) 0/52 (0%) | 0/31 (0%) 0/0 0/1 (0%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | 732 (T) --- 517 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.188N (e) P=0.136 P=0.369N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.172N (e) P=0.098 P=0.369N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.292N (e) P=0.491 P=0.369N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.291N | (e) | |FISHER EXACT | P=0.837N P=0.495 P=0.443N | (e) (e) (e) | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/77 (6%) 0/15 (0%) 3/76 (4%) 0/97 (0%) | 2/70 (3%) 1/23 (4%) 1/48 (2%) 0/100 (0%) | |ADJUSTED (b) | 13.5% 0.0% 34.4% 0.0% | 4.4% 0.0% 1.0% 0.0% | |TERMINAL (d) | 3/27 (11%) 0/0 1/3 (33%) 0/52 (0%) | 1/31 (3%) 0/0 0/1 (0%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | 543 --- 517 --- | 652 681 711 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.010N** P=0.382N P=0.607 P=0.011N* | P=0.083N P=0.588 P=0.635N P=0.156N | |INCIDENTAL TUMOR | P=0.008N** P=0.755N P=0.514 P=0.012N* | P=0.130N P=0.600 P=0.711N P=0.206N | |LOGISTIC REGRESSION | P=0.020N* P=0.395N P=0.384N P=0.017N* | P=0.064N P=0.581 P=0.717 P=0.156N | |COCHRAN-ARMITAGE | P=0.021N* | P=0.087N | |FISHER EXACT | P=0.402N P=0.367N P=0.016N* | P=0.578 P=0.639N P=0.168N | |=================================================================================================================================| | | |Kidney: Pelvis and Transitional Epithelium | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/78 (0%) 0/21 (0%) 2/89 (2%) 0/100 (0%) | 0/71 (0%) 0/23 (0%) 0/52 (0%) 0/100 (0%) | |ADJUSTED (b) | 0.0% 0.0% 1.5% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/28 (0%) 0/4 (0%) 0/11 (0%) 0/53 (0%) | 0/31 (0%) 0/0 0/2 (0%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 487 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.671N (e) P=0.333 (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.612N (e) P=0.295 (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.560N (e) P=0.350 (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.558N | (e) | |FISHER EXACT | (e) P=0.283 (e) | (e) (e) (e) | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/100 (1%) 2/49 (4%) 4/148 (3%) 9/99 (9%) | 0/99 (0%) 0/50 (0%) 2/150 (1%) 1/100 (1%) | |ADJUSTED (b) | 1.4% 5.7% 5.6% 15.4% | 0.0% 0.0% 2.0% 1.4% | |TERMINAL (d) | 0/50 (0%) 1/33 (3%) 4/71 (6%) 5/53 (9%) | 0/60 (0%) 0/27 (0%) 2/99 (2%) 1/69 (1%) | |FIRST INCIDENCE (DAYS) | 662 683 732 (T) 695 | --- --- 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.004 ** P=0.327 P=0.308 P=0.017 * | P=0.439 (e) P=0.355 P=0.528 | |INCIDENTAL TUMOR | P=0.003 ** P=0.187 P=0.313 P=0.009 ** | P=0.439 (e) P=0.355 P=0.528 | |LOGISTIC REGRESSION | P=0.003 ** P=0.264 P=0.325 P=0.012 * | P=0.439 (e) P=0.355 P=0.528 | |COCHRAN-ARMITAGE | P=0.003 ** | P=0.398 | |FISHER EXACT | P=0.252 P=0.329 P=0.009 ** | (e) P=0.362 P=0.503 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/100 (1%) 3/49 (6%) 5/148 (3%) 9/99 (9%) | 0/99 (0%) 0/50 (0%) 2/150 (1%) 1/100 (1%) | |ADJUSTED (b) | 1.4% 8.4% 7.0% 15.4% | 0.0% 0.0% 2.0% 1.4% | |TERMINAL (d) | 0/50 (0%) 1/33 (3%) 5/71 (7%) 5/53 (9%) | 0/60 (0%) 0/27 (0%) 2/99 (2%) 1/69 (1%) | |FIRST INCIDENCE (DAYS) | 662 683 732 (T) 695 | --- --- 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.011 * P=0.159 P=0.210 P=0.017 * | P=0.439 (e) P=0.355 P=0.528 | |INCIDENTAL TUMOR | P=0.008 ** P=0.043 * P=0.213 P=0.009 ** | P=0.439 (e) P=0.355 P=0.528 | |LOGISTIC REGRESSION | P=0.009 ** P=0.107 P=0.226 P=0.012 * | P=0.439 (e) P=0.355 P=0.528 | |COCHRAN-ARMITAGE | P=0.010 ** | P=0.398 | |FISHER EXACT | P=0.104 P=0.225 P=0.009 ** | (e) P=0.362 P=0.503 | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/100 (1%) 3/49 (6%) 5/148 (3%) 9/99 (9%) | 0/99 (0%) 0/50 (0%) 2/150 (1%) 1/100 (1%) | |ADJUSTED (b) | 1.4% 8.4% 7.0% 15.4% | 0.0% 0.0% 2.0% 1.4% | |TERMINAL (d) | 0/50 (0%) 1/33 (3%) 5/71 (7%) 5/53 (9%) | 0/60 (0%) 0/27 (0%) 2/99 (2%) 1/69 (1%) | |FIRST INCIDENCE (DAYS) | 662 683 732 (T) 695 | --- --- 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.011 * P=0.159 P=0.210 P=0.017 * | P=0.439 (e) P=0.355 P=0.528 | |INCIDENTAL TUMOR | P=0.008 ** P=0.043 * P=0.213 P=0.009 ** | P=0.439 (e) P=0.355 P=0.528 | |LOGISTIC REGRESSION | P=0.009 ** P=0.107 P=0.226 P=0.012 * | P=0.439 (e) P=0.355 P=0.528 | |COCHRAN-ARMITAGE | P=0.010 ** | P=0.398 | |FISHER EXACT | P=0.104 P=0.225 P=0.009 ** | (e) P=0.362 P=0.503 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/77 (3%) 0/18 (0%) 1/83 (1%) 2/100 (2%) | 1/72 (1%) 0/24 (0%) 0/54 (0%) 1/100 (1%) | |ADJUSTED (b) | 5.4% 0.0% 1.1% 3.4% | 3.1% 0.0% 0.0% 1.4% | |TERMINAL (d) | 1/27 (4%) 0/1 (0%) 0/4 (0%) 1/53 (2%) | 1/32 (3%) 0/1 (0%) 0/3 (0%) 1/69 (1%) | |FIRST INCIDENCE (DAYS) | 715 --- 694 695 | 729 (T) --- --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.590N P=0.561N P=0.587N P=0.556N | P=0.499N P=0.997N P=0.931N P=0.581N | |INCIDENTAL TUMOR | P=0.607N P=0.709N P=0.565N P=0.602N | P=0.499N P=0.997N P=0.931N P=0.581N | |LOGISTIC REGRESSION | P=0.490N P=0.788N P=0.656N P=0.517N | P=0.499N P=0.997N P=0.931N P=0.581N | |COCHRAN-ARMITAGE | P=0.638 | P=0.684 | |FISHER EXACT | P=0.655N P=0.472N P=0.586N | P=0.750N P=0.571N P=0.663N | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/77 (1%) 1/18 (6%) 0/83 (0%) 4/100 (4%) | 1/72 (1%) 0/24 (0%) 1/54 (2%) 0/100 (0%) | |ADJUSTED (b) | 3.7% 100.0% 0.0% 7.5% | 3.1% 0.0% 1.0% 0.0% | |TERMINAL (d) | 1/27 (4%) 1/1 (100%) 0/4 (0%) 4/53 (8%) | 1/32 (3%) 0/1 (0%) 0/3 (0%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | 732 (T) 732 (T) --- 732 (T) | 729 (T) --- 704 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.527 P=0.048 * P=0.866N P=0.428 | P=0.248N P=0.997N P=0.644 P=0.347N | |INCIDENTAL TUMOR | P=0.527 P=0.048 * P=0.866N P=0.428 | P=0.299N P=0.997N P=0.582 P=0.347N | |LOGISTIC REGRESSION | P=0.527 P=0.048 * P=0.866N P=0.428 | P=0.220N P=0.997N P=0.476 P=0.347N | |COCHRAN-ARMITAGE | P=0.170 | P=0.316N | |FISHER EXACT | P=0.345 P=0.481N P=0.276 | P=0.750N P=0.675 P=0.419N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/77 (4%) 1/18 (6%) 1/83 (1%) 6/100 (6%) | 2/72 (3%) 0/24 (0%) 1/54 (2%) 1/100 (1%) | |ADJUSTED (b) | 9.1% 100.0% 1.1% 10.8% | 6.3% 0.0% 1.0% 1.4% | |TERMINAL (d) | 2/27 (7%) 1/1 (100%) 0/4 (0%) 5/53 (9%) | 2/32 (6%) 0/1 (0%) 0/3 (0%) 1/69 (1%) | |FIRST INCIDENCE (DAYS) | 715 732 (T) 694 695 | 729 (T) --- 704 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.555 P=0.494 P=0.520N P=0.550 | P=0.200N P=0.967N P=0.681 P=0.245N | |INCIDENTAL TUMOR | P=0.546 P=0.366 P=0.498N P=0.518 | P=0.230N P=0.967N P=0.627 P=0.245N | |LOGISTIC REGRESSION | P=0.559 P=0.354 P=0.513N P=0.567 | P=0.196N P=0.967N P=0.566 P=0.245N | |COCHRAN-ARMITAGE | P=0.237 | P=0.383N | |FISHER EXACT | P=0.575 P=0.282N P=0.393 | P=0.561N P=0.607N P=0.378N | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Mammary Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/100 (0%) 0/50 (0%) 0/150 (0%) 0/100 (0%) | 2/100 (2%) 0/50 (0%) 1/150 (1%) 0/100 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 3.3% 0.0% 1.0% 0.0% | |TERMINAL (d) | 0/50 (0%) 0/33 (0%) 0/71 (0%) 0/53 (0%) | 2/60 (3%) 0/27 (0%) 1/99 (1%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 729 (T) --- 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.196N P=0.426N P=0.330N P=0.209N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.196N P=0.426N P=0.330N P=0.209N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.196N P=0.426N P=0.330N P=0.209N | |COCHRAN-ARMITAGE | (e) | P=0.223N | |FISHER EXACT | (e) (e) (e) | P=0.443N P=0.351N P=0.249N | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/100 (1%) 0/50 (0%) 0/150 (0%) 0/100 (0%) | 6/100 (6%) 0/50 (0%) 2/150 (1%) 0/100 (0%) | |ADJUSTED (b) | 2.0% 0.0% 0.0% 0.0% | 8.1% 0.0% 2.0% 0.0% | |TERMINAL (d) | 1/50 (2%) 0/33 (0%) 0/71 (0%) 0/53 (0%) | 2/60 (3%) 0/27 (0%) 1/99 (1%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | 732 (T) --- --- --- | 388 --- 711 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.445N P=0.583N P=0.430N P=0.488N | P=0.020N* P=0.108N P=0.039N* P=0.017N* | |INCIDENTAL TUMOR | P=0.445N P=0.583N P=0.430N P=0.488N | P=0.039N* P=0.102N P=0.068N P=0.043N* | |LOGISTIC REGRESSION | P=0.445N P=0.583N P=0.430N P=0.488N | P=0.022N* P=0.099N P=0.050N P=0.017N* | |COCHRAN-ARMITAGE | P=0.443N | P=0.024N* | |FISHER EXACT | P=0.667N P=0.400N P=0.500N | P=0.083N P=0.047N* P=0.014N* | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/100 (1%) 0/50 (0%) 0/150 (0%) 0/100 (0%) | 8/100 (8%) 0/50 (0%) 3/150 (2%) 0/100 (0%) | |ADJUSTED (b) | 2.0% 0.0% 0.0% 0.0% | 11.3% 0.0% 3.0% 0.0% | |TERMINAL (d) | 1/50 (2%) 0/33 (0%) 0/71 (0%) 0/53 (0%) | 4/60 (7%) 0/27 (0%) 2/99 (2%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | 732 (T) --- --- --- | 388 --- 711 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.445N P=0.583N P=0.430N P=0.488N | P=0.007N** P=0.060N P=0.020N* P=0.004N** | |INCIDENTAL TUMOR | P=0.445N P=0.583N P=0.430N P=0.488N | P=0.013N* P=0.056N P=0.034N* P=0.012N* | |LOGISTIC REGRESSION | P=0.445N P=0.583N P=0.430N P=0.488N | P=0.009N** P=0.049N* P=0.026N* P=0.006N** | |COCHRAN-ARMITAGE | P=0.443N | P=0.009N** | |FISHER EXACT | P=0.667N P=0.400N P=0.500N | P=0.035N* P=0.026N* P=0.003N** | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/100 (4%) 4/50 (8%) 2/150 (1%) 1/100 (1%) | 26/100 (26%) 14/50 (28%) 18/150 (12%) 6/100 (6%) | |ADJUSTED (b) | 6.4% 10.9% 2.1% 1.9% | 34.7% 41.2% 16.2% 8.0% | |TERMINAL (d) | 2/50 (4%) 2/33 (6%) 1/71 (1%) 1/53 (2%) | 14/60 (23%) 8/27 (30%) 12/99 (12%) 3/69 (4%) | |FIRST INCIDENCE (DAYS) | 617 654 597 732 (T) | 586 630 595 630 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.071N P=0.359 P=0.188N P=0.174N | P<0.001N** P=0.374 P=0.002N** P<0.001N** | |INCIDENTAL TUMOR | P=0.071N P=0.233 P=0.181N P=0.187N | P<0.001N** P=0.533 P=0.003N** P<0.001N** | |LOGISTIC REGRESSION | P=0.067N P=0.267 P=0.176N P=0.185N | P<0.001N** P=0.476 P=0.003N** P<0.001N** | |COCHRAN-ARMITAGE | P=0.066N | P<0.001N** | |FISHER EXACT | P=0.254 P=0.176N P=0.184N | P=0.470 P=0.004N** P<0.001N** | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/100 (4%) 4/50 (8%) 2/150 (1%) 1/100 (1%) | 28/100 (28%) 14/50 (28%) 19/150 (13%) 6/100 (6%) | |ADJUSTED (b) | 6.4% 10.9% 2.1% 1.9% | 37.5% 41.2% 17.2% 8.0% | |TERMINAL (d) | 2/50 (4%) 2/33 (6%) 1/71 (1%) 1/53 (2%) | 16/60 (27%) 8/27 (30%) 13/99 (13%) 3/69 (4%) | |FIRST INCIDENCE (DAYS) | 617 654 597 732 (T) | 586 630 595 630 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.071N P=0.359 P=0.188N P=0.174N | P<0.001N** P=0.463 P=0.001N** P<0.001N** | |INCIDENTAL TUMOR | P=0.071N P=0.233 P=0.181N P=0.187N | P<0.001N** P=0.526N P=0.002N** P<0.001N** | |LOGISTIC REGRESSION | P=0.067N P=0.267 P=0.176N P=0.185N | P<0.001N** P=0.577 P=0.002N** P<0.001N** | |COCHRAN-ARMITAGE | P=0.066N | P<0.001N** | |FISHER EXACT | P=0.254 