TDMS Study 05021-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst CI PIGMENT RED 23 DATE: 09/03/94 EXPERIMENT: 05021 TEST: 04 TIME: 23:16:48 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01ES9565102 ROUTE: DOSED FEED NTP C#: 60377 PATHOLOGIST: S. EUSTIS J. SEALY CAS: 6471-49-4 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst CI PIGMENT RED 23 DATE: 09/03/94 EXPERIMENT: 05021 TEST: 04 TIME: 23:16:48 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES9565102 ROUTE: DOSED FEED NTP C#: 60377 PATHOLOGIST: S. EUSTIS J. SEALY CAS: 6471-49-4 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 Epididymis Gallbladder Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst CI PIGMENT RED 23 DATE: 09/03/94 EXPERIMENT: 05021 TEST: 04 TIME: 23:16:48 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES9565102 ROUTE: DOSED FEED NTP C#: 60377 PATHOLOGIST: S. EUSTIS J. SEALY CAS: 6471-49-4 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF CI PIGMENT RED 23 ==================================================================================================== MALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Liver Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma All Organs Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type Malignant and Benign Tumors ==================================================================================================== FEMALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Lung Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Carcinoma or Adenoma ==================================================================================================== DATE: 09/04/94 EXPERIMENT: 05021 TEST: 04 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23 TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/48 (4%) 0/32 (0%) 0/23 (0%) 3/48 (6%) | 0/49 (0%) 1/15 (7%) 0/14 (0%) 1/48 (2%) | |ADJUSTED (b) | 6.2% 0.0% 0.0% 10.0% | 0.0% 0.0% 0.0% 2.7% | |TERMINAL (d) | 1/29 (3%) 0/0 0/0 3/30 (10%) | 0/35 (0%) 0/0 0/0 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 647 --- --- 723 (T) | --- 613 --- 658 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.404 P=0.545N P=0.500N P=0.527 | P=0.414 P=0.486 (e) P=0.484 | |INCIDENTAL TUMOR | P=0.415 P=0.343N P=0.406N P=0.581 | P=0.416 P=0.331 (e) P=0.419 | |LOGISTIC REGRESSION | P=0.352 P=0.470N P=0.537N P=0.521 | P=0.472 P=0.296 (e) P=0.516 | |COCHRAN-ARMITAGE | P=0.268 | P=0.481 | |FISHER EXACT | P=0.357N P=0.454N P=0.500 | P=0.234 (e) P=0.495 | |=================================================================================================================================| | | |Bone Marrow | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 0/31 (0%) 2/22 (9%) 0/48 (0%) | 0/49 (0%) 0/49 (0%) 2/49 (4%) 2/49 (4%) | |ADJUSTED (b) | 3.4% 0.0% 0.0% 0.0% | 0.0% 0.0% 4.8% 5.7% | |TERMINAL (d) | 1/29 (3%) 0/0 0/0 0/30 (0%) | 0/35 (0%) 0/34 (0%) 1/35 (3%) 2/35 (6%) | |FIRST INCIDENCE (DAYS) | 723 (T) --- 590 --- | --- --- 472 723 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.418N (e) P=0.229 P=0.493N | P=0.082 (e) P=0.238 P=0.238 | |INCIDENTAL TUMOR | P=0.472N (e) P=0.231 P=0.493N | P=0.060 (e) P=0.377 P=0.238 | |LOGISTIC REGRESSION | P=0.446N (e) P=0.177 P=0.493N | P=0.077 (e) P=0.305 P=0.238 | |COCHRAN-ARMITAGE | P=0.470N | P=0.080 | |FISHER EXACT | P=0.613N P=0.225 P=0.505N | (e) P=0.247 P=0.247 | |=================================================================================================================================| DATE: 09/04/94 EXPERIMENT: 05021 TEST: 04 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23 TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 2/50 (4%) 3/50 (6%) 0/49 (0%) | |ADJUSTED (b) | 5.9% 5.9% 2.8% 3.3% | 0.0% 5.9% 8.3% 0.0% | |TERMINAL (d) | 1/29 (3%) 1/17 (6%) 0/27 (0%) 1/30 (3%) | 0/35 (0%) 2/34 (6%) 3/36 (8%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 644 723 (T) 622 723 (T) | --- 723 (T) 723 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.360N P=0.655N P=0.530N P=0.486N | P=0.507N P=0.232 P=0.126 (e) | |INCIDENTAL TUMOR | P=0.382N P=0.660N P=0.508N P=0.510N | P=0.507N P=0.232 P=0.126 (e) | |LOGISTIC REGRESSION | P=0.381N P=0.583N P=0.505N P=0.484N | P=0.507N P=0.232 P=0.124 (e) | |COCHRAN-ARMITAGE | P=0.417N | P=0.519N | |FISHER EXACT | P=0.500N P=0.500N P=0.500N | P=0.247 P=0.121 (e) | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 2/50 (4%) 4/50 (8%) 0/49 (0%) | |ADJUSTED (b) | 5.9% 5.9% 2.8% 3.3% | 0.0% 5.9% 10.2% 0.0% | |TERMINAL (d) | 1/29 (3%) 1/17 (6%) 0/27 (0%) 1/30 (3%) | 0/35 (0%) 2/34 (6%) 3/36 (8%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 644 723 (T) 622 723 (T) | --- 723 (T) 452 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.360N P=0.655N P=0.530N P=0.486N | P=0.540N P=0.232 P=0.067 (e) | |INCIDENTAL TUMOR | P=0.382N P=0.660N P=0.508N P=0.510N | P=0.569N P=0.232 P=0.106 (e) | |LOGISTIC REGRESSION | P=0.381N P=0.583N P=0.505N P=0.484N | P=0.552N P=0.232 P=0.070 (e) | |COCHRAN-ARMITAGE | P=0.417N | P=0.552N | |FISHER EXACT | P=0.500N P=0.500N P=0.500N | P=0.247 P=0.059 (e) | |=================================================================================================================================| DATE: 09/04/94 EXPERIMENT: 05021 TEST: 04 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23 TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 4/50 (8%) 0/49 (0%) | 0/49 (0%) 1/49 (2%) 0/50 (0%) 0/48 (0%) | |ADJUSTED (b) | 0.0% 0.0% 11.2% 0.0% | 0.0% 2.3% 0.0% 0.0% | |TERMINAL (d) | 0/29 (0%) 0/17 (0%) 1/27 (4%) 0/30 (0%) | 0/35 (0%) 0/34 (0%) 0/36 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 590 --- | --- 516 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.532 (e) P=0.061 (e) | P=0.527N P=0.479 (e) (e) | |INCIDENTAL TUMOR | P=0.519 (e) P=0.075 (e) | P=0.603N P=0.773 (e) (e) | |LOGISTIC REGRESSION | P=0.482 (e) P=0.065 (e) | P=0.570N P=0.622 (e) (e) | |COCHRAN-ARMITAGE | P=0.472 | P=0.529N | |FISHER EXACT | (e) P=0.061 (e) | P=0.500 (e) (e) | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/49 (6%) 1/50 (2%) 4/50 (8%) 8/49 (16%) | 1/49 (2%) 5/49 (10%) 5/50 (10%) 1/48 (2%) | |ADJUSTED (b) | 10.3% 2.6% 14.8% 23.9% | 2.9% 13.9% 13.1% 2.9% | |TERMINAL (d) | 3/29 (10%) 0/17 (0%) 4/27 (15%) 6/30 (20%) | 1/35 (3%) 4/34 (12%) 4/36 (11%) 1/35 (3%) | |FIRST INCIDENCE (DAYS) | 723 (T) 422 723 (T) 638 | 723 (T) 613 631 723 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.037 * P=0.477N P=0.460 P=0.117 | P=0.388N P=0.097 P=0.111 P=0.762 | |INCIDENTAL TUMOR | P=0.025 * P=0.425N P=0.460 P=0.126 | P=0.370N P=0.070 P=0.079 P=0.762 | |LOGISTIC REGRESSION | P=0.027 * P=0.337N P=0.460 P=0.118 | P=0.401N P=0.093 P=0.108 P=0.762 | |COCHRAN-ARMITAGE | P=0.014 * | P=0.400N | |FISHER EXACT | P=0.301N P=0.511 P=0.100 | P=0.102 P=0.107 P=0.747 | |=================================================================================================================================| DATE: 09/04/94 EXPERIMENT: 05021 TEST: 04 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23 TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/49 (24%) 7/50 (14%) 10/50 (20%) 15/49 (31%) | 4/49 (8%) 4/49 (8%) 5/50 (10%) 3/48 (6%) | |ADJUSTED (b) | 32.2% 29.4% 29.9% 36.5% | 11.4% 11.8% 12.4% 8.6% | |TERMINAL (d) | 6/29 (21%) 3/17 (18%) 6/27 (22%) 5/30 (17%) | 4/35 (11%) 4/34 (12%) 3/36 (8%) 3/35 (9%) | |FIRST