TDMS Study 05079-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: LITRI TALC DATE: 09/10/94 EXPERIMENT: 05079 TEST: 01 TIME: 15:25:13 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 06008 PATHOLOGIST: B. JONES F. HAHN CAS: 14807966 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: LITRI TALC DATE: 09/10/94 EXPERIMENT: 05079 TEST: 01 TIME: 15:25:13 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 06008 PATHOLOGIST: B. JONES F. HAHN CAS: 14807966 RATS(FISCHER344) ---------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED. ---------------- Adrenal Gland Bone Marrow Brain Clitoral Gland Epididymis Heart Islets, Pancreatic Kidney 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 TALC DATE: 09/10/94 EXPERIMENT: 05079 TEST: 01 TIME: 15:25:13 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 06008 PATHOLOGIST: B. JONES F. HAHN CAS: 14807966 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF TALC ==================================================================================================== MALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma: Benign, Complex, Malignant, NOS ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma Malignant Pheochromocytoma: Benign, Complex, Malignant, NOS Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Thyroid Gland: C-Cell Adenoma Carcinoma or Adenoma All Organs Malignant Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 09/10/94 EXPERIMENT: 05079 TEST: 01 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC MALE TERMINAL SACRIFICE AT 115 WEEKS FEMALE TERMINAL SACRIFICE AT 124 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6 MG/M3 18 MG/M3 | CONTROL 6 MG/M3 18 MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 26/60 (43%) 33/63 (52%) 39/57 (68%) | 14/63 (22%) 19/65 (29%) 21/61 (34%) | |ADJUSTED (b) | 87.8% 90.7% 100.0% | 63.8% 64.5% 84.0% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 1/2 (50%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 4 (c)| 1/3 (33%) 3/6 (50%) 2/2 (100%) | 0/5 (0%) 5/9 (56%) 3/3 (100%) | |TERMINAL (d) | 6/9 (67%) 11/14 (79%) 16/16 (100%) | 6/12 (50%) 5/13 (38%) 6/9 (67%) | |FIRST INCIDENCE (DAYS) | 429 558 556 (I) | 678 705 697 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.254 P=0.520N P=0.318 | P=0.037 * P=0.291 P=0.052 | |INCIDENTAL TUMOR | P=0.003 ** P=0.215 P=0.005 ** | P=0.083 P=0.347 P=0.099 | |LOGISTIC REGRESSION | P=0.001 ** P=0.226 P=0.002 ** | P=0.083 P=0.247 P=0.080 | |COCHRAN-ARMITAGE | P=0.004 ** | P=0.093 | |FISHER EXACT | P=0.205 P=0.005 ** | P=0.241 P=0.095 | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Complex | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 2/63 (3%) 1/57 (2%) | 0/63 (0%) 0/65 (0%) 0/61 (0%) | |ADJUSTED (b) | 0.0% 8.9% 4.0% | 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 0/6 (0%) 0/2 (0%) | 0/5 (0%) 0/9 (0%) 0/3 (0%) | |TERMINAL (d) | 0/9 (0%) 1/14 (7%) 0/16 (0%) | 0/12 (0%) 0/13 (0%) 0/9 (0%) | |FIRST INCIDENCE (DAYS) | --- 558 743 | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.555 P=0.297 P=0.517 | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.502 P=0.239 P=0.443 | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.484 P=0.250 P=0.501 | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.481 | (e) | |FISHER EXACT | P=0.260 P=0.487 | (e) (e) | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05079 TEST: 01 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC MALE TERMINAL SACRIFICE AT 115 WEEKS FEMALE TERMINAL SACRIFICE AT 124 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6 MG/M3 18 MG/M3 | CONTROL 6 MG/M3 18 MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/60 (5%) 3/63 (5%) 7/57 (12%) | 0/63 (0%) 1/65 (2%) 10/61 (16%) | |ADJUSTED (b) | 17.1% 14.9% 31.4% | 0.0% 7.1% 56.9% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 0/6 (0%) 0/2 (0%) | 0/5 (0%) 0/9 (0%) 0/3 (0%) | |TERMINAL (d) | 1/9 (11%) 1/14 (7%) 3/16 (19%) | 0/12 (0%) 0/13 (0%) 3/9 (33%) | |FIRST INCIDENCE (DAYS) | 670 544 645 | --- 849 784 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.237 P=0.541N P=0.373 | P<0.001 ** P=0.515 P=0.001 ** | |INCIDENTAL TUMOR | P=0.108 P=0.551N P=0.174 | P<0.001 ** P=0.507 P=0.002 ** | |LOGISTIC REGRESSION | P=0.088 P=0.628N P=0.172 | P<0.001 ** P=0.499 P<0.001 ** | |COCHRAN-ARMITAGE | P=0.076 | P<0.001 ** | |FISHER EXACT | P=0.637N P=0.141 | P=0.508 P<0.001 ** | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 28/60 (47%) 35/63 (56%) 40/57 (70%) | 14/63 (22%) 19/65 (29%) 26/61 (43%) | |ADJUSTED (b) | 92.0% 93.9% 100.0% | 63.8% 64.5% 95.7% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 1/2 (50%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 1/2 (50%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 4 (c)| 1/3 (33%) 3/6 (50%) 2/2 (100%) | 0/5 (0%) 5/9 (56%) 3/3 (100%) | |TERMINAL (d) | 7/9 (78%) 12/14 (86%) 16/16 (100%) | 6/12 (50%) 5/13 (38%) 8/9 (89%) | |FIRST INCIDENCE (DAYS) | 333 (I) 544 556 (I) | 678 705 697 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.348 P=0.480N P=0.424 | P=0.003 ** P=0.291 P=0.006 ** | |INCIDENTAL TUMOR | P=0.007 ** P=0.293 P=0.011 * | P=0.006 ** P=0.347 P=0.010 ** | |LOGISTIC REGRESSION | P=0.002 ** P=0.226 P=0.003 ** | P=0.004 ** P=0.247 P=0.005 ** | |COCHRAN-ARMITAGE | P=0.007 ** | P=0.009 ** | |FISHER EXACT | P=0.210 P=0.008 ** | P=0.241 P=0.012 * | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05079 TEST: 01 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC MALE TERMINAL SACRIFICE AT 115 WEEKS FEMALE TERMINAL SACRIFICE AT 124 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6 MG/M3 18 MG/M3 | CONTROL 6 MG/M3 18 MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/59 (2%) 6/64 (9%) 1/58 (2%) | 2/62 (3%) 0/62 (0%) 1/58 (2%) | |ADJUSTED (b) | 2.1% 22.1% 2.4% | 16.7% 0.0% 11.1% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 0/6 (0%) 0/2 (0%) | 0/5 (0%) 0/9 (0%) 0/3 (0%) | |TERMINAL (d) | 0/9 (0%) 1/14 (7%) 0/16 (0%) | 2/12 (17%) 0/13 (0%) 1/9 (11%) | |FIRST INCIDENCE (DAYS) | 586 527 628 | 862 (T) --- 862 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.369N P=0.096 P=0.758N | P=0.594N P=0.217N P=0.604N | |INCIDENTAL TUMOR | P=0.428N P=0.066 P=0.741 | P=0.594N P=0.217N P=0.604N | |LOGISTIC REGRESSION | P=0.438N P=0.075 P=0.757 | P=0.594N P=0.217N P=0.604N | |COCHRAN-ARMITAGE | P=0.439N | P=0.521N | |FISHER EXACT | P=0.071 P=0.748 | P=0.248N P=0.525N | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/59 (3%) 7/64 (11%) 2/58 (3%) | 2/62 (3%) 0/62 (0%) 2/58 (3%) | |ADJUSTED (b) | 4.0% 28.1% 8.5% | 16.7% 0.0% 16.3% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 0/6 (0%) 0/2 (0%) | 0/5 (0%) 0/9 (0%) 0/3 (0%) | |TERMINAL (d) | 0/9 (0%) 2/14 (14%) 1/16 (6%) | 2/12 (17%) 0/13 (0%) 1/9 (11%) | |FIRST INCIDENCE (DAYS) | 429 527 628 | 862 (T) --- 835 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.341N P=0.142 P=0.640N | P=0.484 P=0.217N P=0.624 | |INCIDENTAL TUMOR | P=0.370N P=0.130 P=0.604N | P=0.492 P=0.217N P=0.631 | |LOGISTIC REGRESSION | P=0.452N P=0.104 P=0.686 | P=0.521 P=0.217N P=0.667 | |COCHRAN-ARMITAGE | P=0.453N | P=0.530 | |FISHER EXACT | P=0.103 P=0.684 | P=0.248N P=0.665 | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05079 TEST: 01 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC MALE TERMINAL SACRIFICE AT 115 WEEKS FEMALE TERMINAL SACRIFICE AT 124 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6 MG/M3 18 MG/M3 | CONTROL 6 MG/M3 18 MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/58 (2%) 0/56 (0%) 2/53 (4%) | 1/65 (2%) 1/63 (2%) 1/61 (2%) | |ADJUSTED (b) | 12.5% 0.0% 9.8% | 5.6% 7.7% 2.1% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 0/6 (0%) 0/2 (0%) | 0/5 (0%) 0/9 (0%) 0/3 (0%) | |TERMINAL (d) | 1/8 (13%) 0/13 (0%) 1/13 (8%) | 0/12 (0%) 1/13 (8%) 0/9 (0%) | |FIRST INCIDENCE (DAYS) | 799 (T) --- 617 | 824 862 (T) 646 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.383 P=0.403N P=0.610 | P=0.662 P=0.749 P=0.752N | |INCIDENTAL TUMOR | P=0.393 P=0.403N P=0.612 | P=0.663N P=0.757 P=0.720N | |LOGISTIC REGRESSION | P=0.298 P=0.403N P=0.475 | P=0.669 P=0.751 P=0.750 | |COCHRAN-ARMITAGE | P=0.296 | P=0.664 | |FISHER EXACT | P=0.509N P=0.466 | P=0.744 P=0.736 | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/58 (3%) 0/56 (0%) 2/53 (4%) | 1/65 (2%) 1/63 (2%) 1/61 (2%) | |ADJUSTED (b) | 25.0% 0.0% 9.8% | 5.6% 7.7% 2.1% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 0/6 (0%) 0/2 (0%) | 0/5 (0%) 0/9 (0%) 0/3 (0%) | |TERMINAL (d) | 2/8 (25%) 0/13 (0%) 1/13 (8%) | 0/12 (0%) 1/13 (8%) 0/9 (0%) | |FIRST INCIDENCE (DAYS) | 799 (T) --- 617 | 824 862 (T) 646 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.647 P=0.135N P=0.563N | P=0.662 P=0.749 P=0.752N | |INCIDENTAL TUMOR | P=0.653 P=0.135N P=0.560N | P=0.663N P=0.757 P=0.720N | |LOGISTIC REGRESSION | P=0.534 P=0.135N P=0.678 | P=0.669 P=0.751 P=0.750 | |COCHRAN-ARMITAGE | P=0.524 | P=0.664 | |FISHER EXACT | P=0.257N P=0.656 | P=0.744 P=0.736 | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05079 TEST: 01 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC MALE TERMINAL SACRIFICE AT 115 WEEKS FEMALE TERMINAL SACRIFICE AT 124 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6 MG/M3 18 MG/M3 | CONTROL 6 MG/M3 18 MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/60 (3%) 0/64 (0%) 0/58 (0%) | 0/64 (0%) 0/65 (0%) 0/61 (0%) | |ADJUSTED (b) | 14.8% 0.0% 0.0% | 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 0/6 (0%) 0/2 (0%) | 0/5 (0%) 0/9 (0%) 0/3 (0%) | |TERMINAL (d) | 0/9 (0%) 0/14 (0%) 0/16 (0%) | 0/12 (0%) 0/13 (0%) 0/9 (0%) | |FIRST INCIDENCE (DAYS) | 782 --- --- | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.111N P=0.200N P=0.138N | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.216N P=0.263N P=0.314N | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.138N P=0.194N P=0.188N | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.175N | (e) | |FISHER EXACT | P=0.232N P=0.256N | (e) (e) | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/60 (3%) 2/65 (3%) 4/58 (7%) | 0/65 (0%) 3/66 (5%) 1/62 (2%) | |ADJUSTED (b) | 11.0% 14.3% 14.3% | 0.0% 13.0% 10.0% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 0/6 (0%) 0/2 (0%) | 0/5 (0%) 0/9 (0%) 0/3 (0%) | |TERMINAL (d) | 0/9 (0%) 2/14 (14%) 1/16 (6%) | 0/12 (0%) 0/13 (0%) 0/9 (0%) | |FIRST INCIDENCE (DAYS) | 698 799 (T) 615 | --- 724 857 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.347 P=0.578N P=0.424 | P=0.530 P=0.112 P=0.448 | |INCIDENTAL TUMOR | P=0.258 P=0.637N P=0.278 | P=0.620 P=0.120 P=0.538 | |LOGISTIC REGRESSION | P=0.234 P=0.642N P=0.329 | P=0.537 P=0.124 P=0.482 | |COCHRAN-ARMITAGE | P=0.226 | P=0.536 | |FISHER EXACT | P=0.660N P=0.324 | P=0.125 P=0.488 | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05079 TEST: 01 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC MALE TERMINAL SACRIFICE AT 115 WEEKS FEMALE TERMINAL SACRIFICE AT 124 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6 MG/M3 18 MG/M3 | CONTROL 6 MG/M3 18 MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/60 (3%) 2/65 (3%) 4/58 (7%) | 0/65 (0%) 4/66 (6%) 1/62 (2%) | |ADJUSTED (b) | 11.0% 14.3% 14.3% | 0.0% 19.7% 10.0% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 0/6 (0%) 0/2 (0%) | 0/5 (0%) 0/9 (0%) 0/3 (0%) | |TERMINAL (d) | 0/9 (0%) 2/14 (14%) 1/16 (6%) | 0/12 (0%) 1/13 (8%) 0/9 (0%) | |FIRST INCIDENCE (DAYS) | 698 799 (T) 615 | --- 724 857 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.347 P=0.578N P=0.424 | P=0.552 P=0.063 P=0.448 | |INCIDENTAL TUMOR | P=0.258 P=0.637N P=0.278 | P=0.633 P=0.067 P=0.538 | |LOGISTIC REGRESSION | P=0.234 P=0.642N P=0.329 | P=0.577 P=0.063 P=0.482 | |COCHRAN-ARMITAGE | P=0.226 | P=0.577 | |FISHER EXACT | P=0.660N P=0.324 | P=0.062 P=0.488 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/60 (3%) 2/65 (3%) 4/58 (7%) | 0/65 (0%) 4/66 (6%) 1/62 (2%) | |ADJUSTED (b) | 11.0% 14.3% 14.3% | 0.0% 19.7% 10.0% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 0/6 (0%) 0/2 (0%) | 0/5 (0%) 0/9 (0%) 0/3 (0%) | |TERMINAL (d) | 0/9 (0%) 2/14 (14%) 1/16 (6%) | 0/12 (0%) 1/13 (8%) 0/9 (0%) | |FIRST INCIDENCE (DAYS) | 698 799 (T) 615 | --- 724 857 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.347 P=0.578N P=0.424 | P=0.552 P=0.063 P=0.448 | |INCIDENTAL TUMOR | P=0.258 P=0.637N P=0.278 | P=0.633 P=0.067 P=0.538 | |LOGISTIC REGRESSION | P=0.234 P=0.642N P=0.329 | P=0.577 P=0.063 P=0.482 | |COCHRAN-ARMITAGE | P=0.226 | P=0.577 | |FISHER EXACT | P=0.660N P=0.324 | P=0.062 P=0.488 | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05079 TEST: 01 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC MALE TERMINAL SACRIFICE AT 115 WEEKS FEMALE TERMINAL SACRIFICE AT 124 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6 MG/M3 18 MG/M3 | CONTROL 6 MG/M3 18 MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 1/65 (2%) 1/60 (2%) | 1/65 (2%) 1/66 (2%) 9/62 (15%) | |ADJUSTED (b) | 0.0% 5.6% 6.3% | 4.3% 1.7% 40.6% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 1/3 (33%) 0/3 (0%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 0/6 (0%) 0/2 (0%) | 0/5 (0%) 0/9 (0%) 0/3 (0%) | |TERMINAL (d) | 0/9 (0%) 0/14 (0%) 1/16 (6%) | 0/12 (0%) 0/13 (0%) 1/9 (11%) | |FIRST INCIDENCE (DAYS) | --- 781 799 (T) | 805 556 (I) 716 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.526 P=0.523 P=0.615 | P=0.001 ** P=0.739 P=0.012 * | |INCIDENTAL TUMOR | P=0.455 P=0.477 P=0.615 | P=0.002 ** P=0.760 P=0.017 * | |LOGISTIC REGRESSION | P=0.495 P=0.535 P=0.615 | P<0.001 ** P=0.760N P=0.003 ** | |COCHRAN-ARMITAGE | P=0.420 | P<0.001 ** | |FISHER EXACT | P=0.520 P=0.500 | P=0.748N P=0.007 ** | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/65 (0%) 1/60 (2%) | 0/65 (0%) 0/66 (0%) 5/62 (8%) | |ADJUSTED (b) | 0.0% 0.0% 6.3% | 0.0% 0.0% 41.7% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 0/6 (0%) 0/2 (0%) | 0/5 (0%) 0/9 (0%) 0/3 (0%) | |TERMINAL (d) | 0/9 (0%) 0/14 (0%) 1/16 (6%) | 0/12 (0%) 0/13 (0%) 3/9 (33%) | |FIRST INCIDENCE (DAYS) | --- --- 799 (T) | --- --- 828 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.370 (e) P=0.615 | P=0.002 ** (e) P=0.022 * | |INCIDENTAL TUMOR | P=0.370 (e) P=0.615 | P=0.002 ** (e) P=0.024 * | |LOGISTIC REGRESSION | P=0.370 (e) P=0.615 | P=0.003 ** (e) P=0.024 * | |COCHRAN-ARMITAGE | P=0.291 | P=0.003 ** | |FISHER EXACT | (e) P=0.500 | (e) P=0.025 * | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05079 TEST: 01 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC MALE TERMINAL SACRIFICE AT 115 WEEKS FEMALE TERMINAL SACRIFICE AT 124 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6 MG/M3 18 MG/M3 | CONTROL 6 MG/M3 18 MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 1/65 (2%) 1/60 (2%) | 1/65 (2%) 1/66 (2%) 13/62 (21%) | |ADJUSTED (b) | 0.0% 5.6% 6.3% | 4.3% 1.7% 65.7% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 1/3 (33%) 0/3 (0%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 0/6 (0%) 0/2 (0%) | 0/5 (0%) 0/9 (0%) 0/3 (0%) | |TERMINAL (d) | 0/9 (0%) 0/14 (0%) 1/16 (6%) | 0/12 (0%) 0/13 (0%) 4/9 (44%) | |FIRST INCIDENCE (DAYS) | --- 781 799 (T) | 805 556 (I) 716 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.526 P=0.523 P=0.615 | P<0.001 ** P=0.739 P<0.001 ** | |INCIDENTAL TUMOR | P=0.455 P=0.477 P=0.615 | P<0.001 ** P=0.760 P<0.001 ** | |LOGISTIC REGRESSION | P=0.495 P=0.535 P=0.615 | P<0.001 ** P=0.760N P<0.001 ** | |COCHRAN-ARMITAGE | P=0.420 | P<0.001 ** | |FISHER EXACT | P=0.520 P=0.500 | P=0.748N P<0.001 ** | |=================================================================================================================================| | | |Mammary Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/65 (0%) 0/60 (0%) | 3/65 (5%) 2/67 (3%) 3/62 (5%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% | 13.3% 15.4% 14.4% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 0/3 (0%) 1/3 (33%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 0/6 (0%) 0/2 (0%) | 2/5 (40%) 0/9 (0%) 0/3 (0%) | |TERMINAL (d) | 0/9 (0%) 