P=0.176N P=0.184N | P=0.580N P=0.002N** P<0.001N** | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 5/100 (5%) 4/50 (8%) 2/150 (1%) 1/100 (1%) | 34/100 (34%) 14/50 (28%) 21/150 (14%) 6/100 (6%) | |ADJUSTED (b) | 8.3% 10.9% 2.1% 1.9% | 43.4% 41.2% 19.0% 8.0% | |TERMINAL (d) | 3/50 (6%) 2/33 (6%) 1/71 (1%) 1/53 (2%) | 18/60 (30%) 8/27 (30%) 14/99 (14%) 3/69 (4%) | |FIRST INCIDENCE (DAYS) | 617 654 597 732 (T) | 388 630 595 630 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.044N* P=0.474 P=0.101N P=0.100N | P<0.001N** P=0.413N P<0.001N** P<0.001N** | |INCIDENTAL TUMOR | P=0.044N* P=0.348 P=0.096N P=0.107N | P<0.001N** P=0.256N P<0.001N** P<0.001N** | |LOGISTIC REGRESSION | P=0.042N* P=0.373 P=0.092N P=0.108N | P<0.001N** P=0.282N P<0.001N** P<0.001N** | |COCHRAN-ARMITAGE | P=0.040N* | P<0.001N** | |FISHER EXACT | P=0.347 P=0.093N P=0.106N | P=0.291N P<0.001N** P<0.001N** | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) | | Papilloma Squamous or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/100 (0%) 0/50 (0%) 2/150 (1%) 0/100 (0%) | 0/100 (0%) 0/50 (0%) 0/150 (0%) 0/100 (0%) | |ADJUSTED (b) | 0.0% 0.0% 2.5% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/50 (0%) 0/33 (0%) 1/71 (1%) 0/53 (0%) | 0/60 (0%) 0/27 (0%) 0/99 (0%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 704 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.662N (e) P=0.329 (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.671N (e) P=0.337 (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.665N (e) P=0.334 (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.664N | (e) | |FISHER EXACT | (e) P=0.359 (e) | (e) (e) (e) | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/100 (0%) 0/50 (0%) 2/150 (1%) 0/100 (0%) | 0/100 (0%) 0/50 (0%) 1/150 (1%) 0/100 (0%) | |ADJUSTED (b) | 0.0% 0.0% 2.5% 0.0% | 0.0% 0.0% 1.0% 0.0% | |TERMINAL (d) | 0/50 (0%) 0/33 (0%) 1/71 (1%) 0/53 (0%) | 0/60 (0%) 0/27 (0%) 1/99 (1%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 704 --- | --- --- 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.662N (e) P=0.329 (e) | P=0.748N (e) P=0.600 (e) | |INCIDENTAL TUMOR | P=0.671N (e) P=0.337 (e) | P=0.748N (e) P=0.600 (e) | |LOGISTIC REGRESSION | P=0.665N (e) P=0.334 (e) | P=0.748N (e) P=0.600 (e) | |COCHRAN-ARMITAGE | P=0.664N | P=0.770N | |FISHER EXACT | (e) P=0.359 (e) | (e) P=0.600 (e) | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 24/84 (29%) 6/20 (30%) 23/88 (26%) 19/97 (20%) | 51/91 (56%) 15/43 (35%) 47/100 (47%) 26/100 (26%)| |ADJUSTED (b) | 49.1% 76.9% 71.4% 28.6% | 65.9% 56.3% 64.1% 33.4% | |TERMINAL (d) | 14/34 (41%) 3/4 (75%) 8/12 (67%) 10/53 (19%) | 27/51 (53%) 10/20 (50%) 30/51 (59%) 19/69 (28%) | |FIRST INCIDENCE (DAYS) | 519 617 518 568 | 470 425 470 575 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.027N* P=0.506N P=0.273 P=0.056N | P<0.001N** P=0.087N P=0.069N P<0.001N** | |INCIDENTAL TUMOR | P=0.028N* P=0.298 P=0.268 P=0.096N | P<0.001N** P=0.023N* P=0.146N P<0.001N** | |LOGISTIC REGRESSION | P=0.034N* P=0.392 P=0.514 P=0.084N | P<0.001N** P=0.016N* P=0.144N P<0.001N** | |COCHRAN-ARMITAGE | P=0.076N | P<0.001N** | |FISHER EXACT | P=0.549 P=0.426N P=0.107N | P=0.017N* P=0.135N P<0.001N** | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 24/84 (29%) 6/20 (30%) 23/88 (26%) 19/97 (20%) | 52/91 (57%) 15/43 (35%) 48/100 (48%) 26/100 (26%)| |ADJUSTED (b) | 49.1% 76.9% 71.4% 28.6% | 67.3% 56.3% 64.4% 33.4% | |TERMINAL (d) | 14/34 (41%) 3/4 (75%) 8/12 (67%) 10/53 (19%) | 28/51 (55%) 10/20 (50%) 30/51 (59%) 19/69 (28%) | |FIRST INCIDENCE (DAYS) | 519 617 518 568 | 470 425 470 575 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.027N* P=0.506N P=0.273 P=0.056N | P<0.001N** P=0.074N P=0.067N P<0.001N** | |INCIDENTAL TUMOR | P=0.028N* P=0.298 P=0.268 P=0.096N | P<0.001N** P=0.018N* P=0.138N P<0.001N** | |LOGISTIC REGRESSION | P=0.034N* P=0.392 P=0.514 P=0.084N | P<0.001N** P=0.012N* P=0.140N P<0.001N** | |COCHRAN-ARMITAGE | P=0.076N | P<0.001N** | |FISHER EXACT | P=0.549 P=0.426N P=0.107N | P=0.013N* P=0.132N P<0.001N** | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Skin | | Basal Cell Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/100 (0%) 0/50 (0%) 2/150 (1%) 1/100 (1%) | 0/100 (0%) 0/50 (0%) 0/150 (0%) 0/100 (0%) | |ADJUSTED (b) | 0.0% 0.0% 2.6% 1.2% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/50 (0%) 0/33 (0%) 1/71 (1%) 0/53 (0%) | 0/60 (0%) 0/27 (0%) 0/99 (0%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 709 639 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.397 (e) P=0.324 P=0.500 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.384 (e) P=0.337 P=0.485 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.394 (e) P=0.334 P=0.518 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.397 | (e) | |FISHER EXACT | (e) P=0.359 P=0.500 | (e) (e) (e) | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/100 (2%) 0/50 (0%) 5/150 (3%) 2/100 (2%) | 1/100 (1%) 0/50 (0%) 1/150 (1%) 0/100 (0%) | |ADJUSTED (b) | 3.0% 0.0% 5.8% 3.6% | 1.7% 0.0% 0.9% 0.0% | |TERMINAL (d) | 0/50 (0%) 0/33 (0%) 2/71 (3%) 1/53 (2%) | 1/60 (2%) 0/27 (0%) 0/99 (0%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | 666 --- 518 722 | 729 (T) --- 699 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.555 P=0.365N P=0.402 P=0.664N | P=0.391N P=0.659N P=0.648N P=0.472N | |INCIDENTAL TUMOR | P=0.567 P=0.547N P=0.407 P=0.659 | P=0.464N P=0.659N P=0.690N