TDMS Study 05156-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest COBALT SULFATE HEPTAHYDRATE DATE: 07/25/96 EXPERIMENT: 05156 TEST: 05 TIME: 10:48:06 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-05287 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 61530B PATHOLOGIST: GRUMBEIN, S. CAS: 10026-24-1 ------------------------------------------------------------------------------------------------------------------------------------ CORE STUDY REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest COBALT SULFATE HEPTAHYDRATE DATE: 07/25/96 EXPERIMENT: 05156 TEST: 05 TIME: 10:48:06 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-05287 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 61530B PATHOLOGIST: GRUMBEIN, S. CAS: 10026-24-1 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 Cortex Adrenal Medulla Bone Marrow Brain Clitoral Gland Clitoral/Preputial Gland Epididymis Heart Islets, Pancreatic Kidney Larynx 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: Battelle Northwest COBALT SULFATE HEPTAHYDRATE DATE: 07/25/96 EXPERIMENT: 05156 TEST: 05 TIME: 10:48:06 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-05287 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 61530B PATHOLOGIST: GRUMBEIN, S. CAS: 10026-24-1 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF 1 COBALT SULFATE HEPTAHYDRATE ==================================================================================================== MALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma: Benign, Complex, Malignant, NOS Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Skin Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma: Benign, Complex, Malignant, NOS Islets, Pancreatic Adenoma Carcinoma or Adenoma Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma ==================================================================================================== DATE: 07/25/96 EXPERIMENT: 05156 TEST: 05 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 1 COBALT SULFATE HEPTAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.3 1.0 3.0 | CONTROL 0.3 1.0 3.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 14/50 (28%) 19/50 (38%) 23/49 (47%) 20/50 (40%) | 2/48 (4%) 1/49 (2%) 3/50 (6%) 8/48 (17%) | |ADJUSTED (b) | 51.0% 70.0% 71.9% 71.4% | 5.1% 3.1% 9.3% 26.4% | |TERMINAL (d) | 6/17 (35%) 8/15 (53%) 13/21 (62%) 8/15 (53%) | 0/27 (0%) 0/25 (0%) 1/26 (4%) 7/29 (24%) | |FIRST INCIDENCE (DAYS) | 534 541 526 526 | 666 702 694 709 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.166 P=0.220 P=0.214 P=0.134 | P=0.006 ** P=0.546N P=0.483 P=0.054 | |INCIDENTAL TUMOR | P=0.190 P=0.199 P=0.040 * P=0.141 | P=0.005 ** P=0.471N P=0.554 P=0.056 | |LOGISTIC REGRESSION | P=0.172 P=0.226 P=0.069 P=0.126 | P=0.004 ** P=0.498N P=0.512 P=0.043 * | |COCHRAN-ARMITAGE | P=0.229 | P=0.003 ** | |FISHER EXACT | P=0.198 P=0.041 * P=0.146 | P=0.492N P=0.520 P=0.045 * | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 2/49 (4%) 2/50 (4%) | 0/48 (0%) 0/49 (0%) 1/50 (2%) 1/48 (2%) | |ADJUSTED (b) | 0.0% 12.5% 7.9% 9.6% | 0.0% 0.0% 2.6% 2.5% | |TERMINAL (d) | 0/17 (0%) 1/15 (7%) 1/21 (5%) 0/15 (0%) | 0/27 (0%) 0/25 (0%) 0/26 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | --- 722 673 663 | --- --- 685 663 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.310 P=0.213 P=0.293 P=0.238 | P=0.303 (e) P=0.495 P=0.495 | |INCIDENTAL TUMOR | P=0.301 P=0.286 P=0.313 P=0.280 | P=0.289 (e) P=0.531 P=0.500 | |LOGISTIC REGRESSION | P=0.315 P=0.225 P=0.271 P=0.232 | P=0.302 (e) P=0.511 P=0.510 | |COCHRAN-ARMITAGE | P=0.342 | P=0.299 | |FISHER EXACT | P=0.247 P=0.242 P=0.247 | (e) P=0.510 P=0.500 | |=================================================================================================================================| DATE: 07/25/96 EXPERIMENT: 05156 TEST: 05 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 1 COBALT SULFATE HEPTAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.3 1.0 3.0 | CONTROL 0.3 1.0 3.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 15/50 (30%) 19/50 (38%) 25/49 (51%) 20/50 (40%) | 2/48 (4%) 1/49 (2%) 4/50 (8%) 10/48 (21%) | |ADJUSTED (b) | 52.1% 70.0% 74.1% 71.4% | 5.1% 3.1% 11.7% 31.5% | |TERMINAL (d) | 6/17 (35%) 8/15 (53%) 13/21 (62%) 8/15 (53%) | 0/27 (0%) 0/25 (0%) 1/26 (4%) 8/29 (28%) | |FIRST INCIDENCE (DAYS) | 534 541 526 526 | 666 702 685 663 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.206 P=0.285 P=0.188 P=0.182 | P=0.001 ** P=0.546N P=0.325 P=0.019 * | |INCIDENTAL TUMOR | P=0.236 P=0.257 P=0.027 * P=0.194 | P<0.001 ** P=0.471N P=0.390 P=0.019 * | |LOGISTIC REGRESSION | P=0.218 P=0.295 P=0.045 * P=0.180 | P<0.001 ** P=0.498N P=0.323 P=0.014 * | |COCHRAN-ARMITAGE | P=0.279 | P<0.001 ** | |FISHER EXACT | P=0.263 P=0.027 * P=0.201 | P=0.492N P=0.359 P=0.014 * | |=================================================================================================================================| | | |Bone | | Osteosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 11.4% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/17 (0%) 0/15 (0%) 0/21 (0%) 0/15 (0%) | 0/28 (0%) 0/25 (0%) 0/26 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | --- 631 --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.258N P=0.146 (e) (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.261N P=0.173 (e) (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.257N P=0.123 (e) (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.255N | (e) | |FISHER EXACT | P=0.121 (e) (e) | (e) (e) (e) | |=================================================================================================================================| DATE: 07/25/96 EXPERIMENT: 05156 TEST: 05 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 1 COBALT SULFATE HEPTAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.3 1.0 3.0 | CONTROL 0.3 1.0 3.