TDMS Study 05155-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst P-NITROBENZOIC ACID DATE: 05/08/95 EXPERIMENT: 05155 TEST: 04 TIME: 19:27:42 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-85217 ROUTE: DOSED FEED NTP C#: 61778B PATHOLOGIST: DR R. THOMPSON HAILEY, JAMESR. CAS: 62-23-7 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst P-NITROBENZOIC ACID DATE: 05/08/95 EXPERIMENT: 05155 TEST: 04 TIME: 19:27:42 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-85217 ROUTE: DOSED FEED NTP C#: 61778B PATHOLOGIST: DR R. THOMPSON HAILEY, JAMESR. CAS: 62-23-7 MICE(B6C3F1) ---------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED. ---------------- Adrenal Cortex Adrenal Medulla Bone Marrow Brain Clitoral Gland Epididymis Gallbladder Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst P-NITROBENZOIC ACID DATE: 05/08/95 EXPERIMENT: 05155 TEST: 04 TIME: 19:27:42 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-85217 ROUTE: DOSED FEED NTP C#: 61778B PATHOLOGIST: DR R. THOMPSON HAILEY, JAMESR. CAS: 62-23-7 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF P-NITROBENZOIC ACID ==================================================================================================== MALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Intestine Small: Jejunum Carcinoma Intestine Small: Site Unspecified Carcinoma Lung Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma All Organs Hemangiosarcoma Hemangiosarcoma or Hemangioma Benign Tumors ==================================================================================================== FEMALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Harderian Gland Adenoma Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma ==================================================================================================== DATE: 05/08/95 EXPERIMENT: 05155 TEST: 04 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROBENZOIC ACID TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Bone Marrow | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) | 1/60 (2%) 1/59 (2%) 2/58 (3%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 2.6% 2.5% 4.7% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | |TERMINAL (d) | 0/39 (0%) 0/36 (0%) 0/39 (0%) 0/44 (0%) | 1/38 (3%) 0/36 (0%) 1/33 (3%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 730 (T) 685 457 (I) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.416N P=0.746 P=0.467 P=0.547N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.382N P=0.730N P=0.467 P=0.547N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.368N P=0.756 P=0.492 P=0.547N | |COCHRAN-ARMITAGE | (e) | P=0.367N | |FISHER EXACT | (e) (e) (e) | P=0.748 P=0.487 P=0.500N | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 3/60 (5%) 3/60 (5%) 1/60 (2%) | 3/60 (5%) 1/59 (2%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 2.3% 7.6% 6.6% 2.3% | 7.2% 2.8% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/39 (0%) 1/36 (3%) 0/39 (0%) 1/44 (2%) | 0/38 (0%) 1/36 (3%) 0/33 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | 720 681 638 729 (T) | 639 730 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.473N P=0.284 P=0.303 P=0.744N | P=0.061N P=0.334N P=0.149N P=0.171N | |INCIDENTAL TUMOR | P=0.349 P=0.362 P=0.313 P=0.602 | P=0.024N* P=0.227N P=0.041N* P=0.045N* | |LOGISTIC REGRESSION | P=0.538 P=0.294 P=0.394 P=0.762N | P=0.050N* P=0.315N P=0.125N P=0.138N | |COCHRAN-ARMITAGE | P=0.500N | P=0.044N* | |FISHER EXACT | P=0.309 P=0.309 P=0.752N | P=0.316N P=0.122N P=0.122N | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 05155 TEST: 04 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROBENZOIC ACID TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Intestine Small: Jejunum | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 1/60 (2%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 0/59 (0%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 7.4% 2.8% 0.0% 0.0% | 0.0% 0.0% 3.