TDMS Study 05063-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Mason PHENYLBUTAZONE DATE: 09/08/94 EXPERIMENT: 05063 TEST: 02 TIME: 21:23:06 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01ES1803301 ROUTE: GAVAGE NTP C#: 56531 PATHOLOGIST: R. FLEISCHMAN CAS: 50-33-9 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Mason PHENYLBUTAZONE DATE: 09/08/94 EXPERIMENT: 05063 TEST: 02 TIME: 21:23:06 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES1803301 ROUTE: GAVAGE NTP C#: 56531 PATHOLOGIST: R. FLEISCHMAN CAS: 50-33-9 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 PHENYLBUTAZONE DATE: 09/08/94 EXPERIMENT: 05063 TEST: 02 TIME: 21:23:06 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES1803301 ROUTE: GAVAGE NTP C#: 56531 PATHOLOGIST: R. FLEISCHMAN CAS: 50-33-9 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF PHENYLBUTAZONE ==================================================================================================== MALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Liver Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Skin: Subcutaneous Tissue Neurofibrosarcoma, Fibrosarcoma, Sarcoma, Neurofibroma, or Fibroma 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 Carcinoma or Adenoma Stomach, Forestomach Squamous Cell Carcinoma or Papilloma Squamous All Organs Benign Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 09/08/94 EXPERIMENT: 05063 TEST: 02 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PHENYLBUTAZONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.15G/KG 0.3 G/KG | VEHICLE 0.15G/KG 0.3 G/KG | | | | | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 5.6% 2.5% 2.8% | 3.6% 0.0% 0.0% | |TERMINAL (d) | 2/36 (6%) 1/40 (3%) 1/36 (3%) | 0/22 (0%) 0/29 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 730 (T) 730 (T) 730 (T) | 710 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.376N P=0.463N P=0.500N | P=0.249N P=0.486N P=0.467N | |INCIDENTAL TUMOR | P=0.376N P=0.463N P=0.500N | P=0.451N P=0.718N P=0.718N | |LOGISTIC REGRESSION | P=0.376N P=0.463N P=0.500N | P=0.273N P=0.513N P=0.504N | |COCHRAN-ARMITAGE | P=0.378N | P=0.270N | |FISHER EXACT | P=0.500N P=0.500N | P=0.500N P=0.500N | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/49 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 4.6% 0.0% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/36 (0%) 1/40 (3%) 0/36 (0%) | 0/22 (0%) 0/29 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | --- 627 --- | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.664 P=0.256 (e) | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.615 P=0.176 (e) | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.668N P=0.242 (e) | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.668 | (e) | |FISHER EXACT | P=0.247 (e) | (e) (e) | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05063 TEST: 02 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PHENYLBUTAZONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.15G/KG 0.3 G/KG | VEHICLE 0.15G/KG 0.3 G/KG | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 12/50 (24%) 24/50 (48%) | 4/50 (8%) 5/49 (10%) 7/50 (14%) | |ADJUSTED (b) | 20.0% 29.1% 61.1% | 16.4% 17.2% 21.9% | |TERMINAL (d) | 5/36 (14%) 