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/49 (4%) 1/50 (2%) | 5/50 (10%) 7/48 (15%) 5/48 (10%) 3/49 (6%) | |ADJUSTED (b) | 0.0% 0.0% 6.8% 3.4% | 16.0% 23.4% 17.8% 8.8% | |TERMINAL (d) | 0/17 (0%) 0/15 (0%) 0/21 (0%) 0/15 (0%) | 2/28 (7%) 4/24 (17%) 3/26 (12%) 1/30 (3%) | |FIRST INCIDENCE (DAYS) | --- --- 654 638 | 727 652 727 680 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.337 (e) P=0.318 P=0.514 | P=0.160N P=0.289 P=0.567 P=0.360N | |INCIDENTAL TUMOR | P=0.341 (e) P=0.338 P=0.489 | P=0.189N P=0.323 P=0.608 P=0.398N | |LOGISTIC REGRESSION | P=0.347 (e) P=0.242 P=0.501 | P=0.182N P=0.286 P=0.581 P=0.384N | |COCHRAN-ARMITAGE | P=0.350 | P=0.189N | |FISHER EXACT | (e) P=0.242 P=0.500 | P=0.351 P=0.603 P=0.369N | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 0/49 (0%) 3/50 (6%) | 2/50 (4%) 3/48 (6%) 4/48 (8%) 3/49 (6%) | |ADJUSTED (b) | 14.7% 11.1% 0.0% 12.8% | 7.1% 9.3% 13.4% 10.0% | |TERMINAL (d) | 1/17 (6%) 0/15 (0%) 0/21 (0%) 1/15 (7%) | 2/28 (7%) 1/24 (4%) 2/26 (8%) 3/30 (10%) | |FIRST INCIDENCE (DAYS) | 679 701 --- 511 | 735 (T) 610 694 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.472 P=0.512N P=0.087N P=0.632 | P=0.548 P=0.439 P=0.305 P=0.532 | |INCIDENTAL TUMOR | P=0.481 P=0.303N P=0.065N P=0.624N | P=0.518 P=0.398 P=0.315 P=0.532 | |LOGISTIC REGRESSION | P=0.486 P=0.229N P=0.093N P=0.657 | P=0.504 P=0.459 P=0.301 P=0.532 | |COCHRAN-ARMITAGE | P=0.500 | P=0.499 | |FISHER EXACT | P=0.500N P=0.125N P=0.661N | P=0.480 P=0.319 P=0.490 | |=================================================================================================================================| DATE: 07/25/96 EXPERIMENT: 05156 TEST: 05 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 1 COBALT SULFATE HEPTAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.3 1.0 3.0 | CONTROL 0.3 1.0 3.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 2/49 (4%) 4/50 (8%) | 7/50 (14%) 10/48 (21%) 8/48 (17%) 6/49 (12%) | |ADJUSTED (b) | 14.7% 11.1% 6.8% 15.8% | 22.5% 31.1% 27.0% 18.2% | |TERMINAL (d) | 1/17 (6%) 0/15 (0%) 0/21 (0%) 1/15 (7%) | 4/28 (14%) 5/24 (21%) 5/26 (19%) 4/30 (13%) | |FIRST INCIDENCE (DAYS) | 679 701 654 511 | 727 610 694 680 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.292 P=0.512N P=0.380N P=0.478 | P=0.234N P=0.207 P=0.429 P=0.480N | |INCIDENTAL TUMOR | P=0.293 P=0.303N P=0.319N P=0.535 | P=0.279N P=0.207 P=0.462 P=0.517N | |LOGISTIC REGRESSION | P=0.305 P=0.229N P=0.329N P=0.494 | P=0.280N P=0.205 P=0.432 P=0.545N | |COCHRAN-ARMITAGE | P=0.320 | P=0.291N | |FISHER EXACT | P=0.500N P=0.510N P=0.500 | P=0.266 P=0.465 P=0.516N | |=================================================================================================================================| | | |Heart | | Schwannoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 2/49 (4%) 2/50 (4%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 3.1% 6.1% 7.7% 3.3% | |TERMINAL (d) | 0/17 (0%) 0/15 (0%) 0/21 (0%) 0/15 (0%) | 0/28 (0%) 1/25 (4%) 2/26 (8%) 1/30 (3%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 727 517 735 (T) 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.489N P=0.458 P=0.471 P=0.760N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.519N P=0.662 P=0.491 P=0.759 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.519N P=0.527 P=0.478 P=0.752 | |COCHRAN-ARMITAGE | (e) | P=0.518N | |FISHER EXACT | (e) (e) (e) | P=0.492 P=0.500 P=0.753N | |=================================================================================================================================| DATE: 07/25/96 EXPERIMENT: 05156 TEST: 05 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 1 COBALT SULFATE HEPTAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.3 1.0 3.0 | CONTROL 0.3 1.0 3.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 5/50 (10%) 5/48 (10%) 5/50 (10%) | 4/49 (8%) 1/49 (2%) 0/50 (0%) 0/48 (0%) | |ADJUSTED (b) | 10.2% 21.3% 18.3% 20.5% | 14.3% 4.0% 0.0% 0.0% | |TERMINAL (d) | 1/17 (6%) 2/15 (13%) 3/21 (14%) 1/15 (7%) | 4/28 (14%) 1/25 (4%) 0/26 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | 679 471 509 611 | 735 (T) 735 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.278 P=0.217 P=0.301 P=0.222 | P=0.049N* P=0.212N P=0.071N P=0.053N | |INCIDENTAL TUMOR | P=0.306 P=0.284 P=0.227 P=0.231 | P=0.049N* P=0.212N P=0.071N P=0.053N | |LOGISTIC REGRESSION | P=0.304 P=0.224 P=0.226 P=0.208 | P=0.049N* P=0.212N P=0.071N P=0.053N | |COCHRAN-ARMITAGE | P=0.316 | P=0.058N | |FISHER EXACT | P=0.218 P=0.201 P=0.218 | P=0.181N P=0.056N P=0.061N | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 4/50 (8%) 4/48 (8%) 7/50 (14%) | 2/49 (4%) 0/49 (0%) 1/50 (2%) 0/48 (0%) | |ADJUSTED (b) | 11.4% 19.8% 14.3% 33.2% | 5.6% 0.0% 3.4% 0.0% | |TERMINAL (d) | 1/17 (6%) 1/15 (7%) 1/21 (5%) 2/15 (13%) | 1/28 (4%) 0/25 (0%) 0/26 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | 526 680 657 638 | 572 --- 727 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.089 P=0.501 P=0.611 P=0.149 | P=0.264N P=0.267N P=0.527N P=0.234N | |INCIDENTAL TUMOR | P=0.077 P=0.642 P=0.654 P=0.185 | P=0.296N P=0.328N P=0.524N P=0.305N | |LOGISTIC REGRESSION | P=0.091 P=0.515 P=0.489 P=0.149 | P=0.279N P=0.209N P=0.484N P=0.242N | |COCHRAN-ARMITAGE | P=0.110 | P=0.275N | |FISHER EXACT | P=0.500 P=0.477 P=0.159 | P=0.247N P=0.492N P=0.253N | |=================================================================================================================================| DATE: 07/25/96 EXPERIMENT: 05156 TEST: 05 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 1 COBALT SULFATE HEPTAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.3 1.0 3.0 | CONTROL 0.3 1.0 3.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 9/50 (18%) 9/48 (19%) 11/50 (22%) | 6/49 (12%) 1/49 (2%) 1/50 (2%) 0/48 (0%) | |ADJUSTED (b) | 20.7% 37.6% 30.6% 44.7% | 19.6% 4.0% 3.4% 0.0% | |TERMINAL (d) | 2/17 (12%) 3/15 (20%) 4/21 (19%) 3/15 (20%) | 5/28 (18%) 1/25 (4%) 0/26 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | 526 471 509 611 | 572 735 (T) 727 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.101 P=0.202 P=0.328 P=0.088 | P=0.023N* P=0.078N P=0.073N P=0.015N* | |INCIDENTAL TUMOR | P=0.100 P=0.322 P=0.288 P=0.099 | P=0.025N* P=0.092N P=0.072N P=0.020N* | |LOGISTIC REGRESSION | P=0.107 P=0.205 P=0.192 P=0.077 | P=0.025N* P=0.069N P=0.059N P=0.019N* | |COCHRAN-ARMITAGE | P=0.127 | P=0.027N* | |FISHER EXACT | P=0.194 P=0.172 P=0.086 | P=0.056N P=0.053N P=0.014N* | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 4/50 (8%) 1/48 (2%) 6/50 (12%) | 0/50 (0%) 1/49 (2%) 10/50 (20%) 9/50 (18%) | |ADJUSTED (b) | 2.3% 17.7% 2.4% 28.4% | 0.0% 3.4% 36.4% 30.0% | |TERMINAL (d) | 0/17 (0%) 2/15 (13%) 0/21 (0%) 2/15 (13%) | 0/28 (0%) 0/25 (0%) 9/26 (35%) 9/30 (30%) | |FIRST INCIDENCE (DAYS) | 568 589 611 638 | --- 714 692 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.042 * P=0.187 P=0.726N P=0.056 | P=0.003 ** P=0.468 P<0.001 ** P=0.003 ** | |INCIDENTAL TUMOR | P=0.054 P=0.124 P=0.538 P=0.064 | P=0.003 ** P=0.500 P<0.001 ** P=0.003 ** | |LOGISTIC REGRESSION | P=0.051 P=0.179 P=0.753 P=0.055 | P=0.001 ** P=0.480 P<0.001 ** P=0.003 ** | |COCHRAN-ARMITAGE | P=0.055 | P=0.002 ** | |FISHER EXACT | P=0.181 P=0.742 P=0.056 | P=0.495 P<0.001 ** P=0.001 ** | |=================================================================================================================================| DATE: 07/25/96 EXPERIMENT: 05156 TEST: 05 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 1 COBALT SULFATE HEPTAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.3 1.0 3.0 | CONTROL 0.3 1.0 3.