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/39 (5%) 1/36 (3%) 0/39 (0%) 0/44 (0%) | 0/38 (0%) 0/36 (0%) 1/33 (3%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | 728 729 (T) --- --- | --- --- 730 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.039N* P=0.338N P=0.126N P=0.105N | P=0.666 (e) P=0.472 (e) | |INCIDENTAL TUMOR | P=0.050N* P=0.305N P=0.132N P=0.188N | P=0.666 (e) P=0.472 (e) | |LOGISTIC REGRESSION | P=0.042N* P=0.336N P=0.131N P=0.113N | P=0.666 (e) P=0.472 (e) | |COCHRAN-ARMITAGE | P=0.044N* | P=0.695 | |FISHER EXACT | P=0.309N P=0.122N P=0.122N | (e) P=0.500 (e) | |=================================================================================================================================| | | |Intestine Small: Site Unspecified | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 1/60 (2%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 0/59 (0%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 7.4% 2.8% 0.0% 0.0% | 0.0% 0.0% 3.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/39 (5%) 1/36 (3%) 0/39 (0%) 0/44 (0%) | 0/38 (0%) 0/36 (0%) 1/33 (3%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | 728 729 (T) --- --- | --- --- 730 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.039N* P=0.338N P=0.126N P=0.105N | P=0.666 (e) P=0.472 (e) | |INCIDENTAL TUMOR | P=0.050N* P=0.305N P=0.132N P=0.188N | P=0.666 (e) P=0.472 (e) | |LOGISTIC REGRESSION | P=0.042N* P=0.336N P=0.131N P=0.113N | P=0.666 (e) P=0.472 (e) | |COCHRAN-ARMITAGE | P=0.044N* | P=0.695 | |FISHER EXACT | P=0.309N P=0.122N P=0.122N | (e) P=0.500 (e) | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 05155 TEST: 04 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROBENZOIC ACID TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 19/60 (32%) 19/60 (32%) 14/60 (23%) 14/58 (24%) | 11/60 (18%) 15/59 (25%) 17/60 (28%) 6/60 (10%) | |ADJUSTED (b) | 38.6% 43.2% 31.5% 31.1% | 27.2% 34.3% 38.4% 17.1% | |INTERIM SACRIFICE 1 (c)| 2/10 (20%) 2/10 (20%) 2/10 (20%) 0/10 (0%) | 0/10 (0%) 2/10 (20%) 4/10 (40%) 1/10 (10%) | |TERMINAL (d) | 10/39 (26%) 13/36 (36%) 10/39 (26%) 13/44 (30%) | 9/38 (24%) 9/36 (25%) 9/33 (27%) 4/30 (13%) | |FIRST INCIDENCE (DAYS) | 456 (I) 442 456 (I) 667 | 589 457 (I) 457 (I) 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.078N P=0.496 P=0.230N P=0.150N | P=0.236N P=0.219 P=0.089 P=0.282N | |INCIDENTAL TUMOR | P=0.202N P=0.546 P=0.217N P=0.446N | P=0.121N P=0.286 P=0.137 P=0.179N | |LOGISTIC REGRESSION | P=0.208N P=0.561N P=0.181N P=0.389N | P=0.123N P=0.231 P=0.133 P=0.202N | |COCHRAN-ARMITAGE | P=0.156N | P=0.099N | |FISHER EXACT | P=0.578N P=0.207N P=0.240N | P=0.238 P=0.140 P=0.148N | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/60 (13%) 15/60 (25%) 16/60 (27%) 8/58 (14%) | 5/60 (8%) 5/59 (8%) 5/60 (8%) 7/60 (12%) | |ADJUSTED (b) | 19.1% 32.0% 35.7% 17.4% | 11.4% 13.0% 15.2% 21.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 2/10 (20%) 0/10 (0%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 6/39 (15%) 6/36 (17%) 11/39 (28%) 6/44 (14%) | 3/38 (8%) 3/36 (8%) 5/33 (15%) 5/30 (17%) | |FIRST INCIDENCE (DAYS) | 597 456 (I) 496 582 | 457 (I) 685 730 (T) 616 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.313N P=0.074 P=0.060 P=0.531N | P=0.179 P=0.596 P=0.556 P=0.262 | |INCIDENTAL TUMOR | P=0.476 P=0.119 P=0.063 P=0.527 | P=0.248 P=0.625 P=0.531 P=0.354 | |LOGISTIC REGRESSION | P=0.466 P=0.085 P=0.057 P=0.421 | P=0.239 P=0.619 P=0.620 P=0.339 | |COCHRAN-ARMITAGE | P=0.440N | P=0.302 | |FISHER EXACT | P=0.082 P=0.054 P=0.577 | P=0.618 P=0.628N P=0.381 | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 05155 TEST: 04 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROBENZOIC ACID TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 24/60 (40%) 30/60 (50%) 25/60 (42%) 19/58 (33%) | 16/60 (27%) 18/59 (31%) 19/60 (32%) 12/60 (20%) | |ADJUSTED (b) | 49.2% 58.9% 52.3% 41.3% | 37.2% 40.8% 43.6% 33.5% | |INTERIM SACRIFICE 1 (c)| 2/10 (20%) 4/10 (40%) 2/10 (20%) 0/10 (0%) | 1/10 (10%) 2/10 (20%) 4/10 (40%) 1/10 (10%) | |TERMINAL (d) | 15/39 (38%) 16/36 (44%) 17/39 (44%) 17/44 (39%) | 12/38 (32%) 11/36 (31%) 11/33 (33%) 8/30 (27%) | |FIRST INCIDENCE (DAYS) | 456 (I) 442 456 (I) 582 | 457 (I) 457 (I) 457 (I) 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.055N P=0.150 P=0.492 P=0.144N | P=0.424N P=0.364 P=0.230 P=0.483N | |INCIDENTAL TUMOR | P=0.230N P=0.181 P=0.510 P=0.404N | P=0.236N P=0.443 P=0.297 P=0.305N | |LOGISTIC REGRESSION | P=0.232N P=0.189 P=0.553 P=0.445N | P=0.243N P=0.393 P=0.332 P=0.339N | |COCHRAN-ARMITAGE | P=0.129N | P=0.190N | |FISHER EXACT | P=0.179 P=0.500 P=0.266N | P=0.397 P=0.344 P=0.259N | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 24/60 (40%) 30/60 (50%) 25/60 (42%) 19/58 (33%) | 16/60 (27%) 18/59 (31%) 19/60 (32%) 12/60 (20%) | |ADJUSTED (b) | 49.2% 58.9% 52.3% 41.3% | 37.2% 40.8% 43.6% 33.5% | |INTERIM SACRIFICE 1 (c)| 2/10 (20%) 4/10 (40%) 2/10 (20%) 0/10 (0%) | 1/10 (10%) 2/10 (20%) 4/10 (40%) 1/10 (10%) | |TERMINAL (d) | 15/39 (38%) 16/36 (44%) 17/39 (44%) 17/44 (39%) | 12/38 (32%) 11/36 (31%) 11/33 (33%) 8/30 (27%) | |FIRST INCIDENCE (DAYS) | 456 (I) 442 456 (I) 582 | 457 (I) 457 (I) 457 (I) 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.055N P=0.150 P=0.492 P=0.144N | P=0.424N P=0.364 P=0.230 P=0.483N | |INCIDENTAL TUMOR | P=0.230N P=0.181 P=0.510 P=0.404N | P=0.236N P=0.443 P=0.297 P=0.305N | |LOGISTIC REGRESSION | P=0.232N P=0.189 P=0.553 P=0.445N | P=0.243N P=0.393 P=0.332 P=0.339N | |COCHRAN-ARMITAGE | P=0.129N | P=0.190N | |FISHER EXACT | P=0.179 P=0.500 P=0.266N | P=0.397 P=0.344 P=0.259N | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 05155 TEST: 04 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROBENZOIC ACID TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/60 (10%) 13/60 (22%) 10/60 (17%) 10/60 (17%) | 3/60 (5%) 5/59 (8%) 3/60 (5%) 8/60 (13%) | |ADJUSTED (b) | 15.4% 30.4% 23.2% 21.9% | 7.5% 12.9% 8.7% 24.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 2/10 (20%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 6/39 (15%) 8/36 (22%) 8/39 (21%) 9/44 (20%) | 2/38 (5%) 3/36 (8%) 2/33 (6%) 6/30 (20%) | |FIRST INCIDENCE (DAYS) | 729 (T) 456 (I) 456 (I) 456 (I) | 689 685 715 570 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.451 P=0.052 P=0.207 P=0.283 | P=0.035 * P=0.324 P=0.599 P=0.050 * | |INCIDENTAL TUMOR | P=0.364 P=0.062 P=0.207 P=0.283 | P=0.060 P=0.406 P=0.619N P=0.088 | |LOGISTIC REGRESSION | P=0.306 P=0.059 P=0.204 P=0.194 | P=0.046 * P=0.336 P=0.637 P=0.064 | |COCHRAN-ARMITAGE | P=0.329 | P=0.080 | |FISHER EXACT | P=0.066 P=0.211 P=0.211 | P=0.349 P=0.660N P=0.102 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 3/60 (5%) 2/60 (3%) 5/60 (8%) | 0/60 (0%) 5/59 (8%) 1/60 (2%) 1/60 (2%) | |ADJUSTED (b) | 2.6% 8.0% 5.1% 11.4% | 0.0% 13.9% 2.9% 3.