TDMS Study 88035-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus PRIMACLONE DATE: 12/30/96 EXPERIMENT: 88035 TEST: 06 TIME: 17:03:04 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-05295 ROUTE: DOSED FEED NTP C#: C88035 PATHOLOGIST: PERSING, R. CAS: 0000125-33-7 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: MERGE 001 001 0 PPM MERGE 002 002 0 PPM MERGE 003 003 300 PPM MERGE 004 004 300 PPM MERGE 005 005 600 PPM MERGE 006 006 600 PPM MERGE 007 007 1300 PPM MERGE 008 008 1300 PPM NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus PRIMACLONE DATE: 12/30/96 EXPERIMENT: 88035 TEST: 06 TIME: 17:03:04 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-05295 ROUTE: DOSED FEED NTP C#: C88035 PATHOLOGIST: PERSING, R. CAS: 0000125-33-7 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: Battelle Columbus PRIMACLONE DATE: 12/30/96 EXPERIMENT: 88035 TEST: 06 TIME: 17:03:04 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-05295 ROUTE: DOSED FEED NTP C#: C88035 PATHOLOGIST: PERSING, R. CAS: 0000125-33-7 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF 3-7PRIMACLONE ==================================================================================================== MALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Liver Hepatoblastoma Hepatocellular Adenoma Hepatocellular Carcinoma Hepatocellular Carcinoma or Hepatoblastoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Stomach, Forestomach Squamous Cell Carcinoma or Papilloma Squamous Thyroid Gland: Follicular Cell Adenoma All Organs Hemangiosarcoma Hemangiosarcoma or Hemangioma 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 Hemangiosarcoma or Hemangioma Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 12/30/96 EXPERIMENT: 88035 TEST: 06 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 3-7PRIMACLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 300 PPM 600 PPM 1300 PPM | 0 PPM 300 PPM 600 PPM 1300 PPM | | | | | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | 3/50 (6%) 5/50 (10%) 3/49 (6%) 1/50 (2%) | |ADJUSTED (b) | 5.7% 5.2% 3.2% 5.3% | 7.3% 11.6% 6.8% 2.6% | |TERMINAL (d) | 2/35 (6%) 1/34 (3%) 1/31 (3%) 1/19 (5%) | 3/41 (7%) 4/42 (10%) 3/44 (7%) 1/39 (3%) | |FIRST INCIDENCE (DAYS) | 726 (T) 639 726 (T) 726 (T) | 727 (T) 726 727 (T) 727 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.534N P=0.692 P=0.543N P=0.708N | P=0.168N P=0.372 P=0.630N P=0.323N | |INCIDENTAL TUMOR | P=0.495N P=0.682N P=0.543N P=0.708N | P=0.152N P=0.424 P=0.630N P=0.323N | |LOGISTIC REGRESSION | P=0.425N P=0.684N P=0.543N P=0.708N | P=0.167N P=0.399 P=0.630N P=0.323N | |COCHRAN-ARMITAGE | P=0.349N | P=0.155N | |FISHER EXACT | P=0.691N P=0.500N P=0.500N | P=0.357 P=0.651 P=0.309N | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 2.5% 0.0% 0.0% | 4.2% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/35 (0%) 0/34 (0%) 0/31 (0%) 0/19 (0%) | 0/41 (0%) 0/42 (0%) 0/44 (0%) 0/39 (0%) | |FIRST INCIDENCE (DAYS) | --- 646 --- --- | 519 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.611N P=0.505 (e) (e) | P=0.134N P=0.231N P=0.237N P=0.233N | |INCIDENTAL TUMOR | P=0.403N P=0.581 (e) (e) | P=0.250N P=0.773N P=0.638N P=0.500N | |LOGISTIC REGRESSION | P=0.551N P=0.438 (e) (e) | P=0.257N P=0.561N P=0.402N P=0.450N | |COCHRAN-ARMITAGE | P=0.582N | P=0.135N | |FISHER EXACT | P=0.500 (e) (e) | P=0.247N P=0.253N P=0.247N | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 88035 TEST: 