11/40 (28%) 21/36 (58%) | 3/22 (14%) 5/29 (17%) 7/32 (22%) | |FIRST INCIDENCE (DAYS) | 627 647 500 | 688 731 (T) 731 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.306 P<0.001 ** | P=0.414 P=0.625N P=0.490 | |INCIDENTAL TUMOR | P<0.001 ** P=0.228 P<0.001 ** | P=0.355 P=0.586 P=0.413 | |LOGISTIC REGRESSION | P<0.001 ** P=0.231 P<0.001 ** | P=0.303 P=0.532 P=0.356 | |COCHRAN-ARMITAGE | P<0.001 ** | P=0.210 | |FISHER EXACT | P=0.227 P<0.001 ** | P=0.487 P=0.262 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 4/50 (8%) 11/50 (22%) | 1/50 (2%) 0/49 (0%) 0/50 (0%) | |ADJUSTED (b) | 18.3% 10.0% 25.1% | 4.5% 0.0% 0.0% | |TERMINAL (d) | 3/36 (8%) 4/40 (10%) 4/36 (11%) | 1/22 (5%) 0/29 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 440 730 (T) 500 | 731 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.248 P=0.157N P=0.310 | P=0.218N P=0.445N P=0.425N | |INCIDENTAL TUMOR | P=0.265 P=0.331N P=0.287 | P=0.218N P=0.445N P=0.425N | |LOGISTIC REGRESSION | P=0.252 P=0.165N P=0.355 | P=0.218N P=0.445N P=0.425N | |COCHRAN-ARMITAGE | P=0.245 | P=0.270N | |FISHER EXACT | P=0.178N P=0.306 | P=0.505N P=0.500N | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05063 TEST: 02 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PHENYLBUTAZONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.15G/KG 0.3 G/KG | VEHICLE 0.15G/KG 0.3 G/KG | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 16/50 (32%) 14/50 (28%) 31/50 (62%) | 5/50 (10%) 5/49 (10%) 7/50 (14%) | |ADJUSTED (b) | 35.6% 34.0% 70.3% | 20.8% 17.2% 21.9% | |TERMINAL (d) | 8/36 (22%) 13/40 (33%) 23/36 (64%) | 4/22 (18%) 5/29 (17%) 7/32 (22%) | |FIRST INCIDENCE (DAYS) | 440 647 500 | 688 731 (T) 731 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.003 ** P=0.326N P=0.007 ** | P=0.564 P=0.466N P=0.613N | |INCIDENTAL TUMOR | P=0.001 ** P=0.564N P=0.002 ** | P=0.504 P=0.537N P=0.570 | |LOGISTIC REGRESSION | P=0.001 ** P=0.421N P=0.002 ** | P=0.441 P=0.599N P=0.502 | |COCHRAN-ARMITAGE | P=0.002 ** | P=0.319 | |FISHER EXACT | P=0.414N P=0.002 ** | P=0.617 P=0.380 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 16/50 (32%) 14/50 (28%) 31/50 (62%) | 5/50 (10%) 5/49 (10%) 7/50 (14%) | |ADJUSTED (b) | 35.6% 34.0% 70.3% | 20.8% 17.2% 21.9% | |TERMINAL (d) | 8/36 (22%) 13/40 (33%) 23/36 (64%) | 4/22 (18%) 5/29 (17%) 7/32 (22%) | |FIRST INCIDENCE (DAYS) | 440 647 500 | 688 731 (T) 731 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.003 ** P=0.326N P=0.007 ** | P=0.564 P=0.466N P=0.613N | |INCIDENTAL TUMOR | P=0.001 ** P=0.564N P=0.002 ** | P=0.504 P=0.537N P=0.570 | |LOGISTIC REGRESSION | P=0.001 ** P=0.421N P=0.002 ** | P=0.441 P=0.599N P=0.502 | |COCHRAN-ARMITAGE | P=0.002 ** | P=0.319 | |FISHER EXACT | P=0.414N P=0.002 ** | P=0.617 P=0.380 | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05063 TEST: 02 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PHENYLBUTAZONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.15G/KG 0.3 G/KG | VEHICLE 0.15G/KG 0.3 G/KG | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 6/14 (43%) 4/50 (8%) | 3/50 (6%) 2/21 (10%) 3/50 (6%) | |ADJUSTED (b) | 16.7% 63.3% 11.1% | 11.4% 33.3% 8.4% | |TERMINAL (d) | 6/36 (17%) 5/8 (63%) 4/36 (11%) | 2/22 (9%) 2/6 (33%) 