TDMS Study 05123-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: LITRI NICKEL OXIDE DATE: 05/20/95 EXPERIMENT: 05123 TEST: 05 TIME: 04:50:32 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: Y01-ES-30108 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C00862 PATHOLOGIST: P. HALEY CAS: 001313991 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: LITRI NICKEL OXIDE DATE: 05/20/95 EXPERIMENT: 05123 TEST: 05 TIME: 04:50:32 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: Y01-ES-30108 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C00862 PATHOLOGIST: P. HALEY CAS: 001313991 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: LITRI NICKEL OXIDE DATE: 05/20/95 EXPERIMENT: 05123 TEST: 05 TIME: 04:50:32 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: Y01-ES-30108 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C00862 PATHOLOGIST: P. HALEY CAS: 001313991 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF NICKEL OXIDE ==================================================================================================== MALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma Malignant Pheochromocytoma: Benign, Complex, Malignant, NOS Lung Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma Testes Adenoma Thyroid Gland: C-Cell Carcinoma or Adenoma ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma: Benign, Complex, Malignant, NOS Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma 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 Uterus Polyp Stromal ==================================================================================================== DATE: 05/20/95 EXPERIMENT: 05123 TEST: 05 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL OXIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 27/59 (46%) 24/57 (42%) 28/58 (48%) 32/57 (56%) | 4/56 (7%) 7/57 (12%) 6/57 (11%) 18/58 (31%) | |ADJUSTED (b) | 81.8% 69.3% 83.7% 93.8% | 15.1% 21.1% 22.0% 56.5% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 2/5 (40%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/4 (0%) 0/5 (0%) | |TERMINAL (d) | 9/14 (64%) 6/15 (40%) 10/15 (67%) 10/12 (83%) | 2/21 (10%) 3/25 (12%) 2/20 (10%) 13/26 (50%) | |FIRST INCIDENCE (DAYS) | 475 570 459 (I) 553 | 558 524 611 519 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.053 P=0.302N P=0.528 P=0.123 | P<0.001 ** P=0.350 P=0.353 P=0.003 ** | |INCIDENTAL TUMOR | P=0.057 P=0.362N P=0.516 P=0.127 | P<0.001 ** P=0.296 P=0.369 P=0.002 ** | |LOGISTIC REGRESSION | P=0.041 * P=0.334N P=0.439 P=0.090 | P<0.001 ** P=0.297 P=0.381 P=0.001 ** | |COCHRAN-ARMITAGE | P=0.100 | P<0.001 ** | |FISHER EXACT | P=0.417N P=0.465 P=0.176 | P=0.274 P=0.382 P=0.001 ** | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/59 (0%) 0/57 (0%) 1/58 (2%) 6/57 (11%) | 0/56 (0%) 0/57 (0%) 0/57 (0%) 0/58 (0%) | |ADJUSTED (b) | 0.0% 0.0% 2.8% 33.9% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/4 (0%) 0/5 (0%) | |TERMINAL (d) | 0/14 (0%) 0/15 (0%) 0/15 (0%) 3/12 (25%) | 0/21 (0%) 0/25 (0%) 0/20 (0%) 0/26 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 619 467 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** (e) P=0.484 P=0.013 * | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P<0.001 ** (e) P=0.453 P=0.018 * | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P<0.001 ** (e) P=0.497 P=0.015 * | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P<0.001 ** | (e) | |FISHER EXACT | (e) P=0.496 P=0.012 * | (e) (e) (e) | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 05 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL OXIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 27/59 (46%) 24/57 (42%) 29/58 (50%) 35/57 (61%) | 4/56 (7%) 7/57 (12%) 6/57 (11%) 18/58 (31%) | |ADJUSTED (b) | 81.8% 69.3% 84.2% 97.0% | 15.1% 21.1% 22.0% 56.5% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 2/5 (40%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/4 (0%) 0/5 (0%) | |TERMINAL (d) | 9/14 (64%) 6/15 (40%) 10/15 (67%) 11/12 (92%) | 2/21 (10%) 3/25 (12%) 2/20 (10%) 13/26 (50%) | |FIRST INCIDENCE (DAYS) | 475 570 459 (I) 467 | 558 524 611 519 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.017 * P=0.302N P=0.464 P=0.055 | P<0.001 ** P=0.350 P=0.353 P=0.003 ** | |INCIDENTAL TUMOR | P=0.012 * P=0.362N P=0.427 P=0.040 * | P<0.001 ** P=0.296 P=0.369 P=0.002 ** | |LOGISTIC REGRESSION | P=0.008 ** P=0.334N P=0.360 P=0.026 * | P<0.001 ** P=0.297 P=0.381 P=0.001 ** | |COCHRAN-ARMITAGE | P=0.028 * | P<0.001 ** | |FISHER EXACT | P=0.417N P=0.392 P=0.066 | P=0.274 P=0.382 P=0.001 ** | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/59 (2%) 3/58 (5%) 2/58 (3%) 2/56 (4%) | 1/58 (2%) 5/58 (9%) 2/56 (4%) 0/55 (0%) | |ADJUSTED (b) | 5.0% 11.2% 6.4% 4.7% | 4.8% 16.2% 10.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/14 (0%) 1/15 (7%) 0/15 (0%) 0/12 (0%) | 1/21 (5%) 3/26 (12%) 2/20 (10%) 0/24 (0%) | |FIRST INCIDENCE (DAYS) | 705 595 578 570 | 729 (T) 537 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.455 P=0.319 P=0.496 P=0.472 | P=0.151N P=0.145 P=0.483 P=0.473N | |INCIDENTAL TUMOR | P=0.481 P=0.248 P=0.473 P=0.467 | P=0.151N P=0.183 P=0.483 P=0.473N | |LOGISTIC REGRESSION | P=0.487 P=0.308 P=0.492 P=0.481 | P=0.183N P=0.117 P=0.483 P=0.473N | |COCHRAN-ARMITAGE | P=0.487 | P=0.175N | |FISHER EXACT | P=0.303 P=0.494 P=0.480 | P=0.103 P=0.487 P=0.513N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 05 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL OXIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/59 (0%) 0/58 (0%) 1/58 (2%) 1/56 (2%) | 2/58 (3%) 0/58 (0%) 0/56 (0%) 1/55 (2%) | |ADJUSTED (b) | 0.0% 0.0% 2.4% 2.0% | 5.3% 0.0% 0.0% 2.5% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/12 (0%) | 0/21 (0%) 0/26 (0%) 0/20 (0%) 0/24 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 578 475 | 594 --- --- 607 