TDMS Study 05123-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: LITRI NICKEL OXIDE DATE: 05/20/95 EXPERIMENT: 05123 TEST: 06 TIME: 05:42:10 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: Y0-ES-30108 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C00862 PATHOLOGIST: P. HALEY CAS: 1313-99-1 ------------------------------------------------------------------------------------------------------------------------------------ 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: 06 TIME: 05:42:10 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: Y0-ES-30108 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C00862 PATHOLOGIST: P. HALEY CAS: 1313-99-1 MICE(B6C3F1) ---------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED. ---------------- Adrenal Cortex Adrenal Medulla Bone Marrow Brain Clitoral Gland Epididymis Gallbladder Heart Islets, Pancreatic Kidney 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: 06 TIME: 05:42:10 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: Y0-ES-30108 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C00862 PATHOLOGIST: P. HALEY CAS: 1313-99-1 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF NICKEL OXIDE ==================================================================================================== MALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Cortex Adenoma Liver Hepatocellular Carcinoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma All Organs Malignant Tumors ==================================================================================================== FEMALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Harderian Gland Adenoma Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma All Organs Malignant and Benign Tumors ==================================================================================================== DATE: 05/20/95 EXPERIMENT: 05123 TEST: 06 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL OXIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | 0 MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/62 (6%) 0/72 (0%) 1/70 (1%) 1/74 (1%) | 0/69 (0%) 0/71 (0%) 0/68 (0%) 1/67 (1%) | |ADJUSTED (b) | 21.1% 0.0% 3.6% 3.7% | 0.0% 0.0% 0.0% 2.6% | |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) | 4/19 (21%) 0/23 (0%) 1/28 (4%) 0/23 (0%) | 0/41 (0%) 0/40 (0%) 0/42 (0%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | 737 (T) --- 737 (T) 716 | --- --- --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.122N P=0.039N* P=0.079N P=0.120N | P=0.188 (e) (e) P=0.485 | |INCIDENTAL TUMOR | P=0.115N P=0.039N* P=0.079N P=0.109N | P=0.188 (e) (e) P=0.485 | |LOGISTIC REGRESSION | P=0.113N P=0.039N* P=0.079N P=0.101N | P=0.188 (e) (e) P=0.485 | |COCHRAN-ARMITAGE | P=0.139N | P=0.192 | |FISHER EXACT | P=0.043N* P=0.147N P=0.133N | (e) (e) P=0.493 | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/62 (0%) 0/72 (0%) 0/70 (0%) 0/73 (0%) | 2/67 (3%) 0/70 (0%) 0/68 (0%) 0/67 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 4.2% 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) | 0/19 (0%) 0/23 (0%) 0/28 (0%) 0/23 (0%) | 0/41 (0%) 0/39 (0%) 0/42 (0%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 599 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.120N P=0.229N P=0.247N P=0.238N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.115N P=0.146N P=0.250N P=0.189N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.118N P=0.227N P=0.235N P=0.236N | |COCHRAN-ARMITAGE | (e) | P=0.118N | |FISHER EXACT | (e) (e) (e) | P=0.237N P=0.244N P=0.248N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 06 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL OXIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | 0 MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/62 (0%) 0/72 (0%) 0/70 (0%) 0/73 (0%) | 3/67 (4%) 0/70 (0%) 1/68 (1%) 0/67 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 6.5% 0.0% 2.4% 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) | 0/19 (0%) 0/23 (0%) 0/28 (0%) 0/23 (0%) | 1/41 (2%) 0/39 (0%) 1/42 (2%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 599 --- 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.094N P=0.121N P=0.310N P=0.128N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.091N P=0.077N P=0.312N P=0.101N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.089N P=0.110N P=0.302N P=0.118N | |COCHRAN-ARMITAGE | (e) | P=0.090N | |FISHER EXACT | (e) (e) (e) | P=0.114N P=0.304N P=0.122N | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/67 (0%) 1/77 (1%) 2/76 (3%) 2/79 (3%) | 0/74 (0%) 1/76 (1%) 2/73 (3%) 3/74 (4%) | |ADJUSTED (b) | 0.0% 4.3% 5.5% 7.8% | 0.0% 1.8% 4.4% 7.9% | |INTERIM SACRIFICE 1 (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%) | |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) | 0/19 (0%) 1/23 (4%) 1/29 (3%) 1/23 (4%) | 0/41 (0%) 0/40 (0%) 1/42 (2%) 3/38 (8%) | |FIRST INCIDENCE (DAYS) | --- 737 (T) 649 714 | --- 609 640 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.197 P=0.538 P=0.341 P=0.299 | P=0.058 P=0.519 P=0.247 P=0.108 | |INCIDENTAL TUMOR | P=0.216 P=0.538 P=0.356 P=0.321 | P=0.048 * P=0.523 P=0.211 P=0.108 | |LOGISTIC REGRESSION | P=0.203 P=0.538 P=0.303 P=0.300 | P=0.063 P=0.507 P=0.239 P=0.108 | |COCHRAN-ARMITAGE | P=0.189 | P=0.061 | |FISHER EXACT | P=0.535 P=0.281 P=0.291 | P=0.507 P=0.245 P=0.122 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 06 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL OXIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | 0 MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/63 (2%) 1/72 (1%) 0/73 (0%) 2/74 (3%) | 0/69 (0%) 1/71 (1%) 1/68 (1%) 1/68 (1%) | |ADJUSTED (b) | 2.2% 3.6% 0.0% 6.9% | 0.0% 1.9% 2.4% 2.0% | |INTERIM SACRIFICE 1 (c)| 0/1 (0%) 0/0 0/2 (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) | 0/19 (0%) 0/23 (0%) 0/29 (0%) 0/23 (0%) | 0/41 (0%) 0/40 (0%) 1/42 (2%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | 559 717 --- 704 | --- 640 729 (T) 640 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.423 P=0.716N P=0.475N P=0.586 | P=0.388 P=0.524 P=0.505 P=0.516 | |INCIDENTAL TUMOR | P=0.440 P=0.758N P=0.731N P=0.589 | P=0.344 P=0.523 P=0.505 P=0.473 | |LOGISTIC REGRESSION | P=0.417 P=0.729N P=0.484N P=0.571 | P=0.386 P=0.508 P=0.505 P=0.500 | |COCHRAN-ARMITAGE | P=0.404 | P=0.379 | |FISHER EXACT | P=0.717N P=0.463N P=0.561 | P=0.507 P=0.496 P=0.496 | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/63 (16%) 6/72 (8%) 17/73 (23%) 9/74 (12%) | 6/69 (9%) 8/71 (11%) 9/68 (13%) 5/68 (7%) | |ADJUSTED (b) | 37.2% 19.3% 36.4% 26.3% | 14.6% 18.3% 19.7% 12.5% | |INTERIM SACRIFICE 1 (c)| 1/1 (100%) 0/0 2/2 (100%) 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 1/5 (20%) 1/5 (20%) 2/5 (40%) 0/5 (0%) | 0/5 (0%) 1/5 (20%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 5/19 (26%) 3/23 (13%) 7/29 (24%) 4/23 (17%) | 6/41 (15%) 6/40 (15%) 6/42 (14%) 3/38 (8%) | |FIRST INCIDENCE (DAYS) | 199 (I) 458 (I) 199 (I) 431 | 729 (T) 459 (I) 640 720 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.529 P=0.185N P=0.403 P=0.423N | P=0.438N P=0.371 P=0.307 P=0.553N | |INCIDENTAL TUMOR | P=0.534 P=0.204N P=0.360 P=0.389N | P=0.379N P=0.412 P=0.308 P=0.458N | |LOGISTIC REGRESSION | P=0.519N P=0.128N P=0.186 P=0.332N | P=0.397N P=0.447 P=0.286 P=0.542N | |COCHRAN-ARMITAGE | P=0.529N | P=0.413N | |FISHER EXACT | P=0.139N P=0.194 P=0.351N | P=0.412 P=0.282 P=0.510N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 06 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL OXIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | 0 MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/63 (11%) 17/72 (24%) 12/73 (16%) 15/74 (20%) | 8/69 (12%) 10/71 (14%) 8/68 (12%) 4/68 (6%) | |ADJUSTED (b) | 20.4% 38.6% 26.0% 39.5% | 18.1% 21.0% 16.2% 9.2% | |INTERIM SACRIFICE 1 (c)| 0/1 (0%) 0/0 0/2 (0%) 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 1/5 (20%) 1/5 (20%) 1/5 (20%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 1/19 (5%) 2/23 (9%) 3/29 (10%) 5/23 (22%) | 6/41 (15%) 5/40 (13%) 4/42 (10%) 2/38 (5%) | |FIRST INCIDENCE (DAYS) | 392 341 458 (I) 459 | 586 469 451 644 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.288 P=0.081 P=0.384 P=0.144 | P=0.126N P=0.409 P=0.591N P=0.208N | |INCIDENTAL TUMOR | P=0.275 P=0.077 P=0.315 P=0.120 | P=0.067N P=0.583 P=0.584N P=0.163N | |LOGISTIC REGRESSION | P=0.227 P=0.048 * P=0.263 P=0.119 | P=0.102N P=0.475 P=0.602N P=0.167N | |COCHRAN-ARMITAGE | P=0.236 | P=0.116N | |FISHER EXACT | P=0.046 * P=0.261 P=0.110 | P=0.426 P=0.592 P=0.190N | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 15/63 (24%) 22/72 (31%) 28/73 (38%) 20/74 (27%) | 14/69 (20%) 17/71 (24%) 17/68 (25%) 9/68 (13%) | |ADJUSTED (b) | 44.4% 48.4% 53.9% 49.3% | 32.2% 34.9% 33.9% 20.9% | |INTERIM SACRIFICE 1 (c)| 1/1 (100%) 0/0 2/2 (100%) 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 2/5 (40%) 2/5 (40%) 3/5 (60%) 0/5 (0%) | 0/5 (0%) 1/5 (20%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 5/19 (26%) 4/23 (17%) 10/29 (34%) 7/23 (30%) | 12/41 (29%) 10/40 (25%) 10/42 (24%) 5/38 (13%) | |FIRST INCIDENCE (DAYS) | 199 (I) 341 199 (I) 431 | 586 459 (I) 451 644 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.443 P=0.255 P=0.197 P=0.379 | P=0.156N P=0.339 P=0.365 P=0.227N | |INCIDENTAL TUMOR | P=0.424 P=0.249 P=0.110 P=0.347 | P=0.077N P=0.505 P=0.369 P=0.142N | |LOGISTIC REGRESSION | P=0.440 P=0.253 P=0.047 * P=0.427 | P=0.110N P=0.443 P=0.345 P=0.163N | |COCHRAN-ARMITAGE | P=0.428 | P=0.134N | |FISHER EXACT | P=0.248 P=0.051 P=0.409 | P=0.376 P=0.325 P=0.191N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 06 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL OXIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | 0 MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 15/63 (24%) 22/72 (31%) 28/73 (38%) 20/74 (27%) | 14/69 (20%) 17/71 (24%) 17/68 (25%) 9/68 (13%) | |ADJUSTED (b) | 44.4% 48.4% 53.9% 49.3% | 32.2% 34.9% 33.9% 20.9% | |INTERIM SACRIFICE 1 (c)| 1/1 (100%) 0/0 2/2 (100%) 0/0 | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| 2/5 (40%) 2/5 (40%) 3/5 (60%) 0/5 (0%) | 0/5 (0%) 1/5 (20%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 5/19 (26%) 4/23 (17%) 10/29 (34%) 7/23 (30%) | 12/41 (29%) 10/40 (25%) 10/42 (24%) 5/38 (13%) | |FIRST INCIDENCE (DAYS) | 199 (I) 341 199 (I) 431 | 586 459 (I) 451 644 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.443 P=0.255 P=0.197 P=0.379 | P=0.156N P=0.339 P=0.365 P=0.227N | |INCIDENTAL TUMOR | P=0.424 P=0.249 P=0.110 P=0.347 | P=0.077N P=0.505 P=0.369 P=0.142N | |LOGISTIC REGRESSION | P=0.440 P=0.253 P=0.047 * P=0.427 | P=0.110N P=0.443 P=0.345 P=0.163N | |COCHRAN-ARMITAGE | P=0.428 | P=0.134N | |FISHER EXACT | P=0.248 P=0.051 P=0.409 | P=0.376 P=0.325 P=0.191N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 9/67 (13%) 5/77 (6%) 6/76 (8%) 11/79 (14%) | 2/74 (3%) 4/76 (5%) 11/73 (15%) 3/74 (4%) | |ADJUSTED (b) | 32.6% 16.2% 18.3% 33.0% | 4.7% 9.3% 22.7% 7.1% | |INTERIM SACRIFICE 1 (c)| 1/5 (20%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 1/5 (20%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 1/5 (20%) 0/5 (0%) | |TERMINAL (d) | 4/19 (21%) 2/23 (9%) 4/29 (14%) 5/23 (22%) | 1/41 (2%) 3/40 (8%) 6/42 (14%) 2/38 (5%) | |FIRST INCIDENCE (DAYS) | 199 (I) 512 676 489 | 728 652 459 (I) 619 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.367 P=0.126N P=0.104N P=0.586N | P=0.348 P=0.334 P=0.013 * P=0.474 | |INCIDENTAL TUMOR | P=0.374 P=0.110N P=0.113N P=0.594 | P=0.398 P=0.449 P=0.011 * P=0.528 | |LOGISTIC REGRESSION | P=0.354 P=0.122N P=0.147N P=0.596N | P=0.381 P=0.366 P=0.010 ** P=0.512 | |COCHRAN-ARMITAGE | P=0.322 | P=0.368 | |FISHER EXACT | P=0.131N P=0.210N P=0.563 | P=0.353 P=0.008 ** P=0.500 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 06 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL OXIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | 0 MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/67 (6%) 10/77 (13%) 9/76 (12%) 6/79 (8%) | 4/74 (5%) 11/76 (14%) 4/73 (5%) 5/74 (7%) | |ADJUSTED (b) | 16.9% 32.4% 27.3% 19.6% | 9.4% 22.8% 9.0% 10.8% | |INTERIM SACRIFICE 1 (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%) | |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) | 2/19 (11%) 5/23 (22%) 7/29 (24%) 3/23 (13%) | 3/41 (7%) 5/40 (13%) 3/42 (7%) 2/38 (5%) | |FIRST INCIDENCE (DAYS) | 559 616 483 571 | 694 583 630 469 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.449N P=0.160 P=0.321 P=0.520 | P=0.407N P=0.057 P=0.633N P=0.483 | |INCIDENTAL TUMOR | P=0.469N P=0.119 P=0.292 P=0.496 | P=0.286N P=0.134 P=0.639N P=0.623N | |LOGISTIC REGRESSION | P=0.443N P=0.141 P=0.268 P=0.521 | P=0.367N P=0.068 P=0.643 P=0.525 | |COCHRAN-ARMITAGE | P=0.502N | P=0.384N | |FISHER EXACT | P=0.128 P=0.177 P=0.480 | P=0.056 P=0.633 P=0.500 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/67 (16%) 14/77 (18%) 15/76 (20%) 14/79 (18%) | 6/74 (8%) 15/76 (20%) 13/73 (18%) 8/74 (11%) | |ADJUSTED (b) | 38.5% 41.4% 43.6% 39.7% | 13.8% 30.8% 27.0% 17.4% | |INTERIM SACRIFICE 1 (c)| 1/5 (20%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 1/5 (20%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 1/5 (20%) 0/5 (0%) | |TERMINAL (d) | 5/19 (26%) 6/23 (26%) 11/29 (38%) 6/23 (26%) | 4/41 (10%) 8/40 (20%) 8/42 (19%) 4/38 (11%) | |FIRST INCIDENCE (DAYS) | 199 (I) 512 483 489 | 694 583 459 (I) 469 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.534N P=0.529 P=0.531N P=0.555 | P=0.530 P=0.034 * P=0.079 P=0.363 | |INCIDENTAL TUMOR | P=0.533 P=0.490 P=0.591N P=0.512 | P=0.412N P=0.094 P=0.078 P=0.532 | |LOGISTIC REGRESSION | P=0.539 P=0.503 P=0.526 P=0.546 | P=0.473N P=0.042 * P=0.067 P=0.418 | |COCHRAN-ARMITAGE | P=0.477 | P=0.526N | |FISHER EXACT | P=0.478 P=0.385 P=0.506 | P=0.034 * P=0.065 P=0.390 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 06 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL OXIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | 0 MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/67 (0%) 0/77 (0%) 0/76 (0%) 0/79 (0%) | 2/74 (3%) 3/76 (4%) 0/73 (0%) 3/74 (4%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 4.6% 7.5% 0.0% 7.4% | |INTERIM SACRIFICE 1 (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%) | |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) | 0/19 (0%) 0/23 (0%) 0/29 (0%) 0/23 (0%) | 1/41 (2%) 3/40 (8%) 0/42 (0%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 694 729 (T) --- 699 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.478 P=0.489 P=0.245N P=0.472 