TR 399 Rat Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Mason TITANOCENE DICHLORIDE DATE: 09/06/94 EXPERIMENT: 05047 TEST: 01 TIME: 22:02:50 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01ES9561904 ROUTE: GAVAGE NTP C#: 04502 PATHOLOGIST: K. MURTHY S. EUSTIS CAS: 1271-19-8 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Mason TITANOCENE DICHLORIDE DATE: 09/06/94 EXPERIMENT: 05047 TEST: 01 TIME: 22:02:50 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES9561904 ROUTE: GAVAGE NTP C#: 04502 PATHOLOGIST: K. MURTHY S. EUSTIS CAS: 1271-19-8 RATS(FISCHER344) ---------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED. ---------------- Adrenal Gland Bone Marrow Brain Clitoral Gland Epididymis Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Mason TITANOCENE DICHLORIDE DATE: 09/06/94 EXPERIMENT: 05047 TEST: 01 TIME: 22:02:50 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES9561904 ROUTE: GAVAGE NTP C#: 04502 PATHOLOGIST: K. MURTHY S. EUSTIS CAS: 1271-19-8 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF TITANOCENE DICHLORIDE ==================================================================================================== MALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Liver Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Pancreas Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Stomach, Forestomach Squamous Cell Carcinoma or Papilloma Squamous Squamous Cell Papilloma Testes Adenoma All Organs Mesothelioma Benign, Malignant, NOS Benign Tumors Malignant and Benign Tumors ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Clitoral/Preputial Gland Adenoma Carcinoma or Adenoma Mammary Gland Carcinoma Carcinoma or Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma All Organs Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 09/06/94 EXPERIMENT: 05047 TEST: 01 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TITANOCENE DICHLORIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.025 G/ 0.05 G/K | VEHICLE 0.025 G/ 0.05 G/K | | | 79VM KG 79 LM G 79 HM | 79 VF KG 79 LF G 79 HF | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 20/60 (33%) 21/60 (35%) 17/59 (29%) | 6/58 (10%) 7/60 (12%) 6/59 (10%) | |ADJUSTED (b) | 46.3% 65.1% 58.3% | 16.0% 21.9% 18.2% | |TERMINAL (d) | 18/41 (44%) 19/30 (63%) 12/24 (50%) | 5/36 (14%) 5/30 (17%) 4/30 (13%) | |FIRST INCIDENCE (DAYS) | 670 536 662 | 702 721 674 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.078 P=0.089 P=0.123 | P=0.414 P=0.368 P=0.475 | |INCIDENTAL TUMOR | P=0.132 P=0.119 P=0.195 | P=0.436 P=0.439 P=0.503 | |LOGISTIC REGRESSION | P=0.152 P=0.126 P=0.198 | P=0.416 P=0.393 P=0.487 | |COCHRAN-ARMITAGE | P=0.335N | P=0.547N | |FISHER EXACT | P=0.500 P=0.369N | P=0.526 P=0.607N | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/60 (5%) 1/60 (2%) 1/59 (2%) | 1/58 (2%) 0/60 (0%) 0/59 (0%) | |ADJUSTED (b) | 6.5% 2.3% 2.8% | 2.8% 0.0% 0.0% | |TERMINAL (d) | 1/41 (2%) 0/30 (0%) 0/24 (0%) | 1/36 (3%) 0/30 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | 647 603 620 | 743 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.332N P=0.407N P=0.482N | P=0.298N P=0.536N P=0.536N | |INCIDENTAL TUMOR | P=0.211N P=0.315N P=0.338N | P=0.298N P=0.536N P=0.536N | |LOGISTIC REGRESSION | P=0.222N P=0.305N P=0.361N | P=0.298N P=0.536N P=0.536N | |COCHRAN-ARMITAGE | P=0.206N | P=0.266N | |FISHER EXACT | P=0.309N P=0.316N | P=0.492N P=0.496N | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05047 TEST: 01 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TITANOCENE DICHLORIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.025 G/ 0.05 G/K | VEHICLE 0.025 G/ 0.05 G/K | | | 79VM KG 79 LM G 79 HM | 79 VF KG 79 LF G 79 HF | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 22/60 (37%) 22/60 (37%) 18/59 (31%) | 7/58 (12%) 7/60 (12%) 6/59 (10%) | |ADJUSTED (b) | 49.6% 65.9% 59.4% | 18.7% 21.9% 18.2% | |TERMINAL (d) | 19/41 (46%) 19/30 (63%) 12/24 (50%) | 6/36 (17%) 5/30 (17%) 4/30 (13%) | |FIRST INCIDENCE (DAYS) | 647 536 620 | 702 721 674 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.103 P=0.122 P=0.149 | P=0.523 P=0.473 P=0.583 | |INCIDENTAL TUMOR | P=0.189 P=0.177 P=0.256 | P=0.548 P=0.545 P=0.610 | |LOGISTIC REGRESSION | P=0.220 P=0.188 P=0.273 | P=0.528 P=0.502 P=0.595 | |COCHRAN-ARMITAGE | P=0.272N | P=0.429N | |FISHER EXACT | P=0.575N P=0.303N | P=0.585N P=0.487N | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/56 (7%) 1/59 (2%) 3/56 (5%) | 12/56 (21%) 8/55 (15%) 2/56 (4%) | |ADJUSTED (b) | 10.8% 2.0% 11.1% | 31.9% 20.7% 5.2% | |TERMINAL (d) | 4/37 (11%) 0/30 (0%) 2/24 (8%) | 10/34 (29%) 4/30 (13%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | 738 (T) 537 662 | 384 510 485 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.574 P=0.245N P=0.585 | P=0.009N** P=0.323N P=0.009N** | |INCIDENTAL TUMOR | P=0.534N P=0.164N P=0.614 | P=0.003N** P=0.212N P=0.003N** | |LOGISTIC REGRESSION | P=0.518N P=0.191N P=0.640 | P=0.005N** P=0.259N P=0.007N** | |COCHRAN-ARMITAGE | P=0.411N | P=0.004N** | |FISHER EXACT | P=0.166N P=0.500N | P=0.244N P=0.004N** | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05047 TEST: 01 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TITANOCENE DICHLORIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.025 G/ 0.05 G/K | VEHICLE 0.025 G/ 0.05 G/K | | | 79VM KG 79 LM G 79 HM | 79 VF KG 79 LF G 79 HF | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/56 (9%) 1/59 (2%) 4/56 (7%) | 13/56 (23%) 9/55 (16%) 2/56 (4%) | |ADJUSTED (b) | 12.8% 2.0% 14.0% | 34.8% 23.8% 5.2% | |TERMINAL (d) | 4/37 (11%) 0/30 (0%) 2/24 (8%) | 11/34 (32%) 5/30 (17%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | 716 537 662 | 384 510 485 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.516 P=0.163N P=0.510 | P=0.006N** P=0.338N P=0.005N** | |INCIDENTAL TUMOR | P=0.531N P=0.099N P=0.601 | P=0.002N** P=0.228N P=0.002N** | |LOGISTIC REGRESSION | P=0.541N P=0.115N P=0.597 | P=0.003N** P=0.277N P=0.004N** | |COCHRAN-ARMITAGE | P=0.420N | P=0.002N** | |FISHER EXACT | P=0.092N P=0.500N | P=0.253N P=0.002N** | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/58 (9%) 5/56 (9%) 1/59 (2%) | 2/59 (3%) 1/61 (2%) 0/59 (0%) | |ADJUSTED (b) | 10.8% 16.7% 4.3% | 5.6% 3.3% 0.0% | |TERMINAL (d) | 2/39 (5%) 5/30 (17%) 1/23 (4%) | 2/36 (6%) 1/30 (3%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 577 738 (T) 738 (T) | 743 (T) 743 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.257N P=0.459 P=0.246N | P=0.172N P=0.564N P=0.272N | |INCIDENTAL TUMOR | P=0.199N P=0.501 P=0.158N | P=0.172N P=0.564N P=0.272N | |LOGISTIC REGRESSION | P=0.186N P=0.519 P=0.156N | P=0.172N P=0.564N P=0.272N | |COCHRAN-ARMITAGE | P=0.088N | P=0.141N | |FISHER EXACT | P=0.606 P=0.099N | P=0.487N P=0.248N | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05047 TEST: 01 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TITANOCENE DICHLORIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.025 G/ 0.05 G/K | VEHICLE 0.025 G/ 0.05 G/K | | | 79VM KG 79 LM G 79 HM | 79 VF KG 79 LF G 79 HF | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/60 (7%) 3/59 (5%) 7/60 (12%) | 0/60 (0%) 1/61 (2%) 2/60 (3%) | |ADJUSTED (b) | 9.8% 10.0% 26.3% | 0.0% 3.3% 6.5% | |TERMINAL (d) | 4/41 (10%) 3/30 (10%) 5/24 (21%) | 0/37 (0%) 1/30 (3%) 2/31 (6%) | |FIRST INCIDENCE (DAYS) | 738 (T) 738 (T) 708 | --- 743 (T) 743 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.042 * P=0.643 P=0.057 | P=0.119 P=0.458 P=0.200 | |INCIDENTAL TUMOR | P=0.053 P=0.643 P=0.076 | P=0.119 P=0.458 P=0.200 | |LOGISTIC REGRESSION | P=0.052 P=0.643 P=0.072 | P=0.119 P=0.458 P=0.200 | |COCHRAN-ARMITAGE | P=0.198 | P=0.142 | |FISHER EXACT | P=0.509N P=0.264 | P=0.504 P=0.248 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/60 (7%) 3/59 (5%) 8/60 (13%) | 0/60 (0%) 1/61 (2%) 2/60 (3%) | |ADJUSTED (b) | 9.8% 10.0% 28.1% | 0.0% 3.3% 6.5% | |TERMINAL (d) | 4/41 (10%) 3/30 (10%) 5/24 (21%) | 0/37 (0%) 1/30 (3%) 2/31 (6%) | |FIRST INCIDENCE (DAYS) | 738 (T) 738 (T) 612 | --- 743 (T) 743 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.022 * P=0.643 P=0.032 * | P=0.119 P=0.458 P=0.200 | |INCIDENTAL TUMOR | P=0.031 * P=0.643 P=0.051 | P=0.119 P=0.458 P=0.200 | |LOGISTIC REGRESSION | P=0.032 * P=0.643 P=0.050 * | P=0.119 P=0.458 P=0.200 | |COCHRAN-ARMITAGE | P=0.124 | P=0.142 | |FISHER EXACT | P=0.509N P=0.181 | P=0.504 P=0.248 | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05047 TEST: 01 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TITANOCENE DICHLORIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.025 