TDMS Study 89006-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst AZT DATE: 06/03/96 EXPERIMENT: 89006 TEST: 06 TIME: 19:43:54 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-85225 ROUTE: GAVAGE NTP C#: C88072 PATHOLOGIST: R.B. THOMPSON CAS: 30516-87-1 ------------------------------------------------------------------------------------------------------------------------------------ TWO-YEAR CHRONIC REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst AZT DATE: 06/03/96 EXPERIMENT: 89006 TEST: 06 TIME: 19:43:54 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-85225 ROUTE: GAVAGE NTP C#: C88072 PATHOLOGIST: R.B. THOMPSON CAS: 30516-87-1 MICE(B6C3F1) ---------------------------- 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: Southern Research Inst AZT DATE: 06/03/96 EXPERIMENT: 89006 TEST: 06 TIME: 19:43:54 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-85225 ROUTE: GAVAGE NTP C#: C88072 PATHOLOGIST: R.B. THOMPSON CAS: 30516-87-1 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF 1 AZT ==================================================================================================== MALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Harderian Gland Adenoma Carcinoma or Adenoma Kidney: Renal Tubule Adenoma Carcinoma or Adenoma Liver Hepatoblastoma All Organs 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 or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Thyroid Gland: Follicular Cell Carcinoma or Adenoma Vagina Squamous Cell Carcinoma Squamous Cell Papilloma All Organs Malignant Tumors ==================================================================================================== DATE: 06/04/96 EXPERIMENT: 89006 TEST: 06 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1 AZT TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 30 MG/KG 60 MG/KG 120 | VEHICLE 30 MG/KG 60 MG/KG 120 | | | CONTROL MG/KG | CONTROL MG/KG | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 4/49 (8%) 1/49 (2%) 2/49 (4%) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 14.9% 11.8% 3.4% 4.9% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 4/32 (13%) 4/34 (12%) 1/29 (3%) 2/41 (5%) | 0/34 (0%) 0/38 (0%) 0/31 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 698 729 (T) 729 (T) 729 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.073N P=0.464N P=0.131N P=0.136N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.082N P=0.477N P=0.123N P=0.176N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.083N P=0.479N P=0.126N P=0.161N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.118N | (e) | |FISHER EXACT | P=0.513N P=0.107N P=0.226N | (e) (e) (e) | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 2/50 (4%) 10/50 (20%) | 4/50 (8%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 9.4% 5.7% 6.3% 23.1% | 11.8% 5.1% 0.0% 3.2% | |TERMINAL (d) | 3/32 (9%) 2/35 (6%) 1/29 (3%) 9/42 (21%) | 4/34 (12%) 2/39 (5%) 0/31 (0%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 667 612 | 731 (T) 731 (T) --- 731 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.016 * P=0.459N P=0.546N P=0.096 | P=0.107N P=0.275N P=0.074N P=0.207N | |INCIDENTAL TUMOR | P=0.010 ** P=0.459N P=0.536N P=0.071 | P=0.107N P=0.275N P=0.074N P=0.207N | |LOGISTIC REGRESSION | P=0.009 ** P=0.459N P=0.546N P=0.059 | P=0.107N P=0.275N P=0.074N P=0.207N | |COCHRAN-ARMITAGE | P=0.004 ** | P=0.086N | |FISHER EXACT | P=0.500N P=0.500N P=0.036 * | P=0.339N P=0.059N P=0.181N | |=================================================================================================================================| DATE: 06/04/96 EXPERIMENT: 89006 TEST: 06 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1 AZT TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 30 MG/KG 60 MG/KG 120 | VEHICLE 30 MG/KG 60 MG/KG 120 | | | CONTROL MG/KG | CONTROL MG/KG | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 7.7% 0.0% 0.0% | 2.9% 0.0% 2.8% 3.2% | |TERMINAL (d) | 0/32 (0%) 2/35 (6%) 0/29 (0%) 0/42 (0%) | 1/34 (3%) 0/39 (0%) 0/31 (0%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | --- 458 --- --- | 731 (T) --- 689 731 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.278N P=0.132 (e) (e) | P=0.516 P=0.473N P=0.744 P=0.741 | |INCIDENTAL TUMOR | P=0.262N P=0.134 (e) (e) | P=0.556 P=0.473N P=0.735 P=0.741 | |LOGISTIC REGRESSION | P=0.321N P=0.126 (e) (e) | P=0.534 P=0.473N P=0.747 P=0.741 | |COCHRAN-ARMITAGE | P=0.311N | P=0.539 | |FISHER EXACT | P=0.121 (e) (e) | P=0.500N P=0.753N P=0.753N | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 5/50 (10%) 2/50 (4%) 10/50 (20%) | 5/50 (10%) 2/50 (4%) 1/50 (2%) 2/50 (4%) | |ADJUSTED (b) | 9.4% 13.3% 6.3% 23.1% | 14.7% 5.1% 2.8% 6.5% | |TERMINAL (d) | 3/32 (9%) 4/35 (11%) 1/29 (3%) 9/42 (21%) | 5/34 (15%) 2/39 (5%) 0/31 (0%) 2/31 (6%) | |FIRST INCIDENCE (DAYS) | 729 (T) 458 667 612 | 731 (T) 731 (T) 689 731 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.055 P=0.399 P=0.546N P=0.096 | P=0.200N P=0.163N P=0.125N P=0.253N | |INCIDENTAL TUMOR | P=0.039 * P=0.400 P=0.536N P=0.071 | P=0.186N P=0.163N P=0.128N P=0.253N | |LOGISTIC REGRESSION | P=0.027 * P=0.355 P=0.546N P=0.059 | P=0.173N P=0.163N P=0.121N P=0.253N | |COCHRAN-ARMITAGE | P=0.019 * | P=0.162N | |FISHER EXACT | P=0.357 P=0.500N P=0.036 * | P=0.218N P=0.102N P=0.218N | |=================================================================================================================================| DATE: 06/04/96 EXPERIMENT: 89006 TEST: 06 