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/39 (3%) 2/36 (6%) 2/39 (5%) 5/44 (11%) | 0/38 (0%) 5/36 (14%) 0/33 (0%) 1/30 (3%) | |FIRST INCIDENCE (DAYS) | 729 (T) 725 729 (T) 729 (T) | --- 730 (T) 720 730 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.116 P=0.279 P=0.500 P=0.133 | P=0.572N P=0.029 * P=0.468 P=0.453 | |INCIDENTAL TUMOR | P=0.084 P=0.307 P=0.500 P=0.133 | P=0.541N P=0.029 * P=0.617 P=0.453 | |LOGISTIC REGRESSION | P=0.095 P=0.279 P=0.500 P=0.133 | P=0.568N P=0.029 * P=0.489 P=0.453 | |COCHRAN-ARMITAGE | P=0.079 | P=0.472N | |FISHER EXACT | P=0.309 P=0.500 P=0.103 | P=0.027 * P=0.500 P=0.500 | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 05155 TEST: 04 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROBENZOIC ACID TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/60 (12%) 15/60 (25%) 12/60 (20%) 14/60 (23%) | 3/60 (5%) 10/59 (17%) 4/60 (7%) 9/60 (15%) | |ADJUSTED (b) | 17.9% 35.4% 28.2% 30.8% | 7.5% 26.1% 11.3% 27.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 2/10 (20%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 7/39 (18%) 10/36 (28%) 10/39 (26%) 13/44 (30%) | 2/38 (5%) 8/36 (22%) 2/33 (6%) 7/30 (23%) | |FIRST INCIDENCE (DAYS) | 729 (T) 456 (I) 456 (I) 456 (I) | 689 685 715 570 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.240 P=0.035 * P=0.154 P=0.118 | P=0.063 P=0.031 * P=0.428 P=0.027 * | |INCIDENTAL TUMOR | P=0.177 P=0.043 * P=0.154 P=0.118 | P=0.102 P=0.042 * P=0.592 P=0.050 * | |LOGISTIC REGRESSION | P=0.120 P=0.042 * P=0.150 P=0.064 | P=0.081 P=0.030 * P=0.468 P=0.035 * | |COCHRAN-ARMITAGE | P=0.138 | P=0.149 | |FISHER EXACT | P=0.049 * P=0.159 P=0.074 | P=0.035 * P=0.500 P=0.063 | |=================================================================================================================================| | | |Ovary | | Cystadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 1/60 (2%) 2/58 (3%) 1/59 (2%) 1/58 (2%) | |ADJUSTED (b) | | 2.6% 5.7% 3.0% 2.9% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | | 1/38 (3%) 2/35 (6%) 1/33 (3%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | | 730 (T) 730 (T) 730 (T) 678 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.623 P=0.471 P=0.730 P=0.703 | |INCIDENTAL TUMOR | | P=0.594N P=0.471 P=0.730 P=0.760N | |LOGISTIC REGRESSION | | P=0.601N P=0.471 P=0.730 P=0.726 | |COCHRAN-ARMITAGE | | P=0.539N | |FISHER EXACT | | P=0.487 P=0.748 P=0.744 | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 05155 TEST: 04 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROBENZOIC ACID TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/56 (0%) 0/55 (0%) 0/60 (0%) 1/56 (2%) | 7/58 (12%) 6/58 (10%) 9/58 (16%) 5/58 (9%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 2.3% | 18.3% 16.7% 24.1% 17.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/36 (0%) 0/35 (0%) 0/39 (0%) 1/43 (2%) | 6/37 (16%) 6/36 (17%) 6/33 (18%) 5/28 (18%) | |FIRST INCIDENCE (DAYS) | --- --- --- 729 (T) | 728 730 (T) 589 730 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.225 (e) (e) P=0.535 | P=0.517 P=0.526N P=0.309 P=0.583N | |INCIDENTAL TUMOR | P=0.225 (e) (e) P=0.535 | P=0.516N P=0.509N P=0.437 P=0.545N | |LOGISTIC REGRESSION | P=0.225 (e) (e) P=0.535 | P=0.543N P=0.564N P=0.371 P=0.615N | |COCHRAN-ARMITAGE | P=0.198 | P=0.378N | |FISHER EXACT | (e) (e) P=0.500 | P=0.500N P=0.394 P=0.381N | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/56 (0%) 0/55 (0%) 0/60 (0%) 1/56 (2%) | 8/58 (14%) 6/58 (10%) 9/58 (16%) 5/58 (9%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 2.3% | 20.2% 16.7% 24.1% 17.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/36 (0%) 0/35 (0%) 0/39 (0%) 1/43 (2%) | 6/37 (16%) 6/36 (17%) 6/33 (18%) 5/28 (18%) | |FIRST INCIDENCE (DAYS) | --- --- --- 729 (T) | 689 730 (T) 589 730 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.225 (e) (e) P=0.535 | P=0.504N P=0.418N P=0.406 P=0.474N | |INCIDENTAL TUMOR | P=0.225 (e) (e) P=0.535 | P=0.407N P=0.384N P=0.575 P=0.403N | |LOGISTIC REGRESSION | P=0.225 (e) (e) P=0.535 | P=0.441N P=0.429N P=0.481 P=0.453N | |COCHRAN-ARMITAGE | P=0.198 | P=0.293N | |FISHER EXACT | (e) (e) P=0.500 | P=0.388N P=0.500 P=0.279N | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 