TDMS Study 05053-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Mason BROMOFORM DATE: 09/08/94 EXPERIMENT: 05053 TEST: 02 TIME: 02:59:35 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01ES2803301 ROUTE: GAVAGE NTP C#: 55130 PATHOLOGIST: K. MURTHY CAS: 75-25-2 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Mason BROMOFORM DATE: 09/08/94 EXPERIMENT: 05053 TEST: 02 TIME: 02:59:35 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES2803301 ROUTE: GAVAGE NTP C#: 55130 PATHOLOGIST: K. MURTHY CAS: 75-25-2 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 Gland 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: Mason BROMOFORM DATE: 09/08/94 EXPERIMENT: 05053 TEST: 02 TIME: 02:59:35 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES2803301 ROUTE: GAVAGE NTP C#: 55130 PATHOLOGIST: K. MURTHY CAS: 75-25-2 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF BROMOFORM ==================================================================================================== MALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Skin: Subcutaneous Tissue Neurofibrosarcoma, Fibrosarcoma, or Sarcoma All Organs Malignant Lymphoma And Histiocytic Sarcoma Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type Benign Tumors Malignant and Benign Tumors ==================================================================================================== FEMALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Pituitary Gland: Pars Distalis or Unspecified Site Adenoma All Organs Hemangiosarcoma Hemangiosarcoma or Hemangioma Malignant Lymphoma And Histiocytic Sarcoma Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type ==================================================================================================== DATE: 09/08/94 EXPERIMENT: 05053 TEST: 02 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BROMOFORM TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE .05 G/KG 0.1 G/KG | VEHICLE 0.1 G/KG 0.2 G/KG | | | 46 VM 46 LM 46 HM | 46 VF 46 LF 46 HF | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) | 0/49 (0%) 1/50 (2%) 0/50 (0%) | |ADJUSTED (b) | 4.9% 2.1% 2.8% | 0.0% 6.7% 0.0% | |TERMINAL (d) | 2/41 (5%) 0/37 (0%) 1/36 (3%) | 0/25 (0%) 1/15 (7%) 0/20 (0%) | |FIRST INCIDENCE (DAYS) | 730 (T) 532 730 (T) | --- 735 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.417N P=0.529N P=0.545N | P=0.686 P=0.398 (e) | |INCIDENTAL TUMOR | P=0.339N P=0.477N P=0.545N | P=0.686 P=0.398 (e) | |LOGISTIC REGRESSION | P=0.360N P=0.455N P=0.545N | P=0.686 P=0.398 (e) | |COCHRAN-ARMITAGE | P=0.378N | P=0.728N | |FISHER EXACT | P=0.500N P=0.500N | P=0.505 (e) | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/49 (4%) | 0/49 (0%) 0/50 (0%) 2/50 (4%) | |ADJUSTED (b) | 2.4% 2.7% 5.3% | 0.0% 0.0% 7.0% | |TERMINAL (d) | 1/41 (2%) 1/37 (3%) 1/36 (3%) | 0/25 (0%) 0/15 (0%) 1/20 (5%) | |FIRST INCIDENCE (DAYS) | 730 (T) 730 (T) 663 | --- --- 372 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.338 P=0.739 P=0.453 | P=0.090 (e) P=0.213 | |INCIDENTAL TUMOR | P=0.345 P=0.739 P=0.470 | P=0.114 (e) P=0.381 | |LOGISTIC REGRESSION | P=0.351 P=0.739 P=0.481 | P=0.151 (e) P=0.403 | |COCHRAN-ARMITAGE | P=0.372 | P=0.097 | |FISHER EXACT | P=0.753N P=0.492 | (e) P=0.253 | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05053 TEST: 02 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BROMOFORM TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE .05 G/KG 0.1 G/KG | VEHICLE 0.1 G/KG 0.2 G/KG | | | 46 VM 46 LM 46 HM | 46 VF 46 LF 46 HF | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/50 (22%) 11/50 (22%) 8/49 (16%) | 3/49 (6%) 6/50 (12%) 4/50 (8%) | |ADJUSTED (b) | 24.6% 26.8% 21.4% | 12.0% 21.1% 15.7% | |TERMINAL (d) | 8/41 (20%) 8/37 (22%) 7/36 (19%) | 3/25 (12%) 0/15 (0%) 2/20 (10%) | |FIRST INCIDENCE (DAYS) | 455 393 632 | 735 (T) 538 566 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.383N P=0.500 P=0.419N | P=0.278 P=0.092 P=0.376 | |INCIDENTAL TUMOR | P=0.283N P=0.576N P=0.330N | P=0.359 P=0.251 P=0.391 | |LOGISTIC REGRESSION | P=0.283N P=0.561N P=0.334N | P=0.398 P=0.248 P=0.391 | |COCHRAN-ARMITAGE | P=0.282N | P=0.442 | |FISHER EXACT | P=0.595N P=0.323N | P=0.254 P=0.511 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 8/50 (16%) 6/49 (12%) | 1/49 (2%) 0/50 (0%) 2/50 (4%) | |ADJUSTED (b) | 15.4% 19.3% 14.4% | 3.0% 0.0% 8.3% | |TERMINAL (d) | 3/41 (7%) 5/37 (14%) 2/36 (6%) | 0/25 (0%) 0/15 (0%) 1/20 (5%) | |FIRST INCIDENCE (DAYS) | 642 602 509 | 692 --- 635 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.552N P=0.421 P=0.603N | P=0.283 P=0.632N P=0.392 | |INCIDENTAL TUMOR | P=0.403N P=0.510 P=0.449N | P=0.316 P=0.519N P=0.440 | |LOGISTIC REGRESSION | P=0.344N P=0.507 P=0.381N | P=0.313 P=0.549N P=0.452 | |COCHRAN-ARMITAGE | P=0.459N | P=0.366 | |FISHER EXACT | P=0.500 P=0.516N | P=0.495N P=0.508 | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05053 TEST: 02 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BROMOFORM TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE .05 G/KG 0.1 G/KG | VEHICLE 0.1 G/KG 0.2 G/KG | | | 46 VM 46 LM 46 HM | 46 VF 46 LF 46 HF | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 16/50 (32%) 19/50 (38%) 14/49 (29%) | 4/49 (8%) 6/50 (12%) 6/50 (12%) | |ADJUSTED (b) | 33.8% 43.5% 33.6% | 14.7% 21.1% 23.1% | |TERMINAL (d) | 10/41 (24%) 13/37 (35%) 9/36 (25%) | 3/25 (12%) 0/15 (0%) 3/20 (15%) | |FIRST INCIDENCE (DAYS) | 455 393 509 | 692 538 566 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.527 P=0.247 P=0.575N | P=0.175 P=0.149 P=0.226 | |INCIDENTAL TUMOR | P=0.358N P=0.338 P=0.394N | P=0.238 P=0.377 P=0.256 | |LOGISTIC REGRESSION | P=0.370N P=0.375 P=0.376N | P=0.265 P=0.369 P=0.258 | |COCHRAN-ARMITAGE | P=0.401N | P=0.326 | |FISHER EXACT | P=0.338 P=0.440N | P=0.383 P=0.383 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 16/50 (32%) 19/50 (38%) 14/49 (29%) | 4/49 (8%) 6/50 (12%) 6/50 (12%) | |ADJUSTED (b) | 33.8% 43.5% 33.6% | 14.7% 21.1% 23.1% | |TERMINAL (d) | 10/41 (24%) 13/37 (35%) 9/36 (25%) | 3/25 (12%) 0/15 (0%) 3/20 (15%) | |FIRST INCIDENCE (DAYS) | 455 393 509 | 692 538 566 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.527 P=0.247 P=0.575N | P=0.175 P=0.149 P=0.226 | |INCIDENTAL TUMOR | P=0.358N P=0.338 P=0.394N | P=0.238 P=0.377 P=0.256 | |LOGISTIC REGRESSION | P=0.370N P=0.375 P=0.376N | P=0.265 P=0.369 P=0.258 | |COCHRAN-ARMITAGE | P=0.401N | P=0.326 | |FISHER EXACT | P=0.338 P=0.440N | P=0.383 P=0.383 | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05053 TEST: 02 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BROMOFORM TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE .05 G/KG 0.1 G/KG | VEHICLE 0.1 G/KG 0.2 G/KG | | | 46 VM 46 LM 46 HM | 46 VF 46 LF 46 HF | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/50 (20%) 5/50 (10%) 2/49 (4%) | 2/49 (4%) 1/27 (4%) 2/50 (4%) | |ADJUSTED (b) | 24.4% 12.7% 5.6% | 8.0% 0.0% 7.4% | |TERMINAL (d) | 10/41 (24%) 4/37 (11%) 2/36 (6%) | 2/25 (8%) 0/0 1/20 (5%) | |FIRST INCIDENCE (DAYS) | 730 (T) 602 730 (T) | 735 (T) 633 560 