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.234 (e) P=0.491 P=0.488 | P=0.496N P=0.222N P=0.247N P=0.511N | |INCIDENTAL TUMOR | P=0.259 (e) P=0.453 P=0.581 | P=0.531N P=0.329N P=0.275N P=0.612N | |LOGISTIC REGRESSION | P=0.216 (e) P=0.500 P=0.415 | P=0.490N P=0.243N P=0.245N P=0.515N | |COCHRAN-ARMITAGE | P=0.236 | P=0.496N | |FISHER EXACT | (e) P=0.496 P=0.487 | P=0.248N P=0.257N P=0.520N | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/59 (2%) 3/58 (5%) 2/58 (3%) 3/56 (5%) | 3/58 (5%) 5/58 (9%) 2/56 (4%) 1/55 (2%) | |ADJUSTED (b) | 5.0% 11.2% 6.4% 6.6% | 9.8% 16.2% 10.0% 2.5% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/14 (0%) 1/15 (7%) 0/15 (0%) 0/12 (0%) | 1/21 (5%) 3/26 (12%) 2/20 (10%) 0/24 (0%) | |FIRST INCIDENCE (DAYS) | 705 595 578 475 | 594 537 729 (T) 607 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.262 P=0.319 P=0.496 P=0.282 | P=0.136N P=0.436 P=0.519N P=0.305N | |INCIDENTAL TUMOR | P=0.296 P=0.248 P=0.473 P=0.317 | P=0.147N P=0.423 P=0.542N P=0.382N | |LOGISTIC REGRESSION | P=0.289 P=0.308 P=0.492 P=0.274 | P=0.159N P=0.377 P=0.522N P=0.326N | |COCHRAN-ARMITAGE | P=0.286 | P=0.153N | |FISHER EXACT | P=0.303 P=0.494 P=0.290 | P=0.358 P=0.517N P=0.329N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 05 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL OXIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/59 (3%) 3/58 (5%) 2/58 (3%) 2/57 (4%) | 1/57 (2%) 1/58 (2%) 1/58 (2%) 0/59 (0%) | |ADJUSTED (b) | 11.8% 15.7% 11.1% 9.4% | 4.8% 3.0% 5.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 1/14 (7%) 1/15 (7%) 1/15 (7%) 0/12 (0%) | 1/21 (5%) 0/26 (0%) 1/20 (5%) 0/26 (0%) | |FIRST INCIDENCE (DAYS) | 705 686 706 671 | 729 (T) 703 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.591 P=0.525 P=0.662N P=0.636 | P=0.292N P=0.718N P=0.752 P=0.457N | |INCIDENTAL TUMOR | P=0.552N P=0.560 P=0.682N P=0.693N | P=0.317N P=0.737N P=0.752 P=0.457N | |LOGISTIC REGRESSION | P=0.596N P=0.533 P=0.696N P=0.654 | P=0.312N P=0.740N P=0.752 P=0.457N | |COCHRAN-ARMITAGE | P=0.540N | P=0.307N | |FISHER EXACT | P=0.492 P=0.684 P=0.678 | P=0.748N P=0.748N P=0.491N | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/59 (2%) 1/58 (2%) 2/58 (3%) 0/57 (0%) | 0/57 (0%) 0/58 (0%) 0/58 (0%) 0/59 (0%) | |ADJUSTED (b) | 7.1% 4.8% 9.1% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 1/14 (7%) 0/15 (0%) 1/15 (7%) 0/12 (0%) | 0/21 (0%) 0/26 (0%) 0/20 (0%) 0/26 (0%) | |FIRST INCIDENCE (DAYS) | 733 (T) 704 606 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.397N P=0.747N P=0.516 P=0.531N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.389N P=0.734N P=0.489 P=0.531N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.392N P=0.748N P=0.493 P=0.531N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.370N | (e) | |FISHER EXACT | P=0.748 P=0.494 P=0.509N | (e) (e) (e) | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 05 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL OXIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/59 (5%) 4/58 (7%) 4/58 (7%) 2/57 (4%) | 1/57 (2%) 1/58 (2%) 1/58 (2%) 0/59 (0%) | |ADJUSTED (b) | 18.6% 19.8% 19.6% 9.4% | 4.8% 3.0% 5.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 2/14 (14%) 1/15 (7%) 2/15 (13%) 0/12 (0%) | 1/21 (5%) 0/26 (0%) 1/20 (5%) 0/26 (0%) | |FIRST INCIDENCE (DAYS) | 705 686 606 671 | 729 (T) 703 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.446N P=0.530 P=0.537 P=0.569N | P=0.292N P=0.718N P=0.752 P=0.457N | |INCIDENTAL TUMOR | P=0.398N P=0.570 P=0.503 P=0.512N | P=0.317N P=0.737N P=0.752 P=0.457N | |LOGISTIC REGRESSION | P=0.435N P=0.541 P=0.495 P=0.559N | P=0.312N P=0.740N P=0.752 P=0.457N | |COCHRAN-ARMITAGE | P=0.380N | P=0.307N | |FISHER EXACT | P=0.490 P=0.490 P=0.516N | P=0.748N P=0.748N P=0.491N | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/59 (5%) 6/58 (10%) 3/59 (5%) 2/57 (4%) | 0/59 (0%) 1/58 (2%) 0/58 (0%) 1/59 (2%) | |ADJUSTED (b) | 11.2% 25.0% 8.9% 12.0% | 0.0% 3.8% 0.0% 3.8% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/1 (0%) 0/0 | 0/1 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 1/14 (7%) 2/15 (13%) 0/15 (0%) 1/12 (8%) | 0/21 (0%) 1/26 (4%) 0/20 (0%) 1/26 (4%) | |FIRST INCIDENCE (DAYS) | 475 670 567 665 | --- 729 (T) --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.347N P=0.283 P=0.634 P=0.555N | P=0.440 P=0.543 (e) P=0.543 | |INCIDENTAL TUMOR | P=0.272N P=0.300 P=0.644 P=0.488N | P=0.440 P=0.543 (e) P=0.543 | |LOGISTIC REGRESSION | P=0.285N P=0.250 P=0.659N P=0.520N | P=0.440 P=0.543 (e) P=0.543 | |COCHRAN-ARMITAGE | P=0.269N | P=0.410 | |FISHER EXACT | P=0.237 P=0.660N P=0.516N | P=0.496 (e) P=0.500 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 05 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL OXIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/59 (3%) 1/58 (2%) 2/59 (3%) 1/57 (2%) | 0/59 (0%) 0/58 (0%) 0/58 (0%) 0/59 (0%) | |ADJUSTED (b) | 6.2% 6.7% 8.7% 8.3% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/1 (0%) 0/0 | 0/1 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/14 (0%) 1/15 (7%) 1/15 (7%) 1/12 (8%) | 0/21 (0%) 0/26 (0%) 0/20 (0%) 0/26 (0%) | |FIRST INCIDENCE (DAYS) | 628 733 (T) 564 733 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.498N P=0.459N P=0.687 P=0.532N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.490N P=0.598N P=0.637 P=0.558N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.474N P=0.497N P=0.691 P=0.521N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.457N | (e) | |FISHER EXACT | P=0.506N P=0.691N P=0.513N | (e) (e) (e) | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/59 (8%) 7/58 (12%) 5/59 (8%) 2/57 (4%) | 0/59 (0%) 1/58 (2%) 0/58 (0%) 1/59 (2%) | |ADJUSTED (b) | 16.7% 30.8% 16.8% 12.0% | 0.0% 3.8% 0.0% 3.8% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/1 (0%) 0/0 | 0/1 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 