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 3/48 (6%) 1/50 (2%) | 0/50 (0%) 2/49 (4%) 6/50 (12%) 6/50 (12%) | |ADJUSTED (b) | 0.0% 0.0% 11.3% 6.7% | 0.0% 8.0% 20.2% 17.5% | |TERMINAL (d) | 0/17 (0%) 0/15 (0%) 1/21 (5%) 1/15 (7%) | 0/28 (0%) 2/25 (8%) 4/26 (15%) 4/30 (13%) | |FIRST INCIDENCE (DAYS) | --- --- 652 734 (T) | --- 735 (T) 694 610 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.355 (e) P=0.181 P=0.475 | P=0.033 * P=0.213 P=0.015 * P=0.022 * | |INCIDENTAL TUMOR | P=0.349 (e) P=0.192 P=0.475 | P=0.028 * P=0.213 P=0.017 * P=0.016 * | |LOGISTIC REGRESSION | P=0.360 (e) P=0.136 P=0.475 | P=0.023 * P=0.213 P=0.015 * P=0.017 * | |COCHRAN-ARMITAGE | P=0.382 | P=0.022 * | |FISHER EXACT | (e) P=0.114 P=0.500 | P=0.242 P=0.013 * P=0.013 * | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 4/50 (8%) 4/48 (8%) 7/50 (14%) | 0/50 (0%) 3/49 (6%) 15/50 (30%) 15/50 (30%) | |ADJUSTED (b) | 2.3% 17.7% 13.4% 33.9% | 0.0% 11.2% 50.6% 46.1% | |TERMINAL (d) | 0/17 (0%) 2/15 (13%) 1/21 (5%) 3/15 (20%) | 0/28 (0%) 2/25 (8%) 12/26 (46%) 13/30 (43%) | |FIRST INCIDENCE (DAYS) | 568 589 611 638 | --- 714 692 610 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.027 * P=0.187 P=0.263 P=0.030 * | P<0.001 ** P=0.101 P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.033 * P=0.124 P=0.131 P=0.034 * | P<0.001 ** P=0.109 P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | P=0.032 * P=0.179 P=0.163 P=0.029 * | P<0.001 ** P=0.096 P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.038 * | P<0.001 ** | |FISHER EXACT | P=0.181 P=0.168 P=0.030 * | P=0.117 P<0.001 ** P<0.001 ** | |=================================================================================================================================| DATE: 07/25/96 EXPERIMENT: 05156 TEST: 05 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 1 COBALT SULFATE HEPTAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.3 1.0 3.0 | CONTROL 0.3 1.0 3.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Mammary Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 5.1% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/17 (0%) 0/15 (0%) 0/21 (0%) 0/15 (0%) | 0/28 (0%) 0/25 (0%) 0/26 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 572 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.242N P=0.274N P=0.258N P=0.249N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.267N P=0.314N P=0.262N P=0.301N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.227N P=0.209N P=0.219N P=0.214N | |COCHRAN-ARMITAGE | (e) | P=0.241N | |FISHER EXACT | (e) (e) (e) | P=0.253N P=0.247N P=0.247N | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 3/50 (6%) 2/49 (4%) 5/50 (10%) 5/50 (10%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 8.5% 5.4% 15.9% 15.9% | |TERMINAL (d) | 0/17 (0%) 0/15 (0%) 0/21 (0%) 0/15 (0%) | 1/28 (4%) 0/25 (0%) 2/26 (8%) 4/30 (13%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 638 526 695 693 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.247 P=0.555N P=0.333 P=0.370 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.205 P=0.438N P=0.342 P=0.339 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.216 P=0.471N P=0.341 P=0.342 | |COCHRAN-ARMITAGE | (e) | P=0.217 | |FISHER EXACT | (e) (e) (e) | P=0.510N P=0.357 P=0.357 | |=================================================================================================================================| DATE: 07/25/96 EXPERIMENT: 05156 TEST: 05 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 1 COBALT SULFATE HEPTAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.3 1.0 3.0 | CONTROL 0.3 1.0 3.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 5/50 (10%) 2/49 (4%) 5/50 (10%) 5/50 (10%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 13.2% 5.4% 15.9% 15.9% | |TERMINAL (d) | 0/17 (0%) 0/15 (0%) 0/21 (0%) 0/15 (0%) | 1/28 (4%) 0/25 (0%) 2/26 (8%) 4/30 (13%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 572 526 695 693 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.423 P=0.280N P=0.589 P=0.621N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.365 P=0.205N P=0.604 P=0.578 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.390 P=0.182N P=0.626 P=0.622 | |COCHRAN-ARMITAGE | (e) | P=0.393 | |FISHER EXACT | (e) (e) (e) | P=0.226N P=0.630N P=0.630N | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 2/50 (4%) 4/50 (8%) | 22/50 (44%) 22/49 (45%) 20/50 (40%) 27/50 (54%) | |ADJUSTED (b) | 17.6% 6.7% 7.6% 21.2% | 54.6% 67.3% 56.5% 70.5% | |TERMINAL (d) | 3/17 (18%) 1/15 (7%) 1/21 (5%) 2/15 (13%) | 11/28 (39%) 15/25 (60%) 12/26 (46%) 19/30 (63%) | |FIRST INCIDENCE (DAYS) | 734 (T) 734 (T) 652 611 | 569 610 510 386 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.199 P=0.346N P=0.391N P=0.449 | P=0.291 P=0.386 P=0.524N P=0.280 | |INCIDENTAL TUMOR | P=0.203 P=0.346N P=0.383N P=0.462 | P=0.170 P=0.303 P=0.481N P=0.205 | |LOGISTIC REGRESSION | P=0.203 P=0.346N P=0.398N P=0.475 | P=0.147 P=0.439 P=0.435N P=0.182 | |COCHRAN-ARMITAGE | P=0.240 | P=0.153 | |FISHER EXACT | P=0.309N P=0.500N P=0.500 | P=0.545 P=0.420N P=0.212 | |=================================================================================================================================| DATE: 07/25/96 EXPERIMENT: 05156 TEST: 05 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 1 COBALT SULFATE HEPTAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.3 1.0 3.0 | CONTROL 0.3 1.0 3.