05155 TEST: 04 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROBENZOIC ACID TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Skeletal Muscle | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 0/59 (0%) 2/60 (3%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 5.4% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/39 (0%) 0/36 (0%) 0/39 (0%) 0/44 (0%) | 0/38 (0%) 0/36 (0%) 0/33 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- 707 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.547 (e) P=0.214 (e) | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.657 (e) P=0.371 (e) | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.568 (e) P=0.228 (e) | |COCHRAN-ARMITAGE | (e) | P=0.596 | |FISHER EXACT | (e) (e) (e) | (e) P=0.248 (e) | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 1/60 (2%) 1/59 (2%) 2/60 (3%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 2.6% 2.8% 4.6% 2.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/39 (0%) 0/36 (0%) 0/39 (0%) 0/44 (0%) | 1/38 (3%) 1/36 (3%) 0/33 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 730 (T) 730 (T) 629 665 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.531 P=0.750 P=0.481 P=0.714 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.594N P=0.750 P=0.609 P=0.752N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.572 P=0.750 P=0.497 P=0.741 | |COCHRAN-ARMITAGE | (e) | P=0.592 | |FISHER EXACT | (e) (e) (e) | P=0.748 P=0.500 P=0.752N | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 05155 TEST: 04 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROBENZOIC ACID TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 1/60 (2%) 1/59 (2%) 2/60 (3%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 2.6% 2.8% 4.6% 2.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/39 (0%) 0/36 (0%) 0/39 (0%) 0/44 (0%) | 1/38 (3%) 1/36 (3%) 0/33 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 730 (T) 730 (T) 629 665 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.531 P=0.750 P=0.481 P=0.714 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.594N P=0.750 P=0.609 P=0.752N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.572 P=0.750 P=0.497 P=0.741 | |COCHRAN-ARMITAGE | (e) | P=0.592 | |FISHER EXACT | (e) (e) (e) | P=0.748 P=0.500 P=0.752N | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/60 (7%) 1/59 (2%) 1/60 (2%) 1/59 (2%) | 1/60 (2%) 1/59 (2%) 1/59 (2%) 0/60 (0%) | |ADJUSTED (b) | 10.3% 2.8% 2.4% 2.3% | 2.4% 2.5% 2.6% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 4/39 (10%) 1/36 (3%) 0/39 (0%) 1/44 (2%) | 0/38 (0%) 0/36 (0%) 0/33 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 695 729 (T) | 693 685 707 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.113N P=0.204N P=0.185N P=0.145N | P=0.357N P=0.741 P=0.741 P=0.542N | |INCIDENTAL TUMOR | P=0.139N P=0.204N P=0.191N P=0.145N | P=0.236N P=0.692N P=0.629N P=0.433N | |LOGISTIC REGRESSION | P=0.132N P=0.204N P=0.187N P=0.145N | P=0.330N P=0.758 P=0.756 P=0.518N | |COCHRAN-ARMITAGE | P=0.137N | P=0.311N | |FISHER EXACT | P=0.187N P=0.182N P=0.187N | P=0.748 P=0.748 P=0.500N | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 05155 TEST: 04 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROBENZOIC ACID TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | 1/60 (2%) 2/59 (3%) 2/60 (3%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 0.0% 2.6% 0.0% | 2.6% 5.2% 6.1% 3.