1/14 (7%) 3/15 (20%) 1/15 (7%) 1/12 (8%) | 0/21 (0%) 1/26 (4%) 0/20 (0%) 1/26 (4%) | |FIRST INCIDENCE (DAYS) | 475 670 564 665 | --- 729 (T) --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.185N P=0.439 P=0.602 P=0.268N | P=0.440 P=0.543 (e) P=0.543 | |INCIDENTAL TUMOR | P=0.137N P=0.389 P=0.575 P=0.231N | P=0.440 P=0.543 (e) P=0.543 | |LOGISTIC REGRESSION | P=0.138N P=0.388 P=0.630N P=0.234N | P=0.440 P=0.543 (e) P=0.543 | |COCHRAN-ARMITAGE | P=0.128N | P=0.410 | |FISHER EXACT | P=0.369 P=0.629N P=0.234N | P=0.496 (e) P=0.500 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 05 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL OXIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/59 (8%) 7/58 (12%) 5/59 (8%) 2/57 (4%) | 0/59 (0%) 1/58 (2%) 0/58 (0%) 1/59 (2%) | |ADJUSTED (b) | 16.7% 30.8% 16.8% 12.0% | 0.0% 3.8% 0.0% 3.8% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/1 (0%) 0/0 | 0/1 (0%) 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 1/14 (7%) 3/15 (20%) 1/15 (7%) 1/12 (8%) | 0/21 (0%) 1/26 (4%) 0/20 (0%) 1/26 (4%) | |FIRST INCIDENCE (DAYS) | 475 670 564 665 | --- 729 (T) --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.185N P=0.439 P=0.602 P=0.268N | P=0.440 P=0.543 (e) P=0.543 | |INCIDENTAL TUMOR | P=0.137N P=0.389 P=0.575 P=0.231N | P=0.440 P=0.543 (e) P=0.543 | |LOGISTIC REGRESSION | P=0.138N P=0.388 P=0.630N P=0.234N | P=0.440 P=0.543 (e) P=0.543 | |COCHRAN-ARMITAGE | P=0.128N | P=0.410 | |FISHER EXACT | P=0.369 P=0.629N P=0.234N | P=0.496 (e) P=0.500 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/65 (0%) 1/65 (2%) 3/65 (5%) 2/64 (3%) | 1/65 (2%) 0/65 (0%) 1/65 (2%) 4/65 (6%) | |ADJUSTED (b) | 0.0% 2.6% 20.0% 11.4% | 4.8% 0.0% 3.1% 15.4% | |INTERIM SACRIFICE 1 (c)| 0/6 (0%) 0/7 (0%) 0/7 (0%) 0/7 (0%) | 0/7 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/14 (0%) 0/15 (0%) 3/15 (20%) 1/12 (8%) | 1/21 (5%) 0/26 (0%) 0/20 (0%) 4/26 (15%) | |FIRST INCIDENCE (DAYS) | --- 623 733 (T) 633 | 729 (T) --- 655 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.135 P=0.516 P=0.128 P=0.223 | P=0.044 * P=0.457N P=0.748 P=0.245 | |INCIDENTAL TUMOR | P=0.139 P=0.408 P=0.128 P=0.205 | P=0.038 * P=0.457N P=0.755 P=0.245 | |LOGISTIC REGRESSION | P=0.139 P=0.501 P=0.128 P=0.218 | P=0.032 * P=0.457N P=0.758 P=0.245 | |COCHRAN-ARMITAGE | P=0.170 | P=0.034 * | |FISHER EXACT | P=0.500 P=0.122 P=0.244 | P=0.500N P=0.752N P=0.183 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 05 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL OXIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/65 (0%) 0/65 (0%) 3/65 (5%) 2/64 (3%) | 0/65 (0%) 0/65 (0%) 5/65 (8%) 1/65 (2%) | |ADJUSTED (b) | 0.0% 0.0% 9.6% 13.2% | 0.0% 0.0% 22.3% 3.8% | |INTERIM SACRIFICE 1 (c)| 0/6 (0%) 0/7 (0%) 0/7 (0%) 0/7 (0%) | 0/7 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/14 (0%) 0/15 (0%) 0/15 (0%) 1/12 (8%) | 0/21 (0%) 0/26 (0%) 4/20 (20%) 1/26 (4%) | |FIRST INCIDENCE (DAYS) | --- --- 567 697 | --- --- 643 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.070 (e) P=0.121 P=0.203 | P=0.302 (e) P=0.029 * P=0.543 | |INCIDENTAL TUMOR | P=0.097 (e) P=0.108 P=0.229 | P=0.304 (e) P=0.026 * P=0.543 | |LOGISTIC REGRESSION | P=0.089 (e) P=0.118 P=0.206 | P=0.262 (e) P=0.030 * P=0.543 | |COCHRAN-ARMITAGE | P=0.102 | P=0.266 | |FISHER EXACT | (e) P=0.122 P=0.244 | (e) P=0.029 * P=0.500 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/65 (0%) 1/65 (2%) 6/65 (9%) 4/64 (6%) | 1/65 (2%) 0/65 (0%) 6/65 (9%) 5/65 (8%) | |ADJUSTED (b) | 0.0% 2.6% 27.7% 23.7% | 4.8% 0.0% 24.7% 19.2% | |INTERIM SACRIFICE 1 (c)| 0/6 (0%) 0/7 (0%) 0/7 (0%) 0/7 (0%) | 0/7 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/14 (0%) 0/15 (0%) 3/15 (20%) 2/12 (17%) | 1/21 (5%) 0/26 (0%) 4/20 (20%) 5/26 (19%) | |FIRST INCIDENCE (DAYS) | --- 623 567 633 | 729 (T) --- 643 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.020 * P=0.516 P=0.020 * P=0.050 * | P=0.035 * P=0.457N P=0.051 P=0.152 | |INCIDENTAL TUMOR | P=0.028 * P=0.408 P=0.018 * P=0.052 | P=0.032 * P=0.457N P=0.048 * P=0.152 | |LOGISTIC REGRESSION | P=0.025 * P=0.501 P=0.016 * P=0.048 * | P=0.022 * P=0.457N P=0.052 P=0.152 | |COCHRAN-ARMITAGE | P=0.036 * | P=0.025 * | |FISHER EXACT | P=0.500 P=0.014 * P=0.058 | P=0.500N P=0.057 P=0.104 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 05 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL OXIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/65 (0%) 0/65 (0%) 0/65 (0%) 0/64 (0%) | 1/65 (2%) 0/65 (0%) 3/65 (5%) 1/65 (2%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 4.8% 0.0% 12.6% 2.1% | |INTERIM SACRIFICE 1 (c)| 0/6 (0%) 0/7 (0%) 0/7 (0%) 0/7 (0%) | 0/7 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/12 (0%) | 1/21 (5%) 0/26 (0%) 2/20 (10%) 0/26 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 729 (T) --- 643 538 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.511 P=0.457N P=0.290 P=0.737N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.540 P=0.457N P=0.271 P=0.642N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.483 P=0.457N P=0.293 P=0.761N | |COCHRAN-ARMITAGE | (e) | P=0.485 | |FISHER EXACT | (e) (e) (e) | P=0.500N P=0.310 P=0.752N | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/65 (0%) 0/65 (0%) 0/65 (0%) 0/64 (0%) | 2/65 (3%) 1/65 (2%) 4/65 (6%) 2/65 (3%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 9.5% 3.8% 14.7% 5.8% | |INTERIM SACRIFICE 1 (c)| 0/6 (0%) 0/7 (0%) 0/7 (0%) 0/7 (0%) | 0/7 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/12 (0%) | 2/21 (10%) 1/26 (4%) 2/20 (10%) 1/26 (4%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 729 (T) 729 (T) 611 538 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.525 P=0.425N P=0.323 P=0.636N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.548 P=0.425N P=0.286 P=0.558N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.485 