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1 AZT TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 30 MG/KG 60 MG/KG 120 | VEHICLE 30 MG/KG 60 MG/KG 120 | | | CONTROL MG/KG | CONTROL MG/KG | |=================================================================================================================================| | | |Intestine Small: Jejunum | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 3.1% 5.5% 3.4% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/32 (3%) 1/35 (3%) 1/29 (3%) 0/42 (0%) | 0/34 (0%) 0/39 (0%) 0/31 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 722 729 (T) --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.204N P=0.534 P=0.740 P=0.446N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.242N P=0.503 P=0.740 P=0.446N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.213N P=0.524 P=0.740 P=0.446N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.247N | (e) | |FISHER EXACT | P=0.500 P=0.753N P=0.500N | (e) (e) (e) | |=================================================================================================================================| | | |Intestine Small: Site Unspecified | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 3.1% 5.5% 3.4% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/32 (3%) 1/35 (3%) 1/29 (3%) 0/42 (0%) | 0/34 (0%) 0/39 (0%) 0/31 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 722 729 (T) --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.204N P=0.534 P=0.740 P=0.446N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.242N P=0.503 P=0.740 P=0.446N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.213N P=0.524 P=0.740 P=0.446N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.247N | (e) | |FISHER EXACT | P=0.500 P=0.753N P=0.500N | (e) (e) (e) | |=================================================================================================================================| DATE: 06/04/96 EXPERIMENT: 89006 TEST: 06 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1 AZT TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 30 MG/KG 60 MG/KG 120 | VEHICLE 30 MG/KG 60 MG/KG 120 | | | CONTROL MG/KG | CONTROL MG/KG | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/49 (2%) 1/49 (2%) 0/50 (0%) | 0/49 (0%) 2/49 (4%) 1/50 (2%) 1/47 (2%) | |ADJUSTED (b) | 0.0% 2.9% 3.4% 0.0% | 0.0% 5.1% 2.7% 3.0% | |TERMINAL (d) | 0/32 (0%) 1/35 (3%) 1/29 (3%) 0/42 (0%) | 0/34 (0%) 2/39 (5%) 0/31 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | --- 729 (T) 729 (T) --- | --- 731 (T) 674 721 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.540N P=0.518 P=0.480 (e) | P=0.469 P=0.269 P=0.490 P=0.483 | |INCIDENTAL TUMOR | P=0.540N P=0.518 P=0.480 (e) | P=0.525 P=0.269 P=0.473 P=0.523 | |LOGISTIC REGRESSION | P=0.540N P=0.518 P=0.480 (e) | P=0.483 P=0.269 P=0.503 P=0.494 | |COCHRAN-ARMITAGE | P=0.594N | P=0.488 | |FISHER EXACT | P=0.495 P=0.495 (e) | P=0.247 P=0.505 P=0.490 | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/48 (0%) 0/49 (0%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 7.1% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/32 (0%) 0/35 (0%) 0/29 (0%) 3/42 (7%) | 0/34 (0%) 0/39 (0%) 0/31 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 729 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.022 * (e) (e) P=0.173 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.022 * (e) (e) P=0.173 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.022 * (e) (e) P=0.173 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.013 * | (e) | |FISHER EXACT | (e) (e) P=0.121 | (e) (e) (e) | |=================================================================================================================================| DATE: 06/04/96 EXPERIMENT: 89006 TEST: 06 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1 AZT TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 30 MG/KG 60 MG/KG 120 | VEHICLE 30 MG/KG 60 MG/KG 120 | | | CONTROL MG/KG | CONTROL MG/KG | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/48 (0%) 0/49 (0%) 4/50 (8%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 9.5% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/32 (0%) 0/35 (0%) 0/29 (0%) 4/42 (10%) | 0/34 (0%) 0/39 (0%) 0/31 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 729 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.007 ** (e) (e) P=0.103 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.007 ** (e) (e) P=0.103 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.007 ** (e) (e) P=0.103 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.003 ** | (e) | |FISHER EXACT | (e) (e) P=0.059 | (e) (e) (e) | |=================================================================================================================================| | | |Liver | | Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 6.3% 0.0% 3.4% 2.4% | 0.0% 0.0% 0.0% 3.0% | |TERMINAL (d) | 2/32 (6%) 0/35 (0%) 1/29 (3%) 1/42 (2%) | 0/34 (0%) 0/39 (0%) 0/31 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- 729 (T) 729 (T) | --- --- --- 721 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.427N P=0.219N P=0.535N P=0.405N | P=0.184 (e) (e) P=0.483 | |INCIDENTAL TUMOR | P=0.427N P=0.219N P=0.535N P=0.405N | P=0.275 (e) (e) P=0.564 | |LOGISTIC REGRESSION | P=0.427N P=0.219N P=0.535N P=0.405N | P=0.197 (e) (e) P=0.502 | |COCHRAN-ARMITAGE | P=0.500N | P=0.198 | |FISHER EXACT | P=0.247N P=0.500N P=0.500N | (e) (e) P=0.500 | |=================================================================================================================================| DATE: 06/04/96 EXPERIMENT: 89006 TEST: 06 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1 AZT TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 30 MG/KG 60 MG/KG 120 | VEHICLE 30 MG/KG 60 MG/KG 120 | | | CONTROL MG/KG | CONTROL MG/KG | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 4/50 (8%) 4/50 (8%) 3/50 (6%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 13.5% 11.0% 12.8% 6.4% | 0.0% 5.1% 0.0% 0.0% | |TERMINAL (d) | 0/32 (0%) 3/35 (9%) 3/29 (10%) 1/42 (2%) | 0/34 (0%) 2/39 (5%) 0/31 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 570 711 639 513 | --- 731 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.160N P=0.350N P=0.440N P=0.209N | P=0.435N P=0.269 (e) (e) | |INCIDENTAL TUMOR | P=0.345N P=0.599N P=0.501N P=0.668N | P=0.435N P=0.269 (e) (e) | |LOGISTIC REGRESSION | P=0.301N P=0.359N P=0.435N P=0.536N | P=0.435N P=0.269 (e) (e) | |COCHRAN-ARMITAGE | P=0.208N | P=0.405N | |FISHER EXACT | P=0.370N P=0.370N P=0.243N | P=0.247 (e) (e) | |=================================================================================================================================| | | |Liver | | Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 6/50 (12%) 2/50 (4%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |ADJUSTED (b) | 3.1% 5.7% 18.1% 4.8% | 2.9% 0.0% 0.0% 6.2% | |TERMINAL (d) | 1/32 (3%) 2/35 (6%) 3/29 (10%) 2/42 (5%) | 1/34 (3%) 0/39 (0%) 0/31 (0%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 638 729 (T) | 731 (T) --- --- 721 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.472 P=0.531 P=0.048 * P=0.595 | P=0.215 P=0.473N P=0.518N P=0.469 | |INCIDENTAL TUMOR | P=0.358 P=0.531 P=0.046 * P=0.595 | P=0.265 P=0.473N P=0.518N P=0.515 | |LOGISTIC REGRESSION | P=0.407 P=0.531 P=0.044 * P=0.595 | P=0.236 P=0.473N P=0.518N P=0.495 | |COCHRAN-ARMITAGE | P=0.357 | P=0.246 | |FISHER EXACT | P=0.500 P=0.056 P=0.500 | P=0.500N P=0.500N P=0.500 | |=================================================================================================================================| DATE: 06/04/96 EXPERIMENT: 89006 TEST: 06 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1 AZT TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 30 MG/KG 60 MG/KG 120 | VEHICLE 30 MG/KG 60 MG/KG 120 | | | CONTROL MG/KG | CONTROL MG/KG | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 25/50 (50%) 23/50 (46%) 23/50 (46%) 26/50 (52%) | 20/50 (40%) 18/50 (36%) 17/50 (34%) 28/50 (56%) | |ADJUSTED (b) | 65.2% 58.3% 66.8% 57.5% | 53.6% 44.9% 53.1% 67.5% | |TERMINAL (d) | 19/32 (59%) 19/35 (54%) 18/29 (62%) 23/42 (55%) | 17/34 (50%) 17/39 (44%) 16/31 (52%) 18/31 (58%) | |FIRST INCIDENCE (DAYS) | 576 458 473 540 | 607 648 722 467 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.239N P=0.292N P=0.550 P=0.215N | P=0.010 * P=0.234N P=0.475N P=0.058 | |INCIDENTAL TUMOR | P=0.433N P=0.414N P=0.575 P=0.483N | P=0.022 * P=0.275N P=0.453N P=0.081 | |LOGISTIC REGRESSION | P=0.537N P=0.422N P=0.574 P=0.528N | P=0.032 * P=0.317N P=0.457N P=0.082 | |COCHRAN-ARMITAGE | P=0.415 | P=0.043 * | |FISHER EXACT | P=0.421N P=0.421N P=0.500 | P=0.418N P=0.339N P=0.080 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 21/50 (42%) 26/50 (52%) 22/50 (44%) 19/50 (38%) | 12/50 (24%) 17/50 (34%) 11/50 (22%) 15/50 (30%) | |ADJUSTED (b) | 46.1% 61.6% 57.0% 40.4% | 30.3% 37.6% 30.7% 40.4% | |TERMINAL (d) | 8/32 (25%) 19/35 (54%) 13/29 (45%) 14/42 (33%) | 8/34 (24%) 11/39 (28%) 7/31 (23%) 10/31 (32%) | |FIRST INCIDENCE (DAYS) | 425 350 505 584 | 470 527 556 556 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.091N P=0.345 P=0.358 P=0.192N | P=0.309 P=0.314 P=0.588N P=0.273 | |INCIDENTAL TUMOR | P=0.385N P=0.134 P=0.424 P=0.428 | P=0.394 P=0.112 P=0.501 P=0.243 | |LOGISTIC REGRESSION | P=0.256N P=0.211 P=0.422 P=0.521N | P=0.411 P=0.159 P=0.544N P=0.325 | |COCHRAN-ARMITAGE | P=0.250N | P=0.426 | |FISHER EXACT | P=0.212 P=0.500 P=0.419N | P=0.189 P=0.500N P=0.326 | |=================================================================================================================================| DATE: 06/04/96 EXPERIMENT: 89006 TEST: 06 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1 AZT TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 30 MG/KG 60 MG/KG 120 | VEHICLE 30 MG/KG 60 MG/KG 120 | | | CONTROL MG/KG | CONTROL MG/KG | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 21/50 (42%) 27/50 (54%) 26/50 (52%) 19/50 (38%) | 13/50 (26%) 17/50 (34%) 11/50 (22%) 16/50 (32%) | |ADJUSTED (b) | 46.1% 64.0% 64.6% 40.4% | 33.0% 37.6% 30.7% 43.2% | |TERMINAL (d) | 8/32 (25%) 20/35 (57%) 15/29 (52%) 14/42 (33%) | 9/34 (26%) 11/39 (28%) 7/31 (23%) 11/31 (35%) | |FIRST INCIDENCE (DAYS) | 425 350 505 584 | 470 527 556 556 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.091N P=0.289 P=0.153 P=0.192N | P=0.288 P=0.396 P=0.503N P=0.271 | |INCIDENTAL TUMOR | P=0.409N P=0.097 P=0.134 P=0.428 | P=0.368 P=0.168 P=0.590 P=0.241 | |LOGISTIC REGRESSION | P=0.260N P=0.157 P=0.140 P=0.521N | P=0.390 P=0.225 P=0.455N P=0.329 | |COCHRAN-ARMITAGE | P=0.259N | P=0.406 | |FISHER EXACT | P=0.158 P=0.212 P=0.419N | P=0.257 P=0.408N P=0.330 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 36/50 (72%) 39/50 (78%) 34/50 (68%) 39/50 (78%) | 27/50 (54%) 29/50 (58%) 23/50 (46%) 36/50 (72%) | |ADJUSTED (b) | 76.5% 88.5% 84.7% 79.6% | 65.2% 63.0% 63.6% 85.3% | |TERMINAL (d) | 21/32 (66%) 30/35 (86%) 23/29 (79%) 