06 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 3-7PRIMACLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 300 PPM 600 PPM 1300 PPM | 0 PPM 300 PPM 600 PPM 1300 PPM | | | | | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 3/50 (6%) 1/50 (2%) 1/50 (2%) | 5/50 (10%) 5/50 (10%) 3/49 (6%) 1/50 (2%) | |ADJUSTED (b) | 5.7% 7.6% 3.2% 5.3% | 11.2% 11.6% 6.8% 2.6% | |TERMINAL (d) | 2/35 (6%) 1/34 (3%) 1/31 (3%) 1/19 (5%) | 3/41 (7%) 4/42 (10%) 3/44 (7%) 1/39 (3%) | |FIRST INCIDENCE (DAYS) | 726 (T) 639 726 (T) 726 (T) | 519 726 727 (T) 727 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.456N P=0.501 P=0.543N P=0.708N | P=0.064N P=0.609N P=0.329N P=0.113N | |INCIDENTAL TUMOR | P=0.341N P=0.548 P=0.543N P=0.708N | P=0.079N P=0.484 P=0.519N P=0.194N | |LOGISTIC REGRESSION | P=0.332N P=0.499 P=0.543N P=0.708N | P=0.064N P=0.534 P=0.444N P=0.134N | |COCHRAN-ARMITAGE | P=0.288N | P=0.058N | |FISHER EXACT | P=0.500 P=0.500N P=0.500N | P=0.630N P=0.369N P=0.102N | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 3/50 (6%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) | |ADJUSTED (b) | 4.4% 8.8% 0.0% 0.0% | 0.0% 0.0% 2.3% 0.0% | |TERMINAL (d) | 0/35 (0%) 3/34 (9%) 0/31 (0%) 0/19 (0%) | 0/41 (0%) 0/42 (0%) 1/44 (2%) 0/39 (0%) | |FIRST INCIDENCE (DAYS) | 552 726 (T) --- --- | --- --- 727 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.121N P=0.511 P=0.226N P=0.252N | P=0.731 (e) P=0.514 (e) | |INCIDENTAL TUMOR | P=0.096N P=0.533 P=0.207N P=0.150N | P=0.731 (e) P=0.514 (e) | |LOGISTIC REGRESSION | P=0.062N P=0.417 P=0.266N P=0.152N | P=0.731 (e) P=0.514 (e) | |COCHRAN-ARMITAGE | P=0.079N | P=0.733 | |FISHER EXACT | P=0.500 P=0.247N P=0.247N | (e) P=0.495 (e) | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 88035 TEST: 06 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 3-7PRIMACLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 300 PPM 600 PPM 1300 PPM | 0 PPM 300 PPM 600 PPM 1300 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 17/50 (34%) 26/50 (52%) 7/50 (14%) | 1/50 (2%) 4/50 (8%) 4/49 (8%) 4/50 (8%) | |ADJUSTED (b) | 0.0% 39.9% 56.9% 23.4% | 2.4% 9.2% 8.8% 9.7% | |TERMINAL (d) | 0/35 (0%) 9/34 (26%) 12/31 (39%) 1/19 (5%) | 1/41 (2%) 3/42 (7%) 3/44 (7%) 3/39 (8%) | |FIRST INCIDENCE (DAYS) | --- 617 422 551 | 727 (T) 718 677 673 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.043 * P<0.001 ** P<0.001 ** P=0.003 ** | P=0.199 P=0.195 P=0.208 P=0.174 | |INCIDENTAL TUMOR | P=0.514 P<0.001 ** P<0.001 ** P=0.050 | P=0.253 P=0.237 P=0.218 P=0.216 | |LOGISTIC REGRESSION | P=0.271 P<0.001 ** P<0.001 ** P=0.009 ** | P=0.220 P=0.212 P=0.182 P=0.185 | |COCHRAN-ARMITAGE | P=0.254 | P=0.220 | |FISHER EXACT | P<0.001 ** P<0.001 ** P=0.006 ** | P=0.181 P=0.175 P=0.181 | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 22/50 (44%) 41/50 (82%) 39/50 (78%) 32/50 (64%) | 15/50 (30%) 42/50 (84%) 45/49 (92%) 47/50 (94%) | |ADJUSTED (b) | 59.2% 93.1% 92.6% 87.3% | 34.9% 91.3% 97.8% 97.9% | |TERMINAL (d) | 20/35 (57%) 31/34 (91%) 28/31 (90%) 15/19 (79%) | 13/41 (32%) 38/42 (90%) 43/44 (98%) 38/39 (97%) | |FIRST INCIDENCE (DAYS) | 551 603 566 368 | 673 701 680 583 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.005 ** P<0.001 ** P<0.001 ** P=0.002 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | P=0.040 * P<0.001 ** P<0.001 ** P=0.013 * | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.155 | P<0.001 ** | |FISHER EXACT | P<0.001 ** P<0.001 ** P=0.035 * | P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 88035 TEST: 06 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 3-7PRIMACLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 300 PPM 600 PPM 1300 PPM | 0 PPM 300 PPM 600 PPM 1300 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/50 (24%) 31/50 (62%) 35/50 (70%) 38/50 (76%) | 3/50 (6%) 11/50 (22%) 19/49 (39%) 38/50 (76%) | |ADJUSTED (b) | 29.1% 71.6% 81.1% 100.0% | 7.1% 24.9% 42.2% 84.4% | |TERMINAL (d) | 7/35 (20%) 22/34 (65%) 23/31 (74%) 19/19 (100%)| 2/41 (5%) 9/42 (21%) 18/44 (41%) 32/39 (82%) | |FIRST INCIDENCE (DAYS) | 526 614 575 470 | 694 701 699 638 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.029 * P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.048 * P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.032 * 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=0.020 * P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/50 (24%) 39/50 (78%) 40/50 (80%) 39/50 (78%) | 4/50 (8%) 12/50 (24%) 20/49 (41%) 39/50 (78%) | |ADJUSTED (b) | 29.1% 81.3% 83.2% 100.0% | 9.5% 26.5% 43.4% 84.7% | |TERMINAL (d) | 7/35 (20%) 25/34 (74%) 23/31 (74%) 19/19 (100%)| 3/41 (7%) 9/42 (21%) 18/44 (41%) 32/39 (82%) | |FIRST INCIDENCE (DAYS) | 526 614 422 470 | 694 701 677 638 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.040 * P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.070 P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.042 * 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=0.027 * P<0.001 ** P<0.001 ** | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 88035 TEST: 06 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 3-7PRIMACLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 300 PPM 600 PPM 1300 PPM | 0 PPM 300 PPM 600 PPM 1300 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 31/50 (62%) 48/50 (96%) 47/50 (94%) 46/50 (92%) | 16/50 (32%) 42/50 (84%) 45/49 (92%) 50/50 (100%)| |ADJUSTED (b) | 73.5% 100.0% 100.0% 100.0% | 37.2% 91.3% 97.8% 100.0% | |TERMINAL (d) | 24/35 (69%) 34/34 (100%) 31/31 (100%) 19/19 (100%)| 14/41 (34%) 38/42 (90%) 43/44 (98%) 39/39 (100%)| |FIRST INCIDENCE (DAYS) | 526 603 566 368 | 673 701 680 583 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.002 ** 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 ** 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 ** 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 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 31/50 (62%) 49/50 (98%) 49/50 (98%) 46/50 (92%) | 16/50 (32%) 42/50 (84%) 46/49 (94%) 50/50 (100%)| |ADJUSTED (b) | 73.5% 100.0% 100.0% 100.0% | 37.2% 91.3% 97.9% 100.0% | |TERMINAL (d) | 24/35 (69%) 34/34 (100%) 31/31 (100%) 19/19 (100%)| 14/41 (34%) 38/42 (90%) 43/44 (98%) 39/39 (100%)| |FIRST INCIDENCE (DAYS) | 526 603 422 368 | 673 701 677 583 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.001 ** 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 ** 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 ** 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 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 88035 TEST: 06 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 3-7PRIMACLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 300 PPM 600 PPM 1300 PPM | 0 PPM 300 PPM 600 PPM 1300 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 7/50 (14%) 5/50 (10%) 6/50 (12%) | 4/50 (8%) 2/50 (4%) 4/49 (8%) 2/50 (4%) | |ADJUSTED (b) | 18.6% 19.4% 16.1% 20.7% | 9.8% 4.8% 8.9% 5.1% | |TERMINAL (d) | 5/35 (14%) 6/34 (18%) 5/31 (16%) 1/19 (5%) | 4/41 (10%) 2/42 (5%) 3/44 (7%) 2/39 (5%) | |FIRST INCIDENCE (DAYS) | 583 617 726 (T) 368 | 727 (T) 727 (T) 699 727 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.345 P=0.610 P=0.455N P=0.426 | P=0.369N P=0.326N P=0.602N P=0.360N | |INCIDENTAL TUMOR | P=0.492N P=0.584N P=0.398N P=0.378N | P=0.344N P=0.326N P=0.588N P=0.360N | |LOGISTIC REGRESSION | P=0.467N P=0.585N P=0.394N P=0.504N | P=0.355N P=0.326N P=0.608N P=0.360N | |COCHRAN-ARMITAGE | P=0.412N | P=0.345N | |FISHER EXACT | P=0.613N P=0.380N P=0.500N | P=0.339N P=0.631 P=0.339N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 2/50 (4%) 1/50 (2%) 3/50 (6%) | 4/50 (8%) 3/50 (6%) 0/49 (0%) 1/50 (2%) | |ADJUSTED (b) | 10.7% 5.9% 2.7% 10.3% | 9.1% 7.1% 0.0% 2.6% | |TERMINAL (d) | 3/35 (9%) 2/34 (6%) 0/31 (0%) 1/19 (5%) | 2/41 (5%) 3/42 (7%) 0/44 (0%) 1/39 (3%) | |FIRST INCIDENCE (DAYS) | 578 726 (T) 658 625 | 621 727 (T) --- 727 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.515 P=0.337N P=0.202N P=0.609 | P=0.087N P=0.476N P=0.057N P=0.186N | |INCIDENTAL TUMOR | P=0.538N P=0.332N P=0.150N P=0.594N | P=0.080N P=0.522N P=0.099N P=0.143N | |LOGISTIC REGRESSION | P=0.497N P=0.324N P=0.180N P=0.517N | P=0.088N P=0.543N P=0.079N P=0.192N | |COCHRAN-ARMITAGE | P=0.487N | P=0.084N | |FISHER EXACT | P=0.339N P=0.181N P=0.500N | P=0.500N P=0.061N P=0.181N | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 88035 TEST: 06 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 3-7PRIMACLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 300 PPM 600 PPM 1300 PPM | 0 PPM 300 PPM 600 PPM 1300 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/50 (22%) 9/50 (18%) 6/50 (12%) 9/50 (18%) | 7/50 (14%) 5/50 (10%) 4/49 (8%) 3/50 (6%) | |ADJUSTED (b) | 28.4% 25.2% 18.4% 29.1% | 16.1% 11.9% 8.9% 7.7% | |TERMINAL (d) | 8/35 (23%) 8/34 (24%) 5/31 (16%) 2/19 (11%) | 5/41 (12%) 5/42 (12%) 3/44 (7%) 3/39 (8%) | |FIRST INCIDENCE (DAYS) | 578 617 658 368 | 621 727 (T) 699 727 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.322 P=0.404N P=0.200N P=0.411 | P=0.140N P=0.356N P=0.227N P=0.174N | |INCIDENTAL TUMOR | P=0.459N P=0.373N P=0.137N P=0.357N | P=0.118N P=0.388N P=0.300N P=0.145N | |LOGISTIC REGRESSION | P=0.415N P=0.367N P=0.144N P=0.413N | P=0.124N P=0.372N P=0.276N P=0.154N | |COCHRAN-ARMITAGE | P=0.364N | P=0.126N | |FISHER EXACT | P=0.402N P=0.143N P=0.402N | P=0.380N P=0.274N P=0.159N | |=================================================================================================================================| | | |Ovary | | Cystadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 3/49 (6%) 0/49 (0%) 2/48 (4%) 1/50 (2%) | |ADJUSTED (b) | | 7.5% 0.0% 4.5% 2.6% | |TERMINAL (d) | | 3/40 (8%) 0/42 (0%) 2/44 (5%) 1/39 (3%) | |FIRST INCIDENCE (DAYS) | | 727 (T) --- 727 (T) 727 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.359N P=0.113N P=0.456N P=0.314N | |INCIDENTAL TUMOR | | P=0.359N P=0.113N P=0.456N P=0.314N | |LOGISTIC REGRESSION | | P=0.359N P=0.113N P=0.456N P=0.314N | |COCHRAN-ARMITAGE | | P=0.343N | |FISHER EXACT | | P=0.121N P=0.510N P=0.301N | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 88035 TEST: 06 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 3-7PRIMACLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 300 PPM 600 PPM 1300 PPM | 0 PPM 300 PPM 600 PPM 1300 