P=0.425N P=0.325 P=0.691N | |COCHRAN-ARMITAGE | (e) | P=0.489 | |FISHER EXACT | (e) (e) (e) | P=0.500N P=0.340 P=0.690N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 05 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL OXIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/65 (3%) 0/65 (0%) 1/65 (2%) 0/64 (0%) | 12/65 (18%) 14/65 (22%) 15/65 (23%) 12/65 (18%) | |ADJUSTED (b) | 14.3% 0.0% 3.8% 0.0% | 40.9% 40.1% 52.5% 37.4% | |INTERIM SACRIFICE 1 (c)| 0/6 (0%) 0/7 (0%) 0/7 (0%) 0/7 (0%) | 0/7 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 2/14 (14%) 0/15 (0%) 0/15 (0%) 0/12 (0%) | 6/21 (29%) 7/26 (27%) 8/20 (40%) 8/26 (31%) | |FIRST INCIDENCE (DAYS) | 733 (T) --- 681 --- | 468 475 614 467 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.224N P=0.221N P=0.484N P=0.270N | P=0.414N P=0.574N P=0.297 P=0.439N | |INCIDENTAL TUMOR | P=0.207N P=0.221N P=0.484N P=0.270N | P=0.487N P=0.587 P=0.350 P=0.449N | |LOGISTIC REGRESSION | P=0.215N P=0.221N P=0.499N P=0.270N | P=0.518N P=0.466 P=0.301 P=0.581N | |COCHRAN-ARMITAGE | P=0.196N | P=0.505N | |FISHER EXACT | P=0.248N P=0.500N P=0.252N | P=0.413 P=0.333 P=0.589N | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/65 (3%) 0/65 (0%) 1/65 (2%) 0/64 (0%) | 13/65 (20%) 15/65 (23%) 16/65 (25%) 13/65 (20%) | |ADJUSTED (b) | 14.3% 0.0% 3.8% 0.0% | 44.8% 43.3% 53.6% 40.9% | |INTERIM SACRIFICE 1 (c)| 0/6 (0%) 0/7 (0%) 0/7 (0%) 0/7 (0%) | 0/7 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 2/14 (14%) 0/15 (0%) 0/15 (0%) 0/12 (0%) | 7/21 (33%) 8/26 (31%) 8/20 (40%) 9/26 (35%) | |FIRST INCIDENCE (DAYS) | 733 (T) --- 681 --- | 468 475 611 467 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.224N P=0.221N P=0.484N P=0.270N | P=0.409N P=0.555N P=0.301 P=0.422N | |INCIDENTAL TUMOR | P=0.207N P=0.221N P=0.484N P=0.270N | P=0.478N P=0.575N P=0.342 P=0.430N | |LOGISTIC REGRESSION | P=0.215N P=0.221N P=0.499N P=0.270N | P=0.519N P=0.475 P=0.304 P=0.578N | |COCHRAN-ARMITAGE | P=0.196N | P=0.505N | |FISHER EXACT | P=0.248N P=0.500N P=0.252N | P=0.416 P=0.337 P=0.587N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 05 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL OXIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/65 (3%) 0/65 (0%) 1/65 (2%) 0/64 (0%) | 13/65 (20%) 15/65 (23%) 17/65 (26%) 14/65 (22%) | |ADJUSTED (b) | 14.3% 0.0% 3.8% 0.0% | 44.8% 43.3% 54.9% 42.1% | |INTERIM SACRIFICE 1 (c)| 0/6 (0%) 0/7 (0%) 0/7 (0%) 0/7 (0%) | 0/7 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 2/14 (14%) 0/15 (0%) 0/15 (0%) 0/12 (0%) | 7/21 (33%) 8/26 (31%) 8/20 (40%) 9/26 (35%) | |FIRST INCIDENCE (DAYS) | 733 (T) --- 681 --- | 468 475 611 467 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.224N P=0.221N P=0.484N P=0.270N | P=0.506N P=0.555N P=0.237 P=0.509N | |INCIDENTAL TUMOR | P=0.207N P=0.221N P=0.484N P=0.270N | P=0.513 P=0.575N P=0.260 P=0.486N | |LOGISTIC REGRESSION | P=0.215N P=0.221N P=0.499N P=0.270N | P=0.466 P=0.475 P=0.233 P=0.512 | |COCHRAN-ARMITAGE | P=0.196N | P=0.479 | |FISHER EXACT | P=0.248N P=0.500N P=0.252N | P=0.416 P=0.266 P=0.500 | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 24/58 (41%) 19/57 (33%) 16/57 (28%) 12/57 (21%) | 21/57 (37%) 24/59 (41%) 19/60 (32%) 21/60 (35%) | |ADJUSTED (b) | 75.2% 67.9% 55.9% 47.8% | 58.1% 62.2% 60.3% 56.5% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/2 (0%) 0/3 (0%) 0/1 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 1/5 (20%) 0/5 (0%) 0/5 (0%) | 1/5 (20%) 3/5 (60%) 0/5 (0%) 1/5 (20%) | |TERMINAL (d) | 7/13 (54%) 8/15 (53%) 5/14 (36%) 3/12 (25%) | 7/20 (35%) 13/26 (50%) 8/19 (42%) 11/26 (42%) | |FIRST INCIDENCE (DAYS) | 569 459 (I) 367 539 | 403 460 (I) 536 460 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.046N* P=0.170N P=0.121N P=0.052N | P=0.329N P=0.513N P=0.479N P=0.384N | |INCIDENTAL TUMOR | P=0.013N* P=0.226N P=0.111N P=0.016N* | P=0.428N P=0.393 P=0.419N P=0.532N | |LOGISTIC REGRESSION | P=0.014N* P=0.174N P=0.094N P=0.016N* | P=0.408N P=0.425 P=0.433N P=0.518N | |COCHRAN-ARMITAGE | P=0.011N* | P=0.365N | |FISHER EXACT | P=0.242N P=0.096N P=0.015N* | P=0.408 P=0.346N P=0.494N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 05 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL OXIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/58 (0%) 0/57 (0%) 0/57 (0%) 0/57 (0%) | 1/57 (2%) 3/59 (5%) 1/60 (2%) 2/60 (3%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 2.2% 7.5% 3.8% 5.1% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/2 (0%) 0/3 (0%) 0/1 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/13 (0%) 0/15 (0%) 0/14 (0%) 0/12 (0%) | 0/20 (0%) 0/26 (0%) 0/19 (0%) 0/26 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 563 509 713 550 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.527 P=0.326 P=0.747 P=0.490 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.523 P=0.371 P=0.734 P=0.401 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.555 P=0.325 P=0.755N P=0.533 | |COCHRAN-ARMITAGE | (e) | P=0.547 | |FISHER EXACT | (e) (e) (e) | P=0.322 P=0.739N P=0.519 | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 24/58 (41%) 19/57 (33%) 16/57 (28%) 12/57 (21%) | 22/57 (39%) 27/59 (46%) 20/60 (33%) 23/60 (38%) | |ADJUSTED (b) | 75.2% 67.9% 55.9% 47.8% | 59.0% 65.1% 61.8% 58.7% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/2 (0%) 0/3 (0%) 0/1 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 1/5 (20%) 0/5 (0%) 0/5 (0%) | 1/5 (20%) 3/5 (60%) 0/5 (0%) 1/5 (20%) | |TERMINAL (d) | 7/13 (54%) 8/15 (53%) 5/14 (36%) 3/12 (25%) | 7/20 (35%) 13/26 (50%) 8/19 (42%) 11/26 (42%) | |FIRST INCIDENCE (DAYS) | 569 459 (I) 367 539 | 403 460 (I) 536 460 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.046N* P=0.170N P=0.121N P=0.052N | P=0.359N P=0.494 P=0.483N P=0.455N | |INCIDENTAL TUMOR | P=0.013N* P=0.226N P=0.111N P=0.016N* | P=0.460N