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.549 P=0.560 P=0.217N P=0.673 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.494 P=0.519 P=0.238N P=0.505 | |COCHRAN-ARMITAGE | (e) | P=0.499 | |FISHER EXACT | (e) (e) (e) | P=0.513 P=0.252N P=0.500 | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/67 (0%) 0/77 (0%) 0/76 (0%) 0/79 (0%) | 2/74 (3%) 4/76 (5%) 0/73 (0%) 3/74 (4%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 4.6% 9.4% 0.0% 7.4% | |INTERIM SACRIFICE 1 (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%) | |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) | 0/19 (0%) 0/23 (0%) 0/29 (0%) 0/23 (0%) | 1/41 (2%) 3/40 (8%) 0/42 (0%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 694 683 --- 699 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.547 P=0.334 P=0.245N P=0.472 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.546N P=0.449 P=0.217N P=0.673 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.569 P=0.367 P=0.238N P=0.505 | |COCHRAN-ARMITAGE | (e) | P=0.569 | |FISHER EXACT | (e) (e) (e) | P=0.353 P=0.252N P=0.500 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 06 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL OXIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | 0 MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/67 (0%) 0/77 (0%) 0/76 (0%) 0/79 (0%) | 2/74 (3%) 4/76 (5%) 0/73 (0%) 3/74 (4%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 4.6% 9.4% 0.0% 7.4% | |INTERIM SACRIFICE 1 (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%) | |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) | 0/19 (0%) 0/23 (0%) 0/29 (0%) 0/23 (0%) | 1/41 (2%) 3/40 (8%) 0/42 (0%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 694 683 --- 699 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.547 P=0.334 P=0.245N P=0.472 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.546N P=0.449 P=0.217N P=0.673 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.569 P=0.367 P=0.238N P=0.505 | |COCHRAN-ARMITAGE | (e) | P=0.569 | |FISHER EXACT | (e) (e) (e) | P=0.353 P=0.252N P=0.500 | |=================================================================================================================================| | | |Ovary | | Cystadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 1/66 (2%) 0/71 (0%) 3/65 (5%) 0/68 (0%) | |ADJUSTED (b) | | 2.6% 0.0% 7.1% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | | 1/38 (3%) 0/40 (0%) 3/42 (7%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | | 729 (T) --- 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.507N P=0.490N P=0.342 P=0.500N | |INCIDENTAL TUMOR | | P=0.507N P=0.490N P=0.342 P=0.500N | |LOGISTIC REGRESSION | | P=0.507N P=0.490N P=0.342 P=0.500N | |COCHRAN-ARMITAGE | | P=0.505N | |FISHER EXACT | | P=0.482N P=0.304 P=0.493N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 06 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL OXIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | 0 MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Ovary | | Teratoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 2/66 (3%) 1/71 (1%) 0/65 (0%) 0/68 (0%) | |ADJUSTED (b) | | 2.9% 1.3% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/0 0/0 0/0 0/0 | |INTERIM SACRIFICE 2 (c)| | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | | 0/38 (0%) 0/40 (0%) 0/42 (0%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | | 92 162 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.099N P=0.469N P=0.241N P=0.229N | |INCIDENTAL TUMOR | | P=0.190N P=0.719 P=0.290N P=0.500N | |LOGISTIC REGRESSION | | P=0.209N P=0.651 P=0.304N P=0.572N | |COCHRAN-ARMITAGE | | P=0.101N | |FISHER EXACT | | P=0.472N P=0.252N P=0.241N | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/61 (0%) 0/67 (0%) 0/68 (0%) 0/71 (0%) | 6/68 (9%) 9/71 (13%) 8/66 (12%) 6/67 (9%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 14.1% 20.5% 18.8% 14.6% | |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) | 0/19 (0%) 0/23 (0%) 0/27 (0%) 0/22 (0%) | 5/41 (12%) 7/40 (18%) 7/41 (17%) 4/38 (11%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 694 597 640 673 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.504N P=0.287 P=0.387 P=0.574 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.477N P=0.362 P=0.390 P=0.560N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.473N P=0.350 P=0.370 P=0.621N | |COCHRAN-ARMITAGE | (e) | P=0.485N | |FISHER EXACT | (e) (e) (e) | P=0.324 P=0.367 P=0.608 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 06 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL OXIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | 0 MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/61 (0%) 0/67 (0%) 0/68 (0%) 0/71 (0%) | 7/68 (10%) 9/71 (13%) 8/66 (12%) 7/67 (10%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 16.5% 20.5% 18.8% 