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/45 (0%) 0/46 (0%) 0/48 (0%) 0/47 (0%) | 3/49 (6%) 5/48 (10%) 6/49 (12%) 6/48 (13%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 7.5% 12.2% 13.3% 15.8% | |TERMINAL (d) | 0/33 (0%) 0/31 (0%) 0/29 (0%) 0/19 (0%) | 3/40 (8%) 5/41 (12%) 5/44 (11%) 6/38 (16%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 727 (T) 727 (T) 694 727 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.190 P=0.369 P=0.293 P=0.216 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.204 P=0.369 P=0.304 P=0.216 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.199 P=0.369 P=0.286 P=0.216 | |COCHRAN-ARMITAGE | (e) | P=0.216 | |FISHER EXACT | (e) (e) (e) | P=0.346 P=0.243 P=0.233 | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 3/50 (6%) 2/50 (4%) 1/49 (2%) 2/50 (4%) | |ADJUSTED (b) | 2.7% 0.0% 0.0% 0.0% | 6.5% 4.8% 2.2% 4.1% | |TERMINAL (d) | 0/35 (0%) 0/34 (0%) 0/31 (0%) 0/19 (0%) | 1/41 (2%) 2/42 (5%) 0/44 (0%) 0/39 (0%) | |FIRST INCIDENCE (DAYS) | 701 --- --- --- | 595 727 (T) 694 583 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.391N P=0.505N P=0.529N P=0.586N | P=0.434N P=0.484N P=0.293N P=0.489N | |INCIDENTAL TUMOR | P=0.195N P=0.419N P=0.338N P=0.252N | P=0.340N P=0.664 P=0.720N P=0.506N | |LOGISTIC REGRESSION | P=0.352N P=0.495N P=0.501N P=0.529N | P=0.358N P=0.660N P=0.428N P=0.683 | |COCHRAN-ARMITAGE | P=0.339N | P=0.427N | |FISHER EXACT | P=0.500N P=0.500N P=0.500N | P=0.500N P=0.316N P=0.500N | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 88035 TEST: 06 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 3-7PRIMACLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 300 PPM 600 PPM 1300 PPM | 0 PPM 300 PPM 600 PPM 1300 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 3/50 (6%) 2/50 (4%) 1/49 (2%) 2/50 (4%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 6.5% 4.8% 2.2% 4.1% | |TERMINAL (d) | 0/35 (0%) 0/34 (0%) 0/31 (0%) 0/19 (0%) | 1/41 (2%) 2/42 (5%) 0/44 (0%) 0/39 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 595 727 (T) 694 583 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.434N P=0.484N P=0.293N P=0.489N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.340N P=0.664 P=0.720N P=0.506N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.358N P=0.660N P=0.428N P=0.683 | |COCHRAN-ARMITAGE | (e) | P=0.427N | |FISHER EXACT | (e) (e) (e) | P=0.500N P=0.316N P=0.500N | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 3/50 (6%) 2/50 (4%) 1/49 (2%) 2/50 (4%) | |ADJUSTED (b) | 2.7% 0.0% 0.0% 0.0% | 6.5% 4.8% 2.2% 4.1% | |TERMINAL (d) | 0/35 (0%) 0/34 (0%) 0/31 (0%) 0/19 (0%) | 1/41 (2%) 2/42 (5%) 0/44 (0%) 0/39 (0%) | |FIRST INCIDENCE (DAYS) | 701 --- --- --- | 595 727 (T) 694 583 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.391N P=0.505N P=0.529N P=0.586N | P=0.434N P=0.484N P=0.293N P=0.489N | |INCIDENTAL TUMOR | P=0.195N P=0.419N P=0.338N P=0.252N | P=0.340N P=0.664 P=0.720N P=0.506N | |LOGISTIC REGRESSION | P=0.352N P=0.495N P=0.501N P=0.529N | P=0.358N P=0.660N P=0.428N P=0.683 | |COCHRAN-ARMITAGE | P=0.339N | P=0.427N | |FISHER EXACT | P=0.500N P=0.500N P=0.500N | P=0.500N P=0.316N P=0.500N | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 88035 TEST: 06 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 3-7PRIMACLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 300 PPM 600 PPM 1300 PPM | 0 PPM 300 PPM 600 PPM 1300 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/48 (4%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | 1/50 (2%) 0/48 (0%) 0/49 (0%) 0/50 (0%) | |ADJUSTED (b) | 5.1% 0.0% 0.0% 0.0% | 2.4% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/35 (3%) 0/34 (0%) 0/31 (0%) 0/19 (0%) | 1/41 (2%) 0/42 (0%) 0/44 (0%) 0/39 (0%) | |FIRST INCIDENCE (DAYS) | 576 --- --- --- | 727 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.161N P=0.229N P=0.246N P=0.314N | P=0.344N P=0.495N P=0.486N P=0.510N | |INCIDENTAL TUMOR | P=0.124N P=0.199N P=0.208N P=0.220N | P=0.344N P=0.495N P=0.486N P=0.510N | |LOGISTIC REGRESSION | P=0.104N P=0.277N P=0.228N P=0.210N | P=0.344N P=0.495N P=0.486N P=0.510N | |COCHRAN-ARMITAGE | P=0.132N | P=0.338N | |FISHER EXACT | P=0.242N P=0.237N P=0.242N | P=0.510N P=0.505N P=0.500N | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma or Papilloma Squamous | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 10.5% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/35 (0%) 0/34 (0%) 0/31 (0%) 2/19 (11%) | 0/41 (0%) 0/42 (0%) 0/44 (0%) 0/39 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 726 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.013 * (e) (e) P=0.117 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.013 * (e) (e) P=0.117 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.013 * (e) (e) P=0.117 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.045 * | (e) | |FISHER EXACT | (e) (e) P=0.247 | (e) (e) (e) | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 88035 TEST: 06 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 3-7PRIMACLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 300 PPM 600 PPM 1300 PPM | 0 PPM 300 PPM 600 PPM 1300 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 3/48 (6%) 3/50 (6%) 6/50 (12%) | 1/50 (2%) 1/48 (2%) 0/48 (0%) 2/50 (4%) | |ADJUSTED (b) | 0.0% 9.1% 9.7% 25.3% | 2.4% 2.4% 0.0% 4.7% | |TERMINAL (d) | 0/35 (0%) 3/33 (9%) 3/31 (10%) 3/19 (16%) | 1/41 (2%) 1/42 (2%) 0/43 (0%) 1/39 (3%) | |FIRST INCIDENCE (DAYS) | --- 726 (T) 726 (T) 674 | 727 (T) 727 (T) --- 673 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.110 P=0.100 P=0.003 ** | P=0.346 P=0.756N P=0.491N P=0.496 | |INCIDENTAL TUMOR | P=0.006 ** P=0.110 P=0.100 P=0.023 * | P=0.399 P=0.756N P=0.490N P=0.583 | |LOGISTIC REGRESSION | P=0.003 ** P=0.110 P=0.100 P=0.008 ** | P=0.361 P=0.756N P=0.490N P=0.501 | |COCHRAN-ARMITAGE | P=0.016 * | P=0.361 | |FISHER EXACT | P=0.117 P=0.125 P=0.014 * | P=0.742 P=0.510N P=0.500 | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 1/50 (2%) 3/50 (6%) 1/49 (2%) 1/50 (2%) | |ADJUSTED (b) | | 2.4% 7.1% 2.3% 2.6% | |TERMINAL (d) | | 1/41 (2%) 3/42 (7%) 1/44 (2%) 1/39 (3%) | |FIRST INCIDENCE (DAYS) | | 727 (T) 727 (T) 727 (T) 727 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.468N P=0.314 P=0.746N P=0.751 | |INCIDENTAL TUMOR | | P=0.468N P=0.314 P=0.746N P=0.751 | |LOGISTIC REGRESSION | | P=0.468N P=0.314 P=0.746N P=0.751 | |COCHRAN-ARMITAGE | | P=0.449N | |FISHER EXACT | | P=0.309 P=0.747 P=0.753N | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 88035 TEST: 06 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 3-7PRIMACLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 300 PPM 600 PPM 1300 PPM | 0 PPM 300 PPM 600 PPM 1300 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 2/50 (4%) 3/50 (6%) 1/49 (2%) 1/50 (2%) | |ADJUSTED (b) | | 4.9% 7.1% 2.3% 2.6% | |TERMINAL (d) | | 2/41 (5%) 3/42 (7%) 1/44 (2%) 