P=0.472N | |LOGISTIC REGRESSION | P=0.551 P=0.402N P=0.408 P=0.692 | P=0.413N P=0.659N P=0.660N P=0.472N | |COCHRAN-ARMITAGE | P=0.555 | P=0.419N | |FISHER EXACT | P=0.443N P=0.418 P=0.689N | P=0.667N P=0.641N P=0.500N | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Skin | | Squamous Cell Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/100 (2%) 0/50 (0%) 1/150 (1%) 3/100 (3%) | 1/100 (1%) 0/50 (0%) 0/150 (0%) 0/100 (0%) | |ADJUSTED (b) | 3.3% 0.0% 1.4% 4.7% | 1.4% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/50 (2%) 0/33 (0%) 1/71 (1%) 0/53 (0%) | 0/60 (0%) 0/27 (0%) 0/99 (0%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | 658 --- 732 (T) 666 | 677 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.235 P=0.363N P=0.373N P=0.526 | P=0.438N P=0.644N P=0.414N P=0.495N | |INCIDENTAL TUMOR | P=0.215 P=0.429N P=0.363N P=0.451 | P=0.535N P=0.648N P=0.473N P=0.629N | |LOGISTIC REGRESSION | P=0.227 P=0.397N P=0.360N P=0.497 | P=0.442N P=0.639N P=0.421N P=0.500N | |COCHRAN-ARMITAGE | P=0.231 | P=0.443N | |FISHER EXACT | P=0.443N P=0.351N P=0.500 | P=0.667N P=0.400N P=0.500N | |=================================================================================================================================| | | |Skin | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/100 (3%) 0/50 (0%) 3/150 (2%) 3/100 (3%) | 2/100 (2%) 0/50 (0%) 4/150 (3%) 1/100 (1%) | |ADJUSTED (b) | 5.3% 0.0% 4.2% 4.7% | 3.0% 0.0% 4.0% 1.4% | |TERMINAL (d) | 2/50 (4%) 0/33 (0%) 3/71 (4%) 0/53 (0%) | 1/60 (2%) 0/27 (0%) 3/99 (3%) 1/69 (1%) | |FIRST INCIDENCE (DAYS) | 658 --- 732 (T) 666 | 677 --- 707 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.437 P=0.223N P=0.488N P=0.632N | P=0.427N P=0.417N P=0.572 P=0.465N | |INCIDENTAL TUMOR | P=0.423 P=0.262N P=0.481N P=0.625 | P=0.503N P=0.420N P=0.519 P=0.541N | |LOGISTIC REGRESSION | P=0.431 P=0.253N P=0.461N P=0.659 | P=0.461N P=0.402N P=0.553 P=0.494N | |COCHRAN-ARMITAGE | P=0.436 | P=0.482N | |FISHER EXACT | P=0.293N P=0.456N P=0.659N | P=0.443N P=0.544 P=0.500N | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/100 (1%) 0/50 (0%) 2/150 (1%) 0/100 (0%) | 1/100 (1%) 0/50 (0%) 4/150 (3%) 1/100 (1%) | |ADJUSTED (b) | 2.0% 0.0% 2.8% 0.0% | 1.7% 0.0% 4.0% 1.4% | |TERMINAL (d) | 1/50 (2%) 0/33 (0%) 2/71 (3%) 0/53 (0%) | 1/60 (2%) 0/27 (0%) 3/99 (3%) 1/69 (1%) | |FIRST INCIDENCE (DAYS) | 732 (T) --- 732 (T) --- | 729 (T) --- 707 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.405N P=0.583N P=0.621 P=0.488N | P=0.588N P=0.659N P=0.358 P=0.730N | |INCIDENTAL TUMOR | P=0.405N P=0.583N P=0.621 P=0.488N | P=0.633N P=0.659N P=0.330 P=0.730N | |LOGISTIC REGRESSION | P=0.405N P=0.583N P=0.621 P=0.488N | P=0.609N P=0.659N P=0.346 P=0.730N | |COCHRAN-ARMITAGE | P=0.402N | P=0.638 | |FISHER EXACT | P=0.667N P=0.649 P=0.500N | P=0.667N P=0.335 P=0.751N | |=================================================================================================================================| | | |Skin | | Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/100 (0%) 0/50 (0%) 2/150 (1%) 1/100 (1%) | 1/100 (1%) 0/50 (0%) 0/150 (0%) 0/100 (0%) | |ADJUSTED (b) | 0.0% 0.0% 2.6% 1.2% | 1.7% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/50 (0%) 0/33 (0%) 1/71 (1%) 0/53 (0%) | 1/60 (2%) 0/27 (0%) 0/99 (0%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 709 639 | 729 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.397 (e) P=0.324 P=0.500 | P=0.420N P=0.659N P=0.400N P=0.472N | |INCIDENTAL TUMOR | P=0.384 (e) P=0.337 P=0.485 | P=0.420N P=0.659N P=0.400N P=0.472N | |LOGISTIC REGRESSION | P=0.394 (e) P=0.334 P=0.518 | P=0.420N P=0.659N P=0.400N P=0.472N | |COCHRAN-ARMITAGE | P=0.397 | P=0.443N | |FISHER EXACT | (e) P=0.359 P=0.500 | P=0.667N P=0.400N P=0.500N | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Skin | | Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, | | Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 5/100 (5%) 0/50 (0%) 9/150 (6%) 6/100 (6%) | 4/100 (4%) 0/50 (0%) 5/150 (3%) 1/100 (1%) | |ADJUSTED (b) | 8.2% 0.0% 11.3% 9.2% | 6.3% 0.0% 4.9% 1.4% | |TERMINAL (d) | 2/50 (4%) 0/33 (0%) 6/71 (8%) 1/53 (2%) | 3/60 (5%) 0/27 (0%) 3/99 (3%) 1/69 (1%) | |FIRST INCIDENCE (DAYS) | 658 --- 518 639 | 677 --- 699 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.294 P=0.102N P=0.456 P=0.540 | P=0.184N P=0.205N P=0.479N P=0.150N | |INCIDENTAL TUMOR | P=0.285 P=0.167N P=0.465 P=0.441 | P=0.249N P=0.206N P=0.545N P=0.184N | |LOGISTIC REGRESSION | P=0.280 P=0.127N P=0.477 P=0.431 | P=0.210N P=0.192N P=0.503N P=0.169N | |COCHRAN-ARMITAGE | P=0.289 | P=0.229N | |FISHER EXACT | P=0.127N P=0.485 P=0.500 | P=0.194N P=0.518N P=0.184N | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/100 (2%) 4/50 (8%) 3/150 (2%) 0/100 (0%) | 0/100 (0%) 0/50 (0%) 1/150 (1%) 0/100 (0%) | |ADJUSTED (b) | 3.4% 11.3% 3.5% 0.0% | 0.0% 0.0% 0.8% 0.0% | |TERMINAL (d) | 1/50 (2%) 3/33 (9%) 0/71 (0%) 0/53 (0%) | 0/60 (0%) 0/27 (0%) 0/99 (0%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | 666 654 664 --- | --- --- 606 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.062N P=0.155 P=0.670 P=0.229N | P=0.773N (e) P=0.583 (e) | |INCIDENTAL TUMOR | P=0.060N P=0.093 P=0.653N P=0.249N | P=0.800N (e) P=0.598 (e) | |LOGISTIC REGRESSION | P=0.060N P=0.105 P=0.678N P=0.240N | P=0.745N (e) P=0.555 (e) | |COCHRAN-ARMITAGE | P=0.059N | P=0.770N | |FISHER EXACT | P=0.096 P=0.665N P=0.249N | (e) P=0.600 (e) | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/100 (1%) 0/50 (0%) 2/150 (1%) 0/100 (0%) | 1/100 (1%) 0/50 (0%) 1/150 (1%) 0/100 (0%) | |ADJUSTED (b) | 1.8% 0.0% 1.7% 0.0% | 1.6% 0.0% 0.8% 0.0% | |TERMINAL (d) | 0/50 (0%) 0/33 (0%) 0/71 (0%) 0/53 (0%) | 0/60 (0%) 0/27 (0%) 0/99 (0%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | 716 --- 568 --- | 707 --- 659 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.403N P=0.590N P=0.640 P=0.489N | P=0.401N P=0.658N P=0.654N P=0.477N | |INCIDENTAL TUMOR | P=0.415N P=0.755N P=0.660 P=0.530N | P=0.550N P=0.648N P=0.733N P=0.629N | |LOGISTIC REGRESSION | P=0.392N P=0.618N P=0.648 P=0.496N | P=0.420N P=0.641N P=0.669N P=0.498N | |COCHRAN-ARMITAGE | P=0.402N | P=0.419N | |FISHER EXACT | P=0.667N P=0.649 P=0.500N | P=0.667N P=0.641N P=0.500N | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/100 (0%) 0/50 (0%) 2/150 (1%) 1/100 (1%) | 0/100 (0%) 0/50 (0%) 0/150 (0%) 0/100 (0%) | |ADJUSTED (b) | 0.0% 0.0% 2.0% 1.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/50 (0%) 0/33 (0%) 0/71 (0%) 0/53 (0%) | 0/60 (0%) 0/27 (0%) 0/99 (0%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 533 209 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.394 (e) P=0.324 P=0.500 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.428 (e) P=0.311 (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.528 (e) P=0.352 (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.397 | (e) | |FISHER EXACT | (e) P=0.359 P=0.500 | (e) (e) (e) | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, Sarcoma, | | Neurofibroma, or Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/100 (3%) 4/50 (8%) 5/150 (3%) 0/100 (0%) | 1/100 (1%) 0/50 (0%) 2/150 (1%) 0/100 (0%) | |ADJUSTED (b) | 5.2% 11.3% 5.2% 0.0% | 1.6% 0.0% 1.6% 0.0% | |TERMINAL (d) | 1/50 (2%) 3/33 (9%) 0/71 (0%) 0/53 (0%) | 0/60 (0%) 0/27 (0%) 0/99 (0%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | 666 654 568 --- | 707 --- 606 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.044N* P=0.263 P=0.582 P=0.115N | P=0.388N P=0.658N P=0.652 P=0.477N | |INCIDENTAL TUMOR | P=0.042N* P=0.144 P=0.625 P=0.137N | P=0.522N P=0.648N P=0.587 P=0.629N | |LOGISTIC REGRESSION | P=0.042N* P=0.192 P=0.587 P=0.122N | P=0.391N P=0.641N P=0.626 P=0.498N | |COCHRAN-ARMITAGE | P=0.040N* | P=0.402N | |FISHER EXACT | P=0.168 P=0.595 P=0.123N | P=0.667N P=0.649 P=0.500N | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma or Papilloma Squamous | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/100 (2%) 0/50 (0%) 0/150 (0%) 0/100 (0%) | 0/100 (0%) 0/50 (0%) 0/150 (0%) 0/100 (0%) | |ADJUSTED (b) | 4.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/50 (4%) 0/33 (0%) 0/71 (0%) 0/53 (0%) | 0/60 (0%) 0/27 (0%) 0/99 (0%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | 732 (T) --- --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.208N P=0.334N P=0.166N P=0.226N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.208N P=0.334N P=0.166N P=0.226N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.208N P=0.334N P=0.166N P=0.226N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.204N | (e) | |FISHER EXACT | P=0.443N P=0.159N P=0.249N | (e) (e) (e) | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 22 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 97/100 (97%) 47/50 (94%) 144/147 (98%) 91/98 (93%) | | |ADJUSTED (b) | 99.0% 100.0% 100.0% 100.0% | | |TERMINAL (d) | 49/50 (98%) 33/33 (100%) 68/68 (100%) 53/53 (100%)| | |FIRST INCIDENCE (DAYS) | 416 549 307 399 | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.305N P=0.030N* P=0.404 P=0.173N | | |INCIDENTAL TUMOR | P=0.060N P=0.595 P=0.368 P=0.141N | | |LOGISTIC REGRESSION | P=0.131N P=0.475N P=0.301 P=0.195N | | |COCHRAN-ARMITAGE | P=0.111N | | |FISHER EXACT | P=0.317N P=0.466 P=0.157N | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 22/75 (29%) 7/14 (50%) 17/72 (24%) 24/97 (25%) | 20/68 (29%) 5/19 (26%) 6/46 (13%) 10/99 (10%) | |ADJUSTED (b) | 33.8% 100.0% 15.2% 36.0% | 40.7% 0.0% 52.0% 13.0% | |TERMINAL (d) | 4/29 (14%) 1/1 (100%) 0/4 (0%) 13/53 (25%) | 10/31 (32%) 0/0 1/2 (50%) 5/69 (7%) | |FIRST INCIDENCE (DAYS) | 519 549 518 568 | 484 575 586 575 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.417N P=0.285N P=0.087N P=0.351N | P<0.001N** P=0.588 P=0.049N* P=0.002N** | |INCIDENTAL TUMOR | P=0.381N P=0.227 P=0.064N P=0.454N | P=0.003N** P=0.587N P=0.089N P=0.006N** | |LOGISTIC REGRESSION | P=0.190N P=0.128 P=0.239N P=0.295N | P<0.001N** P=0.577N P=0.072N P=0.001N** | |COCHRAN-ARMITAGE | P=0.205N | P=0.001N** | |FISHER EXACT | P=0.116 P=0.275N P=0.307N | P=0.519N P=0.033N* P=0.001N** | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 23 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/75 (3%) 0/14 (0%) 3/72 (4%) 5/97 (5%) | 2/68 (3%) 0/19 (0%) 0/46 (0%) 0/99 (0%) | |ADJUSTED (b) | 6.9% 0.0% 50.5% 7.0% | 2.7% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/29 (7%) 0/1 (0%) 2/4 (50%) 1/53 (2%) | 0/31 (0%) 0/0 0/2 (0%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | 732 (T) --- 690 428 | 629 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.327 P=0.959N P=0.038 * P=0.339 | P=0.197N P=0.413N P=0.150N P=0.230N | |INCIDENTAL TUMOR | P=0.336 P=0.959N P=0.037 * P=0.300 | P=0.245N P=0.350N P=0.184N P=0.292N | |LOGISTIC REGRESSION | P=0.253 P=0.959N P=0.153 P=0.327 | P=0.142N P=0.548N P=0.339N P=0.161N | |COCHRAN-ARMITAGE | P=0.243 | P=0.143N | |FISHER EXACT | P=0.709N P=0.481 P=0.340 | P=0.609N P=0.354N P=0.164N | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 24/75 (32%) 7/14 (50%) 20/72 (28%) 28/97 (29%) | 22/68 (32%) 5/19 (26%) 6/46 (13%) 10/99 (10%) | |ADJUSTED (b) | 39.1% 100.0% 58.1% 40.1% | 42.3% 0.0% 52.0% 13.0% | |TERMINAL (d) | 6/29 (21%) 1/1 (100%) 2/4 (50%) 14/53 (26%) | 10/31 (32%) 0/0 1/2 (50%) 5/69 (7%) | |FIRST INCIDENCE (DAYS) | 519 549 518 428 | 484 575 586 575 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.458N P=0.276N P=0.242N P=0.421N | P<0.001N** P=0.490N P=0.016N* P<0.001N** | |INCIDENTAL TUMOR | P=0.422N P=0.242 P=0.228N P=0.541N | P=0.001N** P=0.401N P=0.031N* P=0.002N** | |LOGISTIC REGRESSION | P=0.264N P=0.166 P=0.355N P=0.385N | P<0.001N** P=0.474N P=0.037N* P<0.001N** | |COCHRAN-ARMITAGE | P=0.287N | P<0.001N** | |FISHER EXACT | P=0.160 P=0.353N P=0.390N | P=0.420N P=0.015N* P<0.001N** | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 24 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/75 (4%) 0/14 (0%) 0/72 (0%) 1/97 (1%) | 1/68 (1%) 0/19 (0%) 1/46 (2%) 1/99 (1%) | |ADJUSTED (b) | 6.2% 0.0% 0.0% 1.8% | 3.2% 0.0% 0.7% 1.4% | |TERMINAL (d) | 1/29 (3%) 0/1 (0%) 0/4 (0%) 0/53 (0%) | 1/31 (3%) 0/0 0/2 (0%) 1/69 (1%) | |FIRST INCIDENCE (DAYS) | 645 --- --- 725 | 729 (T) --- 536 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.284N P=0.365N P=0.137N P=0.244N | P=0.454N (e) P=0.621 P=0.573N | |INCIDENTAL TUMOR | P=0.290N P=0.523N P=0.142N P=0.291N | P=0.496N (e) P=0.571 P=0.573N | |LOGISTIC REGRESSION | P=0.222N P=0.538N P=0.145N P=0.208N | P=0.582N (e) P=0.692 P=0.573N | |COCHRAN-ARMITAGE | P=0.253N | P=0.584N | |FISHER EXACT | P=0.595N P=0.130N P=0.221N | P=0.782N P=0.646 P=0.650N | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/75 (4%) 0/14 (0%) 0/72 (0%) 2/97 (2%) | 1/68 (1%) 0/19 (0%) 1/46 (2%) 1/99 (1%) | |ADJUSTED (b) | 6.2% 0.0% 0.0% 3.6% | 3.2% 0.0% 0.7% 1.4% | |TERMINAL (d) | 1/29 (3%) 0/1 (0%) 0/4 (0%) 1/53 (2%) | 1/31 (3%) 0/0 0/2 (0%) 1/69 (1%) | |FIRST INCIDENCE (DAYS) | 645 --- --- 725 | 729 (T) --- 536 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.463N P=0.365N P=0.137N P=0.381N | P=0.454N (e) P=0.621 P=0.573N | |INCIDENTAL TUMOR | P=0.472N P=0.523N P=0.142N P=0.433N | P=0.496N (e) P=0.571 P=0.573N | |LOGISTIC REGRESSION | P=0.413N P=0.538N P=0.145N P=0.356N | P=0.582N (e) P=0.692 P=0.573N | |COCHRAN-ARMITAGE | P=0.484N | P=0.584N | |FISHER EXACT | P=0.595N P=0.130N P=0.380N | P=0.782N P=0.646 P=0.650N | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 25 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Tongue | | Squamous Cell Carcinoma or Papilloma Squamous | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/100 (0%) 0/50 (0%) 2/150 (1%) 0/100 (0%) | 0/100 (0%) 0/50 (0%) 1/150 (1%) 0/100 (0%) | |ADJUSTED (b) | 0.0% 0.0% 2.5% 0.0% | 0.0% 0.0% 1.0% 0.0% | |TERMINAL (d) | 0/50 (0%) 0/33 (0%) 1/71 (1%) 0/53 (0%) | 0/60 (0%) 0/27 (0%) 1/99 (1%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 704 --- | --- --- 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.662N (e) P=0.329 (e) | P=0.748N (e) P=0.600 (e) | |INCIDENTAL TUMOR | P=0.671N (e) P=0.337 (e) | P=0.748N (e) P=0.600 (e) | |LOGISTIC REGRESSION | P=0.665N (e) P=0.334 (e) | P=0.748N (e) P=0.600 (e) | |COCHRAN-ARMITAGE | P=0.664N | P=0.770N | |FISHER EXACT | (e) P=0.359 (e) | (e) P=0.600 (e) | |=================================================================================================================================| | | |Tongue | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/100 (0%) 0/50 (0%) 2/150 (1%) 0/100 (0%) | 0/100 (0%) 0/50 (0%) 0/150 (0%) 0/100 (0%) | |ADJUSTED (b) | 0.0% 0.0% 2.5% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/50 (0%) 0/33 (0%) 1/71 (1%) 0/53 (0%) | 0/60 (0%) 0/27 (0%) 0/99 (0%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 704 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.662N (e) P=0.329 (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.671N (e) P=0.337 (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.665N (e) P=0.334 (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.664N | (e) | |FISHER EXACT | (e) P=0.359 (e) | (e) (e) (e) | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 26 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Uterus | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 0/100 (0%) 0/50 (0%) 3/150 (2%) 1/100 (1%) | |ADJUSTED (b) | | 0.0% 0.0% 2.6% 1.4% | |TERMINAL (d) | | 0/60 (0%) 0/27 (0%) 0/99 (0%) 1/69 (1%) | |FIRST INCIDENCE (DAYS) | | --- --- 630 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.462 (e) P=0.212 P=0.528 | |INCIDENTAL TUMOR | | P=0.342 (e) P=0.169 P=0.528 | |LOGISTIC REGRESSION | | P=0.440 (e) P=0.195 P=0.528 | |COCHRAN-ARMITAGE | | P=0.438 | |FISHER EXACT | | (e) P=0.214 P=0.500 | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 11/100 (11%) 6/50 (12%) 35/150 (23%) 18/100 (18%)| |ADJUSTED (b) | | 15.3% 17.6% 31.0% 24.2% | |TERMINAL (d) | | 6/60 (10%) 2/27 (7%) 24/99 (24%) 14/69 (20%) | |FIRST INCIDENCE (DAYS) | | 388 593 512 622 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.294 P=0.481 P=0.025 * P=0.184 | |INCIDENTAL TUMOR | | P=0.120 P=0.544 P=0.010 ** P=0.111 | |LOGISTIC REGRESSION | | P=0.158 P=0.531 P=0.012 * P=0.112 | |COCHRAN-ARMITAGE | | P=0.164 | |FISHER EXACT | | P=0.527 P=0.010 ** P=0.114 | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 27 