INCIDENCE (DAYS) | 518 515 529 571 | 723 (T) 723 (T) 521 723 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.313 P=0.465N P=0.470N P=0.414 | P=0.425N P=0.629 P=0.512 P=0.500N | |INCIDENTAL TUMOR | P=0.235 P=0.232N P=0.438N P=0.538 | P=0.447N P=0.629 P=0.608 P=0.500N | |LOGISTIC REGRESSION | P=0.324 P=0.260N P=0.401N P=0.554 | P=0.444N P=0.629 P=0.514 P=0.500N | |COCHRAN-ARMITAGE | P=0.129 | P=0.442N | |FISHER EXACT | P=0.142N P=0.384N P=0.326 | P=0.643N P=0.513 P=0.512N | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/49 (27%) 8/50 (16%) 14/50 (28%) 21/49 (43%) | 5/49 (10%) 8/49 (16%) 10/50 (20%) 4/48 (8%) | |ADJUSTED (b) | 35.1% 31.2% 43.3% 50.4% | 14.3% 22.5% 24.7% 11.4% | |TERMINAL (d) | 7/29 (24%) 3/17 (18%) 10/27 (37%) 10/30 (33%) | 5/35 (14%) 7/34 (21%) 7/36 (19%) 4/35 (11%) | |FIRST INCIDENCE (DAYS) | 518 422 529 571 | 723 (T) 613 521 723 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.071 P=0.501N P=0.428 P=0.135 | P=0.359N P=0.253 P=0.145 P=0.500N | |INCIDENTAL TUMOR | P=0.027 * P=0.250N P=0.450 P=0.152 | P=0.361N P=0.218 P=0.158 P=0.500N | |LOGISTIC REGRESSION | P=0.023 * P=0.260N P=0.497 P=0.171 | P=0.381N P=0.253 P=0.139 P=0.500N | |COCHRAN-ARMITAGE | P=0.009 ** | P=0.379N | |FISHER EXACT | P=0.150N P=0.525 P=0.068 | P=0.276 P=0.140 P=0.513N | |=================================================================================================================================| DATE: 09/04/94 EXPERIMENT: 05021 TEST: 04 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23 TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/49 (27%) 8/50 (16%) 14/50 (28%) 21/49 (43%) | 5/49 (10%) 8/49 (16%) 10/50 (20%) 4/48 (8%) | |ADJUSTED (b) | 35.1% 31.2% 43.3% 50.4% | 14.3% 22.5% 24.7% 11.4% | |TERMINAL (d) | 7/29 (24%) 3/17 (18%) 10/27 (37%) 10/30 (33%) | 5/35 (14%) 7/34 (21%) 7/36 (19%) 4/35 (11%) | |FIRST INCIDENCE (DAYS) | 518 422 529 571 | 723 (T) 613 521 723 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.071 P=0.501N P=0.428 P=0.135 | P=0.359N P=0.253 P=0.145 P=0.500N | |INCIDENTAL TUMOR | P=0.027 * P=0.250N P=0.450 P=0.152 | P=0.361N P=0.218 P=0.158 P=0.500N | |LOGISTIC REGRESSION | P=0.023 * P=0.260N P=0.497 P=0.171 | P=0.381N P=0.253 P=0.139 P=0.500N | |COCHRAN-ARMITAGE | P=0.009 ** | P=0.379N | |FISHER EXACT | P=0.150N P=0.525 P=0.068 | P=0.276 P=0.140 P=0.513N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/49 (8%) 6/49 (12%) 6/50 (12%) 3/50 (6%) | 1/50 (2%) 1/50 (2%) 2/49 (4%) 4/49 (8%) | |ADJUSTED (b) | 12.3% 25.5% 17.8% 10.0% | 2.2% 2.9% 5.4% 10.6% | |TERMINAL (d) | 3/29 (10%) 2/16 (13%) 2/27 (7%) 3/30 (10%) | 0/35 (0%) 1/34 (3%) 1/35 (3%) 3/35 (9%) | |FIRST INCIDENCE (DAYS) | 455 598 618 723 (T) | 616 723 (T) 721 588 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.247N P=0.144 P=0.338 P=0.481N | P=0.071 P=0.747 P=0.507 P=0.175 | |INCIDENTAL TUMOR | P=0.254N P=0.259 P=0.381 P=0.563N | P=0.084 P=0.667 P=0.406 P=0.196 | |LOGISTIC REGRESSION | P=0.266N P=0.256 P=0.372 P=0.470N | P=0.066 P=0.761N P=0.496 P=0.184 | |COCHRAN-ARMITAGE | P=0.330N | P=0.065 | |FISHER EXACT | P=0.370 P=0.383 P=0.489N | P=0.753N P=0.492 P=0.175 | |=================================================================================================================================| DATE: 09/04/94 EXPERIMENT: 05021 TEST: 04 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23 TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 1/49 (2%) 2/50 (4%) 4/50 (8%) | 0/50 (0%) 1/50 (2%) 0/49 (0%) 1/49 (2%) | |ADJUSTED (b) | 6.9% 4.3% 7.4% 12.4% | 0.0% 2.4% 0.0% 2.9% | |TERMINAL (d) | 2/29 (7%) 0/16 (0%) 2/27 (7%) 3/30 (10%) | 0/35 (0%) 0/34 (0%) 0/35 (0%) 1/35 (3%) | |FIRST INCIDENCE (DAYS) | 723 (T) 721 723 (T) 672 | --- 619 --- 723 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.230 P=0.665N P=0.670 P=0.359 | P=0.424 P=0.490 (e) P=0.500 | |INCIDENTAL TUMOR | P=0.253 P=0.550N P=0.670 P=0.409 | P=0.471 P=0.331 (e) P=0.500 | |LOGISTIC REGRESSION | P=0.202 P=0.609N P=0.670 P=0.358 | P=0.419 P=0.541 (e) P=0.500 | |COCHRAN-ARMITAGE | P=0.161 | P=0.420 | |FISHER EXACT | P=0.500N P=0.684N P=0.349 | P=0.500 (e) P=0.495 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/49 (10%) 7/49 (14%) 8/50 (16%) 7/50 (14%) | 1/50 (2%) 2/50 (4%) 2/49 (4%) 5/49 (10%) | |ADJUSTED (b) | 15.6% 28.8% 24.4% 22.2% | 2.2% 5.3% 5.4% 13.4% | |TERMINAL (d) | 4/29 (14%) 2/16 (13%) 4/27 (15%) 6/30 (20%) | 0/35 (0%) 1/34 (3%) 1/35 (3%) 4/35 (11%) | |FIRST INCIDENCE (DAYS) | 455 598 618 672 | 616 619 721 588 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.517 P=0.135 P=0.244 P=0.408 | P=0.053 P=0.480 P=0.507 P=0.102 | |INCIDENTAL TUMOR | P=0.518 P=0.283 P=0.275 P=0.382 | P=0.070 P=0.303 P=0.406 P=0.114 | |LOGISTIC REGRESSION | P=0.483 P=0.239 P=0.273 P=0.427 | P=0.048 * P=0.529 P=0.496 P=0.102 | |COCHRAN-ARMITAGE | P=0.374 | P=0.048 * | |FISHER EXACT | P=0.380 P=0.290 P=0.394 | P=0.500 P=0.492 P=0.098 | |=================================================================================================================================| DATE: 09/04/94 EXPERIMENT: 05021 TEST: 04 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23 TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Ovary | | Granulosa Cell Tumor, Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 2/47 (4%) 0/20 (0%) 0/28 (0%) 0/48 (0%) | |ADJUSTED (b) | | 5.2% 0.0% 0.0% 0.0% | |TERMINAL (d) | | 1/35 (3%) 0/5 (0%) 0/14 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | | 655 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.136N P=0.429N P=0.336N P=0.257N | |INCIDENTAL TUMOR | | P=0.134N P=0.388N P=0.291N P=0.268N | |LOGISTIC REGRESSION | | P=0.129N P=0.494N P=0.358N P=0.230N | |COCHRAN-ARMITAGE | | P=0.127N | |FISHER EXACT | | P=0.489N P=0.390N P=0.242N | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/41 (0%) 0/29 (0%) 0/22 (0%) 2/48 (4%) | 16/50 (32%) 7/23 (30%) 6/16 (38%) 11/47 (23%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 6.7% | 41.6% 87.5% 100.0% 32.0% | |TERMINAL (d) | 0/25 (0%) 0/0 0/0 2/30 (7%) | 13/35 (37%) 7/8 (88%) 2/2 (100%) 10/33 (30%) | |FIRST INCIDENCE (DAYS) | --- --- --- 723 (T) | 634 723 (T) 707 633 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.172 (e) (e) P=0.279 | P=0.160N P=0.197 P=0.232 P=0.239N | |INCIDENTAL TUMOR | P=0.172 (e) (e) P=0.279 | P=0.180N P=0.154 P=0.136 P=0.252N | |LOGISTIC REGRESSION | P=0.172 (e) (e) P=0.279 | P=0.196N P=0.257 P=0.061 P=0.278N | |COCHRAN-ARMITAGE | P=0.081 | P=0.208N | |FISHER EXACT | (e) (e) P=0.288 | P=0.559N P=0.453 P=0.237N | |=================================================================================================================================| DATE: 09/04/94 EXPERIMENT: 05021 TEST: 04 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23 TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/41 (0%) 0/29 (0%) 0/22 (0%) 0/48 (0%) | 2/50 (4%) 0/23 (0%) 1/16 (6%) 2/47 (4%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 5.5% 0.0% 2.4% 6.1% | |TERMINAL (d) | 0/25 (0%) 0/0 0/0 0/30 (0%) | 1/35 (3%) 0/8 (0%) 0/2 (0%) 2/33 (6%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 694 --- 661 723 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.480 P=0.385N P=0.712N P=0.673 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.434 P=0.408N P=0.733N P=0.628 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.477 P=0.504N