P=0.283 P=0.429N P=0.513 | |LOGISTIC REGRESSION | P=0.014N* P=0.174N P=0.094N P=0.016N* | P=0.430N P=0.284 P=0.432N P=0.565 | |COCHRAN-ARMITAGE | P=0.011N* | P=0.387N | |FISHER EXACT | P=0.242N P=0.096N P=0.015N* | P=0.277 P=0.344N P=0.564N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 05 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL OXIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Skin | | Basal Cell Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/65 (3%) 0/65 (0%) 1/65 (2%) 0/64 (0%) | 1/65 (2%) 0/65 (0%) 0/65 (0%) 0/65 (0%) | |ADJUSTED (b) | 14.3% 0.0% 4.8% 0.0% | 4.8% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/6 (0%) 0/7 (0%) 0/7 (0%) 0/7 (0%) | 0/7 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 2/14 (14%) 0/15 (0%) 0/15 (0%) 0/12 (0%) | 1/21 (5%) 0/26 (0%) 0/20 (0%) 0/26 (0%) | |FIRST INCIDENCE (DAYS) | 733 (T) --- 706 --- | 729 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.207N P=0.221N P=0.466N P=0.270N | P=0.308N P=0.457N P=0.510N P=0.457N | |INCIDENTAL TUMOR | P=0.207N P=0.221N P=0.484N P=0.270N | P=0.308N P=0.457N P=0.510N P=0.457N | |LOGISTIC REGRESSION | P=0.215N P=0.221N P=0.493N P=0.270N | P=0.308N P=0.457N P=0.510N P=0.457N | |COCHRAN-ARMITAGE | P=0.196N | P=0.323N | |FISHER EXACT | P=0.248N P=0.500N P=0.252N | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | |Skin | | Basal Cell Adenoma, Basosquamous Tumor Benign, or Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/65 (3%) 0/65 (0%) 2/65 (3%) 0/64 (0%) | 1/65 (2%) 0/65 (0%) 0/65 (0%) 0/65 (0%) | |ADJUSTED (b) | 14.3% 0.0% 10.1% 0.0% | 4.8% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/6 (0%) 0/7 (0%) 0/7 (0%) 0/7 (0%) | 0/7 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 2/14 (14%) 0/15 (0%) 0/15 (0%) 0/12 (0%) | 1/21 (5%) 0/26 (0%) 0/20 (0%) 0/26 (0%) | |FIRST INCIDENCE (DAYS) | 733 (T) --- 706 --- | 729 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.266N P=0.221N P=0.667N P=0.270N | P=0.308N P=0.457N P=0.510N P=0.457N | |INCIDENTAL TUMOR | P=0.263N P=0.221N P=0.682N P=0.270N | P=0.308N P=0.457N P=0.510N P=0.457N | |LOGISTIC REGRESSION | P=0.280N P=0.221N P=0.695N P=0.270N | P=0.308N P=0.457N P=0.510N P=0.457N | |COCHRAN-ARMITAGE | P=0.251N | P=0.323N | |FISHER EXACT | P=0.248N P=0.690N P=0.252N | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 05 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL OXIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Skin | | Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign, | | malignant or NOS), or Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/65 (3%) 0/65 (0%) 2/65 (3%) 0/64 (0%) | 1/65 (2%) 0/65 (0%) 0/65 (0%) 0/65 (0%) | |ADJUSTED (b) | 14.3% 0.0% 10.1% 0.0% | 4.8% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/6 (0%) 0/7 (0%) 0/7 (0%) 0/7 (0%) | 0/7 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 2/14 (14%) 0/15 (0%) 0/15 (0%) 0/12 (0%) | 1/21 (5%) 0/26 (0%) 0/20 (0%) 0/26 (0%) | |FIRST INCIDENCE (DAYS) | 733 (T) --- 706 --- | 729 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.266N P=0.221N P=0.667N P=0.270N | P=0.308N P=0.457N P=0.510N P=0.457N | |INCIDENTAL TUMOR | P=0.263N P=0.221N P=0.682N P=0.270N | P=0.308N P=0.457N P=0.510N P=0.457N | |LOGISTIC REGRESSION | P=0.280N P=0.221N P=0.695N P=0.270N | P=0.308N P=0.457N P=0.510N P=0.457N | |COCHRAN-ARMITAGE | P=0.251N | P=0.323N | |FISHER EXACT | P=0.248N P=0.690N P=0.252N | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | |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) | 3/65 (5%) 2/65 (3%) 4/65 (6%) 2/64 (3%) | 4/65 (6%) 0/65 (0%) 0/65 (0%) 2/65 (3%) | |ADJUSTED (b) | 16.1% 6.7% 19.5% 16.7% | 16.2% 0.0% 0.0% 7.2% | |INTERIM SACRIFICE 1 (c)| 0/6 (0%) 0/7 (0%) 0/7 (0%) 0/7 (0%) | 0/7 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 2/14 (14%) 0/15 (0%) 1/15 (7%) 2/12 (17%) | 3/21 (14%) 0/26 (0%) 0/20 (0%) 1/26 (4%) | |FIRST INCIDENCE (DAYS) | 569 570 690 733 (T) | 564 --- --- 718 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.544N P=0.489N P=0.518 P=0.566N | P=0.324N P=0.045N* P=0.069N P=0.261N | |INCIDENTAL TUMOR | P=0.521N P=0.554N P=0.498 P=0.574N | P=0.352N P=0.064N P=0.076N P=0.318N | |LOGISTIC REGRESSION | P=0.535N P=0.493N P=0.491 P=0.553N | P=0.364N P=0.056N P=0.065N P=0.329N | |COCHRAN-ARMITAGE | P=0.485N | P=0.361N | |FISHER EXACT | P=0.500N P=0.500 P=0.507N | P=0.060N P=0.060N P=0.340N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 05 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL OXIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Skin | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/65 (5%) 1/65 (2%) 2/65 (3%) 0/64 (0%) | 0/65 (0%) 0/65 (0%) 1/65 (2%) 2/65 (3%) | |ADJUSTED (b) | 9.3% 2.4% 4.1% 0.0% | 0.0% 0.0% 2.4% 6.9% | |INTERIM SACRIFICE 1 (c)| 0/6 (0%) 0/7 (0%) 0/7 (0%) 0/7 (0%) | 0/7 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/12 (0%) | 0/21 (0%) 0/26 (0%) 0/20 (0%) 1/26 (4%) | |FIRST INCIDENCE (DAYS) | 566 572 525 --- | --- --- 611 671 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.124N P=0.310N P=0.519N P=0.150N | P=0.073 (e) P=0.505 P=0.263 | |INCIDENTAL TUMOR | P=0.094N P=0.415N P=0.469N P=0.139N | P=0.067 (e) P=0.452 P=0.221 | |LOGISTIC REGRESSION | P=0.108N P=0.305N P=0.501N P=0.128N | P=0.072 (e) P=0.500 P=0.241 | |COCHRAN-ARMITAGE | P=0.108N | P=0.072 | |FISHER EXACT | P=0.310N P=0.500N P=0.125N | (e) P=0.500 P=0.248 | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/65 (5%) 1/65 (2%) 3/65 (5%) 0/64 (0%) | 0/65 (0%) 0/65 (0%) 2/65 (3%) 2/65 (3%) | |ADJUSTED (b) | 9.3% 2.4% 10.5% 0.0% | 0.0% 0.0% 4.8% 6.9% | |INTERIM SACRIFICE 1 (c)| 0/6 (0%) 0/7 (0%) 0/7 (0%) 0/7 (0%) | 0/7 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/14 (0%) 0/15 (0%) 1/15 (7%) 0/12 (0%) | 0/21 (0%) 0/26 (0%) 0/20 (0%) 1/26 (4%) | |FIRST INCIDENCE (DAYS) | 566 572 525 --- | --- --- 611 671 