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 2/50 (4%) 4/50 (8%) | 23/50 (46%) 22/49 (45%) 20/50 (40%) 27/50 (54%) | |ADJUSTED (b) | 17.6% 6.7% 7.6% 21.2% | 55.6% 67.3% 56.5% 70.5% | |TERMINAL (d) | 3/17 (18%) 1/15 (7%) 1/21 (5%) 2/15 (13%) | 11/28 (39%) 15/25 (60%) 12/26 (46%) 19/30 (63%) | |FIRST INCIDENCE (DAYS) | 734 (T) 734 (T) 652 611 | 569 610 510 386 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.199 P=0.346N P=0.391N P=0.449 | P=0.334 P=0.452 P=0.457N P=0.343 | |INCIDENTAL TUMOR | P=0.203 P=0.346N P=0.383N P=0.462 | P=0.202 P=0.353 P=0.413N P=0.252 | |LOGISTIC REGRESSION | P=0.203 P=0.346N P=0.398N P=0.475 | P=0.179 P=0.535 P=0.349N P=0.244 | |COCHRAN-ARMITAGE | P=0.240 | P=0.186 | |FISHER EXACT | P=0.309N P=0.500N P=0.500 | P=0.537N P=0.343N P=0.274 | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 2/50 (4%) 4/50 (8%) | 25/50 (50%) 23/49 (47%) 24/50 (48%) 29/50 (58%) | |ADJUSTED (b) | 17.6% 6.7% 7.6% 21.2% | 59.2% 68.1% 65.0% 74.0% | |TERMINAL (d) | 3/17 (18%) 1/15 (7%) 1/21 (5%) 2/15 (13%) | 12/28 (43%) 15/25 (60%) 14/26 (54%) 20/30 (67%) | |FIRST INCIDENCE (DAYS) | 734 (T) 734 (T) 652 611 | 569 526 510 386 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.199 P=0.346N P=0.391N P=0.449 | P=0.324 P=0.511 P=0.528 P=0.348 | |INCIDENTAL TUMOR | P=0.203 P=0.346N P=0.383N P=0.462 | P=0.176 P=0.460 P=0.572 P=0.239 | |LOGISTIC REGRESSION | P=0.203 P=0.346N P=0.398N P=0.475 | P=0.160 P=0.527N P=0.513N P=0.242 | |COCHRAN-ARMITAGE | P=0.240 | P=0.168 | |FISHER EXACT | P=0.309N P=0.500N P=0.500 | P=0.459N P=0.500N P=0.274 | |=================================================================================================================================| DATE: 07/25/96 EXPERIMENT: 05156 TEST: 05 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 1 COBALT SULFATE HEPTAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.3 1.0 3.0 | CONTROL 0.3 1.0 3.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Papilloma Squamous or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 2/49 (4%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 3.6% 8.0% 0.0% 0.0% | |TERMINAL (d) | 0/17 (0%) 0/15 (0%) 0/21 (0%) 0/15 (0%) | 1/28 (4%) 2/25 (8%) 0/26 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 735 (T) 735 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.192N P=0.460 P=0.515N P=0.486N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.192N P=0.460 P=0.515N P=0.486N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.192N P=0.460 P=0.515N P=0.486N | |COCHRAN-ARMITAGE | (e) | P=0.208N | |FISHER EXACT | (e) (e) (e) | P=0.492 P=0.500N P=0.500N | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 2/49 (4%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 3.6% 8.0% 0.0% 0.0% | |TERMINAL (d) | 0/17 (0%) 0/15 (0%) 0/21 (0%) 0/15 (0%) | 1/28 (4%) 2/25 (8%) 0/26 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 735 (T) 735 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.192N P=0.460 P=0.515N P=0.486N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.192N P=0.460 P=0.515N P=0.486N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.192N P=0.460 P=0.515N P=0.486N | |COCHRAN-ARMITAGE | (e) | P=0.208N | |FISHER EXACT | (e) (e) (e) | P=0.492 P=0.500N P=0.500N | |=================================================================================================================================| DATE: 07/25/96 EXPERIMENT: 05156 TEST: 05 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 1 COBALT SULFATE HEPTAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.3 1.0 3.0 | CONTROL 0.3 1.0 3.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Oral Mucosa | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 2/49 (4%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 3.6% 8.0% 0.0% 0.0% | |TERMINAL (d) | 0/17 (0%) 0/15 (0%) 0/21 (0%) 0/15 (0%) | 1/28 (4%) 2/25 (8%) 0/26 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 735 (T) 735 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.192N P=0.460 P=0.515N P=0.486N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.192N P=0.460 P=0.515N P=0.486N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.192N P=0.460 P=0.515N P=0.486N | |COCHRAN-ARMITAGE | (e) | P=0.208N | |FISHER EXACT | (e) (e) (e) | P=0.492 P=0.500N P=0.500N | |=================================================================================================================================| | | |Pancreas | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/48 (4%) 1/50 (2%) | 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/48 (0%) | |ADJUSTED (b) | 0.0% 0.0% 8.2% 5.3% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/17 (0%) 0/15 (0%) 1/21 (5%) 0/15 (0%) | 0/28 (0%) 0/25 (0%) 0/26 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 678 693 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.330 (e) P=0.291 P=0.511 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.320 (e) P=0.313 P=0.540 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.332 (e) P=0.271 P=0.495 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.351 | (e) | |FISHER EXACT | (e) P=0.237 P=0.500 | (e) (e) (e) | |=================================================================================================================================| DATE: 07/25/96 EXPERIMENT: 05156 TEST: 05 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 1 COBALT SULFATE HEPTAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.3 1.0 3.0 | CONTROL 0.3 1.0 3.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 43/49 (88%) 40/49 (82%) 42/50 (84%) 41/49 (84%) | 40/50 (80%) 39/49 (80%) 38/50 (76%) 40/49 (82%) | |ADJUSTED (b) | 97.4% 100.0% 89.3% 95.1% | 86.8% 95.0% 90.3% 90.8% | |TERMINAL (d) | 15/16 (94%) 15/15 (100%) 16/21 (76%) 13/15 (87%) | 22/28 (79%) 23/25 (92%) 22/26 (85%) 26/30 (87%) | |FIRST INCIDENCE (DAYS) | 435 471 467 401 | 569 420 510 386 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.455 P=0.340N P=0.121N P=0.509N | P=0.350N P=0.336 P=0.530 P=0.491N | |INCIDENTAL TUMOR | P=0.484N P=0.294N P=0.511N P=0.392N | P=0.483 P=0.319 P=0.524N P=0.348 | |LOGISTIC REGRESSION | P=0.485N P=0.269N P=0.376N P=0.386N | P=0.450 P=0.451 P=0.474N P=0.449 | |COCHRAN-ARMITAGE | P=0.474N | P=0.450 | |FISHER EXACT | P=0.288N P=0.403N P=0.387N | P=0.579N P=0.405N P=0.520 | |=================================================================================================================================| | | |Prostate | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 4/49 (8%) 1/50 (2%) | | |ADJUSTED (b) | 5.9% 10.7% 17.1% 6.7% | | |TERMINAL (d) | 1/17 (6%) 1/15 (7%) 3/21 (14%) 1/15 (7%) | | |FIRST INCIDENCE (DAYS) | 734 (T) 680 673 734 (T) | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.537N P=0.481 P=0.250 P=0.736 | | |INCIDENTAL TUMOR | P=0.540N P=0.537 P=0.262 P=0.736 | | |LOGISTIC REGRESSION | P=0.533N P=0.508 P=0.251 P=0.736 | | |COCHRAN-ARMITAGE | P=0.500N | | |FISHER EXACT | P=0.500 P=0.175 P=0.753N | | |=================================================================================================================================| DATE: 07/25/96 EXPERIMENT: 05156 TEST: 05 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 1 COBALT SULFATE HEPTAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.3 1.0 3.0 | CONTROL 0.3 1.0 3.