1/39 (3%) | |FIRST INCIDENCE (DAYS) | | 727 (T) 727 (T) 727 (T) 727 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.303N P=0.511 P=0.475N P=0.518N | |INCIDENTAL TUMOR | | P=0.303N P=0.511 P=0.475N P=0.517N | |LOGISTIC REGRESSION | | P=0.303N P=0.511 P=0.475N P=0.517N | |COCHRAN-ARMITAGE | | P=0.289N | |FISHER EXACT | | P=0.500 P=0.508N P=0.500N | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 3/50 (6%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 2/50 (4%) 1/49 (2%) 0/50 (0%) | |ADJUSTED (b) | 7.1% 8.8% 0.0% 0.0% | 4.7% 4.7% 2.3% 0.0% | |TERMINAL (d) | 1/35 (3%) 3/34 (9%) 0/31 (0%) 0/19 (0%) | 1/41 (2%) 1/42 (2%) 1/44 (2%) 0/39 (0%) | |FIRST INCIDENCE (DAYS) | 552 726 (T) --- --- | 673 726 727 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.067N P=0.654N P=0.123N P=0.167N | P=0.134N P=0.672N P=0.471N P=0.238N | |INCIDENTAL TUMOR | P=0.053N P=0.637N P=0.112N P=0.102N | P=0.099N P=0.538N P=0.451N P=0.155N | |LOGISTIC REGRESSION | P=0.033N* P=0.616 P=0.131N P=0.085N | P=0.130N P=0.698N P=0.512N P=0.242N | |COCHRAN-ARMITAGE | P=0.039N* | P=0.131N | |FISHER EXACT | P=0.661N P=0.121N P=0.121N | P=0.691N P=0.508N P=0.247N | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 88035 TEST: 06 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 3-7PRIMACLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 300 PPM 600 PPM 1300 PPM | 0 PPM 300 PPM 600 PPM 1300 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 3/50 (6%) 0/50 (0%) 0/50 (0%) | 3/50 (6%) 2/50 (4%) 1/49 (2%) 0/50 (0%) | |ADJUSTED (b) | 9.9% 8.8% 0.0% 0.0% | 7.1% 4.7% 2.3% 0.0% | |TERMINAL (d) | 2/35 (6%) 3/34 (9%) 0/31 (0%) 0/19 (0%) | 2/41 (5%) 1/42 (2%) 1/44 (2%) 0/39 (0%) | |FIRST INCIDENCE (DAYS) | 552 726 (T) --- --- | 673 726 727 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.037N* P=0.495N P=0.070N P=0.114N | P=0.069N P=0.478N P=0.279N P=0.125N | |INCIDENTAL TUMOR | P=0.029N* P=0.477N P=0.063N P=0.070N | P=0.050N* P=0.345N P=0.264N P=0.081N | |LOGISTIC REGRESSION | P=0.017N* P=0.536N P=0.067N P=0.049N* | P=0.065N P=0.487N P=0.305N P=0.119N | |COCHRAN-ARMITAGE | P=0.019N* | P=0.067N | |FISHER EXACT | P=0.500N P=0.059N P=0.059N | P=0.500N P=0.316N P=0.121N | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 5/50 (10%) | 0/50 (0%) 2/50 (4%) 1/49 (2%) 0/50 (0%) | |ADJUSTED (b) | 2.9% 0.0% 0.0% 18.1% | 0.0% 4.2% 2.3% 0.0% | |TERMINAL (d) | 1/35 (3%) 0/34 (0%) 0/31 (0%) 1/19 (5%) | 0/41 (0%) 0/42 (0%) 1/44 (2%) 0/39 (0%) | |FIRST INCIDENCE (DAYS) | 726 (T) --- --- 551 | --- 673 727 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.001 ** P=0.506N P=0.524N P=0.040 * | P=0.458N P=0.265 P=0.514 (e) | |INCIDENTAL TUMOR | P=0.015 * P=0.506N P=0.524N P=0.174 | P=0.365N P=0.435 P=0.514 (e) | |LOGISTIC REGRESSION | P=0.008 ** P=0.506N P=0.524N P=0.101 | P=0.459N P=0.196 P=0.514 (e) | |COCHRAN-ARMITAGE | P=0.007 ** | P=0.452N | |FISHER EXACT | P=0.500N P=0.500N P=0.102 | P=0.247 P=0.495 (e) | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 88035 TEST: 06 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 3-7PRIMACLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 300 PPM 600 PPM 1300 PPM | 0 PPM 300 PPM 600 PPM 1300 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated | | Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 7/50 (14%) 4/50 (8%) 2/50 (4%) 0/50 (0%) | 8/50 (16%) 6/50 (12%) 8/49 (16%) 5/50 (10%) | |ADJUSTED (b) | 18.3% 10.6% 5.7% 0.0% | 18.4% 13.6% 17.4% 