G/ 0.05 G/K | VEHICLE 0.025 G/ 0.05 G/K | | | 79VM KG 79 LM G 79 HM | 79 VF KG 79 LF G 79 HF | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/60 (7%) 3/59 (5%) 8/60 (13%) | 0/60 (0%) 1/61 (2%) 2/60 (3%) | |ADJUSTED (b) | 9.8% 10.0% 28.1% | 0.0% 3.3% 6.5% | |TERMINAL (d) | 4/41 (10%) 3/30 (10%) 5/24 (21%) | 0/37 (0%) 1/30 (3%) 2/31 (6%) | |FIRST INCIDENCE (DAYS) | 738 (T) 738 (T) 612 | --- 743 (T) 743 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.022 * P=0.643 P=0.032 * | P=0.119 P=0.458 P=0.200 | |INCIDENTAL TUMOR | P=0.031 * P=0.643 P=0.051 | P=0.119 P=0.458 P=0.200 | |LOGISTIC REGRESSION | P=0.032 * P=0.643 P=0.050 * | P=0.119 P=0.458 P=0.200 | |COCHRAN-ARMITAGE | P=0.124 | P=0.142 | |FISHER EXACT | P=0.509N P=0.181 | P=0.504 P=0.248 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/60 (5%) 2/60 (3%) 5/60 (8%) | 1/60 (2%) 1/61 (2%) 2/60 (3%) | |ADJUSTED (b) | 6.6% 6.7% 20.8% | 2.7% 3.3% 6.5% | |TERMINAL (d) | 1/41 (2%) 2/30 (7%) 5/24 (21%) | 1/37 (3%) 1/30 (3%) 2/31 (6%) | |FIRST INCIDENCE (DAYS) | 681 738 (T) 738 (T) | 743 (T) 743 (T) 743 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.098 P=0.633N P=0.132 | P=0.324 P=0.715 P=0.438 | |INCIDENTAL TUMOR | P=0.119 P=0.603N P=0.167 | P=0.324 P=0.715 P=0.438 | |LOGISTIC REGRESSION | P=0.122 P=0.592N P=0.169 | P=0.324 P=0.715 P=0.438 | |COCHRAN-ARMITAGE | P=0.275 | P=0.378 | |FISHER EXACT | P=0.500N P=0.359 | P=0.748N P=0.500 | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05047 TEST: 01 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TITANOCENE DICHLORIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.025 G/ 0.05 G/K | VEHICLE 0.025 G/ 0.05 G/K | | | 79VM KG 79 LM G 79 HM | 79 VF KG 79 LF G 79 HF | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/60 (7%) 2/60 (3%) 5/60 (8%) | 2/60 (3%) 1/61 (2%) 2/60 (3%) | |ADJUSTED (b) | 8.4% 6.7% 20.8% | 5.4% 3.3% 6.5% | |TERMINAL (d) | 1/41 (2%) 2/30 (7%) 5/24 (21%) | 2/37 (5%) 1/30 (3%) 2/31 (6%) | |FIRST INCIDENCE (DAYS) | 605 738 (T) 738 (T) | 743 (T) 743 (T) 743 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.190 P=0.475N P=0.230 | P=0.542 P=0.573N P=0.630 | |INCIDENTAL TUMOR | P=0.239 P=0.396N P=0.307 | P=0.542 P=0.573N P=0.630 | |LOGISTIC REGRESSION | P=0.246 P=0.390N P=0.310 | P=0.542 P=0.573N P=0.630 | |COCHRAN-ARMITAGE | P=0.424 | P=0.610 | |FISHER EXACT | P=0.340N P=0.500 | P=0.494N P=0.691N | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) | 3/60 (5%) 1/61 (2%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% | 7.0% 1.7% 0.0% | |TERMINAL (d) | 0/41 (0%) 0/30 (0%) 0/24 (0%) | 2/37 (5%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- | 342 350 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.077N P=0.341N P=0.149N | |INCIDENTAL TUMOR | (e) (e) (e) | P=0.018N* P=0.331N P=0.072N | |LOGISTIC REGRESSION | (e) (e) (e) | P=0.023N* P=0.227N P=0.084N | |COCHRAN-ARMITAGE | (e) | P=0.060N | |FISHER EXACT | (e) (e) | P=0.303N P=0.122N | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05047 TEST: 01 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TITANOCENE DICHLORIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.025 G/ 0.05 G/K | VEHICLE 0.025 G/ 0.05 G/K | | | 79VM KG 79 LM G 79 HM | 79 VF KG 79 LF G 79 HF | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) | 4/60 (7%) 2/61 (3%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% | 9.7% 3.6% 0.0% | |TERMINAL (d) | 0/41 (0%) 0/30 (0%) 0/24 (0%) | 3/37 (8%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- | 342 350 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.055N P=0.389N P=0.085N | |INCIDENTAL TUMOR | (e) (e) (e) | P=0.017N* P=0.355N P=0.041N* | |LOGISTIC REGRESSION | (e) (e) (e) | P=0.015N* P=0.261N P=0.051N | |COCHRAN-ARMITAGE | (e) | P=0.037N* | |FISHER EXACT | (e) (e) | P=0.332N P=0.059N | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 4/60 (7%) 6/60 (10%) 2/60 (3%) | 26/60 (43%) 24/61 (39%) 18/60 (30%) | |ADJUSTED (b) | 9.8% 19.2% 8.3% | 61.3% 56.8% 50.5% | |TERMINAL (d) | 4/41 (10%) 5/30 (17%) 2/24 (8%) | 21/37 (57%) 13/30 (43%) 14/31 (45%) | |FIRST INCIDENCE (DAYS) | 738 (T) 717 738 (T) | 639 504 496 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.553 P=0.196 P=0.599N | P=0.283N P=0.387 P=0.285N | |INCIDENTAL TUMOR | P=0.570N P=0.204 P=0.599N | P=0.224N P=0.544N P=0.250N | |LOGISTIC REGRESSION | P=0.567N P=0.200 P=0.599N | P=0.238N P=0.571N P=0.280N | |COCHRAN-ARMITAGE | P=0.292N | P=0.079N | |FISHER EXACT | P=0.372 P=0.340N | P=0.397N P=0.092N | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05047 TEST: 01 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TITANOCENE DICHLORIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.025 G/ 0.05 G/K | VEHICLE 0.025 G/ 0.05 G/K | | | 79VM KG 79 LM G 79 HM | 79 VF KG 79 LF G 79 HF | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 4/60 (7%) 6/60 (10%) 2/60 (3%) | 26/60 (43%) 25/61 (41%) 18/60 (30%) | |ADJUSTED (b) | 9.8% 19.2% 8.3% | 61.3% 57.6% 50.5% | |TERMINAL (d) | 4/41 (10%) 5/30 (17%) 2/24 (8%) | 21/37 (57%) 13/30 (43%) 14/31 (45%) | |FIRST INCIDENCE (DAYS) | 738 (T) 717 738 (T) | 639 504 496 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.553 P=0.196 P=0.599N | P=0.289N P=0.323 P=0.285N | |INCIDENTAL TUMOR | P=0.570N P=0.204 P=0.599N | P=0.236N P=0.544 P=0.250N | |LOGISTIC REGRESSION | P=0.567N P=0.200 P=0.599N | P=0.234N P=0.523 P=0.280N | |COCHRAN-ARMITAGE | P=0.292N | P=0.079N | |FISHER EXACT | P=0.372 P=0.340N | P=0.469N P=0.092N | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 4/60 (7%) 6/60 (10%) 2/60 (3%) | 27/60 (45%) 26/61 (43%) 18/60 (30%) | |ADJUSTED (b) | 9.8% 19.2% 8.3% | 62.0% 58.3% 50.5% | |TERMINAL (d) | 4/41 (10%) 5/30 (17%) 2/24 (8%) | 21/37 (57%) 13/30 (43%) 14/31 (45%) | |FIRST INCIDENCE (DAYS) | 738 (T) 717 738 (T) | 342 350 496 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.553 P=0.196 P=0.599N | P=0.239N P=0.329 P=0.228N | |INCIDENTAL TUMOR | P=0.570N P=0.204 P=0.599N | P=0.141N P=0.543 P=0.164N | |LOGISTIC REGRESSION | P=0.567N P=0.200 P=0.599N | P=0.151N P=0.552N P=0.198N | |COCHRAN-ARMITAGE | P=0.292N | P=0.056N | |FISHER EXACT | P=0.372 P=0.340N | P=0.468N P=0.066N | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05047 TEST: 01 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TITANOCENE DICHLORIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.025 G/ 0.05 G/K | VEHICLE 0.025 G/ 0.05 G/K | | | 79VM KG 79 LM G 79 HM | 79 VF KG 79 LF G 79 HF | |=================================================================================================================================| | | |Pancreas | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/59 (0%) 4/56 (7%) 0/59 (0%) | 1/60 (2%) 1/61 (2%) 1/59 (2%) | |ADJUSTED (b) | 0.0% 12.1% 0.0% | 2.7% 3.3% 3.2% | |TERMINAL (d) | 0/40 (0%) 3/30 (10%) 0/23 (0%) | 1/37 (3%) 1/30 (3%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | --- 611 --- | 743 (T) 743 (T) 743 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.468 P=0.036 * (e) | P=0.588 P=0.715 P=0.722 | |INCIDENTAL TUMOR | P=0.511 P=0.047 * (e) | P=0.588 P=0.715 P=0.722 | |LOGISTIC REGRESSION | P=0.525 P=0.043 * (e) | P=0.588 P=0.715 P=0.722 | |COCHRAN-ARMITAGE | P=0.621 | P=0.635 | |FISHER EXACT | P=0.053 (e) | P=0.748N P=0.748 | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 23/56 (41%) 20/59 (34%) 14/56 (25%) | 29/59 (49%) 23/59 (39%) 16/60 (27%) | |ADJUSTED (b) | 50.1% 52.2% 39.7% | 62.3% 58.0% 42.3% | |TERMINAL (d) | 17/39 (44%) 13/30 (43%) 6/24 (25%) | 20/37 (54%) 15/30 (50%) 10/31 (32%) | |FIRST INCIDENCE (DAYS) | 579 400 465 | 549 574 575 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.481N P=0.402 P=0.493N | P=0.079N P=0.481N P=0.089N | |INCIDENTAL TUMOR | P=0.189N P=0.517N P=0.194N | P=0.072N P=0.276N P=0.083N | |LOGISTIC REGRESSION | P=0.159N P=0.478N P=0.171N | P=0.032N* P=0.267N P=0.041N* | |COCHRAN-ARMITAGE | P=0.044N* | P=0.008N** | |FISHER EXACT | P=0.274N P=0.054N | P=0.177N P=0.009N** | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05047 TEST: 01 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TITANOCENE DICHLORIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.025 G/ 0.05 G/K | VEHICLE 0.025 G/ 0.05 G/K | | | 79VM KG 79 LM G 79 HM | 79 VF KG 79 LF G 79 HF | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 0/60 (0%) 1/60 (2%) | 0/60 (0%) 0/61 (0%) 0/60 (0%) | |ADJUSTED (b) | 4.9% 0.0% 4.2% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/41 (5%) 0/30 (0%) 1/24 (4%) | 0/37 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 738 (T) --- 738 (T) | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.511N P=0.309N P=0.683N | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.511N P=0.309N P=0.683N | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.511N P=0.309N P=0.683N | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.361N | (e) | |FISHER EXACT | P=0.248N P=0.500N | (e) (e) | |=================================================================================================================================| | | |Skin | | Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, | | Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 0/60 (0%) 1/60 (2%) | 1/60 (2%) 0/61 (0%) 0/60 (0%) | |ADJUSTED (b) | 7.3% 0.0% 4.2% | 2.7% 0.0% 0.0% | |TERMINAL (d) | 3/41 (7%) 0/30 (0%) 1/24 (4%) | 1/37 (3%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 738 (T) --- 738 (T) | 743 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.311N P=0.181N P=0.510N | P=0.299N P=0.542N P=0.535N | |INCIDENTAL TUMOR | P=0.311N P=0.181N P=0.510N | P=0.299N P=0.542N P=0.535N | |LOGISTIC REGRESSION | P=0.311N P=0.181N P=0.510N | P=0.299N P=0.542N P=0.535N | |COCHRAN-ARMITAGE | P=0.176N | P=0.269N | |FISHER EXACT | P=0.122N P=0.309N | P=0.496N P=0.500N | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05047 TEST: 01 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TITANOCENE DICHLORIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.025 G/ 0.05 G/K | VEHICLE 0.025 G/ 0.05 G/K | | | 79VM KG 79 LM G 79 HM | 79 VF KG 79 LF G 79 HF | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 5/60 (8%) 2/60 (3%) 3/60 (5%) | 0/60 (0%) 1/61 (2%) 0/60 (0%) | |ADJUSTED (b) | 11.0% 5.3% 9.1% | 0.0% 2.9% 0.0% | |TERMINAL (d) | 3/41 (7%) 1/30 (3%) 1/24 (4%) | 0/37 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 499 553 465 | --- 707 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.494N P=0.339N P=0.607N | P=0.698 P=0.468 (e) | |INCIDENTAL TUMOR | P=0.313N P=0.212N P=0.371N | P=0.714 P=0.533 (e) | |LOGISTIC REGRESSION | P=0.298N P=0.215N P=0.392N | P=0.712 P=0.489 (e) | |COCHRAN-ARMITAGE | P=0.275N | P=0.731 | |FISHER EXACT | P=0.219N P=0.359N | P=0.504 (e) | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 2/60 (3%) 0/60 (0%) | 1/60 (2%) 0/61 (0%) 0/60 (0%) | |ADJUSTED (b) | 2.4% 5.0% 0.0% | 2.2% 0.0% 0.0% | |TERMINAL (d) | 1/41 (2%) 1/30 (3%) 0/24 (0%) | 0/37 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 738 (T) 306 --- | 688 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.473N P=0.424 P=0.607N | P=0.313N P=0.538N P=0.560N | |INCIDENTAL TUMOR | P=0.226N P=0.691 P=0.607N | P=0.286N P=0.467N P=0.540N | |LOGISTIC REGRESSION | P=0.278N P=0.627 P=0.607N | P=0.278N P=0.501N P=0.517N | |COCHRAN-ARMITAGE | P=0.361N | P=0.269N | |FISHER EXACT | P=0.500 P=0.500N | P=0.496N P=0.500N | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05047 TEST: 01 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TITANOCENE DICHLORIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.025 G/ 0.05 G/K | VEHICLE 0.025 G/ 0.05 G/K | | | 79VM KG 79 LM G 79 HM | 79 VF KG 79 LF G 79 HF | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, Sarcoma, | | Neurofibroma, or Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 7/60 (12%) 4/60 (7%) 3/60 (5%) | 1/60 (2%) 1/61 (2%) 1/60 (2%) | |ADJUSTED (b) | 15.7% 10.2% 9.1% | 2.2% 2.9% 1.9% | |TERMINAL (d) | 5/41 (12%) 2/30 (7%) 1/24 (4%) | 0/37 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 499 306 465 | 688 707 457 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.312N P=0.426N P=0.403N | P=0.584 P=0.721 P=0.718 | |INCIDENTAL TUMOR | P=0.111N P=0.196N P=0.211N | P=0.557N P=0.727N P=0.644N | |LOGISTIC REGRESSION | P=0.113N P=0.220N P=0.215N | P=0.597N P=0.758 P=0.705N | |COCHRAN-ARMITAGE | P=0.116N | P=0.640 | |FISHER EXACT | P=0.264N P=0.161N | P=0.748N P=0.752N | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, or Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 2/60 (3%) 0/60 (0%) | 1/60 (2%) 1/61 (2%) 1/60 (2%) | |ADJUSTED (b) | 4.9% 5.0% 0.0% | 2.2% 2.9% 1.9% | |TERMINAL (d) | 2/41 (5%) 1/30 (3%) 0/24 (0%) | 0/37 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 738 (T) 306 --- | 688 707 457 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.284N P=0.604 P=0.362N | P=0.584 P=0.721 