1/32 (3%) | |FIRST INCIDENCE (DAYS) | 730 (T) 612 730 (T) | 631 731 (T) 568 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.333N P=0.008 ** P=0.368N | P=0.450N P=0.421 P=0.578N | |INCIDENTAL TUMOR | P=0.349N P=0.005 ** P=0.368N | P=0.508 P=0.395 P=0.474 | |LOGISTIC REGRESSION | P=0.348N P=0.003 ** P=0.368N | P=0.552 P=0.228 P=0.641 | |COCHRAN-ARMITAGE | P=0.334N | P=0.580 | |FISHER EXACT | P=0.017 * P=0.370N | P=0.466 P=0.661N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 6/14 (43%) 5/50 (10%) | 3/50 (6%) 3/21 (14%) 3/50 (6%) | |ADJUSTED (b) | 16.7% 63.3% 13.9% | 11.4% 35.0% 8.4% | |TERMINAL (d) | 6/36 (17%) 5/8 (63%) 5/36 (14%) | 2/22 (9%) 2/6 (33%) 1/32 (3%) | |FIRST INCIDENCE (DAYS) | 730 (T) 612 730 (T) | 631 569 568 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.446N P=0.008 ** P=0.500N | P=0.464N P=0.243 P=0.578N | |INCIDENTAL TUMOR | P=0.462N P=0.005 ** P=0.500N | P=0.445 P=0.206 P=0.474 | |LOGISTIC REGRESSION | P=0.460N P=0.003 ** P=0.500N | P=0.541 P=0.094 P=0.641 | |COCHRAN-ARMITAGE | P=0.446N | P=0.575 | |FISHER EXACT | P=0.017 * P=0.500N | P=0.241 P=0.661N | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05063 TEST: 02 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PHENYLBUTAZONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.15G/KG 0.3 G/KG | VEHICLE 0.15G/KG 0.3 G/KG | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/47 (2%) 0/5 (0%) 1/45 (2%) | 8/44 (18%) 5/17 (29%) 3/47 (6%) | |ADJUSTED (b) | 2.6% 0.0% 3.0% | 35.1% 76.5% 9.4% | |TERMINAL (d) | 0/35 (0%) 0/0 1/33 (3%) | 7/21 (33%) 3/4 (75%) 3/32 (9%) | |FIRST INCIDENCE (DAYS) | 712 --- 730 (T) | 652 624 731 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.641 P=0.490N P=0.751 | P=0.018N* P=0.126 P=0.021N* | |INCIDENTAL TUMOR | P=0.631 (e) P=0.754 | P=0.042N* P=0.016 * P=0.028N* | |LOGISTIC REGRESSION | P=0.626 P=0.995N P=0.750 | P=0.059N P=0.012 * P=0.053N | |COCHRAN-ARMITAGE | P=0.632 | P=0.073N | |FISHER EXACT | P=0.904N P=0.742 | P=0.265 P=0.080N | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/47 (2%) 0/5 (0%) 1/45 (2%) | 8/44 (18%) 5/17 (29%) 4/47 (9%) | |ADJUSTED (b) | 2.6% 0.0% 3.0% | 35.1% 76.5% 11.7% | |TERMINAL (d) | 0/35 (0%) 0/0 1/33 (3%) | 7/21 (33%) 3/4 (75%) 3/32 (9%) | |FIRST INCIDENCE (DAYS) | 712 --- 730 (T) | 652 624 605 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.641 P=0.490N P=0.751 | P=0.040N* P=0.126 P=0.056N | |INCIDENTAL TUMOR | P=0.631 (e) P=0.754 | P=0.101N P=0.016 * P=0.096N | |LOGISTIC REGRESSION | P=0.626 P=0.995N P=0.750 | P=0.125N P=0.012 * P=0.143N | |COCHRAN-ARMITAGE | P=0.632 | P=0.127N | |FISHER EXACT | P=0.904N P=0.742 | P=0.265 P=0.146N | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05063 TEST: 02 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PHENYLBUTAZONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.15G/KG 0.3 G/KG | VEHICLE 0.15G/KG 0.3 G/KG | | | | | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 2.8% 2.5% 5.6% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/36 (3%) 1/40 (3%) 2/36 (6%) | 0/22 (0%) 0/29 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 730 (T) 730 (T) 730 (T) | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.377 P=0.738N P=0.500 | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.377 P=0.738N P=0.500 | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.377 P=0.738N P=0.500 | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.379 | (e) | |FISHER EXACT | P=0.753N P=0.500 | (e) (e) | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 7/50 (14%) | 0/50 (0%) 1/50 (2%) 1/50 (2%) | |ADJUSTED (b) | 6.8% 4.5% 16.8% | 0.0% 2.6% 2.4% | |TERMINAL (d) | 0/36 (0%) 1/40 (3%) 3/36 (8%) | 0/22 (0%) 0/29 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 593 612 618 | --- 606 494 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.101 P=0.475N P=0.164 | P=0.303 P=0.475 P=0.465 | |INCIDENTAL TUMOR | P=0.052 P=0.672 P=0.085 | P=0.325 P=0.419 P=0.846 | |LOGISTIC REGRESSION | P=0.058 P=0.465N P=0.095 | P=0.388 P=0.542 P=0.618 | |COCHRAN-ARMITAGE | P=0.099 | P=0.332 | |FISHER EXACT | P=0.500N P=0.159 | P=0.500 P=0.500 | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05063 TEST: 02 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PHENYLBUTAZONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.15G/KG 0.3 G/KG | VEHICLE 0.15G/KG 0.3 G/KG | | | | | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, Sarcoma, | | Neurofibroma, or Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 3/50 (6%) 9/50 (18%) | 2/50 (4%) 1/50 (2%) 1/50 (2%) | |ADJUSTED (b) | 9.4% 7.0% 21.1% | 5.4% 2.6% 2.4% | |TERMINAL (d) | 1/36 (3%) 2/40 (5%) 4/36 (11%) | 0/22 (0%) 0/29 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 593 612 598 | 652 606 494 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.077 P=0.462N P=0.127 | P=0.407N P=0.544N P=0.523N | |INCIDENTAL TUMOR | P=0.035 * P=0.659 P=0.055 | P=0.564N P=0.698 P=0.582N | |LOGISTIC REGRESSION | P=0.040 * P=0.482N P=0.061 | P=0.331N P=0.472N P=0.440N | |COCHRAN-ARMITAGE | P=0.073 | P=0.378N | |FISHER EXACT | P=0.500N P=0.117 | P=0.500N P=0.500N | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, or Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 8/50 (16%) | 2/50 (4%) 1/50 (2%) 1/50 (2%) | |ADJUSTED (b) | 6.8% 4.5% 18.6% | 5.4% 2.6% 2.4% | |TERMINAL (d) | 0/36 (0%) 1/40 (3%) 3/36 (8%) | 0/22 (0%) 0/29 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | 593 612 598 | 652 606 494 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.058 P=0.475N P=0.109 | P=0.407N P=0.544N P=0.523N | |INCIDENTAL TUMOR | P=0.022 * P=0.672 P=0.040 * | P=0.564N P=0.698 P=0.582N | |LOGISTIC REGRESSION | P=0.024 * P=0.465N P=0.044 * | P=0.331N P=0.472N P=0.440N | |COCHRAN-ARMITAGE | P=0.055 | P=0.378N | |FISHER EXACT | P=0.500N P=0.100 | P=0.500N P=0.500N | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05063 TEST: 02 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PHENYLBUTAZONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.15G/KG 0.3 G/KG | VEHICLE 0.15G/KG 0.3 G/KG | | | | | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 2.2% | 5.4% 0.0% 0.0% | |TERMINAL (d) | 0/36 (0%) 0/40 (0%) 0/36 (0%) | 0/22 (0%) 0/29 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 598 | 652 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.270 (e) P=0.500 | P=0.103N P=0.269N P=0.243N | |INCIDENTAL TUMOR | P=0.225 (e) P=0.419 | P=0.264N P=0.500N P=0.500N | |LOGISTIC REGRESSION | P=0.267 (e) P=0.562 | P=0.094N P=0.228N P=0.231N | |COCHRAN-ARMITAGE | P=0.270 | P=0.095N | |FISHER EXACT | (e) P=0.500 | P=0.247N P=0.247N | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 2.8% | 9.1% 0.0% 0.0% | |TERMINAL (d) | 0/36 (0%) 0/40 (0%) 1/36 (3%) | 2/22 (9%) 0/29 (0%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 730 (T) | 731 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.267 (e) P=0.500 | P=0.060N P=0.179N P=0.160N | |INCIDENTAL TUMOR | P=0.267 (e) P=0.500 | P=0.060N P=0.179N P=0.160N | |LOGISTIC REGRESSION | P=0.267 (e) P=0.500 | P=0.060N P=0.179N P=0.160N | |COCHRAN-ARMITAGE | P=0.270 | P=0.095N | |FISHER EXACT | (e) P=0.500 | P=0.247N P=0.247N | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05063 TEST: 02 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PHENYLBUTAZONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.15G/KG 0.3 G/KG | VEHICLE 0.15G/KG 0.3 G/KG | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma or Papilloma Squamous | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) | 5/50 (10%) 0/50 (0%) 2/50 (4%) | |ADJUSTED (b) | 2.8% 0.0% 2.8% | 18.8% 0.0% 6.3% | |TERMINAL (d) | 1/36 (3%) 0/40 (0%) 1/36 (3%) | 3/22 (14%) 0/29 (0%) 2/32 (6%) | |FIRST INCIDENCE (DAYS) | 730 (T) --- 730 (T) | 669 --- 731 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.671N P=0.479N P=0.762 | P=0.065N P=0.023N* P=0.118N | |INCIDENTAL TUMOR | P=0.671N P=0.479N P=0.762 | P=0.132N P=0.049N* P=0.214N | |LOGISTIC REGRESSION | P=0.671N P=0.479N P=0.762 | P=0.114N P=0.038N* P=0.206N | |COCHRAN-ARMITAGE | P=0.668N | P=0.117N | |FISHER EXACT | P=0.500N P=0.753N | P=0.028N* P=0.218N | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) | 3/50 (6%) 0/50 (0%) 2/50 (4%) | |ADJUSTED (b) | 2.8% 0.0% 0.0% | 10.2% 0.0% 6.3% | |TERMINAL (d) | 1/36 (3%) 0/40 (0%) 0/36 (0%) | 1/22 (5%) 0/29 (0%) 2/32 (6%) | |FIRST INCIDENCE (DAYS) | 730 (T) --- --- | 669 --- 731 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.267N P=0.479N P=0.500N | P=0.303N P=0.111N P=0.384N | |INCIDENTAL TUMOR | P=0.267N P=0.479N P=0.500N | P=0.485N P=0.232N P=0.586N | |LOGISTIC REGRESSION | P=0.267N P=0.479N P=0.500N | P=0.399N P=0.134N P=0.512N | |COCHRAN-ARMITAGE | P=0.270N | P=0.390N | |FISHER EXACT | P=0.500N P=0.500N | P=0.121N P=0.500N | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05063 TEST: 02 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PHENYLBUTAZONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.15G/KG 0.3 G/KG | VEHICLE 0.15G/KG 0.3 G/KG | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/5 (0%) 1/49 (2%) | 2/48 (4%) 0/14 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 2.9% | 7.3% 0.0% 0.0% | |TERMINAL (d) | 0/35 (0%) 0/0 1/35 (3%) | 1/22 (5%) 0/0 0/32 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 730 (T) | 663 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.309 (e) P=0.500 | P=0.094N P=0.518N P=0.196N | |INCIDENTAL TUMOR | P=0.309 (e) P=0.500 | P=0.180N (e) P=0.295N | |LOGISTIC REGRESSION | P=0.309 (e) P=0.500 | P=0.137N P=0.881N P=0.243N | |COCHRAN-ARMITAGE | P=0.307 | P=0.121N | |FISHER EXACT | (e) P=0.505 | P=0.597N P=0.237N | |=================================================================================================================================| | | |Uterus | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # | |----------- | | | |OVERALL (a) | | 0/50 (0%) 2/50 (4%) 0/50 (0%) | |ADJUSTED (b) | | 0.0% 6.9% 0.0% | |TERMINAL (d) | | 0/22 (0%) 2/29 (7%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | | --- 731 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.593N P=0.300 (e) | |INCIDENTAL TUMOR | | P=0.593N P=0.300 (e) | |LOGISTIC REGRESSION | | P=0.593N P=0.300 (e) | |COCHRAN-ARMITAGE | | P=0.668 | |FISHER EXACT | | P=0.247 (e) | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05063 TEST: 02 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PHENYLBUTAZONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.15G/KG 0.3 G/KG | VEHICLE 0.15G/KG 0.3 G/KG | | | | | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 7.0% 0.0% | 0.0% 3.4% 0.0% | |TERMINAL (d) | 0/36 (0%) 2/40 (5%) 0/36 (0%) | 0/22 (0%) 1/29 (3%) 0/32 (0%) | |FIRST INCIDENCE (DAYS) | --- 627 --- | --- 731 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.636 P=0.138 (e) | P=0.684N P=0.555 (e) | |INCIDENTAL TUMOR | P=0.595 P=0.094 (e) | P=0.684N P=0.555 (e) | |LOGISTIC REGRESSION | P=0.639 P=0.120 (e) | P=0.685N P=0.555 (e) | |COCHRAN-ARMITAGE | P=0.638 | P=0.730 | |FISHER EXACT | P=0.121 (e) | P=0.500 (e) | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) | 1/50 (2%) 1/50 (2%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 7.0% 0.0% | 2.1% 3.4% 3.1% | |TERMINAL (d) | 0/36 (0%) 2/40 (5%) 0/36 (0%) | 0/22 (0%) 1/29 (3%) 1/32 (3%) | |FIRST INCIDENCE (DAYS) | --- 627 --- | 572 731 (T) 731 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.636 P=0.138 (e) | P=0.594N P=0.754N P=0.744N | |INCIDENTAL TUMOR | P=0.595 P=0.094 (e) | P=0.604 P=0.749 P=0.678 | |LOGISTIC REGRESSION | P=0.639 P=0.120 (e) | P=0.627 P=0.761N P=0.763N | |COCHRAN-ARMITAGE | P=0.638 | P=0.640 | |FISHER EXACT | P=0.121 (e) | P=0.753N P=0.753N | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05063 TEST: 02 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PHENYLBUTAZONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.15G/KG 0.3 G/KG | VEHICLE 0.15G/KG 0.3 G/KG | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma And Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 7/50 (14%) 8/50 (16%) 1/50 (2%) | 11/50 (22%) 8/50 (16%) 8/50 (16%) | |ADJUSTED (b) | 17.5% 18.2% 2.8% | 34.3% 25.0% 22.8% | |TERMINAL (d) | 5/36 (14%) 5/40 (13%) 1/36 (3%) | 5/22 (23%) 6/29 (21%) 6/32 (19%) | |FIRST INCIDENCE (DAYS) | 558 612 730 (T) | 599 612 492 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.040N* P=0.565 P=0.036N* | P=0.129N P=0.226N P=0.163N | |INCIDENTAL TUMOR | P=0.057N P=0.410 P=0.044N* | P=0.344N P=0.365N P=0.407N | |LOGISTIC REGRESSION | P=0.038N* P=0.501 P=0.031N* | P=0.305N P=0.368N P=0.352N | |COCHRAN-ARMITAGE | P=0.038N* | P=0.257N | |FISHER EXACT | P=0.500 P=0.030N* | P=0.306N P=0.306N | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 7/50 (14%) 8/50 (16%) 1/50 (2%) | 11/50 (22%) 8/50 (16%) 8/50 (16%) | |ADJUSTED (b) | 17.5% 18.2% 2.8% | 34.3% 25.0% 22.8% | |TERMINAL (d) | 5/36 (14%) 5/40 (13%) 1/36 (3%) | 5/22 (23%) 6/29 (21%) 6/32 (19%) | |FIRST INCIDENCE (DAYS) | 558 612 730 (T) | 599 612 492 