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/39 (0%) 0/36 (0%) 1/39 (3%) 0/44 (0%) | 1/38 (3%) 1/36 (3%) 2/33 (6%) 1/30 (3%) | |FIRST INCIDENCE (DAYS) | --- --- 729 (T) --- | 730 (T) 685 730 (T) 730 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.709 (e) P=0.500 (e) | P=0.582 P=0.479 P=0.451 P=0.708 | |INCIDENTAL TUMOR | P=0.709 (e) P=0.500 (e) | P=0.612 P=0.526 P=0.451 P=0.708 | |LOGISTIC REGRESSION | P=0.709 (e) P=0.500 (e) | P=0.605 P=0.487 P=0.451 P=0.708 | |COCHRAN-ARMITAGE | P=0.694 | P=0.553N | |FISHER EXACT | (e) P=0.500 (e) | P=0.494 P=0.500 P=0.752N | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/60 (3%) 1/59 (2%) 0/60 (0%) 0/59 (0%) | 0/60 (0%) 1/59 (2%) 2/60 (3%) 0/60 (0%) | |ADJUSTED (b) | 4.2% 2.5% 0.0% 0.0% | 0.0% 2.8% 5.5% 0.0% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/39 (3%) 0/36 (0%) 0/39 (0%) 0/44 (0%) | 0/38 (0%) 1/36 (3%) 1/33 (3%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | 456 (I) 701 --- --- | --- 730 (T) 689 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.098N P=0.518N P=0.240N P=0.227N | P=0.637 P=0.489 P=0.214 (e) | |INCIDENTAL TUMOR | P=0.126N P=0.480N P=0.240N P=0.227N | P=0.637N P=0.489 P=0.285 (e) | |LOGISTIC REGRESSION | P=0.098N P=0.496N P=0.235N P=0.216N | P=0.654N P=0.489 P=0.229 (e) | |COCHRAN-ARMITAGE | P=0.102N | P=0.614N | |FISHER EXACT | P=0.506N P=0.248N P=0.252N | P=0.496 P=0.248 (e) | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 05155 TEST: 04 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROBENZOIC ACID TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/60 (3%) 1/59 (2%) 0/60 (0%) 0/59 (0%) | 1/60 (2%) 1/59 (2%) 2/60 (3%) 1/60 (2%) | |ADJUSTED (b) | 4.2% 2.5% 0.0% 0.0% | 2.6% 2.8% 5.5% 2.7% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/39 (3%) 0/36 (0%) 0/39 (0%) 0/44 (0%) | 1/38 (3%) 1/36 (3%) 1/33 (3%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | 456 (I) 701 --- --- | 730 (T) 730 (T) 689 646 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.098N P=0.518N P=0.240N P=0.227N | P=0.520 P=0.750 P=0.456 P=0.717 | |INCIDENTAL TUMOR | P=0.126N P=0.480N P=0.240N P=0.227N | P=0.581 P=0.750 P=0.534 P=0.752N | |LOGISTIC REGRESSION | P=0.098N P=0.496N P=0.235N P=0.216N | P=0.555 P=0.750 P=0.483 P=0.745 | |COCHRAN-ARMITAGE | P=0.102N | P=0.592 | |FISHER EXACT | P=0.506N P=0.248N P=0.252N | P=0.748 P=0.500 P=0.752N | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 0/60 (0%) 1/59 (2%) 2/60 (3%) 0/60 (0%) | |ADJUSTED (b) | | 0.0% 2.8% 6.1% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | | 0/38 (0%) 1/36 (3%) 2/33 (6%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | | --- 730 (T) 730 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.635 P=0.489 P=0.208 (e) | |INCIDENTAL TUMOR | | P=0.635 P=0.489 P=0.208 (e) | |LOGISTIC REGRESSION | | P=0.635 P=0.489 P=0.208 (e) | |COCHRAN-ARMITAGE | | P=0.614N | |FISHER EXACT | | P=0.496 P=0.248 (e) | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 05155 TEST: 04 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROBENZOIC ACID TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 1/60 (2%) 1/59 (2%) 2/60 (3%) 0/60 (0%) | |ADJUSTED (b) | | 2.6% 2.8% 6.1% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | | 1/38 (3%) 1/36 (3%) 2/33 (6%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | | 730 (T) 730 (T) 730 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.433N P=0.750 P=0.451 P=0.547N | |INCIDENTAL TUMOR | | P=0.433N P=0.750 P=0.451 P=0.547N | |LOGISTIC REGRESSION | | P=0.433N P=0.750 P=0.451 P=0.547N | |COCHRAN-ARMITAGE | | P=0.365N | |FISHER EXACT | | P=0.748 P=0.500 P=0.500N | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 6/60 (10%) 2/60 (3%) 2/60 (3%) 1/60 (2%) | 4/60 (7%) 1/59 (2%) 3/60 (5%) 0/60 (0%) | |ADJUSTED (b) | 14.9% 5.6% 4.9% 2.3% | 10.1% 2.5% 7.2% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | |TERMINAL (d) | 5/39 (13%) 2/36 (6%) 1/39 (3%) 1/44 (2%) | 3/38 (8%) 0/36 (0%) 1/33 (3%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | 728 729 (T) 695 729 (T) | 693 685 457 (I) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.032N* P=0.164N