TDMS Study 88124-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest INDIUM PHOSPHIDE DATE: 02/24/00 EXPERIMENT: 88124 TEST: 04 TIME: 08:14:38 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C88124 PATHOLOGIST: MILLER, R. CAS: 22398-80-7 ------------------------------------------------------------------------------------------------------------------------------------ FINAL#2, 2 YEAR CHRONIC MICE REASONS FOR REMOVAL: 25022 Accidently Killed 25019 Moribund Sacrifice 25020 Natural Death 25021 Terminal Sacrifice REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE 001 CONTROL INCLUDE 002 CONTROL INCLUDE 005 0.1MG/M3 STOP INCLUDE 006 0.1MG/M3 STOP INCLUDE 007 0.3MG/M3 STOP INCLUDE 008 0.3MG/M3 STOP NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest INDIUM PHOSPHIDE DATE: 02/24/00 EXPERIMENT: 88124 TEST: 04 TIME: 08:14:38 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C88124 PATHOLOGIST: MILLER, R. CAS: 22398-80-7 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 THE NUMBER OF ANIMALS NECROPSIED. --------------- Adrenal Cortex Adrenal Medulla Bone Marrow Brain Islets, Pancreatic Liver Lung Ovary Pituitary Gland Spleen Testes Thyroid Gland NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest INDIUM PHOSPHIDE DATE: 02/24/00 EXPERIMENT: 88124 TEST: 04 TIME: 08:14:38 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C88124 PATHOLOGIST: MILLER, R. CAS: 22398-80-7 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF INDIUM PHOSPHIDE =============================================================== Male Mice ------------ Organ Morphology ----- ---------- Intestine Small: Site Unspecified Carcinoma Carcinoma or Adenoma Islets, Pancreatic Adenoma Liver Hepatocellular Adenoma Hepatocellular Carcinoma Hepatocellular Carcinoma or Hepatoblastoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Alveolar/Bronchiolar Carcinoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma All Organs Benign Tumors Malignant Tumors Malignant and Benign Tumors =============================================================== Female Mice ------------ Organ Morphology ----- ---------- Liver Hepatocellular Adenoma Hepatocellular Carcinoma Hepatocellular Carcinoma or Hepatoblastoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma All Organs Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type Benign Tumors Malignant Tumors Malignant and Benign Tumors =============================================================== Date: 02/24/00 EXPERIMENT: 88124 TEST: 04 Page 1 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/48 (2%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 4.3% 2.4% 0.0% | 0.0% 0.0% 2.6% | |TERMINAL (d) | 2/37 (5%) 1/29 (3%) 0/27 (0%) | 0/42 (0%) 0/33 (0%) 0/21 (0%) | |FIRST INCIDENCE | 733 (T) 733 (T) --- | --- --- 658 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.232N P=0.585N P=0.310N | P=0.228 (e) P=0.421 | |POLY 3 | P=0.189N P=0.541N P=0.262N | P=0.261 (e) P=0.460 | |POLY 1.5 | P=0.183N P=0.530N P=0.252N | P=0.275 (e) P=0.476 | |POLY 6 | P=0.197N P=0.554N P=0.275N | P=0.245 (e) P=0.439 | |LOGISTIC REGRESSION| P=0.232N P=0.585N (e) | P=0.327 (e) P=0.527 | |COCH-ARM / FISHERS | P=0.175N P=0.515N P=0.247N | P=0.296 (e) P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/48 (2%) 1/49 (2%) | 2/49 (4%) 2/50 (4%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.4% 2.5% | 4.3% 4.4% 0.0% | |TERMINAL (d) | 0/37 (0%) 1/29 (3%) 1/27 (4%) | 1/41 (2%) 2/33 (6%) 