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.159N P=0.310N P=0.648 P=0.150N | P=0.089 (e) P=0.242 P=0.263 | |INCIDENTAL TUMOR | P=0.124N P=0.415N P=0.632N P=0.139N | P=0.086 (e) P=0.183 P=0.221 | |LOGISTIC REGRESSION | P=0.139N P=0.305N P=0.658 P=0.128N | P=0.090 (e) P=0.238 P=0.241 | |COCHRAN-ARMITAGE | P=0.137N | P=0.091 | |FISHER EXACT | P=0.310N P=0.660N P=0.125N | (e) P=0.248 P=0.248 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 05 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL OXIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/65 (0%) 1/65 (2%) 1/65 (2%) 0/64 (0%) | 2/65 (3%) 0/65 (0%) 0/65 (0%) 0/65 (0%) | |ADJUSTED (b) | 0.0% 2.3% 4.2% 0.0% | 6.9% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/6 (0%) 0/7 (0%) 0/7 (0%) 0/7 (0%) | 0/7 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/12 (0%) | 1/21 (5%) 0/26 (0%) 0/20 (0%) 0/26 (0%) | |FIRST INCIDENCE (DAYS) | --- 570 690 --- | 564 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.628N P=0.491 P=0.492 (e) | P=0.122N P=0.216N P=0.248N P=0.219N | |INCIDENTAL TUMOR | P=0.596N P=0.408 P=0.500 (e) | P=0.130N P=0.301N P=0.272N P=0.241N | |LOGISTIC REGRESSION | P=0.600N P=0.500 P=0.496 (e) | P=0.125N P=0.233N P=0.240N P=0.236N | |COCHRAN-ARMITAGE | P=0.594N | P=0.125N | |FISHER EXACT | P=0.500 P=0.500 (e) | P=0.248N P=0.248N P=0.248N | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/65 (0%) 1/65 (2%) 1/65 (2%) 1/64 (2%) | 2/65 (3%) 0/65 (0%) 0/65 (0%) 1/65 (2%) | |ADJUSTED (b) | 0.0% 2.3% 4.2% 8.3% | 6.9% 0.0% 0.0% 3.8% | |INTERIM SACRIFICE 1 (c)| 0/6 (0%) 0/7 (0%) 0/7 (0%) 0/7 (0%) | 0/7 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/14 (0%) 0/15 (0%) 0/15 (0%) 1/12 (8%) | 1/21 (5%) 0/26 (0%) 0/20 (0%) 1/26 (4%) | |FIRST INCIDENCE (DAYS) | --- 570 690 733 (T) | 564 --- --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.350 P=0.491 P=0.492 P=0.469 | P=0.459N P=0.216N P=0.248N P=0.453N | |INCIDENTAL TUMOR | P=0.376 P=0.408 P=0.500 P=0.469 | P=0.463N P=0.301N P=0.272N P=0.478N | |LOGISTIC REGRESSION | P=0.375 P=0.500 P=0.496 P=0.469 | P=0.483N P=0.233N P=0.240N P=0.496N | |COCHRAN-ARMITAGE | P=0.391 | P=0.481N | |FISHER EXACT | P=0.500 P=0.500 P=0.496 | P=0.248N P=0.248N P=0.500N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 05 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL OXIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/65 (2%) 2/65 (3%) 2/65 (3%) 2/64 (3%) | 3/65 (5%) 0/65 (0%) 0/65 (0%) 2/65 (3%) | |ADJUSTED (b) | 2.1% 6.7% 10.6% 16.7% | 11.5% 0.0% 0.0% 7.2% | |INTERIM SACRIFICE 1 (c)| 0/6 (0%) 0/7 (0%) 0/7 (0%) 0/7 (0%) | 0/7 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/14 (0%) 0/15 (0%) 1/15 (7%) 2/12 (17%) | 2/21 (10%) 0/26 (0%) 0/20 (0%) 1/26 (4%) | |FIRST INCIDENCE (DAYS) | 569 570 690 733 (T) | 564 --- --- 718 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.369 P=0.498 P=0.493 P=0.454 | P=0.517N P=0.098N P=0.129N P=0.424N | |INCIDENTAL TUMOR | P=0.394 P=0.414 P=0.481 P=0.444 | P=0.551N P=0.138N P=0.143N P=0.497N | |LOGISTIC REGRESSION | P=0.394 P=0.501 P=0.493 P=0.471 | P=0.557N P=0.113N P=0.123N P=0.494N | |COCHRAN-ARMITAGE | P=0.424 | P=0.553N | |FISHER EXACT | P=0.500 P=0.500 P=0.494 | P=0.122N P=0.122N P=0.500N | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/65 (2%) 1/65 (2%) 2/65 (3%) 2/64 (3%) | 3/65 (5%) 0/65 (0%) 0/65 (0%) 1/65 (2%) | |ADJUSTED (b) | 2.1% 2.3% 10.6% 16.7% | 11.5% 0.0% 0.0% 3.8% | |INTERIM SACRIFICE 1 (c)| 0/6 (0%) 0/7 (0%) 0/7 (0%) 0/7 (0%) | 0/7 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/14 (0%) 0/15 (0%) 1/15 (7%) 2/12 (17%) | 2/21 (10%) 0/26 (0%) 0/20 (0%) 1/26 (4%) | |FIRST INCIDENCE (DAYS) | 569 570 690 733 (T) | 564 --- --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.289 P=0.748 P=0.493 P=0.454 | P=0.244N P=0.098N P=0.129N P=0.252N | |INCIDENTAL TUMOR | P=0.307 P=0.657 P=0.481 P=0.444 | P=0.249N P=0.138N P=0.143N P=0.270N | |LOGISTIC REGRESSION | P=0.314 P=0.762 P=0.493 P=0.471 | P=0.267N P=0.113N P=0.123N P=0.300N | |COCHRAN-ARMITAGE | P=0.338 | P=0.266N | |FISHER EXACT | P=0.752N P=0.500 P=0.494 | P=0.122N P=0.122N P=0.310N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 05 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL OXIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 43/59 (73%) 50/58 (86%) 43/58 (74%) 51/57 (89%) | | |ADJUSTED (b) | 95.1% 100.0% 100.0% 100.0% | | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | | |INTERIM SACRIFICE 2 (c)| 3/5 (60%) 4/5 (80%) 0/5 (0%) 4/5 (80%) | | |TERMINAL (d) | 12/14 (86%) 15/15 (100%) 15/15 (100%) 12/12 (100%)| | |FIRST INCIDENCE (DAYS) | 459 (I) 459 (I) 457 459 (I) | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.060 P=0.328 P=0.544N P=0.064 | | |INCIDENTAL TUMOR | P=0.039 * P=0.090 P=0.510 P=0.025 * | | |LOGISTIC REGRESSION | P=0.027 * P=0.069 P=0.471 P=0.017 * | | |COCHRAN-ARMITAGE | P=0.045 * | | |FISHER EXACT | P=0.059 P=0.522 P=0.020 * | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/59 (12%) 5/58 (9%) 5/57 (9%) 2/57 (4%) | 2/57 (4%) 2/57 (4%) 3/58 (5%) 2/58 (3%) | |ADJUSTED (b) | 29.3% 18.1% 26.1% 13.2% | 6.5% 4.2% 15.0% 7.7% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 1/5 (20%) 0/5 (0%) 1/5 (20%) 0/5 (0%) | 1/5 (20%) 1/5 (20%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 2/14 (14%) 0/15 (0%) 3/15 (20%) 1/12 (8%) | 1/21 (5%) 0/26 (0%) 3/20 (15%) 2/26 (8%) | |FIRST INCIDENCE (DAYS) | 459 (I) 647 459 (I) 697 | 460 (I) 460 (I) 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.105N P=0.341N P=0.352N P=0.126N | P=0.573N P=0.670N P=0.482 P=0.636N | |INCIDENTAL TUMOR | P=0.069N P=0.262N P=0.347N P=0.074N | P=0.571N P=0.645 P=0.482 P=0.636N | |LOGISTIC REGRESSION | P=0.082N P=0.377N P=0.405N P=0.095N | P=0.583 P=0.670 P=0.497 P=0.689N | |COCHRAN-ARMITAGE | P=0.075N | P=0.585 | |FISHER EXACT | P=0.393N P=0.406N P=0.090N | P=0.691N P=0.508 