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.016N* P=0.178N P=0.026N* | P=0.501 P=0.424 P=0.616 | |INCIDENTAL TUMOR | P=0.015N* P=0.192N P=0.026N* | P=0.552 P=0.545 P=0.648 | |LOGISTIC REGRESSION | P=0.016N* P=0.162N P=0.026N* | P=0.523 P=0.381 P=0.641 | |COCHRAN-ARMITAGE | P=0.010N** | P=0.594N | |FISHER EXACT | P=0.131N P=0.015N* | P=0.714N P=0.684N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 0/49 (0%) | 1/49 (2%) 0/27 (0%) 0/50 (0%) | |ADJUSTED (b) | 2.4% 7.4% 0.0% | 4.0% 0.0% 0.0% | |TERMINAL (d) | 1/41 (2%) 2/37 (5%) 0/36 (0%) | 1/25 (4%) 0/0 0/20 (0%) | |FIRST INCIDENCE (DAYS) | 730 (T) 507 --- | 735 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.412N P=0.278 P=0.526N | P=0.348N (e) P=0.545N | |INCIDENTAL TUMOR | P=0.339N P=0.314 P=0.526N | P=0.348N (e) P=0.545N | |LOGISTIC REGRESSION | P=0.361N P=0.334 P=0.526N | P=0.348N (e) P=0.545N | |COCHRAN-ARMITAGE | P=0.384N | P=0.283N | |FISHER EXACT | P=0.309 P=0.505N | P=0.645N P=0.495N | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05053 TEST: 02 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BROMOFORM TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE .05 G/KG 0.1 G/KG | VEHICLE 0.1 G/KG 0.2 G/KG | | | 46 VM 46 LM 46 HM | 46 VF 46 LF 46 HF | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/50 (22%) 7/50 (14%) 2/49 (4%) | 3/49 (6%) 1/27 (4%) 2/50 (4%) | |ADJUSTED (b) | 26.8% 17.2% 5.6% | 12.0% 0.0% 7.4% | |TERMINAL (d) | 11/41 (27%) 5/37 (14%) 2/36 (6%) | 3/25 (12%) 0/0 1/20 (5%) | |FIRST INCIDENCE (DAYS) | 730 (T) 507 730 (T) | 735 (T) 633 560 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.012N* P=0.288N P=0.015N* | P=0.519N P=0.424 P=0.598N | |INCIDENTAL TUMOR | P=0.009N** P=0.285N P=0.015N* | P=0.472N P=0.545 P=0.567N | |LOGISTIC REGRESSION | P=0.009N** P=0.236N P=0.015N* | P=0.513N P=0.371 P=0.595N | |COCHRAN-ARMITAGE | P=0.007N** | P=0.398N | |FISHER EXACT | P=0.218N P=0.008N** | P=0.553N P=0.490N | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/45 (0%) 0/6 (0%) 0/40 (0%) | 7/44 (16%) 6/27 (22%) 6/46 (13%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% | 25.5% 65.9% 28.3% | |TERMINAL (d) | 0/38 (0%) 0/0 0/32 (0%) | 4/22 (18%) 3/5 (60%) 5/20 (25%) | |FIRST INCIDENCE (DAYS) | --- --- --- | 600 628 672 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.512 P=0.094 P=0.605 | |INCIDENTAL TUMOR | (e) (e) (e) | P=0.458 P=0.030 * P=0.580 | |LOGISTIC REGRESSION | (e) (e) (e) | P=0.472 P=0.023 * P=0.579 | |COCHRAN-ARMITAGE | (e) | P=0.407N | |FISHER EXACT | (e) (e) | P=0.358 P=0.465N | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05053 TEST: 02 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BROMOFORM TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE .05 G/KG 0.1 G/KG | VEHICLE 0.1 G/KG 0.2 G/KG | | | 46 VM 46 LM 46 HM | 46 VF 46 LF 46 HF | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 5/50 (10%) 2/50 (4%) | 0/49 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 7.3% 13.1% 5.6% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 3/41 (7%) 4/37 (11%) 2/36 (6%) | 0/25 (0%) 0/15 (0%) 0/20 (0%) | |FIRST INCIDENCE (DAYS) | 730 (T) 688 730 (T) | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.495N P=0.300 P=0.559N | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.483N P=0.344 P=0.559N | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.499N P=0.310 P=0.559N | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.421N | (e) | |FISHER EXACT | P=0.357 P=0.500N | (e) (e) | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 