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.040N* P=0.565 P=0.036N* | P=0.129N P=0.226N P=0.163N | |INCIDENTAL TUMOR | P=0.057N P=0.410 P=0.044N* | P=0.344N P=0.365N P=0.407N | |LOGISTIC REGRESSION | P=0.038N* P=0.501 P=0.031N* | P=0.305N P=0.368N P=0.352N | |COCHRAN-ARMITAGE | P=0.038N* | P=0.257N | |FISHER EXACT | P=0.500 P=0.030N* | P=0.306N P=0.306N | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05063 TEST: 02 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PHENYLBUTAZONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.15G/KG 0.3 G/KG | VEHICLE 0.15G/KG 0.3 G/KG | | | | | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 17/50 (34%) 17/50 (34%) 30/50 (60%) | 20/50 (40%) 13/50 (26%) 15/50 (30%) | |ADJUSTED (b) | 42.2% 40.2% 76.7% | 64.0% 40.0% 42.4% | |TERMINAL (d) | 13/36 (36%) 15/40 (38%) 27/36 (75%) | 12/22 (55%) 10/29 (34%) 12/32 (38%) | |FIRST INCIDENCE (DAYS) | 627 612 500 | 572 569 568 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.005 ** P=0.450N P=0.008 ** | P=0.034N* P=0.037N* P=0.041N* | |INCIDENTAL TUMOR | P=0.005 ** P=0.572N P=0.006 ** | P=0.241N P=0.142N P=0.278N | |LOGISTIC REGRESSION | P=0.004 ** P=0.567N P=0.005 ** | P=0.205N P=0.155N P=0.253N | |COCHRAN-ARMITAGE | P=0.006 ** | P=0.167N | |FISHER EXACT | P=0.583N P=0.008 ** | P=0.101N P=0.201N | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 18/50 (36%) 17/50 (34%) 21/50 (42%) | 17/50 (34%) 12/50 (24%) 12/50 (24%) | |ADJUSTED (b) | 37.6% 38.3% 44.7% | 49.9% 33.4% 30.9% | |TERMINAL (d) | 7/36 (19%) 13/40 (33%) 10/36 (28%) | 8/22 (36%) 7/29 (24%) 7/32 (22%) | |FIRST INCIDENCE (DAYS) | 440 612 500 | 596 431 376 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.316 P=0.409N P=0.352 | P=0.082N P=0.147N P=0.096N | |INCIDENTAL TUMOR | P=0.199 P=0.372 P=0.201 | P=0.231N P=0.255N P=0.247N | |LOGISTIC REGRESSION | P=0.229 P=0.486N P=0.249 | P=0.178N P=0.219N P=0.203N | |COCHRAN-ARMITAGE | P=0.303 | P=0.156N | |FISHER EXACT | P=0.500N P=0.341 | P=0.189N P=0.189N | |=================================================================================================================================| DATE: 09/08/94 EXPERIMENT: 05063 TEST: 02 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- PHENYLBUTAZONE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.15G/KG 0.3 G/KG | VEHICLE 0.15G/KG 0.3 G/KG | | | | | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 30/50 (60%) 28/50 (56%) 40/50 (80%) | 31/50 (62%) 20/50 (40%) 25/50 (50%) | |ADJUSTED (b) | 62.3% 62.0% 85.1% | 84.5% 56.1% 63.4% | |TERMINAL (d) | 18/36 (50%) 23/40 (58%) 29/36 (81%) | 17/22 (77%) 14/29 (48%) 18/32 (56%) | |FIRST INCIDENCE (DAYS) | 440 612 500 | 572 431 376 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.051 P=0.285N P=0.070 | P=0.024N* P=0.010N** P=0.026N* | |INCIDENTAL TUMOR | P=0.010 ** P=0.527 P=0.009 ** | P=0.183N P=0.031N* P=0.199N | |LOGISTIC REGRESSION | P=0.012 * P=0.437N P=0.012 * | P=0.221N P=0.051N P=0.254N | |COCHRAN-ARMITAGE | P=0.023 * | P=0.135N | |FISHER EXACT | P=0.420N P=0.024 * | P=0.022N* P=0.157N | |=================================================================================================================================| (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).