P=0.684N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 05 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL OXIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/59 (14%) 5/58 (9%) 6/57 (11%) 2/57 (4%) | 2/57 (4%) 2/57 (4%) 3/58 (5%) 2/58 (3%) | |ADJUSTED (b) | 33.8% 18.1% 28.0% 13.2% | 6.5% 4.2% 15.0% 7.7% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 1/5 (20%) 0/5 (0%) 1/5 (20%) 0/5 (0%) | 1/5 (20%) 1/5 (20%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 2/14 (14%) 0/15 (0%) 3/15 (20%) 1/12 (8%) | 1/21 (5%) 0/26 (0%) 3/20 (15%) 2/26 (8%) | |FIRST INCIDENCE (DAYS) | 459 (I) 647 459 (I) 697 | 460 (I) 460 (I) 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.079N P=0.245N P=0.360N P=0.081N | P=0.573N P=0.670N P=0.482 P=0.636N | |INCIDENTAL TUMOR | P=0.050N P=0.170N P=0.370N P=0.042N* | P=0.571N P=0.645 P=0.482 P=0.636N | |LOGISTIC REGRESSION | P=0.060N P=0.272N P=0.415N P=0.059N | P=0.583 P=0.670 P=0.497 P=0.689N | |COCHRAN-ARMITAGE | P=0.054N | P=0.585 | |FISHER EXACT | P=0.290N P=0.415N P=0.053N | P=0.691N P=0.508 P=0.684N | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/59 (2%) 3/58 (5%) 2/57 (4%) 1/57 (2%) | 0/57 (0%) 0/57 (0%) 0/58 (0%) 0/58 (0%) | |ADJUSTED (b) | 4.5% 9.8% 13.3% 3.7% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/14 (0%) 0/15 (0%) 2/15 (13%) 0/12 (0%) | 0/21 (0%) 0/26 (0%) 0/20 (0%) 0/26 (0%) | |FIRST INCIDENCE (DAYS) | 699 629 733 (T) 660 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.529N P=0.349 P=0.511 P=0.730 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.494N P=0.309 P=0.516 P=0.750N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.512N P=0.310 P=0.505 P=0.745 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.484N | (e) | |FISHER EXACT | P=0.303 P=0.487 P=0.743 | (e) (e) (e) | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 05 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL OXIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/59 (3%) 3/58 (5%) 2/57 (4%) 2/57 (4%) | 0/57 (0%) 0/57 (0%) 0/58 (0%) 0/58 (0%) | |ADJUSTED (b) | 9.8% 9.8% 13.3% 7.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/14 (0%) 0/15 (0%) 2/15 (13%) 0/12 (0%) | 0/21 (0%) 0/26 (0%) 0/20 (0%) 0/26 (0%) | |FIRST INCIDENCE (DAYS) | 699 629 733 (T) 647 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.590N P=0.541 P=0.690N P=0.648 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.546N P=0.522 P=0.682N P=0.678N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.572N P=0.510 P=0.696N P=0.666 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.541N | (e) | |FISHER EXACT | P=0.492 P=0.678 P=0.678 | (e) (e) (e) | |=================================================================================================================================| | | |Tissue NOS | | Lipoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/65 (0%) 0/65 (0%) 2/65 (3%) 0/64 (0%) | 0/65 (0%) 0/65 (0%) 2/65 (3%) 0/65 (0%) | |ADJUSTED (b) | 0.0% 0.0% 9.1% 0.0% | 0.0% 0.0% 6.9% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/6 (0%) 0/7 (0%) 0/7 (0%) 0/7 (0%) | 0/7 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/14 (0%) 0/15 (0%) 1/15 (7%) 0/12 (0%) | 0/21 (0%) 0/26 (0%) 1/20 (5%) 0/26 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 618 --- | --- --- 466 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.591 (e) P=0.244 (e) | P=0.638 (e) P=0.237 (e) | |INCIDENTAL TUMOR | P=0.596 (e) P=0.221 (e) | P=0.682 (e) P=0.335 (e) | |LOGISTIC REGRESSION | P=0.604 (e) P=0.233 (e) | P=0.621 (e) P=0.238 (e) | |COCHRAN-ARMITAGE | P=0.618 | P=0.620 | |FISHER EXACT | (e) P=0.248 (e) | (e) P=0.248 (e) | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 05 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL OXIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Tissue NOS | | Squamous Cell Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/65 (0%) 0/65 (0%) 0/65 (0%) 0/64 (0%) | 3/65 (5%) 0/65 (0%) 0/65 (0%) 0/65 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 9.6% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/6 (0%) 0/7 (0%) 0/7 (0%) 0/7 (0%) | 0/7 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/12 (0%) | 0/21 (0%) 0/26 (0%) 0/20 (0%) 0/26 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 586 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.055N P=0.110N P=0.134N P=0.119N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.068N P=0.168N P=0.135N P=0.184N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.053N P=0.114N P=0.123N P=0.119N | |COCHRAN-ARMITAGE | (e) | P=0.053N | |FISHER EXACT | (e) (e) (e) | P=0.122N P=0.122N P=0.122N | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 9/65 (14%) 2/65 (3%) 8/65 (12%) 6/65 (9%) | |ADJUSTED (b) | | 34.3% 7.3% 24.4% 18.4% | |INTERIM SACRIFICE 1 (c)| | 0/7 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/5 (0%) 0/5 (0%) 2/5 (40%) 1/5 (20%) | |TERMINAL (d) | | 6/21 (29%) 1/26 (4%) 1/20 (5%) 4/26 (15%) | |FIRST INCIDENCE (DAYS) | | 618 725 460 (I) 460 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.407N P=0.014N* P=0.526N P=0.200N | |INCIDENTAL TUMOR | | P=0.464N P=0.027N* P=0.555N P=0.196N | |LOGISTIC REGRESSION | | P=0.465N P=0.019N* P=0.513N P=0.281N | |COCHRAN-ARMITAGE | | P=0.462N | |FISHER EXACT | | P=0.027N* P=0.500N P=0.292N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 05 PAGE 22 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL OXIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/65 (0%) 2/65 (3%) 0/65 (0%) 0/64 (0%) | 0/65 (0%) 2/65 (3%) 0/65 (0%) 0/65 (0%) | |ADJUSTED (b) | 0.0% 11.6% 0.0% 0.0% | 0.0% 5.8% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/6 (0%) 0/7 (0%) 0/7 (0%) 0/7 (0%) | 0/7 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/14 (0%) 1/15 (7%) 0/15 (0%) 0/12 (0%) | 0/21 (0%) 0/26 (0%) 0/20 (0%) 0/26 (0%) | |FIRST INCIDENCE (DAYS) | --- 712 --- --- | --- 