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 1/100 (1%) 0/50 (0%) 3/150 (2%) 2/100 (2%) | |ADJUSTED (b) | | 1.4% 0.0% 2.6% 2.7% | |TERMINAL (d) | | 0/60 (0%) 0/27 (0%) 1/99 (1%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | | 698 --- 509 672 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.389 P=0.659N P=0.486 P=0.528 | |INCIDENTAL TUMOR | | P=0.201 P=0.648N P=0.391 P=0.278 | |LOGISTIC REGRESSION | | P=0.361 P=0.639N P=0.444 P=0.499 | |COCHRAN-ARMITAGE | | P=0.355 | |FISHER EXACT | | P=0.667N P=0.475 P=0.500 | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 12/100 (12%) 6/50 (12%) 38/150 (25%) 20/100 (20%)| |ADJUSTED (b) | | 16.5% 17.6% 33.0% 26.2% | |TERMINAL (d) | | 6/60 (10%) 2/27 (7%) 25/99 (25%) 14/69 (20%) | |FIRST INCIDENCE (DAYS) | | 388 593 509 622 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.239 P=0.545 P=0.020 * P=0.155 | |INCIDENTAL TUMOR | | P=0.066 P=0.600N P=0.006 ** P=0.060 | |LOGISTIC REGRESSION | | P=0.114 P=0.601 P=0.008 ** P=0.086 | |COCHRAN-ARMITAGE | | P=0.120 | |FISHER EXACT | | P=0.613N P=0.007 ** P=0.088 | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 28 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/100 (0%) 0/50 (0%) 3/150 (2%) 1/100 (1%) | 1/100 (1%) 1/50 (2%) 1/150 (1%) 1/100 (1%) | |ADJUSTED (b) | 0.0% 0.0% 2.3% 1.0% | 1.2% 2.3% 0.8% 1.1% | |TERMINAL (d) | 0/50 (0%) 0/33 (0%) 0/71 (0%) 0/53 (0%) | 0/60 (0%) 0/27 (0%) 0/99 (0%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 568 438 | 644 621 624 575 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.430 (e) P=0.207 P=0.494 | P=0.618N P=0.589 P=0.669N P=0.756 | |INCIDENTAL TUMOR | P=0.461 (e) P=0.198 P=0.527 | P=0.678N P=0.744 P=0.649N P=0.766 | |LOGISTIC REGRESSION | P=0.520 (e) P=0.229 P=0.715 | P=0.566N P=0.582 P=0.689N P=0.748N | |COCHRAN-ARMITAGE | P=0.438 | P=0.613N | |FISHER EXACT | (e) P=0.214 P=0.500 | P=0.557 P=0.641N P=0.751N | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/100 (0%) 0/50 (0%) 4/150 (3%) 1/100 (1%) | 1/100 (1%) 1/50 (2%) 1/150 (1%) 1/100 (1%) | |ADJUSTED (b) | 0.0% 0.0% 3.2% 1.0% | 1.2% 2.3% 0.8% 1.1% | |TERMINAL (d) | 0/50 (0%) 0/33 (0%) 0/71 (0%) 0/53 (0%) | 0/60 (0%) 0/27 (0%) 0/99 (0%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 568 438 | 644 621 624 575 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.464 (e) P=0.134 P=0.494 | P=0.618N P=0.589 P=0.669N P=0.756 | |INCIDENTAL TUMOR | P=0.487 (e) P=0.130 P=0.527 | P=0.678N P=0.744 P=0.649N P=0.766 | |LOGISTIC REGRESSION | P=0.543 (e) P=0.144 P=0.715 | P=0.566N P=0.582 P=0.689N P=0.748N | |COCHRAN-ARMITAGE | P=0.470 | P=0.613N | |FISHER EXACT | (e) P=0.128 P=0.500 | P=0.557 P=0.641N P=0.751N | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 29 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/100 (0%) 0/50 (0%) 3/150 (2%) 1/100 (1%) | 0/100 (0%) 0/50 (0%) 0/150 (0%) 0/100 (0%) | |ADJUSTED (b) | 0.0% 0.0% 2.9% 1.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/50 (0%) 0/33 (0%) 0/71 (0%) 0/53 (0%) | 0/60 (0%) 0/27 (0%) 0/99 (0%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 533 209 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.436 (e) P=0.201 P=0.500 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.462 (e) P=0.197 (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.549 (e) P=0.215 (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.438 | (e) | |FISHER EXACT | (e) P=0.214 P=0.500 | (e) (e) (e) | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/100 (0%) 0/50 (0%) 3/150 (2%) 1/100 (1%) | 0/100 (0%) 1/50 (2%) 0/150 (0%) 0/100 (0%) | |ADJUSTED (b) | 0.0% 0.0% 2.9% 1.0% | 0.0% 2.8% 0.0% 0.0% | |TERMINAL (d) | 0/50 (0%) 0/33 (0%) 0/71 (0%) 0/53 (0%) | 0/60 (0%) 0/27 (0%) 0/99 (0%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 533 209 | --- 681 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.436 (e) P=0.201 P=0.500 | P=0.542N P=0.359 (e) (e) | |INCIDENTAL TUMOR | P=0.462 (e) P=0.197 (e) | P=0.649N P=0.352 (e) (e) | |LOGISTIC REGRESSION | P=0.549 (e) P=0.215 (e) | P=0.548N P=0.361 (e) (e) | |COCHRAN-ARMITAGE | P=0.438 | P=0.548N | |FISHER EXACT | (e) P=0.214 P=0.500 | P=0.333 (e) (e) | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 30 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, | | or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 50/100 (50%) 22/50 (44%) 55/150 (37%) 39/100 (39%)| 29/100 (29%) 21/50 (42%) 34/150 (23%) 21/100 (21%)| |ADJUSTED (b) | 58.6% 51.7% 49.4% 46.3% | 36.8% 52.9% 26.9% 26.1% | |TERMINAL (d) | 17/50 (34%) 13/33 (39%) 21/71 (30%) 12/53 (23%) | 13/60 (22%) 10/27 (37%) 13/99 (13%) 12/69 (17%) | |FIRST INCIDENCE (DAYS) | 416 549 426 425 | 484 425 519 499 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.176N P=0.120N P=0.065N P=0.102N | P=0.024N* P=0.069 P=0.128N P=0.085N | |INCIDENTAL TUMOR | P=0.119N P=0.458 P=0.021N* P=0.109N | P=0.131N P=0.081 P=0.227N P=0.284N | |LOGISTIC REGRESSION | P=0.148N P=0.489N P=0.033N* P=0.132N | P=0.079N P=0.080 P=0.154N P=0.177N | |COCHRAN-ARMITAGE | P=0.116N | P=0.037N* | |FISHER EXACT | P=0.302N P=0.025N* P=0.077N | P=0.080 P=0.163N P=0.126N | |=================================================================================================================================| | | |All Organs | | Mesothelioma Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/100 (3%) 1/50 (2%) 7/150 (5%) 3/100 (3%) | 0/100 (0%) 0/50 (0%) 0/150 (0%) 0/100 (0%) | |ADJUSTED (b) | 5.0% 2.6% 6.4% 