16.5% | |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) | 0/19 (0%) 0/23 (0%) 0/27 (0%) 0/22 (0%) | 6/41 (15%) 7/40 (18%) 7/41 (17%) 4/38 (11%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 694 597 640 673 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.534N P=0.388 P=0.498 P=0.564 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.499N P=0.469 P=0.502 P=0.528N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.501N P=0.461 P=0.482 P=0.608N | |COCHRAN-ARMITAGE | (e) | P=0.515N | |FISHER EXACT | (e) (e) (e) | P=0.432 P=0.475 P=0.599 | |=================================================================================================================================| | | |Skin | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/67 (0%) 0/77 (0%) 0/76 (0%) 0/79 (0%) | 1/74 (1%) 2/76 (3%) 0/73 (0%) 0/74 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 2.4% 4.8% 0.0% 0.0% | |INTERIM SACRIFICE 1 (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%) | |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) | 0/19 (0%) 0/23 (0%) 0/29 (0%) 0/23 (0%) | 1/41 (2%) 1/40 (3%) 0/42 (0%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 729 (T) 720 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.194N P=0.492 P=0.495N P=0.515N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.169N P=0.582 P=0.495N P=0.515N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.190N P=0.505 P=0.495N P=0.515N | |COCHRAN-ARMITAGE | (e) | P=0.186N | |FISHER EXACT | (e) (e) (e) | P=0.510 P=0.503N P=0.500N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 06 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL OXIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | 0 MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Skin | | Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/67 (0%) 0/77 (0%) 0/76 (0%) 0/79 (0%) | 0/74 (0%) 2/76 (3%) 1/73 (1%) 1/74 (1%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 3.5% 2.4% 2.6% | |INTERIM SACRIFICE 1 (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%) | |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) | 0/19 (0%) 0/23 (0%) 0/29 (0%) 0/23 (0%) | 0/41 (0%) 0/40 (0%) 1/42 (2%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- 593 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.498 P=0.267 P=0.505 P=0.485 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.463 P=0.259 P=0.505 P=0.485 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.509 P=0.245 P=0.505 P=0.485 | |COCHRAN-ARMITAGE | (e) | P=0.502 | |FISHER EXACT | (e) (e) (e) | P=0.255 P=0.497 P=0.500 | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/61 (2%) 1/72 (1%) 2/71 (3%) 1/74 (1%) | 2/69 (3%) 2/72 (3%) 5/68 (7%) 2/68 (3%) | |ADJUSTED (b) | 5.3% 2.2% 6.9% 1.4% | 4.7% 4.8% 10.7% 4.4% | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | 0/0 0/1 (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) | 1/19 (5%) 0/23 (0%) 2/29 (7%) 0/23 (0%) | 1/41 (2%) 1/40 (3%) 3/42 (7%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | 737 (T) 604 737 (T) 271 | 728 720 538 658 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.600N P=0.708N P=0.647 P=0.719N | P=0.496 P=0.679 P=0.230 P=0.678 | |INCIDENTAL TUMOR | P=0.601 P=0.758 P=0.647 P=0.722N | P=0.503N P=0.558N P=0.287 P=0.508N | |LOGISTIC REGRESSION | P=0.600N P=0.722N P=0.647 P=0.725N | P=0.519 P=0.693N P=0.220 P=0.685N | |COCHRAN-ARMITAGE | P=0.601N | P=0.502 | |FISHER EXACT | P=0.709N P=0.557 P=0.701N | P=0.674N P=0.214 P=0.685 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 06 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL OXIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | 0 MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma or Papilloma Squamous | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/67 (1%) 1/77 (1%) 0/76 (0%) 1/79 (1%) | 2/74 (3%) 0/76 (0%) 0/73 (0%) 1/74 (1%) | |ADJUSTED (b) | 5.3% 4.3% 0.0% 4.3% | 4.9% 0.0% 0.0% 2.3% | |INTERIM SACRIFICE 1 (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%) | |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) | 1/19 (5%) 1/23 (4%) 0/29 (0%) 1/23 (4%) | 2/41 (5%) 0/40 (0%) 0/42 (0%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | 737 (T) 737 (T) --- 737 (T) | 729 (T) --- --- 696 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.576N P=0.720N P=0.416N P=0.720N | P=0.477N P=0.244N P=0.233N P=0.518N | |INCIDENTAL TUMOR | P=0.576N P=0.720N P=0.416N P=0.720N | P=0.443N P=0.244N P=0.233N P=0.440N | |LOGISTIC REGRESSION | P=0.576N P=0.720N P=0.416N P=0.720N | P=0.470N P=0.244N P=0.233N P=0.498N | |COCHRAN-ARMITAGE | P=0.581N | P=0.469N | |FISHER EXACT | P=0.716N P=0.469N P=0.709N | P=0.242N P=0.252N P=0.500N | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/62 (0%) 0/71 (0%) 2/71 (3%) 0/74 (0%) | | |ADJUSTED (b) | 0.0% 0.0% 5.5% 0.0% | | |INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | | |INTERIM