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Skin | | Basal Cell Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 11.8% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 3.2% | |TERMINAL (d) | 2/17 (12%) 0/15 (0%) 0/21 (0%) 0/15 (0%) | 0/28 (0%) 0/25 (0%) 0/26 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | 734 (T) --- --- --- | --- --- --- 722 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.246N P=0.264N P=0.191N P=0.264N | P=0.216 (e) (e) P=0.494 | |INCIDENTAL TUMOR | P=0.246N P=0.264N P=0.191N P=0.264N | P=0.199 (e) (e) P=0.484 | |LOGISTIC REGRESSION | P=0.246N P=0.264N P=0.191N P=0.264N | P=0.217 (e) (e) P=0.493 | |COCHRAN-ARMITAGE | P=0.242N | P=0.215 | |FISHER EXACT | P=0.247N P=0.247N P=0.247N | (e) (e) P=0.500 | |=================================================================================================================================| | | |Skin | | Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign, | | malignant or NOS), or Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 11.8% 0.0% 0.0% 6.7% | 0.0% 0.0% 0.0% 3.2% | |TERMINAL (d) | 2/17 (12%) 0/15 (0%) 0/21 (0%) 1/15 (7%) | 0/28 (0%) 0/25 (0%) 0/26 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | 734 (T) --- --- 734 (T) | --- --- --- 722 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.680N P=0.264N P=0.191N P=0.545N | P=0.216 (e) (e) P=0.494 | |INCIDENTAL TUMOR | P=0.680N P=0.264N P=0.191N P=0.545N | P=0.199 (e) (e) P=0.484 | |LOGISTIC REGRESSION | P=0.680N P=0.264N P=0.191N P=0.545N | P=0.217 (e) (e) P=0.493 | |COCHRAN-ARMITAGE | P=0.650N | P=0.215 | |FISHER EXACT | P=0.247N P=0.247N P=0.500N | (e) (e) P=0.500 | |=================================================================================================================================| DATE: 07/25/96 EXPERIMENT: 05156 TEST: 05 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 1 COBALT SULFATE HEPTAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.3 1.0 3.0 | CONTROL 0.3 1.0 3.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Skin | | Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal | | Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 5/50 (10%) 0/50 (0%) 5/50 (10%) | 1/50 (2%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 22.2% 17.8% 0.0% 33.3% | 3.6% 0.0% 0.0% 3.2% | |TERMINAL (d) | 3/17 (18%) 1/15 (7%) 0/21 (0%) 5/15 (33%) | 1/28 (4%) 0/25 (0%) 0/26 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | 727 589 --- 734 (T) | 735 (T) --- --- 722 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.406 P=0.493 P=0.040N* P=0.413 | P=0.551 P=0.523N P=0.515N P=0.756N | |INCIDENTAL TUMOR | P=0.426 P=0.491 P=0.034N* P=0.441 | P=0.541 P=0.523N P=0.515N P=0.759 | |LOGISTIC REGRESSION | P=0.420 P=0.526 P=0.033N* P=0.414 | P=0.538 P=0.523N P=0.515N P=0.753 | |COCHRAN-ARMITAGE | P=0.458 | P=0.538 | |FISHER EXACT | P=0.500 P=0.059N P=0.500 | P=0.505N P=0.500N P=0.753N | |=================================================================================================================================| | | |Skin | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 2/50 (4%) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 6.3% 7.9% 10.4% | 0.0% 0.0% 0.0% 3.3% | |TERMINAL (d) | 0/17 (0%) 0/15 (0%) 1/21 (5%) 1/15 (7%) | 0/28 (0%) 0/25 (0%) 0/26 (0%) 1/30 (3%) | |FIRST INCIDENCE (DAYS) | --- 722 673 663 | --- --- --- 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.198 P=0.477 P=0.293 P=0.230 | P=0.236 (e) (e) P=0.514 | |INCIDENTAL TUMOR | P=0.192 P=0.615 P=0.313 P=0.247 | P=0.236 (e) (e) P=0.514 | |LOGISTIC REGRESSION | P=0.204 P=0.500 P=0.272 P=0.230 | P=0.236 (e) (e) P=0.514 | |COCHRAN-ARMITAGE | P=0.228 | P=0.215 | |FISHER EXACT | P=0.500 P=0.247 P=0.247 | (e) (e) P=0.500 | |=================================================================================================================================| DATE: 07/25/96 EXPERIMENT: 05156 TEST: 05 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 1 COBALT SULFATE HEPTAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.3 1.0 3.0 | CONTROL 0.3 1.0 3.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 2/50 (4%) 5/50 (10%) | 0/50 (0%) 0/49 (0%) 1/50 (2%) 2/50 (4%) | |ADJUSTED (b) | 0.0% 15.4% 7.9% 25.9% | 0.0% 0.0% 2.2% 5.5% | |TERMINAL (d) | 0/17 (0%) 1/15 (7%) 1/21 (5%) 2/15 (13%) | 0/28 (0%) 0/25 (0%) 0/26 (0%) 1/30 (3%) | |FIRST INCIDENCE (DAYS) | --- 646 673 663 | --- --- 568 632 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.033 * P=0.120 P=0.293 P=0.031 * | P=0.098 (e) P=0.487 P=0.250 | |INCIDENTAL TUMOR | P=0.026 * P=0.183 P=0.313 P=0.037 * | P=0.069 (e) P=0.443 P=0.196 | |LOGISTIC REGRESSION | P=0.031 * P=0.126 P=0.272 P=0.028 * | P=0.094 (e) P=0.543 P=0.239 | |COCHRAN-ARMITAGE | P=0.044 * | P=0.085 | |FISHER EXACT | P=0.121 P=0.247 P=0.028 * | (e) P=0.500 P=0.247 | |=================================================================================================================================| | | |Skin | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 9.8% 3.3% 12.5% | 0.0% 0.0% 2.2% 0.0% | |TERMINAL (d) | 0/17 (0%) 1/15 (7%) 0/21 (0%) 1/15 (7%) | 0/28 (0%) 0/25 (0%) 0/26 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | --- 646 673 720 | --- --- 568 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.287 P=0.245 P=0.553 P=0.213 | P=0.781N (e) P=0.487 (e) | |INCIDENTAL TUMOR | P=0.280 P=0.286 P=0.588 P=0.247 | P=0.801 (e) P=0.443 (e) | |LOGISTIC REGRESSION | P=0.294 P=0.246 P=0.509 P=0.217 | P=0.742N (e) P=0.543 (e) | |COCHRAN-ARMITAGE | P=0.318 | P=0.785N | |FISHER EXACT | P=0.247 P=0.500 P=0.247 | (e) P=0.500 (e) | |=================================================================================================================================| DATE: 07/25/96 EXPERIMENT: 05156 TEST: 05 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 1 COBALT SULFATE HEPTAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.3 1.0 3.0 | CONTROL 0.3 1.0 3.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 3/50 (6%) | 0/50 (0%) 0/49 (0%) 1/50 (2%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 9.8% 3.3% 16.9% | 0.0% 0.0% 2.2% 2.3% | |TERMINAL (d) | 0/17 (0%) 1/15 (7%) 0/21 (0%) 1/15 (7%) | 0/28 (0%) 0/25 (0%) 0/26 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | --- 646 673 692 | --- --- 568 632 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.113 P=0.245 P=0.553 P=0.113 | P=0.316 (e) P=0.487 P=0.505 | |INCIDENTAL TUMOR | P=0.101 P=0.286 P=0.588 P=0.136 | P=0.249 (e) P=0.443 P=0.406 | |LOGISTIC REGRESSION | P=0.113 P=0.246 P=0.509 P=0.109 | P=0.354 (e) P=0.543 P=0.527 | |COCHRAN-ARMITAGE | P=0.132 | P=0.305 | |FISHER EXACT | P=0.247 P=0.500 P=0.121 | (e) P=0.500 P=0.500 | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 5/50 (10%) 0/50 (0%) 3/50 (6%) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 11.1% 17.8% 0.0% 20.