P=0.142N P=0.044N* | P=0.104N P=0.204N P=0.556N P=0.098N | |INCIDENTAL TUMOR | P=0.048N* P=0.148N P=0.148N P=0.071N | P=0.069N P=0.149N P=0.455N P=0.076N | |LOGISTIC REGRESSION | P=0.040N* P=0.162N P=0.144N P=0.049N* | P=0.080N P=0.190N P=0.509N P=0.085N | |COCHRAN-ARMITAGE | P=0.043N* | P=0.072N | |FISHER EXACT | P=0.136N P=0.136N P=0.057N | P=0.187N P=0.500N P=0.059N | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 05155 TEST: 04 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROBENZOIC ACID TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 6/60 (10%) 3/60 (5%) 2/60 (3%) 1/60 (2%) | 4/60 (7%) 1/59 (2%) 3/60 (5%) 0/60 (0%) | |ADJUSTED (b) | 14.9% 7.8% 4.9% 2.3% | 10.1% 2.5% 7.2% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | |TERMINAL (d) | 5/39 (13%) 2/36 (6%) 1/39 (3%) 1/44 (2%) | 3/38 (8%) 0/36 (0%) 1/33 (3%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | 728 695 695 729 (T) | 693 685 457 (I) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.028N* P=0.284N P=0.142N P=0.044N* | P=0.104N P=0.204N P=0.556N P=0.098N | |INCIDENTAL TUMOR | P=0.050N* P=0.247N P=0.148N P=0.071N | P=0.069N P=0.149N P=0.455N P=0.076N | |LOGISTIC REGRESSION | P=0.034N* P=0.263N P=0.144N P=0.049N* | P=0.080N P=0.190N P=0.509N P=0.085N | |COCHRAN-ARMITAGE | P=0.036N* | P=0.072N | |FISHER EXACT | P=0.245N P=0.136N P=0.057N | P=0.187N P=0.500N P=0.059N | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 1/60 (2%) 2/59 (3%) 3/60 (5%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 2.6% 4.2% 7.5% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/39 (0%) 0/36 (0%) 0/39 (0%) 0/44 (0%) | 1/38 (3%) 0/36 (0%) 1/33 (3%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 730 (T) 526 624 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.388N P=0.496 P=0.281 P=0.547N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.241N P=0.480 P=0.378 P=0.547N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.225N P=0.564 P=0.298 P=0.547N | |COCHRAN-ARMITAGE | (e) | P=0.336N | |FISHER EXACT | (e) (e) (e) | P=0.494 P=0.309 P=0.500N | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 05155 TEST: 04 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROBENZOIC ACID TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma And Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 1/60 (2%) 3/60 (5%) 2/60 (3%) | 10/60 (17%) 13/59 (22%) 11/60 (18%) 7/60 (12%) | |ADJUSTED (b) | 5.1% 2.8% 6.7% 4.5% | 23.7% 33.4% 27.5% 20.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/39 (5%) 1/36 (3%) 2/39 (5%) 2/44 (5%) | 7/38 (18%) 11/36 (31%) 6/33 (18%) 3/30 (10%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 451 729 (T) | 423 526 569 700 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.554 P=0.528N P=0.502 P=0.651N | P=0.367N P=0.274 P=0.390 P=0.495N | |INCIDENTAL TUMOR | P=0.518 P=0.528N P=0.500 P=0.651N | P=0.178N P=0.285 P=0.576 P=0.291N | |LOGISTIC REGRESSION | P=0.491 P=0.528N P=0.499 P=0.651N | P=0.254N P=0.296 P=0.477 P=0.395N | |COCHRAN-ARMITAGE | P=0.500 | P=0.181N | |FISHER EXACT | P=0.500N P=0.500 P=0.691N | P=0.306 P=0.500 P=0.301N | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated | | Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 1/60 (2%) 3/60 (5%) 2/60 (3%) | 9/60 (15%) 11/59 (19%) 9/60 (15%) 7/60 (12%) | |ADJUSTED (b) | 5.1% 2.8% 6.7% 4.5% | 21.3% 30.6% 24.0% 20.