7/50 (14%) 4/50 (8%) | 0/49 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 4.8% 17.4% 9.9% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/41 (2%) 4/37 (11%) 2/36 (6%) | 0/25 (0%) 0/15 (0%) 0/20 (0%) | |FIRST INCIDENCE (DAYS) | 721 673 526 | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.233 P=0.063 P=0.289 | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.284 P=0.121 P=0.371 | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.297 P=0.071 P=0.382 | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.297 | (e) | |FISHER EXACT | P=0.080 P=0.339 | (e) (e) | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05053 TEST: 02 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BROMOFORM TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE .05 G/KG 0.1 G/KG | VEHICLE 0.1 G/KG 0.2 G/KG | | | 46 VM 46 LM 46 HM | 46 VF 46 LF 46 HF | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, Sarcoma, | | Neurofibroma, or Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 6/50 (12%) 11/50 (22%) 6/50 (12%) | 0/49 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 13.8% 27.5% 15.2% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 4/41 (10%) 8/37 (22%) 4/36 (11%) | 0/25 (0%) 0/15 (0%) 0/20 (0%) | |FIRST INCIDENCE (DAYS) | 629 673 526 | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.441 P=0.105 P=0.532 | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.533 P=0.158 P=0.601N | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.523 P=0.120 P=0.609N | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.555 | (e) | |FISHER EXACT | P=0.143 P=0.620N | (e) (e) | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, or Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 9/50 (18%) 4/50 (8%) | 0/49 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 6.8% 22.5% 9.9% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/41 (2%) 6/37 (16%) 2/36 (6%) | 0/25 (0%) 0/15 (0%) 0/20 (0%) | |FIRST INCIDENCE (DAYS) | 629 673 526 | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.349 P=0.048 * P=0.438 | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.447 P=0.079 P=0.576 | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.437 P=0.055 P=0.577 | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.436 | (e) | |FISHER EXACT | P=0.061 P=0.500 | (e) (e) | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05053 TEST: 02 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BROMOFORM TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE .05 G/KG 0.1 G/KG | VEHICLE 0.1 G/KG 0.2 G/KG | | | 46 VM 46 LM 46 HM | 46 VF 46 LF 46 HF | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 4/50 (8%) 0/50 (0%) | 0/49 (0%) 0/50 (0%) 2/50 (4%) | |ADJUSTED (b) | 0.0% 10.8% 0.0% | 0.0% 0.0% 8.0% | |TERMINAL (d) | 0/41 (0%) 4/37 (11%) 0/36 (0%) | 0/25 (0%) 0/15 (0%) 1/20 (5%) | |FIRST INCIDENCE (DAYS) | --- 730 (T) --- | --- --- 609 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.579 P=0.051 (e) | P=0.083 (e) P=0.190 | |INCIDENTAL TUMOR | P=0.579 P=0.051 (e) | P=0.095 (e) P=0.231 | |LOGISTIC REGRESSION | P=0.579 P=0.051 (e) | P=0.084 (e) P=0.220 | |COCHRAN-ARMITAGE | P=0.622 | P=0.097 | |FISHER EXACT | P=0.059 (e) | (e) P=0.253 | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # | |----------- | | | |OVERALL (a) | | 1/49 (2%) 1/50 (2%) 3/50 (6%) | |ADJUSTED (b) | | 3.0% 6.7% 11.6% | |TERMINAL (d) | | 0/25 (0%) 1/15 (7%) 1/20 (5%) | |FIRST INCIDENCE (DAYS) | | 692 735 (T) 537 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.151 