12.4% | |TERMINAL (d) | 5/35 (14%) 3/34 (9%) 1/31 (3%) 0/19 (0%) | 6/41 (15%) 4/42 (10%) 6/44 (14%) 4/39 (10%) | |FIRST INCIDENCE (DAYS) | 432 603 646 --- | 621 724 680 693 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.015N* P=0.268N P=0.112N P=0.042N* | P=0.311N P=0.361N P=0.542N P=0.301N | |INCIDENTAL TUMOR | P=0.005N** P=0.346N P=0.081N P=0.016N* | P=0.213N P=0.306N P=0.596 P=0.225N | |LOGISTIC REGRESSION | P=0.004N** P=0.278N P=0.082N P=0.010N* | P=0.272N P=0.368N P=0.597 P=0.268N | |COCHRAN-ARMITAGE | P=0.004N** | P=0.275N | |FISHER EXACT | P=0.262N P=0.080N P=0.006N** | P=0.387N P=0.590 P=0.277N | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 26/50 (52%) 42/50 (84%) 39/50 (78%) 36/50 (72%) | 26/50 (52%) 45/50 (90%) 46/49 (94%) 47/50 (94%) | |ADJUSTED (b) | 68.1% 93.2% 92.6% 91.5% | 60.5% 97.8% 97.9% 97.9% | |TERMINAL (d) | 23/35 (66%) 31/34 (91%) 28/31 (90%) 16/19 (84%) | 24/41 (59%) 41/42 (98%) 43/44 (98%) 38/39 (97%) | |FIRST INCIDENCE (DAYS) | 551 603 566 368 | 673 701 680 583 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.001 ** P=0.002 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.003 ** P<0.001 ** P=0.001 ** P=0.002 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | P=0.023 * P=0.001 ** P=0.005 ** P=0.010 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.109 | P<0.001 ** | |FISHER EXACT | P<0.001 ** P=0.006 ** P=0.032 * | P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 88035 TEST: 06 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 3-7PRIMACLONE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 300 PPM 600 PPM 1300 PPM | 0 PPM 300 PPM 600 PPM 1300 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 22/50 (44%) 42/50 (84%) 42/50 (84%) 42/50 (84%) | 20/50 (40%) 23/50 (46%) 26/49 (53%) 40/50 (80%) | |ADJUSTED (b) | 49.3% 85.7% 85.7% 100.0% | 42.3% 47.9% 54.2% 85.0% | |TERMINAL (d) | 13/35 (37%) 27/34 (79%) 24/31 (77%) 19/19 (100%)| 14/41 (34%) 17/42 (40%) 22/44 (50%) 32/39 (82%) | |FIRST INCIDENCE (DAYS) | 432 603 422 470 | 519 673 677 583 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.421 P=0.271 P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.397 P=0.097 P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.288 P=0.080 P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** | |FISHER EXACT | P<0.001 ** P<0.001 ** P<0.001 ** | P=0.343 P=0.135 P<0.001 ** | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 40/50 (80%) 50/50 (100%) 50/50 (100%) 47/50 (94%) | 34/50 (68%) 47/50 (94%) 47/49 (96%) 50/50 (100%)| |ADJUSTED (b) | 86.8% 100.0% 100.0% 100.0% | 72.2% 97.9% 97.9% 100.0% | |TERMINAL (d) | 29/35 (83%) 34/34 (100%) 31/31 (100%) 19/19 (100%)| 28/41 (68%) 41/42 (98%) 43/44 (98%) 39/39 (100%)| |FIRST INCIDENCE (DAYS) | 432 603 422 368 | 519 673 677 583 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.058 P=0.017 * P<0.001 ** | P<0.001 ** P=0.014 * P=0.025 * P<0.001 ** | |INCIDENTAL TUMOR | P=0.007 ** P=0.002 ** P=0.002 ** P=0.016 * | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | P=0.007 ** P=0.002 ** P=0.001 ** P=0.010 * | P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.042 * | P<0.001 ** | |FISHER EXACT | P<0.001 ** P<0.001 ** P=0.036 * | P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| DATE: 12/30/96 EXPERIMENT: 88035 TEST: 06 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 3-7PRIMACLONE TERMINAL SACRIFICE AT 104 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).