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/17 (6%) 1/15 (7%) 0/21 (0%) 3/15 (20%) | 0/28 (0%) 0/25 (0%) 0/26 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | 727 589 --- 734 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.602 P=0.231 P=0.196N P=0.437 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.601N P=0.223 P=0.171N P=0.472 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.608N P=0.227 P=0.183N P=0.445 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.582N | (e) | |FISHER EXACT | P=0.218 P=0.247N P=0.500 | (e) (e) (e) | |=================================================================================================================================| DATE: 07/25/96 EXPERIMENT: 05156 TEST: 05 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 1 COBALT SULFATE HEPTAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.3 1.0 3.0 | CONTROL 0.3 1.0 3.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Skin | | Lipoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 6.7% 3.2% 6.7% | 6.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/17 (0%) 1/15 (7%) 0/21 (0%) 1/15 (7%) | 1/28 (4%) 0/25 (0%) 0/26 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | --- 734 (T) 671 734 (T) | 709 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.460 P=0.475 P=0.560 P=0.475 | P=0.238N P=0.269N P=0.254N P=0.242N | |INCIDENTAL TUMOR | P=0.460 P=0.475 P=0.588 P=0.475 | P=0.240N P=0.252N P=0.240N P=0.241N | |LOGISTIC REGRESSION | P=0.467 P=0.475 P=0.508 P=0.475 | P=0.241N P=0.264N P=0.247N P=0.245N | |COCHRAN-ARMITAGE | P=0.485 | P=0.241N | |FISHER EXACT | P=0.500 P=0.500 P=0.500 | P=0.253N P=0.247N P=0.247N | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 5/50 (10%) 0/50 (0%) 4/50 (8%) | 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 11.1% 17.8% 0.0% 26.7% | 3.6% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/17 (6%) 1/15 (7%) 0/21 (0%) 4/15 (27%) | 1/28 (4%) 0/25 (0%) 0/26 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | 727 589 --- 734 (T) | 735 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.385 P=0.231 P=0.196N P=0.272 | P=0.456N P=0.523N P=0.515N P=0.486N | |INCIDENTAL TUMOR | P=0.407 P=0.223 P=0.171N P=0.300 | P=0.456N P=0.523N P=0.515N P=0.486N | |LOGISTIC REGRESSION | P=0.400 P=0.227 P=0.183N P=0.271 | P=0.456N P=0.523N P=0.515N P=0.486N | |COCHRAN-ARMITAGE | P=0.429 | P=0.473N | |FISHER EXACT | P=0.218 P=0.247N P=0.339 | P=0.505N P=0.500N P=0.500N | |=================================================================================================================================| DATE: 07/25/96 EXPERIMENT: 05156 TEST: 05 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 1 COBALT SULFATE HEPTAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.3 1.0 3.0 | CONTROL 0.3 1.0 3.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 5/50 (10%) 0/50 (0%) 4/50 (8%) | 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 11.1% 17.8% 0.0% 26.7% | 3.6% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/17 (6%) 1/15 (7%) 0/21 (0%) 4/15 (27%) | 1/28 (4%) 0/25 (0%) 0/26 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | 727 589 --- 734 (T) | 735 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.385 P=0.231 P=0.196N P=0.272 | P=0.456N P=0.523N P=0.515N P=0.486N | |INCIDENTAL TUMOR | P=0.407 P=0.223 P=0.171N P=0.300 | P=0.456N P=0.523N P=0.515N P=0.486N | |LOGISTIC REGRESSION | P=0.400 P=0.227 P=0.183N P=0.271 | P=0.456N P=0.523N P=0.515N P=0.486N | |COCHRAN-ARMITAGE | P=0.429 | P=0.473N | |FISHER EXACT | P=0.218 P=0.247N P=0.339 | P=0.505N P=0.500N P=0.500N | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 35/50 (70%) 31/50 (62%) 33/50 (66%) 29/50 (58%) | | |ADJUSTED (b) | 94.3% 90.5% 88.7% 92.7% | | |TERMINAL (d) | 15/17 (88%) 12/15 (80%) 17/21 (81%) 13/15 (87%) | | |FIRST INCIDENCE (DAYS) | 568 475 534 526 | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.369N P=0.321N P=0.093N P=0.319N | | |INCIDENTAL TUMOR | P=0.237N P=0.160N P=0.272N P=0.153N | | |LOGISTIC REGRESSION | P=0.236N P=0.142N P=0.185N P=0.145N | | |COCHRAN-ARMITAGE | P=0.179N | | |FISHER EXACT | P=0.263N P=0.415N P=0.149N | | |=================================================================================================================================| DATE: 07/25/96 EXPERIMENT: 05156 TEST: 05 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 1 COBALT SULFATE HEPTAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.3 1.0 3.0 | CONTROL 0.3 1.0 3.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/49 (8%) 2/50 (4%) 3/48 (6%) 4/50 (8%) | 6/49 (12%) 6/49 (12%) 7/50 (14%) 3/48 (6%) | |ADJUSTED (b) | 18.8% 13.3% 12.1% 20.3% | 21.4% 19.1% 24.5% 8.3% | |TERMINAL (d) | 2/17 (12%) 2/15 (13%) 2/21 (10%) 2/15 (13%) | 6/28 (21%) 3/25 (12%) 5/26 (19%) 1/30 (3%) | |FIRST INCIDENCE (DAYS) | 645 734 (T) 649 586 | 735 (T) 517 722 611 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.391 P=0.358N P=0.368N P=0.602 | P=0.139N P=0.540 P=0.449 P=0.220N | |INCIDENTAL TUMOR | P=0.393 P=0.286N P=0.334N P=0.642N | P=0.167N P=0.505N P=0.469 P=0.264N | |LOGISTIC REGRESSION | P=0.406 P=0.316N P=0.426N P=0.634 | P=0.177N P=0.597 P=0.469 P=0.254N | |COCHRAN-ARMITAGE | P=0.447 | P=0.184N | |FISHER EXACT | P=0.329N P=0.512N P=0.631N | P=0.620N P=0.516 P=0.254N | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/49 (6%) 3/50 (6%) 4/48 (8%) 3/50 (6%) | 3/49 (6%) 0/49 (0%) 2/50 (4%) 3/48 (6%) | |ADJUSTED (b) | 12.4% 13.6% 13.6% 15.3% | 10.0% 0.0% 6.5% 9.3% | |TERMINAL (d) | 1/17 (6%) 1/15 (7%) 1/21 (5%) 2/15 (13%) | 2/28 (7%) 0/25 (0%) 0/26 (0%) 2/30 (7%) | |FIRST INCIDENCE (DAYS) | 435 576 582 562 | 721 --- 709 686 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.569 P=0.647 P=0.597 P=0.631 | P=0.365 P=0.147N P=0.528N P=0.651N | |INCIDENTAL TUMOR | P=0.596N P=0.614N P=0.567 P=0.654N | P=0.351 P=0.131N P=0.471N P=0.641N | |LOGISTIC REGRESSION | P=0.587N P=0.656N P=0.479 P=0.655N | P=0.340 P=0.140N P=0.511N P=0.653 | |COCHRAN-ARMITAGE | P=0.582N | P=0.323 | |FISHER EXACT | P=0.651N P=0.488 P=0.651N | P=0.121N P=0.490N P=0.651 | |=================================================================================================================================| DATE: 07/25/96 EXPERIMENT: 05156 TEST: 05 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 1 COBALT SULFATE HEPTAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.3 1.0 3.0 | CONTROL 0.3 1.0 3.