0/14 (0%) 0/16 (0%) | 1/12 (8%) 2/13 (15%) 0/9 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- | 739 (I) 862 (T) 556 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.465 P=0.371N P=0.570 | |INCIDENTAL TUMOR | (e) (e) (e) | P=0.483 P=0.371N P=0.592 | |LOGISTIC REGRESSION | (e) (e) (e) | P=0.555 P=0.501N P=0.646 | |COCHRAN-ARMITAGE | (e) | P=0.550 | |FISHER EXACT | (e) (e) | P=0.486N P=0.637 | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05079 TEST: 01 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC MALE TERMINAL SACRIFICE AT 115 WEEKS FEMALE TERMINAL SACRIFICE AT 124 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6 MG/M3 18 MG/M3 | CONTROL 6 MG/M3 18 MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/65 (0%) 0/60 (0%) | 2/65 (3%) 0/67 (0%) 2/62 (3%) | |ADJUSTED (b) | 7.7% 0.0% 0.0% | 3.7% 0.0% 10.7% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 0/6 (0%) 0/2 (0%) | 0/5 (0%) 0/9 (0%) 0/3 (0%) | |TERMINAL (d) | 0/9 (0%) 0/14 (0%) 0/16 (0%) | 0/12 (0%) 0/13 (0%) 0/9 (0%) | |FIRST INCIDENCE (DAYS) | 786 --- --- | 370 --- 822 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.316N P=0.459N P=0.395N | P=0.572 P=0.234N P=0.675N | |INCIDENTAL TUMOR | P=0.431N P=0.523N P=0.548N | P=0.488 P=0.300N P=0.607 | |LOGISTIC REGRESSION | P=0.356N P=0.462N P=0.450N | P=0.532 P=0.243N P=0.674 | |COCHRAN-ARMITAGE | P=0.396N | P=0.535 | |FISHER EXACT | P=0.480N P=0.500N | P=0.241N P=0.672 | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/65 (0%) 0/60 (0%) | 5/65 (8%) 2/67 (3%) 5/62 (8%) | |ADJUSTED (b) | 7.7% 0.0% 0.0% | 16.5% 15.4% 23.6% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 0/3 (0%) 1/3 (33%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 0/6 (0%) 0/2 (0%) | 2/5 (40%) 0/9 (0%) 0/3 (0%) | |TERMINAL (d) | 0/9 (0%) 0/14 (0%) 0/16 (0%) | 1/12 (8%) 2/13 (15%) 0/9 (0%) | |FIRST INCIDENCE (DAYS) | 786 --- --- | 370 862 (T) 556 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.316N P=0.459N P=0.395N | P=0.420 P=0.142N P=0.565 | |INCIDENTAL TUMOR | P=0.431N P=0.523N P=0.548N | P=0.382 P=0.169N P=0.509 | |LOGISTIC REGRESSION | P=0.356N P=0.462N P=0.450N | P=0.471 P=0.205N P=0.603 | |COCHRAN-ARMITAGE | P=0.396N | P=0.466 | |FISHER EXACT | P=0.480N P=0.500N | P=0.208N P=0.598 | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05079 TEST: 01 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC MALE TERMINAL SACRIFICE AT 115 WEEKS FEMALE TERMINAL SACRIFICE AT 124 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6 MG/M3 18 MG/M3 | CONTROL 6 MG/M3 18 MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/65 (0%) 0/60 (0%) | 12/65 (18%) 12/67 (18%) 14/62 (23%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% | 46.5% 43.9% 64.4% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 0/3 (0%) 1/3 (33%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 0/6 (0%) 0/2 (0%) | 1/5 (20%) 2/9 (22%) 0/3 (0%) | |TERMINAL (d) | 0/9 (0%) 0/14 (0%) 0/16 (0%) | 2/12 (17%) 3/13 (23%) 4/9 (44%) | |FIRST INCIDENCE (DAYS) | --- --- --- | 634 482 556 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.240 P=0.535N P=0.319 | |INCIDENTAL TUMOR | (e) (e) (e) | P=0.329 P=0.544N P=0.439 | |LOGISTIC REGRESSION | (e) (e) (e) | P=0.313 P=0.556N P=0.365 | |COCHRAN-ARMITAGE | (e) | P=0.307 | |FISHER EXACT | (e) (e) | P=0.557N P=0.361 | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/65 (0%) 0/60 (0%) | 16/65 (25%) 15/67 (22%) 17/62 (27%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% | 55.6% 60.7% 69.5% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 0/3 (0%) 2/3 (67%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 0/6 (0%) 0/2 (0%) | 3/5 (60%) 2/9 (22%) 0/3 (0%) | |TERMINAL (d) | 0/9 (0%) 0/14 (0%) 0/16 (0%) | 3/12 (25%) 6/13 (46%) 4/9 (44%) | |FIRST INCIDENCE (DAYS) | --- --- --- | 634 482 556 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.264 P=0.395N P=0.361 | |INCIDENTAL TUMOR | (e) (e) (e) | P=0.365 P=0.397N P=0.497 | |LOGISTIC REGRESSION | (e) (e) (e) | P=0.382 P=0.459N P=0.449 | |COCHRAN-ARMITAGE | (e) | P=0.373 | |FISHER EXACT | (e) (e) | P=0.461N P=0.437 | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05079 TEST: 01 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC MALE TERMINAL SACRIFICE AT 115 WEEKS FEMALE TERMINAL SACRIFICE AT 124 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6 MG/M3 18 MG/M3 | CONTROL 6 MG/M3 18 MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/65 (0%) 0/60 (0%) | 18/65 (28%) 15/67 (22%) 18/62 (29%) | |ADJUSTED (b) | 7.7% 0.0% 0.0% | 57.2% 60.7% 71.0% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 0/3 (0%) 2/3 (67%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 0/6 (0%) 0/2 (0%) | 3/5 (60%) 2/9 (22%) 0/3 (0%) | |TERMINAL (d) | 0/9 (0%) 0/14 (0%) 0/16 (0%) | 3/12 (25%) 6/13 (46%) 4/9 (44%) | |FIRST INCIDENCE (DAYS) | 786 --- --- | 370 482 556 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.316N P=0.459N P=0.395N | P=0.318 P=0.262N P=0.439 | |INCIDENTAL TUMOR | P=0.431N P=0.523N P=0.548N | P=0.393 P=0.271N P=0.531 | |LOGISTIC REGRESSION | P=0.356N P=0.462N P=0.450N | P=0.435 P=0.297N P=0.530 | |COCHRAN-ARMITAGE | P=0.396N | P=0.422 | |FISHER EXACT | P=0.480N P=0.500N | P=0.308N P=0.511 | |=================================================================================================================================| | | |Ovary | | Granulosa Cell Tumor Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 0/65 (0%) 2/65 (3%) 0/62 (0%) | |ADJUSTED (b) | | 0.0% 16.7% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 4 (c)| | 0/5 (0%) 0/9 (0%) 0/3 (0%) | |TERMINAL (d) | | 0/12 (0%) 2/12 (17%) 0/9 (0%) | |FIRST INCIDENCE (DAYS) | | --- 862 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.649N P=0.235 (e) | |INCIDENTAL TUMOR | | P=0.649N P=0.235 (e) | |LOGISTIC REGRESSION | | P=0.649N P=0.235 (e) | |COCHRAN-ARMITAGE | | P=0.587N | |FISHER EXACT | | P=0.248 (e) | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05079 TEST: 01 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC MALE TERMINAL SACRIFICE AT 115 WEEKS FEMALE TERMINAL SACRIFICE AT 124 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6 MG/M3 18 MG/M3 | CONTROL 6 MG/M3 18 MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Ovary | | Granulosa Cell Tumor, Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 1/65 (2%) 2/65 (3%) 0/62 (0%) | |ADJUSTED (b) | | 3.3% 16.7% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 4 (c)| | 0/5 (0%) 0/9 (0%) 0/3 (0%) | |TERMINAL (d) | | 0/12 (0%) 2/12 (17%) 0/9 (0%) | |FIRST INCIDENCE (DAYS) | | 767 862 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.380N P=0.479 P=0.529N | |INCIDENTAL TUMOR | | P=0.350N P=0.500 P=0.462N | |LOGISTIC REGRESSION | | P=0.331N P=0.474 P=0.507N | |COCHRAN-ARMITAGE | | P=0.333N | |FISHER EXACT | | P=0.500 P=0.512N | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/58 (22%) 13/65 (20%) 11/59 (19%) | 23/65 (35%) 25/65 (38%) 26/62 (42%) | |ADJUSTED (b) | 53.9% 45.4% 43.9% | 63.1% 66.8% 80.5% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 1/3 (33%) | |INTERIM SACRIFICE 3 (c)| 1/3 (33%) 0/3 (0%) 0/2 (0%) | 1/3 (33%) 0/3 (0%) 2/3 (67%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 2/6 (33%) 1/2 (50%) | 3/5 (60%) 7/9 (78%) 2/3 (67%) | |TERMINAL (d) | 3/9 (33%) 3/14 (21%) 4/16 (25%) | 3/12 (25%) 3/13 (23%) 4/9 (44%) | |FIRST INCIDENCE (DAYS) | 556 (I) 558 697 | 556 (I) 697 333 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.216N P=0.345N P=0.202N | P=0.172 P=0.550N P=0.232 | |INCIDENTAL TUMOR | P=0.369N P=0.490N P=0.372N | P=0.303 P=0.542 P=0.323 | |LOGISTIC REGRESSION | P=0.333N P=0.438N P=0.355N | P=0.271 P=0.538 P=0.295 | |COCHRAN-ARMITAGE | P=0.371N | P=0.265 | |FISHER EXACT | P=0.457N P=0.391N | P=0.428 P=0.282 | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05079 TEST: 01 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC MALE TERMINAL SACRIFICE AT 115 WEEKS FEMALE TERMINAL SACRIFICE AT 124 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6 MG/M3 18 MG/M3 | CONTROL 6 MG/M3 18 MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/58 (0%) 1/65 (2%) 0/59 (0%) | 4/65 (6%) 3/65 (5%) 2/62 (3%) | |ADJUSTED (b) | 0.0% 5.3% 0.0% | 23.4% 11.4% 5.2% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 0/6 (0%) 0/2 (0%) | 0/5 (0%) 0/9 (0%) 0/3 (0%) | |TERMINAL (d) | 0/9 (0%) 0/14 (0%) 0/16 (0%) | 2/12 (17%) 1/13 (8%) 0/9 (0%) | |FIRST INCIDENCE (DAYS) | --- 780 --- | 696 566 676 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.649N P=0.534 (e) | P=0.350N P=0.474N P=0.395N | |INCIDENTAL TUMOR | P=0.731N P=0.492 (e) | P=0.297N P=0.532N P=0.323N | |LOGISTIC REGRESSION | P=0.681N P=0.536 (e) | P=0.309N P=0.492N P=0.355N | |COCHRAN-ARMITAGE | P=0.708N | P=0.313N | |FISHER EXACT | P=0.528 (e) | P=0.500N P=0.363N | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/58 (22%) 14/65 (22%) 11/59 (19%) | 27/65 (42%) 28/65 (43%) 28/62 (45%) | |ADJUSTED (b) | 53.9% 48.3% 43.9% | 73.6% 71.3% 81.5% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 1/3 (33%) | |INTERIM SACRIFICE 3 (c)| 1/3 (33%) 0/3 (0%) 0/2 (0%) | 1/3 (33%) 0/3 (0%) 2/3 (67%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 2/6 (33%) 1/2 (50%) | 3/5 (60%) 7/9 (78%) 2/3 (67%) | |TERMINAL (d) | 3/9 (33%) 3/14 (21%) 4/16 (25%) | 5/12 (42%) 4/13 (31%) 4/9 (44%) | |FIRST INCIDENCE (DAYS) | 556 (I) 558 697 | 556 (I) 566 333 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.199N P=0.418N P=0.202N | P=0.254 P=0.477N P=0.325 | |INCIDENTAL TUMOR | P=0.356N P=0.580N P=0.372N | P=0.443 P=0.551N P=0.473 | |LOGISTIC REGRESSION | P=0.314N P=0.520N P=0.355N | P=0.401 P=0.546N P=0.430 | |COCHRAN-ARMITAGE | P=0.354N | P=0.385 | |FISHER EXACT | P=0.539N P=0.391N | P=0.500 P=0.408 | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05079 TEST: 01 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC MALE TERMINAL SACRIFICE AT 115 WEEKS FEMALE TERMINAL SACRIFICE AT 124 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6 MG/M3 18 MG/M3 | CONTROL 6 MG/M3 18 MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Pituitary Gland: Pars Intermedia | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/58 (0%) 0/65 (0%) 2/59 (3%) | 0/65 (0%) 0/65 (0%) 0/62 (0%) | |ADJUSTED (b) | 0.0% 0.0% 4.7% | 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 0/6 (0%) 0/2 (0%) | 0/5 (0%) 0/9 (0%) 0/3 (0%) | |TERMINAL (d) | 0/9 (0%) 0/14 (0%) 0/16 (0%) | 0/12 (0%) 0/13 (0%) 0/9 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 617 | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.088 (e) P=0.237 | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.085 (e) P=0.207 | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.087 (e) P=0.240 | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.088 | (e) | |FISHER EXACT | (e) P=0.252 | (e) (e) | |=================================================================================================================================| | | |Skin | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 2/65 (3%) 0/60 (0%) | 0/65 (0%) 0/67 (0%) 0/62 (0%) | |ADJUSTED (b) | 0.0% 9.3% 0.0% | 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 0/6 (0%) 0/2 (0%) | 0/5 (0%) 0/9 (0%) 0/3 (0%) | |TERMINAL (d) | 0/9 (0%) 1/14 (7%) 0/16 (0%) | 0/12 (0%) 0/13 (0%) 0/9 (0%) | |FIRST INCIDENCE (DAYS) | --- 657 --- | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.528N P=0.303 (e) | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.545N P=0.274 (e) | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.574N P=0.261 (e) | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.580N | (e) | |FISHER EXACT | P=0.268 (e) | (e) (e) | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05079 TEST: 01 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC MALE TERMINAL SACRIFICE AT 115 WEEKS FEMALE TERMINAL SACRIFICE AT 124 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6 MG/M3 18 MG/M3 | CONTROL 6 MG/M3 18 MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 2/65 (3%) 2/60 (3%) | 0/65 (0%) 1/67 (1%) 1/62 (2%) | |ADJUSTED (b) | 0.0% 9.4% 6.5% | 0.0% 7.7% 1.9% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 0/6 (0%) 0/2 (0%) | 0/5 (0%) 0/9 (0%) 0/3 (0%) | |TERMINAL (d) | 0/9 (0%) 1/14 (7%) 0/16 (0%) | 0/12 (0%) 1/13 (8%) 0/9 (0%) | |FIRST INCIDENCE (DAYS) | --- 663 594 | --- 862 (T) 558 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.337 P=0.300 P=0.328 | P=0.384 P=0.516 P=0.496 | |INCIDENTAL TUMOR | P=0.256 P=0.274 P=0.213 | P=0.357 P=0.516 P=0.433 | |LOGISTIC REGRESSION | P=0.246 P=0.261 P=0.239 | P=0.411 P=0.516 P=0.483 | |COCHRAN-ARMITAGE | P=0.242 | P=0.411 | |FISHER EXACT | P=0.268 P=0.248 | P=0.508 P=0.488 | |=================================================================================================================================| | | |Skin | | Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, | | Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 3/65 (5%) 2/60 (3%) | 0/65 (0%) 1/67 (1%) 1/62 (2%) | |ADJUSTED (b) | 0.0% 13.1% 6.5% | 0.0% 7.7% 1.9% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 0/6 (0%) 0/2 (0%) | 0/5 (0%) 0/9 (0%) 0/3 (0%) | |TERMINAL (d) | 0/9 (0%) 1/14 (7%) 0/16 (0%) | 0/12 (0%) 1/13 (8%) 0/9 (0%) | |FIRST INCIDENCE (DAYS) | --- 663 594 | --- 862 (T) 558 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.407 P=0.166 P=0.328 | P=0.384 P=0.516 P=0.496 | |INCIDENTAL TUMOR | P=0.304 P=0.133 P=0.213 | P=0.357 P=0.516 P=0.433 | |LOGISTIC REGRESSION | P=0.312 P=0.140 P=0.239 | P=0.411 P=0.516 P=0.483 | |COCHRAN-ARMITAGE | P=0.306 | P=0.411 | |FISHER EXACT | P=0.137 P=0.248 | P=0.508 P=0.488 | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05079 TEST: 01 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC MALE TERMINAL SACRIFICE AT 115 WEEKS FEMALE TERMINAL SACRIFICE AT 124 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6 MG/M3 18 MG/M3 | CONTROL 6 MG/M3 18 MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, Sarcoma, | | Neurofibroma, or Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 2/65 (3%) 0/60 (0%) | 0/65 (0%) 1/67 (1%) 1/62 (2%) | |ADJUSTED (b) | 0.0% 11.2% 0.0% | 0.0% 3.2% 2.2% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 0/6 (0%) 0/2 (0%) | 0/5 (0%) 0/9 (0%) 0/3 (0%) | |TERMINAL (d) | 0/9 (0%) 1/14 (7%) 0/16 (0%) | 0/12 (0%) 0/13 (0%) 0/9 (0%) | |FIRST INCIDENCE (DAYS) | --- 757 --- | --- 740 661 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.498N P=0.305 (e) | P=0.411 P=0.494 P=0.500 | |INCIDENTAL TUMOR | P=0.545N P=0.274 (e) | P=0.474 P=0.500 P=0.538 | |LOGISTIC REGRESSION | P=0.541N P=0.273 (e) | P=0.411 P=0.507 P=0.489 | |COCHRAN-ARMITAGE | P=0.580N | P=0.411 | |FISHER EXACT | P=0.268 (e) | P=0.508 P=0.488 | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 35/60 (58%) 45/65 (69%) 40/60 (67%) | | |ADJUSTED (b) | 100.0% 100.0% 97.3% | | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | | |INTERIM SACRIFICE 3 (c)| 1/3 (33%) 2/3 (67%) 2/2 (100%) | | |INTERIM SACRIFICE 4 (c)| 3/3 (100%) 4/6 (67%) 2/2 (100%) | | |TERMINAL (d) | 9/9 (100%) 14/14 (100%) 15/16 (94%) | | |FIRST INCIDENCE (DAYS) | 551 544 556 (I) | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.304N P=0.532N P=0.349N | | |INCIDENTAL TUMOR | P=0.266 P=0.160 P=0.219 | | |LOGISTIC REGRESSION | P=0.235 P=0.101 P=0.202 | | |COCHRAN-ARMITAGE | P=0.263 | | |FISHER EXACT | P=0.140 P=0.225 | | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05079 TEST: 01 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC MALE TERMINAL SACRIFICE AT 115 WEEKS FEMALE TERMINAL SACRIFICE AT 124 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6 MG/M3 18 MG/M3 | CONTROL 6 MG/M3 18 MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/56 (7%) 4/61 (7%) 3/56 (5%) | 6/65 (9%) 0/65 (0%) 6/61 (10%) | |ADJUSTED (b) | 26.9% 28.6% 14.4% | 33.2% 0.0% 33.7% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 4 (c)| 1/3 (33%) 0/6 (0%) 0/2 (0%) | 1/5 (20%) 0/9 (0%) 0/3 (0%) | |TERMINAL (d) | 2/9 (22%) 4/14 (29%) 2/16 (13%) | 2/12 (17%) 0/13 (0%) 2/9 (22%) | |FIRST INCIDENCE (DAYS) | 682 799 (T) 614 | 739 (I) --- 678 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.255N P=0.396N P=0.357N | P=0.315 P=0.014N* P=0.510 | |INCIDENTAL TUMOR | P=0.264N P=0.403N P=0.377N | P=0.393 P=0.013N* P=0.601 | |LOGISTIC REGRESSION | P=0.391N P=0.491N P=0.466N | P=0.372 P=0.018N* P=0.585 | |COCHRAN-ARMITAGE | P=0.444N | P=0.366 | |FISHER EXACT | P=0.593N P=0.500N | P=0.014N* P=0.573 | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/56 (0%) 1/61 (2%) 0/56 (0%) | 3/65 (5%) 2/65 (3%) 3/61 (5%) | |ADJUSTED (b) | 0.0% 6.3% 0.0% | 10.5% 12.2% 7.4% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 0/6 (0%) 0/2 (0%) | 0/5 (0%) 0/9 (0%) 1/3 (33%) | |TERMINAL (d) | 0/9 (0%) 0/14 (0%) 0/16 (0%) | 0/12 (0%) 0/13 (0%) 0/9 (0%) | |FIRST INCIDENCE (DAYS) | --- 787 --- | 677 818 675 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.612N P=0.557 (e) | P=0.547 P=0.520N P=0.604 | |INCIDENTAL TUMOR | P=0.751N P=0.492 (e) | P=0.595N P=0.516N P=0.630N | |LOGISTIC REGRESSION | P=0.671N P=0.562 (e) | P=0.552 P=0.498N P=0.637 | |COCHRAN-ARMITAGE | P=0.709N | P=0.545 | |FISHER EXACT | P=0.521 (e) | P=0.500N P=0.629 | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05079 TEST: 01 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC MALE TERMINAL SACRIFICE AT 115 WEEKS FEMALE TERMINAL SACRIFICE AT 124 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6 MG/M3 18 MG/M3 | CONTROL 6 MG/M3 18 MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/56 (7%) 5/61 (8%) 3/56 (5%) | 9/65 (14%) 2/65 (3%) 9/61 (15%) | |ADJUSTED (b) | 26.9% 33.0% 14.4% | 40.2% 12.2% 38.7% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 4 (c)| 1/3 (33%) 0/6 (0%) 0/2 (0%) | 1/5 (20%) 0/9 (0%) 1/3 (33%) | |TERMINAL (d) | 2/9 (22%) 4/14 (29%) 2/16 (13%) | 2/12 (17%) 0/13 (0%) 2/9 (22%) | |FIRST INCIDENCE (DAYS) | 682 787 614 | 677 818 675 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.216N P=0.529N P=0.357N | P=0.315 P=0.030N* P=0.473 | |INCIDENTAL TUMOR | P=0.258N P=0.560N P=0.377N | P=0.428 P=0.024N* P=0.597N | |LOGISTIC REGRESSION | P=0.355N P=0.614N P=0.466N | P=0.359 P=0.027N* P=0.561 | |COCHRAN-ARMITAGE | P=0.415N | P=0.349 | |FISHER EXACT | P=0.554 P=0.500N | P=0.027N* P=0.543 | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # | |----------- | | | |OVERALL (a) | | 6/65 (9%) 8/67 (12%) 6/62 (10%) | |ADJUSTED (b) | | 23.0% 35.3% 23.0% | |INTERIM SACRIFICE 1 (c)| | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| | 0/3 (0%) 0/3 (0%) 1/3 (33%) | |INTERIM SACRIFICE 4 (c)| | 1/5 (20%) 1/9 (11%) 1/3 (33%) | |TERMINAL (d) | | 1/12 (8%) 3/13 (23%) 1/9 (11%) | |FIRST INCIDENCE (DAYS) | | 398 678 556 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.480 P=0.447 P=0.498 | |INCIDENTAL TUMOR | | P=0.551 P=0.470 P=0.534 | |LOGISTIC REGRESSION | | P=0.563N P=0.413 P=0.591 | |COCHRAN-ARMITAGE | | P=0.570N | |FISHER EXACT | | P=0.413 P=0.585 | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05079 TEST: 01 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC MALE TERMINAL SACRIFICE AT 115 WEEKS FEMALE TERMINAL SACRIFICE AT 124 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6 MG/M3 18 MG/M3 | CONTROL 6 MG/M3 18 MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # | |----------- | | | |OVERALL (a) | | 7/65 (11%) 9/67 (13%) 6/62 (10%) | |ADJUSTED (b) | | 30.0% 36.5% 23.0% | |INTERIM SACRIFICE 1 (c)| | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| | 0/3 (0%) 0/3 (0%) 1/3 (33%) | |INTERIM SACRIFICE 4 (c)| | 1/5 (20%) 1/9 (11%) 1/3 (33%) | |TERMINAL (d) | | 2/12 (17%) 3/13 (23%) 1/9 (11%) | |FIRST INCIDENCE (DAYS) | | 398 557 556 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.556N P=0.456 P=0.595 | |INCIDENTAL TUMOR | | P=0.498N P=0.447 P=0.601N | |LOGISTIC REGRESSION | | P=0.442N P=0.423 P=0.529N | |COCHRAN-ARMITAGE | | P=0.450N | |FISHER EXACT | | P=0.421 P=0.536N | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, | | or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 24/60 (40%) 22/65 (34%) 23/60 (38%) | 14/65 (22%) 21/67 (31%) 18/62 (29%) | |ADJUSTED (b) | 69.3% 59.7% 61.7% | 44.4% 72.8% 59.4% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 1/6 (17%) 0/2 (0%) | 1/5 (20%) 1/9 (11%) 0/3 (0%) | |TERMINAL (d) | 3/9 (33%) 4/14 (29%) 6/16 (38%) | 1/12 (8%) 8/13 (62%) 3/9 (33%) | |FIRST INCIDENCE (DAYS) | 334 529 492 | 390 526 536 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.325N P=0.229N P=0.289N | P=0.211 P=0.188 P=0.222 | |INCIDENTAL TUMOR | P=0.535N P=0.427N P=0.539N | P=0.231 P=0.116 P=0.173 | |LOGISTIC REGRESSION | P=0.520 P=0.297N P=0.549N | P=0.269 P=0.142 P=0.226 | |COCHRAN-ARMITAGE | P=0.531N | P=0.262 | |FISHER EXACT | P=0.299N P=0.500N | P=0.140 P=0.221 | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05079 TEST: 01 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC MALE TERMINAL SACRIFICE AT 115 WEEKS FEMALE TERMINAL SACRIFICE AT 124 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6 MG/M3 18 MG/M3 | CONTROL 6 MG/M3 18 MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma And Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/65 (0%) 0/60 (0%) | 0/65 (0%) 3/67 (4%) 0/62 (0%) | |ADJUSTED (b) | 11.1% 0.0% 0.0% | 0.0% 9.7% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 0/6 (0%) 0/2 (0%) | 0/5 (0%) 0/9 (0%) 0/3 (0%) | |TERMINAL (d) | 