TDMS Study 05212-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus OXAZEPAM DATE: 09/18/94 EXPERIMENT: 05212 TEST: 04 TIME: 12:07:43 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1ES85213 ROUTE: DOSED FEED NTP C#: 062453 PATHOLOGIST: M. RYAN HAILEY, JAMESR. CAS: 604-75-1 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus OXAZEPAM DATE: 09/18/94 EXPERIMENT: 05212 TEST: 04 TIME: 12:07:43 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1ES85213 ROUTE: DOSED FEED NTP C#: 062453 PATHOLOGIST: M. RYAN HAILEY, JAMESR. CAS: 604-75-1 35( ) ---------------------------- 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 Cortex Adrenal Medulla Bone Marrow Brain Clitoral Gland Epididymis Gallbladder 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 OXAZEPAM DATE: 09/18/94 EXPERIMENT: 05212 TEST: 04 TIME: 12:07:43 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1ES85213 ROUTE: DOSED FEED NTP C#: 062453 PATHOLOGIST: M. RYAN HAILEY, JAMESR. CAS: 604-75-1 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF OXAZEPAM ==================================================================================================== MALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Liver Hepatocellular Adenoma Hepatocellular Carcinoma Hepatocellular Carcinoma or Hepatoblastoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Alveolar/Bronchiolar Carcinoma All Organs Malignant Lymphoma And Histiocytic Sarcoma Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== FEMALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Liver Hepatocellular Adenoma Hepatocellular Carcinoma Hepatocellular Carcinoma or Hepatoblastoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma All Organs Malignant Lymphoma And Histiocytic Sarcoma Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 09/18/94 EXPERIMENT: 05212 TEST: 04 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN 35( ) -- OXAZEPAM TERMINAL SACRIFICE AT 57 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2500 PPM 5000 PPM | 0 PPM 2500 PPM 5000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 35/60 (58%) 50/60 (83%) | 0/60 (0%) 22/59 (37%) 47/59 (80%) | |ADJUSTED (b) | 2.2% 88.7% 98.0% | 0.0% 52.6% 95.7% | |TERMINAL (d) | 1/45 (2%) 15/19 (79%) 9/10 (90%) | 0/47 (0%) 10/28 (36%) 15/17 (88%) | |FIRST INCIDENCE (DAYS) | 397 (T) 268 231 | --- 291 284 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** | |FISHER EXACT | P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 5/60 (8%) 19/60 (32%) | 1/60 (2%) 1/59 (2%) 11/59 (19%) | |ADJUSTED (b) | 0.0% 21.7% 72.0% | 2.1% 3.6% 51.6% | |TERMINAL (d) | 0/45 (0%) 3/19 (16%) 5/10 (50%) | 1/47 (2%) 1/28 (4%) 8/17 (47%) | |FIRST INCIDENCE (DAYS) | --- 356 302 | 397 (T) 397 (T) 337 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.003 ** P<0.001 ** | P<0.001 ** P=0.642 P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P=0.017 * P<0.001 ** | P<0.001 ** P=0.642 P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P=0.010 * P<0.001 ** | P<0.001 ** P=0.642 P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** | |FISHER EXACT | P=0.029 * P<0.001 ** | P=0.748 P=0.002 ** | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05212 TEST: 04 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN 35( ) -- OXAZEPAM TERMINAL SACRIFICE AT 57 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2500 PPM 5000 PPM | 0 PPM 2500 PPM 5000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 5/60 (8%) 19/60 (32%) | 1/60 (2%) 1/59 (2%) 11/59 (19%) | |ADJUSTED (b) | 0.0% 21.7% 72.0% | 2.1% 3.6% 51.6% | |TERMINAL (d) | 0/45 (0%) 3/19 (16%) 5/10 (50%) | 1/47 (2%) 1/28 (4%) 8/17 (47%) | |FIRST INCIDENCE (DAYS) | --- 356 302 | 397 (T) 397 (T) 337 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.003 ** P<0.001 ** | P<0.001 ** P=0.642 P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P=0.017 * P<0.001 ** | P<0.001 ** P=0.642 P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P=0.010 * P<0.001 ** | P<0.001 ** P=0.642 P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** | |FISHER