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/49 (14%) 5/50 (10%) 6/48 (13%) 7/50 (14%) | 9/49 (18%) 6/49 (12%) 9/50 (18%) 6/48 (13%) | |ADJUSTED (b) | 29.5% 25.9% 22.3% 34.1% | 30.7% 19.1% 29.4% 17.0% | |TERMINAL (d) | 3/17 (18%) 3/15 (20%) 3/21 (14%) 4/15 (27%) | 8/28 (29%) 3/25 (12%) 5/26 (19%) 3/30 (10%) | |FIRST INCIDENCE (DAYS) | 435 576 582 562 | 721 517 709 611 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.394 P=0.408N P=0.349N P=0.558 | P=0.277N P=0.376N P=0.543 P=0.263N | |INCIDENTAL TUMOR | P=0.420 P=0.306N P=0.349N P=0.606N | P=0.320N P=0.198N P=0.595 P=0.294N | |LOGISTIC REGRESSION | P=0.430 P=0.353N P=0.479N P=0.609 | P=0.339N P=0.326N P=0.578 P=0.303N | |COCHRAN-ARMITAGE | P=0.466 | P=0.357N | |FISHER EXACT | P=0.365N P=0.516N P=0.597N | P=0.288N P=0.584N P=0.303N | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 2/50 (4%) 0/48 (0%) 0/50 (0%) | 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/48 (0%) | |ADJUSTED (b) | 5.9% 12.2% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/17 (6%) 1/15 (7%) 0/21 (0%) 0/15 (0%) | 0/28 (0%) 0/25 (0%) 0/26 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | 734 (T) 719 --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.217N P=0.464 P=0.458N P=0.525N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.215N P=0.537 P=0.458N P=0.525N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.211N P=0.484 P=0.458N P=0.525N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.208N | (e) | |FISHER EXACT | P=0.508 P=0.505N P=0.495N | (e) (e) (e) | |=================================================================================================================================| DATE: 07/25/96 EXPERIMENT: 05156 TEST: 05 PAGE 22 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 1 COBALT SULFATE HEPTAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.3 1.0 3.0 | CONTROL 0.3 1.0 3.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 3/50 (6%) 0/48 (0%) 1/50 (2%) | 0/49 (0%) 1/49 (2%) 0/50 (0%) 1/48 (2%) | |ADJUSTED (b) | 5.9% 16.0% 0.0% 6.7% | 0.0% 2.3% 0.0% 2.4% | |TERMINAL (d) | 1/17 (6%) 1/15 (7%) 0/21 (0%) 1/15 (7%) | 0/28 (0%) 0/25 (0%) 0/26 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | 734 (T) 680 --- 734 (T) | --- 526 --- 652 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.453N P=0.288 P=0.458N P=0.736 | P=0.468 P=0.479 (e) P=0.500 | |INCIDENTAL TUMOR | P=0.454N P=0.384 P=0.458N P=0.736 | P=0.410 P=0.846 (e) P=0.500 | |LOGISTIC REGRESSION | P=0.448N P=0.309 P=0.458N P=0.736 | P=0.525 P=0.610 (e) P=0.511 | |COCHRAN-ARMITAGE | P=0.423N | P=0.458 | |FISHER EXACT | P=0.316 P=0.505N P=0.747N | P=0.500 (e) P=0.495 | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 8/50 (16%) 7/49 (14%) 11/50 (22%) 4/50 (8%) | |ADJUSTED (b) | | 23.9% 20.0% 35.6% 13.3% | |TERMINAL (d) | | 5/28 (18%) 3/25 (12%) 8/26 (31%) 4/30 (13%) | |FIRST INCIDENCE (DAYS) | | 569 483 600 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.113N P=0.585N P=0.254 P=0.159N | |INCIDENTAL TUMOR | | P=0.143N P=0.503N P=0.221 P=0.193N | |LOGISTIC REGRESSION | | P=0.146N P=0.467N P=0.294 P=0.189N | |COCHRAN-ARMITAGE | | P=0.144N | |FISHER EXACT | | P=0.517N P=0.306 P=0.178N | |=================================================================================================================================| DATE: 07/25/96 EXPERIMENT: 05156 TEST: 05 PAGE 23 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 1 COBALT SULFATE HEPTAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.3 1.0 3.0 | CONTROL 0.3 1.0 3.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 1/50 (2%) 2/49 (4%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | | 3.1% 4.4% 0.0% 0.0% | |TERMINAL (d) | | 0/28 (0%) 0/25 (0%) 0/26 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | | 727 362 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.209N P=0.470 P=0.520N P=0.513N | |INCIDENTAL TUMOR | | P=0.177N P=0.686 P=0.485N P=0.516N | |LOGISTIC REGRESSION | | P=0.130N P=0.646 P=0.510N P=0.509N | |COCHRAN-ARMITAGE | | P=0.208N | |FISHER EXACT | | P=0.492 P=0.500N P=0.500N | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 9/50 (18%) 9/49 (18%) 11/50 (22%) 4/50 (8%) | |ADJUSTED (b) | | 26.3% 23.6% 35.6% 13.3% | |TERMINAL (d) | | 5/28 (18%) 3/25 (12%) 8/26 (31%) 4/30 (13%) | |FIRST INCIDENCE (DAYS) | | 569 362 600 735 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.059N P=0.507 P=0.341 P=0.108N | |INCIDENTAL TUMOR | | P=0.069N P=0.539N P=0.313 P=0.132N | |LOGISTIC REGRESSION | | P=0.071N P=0.513N P=0.387 P=0.126N | |COCHRAN-ARMITAGE | | P=0.074N | |FISHER EXACT | | P=0.584 P=0.402 P=0.117N | |=================================================================================================================================| DATE: 07/25/96 EXPERIMENT: 05156 TEST: 05 PAGE 24 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 1 COBALT SULFATE HEPTAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.3 1.0 3.0 | CONTROL 0.3 1.0 3.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 1/49 (2%) 1/50 (2%) 0/50 (0%) | |ADJUSTED (b) | 2.2% 0.0% 0.0% 4.4% | 0.0% 2.4% 3.4% 0.0% | |TERMINAL (d) | 0/17 (0%) 0/15 (0%) 0/21 (0%) 0/15 (0%) | 0/28 (0%) 0/25 (0%) 0/26 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | 527 --- --- 401 | --- 610 727 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.185 P=0.500N P=0.509N P=0.492 | P=0.526N P=0.486 P=0.480 (e) | |INCIDENTAL TUMOR | P=0.236 P=0.536N P=0.500N P=0.530 | P=0.573N P=0.362 P=0.515 (e) | |LOGISTIC REGRESSION | P=0.201 P=0.497N P=0.458N P=0.592 | P=0.528N P=0.550 P=0.490 (e) | |COCHRAN-ARMITAGE | P=0.189 | P=0.534N | |FISHER EXACT | P=0.500N P=0.500N P=0.500 | P=0.495 P=0.500 (e) | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 30/50 (60%) 32/50 (64%) 29/50 (58%) 28/50 (56%) | 15/50 (30%) 16/49 (33%) 19/50 (38%) 10/50 (20%) | |ADJUSTED (b) | 77.3% 80.6% 74.9% 75.6% | 37.4% 41.1% 47.7% 25.6% | |TERMINAL (d) | 9/17 (53%) 8/15 (53%) 12/21 (57%) 8/15 (53%) | 5/28 (18%) 5/25 (20%) 7/26 (27%) 3/30 (10%) | |FIRST INCIDENCE (DAYS) | 453 475 435 463 | 385 483 526 470 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.468N P=0.501 P=0.199N P=0.507N | P=0.107N P=0.367 P=0.242 P=0.217N | |INCIDENTAL TUMOR | P=0.306N P=0.509 P=0.571N P=0.425N | P=0.130N P=0.523 P=0.295 P=0.162N | |LOGISTIC REGRESSION | P=0.313N P=0.433 P=0.467N P=0.420N | P=0.091N P=0.529 P=0.273 P=0.166N | |COCHRAN-ARMITAGE | P=0.297N | P=0.095N | |FISHER EXACT | P=0.418 P=0.500N P=0.420N | P=0.473 P=0.263 P=0.178N | |=================================================================================================================================| DATE: 07/25/96 EXPERIMENT: 05156 TEST: 05 PAGE 25 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 1 COBALT SULFATE HEPTAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.3 1.0 3.0 | CONTROL 0.3 1.0 3.