TDMS Study 88066-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: A. D. Little POLYVINYL ALCOHOL DATE: 08/14/96 EXPERIMENT: 88066 TEST: 01 TIME: 19:29:43 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-15330 ROUTE: VAGINAL NTP C#: 88066 PATHOLOGIST: GOAD, MARY CAS: 9002-89-5 ------------------------------------------------------------------------------------------------------------------------------------ UNTREATED CONTROL VS 25% REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE 001 UNTREATDCONTROL INCLUDE 003 25% NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: A. D. Little POLYVINYL ALCOHOL DATE: 08/14/96 EXPERIMENT: 88066 TEST: 01 TIME: 19:29:43 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-15330 ROUTE: VAGINAL NTP C#: 88066 PATHOLOGIST: GOAD, MARY CAS: 9002-89-5 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 Gallbladder Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Salivary Glands Spleen Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: A. D. Little POLYVINYL ALCOHOL DATE: 08/14/96 EXPERIMENT: 88066 TEST: 01 TIME: 19:29:43 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-15330 ROUTE: VAGINAL NTP C#: 88066 PATHOLOGIST: GOAD, MARY CAS: 9002-89-5 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF POLYVINYL ALCOHOL ==================================================================================================== FEMALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ All Organs Malignant and Benign Tumors ==================================================================================================== DATE: 08/15/96 EXPERIMENT: 88066 TEST: 01 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | UNTREATD 25% | | | CONTROL | |==============================================================================| | | |Harderian Gland | | Adenoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # | |----------- | | |OVERALL (a) | 4/100 (4%) 4/100 (4%) | |ADJUSTED (b) | 7.1% 6.3% | |TERMINAL (d) | 2/47 (4%) 3/61 (5%) | |FIRST INCIDENCE (DAYS) | 640 690 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.521N | |INCIDENTAL TUMOR | P=0.581N | |LOGISTIC REGRESSION | P=0.582N | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.640N | |==============================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # | |----------- | | |OVERALL (a) | 5/100 (5%) 5/100 (5%) | |ADJUSTED (b) | 8.3% 7.4% | |TERMINAL (d) | 2/47 (4%) 3/61 (5%) | |FIRST INCIDENCE (DAYS) | 640 646 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.507N | |INCIDENTAL TUMOR | P=0.612N | |LOGISTIC REGRESSION | P=0.583N | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.626N | |==============================================================================| DATE: 08/15/96 EXPERIMENT: 88066 TEST: 01 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | UNTREATD 25% | | | CONTROL | |==============================================================================| | | |Liver | | Hepatocellular Adenoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 55/99 (56%) 55/100 (55%) | |ADJUSTED (b) | 80.3% 69.2% | |TERMINAL (d) | 34/47 (72%) 37/61 (61%) | |FIRST INCIDENCE (DAYS) | 365 514 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.081N | |INCIDENTAL TUMOR | P=0.293N | |LOGISTIC REGRESSION | P=0.239N | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.525N | |==============================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 11/99 (11%) 20/100 (20%) | |ADJUSTED (b) | 18.6% 28.0% | |TERMINAL (d) | 5/47 (11%) 13/61 (21%) | |FIRST INCIDENCE (DAYS) | 538 507 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.181 | |INCIDENTAL TUMOR | P=0.087 | |LOGISTIC REGRESSION | P=0.088 | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.062 | |==============================================================================| DATE: 08/15/96 EXPERIMENT: 88066 TEST: 01 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | UNTREATD 25% | | | CONTROL | |==============================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 59/99 (60%) 62/100 (62%) | |ADJUSTED (b) | 82.6% 73.4% | |TERMINAL (d) | 35/47 (74%) 39/61 (64%) | |FIRST INCIDENCE (DAYS) | 365 507 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.143N | |INCIDENTAL TUMOR | P=0.454N | |LOGISTIC REGRESSION | P=0.416N | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.420 | |==============================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 