P=0.718 | |INCIDENTAL TUMOR | P=0.116N P=0.609N P=0.362N | P=0.557N P=0.727N P=0.644N | |LOGISTIC REGRESSION | P=0.145N P=0.634N P=0.362N | P=0.597N P=0.758 P=0.705N | |COCHRAN-ARMITAGE | P=0.176N | P=0.640 | |FISHER EXACT | P=0.691N P=0.248N | P=0.748N P=0.752N | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05047 TEST: 01 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TITANOCENE DICHLORIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.025 G/ 0.05 G/K | VEHICLE 0.025 G/ 0.05 G/K | | | 79VM KG 79 LM G 79 HM | 79 VF KG 79 LF G 79 HF | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma or Papilloma Squamous | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 4/60 (7%) 1/60 (2%) | 0/60 (0%) 1/61 (2%) 2/60 (3%) | |ADJUSTED (b) | 0.0% 13.3% 4.2% | 0.0% 3.3% 6.5% | |TERMINAL (d) | 0/41 (0%) 4/30 (13%) 1/24 (4%) | 0/37 (0%) 1/30 (3%) 2/31 (6%) | |FIRST INCIDENCE (DAYS) | --- 738 (T) 738 (T) | --- 743 (T) 743 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.215 P=0.031 * P=0.393 | P=0.119 P=0.458 P=0.200 | |INCIDENTAL TUMOR | P=0.215 P=0.031 * P=0.393 | P=0.119 P=0.458 P=0.200 | |LOGISTIC REGRESSION | P=0.215 P=0.031 * P=0.393 | P=0.119 P=0.458 P=0.200 | |COCHRAN-ARMITAGE | P=0.391 | P=0.142 | |FISHER EXACT | P=0.059 P=0.500 | P=0.504 P=0.248 | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 4/60 (7%) 1/60 (2%) | 0/60 (0%) 1/61 (2%) 2/60 (3%) | |ADJUSTED (b) | 0.0% 13.3% 4.2% | 0.0% 3.3% 6.5% | |TERMINAL (d) | 0/41 (0%) 4/30 (13%) 1/24 (4%) | 0/37 (0%) 1/30 (3%) 2/31 (6%) | |FIRST INCIDENCE (DAYS) | --- 738 (T) 738 (T) | --- 743 (T) 743 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.215 P=0.031 * P=0.393 | P=0.119 P=0.458 P=0.200 | |INCIDENTAL TUMOR | P=0.215 P=0.031 * P=0.393 | P=0.119 P=0.458 P=0.200 | |LOGISTIC REGRESSION | P=0.215 P=0.031 * P=0.393 | P=0.119 P=0.458 P=0.200 | |COCHRAN-ARMITAGE | P=0.391 | P=0.142 | |FISHER EXACT | P=0.059 P=0.500 | P=0.504 P=0.248 | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05047 TEST: 01 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TITANOCENE DICHLORIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.025 G/ 0.05 G/K | VEHICLE 0.025 G/ 0.05 G/K | | | 79VM KG 79 LM G 79 HM | 79 VF KG 79 LF G 79 HF | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 51/60 (85%) 50/60 (83%) 46/60 (77%) | | |ADJUSTED (b) | 92.6% 96.1% 100.0% | | |TERMINAL (d) | 37/41 (90%) 28/30 (93%) 24/24 (100%) | | |FIRST INCIDENCE (DAYS) | 474 474 405 | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.004 ** P=0.031 * P=0.004 ** | | |INCIDENTAL TUMOR | P=0.037 * P=0.263 P=0.057 | | |LOGISTIC REGRESSION | P=0.018 * P=0.195 P=0.042 * | | |COCHRAN-ARMITAGE | P=0.144N | | |FISHER EXACT | P=0.500N P=0.177N | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/60 (20%) 9/55 (16%) 9/58 (16%) | 9/60 (15%) 8/57 (14%) 7/59 (12%) | |ADJUSTED (b) | 29.3% 23.7% 26.8% | 22.4% 22.4% 21.4% | |TERMINAL (d) | 12/41 (29%) 4/30 (13%) 2/24 (8%) | 7/37 (19%) 4/30 (13%) 6/31 (19%) | |FIRST INCIDENCE (DAYS) | 738 (T) 509 612 | 622 631 653 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.383 P=0.594 P=0.405 | P=0.500N P=0.546 P=0.548N | |INCIDENTAL TUMOR | P=0.544N P=0.526N P=0.534 | P=0.524N P=0.573N P=0.574N | |LOGISTIC REGRESSION | P=0.549 P=0.512N P=0.538 | P=0.501N P=0.601N P=0.558N | |COCHRAN-ARMITAGE | P=0.300N | P=0.358N | |FISHER EXACT | P=0.398N P=0.347N | P=0.546N P=0.409N | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05047 TEST: 01 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TITANOCENE DICHLORIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.025 G/ 0.05 G/K | VEHICLE 0.025 G/ 0.05 G/K | | | 79VM KG 79 LM G 79 HM | 79 VF KG 79 LF G 79 HF | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/55 (0%) 1/58 (2%) | 1/60 (2%) 3/57 (5%) 0/59 (0%) | |ADJUSTED (b) | 2.4% 0.0% 3.2% | 1.8% 10.0% 0.0% | |TERMINAL (d) | 1/41 (2%) 0/30 (0%) 0/24 (0%) | 0/37 (0%) 3/30 (10%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 738 (T) --- 690 | 598 743 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.565 P=0.562N P=0.654 | P=0.443N P=0.243 P=0.549N | |INCIDENTAL TUMOR | P=0.608 P=0.562N P=0.702 | P=0.469N P=0.262 P=0.638N | |LOGISTIC REGRESSION | P=0.591 P=0.562N P=0.685 | P=0.424N P=0.277 P=0.461N | |COCHRAN-ARMITAGE | P=0.659 | P=0.385N | |FISHER EXACT | P=0.522N P=0.744 | P=0.290 P=0.504N | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/60 (22%) 9/55 (16%) 9/58 (16%) | 10/60 (17%) 11/57 (19%) 7/59 (12%) | |ADJUSTED (b) | 31.7% 23.7% 26.8% | 23.8% 31.4% 21.4% | |TERMINAL (d) | 13/41 (32%) 4/30 (13%) 2/24 (8%) | 7/37 (19%) 7/30 (23%) 6/31 (19%) | |FIRST INCIDENCE (DAYS) | 738 (T) 509 612 | 598 631 653 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.460 P=0.516N P=0.476 | P=0.428N P=0.326 P=0.455N | |INCIDENTAL TUMOR | P=0.463N P=0.445N P=0.589N | P=0.459N P=0.409 P=0.501N | |LOGISTIC REGRESSION | P=0.467N P=0.430N P=0.583N | P=0.420N P=0.394 P=0.446N | |COCHRAN-ARMITAGE | P=0.225N | P=0.279N | |FISHER EXACT | P=0.315N P=0.268N | P=0.448 P=0.314N | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05047 TEST: 01 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TITANOCENE DICHLORIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.025 G/ 0.05 G/K | VEHICLE 0.025 G/ 0.05 G/K | | | 79VM KG 79 LM G 79 HM | 79 VF KG 79 LF G 79 HF | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/60 (3%) 1/55 (2%) 1/58 (2%) | 1/60 (2%) 0/57 (0%) 1/59 (2%) | |ADJUSTED (b) | 4.4% 3.3% 4.2% | 2.7% 0.0% 2.9% | |TERMINAL (d) | 1/41 (2%) 1/30 (3%) 1/24 (4%) | 1/37 (3%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | 647 738 (T) 738 (T) | 743 (T) --- 693 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.543N P=0.603N P=0.667N | P=0.615 P=0.542N P=0.709 | |INCIDENTAL TUMOR | P=0.509N P=0.597N P=0.622N | P=0.630 P=0.542N P=0.718 | |LOGISTIC REGRESSION | P=0.495N P=0.566N P=0.611N | P=0.631 P=0.542N P=0.725 | |COCHRAN-ARMITAGE | P=0.391N | P=0.664 | |FISHER EXACT | P=0.533N P=0.513N | P=0.513N P=0.748 | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # | |----------- | | | |OVERALL (a) | | 11/60 (18%) 10/61 (16%) 16/60 (27%) | |ADJUSTED (b) | | 25.3% 25.8% 43.2% | |TERMINAL (d) | | 7/37 (19%) 5/30 (17%) 11/31 (35%) | |FIRST INCIDENCE (DAYS) | | 384 570 493 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.072 P=0.525 P=0.087 | |INCIDENTAL TUMOR | | P=0.067 P=0.487N P=0.100 | |LOGISTIC REGRESSION | | P=0.086 P=0.504N P=0.103 | |COCHRAN-ARMITAGE | | P=0.154 | |FISHER EXACT | | P=0.483N P=0.191 | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05047 TEST: 01 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TITANOCENE DICHLORIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.025 G/ 0.05 G/K | VEHICLE 0.025 G/ 0.05 G/K | | | 79VM KG 79 LM G 79 HM | 79 VF KG 79 LF G 79 HF | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 2/60 (3%) 1/60 (2%) | 0/60 (0%) 0/61 (0%) 1/60 (2%) | |ADJUSTED (b) | 6.7% 5.2% 4.2% | 0.0% 0.0% 3.2% | |TERMINAL (d) | 2/41 (5%) 1/30 (3%) 1/24 (4%) | 0/37 (0%) 0/30 (0%) 1/31 (3%) | |FIRST INCIDENCE (DAYS) | 605 484 738 (T) | --- --- 743 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.379N P=0.612N P=0.482N | P=0.250 (e) P=0.465 | |INCIDENTAL TUMOR | P=0.278N P=0.456N P=0.426N | P=0.250 (e) P=0.465 | |LOGISTIC REGRESSION | P=0.258N P=0.474N P=0.406N | P=0.250 (e) P=0.465 | |COCHRAN-ARMITAGE | P=0.223N | P=0.269 | |FISHER EXACT | P=0.500N P=0.309N | (e) P=0.500 | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, | | or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 15/60 (25%) 12/60 (20%) 11/60 (18%) | 21/60 (35%) 20/61 (33%) 15/60 (25%) | |ADJUSTED (b) | 30.9% 36.3% 35.3% | 43.3% 45.5% 41.7% | |TERMINAL (d) | 9/41 (22%) 10/30 (33%) 5/24 (21%) | 11/37 (30%) 7/30 (23%) 11/31 (35%) | |FIRST INCIDENCE (DAYS) | 474 474 612 | 598 570 344 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.356 P=0.514 P=0.407 | P=0.372N P=0.403 P=0.377N | |INCIDENTAL TUMOR | P=0.511N P=0.501N P=0.493N | P=0.370N P=0.443N P=0.406N | |LOGISTIC REGRESSION | P=0.512N P=0.481N P=0.537N | P=0.252N P=0.477N P=0.283N | |COCHRAN-ARMITAGE | P=0.217N | P=0.139N | |FISHER EXACT | P=0.331N P=0.253N | P=0.474N P=0.160N | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05047 TEST: 01 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TITANOCENE DICHLORIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.025 G/ 0.05 G/K | VEHICLE 0.025 G/ 0.05 G/K | | | 79VM KG 79 LM G 79 HM | 79 VF KG 79 LF G 79 HF | |=================================================================================================================================| | | |All