P=0.625 P=0.224 | |INCIDENTAL TUMOR | | P=0.175 P=0.693 P=0.327 | |LOGISTIC REGRESSION | | P=0.161 P=0.670 P=0.285 | |COCHRAN-ARMITAGE | | P=0.207 | |FISHER EXACT | | P=0.747N P=0.316 | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05053 TEST: 02 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BROMOFORM TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE .05 G/KG 0.1 G/KG | VEHICLE 0.1 G/KG 0.2 G/KG | | | 46 VM 46 LM 46 HM | 46 VF 46 LF 46 HF | |=================================================================================================================================| | | |All Organs | | Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/50 (0%) | 0/49 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 6.8% 2.7% 0.0% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/41 (2%) 1/37 (3%) 0/36 (0%) | 0/25 (0%) 0/15 (0%) 0/20 (0%) | |FIRST INCIDENCE (DAYS) | 642 730 (T) --- | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.079N P=0.344N P=0.152N | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.054N P=0.311N P=0.101N | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.062N P=0.306N P=0.112N | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.060N | (e) | |FISHER EXACT | P=0.309N P=0.121N | (e) (e) | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) | 0/49 (0%) 0/50 (0%) 3/50 (6%) | |ADJUSTED (b) | 2.4% 2.7% 5.3% | 0.0% 0.0% 11.9% | |TERMINAL (d) | 1/41 (2%) 1/37 (3%) 1/36 (3%) | 0/25 (0%) 0/15 (0%) 2/20 (10%) | |FIRST INCIDENCE (DAYS) | 730 (T) 730 (T) 663 | --- --- 372 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.338 P=0.739 P=0.453 | P=0.033 * (e) P=0.096 | |INCIDENTAL TUMOR | P=0.345 P=0.739 P=0.470 | P=0.041 * (e) P=0.169 | |LOGISTIC REGRESSION | P=0.355 P=0.739 P=0.486 | P=0.043 * (e) P=0.163 | |COCHRAN-ARMITAGE | P=0.378 | P=0.038 * | |FISHER EXACT | P=0.753N P=0.500 | (e) P=0.125 | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05053 TEST: 02 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BROMOFORM TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE .05 G/KG 0.1 G/KG | VEHICLE 0.1 G/KG 0.2 G/KG | | | 46 VM 46 LM 46 HM | 46 VF 46 LF 46 HF | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 2/50 (4%) 2/50 (4%) | 0/49 (0%) 0/50 (0%) 3/50 (6%) | |ADJUSTED (b) | 9.1% 5.4% 5.3% | 0.0% 0.0% 11.9% | |TERMINAL (d) | 2/41 (5%) 2/37 (5%) 1/36 (3%) | 0/25 (0%) 0/15 (0%) 2/20 (10%) | |FIRST INCIDENCE (DAYS) | 642 730 (T) 663 | --- --- 372 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.311N P=0.386N P=0.406N | P=0.033 * (e) P=0.096 | |INCIDENTAL TUMOR | P=0.254N P=0.358N P=0.327N | P=0.041 * (e) P=0.169 | |LOGISTIC REGRESSION | P=0.269N P=0.353N P=0.337N | P=0.043 * (e) P=0.163 | |COCHRAN-ARMITAGE | P=0.252N | P=0.038 * | |FISHER EXACT | P=0.339N P=0.339N | (e) P=0.125 | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma And Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 6/50 (12%) 0/50 (0%) 4/50 (8%) | 11/49 (22%) 6/50 (12%) 3/50 (6%) | |ADJUSTED (b) | 13.4% 0.0% 9.8% | 34.7% 27.0% 13.9% | |TERMINAL (d) | 4/41 (10%) 0/37 (0%) 2/36 (6%) | 7/25 (28%) 1/15 (7%) 2/20 (10%) | |FIRST INCIDENCE (DAYS) | 544 --- 565 | 502 601 672 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.331N P=0.025N* P=0.444N | P=0.067N P=0.484N P=0.066N | |INCIDENTAL TUMOR | P=0.196N P=0.023N* P=0.269N | P=0.029N* P=0.200N P=0.023N* | |LOGISTIC REGRESSION | P=0.235N P=0.012N* P=0.271N | P=0.031N* P=0.220N P=0.039N* | |COCHRAN-ARMITAGE | P=0.274N | P=0.012N* | |FISHER EXACT | P=0.013N* P=0.370N | P=0.133N P=0.018N* | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05053 TEST: 02 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BROMOFORM TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE .05 G/KG 0.1 G/KG | VEHICLE 0.1 G/KG 0.2 G/KG | | | 46 VM 46 LM 46 HM | 46 VF 46 LF 46 HF | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 6/50 (12%) 0/50 (0%) 4/50 (8%) | 11/49 (22%) 5/50 (10%) 3/50 (6%) | |ADJUSTED (b) | 13.4% 0.0% 9.8% | 34.7% 22.9% 13.9% | |TERMINAL (d) | 4/41 (10%) 0/37 (0%) 2/36 (6%) | 7/25 (28%) 1/15 (7%) 2/20 (10%) | |FIRST INCIDENCE (DAYS) | 544 --- 565 | 502 601 672 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.331N P=0.025N* P=0.444N | P=0.056N P=0.349N P=0.066N | |INCIDENTAL TUMOR | P=0.196N P=0.023N* P=0.269N | P=0.024N* P=0.124N P=0.023N* | |LOGISTIC REGRESSION | P=0.235N P=0.012N* P=0.271N | P=0.028N* P=0.137N P=0.039N* | |COCHRAN-ARMITAGE | P=0.274N | P=0.011N* | |FISHER EXACT | P=0.013N* P=0.370N | P=0.079N P=0.018N* | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 25/50 (50%) 24/50 (48%) 13/50 (26%) | 11/49 (22%) 13/50 (26%) 15/50 (30%) | |ADJUSTED (b) | 55.3% 55.3% 34.9% | 36.5% 49.8% 52.7% | |TERMINAL (d) | 21/41 (51%) 18/37 (49%) 12/36 (33%) | 7/25 (28%) 4/15 (27%) 8/20 (40%) | |FIRST INCIDENCE (DAYS) | 455 393 632 | 600 538 537 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.043N* P=0.477 P=0.040N* | P=0.071 P=0.070 P=0.087 | |INCIDENTAL TUMOR | P=0.013N* P=0.572N P=0.018N* | P=0.104 P=0.256 P=0.122 | |LOGISTIC REGRESSION | P=0.014N* P=0.511N P=0.022N* | P=0.089 P=0.195 P=0.104 | |COCHRAN-ARMITAGE | P=0.010N** | P=0.230 | |FISHER EXACT | P=0.500N P=0.011N* | P=0.430 P=0.266 | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05053 TEST: 02 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BROMOFORM TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE .05 G/KG 0.1 G/KG | VEHICLE 0.1 G/KG 0.2 G/KG | | | 46 VM 46 LM 46 HM | 46 VF 46 LF 46 HF | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 17/50 (34%) 21/50 (42%) 15/50 (30%) | 15/49 (31%) 6/50 (12%) 9/50 (18%) | |ADJUSTED (b) | 34.7% 46.3% 32.9% | 47.2% 27.0% 33.5% | |TERMINAL (d) | 9/41 (22%) 13/37 (35%) 6/36 (17%) | 10/25 (40%) 1/15 (7%) 5/20 (25%) | |FIRST INCIDENCE (DAYS) | 544 507 509 | 502 601 303 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.513 P=0.196 P=0.571 | P=0.265N P=0.228N P=0.304N | |INCIDENTAL TUMOR | P=0.218N P=0.298 P=0.237N | P=0.092N P=0.055N P=0.078N | |LOGISTIC REGRESSION | P=0.139N P=0.378 P=0.141N | P=0.079N P=0.068N P=0.099N | |COCHRAN-ARMITAGE | P=0.377N | P=0.077N | |FISHER EXACT | P=0.268 P=0.415N | P=0.021N* P=0.109N | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 34/50 (68%) 33/50 (66%) 27/50 (54%) | 24/49 (49%) 18/50 (36%) 19/50 (38%) | |ADJUSTED (b) | 68.0% 68.7% 58.5% | 71.2% 62.5% 59.9% | |TERMINAL (d) | 25/41 (61%) 22/37 (59%) 17/36 (47%) | 16/25 (64%) 5/15 (33%) 9/20 (45%) | |FIRST INCIDENCE (DAYS) | 455 393 509 | 502 538 303 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.348N P=0.423 P=0.364N | P=0.495 P=0.310 P=0.573N | |INCIDENTAL TUMOR | P=0.052N P=0.472N P=0.075N | P=0.257N P=0.341N P=0.211N | |LOGISTIC REGRESSION | P=0.037N* P=0.460N P=0.052N | P=0.325N P=0.439N P=0.264N | |COCHRAN-ARMITAGE | P=0.090N | P=0.158N | |FISHER EXACT | P=0.500N P=0.109N | P=0.135N P=0.184N | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05053 TEST: 02 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BROMOFORM 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).