5.5% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/50 (2%) 0/33 (0%) 1/71 (1%) 2/53 (4%) | 0/60 (0%) 0/27 (0%) 0/99 (0%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | 667 673 410 725 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.590 P=0.496N P=0.375 P=0.628N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.575N P=0.704N P=0.355 P=0.640 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.576N P=0.571N P=0.405 P=0.657N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.593 | (e) | |FISHER EXACT | P=0.593N P=0.379 P=0.659N | (e) (e) (e) | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 31 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |All Organs | | Osteosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/100 (1%) 0/50 (0%) 2/150 (1%) 1/100 (1%) | 0/100 (0%) 0/50 (0%) 0/150 (0%) 0/100 (0%) | |ADJUSTED (b) | 2.0% 0.0% 1.8% 1.2% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/50 (2%) 0/33 (0%) 0/71 (0%) 0/53 (0%) | 0/60 (0%) 0/27 (0%) 0/99 (0%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | 732 (T) --- 652 609 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.609 P=0.583N P=0.639 P=0.756N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.601 P=0.583N P=0.654 P=0.759 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.622 P=0.583N P=0.639 P=0.759N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.613 | (e) | |FISHER EXACT | P=0.667N P=0.649 P=0.751N | (e) (e) (e) | |=================================================================================================================================| | | |All Organs | | Osteosarcoma or Osteoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/100 (1%) 0/50 (0%) 2/150 (1%) 1/100 (1%) | 0/100 (0%) 0/50 (0%) 0/150 (0%) 0/100 (0%) | |ADJUSTED (b) | 2.0% 0.0% 1.8% 1.2% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/50 (2%) 0/33 (0%) 0/71 (0%) 0/53 (0%) | 0/60 (0%) 0/27 (0%) 0/99 (0%) 0/69 (0%) | |FIRST INCIDENCE (DAYS) | 732 (T) --- 652 609 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.609 P=0.583N P=0.639 P=0.756N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.601 P=0.583N P=0.654 P=0.759 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.622 P=0.583N P=0.639 P=0.759N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.613 | (e) | |FISHER EXACT | P=0.667N P=0.649 P=0.751N | (e) (e) (e) | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 32 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) |100/100 (100% 48/50 (96%) 147/150 (98%) 97/100 (97%)| 74/100 (74%) 27/50 (54%) 94/150 (63%) 52/100 (52%)| |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 79.4% 64.5% 70.7% 62.3% | |TERMINAL (d) | 50/50 (100%) 33/33 (100%) 71/71 (100%) 53/53 (100%)| 41/60 (68%) 13/27 (48%) 61/99 (62%) 38/69 (55%) | |FIRST INCIDENCE (DAYS) | 416 549 307 399 | 388 425 439 575 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.475N P=0.024N* P=0.532 P=0.273N | P=0.002N** P=0.117N P=0.031N* P<0.001N** | |INCIDENTAL TUMOR | P=0.268N (e) P=0.262N P=0.262N | P=0.020N* P=0.004N** P=0.041N* P=0.003N** | |LOGISTIC REGRESSION | P=0.464N (e) P=0.443N P=0.401N | P=0.014N* P=0.003N** P=0.026N* P=0.002N** | |COCHRAN-ARMITAGE | P=0.234N | P=0.005N** | |FISHER EXACT | P=0.110N P=0.214N P=0.123N | P=0.012N* P=0.041N* P=0.001N** | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 66/100 (66%) 28/50 (56%) 82/150 (55%) 56/100 (56%)| 43/100 (43%) 23/50 (46%) 50/150 (33%) 30/100 (30%)| |ADJUSTED (b) | 71.4% 59.2% 63.0% 60.0% | 50.7% 56.7% 37.3% 35.5% | |TERMINAL (d) | 24/50 (48%) 14/33 (42%) 27/71 (38%) 17/53 (32%) | 19/60 (32%) 11/27 (41%) 18/99 (18%) 16/69 (23%) | |FIRST INCIDENCE (DAYS) | 416 340 307 209 | 388 425 491 499 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.276N P=0.060N P=0.144N P=0.141N | P=0.016N* P=0.331 P=0.068N P=0.028N* | |INCIDENTAL TUMOR | P=0.165N P=0.435N P=0.032N* P=0.112N | P=0.134N P=0.478 P=0.129N P=0.155N | |LOGISTIC REGRESSION | P=0.182N P=0.353N P=0.058N P=0.110N | P=0.064N P=0.432 P=0.058N P=0.065N | |COCHRAN-ARMITAGE | P=0.179N | P=0.023N* | |FISHER EXACT | P=0.155N P=0.049N* P=0.096N | P=0.430 P=0.079N P=0.039N* | |=================================================================================================================================| DATE: 09/09/94 EXPERIMENT: 05075 TEST: 01 PAGE 33 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIPHENYLHYDANTOIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 240 PPM 800 PPM 2400 PPM | 0 PPM 240 PPM 800 PPM 2400 PPM | | | 10-0 1-1 10-3 10-10 | 10-0 1-1 10-3 10-10 | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) |100/100 (100% 49/50 (98%) 149/150 (99%) 99/100 (99%)| 85/100 (85%) 40/50 (80%) 116/150 (77%) 65/100 (65%)| |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 87.6% 81.6% 79.4% 73.0% | |TERMINAL (d) | 50/50 (100%) 33/33 (100%) 71/71 (100%) 53/53 (100%)| 48/60 (80%) 18/27 (67%) 69/99 (70%) 45/69 (65%) | |FIRST INCIDENCE (DAYS) | 416 340 307 209 | 388 425 439 499 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.511 P=0.037N* P=0.474 P=0.347N | P=0.001N** P=0.522 P=0.076N P=0.002N** | |INCIDENTAL TUMOR | P=0.576N (e) (e) P=0.527N | P=0.008N** P=0.119N P=0.099N P=0.005N** | |LOGISTIC REGRESSION | P=0.669 (e) (e) P=0.622N | P=0.004N** P=0.111N P=0.066N P=0.002N** | |COCHRAN-ARMITAGE | P=0.538N | P<0.001N** | |FISHER EXACT | P=0.333N P=0.600N P=0.500N | P=0.290N P=0.090N 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).