Organs | | Mesothelioma Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 3/60 (5%) 4/60 (7%) | 0/60 (0%) 0/61 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 8.7% 13.6% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/41 (0%) 2/30 (7%) 2/24 (8%) | 0/37 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE (DAYS) | --- 583 618 | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.017 * P=0.081 P=0.023 * | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.026 * P=0.107 P=0.042 * | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.027 * P=0.105 P=0.035 * | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.049 * | (e) | |FISHER EXACT | P=0.122 P=0.059 | (e) (e) | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 59/60 (98%) 55/60 (92%) 48/60 (80%) | 46/60 (77%) 50/61 (82%) 40/60 (67%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% | 88.2% 94.3% 88.7% | |TERMINAL (d) | 41/41 (100%) 30/30 (100%) 24/24 (100%) | 31/37 (84%) 27/30 (90%) 26/31 (84%) | |FIRST INCIDENCE (DAYS) | 474 400 405 | 384 504 485 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.021 * P=0.052 P=0.025 * | P=0.366 P=0.046 * P=0.431 | |INCIDENTAL TUMOR | P=0.609 P=0.700 P=0.729 | P=0.403 P=0.176 P=0.469 | |LOGISTIC REGRESSION | P=0.396 P=0.556 P=0.572 | P=0.525 P=0.152 P=0.588 | |COCHRAN-ARMITAGE | P<0.001N** | P=0.123N | |FISHER EXACT | P=0.103N P=0.001N** | P=0.310 P=0.156N | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05047 TEST: 01 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TITANOCENE DICHLORIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | VEHICLE 0.025 G/ 0.05 G/K | VEHICLE 0.025 G/ 0.05 G/K | | | 79VM KG 79 LM G 79 HM | 79 VF KG 79 LF G 79 HF | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 24/60 (40%) 19/60 (32%) 19/60 (32%) | 30/60 (50%) 25/61 (41%) 18/60 (30%) | |ADJUSTED (b) | 45.4% 50.1% 54.5% | 59.1% 55.7% 45.6% | |TERMINAL (d) | 13/41 (32%) 13/30 (43%) 9/24 (38%) | 17/37 (46%) 11/30 (37%) 11/31 (35%) | |FIRST INCIDENCE (DAYS) | 474 306 612 | 342 350 344 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.239 P=0.513 P=0.258 | P=0.136N P=0.540N P=0.136N | |INCIDENTAL TUMOR | P=0.457N P=0.277N P=0.525N | P=0.060N P=0.235N P=0.081N | |LOGISTIC REGRESSION | P=0.474N P=0.270N P=0.532N | P=0.037N* P=0.247N P=0.044N* | |COCHRAN-ARMITAGE | P=0.194N | P=0.016N* | |FISHER EXACT | P=0.223N P=0.223N | P=0.208N P=0.020N* | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 60/60 (100%) 56/60 (93%) 48/60 (80%) | 56/60 (93%) 53/61 (87%) 46/60 (77%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% | 96.5% 96.3% 93.8% | |TERMINAL (d) | 41/41 (100%) 30/30 (100%) 24/24 (100%) | 35/37 (95%) 28/30 (93%) 28/31 (90%) | |FIRST INCIDENCE (DAYS) | 474 306 405 | 342 350 344 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.031 * P=0.054 P=0.035 * | P=0.519N P=0.226 P=0.524N | |INCIDENTAL TUMOR | P=0.173N P=0.500N P=0.470N | P=0.196N P=0.310N P=0.265N | |LOGISTIC REGRESSION | P=0.348N P=0.853N P=0.470N | P=0.092N P=0.267N P=0.119N | |COCHRAN-ARMITAGE | P<0.001N** | P=0.007N** | |FISHER EXACT | P=0.059N P<0.001N** | P=0.189N P=0.010N** | |=================================================================================================================================| DATE: 09/06/94 EXPERIMENT: 05047 TEST: 01 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TITANOCENE DICHLORIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 107 WEEKS (a) Number of tumor-bearing animals / number of animals examined at site. (b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for intercurrent mortality. (d) Observed incidence at terminal kill. (f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between the controls and that dosed group. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. The incidental tumor test regards these lesions as non-fatal. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fisher's exact tests compare directly the overall incidence rates. For all tests, a negative trend is indicated by "N". (e) Value of Statistic cannot be computed. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01). --multipart-boundary Content-type: text/plain Range: bytes 137822-137822/137822 --multipart-boundary--