1/9 (11%) 0/14 (0%) 0/16 (0%) | 0/12 (0%) 0/13 (0%) 0/9 (0%) | |FIRST INCIDENCE (DAYS) | 799 (T) --- --- | --- 724 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.316N P=0.412N P=0.385N | P=0.540N P=0.123 (e) | |INCIDENTAL TUMOR | P=0.316N P=0.412N P=0.385N | P=0.441N P=0.120 (e) | |LOGISTIC REGRESSION | P=0.316N P=0.412N P=0.385N | P=0.514N P=0.127 (e) | |COCHRAN-ARMITAGE | P=0.396N | P=0.516N | |FISHER EXACT | P=0.480N P=0.500N | P=0.128 (e) | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/65 (0%) 0/60 (0%) | 0/65 (0%) 3/67 (4%) 0/62 (0%) | |ADJUSTED (b) | 11.1% 0.0% 0.0% | 0.0% 9.7% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 0/3 (0%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 0/6 (0%) 0/2 (0%) | 0/5 (0%) 0/9 (0%) 0/3 (0%) | |TERMINAL (d) | 1/9 (11%) 0/14 (0%) 0/16 (0%) | 0/12 (0%) 0/13 (0%) 0/9 (0%) | |FIRST INCIDENCE (DAYS) | 799 (T) --- --- | --- 724 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.316N P=0.412N P=0.385N | P=0.540N P=0.123 (e) | |INCIDENTAL TUMOR | P=0.316N P=0.412N P=0.385N | P=0.441N P=0.120 (e) | |LOGISTIC REGRESSION | P=0.316N P=0.412N P=0.385N | P=0.514N P=0.127 (e) | |COCHRAN-ARMITAGE | P=0.396N | P=0.516N | |FISHER EXACT | P=0.480N P=0.500N | P=0.128 (e) | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05079 TEST: 01 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC MALE TERMINAL SACRIFICE AT 115 WEEKS FEMALE TERMINAL SACRIFICE AT 124 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6 MG/M3 18 MG/M3 | CONTROL 6 MG/M3 18 MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 47/60 (78%) 53/65 (82%) 49/60 (82%) | 44/65 (68%) 43/67 (64%) 46/62 (74%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% | 97.6% 97.4% 97.7% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 1/3 (33%) | |INTERIM SACRIFICE 3 (c)| 2/3 (67%) 2/3 (67%) 2/2 (100%) | 1/3 (33%) 1/3 (33%) 3/3 (100%) | |INTERIM SACRIFICE 4 (c)| 3/3 (100%) 6/6 (100%) 2/2 (100%) | 4/5 (80%) 7/9 (78%) 3/3 (100%) | |TERMINAL (d) | 9/9 (100%) 14/14 (100%) 16/16 (100%) | 11/12 (92%) 12/13 (92%) 8/9 (89%) | |FIRST INCIDENCE (DAYS) | 429 544 556 (I) | 398 482 333 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.217N P=0.268N P=0.198N | P=0.126 P=0.353N P=0.204 | |INCIDENTAL TUMOR | P=0.275 P=0.472 P=0.306 | P=0.202 P=0.301N P=0.298 | |LOGISTIC REGRESSION | P=0.371 P=0.434 P=0.401 | P=0.216 P=0.319N P=0.308 | |COCHRAN-ARMITAGE | P=0.400 | P=0.206 | |FISHER EXACT | P=0.411 P=0.410 | P=0.405N P=0.271 | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 35/60 (58%) 35/65 (54%) 34/60 (57%) | 25/65 (38%) 32/67 (48%) 36/62 (58%) | |ADJUSTED (b) | 88.2% 80.5% 79.4% | 70.8% 85.2% 90.5% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 0/2 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 3 (c)| 1/3 (33%) 0/3 (0%) 0/2 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 4 (c)| 0/3 (0%) 1/6 (17%) 0/2 (0%) | 1/5 (20%) 1/9 (11%) 1/3 (33%) | |TERMINAL (d) | 6/9 (67%) 7/14 (50%) 9/16 (56%) | 5/12 (42%) 9/13 (69%) 6/9 (67%) | |FIRST INCIDENCE (DAYS) | 334 527 248 | 370 526 536 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.222N P=0.250N P=0.208N | P=0.031 * P=0.252 P=0.041 * | |INCIDENTAL TUMOR | P=0.501N P=0.560N P=0.535N | P=0.013 * P=0.096 P=0.010 * | |LOGISTIC REGRESSION | P=0.537 P=0.371N P=0.551N | P=0.019 * P=0.188 P=0.021 * | |COCHRAN-ARMITAGE | P=0.513N | P=0.019 * | |FISHER EXACT | P=0.373N P=0.500N | P=0.183 P=0.021 * | |=================================================================================================================================| DATE: 09/10/94 EXPERIMENT: 05079 TEST: 01 PAGE 22 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TALC MALE TERMINAL SACRIFICE AT 115 WEEKS FEMALE TERMINAL SACRIFICE AT 124 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 6 MG/M3 18 MG/M3 | CONTROL 6 MG/M3 18 MG/M3 | | | LUNG TOX LUNG TOX LUNG TOX | LUNG TOX LUNG TOX LUNG TOX | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 55/60 (92%) 57/65 (88%) 54/60 (90%) | 50/65 (77%) 55/67 (82%) 56/62 (90%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% | 97.8% 98.2% 100.0% | |INTERIM SACRIFICE 1 (c)| 0/3 (0%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/3 (0%) | |INTERIM SACRIFICE 2 (c)| 1/2 (50%) 0/3 (0%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 1/3 (33%) | |INTERIM SACRIFICE 3 (c)| 3/3 (100%) 2/3 (67%) 2/2 (100%) | 1/3 (33%) 1/3 (33%) 3/3 (100%) | |INTERIM SACRIFICE 4 (c)| 3/3 (100%) 6/6 (100%) 2/2 (100%) | 4/5 (80%) 7/9 (78%) 3/3 (100%) | |TERMINAL (d) | 9/9 (100%) 14/14 (100%) 16/16 (100%) | 11/12 (92%) 12/13 (92%) 9/9 (100%) | |FIRST INCIDENCE (DAYS) | 333 (I) 527 248 | 370 482 333 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.158N P=0.133N P=0.127N | P=0.080 P=0.467 P=0.106 | |INCIDENTAL TUMOR | P=0.656N P=0.198N P=0.716N | P=0.005 ** P=0.217 P=0.006 ** | |LOGISTIC REGRESSION | P=0.578N P=0.179N P=0.558N | P=0.019 * P=0.347 P=0.026 * | |COCHRAN-ARMITAGE | P=0.513N | P=0.031 * | |FISHER EXACT | P=0.334N P=0.500N | P=0.302 P=0.035 * | |=================================================================================================================================| (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): 192 333 556 738 Female interim sacrifices(days): 192 333 556 739 (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).