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/39 (5%) 1/36 (3%) 2/39 (5%) 2/44 (5%) | 6/38 (16%) 11/36 (31%) 6/33 (18%) 3/30 (10%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 451 729 (T) | 423 730 (T) 569 700 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.554 P=0.528N P=0.502 P=0.651N | P=0.472N P=0.347 P=0.487 P=0.586N | |INCIDENTAL TUMOR | P=0.518 P=0.528N P=0.500 P=0.651N | P=0.315N P=0.370 P=0.571N P=0.377N | |LOGISTIC REGRESSION | P=0.491 P=0.528N P=0.499 P=0.651N | P=0.375N P=0.288 P=0.580 P=0.492N | |COCHRAN-ARMITAGE | P=0.500 | P=0.266N | |FISHER EXACT | P=0.500N P=0.500 P=0.691N | P=0.387 P=0.601N P=0.395N | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 05155 TEST: 04 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROBENZOIC ACID TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 22/60 (37%) 32/60 (53%) 26/60 (43%) 23/60 (38%) | 22/60 (37%) 24/59 (41%) 27/60 (45%) 21/60 (35%) | |ADJUSTED (b) | 44.9% 64.6% 51.7% 49.8% | 49.8% 54.9% 59.5% 57.3% | |INTERIM SACRIFICE 1 (c)| 2/10 (20%) 3/10 (30%) 6/10 (60%) 1/10 (10%) | 0/10 (0%) 2/10 (20%) 4/10 (40%) 1/10 (10%) | |TERMINAL (d) | 13/39 (33%) 19/36 (53%) 16/39 (41%) 21/44 (48%) | 16/38 (42%) 17/36 (47%) 16/33 (48%) 15/30 (50%) | |FIRST INCIDENCE (DAYS) | 456 (I) 442 456 (I) 456 (I) | 589 457 (I) 457 (I) 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.229N P=0.046 * P=0.298 P=0.499N | P=0.273 P=0.348 P=0.126 P=0.309 | |INCIDENTAL TUMOR | P=0.474 P=0.044 * P=0.298 P=0.298 | P=0.532N P=0.488 P=0.271 P=0.553N | |LOGISTIC REGRESSION | P=0.517 P=0.047 * P=0.288 P=0.302 | P=0.483 P=0.382 P=0.201 P=0.465 | |COCHRAN-ARMITAGE | P=0.387N | P=0.436N | |FISHER EXACT | P=0.049 * P=0.288 P=0.500 | P=0.397 P=0.229 P=0.500N | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 18/60 (30%) 21/60 (35%) 21/60 (35%) 14/60 (23%) | 24/60 (40%) 23/59 (39%) 24/60 (40%) 17/60 (28%) | |ADJUSTED (b) | 40.4% 44.9% 45.8% 30.4% | 52.6% 54.3% 52.7% 43.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 2/10 (20%) 0/10 (0%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | |TERMINAL (d) | 13/39 (33%) 11/36 (31%) 15/39 (38%) 12/44 (27%) | 17/38 (45%) 17/36 (47%) 12/33 (36%) 8/30 (27%) | |FIRST INCIDENCE (DAYS) | 419 456 (I) 451 582 | 423 526 457 (I) 471 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.111N P=0.280 P=0.351 P=0.181N | P=0.365N P=0.552 P=0.390 P=0.378N | |INCIDENTAL TUMOR | P=0.348N P=0.415 P=0.363 P=0.410N | P=0.077N P=0.505N P=0.444N P=0.102N | |LOGISTIC REGRESSION | P=0.293N P=0.321 P=0.336 P=0.291N | P=0.100N P=0.538N P=0.542 P=0.195N | |COCHRAN-ARMITAGE | P=0.185N | P=0.098N | |FISHER EXACT | P=0.348 P=0.348 P=0.268N | P=0.530N P=0.574N P=0.124N | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 05155 TEST: 04 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- P-NITROBENZOIC ACID TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0.0% 0.125% 0.25% 0.5% | 0.0% 0.125% 0.25% 0.5% | | | | | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 35/60 (58%) 41/60 (68%) 41/60 (68%) 31/60 (52%) | 37/60 (62%) 40/59 (68%) 39/60 (65%) 33/60 (55%) | |ADJUSTED (b) | 69.5% 75.7% 75.4% 65.8% | 75.3% 83.1% 74.6% 76.5% | |INTERIM SACRIFICE 1 (c)| 2/10 (20%) 5/10 (50%) 6/10 (60%) 1/10 (10%) | 1/10 (10%) 2/10 (20%) 4/10 (40%) 1/10 (10%) | |TERMINAL (d) | 24/39 (62%) 23/36 (64%) 26/39 (67%) 28/44 (64%) | 26/38 (68%) 28/36 (78%) 20/33 (61%) 20/30 (67%) | |FIRST INCIDENCE (DAYS) | 419 442 451 456 (I) | 423 457 (I) 457 (I) 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.069N P=0.137 P=0.212 P=0.145N | P=0.367 P=0.261 P=0.227 P=0.357 | |INCIDENTAL TUMOR | P=0.380N P=0.149 P=0.180 P=0.489N | P=0.154N P=0.380 P=0.557 P=0.268N | |LOGISTIC REGRESSION | P=0.349N P=0.159 P=0.168 P=0.356N | P=0.185N P=0.370 P=0.532 P=0.485N | |COCHRAN-ARMITAGE | P=0.162N | P=0.179N | |FISHER EXACT | P=0.172 P=0.172 P=0.291N | P=0.306 P=0.425 P=0.289N | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for intercurrent mortality. (c) Observed incidence at interim kill. Male interim sacrifices(days): 456 Female interim sacrifices(days): 457 (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).