32/42 (76%) | 20/34 (59%) 22/39 (56%) 18/31 (58%) 25/31 (81%) | |FIRST INCIDENCE (DAYS) | 425 350 473 540 | 470 527 556 467 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.160N P=0.543 P=0.469 P=0.236N | P=0.018 * P=0.478N P=0.443N P=0.038 * | |INCIDENTAL TUMOR | P=0.452 P=0.257 P=0.580N P=0.241 | P=0.028 * P=0.389 P=0.501N P=0.027 * | |LOGISTIC REGRESSION | P=0.487 P=0.301 P=0.580N P=0.341 | P=0.040 * P=0.463 P=0.394N P=0.046 * | |COCHRAN-ARMITAGE | P=0.372 | P=0.053 | |FISHER EXACT | P=0.322 P=0.414N P=0.322 | P=0.420 P=0.274N P=0.048 * | |=================================================================================================================================| DATE: 06/04/96 EXPERIMENT: 89006 TEST: 06 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1 AZT TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 30 MG/KG 60 MG/KG 120 | VEHICLE 30 MG/KG 60 MG/KG 120 | | | CONTROL MG/KG | CONTROL MG/KG | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 36/50 (72%) 39/50 (78%) 36/50 (72%) 39/50 (78%) | 27/50 (54%) 29/50 (58%) 23/50 (46%) 36/50 (72%) | |ADJUSTED (b) | 76.5% 88.5% 87.6% 79.6% | 65.2% 63.0% 63.6% 85.3% | |TERMINAL (d) | 21/32 (66%) 30/35 (86%) 24/29 (83%) 32/42 (76%) | 20/34 (59%) 22/39 (56%) 18/31 (58%) 25/31 (81%) | |FIRST INCIDENCE (DAYS) | 425 350 473 540 | 470 527 556 467 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.165N P=0.543 P=0.341 P=0.236N | P=0.018 * P=0.478N P=0.443N P=0.038 * | |INCIDENTAL TUMOR | P=0.418 P=0.257 P=0.413 P=0.241 | P=0.028 * P=0.389 P=0.501N P=0.027 * | |LOGISTIC REGRESSION | P=0.468 P=0.301 P=0.404 P=0.341 | P=0.040 * P=0.463 P=0.394N P=0.046 * | |COCHRAN-ARMITAGE | P=0.350 | P=0.053 | |FISHER EXACT | P=0.322 P=0.588N P=0.322 | P=0.420 P=0.274N P=0.048 * | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/50 (24%) 7/50 (14%) 11/50 (22%) 8/50 (16%) | 3/49 (6%) 3/50 (6%) 2/50 (4%) 7/50 (14%) | |ADJUSTED (b) | 33.2% 19.1% 32.8% 18.6% | 7.6% 7.7% 5.3% 21.5% | |TERMINAL (d) | 9/32 (28%) 6/35 (17%) 7/29 (24%) 7/42 (17%) | 1/34 (3%) 3/39 (8%) 1/31 (3%) 6/31 (19%) | |FIRST INCIDENCE (DAYS) | 565 624 584 694 | 647 731 (T) 288 709 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.146N P=0.118N P=0.572 P=0.093N | P=0.057 P=0.611N P=0.538N P=0.140 | |INCIDENTAL TUMOR | P=0.267N P=0.176N P=0.574 P=0.189N | P=0.091 P=0.635 P=0.346N P=0.170 | |LOGISTIC REGRESSION | P=0.228N P=0.150N P=0.592N P=0.172N | P=0.082 P=0.649N P=0.415N P=0.164 | |COCHRAN-ARMITAGE | P=0.292N | P=0.083 | |FISHER EXACT | P=0.154N P=0.500N P=0.227N | P=0.651N P=0.490N P=0.167 | |=================================================================================================================================| DATE: 06/04/96 EXPERIMENT: 89006 TEST: 06 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1 AZT TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 30 MG/KG 60 MG/KG 120 | VEHICLE 30 MG/KG 60 MG/KG 120 | | | CONTROL MG/KG | CONTROL MG/KG | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 2/50 (4%) 3/50 (6%) 4/50 (8%) | 3/49 (6%) 5/50 (10%) 0/50 (0%) 4/50 (8%) | |ADJUSTED (b) | 11.2% 5.7% 10.3% 9.3% | 8.8% 11.6% 0.0% 10.4% | |TERMINAL (d) | 2/32 (6%) 2/35 (6%) 3/29 (10%) 3/42 (7%) | 3/34 (9%) 3/39 (8%) 0/31 (0%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | 596 729 (T) 729 (T) 695 | 731 (T) 589 --- 625 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.545N P=0.304N P=0.550N P=0.514N | P=0.532 P=0.426 P=0.137N P=0.480 | |INCIDENTAL TUMOR | P=0.502 P=0.374N P=0.560N P=0.564 | P=0.522N P=0.455 P=0.137N P=0.559 | |LOGISTIC REGRESSION | P=0.536 P=0.335N P=0.550N P=0.616N | P=0.578N P=0.365 P=0.137N P=0.509 | |COCHRAN-ARMITAGE | P=0.481 | P=0.572N | |FISHER EXACT | P=0.339N P=0.500N P=0.643N | P=0.369 P=0.117N P=0.511 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 14/50 (28%) 9/50 (18%) 14/50 (28%) 11/50 (22%) | 6/49 (12%) 8/50 (16%) 2/50 (4%) 11/50 (22%) | |ADJUSTED (b) | 38.0% 24.7% 41.9% 25.0% | 16.0% 18.9% 5.3% 30.3% | |TERMINAL (d) | 10/32 (31%) 8/35 (23%) 10/29 (34%) 9/42 (21%) | 4/34 (12%) 6/39 (15%) 1/31 (3%) 7/31 (23%) | |FIRST INCIDENCE (DAYS) | 565 624 584 694 | 647 589 288 625 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.201N P=0.127N P=0.462 P=0.134N | P=0.101 P=0.479 P=0.169N P=0.128 | |INCIDENTAL TUMOR | P=0.366N P=0.190N P=0.463 P=0.312N | P=0.180 P=0.444 P=0.077N P=0.177 | |LOGISTIC REGRESSION | P=0.312N P=0.163N P=0.476 P=0.238N | P=0.142 P=0.405 P=0.112N P=0.151 | |COCHRAN-ARMITAGE | P=0.411N | P=0.146 | |FISHER EXACT | P=0.171N P=0.588N P=0.322N | P=0.403 P=0.128N P=0.154 | |=================================================================================================================================| DATE: 06/04/96 EXPERIMENT: 89006 TEST: 06 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1 AZT TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 30 MG/KG 60 MG/KG 120 | VEHICLE 30 MG/KG 60 MG/KG 120 | | | CONTROL MG/KG | CONTROL MG/KG | |=================================================================================================================================| | | |Mesentery | | Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 3.4% 0.0% | 4.7% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/32 (0%) 0/35 (0%) 1/29 (3%) 0/42 (0%) | 0/34 (0%) 0/39 (0%) 0/31 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 729 (T) --- | 610 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.718 (e) P=0.480 (e) | P=0.119N P=0.227N P=0.256N P=0.237N | |INCIDENTAL TUMOR | P=0.718 (e) P=0.480 (e) | P=0.082N P=0.256N P=0.197N P=0.154N | |LOGISTIC REGRESSION | P=0.718 (e) P=0.480 (e) | P=0.102N P=0.300N P=0.209N P=0.220N | |COCHRAN-ARMITAGE | P=0.694 | P=0.115N | |FISHER EXACT | (e) P=0.500 (e) | P=0.247N P=0.247N P=0.247N | |=================================================================================================================================| | | |Ovary | | Cystadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 2/50 (4%) 2/50 (4%) 3/47 (6%) 0/48 (0%) | |ADJUSTED (b) | | 5.9% 4.7% 10.0% 0.0% | |TERMINAL (d) | | 2/34 (6%) 1/39 (3%) 2/28 (7%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | | 731 (T) 617 713 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.251N P=0.648N P=0.422 P=0.274N | |INCIDENTAL TUMOR | | P=0.207N P=0.630N P=0.418 P=0.274N | |LOGISTIC REGRESSION | | P=0.221N P=0.691N P=0.417 P=0.274N | |COCHRAN-ARMITAGE | | P=0.213N | |FISHER EXACT | | P=0.691N P=0.470 P=0.258N | |=================================================================================================================================| DATE: 06/04/96 EXPERIMENT: 89006 TEST: 06 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1 AZT TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 30 MG/KG 60 MG/KG 120 | VEHICLE 30 MG/KG 60 MG/KG 120 | | | CONTROL MG/KG | CONTROL MG/KG | |=================================================================================================================================| | | |Ovary | | Granulosa Cell Tumor Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 0/50 (0%) 2/50 (4%) 0/47 (0%) 0/48 (0%) | |ADJUSTED (b) | | 0.0% 5.0% 0.0% 0.0% | |TERMINAL (d) | | 0/34 (0%) 1/39 (3%) 0/28 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | | --- 690 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.426N P=0.261 (e) (e) | |INCIDENTAL TUMOR | | P=0.381N P=0.202 (e) (e) | |LOGISTIC REGRESSION | | P=0.420N P=0.246 (e) (e) | |COCHRAN-ARMITAGE | | P=0.415N | |FISHER EXACT | | P=0.247 (e) (e) | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/40 (0%) 0/46 (0%) 0/42 (0%) 0/47 (0%) | 2/46 (4%) 5/49 (10%) 1/46 (2%) 0/46 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 6.3% 12.1% 3.4% 0.0% | |TERMINAL (d) | 0/25 (0%) 0/34 (0%) 0/26 (0%) 0/39 (0%) | 2/32 (6%) 4/39 (10%) 1/29 (3%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 731 (T) 589 731 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.093N P=0.295 P=0.535N P=0.260N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.074N P=0.317 P=0.535N P=0.260N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.077N P=0.257 P=0.535N P=0.260N | |COCHRAN-ARMITAGE | (e) | P=0.073N | |FISHER EXACT | (e) (e) (e) | P=0.245 P=0.500N P=0.247N | |=================================================================================================================================| DATE: 06/04/96 EXPERIMENT: 89006 TEST: 06 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1 AZT TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 30 MG/KG 60 MG/KG 120 | VEHICLE 30 MG/KG 60 MG/KG 120 | | | CONTROL MG/KG | CONTROL MG/KG | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 3/50 (6%) 1/50 (2%) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 2/50 (4%) | |ADJUSTED (b) | 5.0% 2.2% 8.3% 2.4% | 0.0% 2.6% 6.5% 5.1% | |TERMINAL (d) | 0/32 (0%) 0/35 (0%) 1/29 (3%) 1/42 (2%) | 0/34 (0%) 1/39 (3%) 2/31 (6%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 325 568 422 729 (T) | --- 731 (T) 731 (T) 695 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.425N P=0.492N P=0.465 P=0.441N | P=0.144 P=0.527 P=0.218 P=0.251 | |INCIDENTAL TUMOR | P=0.614N P=0.478N P=0.662 P=0.707 | P=0.191 P=0.527 P=0.218 P=0.307 | |LOGISTIC REGRESSION | P=0.524N P=0.421N P=0.616 P=0.695N | P=0.157 P=0.527 P=0.218 P=0.238 | |COCHRAN-ARMITAGE | P=0.474N | P=0.160 | |FISHER EXACT | P=0.500N P=0.500 P=0.500N | P=0.500 P=0.247 P=0.247 | |=================================================================================================================================| | | |Skin | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 2/50 (4%) | |ADJUSTED (b) | 2.0% 0.0% 5.5% 2.4% | 0.0% 2.6% 6.5% 5.1% | |TERMINAL (d) | 0/32 (0%) 0/35 (0%) 1/29 (3%) 1/42 (2%) | 0/34 (0%) 1/39 (3%) 2/31 (6%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 325 --- 422 729 (T) | --- 731 (T) 731 (T) 695 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.539 P=0.504N P=0.474 P=0.731N | P=0.144 P=0.527 P=0.218 P=0.251 | |INCIDENTAL TUMOR | P=0.483 P=0.282N P=0.709 P=0.554 | P=0.191 P=0.527 P=0.218 P=0.307 | |LOGISTIC REGRESSION | P=0.449 P=0.267N P=0.680 P=0.553 | P=0.157 P=0.527 P=0.218 P=0.238 | |COCHRAN-ARMITAGE | P=0.500 | P=0.160 | |FISHER EXACT | P=0.500N P=0.500 P=0.753N | P=0.500 P=0.247 P=0.247 | |=================================================================================================================================| DATE: 06/04/96 EXPERIMENT: 89006 TEST: 06 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1 AZT TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 30 MG/KG 60 MG/KG 120 | VEHICLE 30 MG/KG 60 MG/KG 120 | | | CONTROL MG/KG | CONTROL MG/KG | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 3/50 (6%) 1/50 (2%) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 2/50 (4%) | |ADJUSTED (b) | 5.0% 2.2% 8.3% 2.4% | 0.0% 2.6% 6.5% 5.1% | |TERMINAL (d) | 0/32 (0%) 0/35 (0%) 1/29 (3%) 1/42 (2%) | 0/34 (0%) 1/39 (3%) 2/31 (6%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 325 568 422 729 (T) | --- 731 (T) 731 (T) 695 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.425N P=0.492N P=0.465 P=0.441N | P=0.144 P=0.527 P=0.218 P=0.251 | |INCIDENTAL TUMOR | P=0.614N P=0.478N P=0.662 P=0.707 | P=0.191 P=0.527 P=0.218 P=0.307 | |LOGISTIC REGRESSION | P=0.524N P=0.421N P=0.616 P=0.695N | P=0.157 P=0.527 P=0.218 P=0.238 | |COCHRAN-ARMITAGE | P=0.474N | P=0.160 | |FISHER EXACT | P=0.500N P=0.500 P=0.500N | P=0.500 P=0.247 P=0.247 | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/49 (2%) 0/48 (0%) 0/50 (0%) | 1/49 (2%) 0/48 (0%) 1/49 (2%) 0/50 (0%) | |ADJUSTED (b) | 5.7% 2.9% 0.0% 0.0% | 2.2% 0.0% 2.4% 0.0% | |TERMINAL (d) | 1/32 (3%) 1/35 (3%) 0/28 (0%) 0/42 (0%) | 0/34 (0%) 0/39 (0%) 0/31 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 698 729 (T) --- --- | 523 --- 612 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.089N P=0.476N P=0.274N P=0.197N | P=0.406N P=0.483N P=0.753 P=0.496N | |INCIDENTAL TUMOR | P=0.105N P=0.497N P=0.254N P=0.293N | P=0.413N P=0.638N P=0.751 P=0.638N | |LOGISTIC REGRESSION | P=0.095N P=0.494N P=0.266N P=0.217N | P=0.350N P=0.728N P=0.709N P=0.428N | |COCHRAN-ARMITAGE | P=0.102N | P=0.400N | |FISHER EXACT | P=0.508N P=0.258N P=0.247N | P=0.505N P=0.753N P=0.495N | |=================================================================================================================================| DATE: 06/04/96 EXPERIMENT: 89006 TEST: 06 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1 AZT TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 30 MG/KG 60 MG/KG 120 | VEHICLE 30 MG/KG 60 MG/KG 120 | | | CONTROL MG/KG | CONTROL MG/KG | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma or Papilloma Squamous | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 3/50 (6%) 3/50 (6%) 1/50 (2%) 2/50 (4%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 8.8% 7.7% 3.2% 5.4% | |TERMINAL (d) | 0/32 (0%) 0/35 (0%) 0/29 (0%) 0/42 (0%) | 3/34 (9%) 3/39 (8%) 1/31 (3%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 731 (T) 731 (T) 731 (T) 612 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.399N P=0.599N P=0.338N P=0.529N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.377N P=0.599N P=0.338N P=0.488N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.351N P=0.599N P=0.338N P=0.498N | |COCHRAN-ARMITAGE | (e) | P=0.343N | |FISHER EXACT | (e) (e) (e) | P=0.661N P=0.309N P=0.500N | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 3/50 (6%) 3/50 (6%) 1/50 (2%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 8.8% 7.7% 3.2% 3.2% | |TERMINAL (d) | 0/32 (0%) 0/35 (0%) 0/29 (0%) 0/42 (0%) | 3/34 (9%) 3/39 (8%) 1/31 (3%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 731 (T) 731 (T) 731 (T) 731 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.202N P=0.599N P=0.338N P=0.338N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.202N P=0.599N P=0.338N P=0.338N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.202N P=0.599N P=0.338N P=0.338N | |COCHRAN-ARMITAGE | (e) | P=0.165N | |FISHER EXACT | (e) (e) (e) | P=0.661N P=0.309N P=0.309N | |=================================================================================================================================| DATE: 06/04/96 EXPERIMENT: 89006 TEST: 06 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1 AZT TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 30 MG/KG 60 MG/KG 120 | VEHICLE 30 MG/KG 60 MG/KG 120 | | | CONTROL MG/KG | CONTROL MG/KG | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 4/49 (8%) 2/48 (4%) 1/50 (2%) | 3/49 (6%) 2/50 (4%) 4/50 (8%) 0/50 (0%) | |ADJUSTED (b) | 5.5% 11.4% 6.5% 2.4% | 8.1% 5.1% 12.9% 0.0% | |TERMINAL (d) | 1/32 (3%) 4/35 (11%) 1/29 (3%) 1/42 (2%) | 2/34 (6%) 2/39 (5%) 4/31 (13%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 638 729 (T) 691 729 (T) | 647 731 (T) 731 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.196N P=0.374 P=0.657 P=0.424N | P=0.170N P=0.446N P=0.449 P=0.134N | |INCIDENTAL TUMOR | P=0.256N P=0.300 P=0.614 P=0.544N | P=0.155N P=0.492N P=0.446 P=0.114N | |LOGISTIC REGRESSION | P=0.233N P=0.337 P=0.661 P=0.496N | P=0.142N P=0.475N P=0.460 P=0.118N | |COCHRAN-ARMITAGE | P=0.263N | P=0.132N | |FISHER EXACT | P=0.329 P=0.676 P=0.500N | P=0.490N P=0.511 P=0.117N | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 4/49 (8%) 2/48 (4%) 1/50 (2%) | 4/49 (8%) 3/50 (6%) 4/50 (8%) 0/50 (0%) | |ADJUSTED (b) | 5.5% 11.4% 6.5% 2.4% | 10.7% 7.7% 12.9% 0.0% | |TERMINAL (d) | 1/32 (3%) 4/35 (11%) 1/29 (3%) 1/42 (2%) | 2/34 (6%) 3/39 (8%) 4/31 (13%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 638 729 (T) 691 729 (T) | 647 731 (T) 731 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.196N P=0.374 P=0.657 P=0.424N | P=0.088N P=0.438N P=0.586 P=0.077N | |INCIDENTAL TUMOR | P=0.256N P=0.300 P=0.614 P=0.544N | P=0.070N P=0.519N P=0.586 P=0.049N* | |LOGISTIC REGRESSION | P=0.233N P=0.337 P=0.661 P=0.496N | P=0.068N P=0.467N P=0.603 P=0.061N | |COCHRAN-ARMITAGE | P=0.263N | P=0.061N | |FISHER EXACT | P=0.329 P=0.676 P=0.500N | P=0.489N P=0.631N P=0.056N | |=================================================================================================================================| DATE: 06/04/96 EXPERIMENT: 89006 TEST: 06 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1 AZT TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 30 MG/KG 60 MG/KG 120 | VEHICLE 30 MG/KG 60 MG/KG 120 | | | CONTROL MG/KG | CONTROL MG/KG | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | | 2.6% 5.1% 0.0% 0.0% | |TERMINAL (d) | | 0/34 (0%) 2/39 (5%) 0/31 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | | 691 731 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.204N P=0.535 P=0.522N P=0.490N | |INCIDENTAL TUMOR | | P=0.182N P=0.478 P=0.527N P=0.436N | |LOGISTIC REGRESSION | | P=0.192N P=0.519 P=0.509N P=0.500N | |COCHRAN-ARMITAGE | | P=0.188N | |FISHER EXACT | | P=0.500 P=0.500N P=0.500N | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | | 2.6% 5.1% 0.0% 3.2% | |TERMINAL (d) | | 0/34 (0%) 2/39 (5%) 0/31 (0%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | | 691 731 (T) --- 731 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.532N P=0.535 P=0.522N P=0.756 | |INCIDENTAL TUMOR | | P=0.496N P=0.478 P=0.527N P=0.736N | |LOGISTIC REGRESSION | | P=0.507N P=0.519 P=0.509N P=0.761N | |COCHRAN-ARMITAGE | | P=0.500N | |FISHER EXACT | | P=0.500 P=0.500N P=0.753N | |=================================================================================================================================| DATE: 06/04/96 EXPERIMENT: 89006 TEST: 06 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1 AZT TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 30 MG/KG 60 MG/KG 120 | VEHICLE 30 MG/KG 60 MG/KG 120 | | | CONTROL MG/KG | CONTROL MG/KG | |=================================================================================================================================| | | |Vagina | | Squamous Cell Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 0/50 (0%) 0/50 (0%) 5/50 (10%) 9/50 (18%) | |ADJUSTED (b) | | 0.0% 0.0% 12.7% 26.8% | |TERMINAL (d) | | 0/34 (0%) 0/39 (0%) 1/31 (3%) 7/31 (23%) | |FIRST INCIDENCE (DAYS) | | --- --- 493 695 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P<0.001 ** (e) P=0.031 * P=0.002 ** | |INCIDENTAL TUMOR | | P<0.001 ** (e) P=0.027 * P=0.003 ** | |LOGISTIC REGRESSION | | P<0.001 ** (e) P=0.037 * P=0.002 ** | |COCHRAN-ARMITAGE | | P<0.001 ** | |FISHER EXACT | | (e) P=0.028 * P=0.001 ** | |=================================================================================================================================| | | |Vagina | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |ADJUSTED (b) | | 0.0% 0.0% 0.0% 6.5% | |TERMINAL (d) | | 0/34 (0%) 0/39 (0%) 0/31 (0%) 2/31 (6%) | |FIRST INCIDENCE (DAYS) | | --- --- --- 731 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.036 * (e) (e) P=0.218 | |INCIDENTAL TUMOR | | P=0.036 * (e) (e) P=0.218 | |LOGISTIC REGRESSION | | P=0.036 * (e) (e) P=0.218 | |COCHRAN-ARMITAGE | | P=0.046 * | |FISHER EXACT | | (e) (e) P=0.247 | |=================================================================================================================================| DATE: 06/04/96 EXPERIMENT: 89006 TEST: 06 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1 AZT TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 30 MG/KG 60 MG/KG 120 | VEHICLE 30 MG/KG 60 MG/KG 120 | | | CONTROL MG/KG | CONTROL MG/KG | |=================================================================================================================================| | | |All Organs | | Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | |ADJUSTED (b) | 6.3% 2.9% 6.9% 2.4% | 0.0% 0.0% 2.3% 5.3% | |TERMINAL (d) | 2/32 (6%) 1/35 (3%) 2/29 (7%) 1/42 (2%) | 0/34 (0%) 0/39 (0%) 0/31 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) 729 (T) | --- --- 556 666 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.358N P=0.469N P=0.660 P=0.405N | P=0.070 (e) P=0.491 P=0.238 | |INCIDENTAL TUMOR | P=0.358N P=0.469N P=0.660 P=0.405N | P=0.136 (e) P=0.602 P=0.307 | |LOGISTIC REGRESSION | P=0.358N P=0.469N P=0.660 P=0.405N | P=0.072 (e) P=0.565 P=0.237 | |COCHRAN-ARMITAGE | P=0.444N | P=0.070 | |FISHER EXACT | P=0.500N P=0.691N P=0.500N | (e) P=0.500 P=0.247 | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 7/50 (14%) 6/50 (12%) 4/50 (8%) 3/50 (6%) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 2/50 (4%) | |ADJUSTED (b) | 16.2% 16.1% 12.8% 6.4% | 2.2% 5.1% 2.4% 4.7% | |TERMINAL (d) | 1/32 (3%) 4/35 (11%) 3/29 (10%) 1/42 (2%) | 0/34 (0%) 2/39 (5%) 0/31 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 570 711 639 513 | 523 731 (T) 612 601 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.072N P=0.460N P=0.332N P=0.129N | P=0.426 P=0.541 P=0.753 P=0.508 | |INCIDENTAL TUMOR | P=0.184N P=0.541 P=0.372N P=0.477N | P=0.460 P=0.431 P=0.732 P=0.495 | |LOGISTIC REGRESSION | P=0.146N P=0.497N P=0.250N P=0.357N | P=0.459 P=0.445 P=0.714N P=0.533 | |COCHRAN-ARMITAGE | P=0.101N | P=0.444 | |FISHER EXACT | P=0.500N P=0.262N P=0.159N | P=0.500 P=0.753N P=0.500 | |=================================================================================================================================| DATE: 06/04/96 EXPERIMENT: 89006 TEST: 06 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1 AZT TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 30 MG/KG 60 MG/KG 120 | VEHICLE 30 MG/KG 60 MG/KG 120 | | | CONTROL MG/KG | CONTROL MG/KG | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 9/50 (18%) 6/50 (12%) 6/50 (12%) 4/50 (8%) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 4/50 (8%) | |ADJUSTED (b) | 21.6% 16.1% 19.5% 8.7% | 2.2% 5.1% 4.7% 9.8% | |TERMINAL (d) | 3/32 (9%) 4/35 (11%) 5/29 (17%) 2/42 (5%) | 0/34 (0%) 2/39 (5%) 0/31 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 570 711 639 513 | 523 731 (T) 556 601 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.064N P=0.259N P=0.372N P=0.081N | P=0.109 P=0.541 P=0.487 P=0.189 | |INCIDENTAL TUMOR | P=0.156N P=0.452N P=0.413N P=0.301N | P=0.164 P=0.431 P=0.518 P=0.207 | |LOGISTIC REGRESSION | P=0.101N P=0.288N P=0.307N P=0.239N | P=0.119 P=0.445 P=0.603 P=0.189 | |COCHRAN-ARMITAGE | P=0.103N | P=0.113 | |FISHER EXACT | P=0.288N P=0.288N P=0.117N | P=0.500 P=0.500 P=0.181 | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 1/50 (2%) 3/50 (6%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 5.3% 0.0% 0.0% | 4.0% 2.0% 8.3% 2.7% | |TERMINAL (d) | 0/32 (0%) 1/35 (3%) 0/29 (0%) 0/42 (0%) | 0/34 (0%) 0/39 (0%) 1/31 (3%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | --- 665 --- --- | 379 527 582 709 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.369N P=0.255 (e) (e) | P=0.486N P=0.488N P=0.461 P=0.499N | |INCIDENTAL TUMOR | P=0.444N P=0.232 (e) (e) | P=0.547N P=0.712 P=0.364 P=0.676N | |LOGISTIC REGRESSION | P=0.398N P=0.237 (e) (e) | P=0.404N P=0.319 P=0.637 P=0.396N | |COCHRAN-ARMITAGE | P=0.405N | P=0.474N | |FISHER EXACT | P=0.247 (e) (e) | P=0.500N P=0.500 P=0.500N | |=================================================================================================================================| DATE: 06/04/96 EXPERIMENT: 89006 TEST: 06 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1 AZT TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 30 MG/KG 60 MG/KG 120 | VEHICLE 30 MG/KG 60 MG/KG 120 | | | CONTROL MG/KG | CONTROL MG/KG | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated | | Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 6/50 (12%) 7/50 (14%) 5/50 (10%) | 5/50 (10%) 10/50 (20%) 7/50 (14%) 9/50 (18%) | |ADJUSTED (b) | 2.5% 13.3% 22.0% 11.5% | 12.6% 24.0% 18.4% 25.3% | |TERMINAL (d) | 0/32 (0%) 1/35 (3%) 5/29 (17%) 4/42 (10%) | 2/34 (6%) 8/39 (21%) 3/31 (10%) 6/31 (19%) | |FIRST INCIDENCE (DAYS) | 638 257 596 612 | 603 636 219 625 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.277 P=0.070 P=0.027 * P=0.164 | P=0.203 P=0.195 P=0.328 P=0.180 | |INCIDENTAL TUMOR | P=0.097 P=0.059 P=0.021 * P=0.070 | P=0.372 P=0.148 P=0.600 P=0.259 | |LOGISTIC REGRESSION | P=0.141 P=0.073 P=0.025 * P=0.097 | P=0.268 P=0.139 P=0.450 P=0.194 | |COCHRAN-ARMITAGE | P=0.174 | P=0.265 | |FISHER EXACT | P=0.056 P=0.030 * P=0.102 | P=0.131 P=0.380 P=0.194 | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 33/50 (66%) 31/50 (62%) 29/50 (58%) 42/50 (84%) | 30/50 (60%) 33/50 (66%) 26/50 (52%) 31/50 (62%) | |ADJUSTED (b) | 78.2% 77.1% 78.0% 89.3% | 76.7% 76.6% 69.8% 73.3% | |TERMINAL (d) | 23/32 (72%) 26/35 (74%) 21/29 (72%) 37/42 (88%) | 25/34 (74%) 29/39 (74%) 20/31 (65%) 20/31 (65%) | |FIRST INCIDENCE (DAYS) | 565 458 473 540 | 607 589 288 467 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.392 P=0.264N P=0.507N P=0.566 | P=0.288 P=0.504N P=0.462N P=0.362 | |INCIDENTAL TUMOR | P=0.064 P=0.487N P=0.489N P=0.068 | P=0.534 P=0.567 P=0.311N P=0.512 | |LOGISTIC REGRESSION | P=0.048 * P=0.431N P=0.464N P=0.075 | P=0.535N P=0.490 P=0.414N P=0.534 | |COCHRAN-ARMITAGE | P=0.022 * | P=0.500N | |FISHER EXACT | P=0.418N P=0.268N P=0.032 * | P=0.339 P=0.273N P=0.500 | |=================================================================================================================================| DATE: 06/04/96 EXPERIMENT: 89006 TEST: 06 PAGE 22 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1 AZT TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 30 MG/KG 60 MG/KG 120 | VEHICLE 30 MG/KG 60 MG/KG 120 | | | CONTROL MG/KG | CONTROL MG/KG | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 28/50 (56%) 40/50 (80%) 39/50 (78%) 29/50 (58%) | 26/50 (52%) 30/50 (60%) 28/50 (56%) 35/50 (70%) | |ADJUSTED (b) | 58.0% 80.0% 84.8% 60.4% | 55.8% 62.5% 60.8% 77.4% | |TERMINAL (d) | 12/32 (38%) 25/35 (71%) 22/29 (76%) 23/42 (55%) | 14/34 (41%) 21/39 (54%) 13/31 (42%) 21/31 (68%) | |FIRST INCIDENCE (DAYS) | 325 257 422 513 | 379 527 219 556 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.109N P=0.098 P=0.028 * P=0.270N | P=0.044 * P=0.500 P=0.309 P=0.071 | |INCIDENTAL TUMOR | P=0.480 P=0.003 ** P=0.008 ** P=0.197 | P=0.080 P=0.161 P=0.339 P=0.050 * | |LOGISTIC REGRESSION | P=0.512N P=0.004 ** P=0.006 ** P=0.335 | P=0.031 * P=0.190 P=0.335 P=0.051 | |COCHRAN-ARMITAGE | P=0.379N | P=0.051 | |FISHER EXACT | P=0.009 ** P=0.016 * P=0.500 | P=0.273 P=0.421 P=0.050 | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 43/50 (86%) 49/50 (98%) 45/50 (90%) 50/50 (100%)| 41/50 (82%) 42/50 (84%) 41/50 (82%) 43/50 (86%) | |ADJUSTED (b) | 86.0% 98.0% 97.8% 100.0% | 85.3% 87.5% 87.2% 91.4% | |TERMINAL (d) | 25/32 (78%) 34/35 (97%) 28/29 (97%) 42/42 (100%)| 27/34 (79%) 33/39 (85%) 25/31 (81%) 27/31 (87%) | |FIRST INCIDENCE (DAYS) | 325 257 422 513 | 379 527 219 467 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.244N P=0.379 P=0.206 P=0.341N | P=0.161 P=0.318N P=0.345 P=0.293 | |INCIDENTAL TUMOR | P=0.013 * P=0.022 * P=0.194 P=0.003 ** | P=0.382 P=0.485 P=0.518 P=0.333 | |LOGISTIC REGRESSION | P=0.010 * P=0.022 * P=0.151 P=0.003 ** | P=0.317 P=0.480 P=0.535 P=0.382 | |COCHRAN-ARMITAGE | P=0.019 * | P=0.362 | |FISHER EXACT | P=0.030 * P=0.380 P=0.006 ** | P=0.500 P=0.602N P=0.393 | |=================================================================================================================================| DATE: 06/04/96 EXPERIMENT: 89006 TEST: 06 PAGE 23 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 1 AZT TERMINAL SACRIFICE AT 105 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).