660 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.446N P=0.253 (e) (e) | P=0.402N P=0.289 (e) (e) | |INCIDENTAL TUMOR | P=0.425N P=0.266 (e) (e) | P=0.479N P=0.235 (e) (e) | |LOGISTIC REGRESSION | P=0.442N P=0.253 (e) (e) | P=0.411N P=0.250 (e) (e) | |COCHRAN-ARMITAGE | P=0.412N | P=0.409N | |FISHER EXACT | P=0.248 (e) (e) | P=0.248 (e) (e) | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 31/65 (48%) 32/65 (49%) 26/65 (40%) 35/64 (55%) | 22/65 (34%) 19/65 (29%) 21/65 (32%) 18/65 (28%) | |ADJUSTED (b) | 77.2% 73.3% 63.0% 90.1% | 57.1% 47.6% 55.6% 44.7% | |INTERIM SACRIFICE 1 (c)| 0/6 (0%) 0/7 (0%) 0/7 (0%) 0/7 (0%) | 0/7 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 7/14 (50%) 5/15 (33%) 3/15 (20%) 9/12 (75%) | 7/21 (33%) 8/26 (31%) 6/20 (30%) 6/26 (23%) | |FIRST INCIDENCE (DAYS) | 475 503 202 536 | 348 423 494 466 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.155 P=0.521N P=0.309N P=0.173 | P=0.269N P=0.222N P=0.544N P=0.221N | |INCIDENTAL TUMOR | P=0.204 P=0.409 P=0.288N P=0.187 | P=0.323N P=0.470N P=0.558N P=0.361N | |LOGISTIC REGRESSION | P=0.232 P=0.401 P=0.278N P=0.201 | P=0.259N P=0.304N P=0.517N P=0.268N | |COCHRAN-ARMITAGE | P=0.266 | P=0.293N | |FISHER EXACT | P=0.500 P=0.240N P=0.268 | P=0.353N P=0.500N P=0.284N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 05 PAGE 23 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL OXIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/65 (0%) 1/65 (2%) 0/65 (0%) 2/64 (3%) | 0/65 (0%) 0/65 (0%) 0/65 (0%) 0/65 (0%) | |ADJUSTED (b) | 0.0% 2.0% 0.0% 10.1% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/6 (0%) 0/7 (0%) 0/7 (0%) 0/7 (0%) | 0/7 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 0/14 (0%) 0/15 (0%) 0/15 (0%) 1/12 (8%) | 0/21 (0%) 0/26 (0%) 0/20 (0%) 0/26 (0%) | |FIRST INCIDENCE (DAYS) | --- 524 --- 467 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.129 P=0.496 (e) P=0.221 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.162 P=0.612 (e) P=0.281 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.138 P=0.499 (e) P=0.233 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.137 | (e) | |FISHER EXACT | P=0.500 (e) P=0.244 | (e) (e) (e) | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 56/65 (86%) 55/65 (85%) 55/65 (85%) 57/64 (89%) | 40/65 (62%) 42/65 (65%) 40/65 (62%) 44/65 (68%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 90.5% 87.0% 92.6% 95.4% | |INTERIM SACRIFICE 1 (c)| 0/6 (0%) 0/7 (0%) 0/7 (0%) 0/7 (0%) | 0/7 (0%) 0/7 (0%) 1/7 (14%) 0/6 (0%) | |INTERIM SACRIFICE 2 (c)| 4/5 (80%) 4/5 (80%) 3/5 (60%) 5/5 (100%) | 1/5 (20%) 4/5 (80%) 2/5 (40%) 3/5 (60%) | |TERMINAL (d) | 14/14 (100%) 15/15 (100%) 15/15 (100%) 12/12 (100%)| 17/21 (81%) 20/26 (77%) 17/20 (85%) 24/26 (92%) | |FIRST INCIDENCE (DAYS) | 459 (I) 459 (I) 367 459 (I) | 403 460 (I) 200 (I) 460 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.170 P=0.380N P=0.506N P=0.244 | P=0.480 P=0.334N P=0.474 P=0.512N | |INCIDENTAL TUMOR | P=0.121 P=0.467N P=0.686N P=0.259 | P=0.282 P=0.540 P=0.555 P=0.435 | |LOGISTIC REGRESSION | P=0.094 P=0.521N P=0.581 P=0.214 | P=0.247 P=0.523 P=0.554 P=0.285 | |COCHRAN-ARMITAGE | P=0.324 | P=0.284 | |FISHER EXACT | P=0.500N P=0.500N P=0.408 | P=0.428 P=0.571N P=0.291 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 05 PAGE 24 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL OXIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | 0 MG/M3 0.62MGM3 1.25MGM3 2.5MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 37/65 (57%) 38/65 (58%) 35/65 (54%) 43/64 (67%) | 32/65 (49%) 26/65 (40%) 30/65 (46%) 25/65 (38%) | |ADJUSTED (b) | 84.1% 80.1% 77.8% 97.3% | 69.2% 57.8% 72.1% 55.0% | |INTERIM SACRIFICE 1 (c)| 0/6 (0%) 0/7 (0%) 0/7 (0%) 0/7 (0%) | 0/7 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%) | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 8/14 (57%) 6/15 (40%) 6/15 (40%) 11/12 (92%) | 8/21 (38%) 9/26 (35%) 10/20 (50%) 7/26 (27%) | |FIRST INCIDENCE (DAYS) | 475 466 202 467 | 348 423 436 466 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.089 P=0.504N P=0.465N P=0.116 | P=0.193N P=0.121N P=0.502N P=0.136N | |INCIDENTAL TUMOR | P=0.078 P=0.476 P=0.522N P=0.099 | P=0.193N P=0.409N P=0.509N P=0.251N | |LOGISTIC REGRESSION | P=0.090 P=0.417 P=0.483N P=0.089 | P=0.123N P=0.162N P=0.403N P=0.095N | |COCHRAN-ARMITAGE | P=0.136 | P=0.182N | |FISHER EXACT | P=0.500 P=0.430N P=0.154 | P=0.189N P=0.430N P=0.144N | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 57/65 (88%) 57/65 (88%) 56/65 (86%) 57/64 (89%) | 53/65 (82%) 53/65 (82%) 54/65 (83%) 53/65 (82%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 98.1% 94.6% 100.0% 96.4% | |INTERIM SACRIFICE 1 (c)| 0/6 (0%) 0/7 (0%) 0/7 (0%) 0/7 (0%) | 0/7 (0%) 0/7 (0%) 1/7 (14%) 0/6 (0%) | |INTERIM SACRIFICE 2 (c)| 4/5 (80%) 4/5 (80%) 3/5 (60%) 5/5 (100%) | 1/5 (20%) 4/5 (80%) 2/5 (40%) 3/5 (60%) | |TERMINAL (d) | 14/14 (100%) 15/15 (100%) 15/15 (100%) 12/12 (100%)| 20/21 (95%) 23/26 (88%) 20/20 (100%) 24/26 (92%) | |FIRST INCIDENCE (DAYS) | 459 (I) 459 (I) 202 459 (I) | 348 423 200 (I) 460 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.217 P=0.430N P=0.508N P=0.280 | P=0.384N P=0.223N P=0.414 P=0.304N | |INCIDENTAL TUMOR | P=0.244 P=0.773 P=0.708 P=0.500 | P=0.467N P=0.518 P=0.576 P=0.557N | |LOGISTIC REGRESSION | P=0.294 P=0.773 P=0.641 P=0.500 | P=0.482N P=0.488N P=0.515 P=0.517N | |COCHRAN-ARMITAGE | P=0.461 | P=0.536 | |FISHER EXACT | P=0.605N P=0.500N P=0.513 | P=0.589N P=0.500 P=0.589N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 05 PAGE 25 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- NICKEL OXIDE 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. (c) Observed incidence at interim kill. Male interim sacrifices(days): 199 459 Female interim sacrifices(days): 200 460 (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).