P=0.577 P=0.656 | |COCHRAN-ARMITAGE | (e) | P=0.475 | |FISHER EXACT | (e) (e) (e) | P=0.466N P=0.572 P=0.668 | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/41 (0%) 0/29 (0%) 0/22 (0%) 2/48 (4%) | 18/50 (36%) 7/23 (30%) 7/16 (44%) 13/47 (28%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 6.7% | 45.8% 87.5% 100.0% 38.0% | |TERMINAL (d) | 0/25 (0%) 0/0 0/0 2/30 (7%) | 14/35 (40%) 7/8 (88%) 2/2 (100%) 12/33 (36%) | |FIRST INCIDENCE (DAYS) | --- --- --- 723 (T) | 634 723 (T) 661 633 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.172 (e) (e) P=0.279 | P=0.201N P=0.348 P=0.271 P=0.256N | |INCIDENTAL TUMOR | P=0.172 (e) (e) P=0.279 | P=0.235N P=0.283 P=0.146 P=0.286N | |LOGISTIC REGRESSION | P=0.172 (e) (e) P=0.279 | P=0.243N P=0.370 P=0.041 * P=0.302N | |COCHRAN-ARMITAGE | P=0.081 | P=0.256N | |FISHER EXACT | (e) (e) P=0.288 | P=0.425N P=0.393 P=0.254N | |=================================================================================================================================| DATE: 09/04/94 EXPERIMENT: 05021 TEST: 04 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23 TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Skin | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 1/50 (2%) 2/50 (4%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |ADJUSTED (b) | 13.8% 5.9% 6.2% 6.7% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 4/29 (14%) 1/17 (6%) 1/27 (4%) 2/30 (7%) | 0/35 (0%) 0/34 (0%) 0/36 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 723 (T) 723 (T) 603 723 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.289N P=0.368N P=0.370N P=0.319N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.296N P=0.368N P=0.365N P=0.319N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.314N P=0.368N P=0.354N P=0.319N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.367N | (e) | |FISHER EXACT | P=0.181N P=0.339N P=0.339N | (e) (e) (e) | |=================================================================================================================================| | | |Skin | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 5/50 (10%) 5/50 (10%) 5/50 (10%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | |ADJUSTED (b) | 15.9% 21.7% 14.7% 13.7% | 2.3% 0.0% 0.0% 2.4% | |TERMINAL (d) | 3/29 (10%) 2/17 (12%) 1/27 (4%) 2/30 (7%) | 0/35 (0%) 0/34 (0%) 0/36 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 687 515 603 542 | 618 --- --- 627 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.442N P=0.370 P=0.595 P=0.604N | P=0.571 P=0.514N P=0.500N P=0.750 | |INCIDENTAL TUMOR | P=0.456N P=0.635N P=0.560N P=0.533N | P=0.637 P=0.669N P=0.669N P=0.738N | |LOGISTIC REGRESSION | P=0.488N P=0.482 P=0.612 P=0.606N | P=0.560 P=0.459N P=0.449N P=0.721N | |COCHRAN-ARMITAGE | P=0.562 | P=0.571 | |FISHER EXACT | P=0.630N P=0.630N P=0.630N | P=0.500N P=0.500N P=0.747 | |=================================================================================================================================| DATE: 09/04/94 EXPERIMENT: 05021 TEST: 04 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23 TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Skin | | Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 7/50 (14%) 5/50 (10%) 6/50 (12%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/49 (2%) | |ADJUSTED (b) | 12.5% 22.7% 16.0% 18.6% | 0.0% 4.5% 0.0% 2.5% | |TERMINAL (d) | 0/29 (0%) 0/17 (0%) 2/27 (7%) 5/30 (17%) | 0/35 (0%) 0/34 (0%) 0/36 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 463 472 647 603 | --- 420 --- 633 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.459N P=0.213 P=0.595 P=0.530 | P=0.564 P=0.230 (e) P=0.486 | |INCIDENTAL