SACRIFICE 2 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | | |TERMINAL (d) | 0/19 (0%) 0/23 (0%) 1/29 (3%) 0/23 (0%) | | |FIRST INCIDENCE (DAYS) | --- --- 649 --- | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.639 (e) P=0.341 (e) | | |INCIDENTAL TUMOR | P=0.657 (e) P=0.356 (e) | | |LOGISTIC REGRESSION | P=0.632 (e) P=0.302 (e) | | |COCHRAN-ARMITAGE | P=0.621 | | |FISHER EXACT | (e) P=0.283 (e) | | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 06 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL OXIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | 0 MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/60 (5%) 2/72 (3%) 2/71 (3%) 2/74 (3%) | 2/67 (3%) 1/71 (1%) 1/68 (1%) 1/69 (1%) | |ADJUSTED (b) | 9.8% 8.7% 6.0% 8.7% | 4.9% 2.3% 2.4% 2.1% | |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%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 1/19 (5%) 2/23 (9%) 1/29 (3%) 2/23 (9%) | 2/41 (5%) 0/40 (0%) 1/42 (2%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | 458 (I) 737 (T) 679 737 (T) | 729 (T) 711 729 (T) 658 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.358N P=0.434N P=0.359N P=0.429N | P=0.425N P=0.506N P=0.492N P=0.513N | |INCIDENTAL TUMOR | P=0.374N P=0.468N P=0.462N P=0.468N | P=0.373N P=0.418N P=0.492N P=0.440N | |LOGISTIC REGRESSION | P=0.345N P=0.419N P=0.403N P=0.401N | P=0.412N P=0.487N P=0.492N P=0.489N | |COCHRAN-ARMITAGE | P=0.361N | P=0.407N | |FISHER EXACT | P=0.414N P=0.420N P=0.401N | P=0.478N P=0.494N P=0.489N | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/60 (5%) 2/72 (3%) 2/71 (3%) 2/74 (3%) | 3/67 (4%) 1/71 (1%) 1/68 (1%) 1/69 (1%) | |ADJUSTED (b) | 9.8% 8.7% 6.0% 8.7% | 7.3% 2.3% 2.4% 2.1% | |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%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 1/19 (5%) 2/23 (9%) 1/29 (3%) 2/23 (9%) | 3/41 (7%) 0/40 (0%) 1/42 (2%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | 458 (I) 737 (T) 679 737 (T) | 729 (T) 711 729 (T) 658 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.358N P=0.434N P=0.359N P=0.429N | P=0.258N P=0.313N P=0.297N P=0.323N | |INCIDENTAL TUMOR | P=0.374N P=0.468N P=0.462N P=0.468N | P=0.219N P=0.246N P=0.297N P=0.266N | |LOGISTIC REGRESSION | P=0.345N P=0.419N P=0.403N P=0.401N | P=0.246N P=0.295N P=0.297N P=0.297N | |COCHRAN-ARMITAGE | P=0.361N | P=0.242N | |FISHER EXACT | P=0.414N P=0.420N P=0.401N | P=0.288N P=0.304N P=0.299N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 06 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL OXIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | 0 MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Tooth | | Odontoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/67 (0%) 1/77 (1%) 2/76 (3%) 1/79 (1%) | 0/74 (0%) 0/76 (0%) 0/73 (0%) 1/74 (1%) | |ADJUSTED (b) | 0.0% 4.3% 6.9% 4.3% | 0.0% 0.0% 0.0% 2.6% | |INTERIM SACRIFICE 1 (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%) | |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) | 0/19 (0%) 1/23 (4%) 2/29 (7%) 1/23 (4%) | 0/41 (0%) 0/40 (0%) 0/42 (0%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | --- 737 (T) 737 (T) 737 (T) | --- --- --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.410 P=0.538 P=0.335 P=0.538 | P=0.188 (e) (e) P=0.485 | |INCIDENTAL TUMOR | P=0.410 P=0.538 P=0.335 P=0.538 | P=0.188 (e) (e) P=0.485 | |LOGISTIC REGRESSION | P=0.410 P=0.538 P=0.335 P=0.538 | P=0.188 (e) (e) P=0.485 | |COCHRAN-ARMITAGE | P=0.405 | P=0.196 | |FISHER EXACT | P=0.535 P=0.281 P=0.541 | (e) (e) P=0.500 | |=================================================================================================================================| | | |Uterus | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 0/74 (0%) 3/76 (4%) 1/73 (1%) 1/74 (1%) | |ADJUSTED (b) | | 0.0% 6.9% 2.3% 2.6% | |INTERIM SACRIFICE 1 (c)| | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | | 0/41 (0%) 2/40 (5%) 0/42 (0%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | | --- 657 681 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.583 P=0.125 P=0.487 P=0.485 | |INCIDENTAL TUMOR | | P=0.603N P=0.164 P=0.536 P=0.485 | |LOGISTIC REGRESSION | | P=0.599 P=0.135 P=0.501 P=0.485 | |COCHRAN-ARMITAGE | | P=0.595 | |FISHER EXACT | | P=0.128 P=0.497 P=0.500 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 06 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL OXIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | 0 MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 2/74 (3%) 4/76 (5%) 0/73 (0%) 1/74 (1%) | |ADJUSTED (b) | | 4.3% 8.3% 0.0% 2.6% | |INTERIM SACRIFICE 1 (c)| | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | | 1/41 (2%) 2/40 (5%) 0/42 (0%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | | 559 583 --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.204N P=0.361 P=0.235N P=0.513N | |INCIDENTAL TUMOR | | P=0.228N P=0.357 P=0.268N P=0.533N | |LOGISTIC REGRESSION | | P=0.191N P=0.370 P=0.238N P=0.486N | |COCHRAN-ARMITAGE | | P=0.198N | |FISHER EXACT | | P=0.353 P=0.252N P=0.500N | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 3/74 (4%) 4/76 (5%) 1/73 (1%) 1/74 (1%) | |ADJUSTED (b) | | 6.7% 8.3% 2.4% 2.6% | |INTERIM SACRIFICE 1 (c)| | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | | 2/41 (5%) 2/40 (5%) 1/42 (2%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | | 559 583 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.145N P=0.519 P=0.299N P=0.324N | |INCIDENTAL TUMOR | | P=0.162N P=0.520 P=0.326N P=0.339N | |LOGISTIC REGRESSION | | P=0.132N P=0.541 P=0.304N P=0.292N | |COCHRAN-ARMITAGE | | P=0.138N | |FISHER EXACT | | P=0.515 P=0.315N P=0.310N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 06 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL OXIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | 0 MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/67 (4%) 2/77 (3%) 2/76 (3%) 3/79 (4%) | 3/74 (4%) 6/76 (8%) 8/73 (11%) 4/74 (5%) | |ADJUSTED (b) | 10.3% 5.7% 6.9% 8.3% | 7.1% 13.2% 17.3% 8.7% | |INTERIM SACRIFICE 1 (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%) | |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) | 1/19 (5%) 0/23 (0%) 2/29 (7%) 0/23 (0%) | 2/41 (5%) 3/40 (8%) 5/42 (12%) 1/38 (3%) | |FIRST INCIDENCE (DAYS) | 559 604 737 (T) 271 | 728 640 538 640 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.545N P=0.404N P=0.343N P=0.553N | P=0.459 P=0.249 P=0.112 P=0.483 | |INCIDENTAL TUMOR | P=0.578 P=0.531N P=0.582N P=0.599N | P=0.523N P=0.378 P=0.145 P=0.629 | |LOGISTIC REGRESSION | P=0.555N P=0.428N P=0.379N P=0.578N | P=0.492 P=0.280 P=0.103 P=0.518 | |COCHRAN-ARMITAGE | P=0.569N | P=0.479 | |FISHER EXACT | P=0.434N P=0.440N P=0.578N | P=0.261 P=0.100 P=0.500 | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/67 (4%) 2/77 (3%) 2/76 (3%) 4/79 (5%) | 3/74 (4%) 6/76 (8%) 9/73 (12%) 5/74 (7%) | |ADJUSTED (b) | 10.3% 5.7% 6.9% 11.0% | 7.1% 13.2% 18.9% 11.2% | |INTERIM SACRIFICE 1 (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%) | |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) | 1/19 (5%) 0/23 (0%) 2/29 (7%) 0/23 (0%) | 2/41 (5%) 3/40 (8%) 5/42 (12%) 2/38 (5%) | |FIRST INCIDENCE (DAYS) | 559 604 737 (T) 271 | 728 640 538 640 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.453 P=0.404N P=0.343N P=0.633 | P=0.320 P=0.249 P=0.073 P=0.340 | |INCIDENTAL TUMOR | P=0.411 P=0.531N P=0.582N P=0.603 | P=0.438 P=0.378 P=0.087 P=0.467 | |LOGISTIC REGRESSION | P=0.434 P=0.428N P=0.379N P=0.598 | P=0.350 P=0.280 P=0.065 P=0.373 | |COCHRAN-ARMITAGE | P=0.419 | P=0.337 | |FISHER EXACT | P=0.434N P=0.440N P=0.591 | P=0.261 P=0.062 P=0.359 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 06 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL OXIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | 0 MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/67 (0%) 0/77 (0%) 0/76 (0%) 1/79 (1%) | 2/74 (3%) 0/76 (0%) 0/73 (0%) 2/74 (3%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 1.5% | 4.9% 0.0% 0.0% 3.5% | |INTERIM SACRIFICE 1 (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%) | |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) | 0/19 (0%) 0/23 (0%) 0/29 (0%) 0/23 (0%) | 2/41 (5%) 0/40 (0%) 0/42 (0%) 0/38 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 422 | 729 (T) --- --- 495 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.214 (e) (e) P=0.539 | P=0.489 P=0.244N P=0.233N P=0.690 | |INCIDENTAL TUMOR | P=0.227 (e) (e) P=0.602 | P=0.601 P=0.244N P=0.233N P=0.591N | |LOGISTIC REGRESSION | P=0.207 (e) (e) P=0.523 | P=0.496 P=0.244N P=0.233N P=0.685N | |COCHRAN-ARMITAGE | P=0.211 | P=0.491 | |FISHER EXACT | (e) (e) P=0.541 | P=0.242N P=0.252N P=0.690N | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma And Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/67 (3%) 2/77 (3%) 2/76 (3%) 6/79 (8%) | 15/74 (20%) 12/76 (16%) 9/73 (12%) 9/74 (12%) | |ADJUSTED (b) | 6.5% 4.5% 6.9% 14.0% | 33.1% 25.3% 18.5% 18.6% | |INTERIM SACRIFICE 1 (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%) | |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) | 0/19 (0%) 0/23 (0%) 2/29 (7%) 1/23 (4%) | 11/41 (27%) 6/40 (15%) 5/42 (12%) 4/38 (11%) | |FIRST INCIDENCE (DAYS) | 590 501 737 (T) 137 | 618 597 321 426 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.093 P=0.626N P=0.558N P=0.243 | P=0.129N P=0.347N P=0.130N P=0.167N | |INCIDENTAL TUMOR | P=0.089 P=0.613N P=0.669N P=0.221 | P=0.071N P=0.171N P=0.128N P=0.063N | |LOGISTIC REGRESSION | P=0.078 P=0.641N P=0.590N P=0.196 | P=0.090N P=0.252N P=0.125N P=0.106N | |COCHRAN-ARMITAGE | P=0.077 | P=0.105N | |FISHER EXACT | P=0.636N P=0.641N P=0.198 | P=0.308N P=0.140N P=0.132N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 