59/99 (60%) 62/100 (62%) | |ADJUSTED (b) | 82.6% 73.4% | |TERMINAL (d) | 35/47 (74%) 39/61 (64%) | |FIRST INCIDENCE (DAYS) | 365 507 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.143N | |INCIDENTAL TUMOR | P=0.454N | |LOGISTIC REGRESSION | P=0.416N | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.420 | |==============================================================================| DATE: 08/15/96 EXPERIMENT: 88066 TEST: 01 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | UNTREATD 25% | | | CONTROL | |==============================================================================| | | |Liver | | Hepatocholangiocarcinoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/99 (0%) 2/100 (2%) | |ADJUSTED (b) | 0.0% 2.2% | |TERMINAL (d) | 0/47 (0%) 0/61 (0%) | |FIRST INCIDENCE (DAYS) | --- 553 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.267 | |INCIDENTAL TUMOR | P=0.307 | |LOGISTIC REGRESSION | P=0.215 | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.251 | |==============================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 6/100 (6%) 8/100 (8%) | |ADJUSTED (b) | 11.0% 11.7% | |TERMINAL (d) | 4/47 (9%) 6/61 (10%) | |FIRST INCIDENCE (DAYS) | 643 313 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.548 | |INCIDENTAL TUMOR | P=0.455 | |LOGISTIC REGRESSION | P=0.410 | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.391 | |==============================================================================| DATE: 08/15/96 EXPERIMENT: 88066 TEST: 01 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | UNTREATD 25% | | | CONTROL | |==============================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 3/100 (3%) 5/100 (5%) | |ADJUSTED (b) | 4.7% 7.8% | |TERMINAL (d) | 0/47 (0%) 4/61 (7%) | |FIRST INCIDENCE (DAYS) | 473 675 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.474 | |INCIDENTAL TUMOR | P=0.314 | |LOGISTIC REGRESSION | P=0.383 | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.360 | |==============================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 9/100 (9%) 13/100 (13%) | |ADJUSTED (b) | 15.2% 19.3% | |TERMINAL (d) | 4/47 (9%) 10/61 (16%) | |FIRST INCIDENCE (DAYS) | 473 313 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.434 | |INCIDENTAL TUMOR | P=0.267 | |LOGISTIC REGRESSION | P=0.274 | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.249 | |==============================================================================| DATE: 08/15/96 EXPERIMENT: 88066 TEST: 01 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | UNTREATD 25% | | | CONTROL | |==============================================================================| | | |Ovary | | Cystadenoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 6/95 (6%) 3/97 (3%) | |ADJUSTED (b) | 11.1% 4.8% | |TERMINAL (d) | 3/45 (7%) 2/59 (3%) | |FIRST INCIDENCE (DAYS) | 529 690 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.157N | |INCIDENTAL TUMOR | P=0.257N | |LOGISTIC REGRESSION | P=0.204N | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.238N | |==============================================================================| | | |Ovary | | Luteoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/95 (1%) 2/97 (2%) | |ADJUSTED (b) | 2.2% 3.0% | |TERMINAL (d) | 1/45 (2%) 1/59 (2%) | |FIRST INCIDENCE (DAYS) | 729 (T) 658 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.578 | |INCIDENTAL TUMOR | P=0.531 | |LOGISTIC REGRESSION | P=0.540 | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.508 | |==============================================================================| DATE: 08/15/96 EXPERIMENT: 88066 TEST: 01 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | UNTREATD 25% | | | CONTROL | |==============================================================================| | | |Ovary | | Yolk Sac Carcinoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/95 (0%) 2/97 (2%) | |ADJUSTED (b) | 0.0% 2.7% | |TERMINAL (d) | 0/45 (0%) 1/59 (2%) | |FIRST INCIDENCE (DAYS) | --- 372 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.273 | |INCIDENTAL TUMOR | P=0.180 | |LOGISTIC REGRESSION | P=0.210 | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.254 | |==============================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 13/88 (15%) 10/84 (12%) | |ADJUSTED (b) | 26.2% 16.5% | |TERMINAL (d) | 9/43 (21%) 6/50 (12%) | |FIRST INCIDENCE (DAYS) | 657 634 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.206N | |INCIDENTAL TUMOR | P=0.284N | |LOGISTIC REGRESSION | P=0.293N | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.372N | |==============================================================================| DATE: 08/15/96 EXPERIMENT: 88066 TEST: 01 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | UNTREATD 25% | | | CONTROL | |==============================================================================| | | |Skeletal Muscle | | Rhabdomyosarcoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # | |----------- | | |OVERALL (a) | 2/100 (2%) 2/100 (2%) | |ADJUSTED (b) | 4.3% 3.3% | |TERMINAL (d) | 2/47 (4%) 2/61 (3%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.597N | |INCIDENTAL TUMOR | P=0.597N | |LOGISTIC REGRESSION | P=0.597N | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.689N | |==============================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocyt|ma | | |------------------------------------------------------------------------------| |TUMOR RATES | # # | |----------- | | |OVERALL (a) | 4/100 (4%) 1/100 (1%) | |ADJUSTED (b) | 7.7% 1.6% | |TERMINAL (d) | 2/47 (4%) 1/61 (2%) | |FIRST INCIDENCE (DAYS) | 703 729 (T) | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.124N | |INCIDENTAL TUMOR | P=0.172N | |LOGISTIC REGRESSION | P=0.137N | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.184N | |==============================================================================| DATE: 08/15/96 EXPERIMENT: 88066 TEST: 01 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | UNTREATD 25% | | | CONTROL | |==============================================================================| | | |Skin | | Fibrosarcoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # | |----------- | | |OVERALL (a) | 2/100 (2%) 1/100 (1%) | |ADJUSTED (b) | 3.6% 1.6% | |TERMINAL (d) | 0/47 (0%) 1/61 (2%) | |FIRST INCIDENCE (DAYS) | 703 729 (T) | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.432N | |INCIDENTAL TUMOR | P=0.543N | |LOGISTIC REGRESSION | P=0.454N | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.500N | |==============================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # | |----------- | | |OVERALL (a) | 4/100 (4%) 1/100 (1%) | |ADJUSTED (b) | 7.7% 1.6% | |TERMINAL (d) | 2/47 (4%) 1/61 (2%) | |FIRST INCIDENCE (DAYS) | 703 729 (T) | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.124N | |INCIDENTAL TUMOR | P=0.172N | |LOGISTIC REGRESSION | P=0.137N | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.184N | |==============================================================================| DATE: 08/15/96 EXPERIMENT: 88066 TEST: 01 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | UNTREATD 25% | | | CONTROL | |==============================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma or Papilloma Squamous | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # | |----------- | | |OVERALL (a) | 3/100 (3%) 0/100 (0%) | |ADJUSTED (b) | 4.7% 0.0% | |TERMINAL (d) | 1/47 (2%) 0/61 (0%) | |FIRST INCIDENCE (DAYS) | 410 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.100N | |INCIDENTAL TUMOR | P=0.170N | |LOGISTIC REGRESSION | P=0.136N | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.123N | |==============================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # | |----------- | | |OVERALL (a) | 2/100 (2%) 0/100 (0%) | |ADJUSTED (b) | 3.6% 0.0% | |TERMINAL (d) | 1/47 (2%) 0/61 (0%) | |FIRST INCIDENCE (DAYS) | 666 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.198N | |INCIDENTAL TUMOR | P=0.243N | |LOGISTIC REGRESSION | P=0.220N | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.249N | |==============================================================================| DATE: 08/15/96 EXPERIMENT: 88066 TEST: 01 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | UNTREATD 25% | | | CONTROL | |==============================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 8/100 (8%) 11/100 (11%) | |ADJUSTED (b) | 16.3% 16.7% | |TERMINAL (d) | 7/47 (15%) 8/61 (13%) | |FIRST INCIDENCE (DAYS) | 686 637 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.528 | |INCIDENTAL TUMOR | P=0.459 | |LOGISTIC REGRESSION | P=0.445 | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.315 | |==============================================================================| | | |Uterus | | Polyp Stromal | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # | |----------- | | |OVERALL (a) | 0/100 (0%) 3/100 (3%) | |ADJUSTED (b) | 0.0% 4.4% | |TERMINAL (d) | 0/47 (0%) 2/61 (3%) | |FIRST INCIDENCE (DAYS) | --- 620 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.165 | |INCIDENTAL TUMOR | P=0.169 | |LOGISTIC REGRESSION | P=0.133 | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.123 | |==============================================================================| DATE: 08/15/96 EXPERIMENT: 88066 TEST: 01 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | UNTREATD 25% | | | CONTROL | |==============================================================================| | | |All Organs | | Hemangiosarcoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # | |----------- | | |OVERALL (a) | 2/100 (2%) 0/100 (0%) | |ADJUSTED (b) | 3.3% 0.0% | |TERMINAL (d) | 1/47 (2%) 0/61 (0%) | |FIRST INCIDENCE (DAYS) | 592 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.200N | |INCIDENTAL TUMOR | P=0.191N | |LOGISTIC REGRESSION | P=0.237N | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.249N | |==============================================================================| | | |All Organs | | Histiocytic Sarcoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # | |----------- | | |OVERALL (a) | 4/100 (4%) 1/100 (1%) | |ADJUSTED (b) | 5.8% 1.6% | |TERMINAL (d) | 0/47 (0%) 1/61 (2%) | |FIRST INCIDENCE (DAYS) | 595 729 (T) | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.142N | |INCIDENTAL TUMOR | P=0.210N | |LOGISTIC REGRESSION | P=0.176N | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.184N | |==============================================================================| DATE: 08/15/96 EXPERIMENT: 88066 TEST: 01 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | UNTREATD 25% | | | CONTROL | |==============================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferenti|ted | Cell Type | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # | |----------- | | |OVERALL (a) | 13/100 (13%) 18/100 (18%) | |ADJUSTED (b) | 23.1% 25.8% | |TERMINAL (d) | 7/47 (15%) 12/61 (20%) | |FIRST INCIDENCE (DAYS) | 652 624 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.451 | |INCIDENTAL TUMOR | P=0.300 | |LOGISTIC REGRESSION | P=0.324 | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.217 | |==============================================================================| | | |All Organs | | Benign Tumors | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # | |----------- | | |OVERALL (a) | 67/100 (67%) 69/100 (69%) | |ADJUSTED (b) | 90.3% 81.9% | |TERMINAL (d) | 40/47 (85%) 46/61 (75%) | |FIRST INCIDENCE (DAYS) | 365 313 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.076N | |INCIDENTAL TUMOR | P=0.365N | |LOGISTIC REGRESSION | P=0.332N | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.440 | |==============================================================================| DATE: 08/15/96 EXPERIMENT: 88066 TEST: 01 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL TERMINAL SACRIFICE AT 105 WEEKS |==============================================================================| |DOSE | UNTREATD 25% | | | CONTROL | |==============================================================================| | | |All Organs | | Malignant Tumors | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # | |----------- | | |OVERALL (a) | 39/100 (39%) 51/100 (51%) | |ADJUSTED (b) | 52.7% 60.9% | |TERMINAL (d) | 14/47 (30%) 30/61 (49%) | |FIRST INCIDENCE (DAYS) | 410 324 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.393 | |INCIDENTAL TUMOR | P=0.051 | |LOGISTIC REGRESSION | P=0.088 | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.059 | |==============================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # | |----------- | | |OVERALL (a) | 78/100 (78%) 88/100 (88%) | |ADJUSTED (b) | 93.9% 91.6% | |TERMINAL (d) | 42/47 (89%) 53/61 (87%) | |FIRST INCIDENCE (DAYS) | 365 313 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.257N | |INCIDENTAL TUMOR | P=0.120 | |LOGISTIC REGRESSION | P=0.135 | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.045 * | |==============================================================================| DATE: 08/15/96 EXPERIMENT: 88066 TEST: 01 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL 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).