TUMOR | P=0.514N P=0.489 P=0.577N P=0.493 | P=0.537 P=0.371 (e) P=0.527 | |LOGISTIC REGRESSION | P=0.539N P=0.243 P=0.625 P=0.497 | P=0.538 P=0.336 (e) P=0.539 | |COCHRAN-ARMITAGE | P=0.529 | P=0.572 | |FISHER EXACT | P=0.380 P=0.630N P=0.500 | P=0.247 (e) P=0.495 | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 1/31 (3%) 1/26 (4%) 0/47 (0%) | 0/50 (0%) 0/21 (0%) 2/25 (8%) 0/48 (0%) | |ADJUSTED (b) | 3.4% 0.0% 2.5% 0.0% | 0.0% 0.0% 11.0% 0.0% | |TERMINAL (d) | 1/29 (3%) 0/0 0/3 (0%) 0/30 (0%) | 0/35 (0%) 0/6 (0%) 1/11 (9%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 723 (T) 598 590 --- | --- --- 516 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.270N P=0.446 P=0.556 P=0.493N | P=0.603 (e) P=0.122 (e) | |INCIDENTAL TUMOR | P=0.309N P=0.433 P=0.564 P=0.493N | P=0.582 (e) P=0.215 (e) | |LOGISTIC REGRESSION | P=0.296N P=0.573 P=0.579 P=0.493N | P=0.587 (e) P=0.173 (e) | |COCHRAN-ARMITAGE | P=0.312N | P=0.598 | |FISHER EXACT | P=0.628 P=0.576 P=0.510N | (e) P=0.108 (e) | |=================================================================================================================================| DATE: 09/04/94 EXPERIMENT: 05021 TEST: 04 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23 TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 2/30 (7%) 0/23 (0%) 2/50 (4%) | 2/50 (4%) 1/15 (7%) 1/14 (7%) 3/49 (6%) | |ADJUSTED (b) | 6.7% 0.0% 0.0% 5.4% | 5.7% 100.0% 0.0% 7.9% | |TERMINAL (d) | 1/29 (3%) 0/0 0/0 0/30 (0%) | 2/35 (6%) 1/1 (100%) 0/0 2/35 (6%) | |FIRST INCIDENCE (DAYS) | 722 721 --- 672 | 723 (T) 723 (T) 707 588 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.463N P=0.377 P=0.521N P=0.669N | P=0.458 P=0.066 P=0.521 P=0.494 | |INCIDENTAL TUMOR | P=0.368N P=0.721N P=0.406N P=0.469N | P=0.458 P=0.066 P=0.500 P=0.512 | |LOGISTIC REGRESSION | P=0.423N P=0.131 P=0.841N P=0.671N | P=0.437 P=0.066 P=0.335 P=0.484 | |COCHRAN-ARMITAGE | P=0.494N | P=0.423 | |FISHER EXACT | P=0.491 P=0.460N P=0.684N | P=0.551 P=0.530 P=0.490 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/49 (6%) 2/30 (7%) 1/23 (4%) 3/50 (6%) | 2/50 (4%) 1/15 (7%) 1/14 (7%) 3/49 (6%) | |ADJUSTED (b) | 10.0% 0.0% 0.0% 7.8% | 5.7% 100.0% 0.0% 7.9% | |TERMINAL (d) | 2/29 (7%) 0/0 0/0 0/30 (0%) | 2/35 (6%) 1/1 (100%) 0/0 2/35 (6%) | |FIRST INCIDENCE (DAYS) | 722 721 452 648 | 723 (T) 723 (T) 707 588 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.496N P=0.377 P=0.746 P=0.622N | P=0.458 P=0.066 P=0.521 P=0.494 | |INCIDENTAL TUMOR | P=0.467N P=0.721N P=0.759N P=0.403N | P=0.458 P=0.066 P=0.500 P=0.512 | |LOGISTIC REGRESSION | P=0.482N P=0.207 P=0.687N P=0.633N | P=0.437 P=0.066 P=0.335 P=0.484 | |COCHRAN-ARMITAGE | P=0.550N | P=0.423 | |FISHER EXACT | P=0.633 P=0.618N P=0.651N | P=0.551 P=0.530 P=0.490 | |=================================================================================================================================| DATE: 09/04/94 EXPERIMENT: 05021 TEST: 04 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23 TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 1/50 (2%) 4/50 (8%) 0/50 (0%) 4/49 (8%) | |ADJUSTED (b) | | 2.9% 11.8% 0.0% 11.4% | |TERMINAL (d) | | 1/35 (3%) 4/34 (12%) 0/36 (0%) 4/35 (11%) | |FIRST INCIDENCE (DAYS) | | 723 (T) 723 (T) --- 723 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.260 P=0.170 P=0.494N P=0.178 | |INCIDENTAL TUMOR | | P=0.260 P=0.170 P=0.494N P=0.178 | |LOGISTIC REGRESSION | | P=0.260 P=0.170 P=0.494N P=0.178 | |COCHRAN-ARMITAGE | | P=0.247 | |FISHER EXACT | | P=0.181 P=0.500N P=0.175 | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 4/50 (8%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 4/50 (8%) 2/49 (4%) | |ADJUSTED (b) | 5.9% 3.1% 11.2% 0.0% | 0.0% 4.5% 9.4% 5.7% | |TERMINAL (d) | 1/29 (3%) 0/17 (0%) 1/27 (4%) 0/30 (0%) | 0/35 (0%) 0/34 (0%) 2/36 (6%) 2/35 (6%) | |FIRST INCIDENCE (DAYS) | 618 598 590 --- | --- 516 472 723 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.246N P=0.628N P=0.317 P=0.231N | P=0.242 P=0.216 P=0.067 P=0.238 | |INCIDENTAL TUMOR | P=0.263N P=0.641N P=0.346 P=0.253N | P=0.181 P=0.267 P=0.150 P=0.238 | |LOGISTIC REGRESSION | P=0.199N P=0.540N P=0.334 P=0.234N | P=0.206 P=0.327 P=0.086 P=0.238 | |COCHRAN-ARMITAGE | P=0.296N | P=0.229 | |FISHER EXACT | P=0.500N P=0.339 P=0.247N | P=0.247 P=0.059 P=0.242 | |=================================================================================================================================| DATE: 09/04/94 EXPERIMENT: 05021 TEST: 04 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23 TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 4/50 (8%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 4/50 (8%) 2/49 (4%) | |ADJUSTED (b) | 5.9% 3.1% 11.2% 0.0% | 0.0% 4.5% 9.4% 5.7% | |TERMINAL (d) | 1/29 (3%) 0/17 (0%) 1/27 (4%) 0/30 (0%) | 0/35 (0%) 0/34 (0%) 2/36 (6%) 2/35 (6%) | |FIRST INCIDENCE (DAYS) | 618 598 590 --- | --- 516 472 723 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.246N P=0.628N P=0.317 P=0.231N | P=0.242 P=0.216 P=0.067 P=0.238 | |INCIDENTAL TUMOR | P=0.263N P=0.641N P=0.346 P=0.253N | P=0.181 P=0.267 P=0.150 P=0.238 | |LOGISTIC REGRESSION | P=0.199N P=0.540N P=0.334 P=0.234N | P=0.206 P=0.327 P=0.086 P=0.238 | |COCHRAN-ARMITAGE | P=0.296N | P=0.229 | |FISHER EXACT | P=0.500N P=0.339 P=0.247N | P=0.247 P=0.059 P=0.242 | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 2/50 (4%) 0/50 (0%) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 1/49 (2%) | |ADJUSTED (b) | 0.0% 11.1% 5.3% 0.0% | 4.8% 2.9% 2.2% 2.1% | |TERMINAL (d) | 0/29 (0%) 1/17 (6%) 0/27 (0%) 0/30 (0%) | 0/35 (0%) 1/34 (3%) 0/36 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | --- 436 452 --- | 634 723 (T) 585 515 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.332N P=0.071 P=0.231 (e) | P=0.427N P=0.515N P=0.502N P=0.526N | |INCIDENTAL TUMOR | P=0.542N P=0.116 P=0.224 (e) | P=0.421N P=0.615N P=0.694N P=0.548N | |LOGISTIC REGRESSION | P=0.411N P=0.130 P=0.247 (e) | P=0.439N P=0.499N P=0.436N P=0.394N | |COCHRAN-ARMITAGE | P=0.370N | P=0.423N | |FISHER EXACT | P=0.121 P=0.247 (e) | P=0.500N P=0.500N P=0.508N | |=================================================================================================================================| DATE: 09/04/94 EXPERIMENT: 05021 TEST: 04 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23 TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma And Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 3/50 (6%) 3/50 (6%) 6/50 (12%) | 8/50 (16%) 10/50 (20%) 10/50 (20%) 10/49 (20%) | |ADJUSTED (b) | 5.9% 11.1% 8.0% 16.1% | 20.0% 26.9% 25.0% 24.6% | |TERMINAL (d) | 1/29 (3%) 1/17 (6%) 0/27 (0%) 2/30 (7%) | 4/35 (11%) 7/34 (21%) 7/36 (19%) 6/35 (17%) | |FIRST INCIDENCE (DAYS) | 644 436 452 606 | 634 683 585 515 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.140 P=0.339 P=0.469 P=0.158 | P=0.388 P=0.383 P=0.426 P=0.376 | |INCIDENTAL TUMOR | P=0.058 P=0.426 P=0.483 P=0.165 | P=0.345 P=0.293 P=0.295 P=0.312 | |LOGISTIC REGRESSION | P=0.081 P=0.491 P=0.505 P=0.140 | P=0.367 P=0.254 P=0.396 P=0.400 | |COCHRAN-ARMITAGE | P=0.081 | P=0.367 | |FISHER EXACT | P=0.500 P=0.500 P=0.134 | P=0.398 P=0.398 P=0.379 | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 6/50 (12%) | 6/50 (12%) 9/50 (18%) 9/50 (18%) 9/49 (18%) | |ADJUSTED (b) | 5.9% 0.0% 2.8% 16.1% | 16.0% 24.2% 23.3% 23.0% | |TERMINAL (d) | 1/29 (3%) 0/17 (0%) 0/27 (0%) 2/30 (7%) | 4/35 (11%) 6/34 (18%) 7/36 (19%) 6/35 (17%) | |FIRST INCIDENCE (DAYS) | 644 --- 622 606 | 661 683 606 583 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.030 * P=0.334N P=0.530N P=0.158 | P=0.307 P=0.281 P=0.316 P=0.278 | |INCIDENTAL TUMOR | P=0.022 * P=0.339N P=0.508N P=0.165 | P=0.263 P=0.233 P=0.265 P=0.226 | |LOGISTIC REGRESSION | P=0.019 * P=0.283N P=0.505N P=0.140 | P=0.280 P=0.248 P=0.291 P=0.263 | |COCHRAN-ARMITAGE | P=0.014 * | P=0.285 | |FISHER EXACT | P=0.247N P=0.500N P=0.134 | P=0.288 P=0.288 P=0.274 | |=================================================================================================================================| DATE: 09/04/94 EXPERIMENT: 05021 TEST: 04 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23 TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 17/50 (34%) 13/50 (26%) 12/50 (24%) 20/50 (40%) | 19/50 (38%) 19/50 (38%) 17/50 (34%) 18/49 (37%) | |ADJUSTED (b) | 50.6% 48.0% 36.0% 58.0% | 48.1% 52.5% 40.2% 47.0% | |TERMINAL (d) | 13/29 (45%) 4/17 (24%) 7/27 (26%) 16/30 (53%) | 15/35 (43%) 17/34 (50%) 11/36 (31%) 15/35 (43%) | |FIRST INCIDENCE (DAYS) | 455 422 603 638 | 616 613 585 588 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.456 P=0.383 P=0.260N P=0.406 | P=0.421N P=0.530 P=0.382N P=0.524N | |INCIDENTAL TUMOR | P=0.431 P=0.435N P=0.207N P=0.440 | P=0.423N P=0.424 P=0.520N P=0.546N | |LOGISTIC REGRESSION | P=0.371 P=0.530N P=0.213N P=0.411 | P=0.472N P=0.488 P=0.415N P=0.584N | |COCHRAN-ARMITAGE | P=0.208 | P=0.459N | |FISHER EXACT | P=0.257N P=0.189N P=0.339 | P=0.582N P=0.418N P=0.531N | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 27/50 (54%) 22/50 (44%) 28/50 (56%) 31/50 (62%) | 14/50 (28%) 20/50 (40%) 21/50 (42%) 18/49 (37%) | |ADJUSTED (b) | 62.4% 64.3% 65.0% 67.1% | 33.6% 45.2% 44.6% 41.1% | |TERMINAL (d) | 13/29 (45%) 6/17 (35%) 12/27 (44%) 15/30 (50%) | 8/35 (23%) 10/34 (29%) 11/36 (31%) 10/35 (29%) | |FIRST INCIDENCE (DAYS) | 463 436 452 542 | 618 420 452 515 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.459 P=0.312 P=0.405 P=0.418 | P=0.329 P=0.151 P=0.152 P=0.253 | |INCIDENTAL TUMOR | P=0.243 P=0.329N P=0.515 P=0.451 | P=0.225 P=0.068 P=0.139 P=0.183 | |LOGISTIC REGRESSION | P=0.403 P=0.549 P=0.512 P=0.517 | P=0.315 P=0.135 P=0.103 P=0.261 | |COCHRAN-ARMITAGE | P=0.110 | P=0.287 | |FISHER EXACT | P=0.212N P=0.500 P=0.272 | P=0.146 P=0.104 P=0.238 | |=================================================================================================================================| DATE: 09/04/94 EXPERIMENT: 05021 TEST: 04 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 23 TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 35/50 (70%) 27/50 (54%) 33/50 (66%) 41/50 (82%) | 27/50 (54%) 31/50 (62%) 31/50 (62%) 32/49 (65%) | |ADJUSTED (b) | 79.3% 74.2% 76.7% 89.0% | 61.1% 70.3% 62.0% 72.4% | |TERMINAL (d) | 20/29 (69%) 8/17 (47%) 17/27 (63%) 25/30 (83%) | 18/35 (51%) 21/34 (62%) 17/36 (47%) 23/35 (66%) | |FIRST INCIDENCE (DAYS) | 455 422 452 542 | 616 420 452 515 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.373 P=0.324 P=0.558 P=0.316 | P=0.265 P=0.253 P=0.363 P=0.216 | |INCIDENTAL TUMOR | P=0.110 P=0.202N P=0.449N P=0.241 | P=0.143 P=0.122 P=0.296 P=0.129 | |LOGISTIC REGRESSION | P=0.156 P=0.448N P=0.455N P=0.185 | P=0.181 P=0.179 P=0.273 P=0.155 | |COCHRAN-ARMITAGE | P=0.025 * | P=0.179 | |FISHER EXACT | P=0.074N P=0.415N P=0.121 | P=0.272 P=0.272 P=0.173 | |=================================================================================================================================| (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).