06 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL OXIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | 0 MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated | | Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/67 (3%) 2/77 (3%) 2/76 (3%) 5/79 (6%) | 13/74 (18%) 12/76 (16%) 9/73 (12%) 7/74 (9%) | |ADJUSTED (b) | 6.5% 4.5% 6.9% 12.7% | 28.6% 25.3% 18.5% 15.7% | |INTERIM SACRIFICE 1 (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%) | |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) | 0/19 (0%) 0/23 (0%) 2/29 (7%) 1/23 (4%) | 9/41 (22%) 6/40 (15%) 5/42 (12%) 4/38 (11%) | |FIRST INCIDENCE (DAYS) | 590 501 737 (T) 137 | 618 597 321 426 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.176 P=0.626N P=0.558N P=0.344 | P=0.096N P=0.506N P=0.240N P=0.146N | |INCIDENTAL TUMOR | P=0.165 P=0.613N P=0.669N P=0.300 | P=0.060N P=0.299N P=0.241N P=0.068N | |LOGISTIC REGRESSION | P=0.154 P=0.641N P=0.590N P=0.293 | P=0.066N P=0.413N P=0.236N P=0.094N | |COCHRAN-ARMITAGE | P=0.151 | P=0.077N | |FISHER EXACT | P=0.636N P=0.641N P=0.294 | P=0.471N P=0.255N P=0.114N | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 22/67 (33%) 17/77 (22%) 29/76 (38%) 26/79 (33%) | 21/74 (28%) 28/76 (37%) 29/73 (40%) 24/74 (32%) | |ADJUSTED (b) | 72.6% 49.0% 63.4% 67.1% | 44.5% 55.7% 56.6% 53.0% | |INTERIM SACRIFICE 1 (c)| 2/5 (40%) 0/5 (0%) 2/5 (40%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 2/5 (40%) 1/5 (20%) 2/5 (40%) 0/5 (0%) | 0/5 (0%) 1/5 (20%) 1/5 (20%) 0/5 (0%) | |TERMINAL (d) | 12/19 (63%) 8/23 (35%) 15/29 (52%) 12/23 (52%) | 16/41 (39%) 19/40 (48%) 20/42 (48%) 17/38 (45%) | |FIRST INCIDENCE (DAYS) | 199 (I) 458 (I) 199 (I) 431 | 92 162 459 (I) 619 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.345 P=0.083N P=0.478N P=0.502N | P=0.336 P=0.150 P=0.131 P=0.277 | |INCIDENTAL TUMOR | P=0.344 P=0.077N P=0.513 P=0.498N | P=0.375 P=0.176 P=0.106 P=0.368 | |LOGISTIC REGRESSION | P=0.323 P=0.082N P=0.425 P=0.515N | P=0.447 P=0.234 P=0.106 P=0.305 | |COCHRAN-ARMITAGE | P=0.280 | P=0.402 | |FISHER EXACT | P=0.104N P=0.313 P=0.567 | P=0.176 P=0.101 P=0.361 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 06 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL OXIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | O MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | 0 MG/M3 1.25MGM3 2.5MG/M3 5.0MG/M3 | | | LUNGTX LUNGTX LUNGTX LUNGTX | LUNGTX LUNGTX LUNGTX LUNGTX | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 16/67 (24%) 29/77 (38%) 23/76 (30%) 30/79 (38%) | 30/74 (41%) 37/76 (49%) 28/73 (38%) 28/74 (38%) | |ADJUSTED (b) | 44.2% 61.2% 53.7% 61.7% | 61.0% 64.6% 51.0% 49.8% | |INTERIM SACRIFICE 1 (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%) | |INTERIM SACRIFICE 2 (c)| 1/5 (20%) 1/5 (20%) 1/5 (20%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |TERMINAL (d) | 4/19 (21%) 7/23 (30%) 12/29 (41%) 8/23 (35%) | 22/41 (54%) 20/40 (50%) 16/42 (38%) 11/38 (29%) | |FIRST INCIDENCE (DAYS) | 392 341 458 (I) 137 | 586 469 321 426 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.180 P=0.115 P=0.525 P=0.107 | P=0.315N P=0.192 P=0.410N P=0.503N | |INCIDENTAL TUMOR | P=0.110 P=0.054 P=0.267 P=0.046 * | P=0.079N P=0.450 P=0.394N P=0.139N | |LOGISTIC REGRESSION | P=0.106 P=0.042 * P=0.354 P=0.054 | P=0.135N P=0.396 P=0.413N P=0.245N | |COCHRAN-ARMITAGE | P=0.103 | P=0.244N | |FISHER EXACT | P=0.054 P=0.253 P=0.049 * | P=0.201 P=0.459N P=0.433N | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 34/67 (51%) 39/77 (51%) 45/76 (59%) 44/79 (56%) | 37/74 (50%) 50/76 (66%) 46/73 (63%) 40/74 (54%) | |ADJUSTED (b) | 85.0% 76.6% 86.8% 81.4% | 70.7% 80.6% 77.9% 72.1% | |INTERIM SACRIFICE 1 (c)| 2/5 (40%) 0/5 (0%) 2/5 (40%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 0/5 (0%) | |INTERIM SACRIFICE 2 (c)| 3/5 (60%) 2/5 (40%) 3/5 (60%) 0/5 (0%) | 0/5 (0%) 1/5 (20%) 1/5 (20%) 0/5 (0%) | |TERMINAL (d) | 14/19 (74%) 12/23 (52%) 23/29 (79%) 14/23 (61%) | 26/41 (63%) 28/40 (70%) 29/42 (69%) 23/38 (61%) | |FIRST INCIDENCE (DAYS) | 199 (I) 341 199 (I) 137 | 92 162 321 426 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.377 P=0.471N P=0.465N P=0.451 | P=0.449 P=0.051 P=0.142 P=0.300 | |INCIDENTAL TUMOR | P=0.299 P=0.539N P=0.355 P=0.382 | P=0.356N P=0.083 P=0.067 P=0.571 | |LOGISTIC REGRESSION | P=0.288 P=0.540N P=0.327 P=0.373 | P=0.423N P=0.067 P=0.080 P=0.498 | |COCHRAN-ARMITAGE | P=0.245 | P=0.530 | |FISHER EXACT | P=0.562N P=0.198 P=0.333 | P=0.036 * P=0.077 P=0.371 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05123 TEST: 06 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NICKEL OXIDE MALE TERMINAL SACRIFICE AT 106 WEEKS FEMALE 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): 199 458 Female interim sacrifices(days): 200 459 (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).