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 2/50 (4%) 2/50 (4%) | 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 10.2% 11.1% 6.5% 9.3% | 0.0% 2.4% 0.0% 0.0% | |TERMINAL (d) | 0/17 (0%) 1/15 (7%) 0/21 (0%) 1/15 (7%) | 0/28 (0%) 0/25 (0%) 0/26 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | 589 681 649 603 | --- 610 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.523N P=0.477N P=0.397N P=0.517N | P=0.563N P=0.486 (e) (e) | |INCIDENTAL TUMOR | P=0.507N P=0.454N P=0.523N P=0.509N | P=0.615N P=0.362 (e) (e) | |LOGISTIC REGRESSION | P=0.498N P=0.494N P=0.507N P=0.501N | P=0.541N P=0.550 (e) (e) | |COCHRAN-ARMITAGE | P=0.491N | P=0.575N | |FISHER EXACT | P=0.500N P=0.500N P=0.500N | P=0.495 (e) (e) | |=================================================================================================================================| | | |All Organs | | Osteosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 11.4% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/17 (0%) 0/15 (0%) 0/21 (0%) 0/15 (0%) | 0/28 (0%) 0/25 (0%) 0/26 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | --- 631 --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.258N P=0.146 (e) (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.261N P=0.173 (e) (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.257N P=0.123 (e) (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.255N | (e) | |FISHER EXACT | P=0.121 (e) (e) | (e) (e) (e) | |=================================================================================================================================| DATE: 07/25/96 EXPERIMENT: 05156 TEST: 05 PAGE 26 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 1 COBALT SULFATE HEPTAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.3 1.0 3.0 | CONTROL 0.3 1.0 3.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |All Organs | | Osteosarcoma or Osteoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 11.4% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/17 (0%) 0/15 (0%) 0/21 (0%) 0/15 (0%) | 0/28 (0%) 0/25 (0%) 0/26 (0%) 0/30 (0%) | |FIRST INCIDENCE (DAYS) | --- 631 --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.258N P=0.146 (e) (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.261N P=0.173 (e) (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.257N P=0.123 (e) (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.255N | (e) | |FISHER EXACT | P=0.121 (e) (e) | (e) (e) (e) | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 48/50 (96%) 46/50 (92%) 47/50 (94%) 48/50 (96%) | 45/50 (90%) 44/49 (90%) 47/50 (94%) 44/50 (88%) | |ADJUSTED (b) | 97.9% 100.0% 97.9% 100.0% | 93.7% 95.6% 100.0% 97.8% | |TERMINAL (d) | 16/17 (94%) 15/15 (100%) 20/21 (95%) 15/15 (100%)| 25/28 (89%) 23/25 (92%) 26/26 (100%) 29/30 (97%) | |FIRST INCIDENCE (DAYS) | 435 471 467 401 | 569 420 510 386 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.317 P=0.419N P=0.125N P=0.437 | P=0.259N P=0.318 P=0.275 P=0.420N | |INCIDENTAL TUMOR | P=0.410 P=0.361N P=0.665N P=0.685N | P=0.440N P=0.439 P=0.125 P=0.601 | |LOGISTIC REGRESSION | P=0.385 P=0.319N P=0.517N P=0.687 | P=0.483N P=0.566 P=0.248 P=0.636N | |COCHRAN-ARMITAGE | P=0.434 | P=0.418N | |FISHER EXACT | P=0.339N P=0.500N P=0.691N | P=0.617N P=0.357 P=0.500N | |=================================================================================================================================| DATE: 07/25/96 EXPERIMENT: 05156 TEST: 05 PAGE 27 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 1 COBALT SULFATE HEPTAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.3 1.0 3.0 | CONTROL 0.3 1.0 3.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 38/50 (76%) 42/50 (84%) 35/50 (70%) 38/50 (76%) | 25/50 (50%) 23/49 (47%) 32/50 (64%) 27/50 (54%) | |ADJUSTED (b) | 89.9% 93.1% 78.9% 87.5% | 58.3% 54.9% 72.0% 65.0% | |TERMINAL (d) | 13/17 (76%) 12/15 (80%) 12/21 (57%) 10/15 (67%) | 11/28 (39%) 8/25 (32%) 14/26 (54%) 16/30 (53%) | |FIRST INCIDENCE (DAYS) | 435 408 272 401 | 385 362 355 470 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.490 P=0.386 P=0.115N P=0.469 | P=0.472 P=0.513 P=0.129 P=0.464 | |INCIDENTAL TUMOR | P=0.413N P=0.317 P=0.249N P=0.565N | P=0.296 P=0.380N P=0.141 P=0.370 | |LOGISTIC REGRESSION | P=0.396N P=0.241 P=0.329N P=0.592N | P=0.341 P=0.376N P=0.119 P=0.402 | |COCHRAN-ARMITAGE | P=0.395N | P=0.337 | |FISHER EXACT | P=0.227 P=0.326N P=0.592N | P=0.459N P=0.113 P=0.421 | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 50/50 (100%) 50/50 (100%) 50/50 (100%) 50/50 (100%)| 48/50 (96%) 47/49 (96%) 50/50 (100%) 46/50 (92%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 96.0% 95.9% 100.0% 97.9% | |TERMINAL (d) | 17/17 (100%) 15/15 (100%) 21/21 (100%) 15/15 (100%)| 26/28 (93%) 23/25 (92%) 26/26 (100%) 29/30 (97%) | |FIRST INCIDENCE (DAYS) | 435 408 272 401 | 385 362 355 386 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.361 P=0.510N P=0.146N P=0.438 | P=0.216N P=0.310 P=0.280 P=0.365N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.224N P=0.655N P=0.254 P=0.470N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.228N P=0.655N P=0.254 P=0.450N | |COCHRAN-ARMITAGE | (e) | P=0.180N | |FISHER EXACT | P=1.000N P=1.000N P=1.000N | P=0.684N P=0.247 P=0.339N | |=================================================================================================================================| DATE: 07/25/96 EXPERIMENT: 05156 TEST: 05 PAGE 28 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 1 COBALT SULFATE HEPTAHYDRATE TERMINAL SACRIFICE AT 105 WEEKS (a) Number of tumor-bearing animals / number of animals examined at site. (b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for intercurrent mortality. (d) Observed incidence at terminal kill. (f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between the controls and that dosed group. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. The incidental tumor test regards these lesions as non-fatal. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fisher's exact tests compare directly the overall incidence rates. For all tests, a negative trend is indicated by "N". (e) Value of Statistic cannot be computed. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01).