EXACT | P=0.029 * P<0.001 ** | P=0.748 P=0.002 ** | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 35/60 (58%) 52/60 (87%) | 1/60 (2%) 23/59 (39%) 47/59 (80%) | |ADJUSTED (b) | 2.2% 88.7% 98.1% | 2.1% 55.2% 95.7% | |TERMINAL (d) | 1/45 (2%) 15/19 (79%) 9/10 (90%) | 1/47 (2%) 11/28 (39%) 15/17 (88%) | |FIRST INCIDENCE (DAYS) | 397 (T) 268 231 | 397 (T) 291 284 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** | |FISHER EXACT | P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05212 TEST: 04 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN 35( ) -- OXAZEPAM TERMINAL SACRIFICE AT 57 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2500 PPM 5000 PPM | 0 PPM 2500 PPM 5000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 35/60 (58%) 52/60 (87%) | 1/60 (2%) 23/59 (39%) 47/59 (80%) | |ADJUSTED (b) | 2.2% 88.7% 98.1% | 2.1% 55.2% 95.7% | |TERMINAL (d) | 1/45 (2%) 15/19 (79%) 9/10 (90%) | 1/47 (2%) 11/28 (39%) 15/17 (88%) | |FIRST INCIDENCE (DAYS) | 397 (T) 268 231 | 397 (T) 291 284 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** | |FISHER EXACT | P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/60 (20%) 6/60 (10%) 7/60 (12%) | 6/60 (10%) 4/59 (7%) 6/59 (10%) | |ADJUSTED (b) | 26.7% 28.9% 26.0% | 12.8% 12.4% 24.2% | |TERMINAL (d) | 12/45 (27%) 5/19 (26%) 0/10 (0%) | 6/47 (13%) 3/28 (11%) 2/17 (12%) | |FIRST INCIDENCE (DAYS) | 397 (T) 369 272 | 397 (T) 294 325 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.123 P=0.482 P=0.164 | P=0.103 P=0.593 P=0.105 | |INCIDENTAL TUMOR | P=0.538N P=0.606 P=0.406N | P=0.305 P=0.609N P=0.389 | |LOGISTIC REGRESSION | P=0.353N P=0.570N P=0.329N | P=0.385 P=0.515N P=0.393 | |COCHRAN-ARMITAGE | P=0.117N | P=0.552 | |FISHER EXACT | P=0.100N P=0.159N | P=0.382N P=0.607 | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05212 TEST: 04 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN 35( ) -- OXAZEPAM TERMINAL SACRIFICE AT 57 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2500 PPM 5000 PPM | 0 PPM 2500 PPM 5000 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/60 (8%) 4/60 (7%) 0/60 (0%) | 5/60 (8%) 3/59 (5%) 1/59 (2%) | |ADJUSTED (b) | 10.5% 14.2% 0.0% | 10.6% 8.9% 2.6% | |TERMINAL (d) | 4/45 (9%) 1/19 (5%) 0/10 (0%) | 5/47 (11%) 2/28 (7%) 0/17 (0%) | |FIRST INCIDENCE (DAYS) | 281 268 --- | 397 (T) 294 342 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.266N P=0.407 P=0.217N | P=0.317N P=0.620N P=0.413N | |INCIDENTAL TUMOR | P=0.033N* P=0.444N P=0.139N | P=0.186N P=0.544N P=0.274N | |LOGISTIC REGRESSION | P=0.043N* P=0.551N P=0.051N | P=0.111N P=0.458N P=0.213N | |COCHRAN-ARMITAGE | P=0.030N* | P=0.074N | |FISHER EXACT | P=0.500N P=0.029N* | P=0.368N P=0.107N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 14/60 (23%) 9/60 (15%) 7/60 (12%) | 11/60 (18%) 6/59 (10%) 7/59 (12%) | |ADJUSTED (b) | 30.2% 35.7% 26.0% | 23.4% 19.4% 26.2% | |TERMINAL (d) | 13/45 (29%) 5/19 (26%) 0/10 (0%) | 11/47 (23%) 5/28 (18%) 2/17 (12%) | |FIRST INCIDENCE (DAYS) | 281 268 272 | 397 (T) 294 325 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.200 P=0.291 P=0.286 | P=0.266 P=0.510N P=0.259 | |INCIDENTAL TUMOR | P=0.203N P=0.514N P=0.216N | P=0.545N P=0.452N P=0.567N | |LOGISTIC REGRESSION | P=0.158N P=0.415N P=0.155N | P=0.407N P=0.346N P=0.506N | |COCHRAN-ARMITAGE | P=0.056N | P=0.183N | |FISHER EXACT | P=0.177N P=0.074N | P=0.156N P=0.234N | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05212 TEST: 04 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN 35( ) -- OXAZEPAM TERMINAL SACRIFICE AT 57 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2500 PPM 5000 PPM | 0 PPM 2500 PPM 5000 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # | |----------- | | | |OVERALL (a) | | 2/60 (3%) 0/59 (0%) 1/59 (2%) | |ADJUSTED (b) | | 3.7% 0.0% 5.9% | |TERMINAL (d) | | 0/47 (0%) 0/28 (0%) 1/17 (6%) | |FIRST INCIDENCE (DAYS) | | 322 --- 397 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.527N P=0.309N P=0.699N | |INCIDENTAL TUMOR | | P=0.270N P=0.095N P=0.372N | |LOGISTIC REGRESSION | | P=0.361N P=0.200N P=0.485N | |COCHRAN-ARMITAGE | | P=0.365N | |FISHER EXACT | | P=0.252N P=0.506N | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma And Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 10/60 (17%) 7/60 (12%) 6/60 (10%) | 9/60 (15%) 13/59 (22%) 7/59 (12%) | |ADJUSTED (b) | 17.6% 13.9% 28.3% | 15.4% 26.2% 17.9% | |TERMINAL (d) | 0/45 (0%) 0/19 (0%) 2/10 (20%) | 0/47 (0%) 2/28 (7%) 1/17 (6%) | |FIRST INCIDENCE (DAYS) | 244 145 272 | 184 106 197 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.415N P=0.435N P=0.519N | P=0.447 P=0.117 P=0.516 | |INCIDENTAL TUMOR | P=0.002N** P=0.002N** P=0.002N** | P=0.002N** P=0.144N P=0.002N** | |LOGISTIC REGRESSION | P=0.005N** P=0.036N* P=0.007N** | P=0.017N* P=0.260N P=0.056N | |COCHRAN-ARMITAGE | P=0.169N | P=0.370N | |FISHER EXACT | P=0.301N P=0.211N | P=0.226 P=0.409N | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05212 TEST: 04 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN 35( ) -- OXAZEPAM TERMINAL SACRIFICE AT 57 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2500 PPM 5000 PPM | 0 PPM 2500 PPM 5000 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 9/60 (15%) 7/60 (12%) 6/60 (10%) | 9/60 (15%) 13/59 (22%) 6/59 (10%) | |ADJUSTED (b) | 16.0% 13.9% 28.3% | 15.4% 26.2% 16.1% | |TERMINAL (d) | 0/45 (0%) 0/19 (0%) 2/10 (20%) | 0/47 (0%) 2/28 (7%) 1/17 (6%) | |FIRST INCIDENCE (DAYS) | 244 145 272 | 184 106 197 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.508N P=0.526N P=0.603 | P=0.543 P=0.117 P=0.581N | |INCIDENTAL TUMOR | P=0.007N** P=0.006N** P=0.007N** | P<0.001N** P=0.144N P=0.001N** | |LOGISTIC REGRESSION | P=0.014N* P=0.080N P=0.021N* | P=0.010N** P=0.260N P=0.036N* | |COCHRAN-ARMITAGE | P=0.243N | P=0.278N | |FISHER EXACT | P=0.395N P=0.291N | P=0.226 P=0.303N | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 14/60 (23%) 36/60 (60%) 51/60 (85%) | 9/60 (15%) 26/59 (44%) 47/59 (80%) | |ADJUSTED (b) | 30.4% 91.5% 98.0% | 18.5% 61.2% 95.7% | |TERMINAL (d) | 13/45 (29%) 16/19 (84%) 9/10 (90%) | 8/47 (17%) 13/28 (46%) 15/17 (88%) | |FIRST INCIDENCE (DAYS) | 344 268 231 | 322 291 284 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** | |FISHER EXACT | P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05212 TEST: 04 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN 35( ) -- OXAZEPAM TERMINAL SACRIFICE AT 57 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2500 PPM 5000 PPM | 0 PPM 2500 PPM 5000 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 17/60 (28%) 17/60 (28%) 25/60 (42%) | 16/60 (27%) 16/59 (27%) 17/59 (29%) | |ADJUSTED (b) | 29.6% 44.1% 80.3% | 27.7% 34.7% 61.0% | |TERMINAL (d) | 5/45 (11%) 4/19 (21%) 6/10 (60%) | 6/47 (13%) 5/28 (18%) 9/17 (53%) | |FIRST INCIDENCE (DAYS) | 244 145 271 | 184 106 197 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.170 P<0.001 ** | P=0.037 * P=0.230 P=0.025 * | |INCIDENTAL TUMOR | P=0.495 P=0.053N P=0.439N | P=0.313N P=0.102N P=0.452N | |LOGISTIC REGRESSION | P=0.321 P=0.203N P=0.555 | P=0.390N P=0.236N P=0.427N | |COCHRAN-ARMITAGE | P=0.072 | P=0.437 | |FISHER EXACT | P=0.580N P=0.090 | P=0.560 P=0.477 | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 26/60 (43%) 42/60 (70%) 54/60 (90%) | 24/60 (40%) 37/59 (63%) 49/59 (83%) | |ADJUSTED (b) | 45.4% 92.6% 100.0% | 41.8% 73.8% 95.8% | |TERMINAL (d) | 14/45 (31%) 16/19 (84%) 10/10 (100%) | 14/47 (30%) 16/28 (57%) 15/17 (88%) | |FIRST INCIDENCE (DAYS) | 244 145 231 | 184 106 197 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P=0.025 * P=0.001 ** | P<0.001 ** P=0.092 P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P=0.005 ** P<0.001 ** | P<0.001 ** P=0.037 * P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** | |FISHER EXACT | P=0.003 ** P<0.001 ** | P=0.011 * P<0.001 ** | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05212 TEST: 04 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN 35( ) -- OXAZEPAM TERMINAL SACRIFICE AT 57 WEEKS (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).