0/21 (0%) | |FIRST INCIDENCE | --- 733 (T) 733 (T) | 699 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.357 P=0.451 P=0.437 | P=0.314N P=0.618 P=0.378N | |POLY 3 | P=0.382 P=0.477 P=0.474 | P=0.219N P=0.693 P=0.284N | |POLY 1.5 | P=0.398 P=0.483 P=0.483 | P=0.199N P=0.689N P=0.264N | |POLY 6 | P=0.363 P=0.469 P=0.463 | P=0.246N P=0.680 P=0.312N | |LOGISTIC REGRESSION| (e) P=0.451 P=0.437 | P=0.246N P=0.685 P=0.287N | |COCH-ARM / FISHERS | P=0.422 P=0.490 P=0.495 | P=0.172N P=0.684N P=0.247N | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88124 TEST: 04 Page 2 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) | 3/50 (6%) 2/50 (4%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 2.2% 4.7% 4.8% | 6.4% 4.4% 5.2% | |TERMINAL (d) | 1/37 (3%) 1/29 (3%) 2/27 (7%) | 3/42 (7%) 2/33 (6%) 1/21 (5%) | |FIRST INCIDENCE | 733 (T) 669 733 (T) | 735 (T) 735 (T) 512 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.350 P=0.423 P=0.390 | P=0.535 P=0.609N P=0.613 | |POLY 3 | P=0.405 P=0.471 P=0.462 | P=0.532N P=0.510N P=0.586N | |POLY 1.5 | P=0.424 P=0.483 P=0.478 | P=0.503N P=0.502N P=0.551N | |POLY 6 | P=0.380 P=0.455 P=0.443 | P=0.567N P=0.525N P=0.631N | |LOGISTIC REGRESSION| P=0.390 P=0.468 P=0.390 | P=0.502N P=0.609N P=0.521N | |COCH-ARM / FISHERS | P=0.452 P=0.500 P=0.500 | P=0.459N P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 2/50 (4%) | 3/50 (6%) 2/50 (4%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 2.2% 7.1% 4.8% | 6.4% 4.4% 5.2% | |TERMINAL (d) | 1/37 (3%) 2/29 (7%) 2/27 (7%) | 3/42 (7%) 2/33 (6%) 1/21 (5%) | |FIRST INCIDENCE | 733 (T) 669 733 (T) | 735 (T) 735 (T) 512 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.386 P=0.230 P=0.390 | P=0.535 P=0.609N P=0.613 | |POLY 3 | P=0.442 P=0.275 P=0.462 | P=0.532N P=0.510N P=0.586N | |POLY 1.5 | P=0.466 P=0.288 P=0.478 | P=0.503N P=0.502N P=0.551N | |POLY 6 | P=0.412 P=0.261 P=0.443 | P=0.567N P=0.525N P=0.631N | |LOGISTIC REGRESSION| P=0.426 P=0.260 P=0.390 | P=0.502N P=0.609N P=0.521N | |COCH-ARM / FISHERS | P=0.500 P=0.309 P=0.500 | P=0.459N P=0.500N P=0.500N | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88124 TEST: 04 Page 3 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Intestine Small: Ileum | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 4.7% 2.4% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/37 (0%) 0/29 (0%) 1/27 (4%) | 0/42 (0%) 0/33 (0%) 0/21 (0%) | |FIRST INCIDENCE | --- 669 733 (T) | --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.434 P=0.191 P=0.437 | (e) (e) (e) | |POLY 3 | P=0.447 P=0.220 P=0.478 | (e) (e) (e) | |POLY 1.5 | P=0.469 P=0.227 P=0.487 | (e) (e) (e) | |POLY 6 | P=0.421 P=0.211 P=0.467 | (e) (e) (e) | |LOGISTIC REGRESSION| P=0.495 P=0.262 P=0.437 | (e) (e) (e) | |COCH-ARM / FISHERS | P=0.500 P=0.247 P=0.500 | (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Intestine Small: Jejunum | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 2/50 (4%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 7.1% 4.8% | 2.1% 0.0% 0.0% | |TERMINAL (d) | 0/37 (0%) 2/29 (7%) 1/27 (4%) | 1/42 (2%) 0/33 (0%) 0/21 (0%) | |FIRST INCIDENCE | --- 728 608 | 735 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.234 P=0.085 P=0.194 | P=0.500N P=0.548N P=0.638N | |POLY 3 | P=0.265 P=0.103 P=0.216 | P=0.392N P=0.504N P=0.541N | |POLY 1.5 | P=0.284 P=0.110 P=0.224 | P=0.395N P=0.501N P=0.524N | |POLY 6 | P=0.242 P=0.096 P=0.206 | P=0.386N P=0.511N P=0.563N | |LOGISTIC REGRESSION| P=0.283 P=0.081 P=0.264 | P=0.500N (e) (e) | |COCH-ARM / FISHERS | P=0.313 P=0.121 P=0.247 | P=0.394N P=0.500N P=0.500N | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88124 TEST: 04 Page 4 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Intestine Small: Site Unspecified | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 5/50 (10%) 3/50 (6%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 11.7% 7.2% | 2.1% 0.0% 0.0% | |TERMINAL (d) | 0/37 (0%) 2/29 (7%) 2/27 (7%) | 1/42 (2%) 0/33 (0%) 0/21 (0%) | |FIRST INCIDENCE | --- 669 608 | 735 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.167 P=0.019 * P=0.083 | P=0.500N P=0.548N P=0.638N | |POLY 3 | P=0.192 P=0.024 * P=0.102 | P=0.392N P=0.504N P=0.541N | |POLY 1.5 | P=0.213 P=0.027 * P=0.109 | P=0.395N P=0.501N P=0.524N | |POLY 6 | P=0.169 P=0.021 * P=0.094 | P=0.386N P=0.511N P=0.563N | |LOGISTIC REGRESSION| P=0.223 P=0.026 * P=0.118 | P=0.500N (e) (e) | |COCH-ARM / FISHERS | P=0.248 P=0.028 * P=0.121 | P=0.394N P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Intestine Small: Site Unspecified | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 6/50 (12%) 3/50 (6%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.2% 14.1% 7.2% | 2.1% 0.0% 0.0% | |TERMINAL (d) | 1/37 (3%) 3/29 (10%) 2/27 (7%) | 1/42 (2%) 0/33 (0%) 0/21 (0%) | |FIRST INCIDENCE | 733 (T) 669 608 | 735 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.303 P=0.032 * P=0.218 | P=0.500N P=0.548N P=0.638N | |POLY 3 | P=0.356 P=0.044 * P=0.271 | P=0.392N P=0.504N P=0.541N | |POLY 1.5 | P=0.386 P=0.049 * P=0.285 | P=0.395N P=0.501N P=0.524N | |POLY 6 | P=0.322 P=0.038 * P=0.255 | P=0.386N P=0.511N P=0.563N | |LOGISTIC REGRESSION| P=0.379 P=0.040 * P=0.284 | P=0.500N (e) (e) | |COCH-ARM / FISHERS | P=0.431 P=0.056 P=0.309 | P=0.394N P=0.500N P=0.500N | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88124 TEST: 04 Page 5 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/49 (0%) 0/47 (0%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 6.4% 0.0% 0.0% | 0.0% 4.3% 0.0% | |TERMINAL (d) | 1/37 (3%) 0/29 (0%) 0/27 (0%) | 0/42 (0%) 0/33 (0%) 0/21 (0%) | |FIRST INCIDENCE | 561 --- --- | --- 699 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.100N P=0.147N P=0.156N | P=0.709N P=0.199 (e) | |POLY 3 | P=0.083N P=0.142N P=0.148N | P=0.649N P=0.233 (e) | |POLY 1.5 | P=0.083N P=0.134N P=0.140N | P=0.619N P=0.237 (e) | |POLY 6 | P=0.085N P=0.154N P=0.160N | P=0.687N P=0.226 (e) | |LOGISTIC REGRESSION| P=0.058N P=0.048N* P=0.055N | P=0.633N P=0.237 (e) | |COCH-ARM / FISHERS | P=0.086N P=0.125N P=0.133N | P=0.575N P=0.247 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 4.3% 0.0% 4.8% | 0.0% 0.0% 2.6% | |TERMINAL (d) | 1/37 (3%) 0/29 (0%) 2/27 (7%) | 0/42 (0%) 0/33 (0%) 0/21 (0%) | |FIRST INCIDENCE | 669 --- 733 (T) | --- --- 727 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.463 P=0.287N P=0.584 | P=0.203 (e) P=0.380 | |POLY 3 | P=0.531 P=0.259N P=0.652 | P=0.260 (e) P=0.459 | |POLY 1.5 | P=0.541 P=0.250N P=0.670 | P=0.275 (e) P=0.476 | |POLY 6 | P=0.518 P=0.272N P=0.630 | P=0.243 (e) P=0.437 | |LOGISTIC REGRESSION| P=0.506 P=0.238N P=0.642 | P=0.225 (e) P=0.416 | |COCH-ARM / FISHERS | P=0.554 P=0.247N P=0.691N | P=0.296 (e) P=0.500 | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88124 TEST: 04 Page 6 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 17/50 (34%) 23/50 (46%) 32/50 (64%) | 12/50 (24%) 18/50 (36%) 14/50 (28%) | |POLY-3 ADJUSTED (b)| 36.5% 51.8% 70.5% | 25.6% 37.7% 34.7% | |TERMINAL (d) | 15/37 (41%) 18/29 (62%) 21/27 (78%) | 12/42 (29%) 10/33 (30%) 6/21 (29%) | |FIRST INCIDENCE | 664 481 370 | 735 (T) 617 496 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.025 * P<0.001 ** | P=0.033 * P=0.053 P=0.028 * | |POLY 3 | P<0.001 ** P=0.099 P<0.001 ** | P=0.265 P=0.148 P=0.245 | |POLY 1.5 | P<0.001 ** P=0.121 P<0.001 ** | P=0.345 P=0.147 P=0.308 | |POLY 6 | P<0.001 ** P=0.074 P<0.001 ** | P=0.184 P=0.146 P=0.178 | |LOGISTIC REGRESSION| P<0.001 ** P=0.076 P<0.001 ** | P=0.310 P=0.133 P=0.223 | |COCH-ARM / FISHERS | P=0.002 ** P=0.154 P=0.002 ** | P=0.481 P=0.138 P=0.410 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/50 (22%) 23/50 (46%) 16/50 (32%) | 6/50 (12%) 8/50 (16%) 10/50 (20%) | |POLY-3 ADJUSTED (b)| 23.2% 47.3% 36.1% | 12.7% 17.4% 24.7% | |TERMINAL (d) | 5/37 (14%) 6/29 (21%) 7/27 (26%) | 4/42 (10%) 7/33 (21%) 2/21 (10%) | |FIRST INCIDENCE | 607 478 562 | 626 691 594 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.153 P=0.007 ** P=0.070 | P=0.019 * P=0.238 P=0.038 * | |POLY 3 | P=0.215 P=0.010 * P=0.130 | P=0.102 P=0.365 P=0.120 | |POLY 1.5 | P=0.252 P=0.009 ** P=0.149 | P=0.130 P=0.380 P=0.150 | |POLY 6 | P=0.179 P=0.012 * P=0.111 | P=0.076 P=0.336 P=0.091 | |LOGISTIC REGRESSION| P=0.487 P=0.040 * P=0.208 | P=0.148 P=0.365 P=0.201 | |COCH-ARM / FISHERS | P=0.322 P=0.010 * P=0.184 | P=0.186 P=0.387 P=0.207 | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88124 TEST: 04 Page 7 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatoblastoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/50 (22%) 23/50 (46%) 16/50 (32%) | 6/50 (12%) 8/50 (16%) 10/50 (20%) | |POLY-3 ADJUSTED (b)| 23.2% 47.3% 36.1% | 12.7% 17.4% 24.7% | |TERMINAL (d) | 5/37 (14%) 6/29 (21%) 7/27 (26%) | 4/42 (10%) 7/33 (21%) 2/21 (10%) | |FIRST INCIDENCE | 607 478 562 | 626 691 594 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.153 P=0.007 ** P=0.070 | P=0.019 * P=0.238 P=0.038 * | |POLY 3 | P=0.215 P=0.010 * P=0.130 | P=0.102 P=0.365 P=0.120 | |POLY 1.5 | P=0.252 P=0.009 ** P=0.149 | P=0.130 P=0.380 P=0.150 | |POLY 6 | P=0.179 P=0.012 * P=0.111 | P=0.076 P=0.336 P=0.091 | |LOGISTIC REGRESSION| P=0.487 P=0.040 * P=0.208 | P=0.148 P=0.365 P=0.201 | |COCH-ARM / FISHERS | P=0.322 P=0.010 * P=0.184 | P=0.186 P=0.387 P=0.207 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 26/50 (52%) 37/50 (74%) 39/50 (78%) | 18/50 (36%) 24/50 (48%) 23/50 (46%) | |POLY-3 ADJUSTED (b)| 54.6% 76.1% 82.7% | 38.1% 50.1% 54.2% | |TERMINAL (d) | 19/37 (51%) 20/29 (69%) 22/27 (82%) | 16/42 (38%) 15/33 (46%) 8/21 (38%) | |FIRST INCIDENCE | 607 478 370 | 626 617 496 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.005 ** P<0.001 ** | P=0.002 ** P=0.046 * P=0.003 ** | |POLY 3 | P=0.003 ** P=0.019 * P=0.002 ** | P=0.096 P=0.163 P=0.090 | |POLY 1.5 | P=0.004 ** P=0.018 * P=0.003 ** | P=0.139 P=0.165 P=0.126 | |POLY 6 | P=0.002 ** P=0.021 * P<0.001 ** | P=0.063 P=0.156 P=0.061 | |LOGISTIC REGRESSION| P=0.007 ** P=0.022 * P=0.002 ** | P=0.110 P=0.148 P=0.092 | |COCH-ARM / FISHERS | P=0.009 ** P=0.019 * P=0.006 ** | P=0.241 P=0.156 P=0.208 | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88124 TEST: 04 Page 8 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, | | or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 26/50 (52%) 37/50 (74%) 39/50 (78%) | 18/50 (36%) 24/50 (48%) 23/50 (46%) | |POLY-3 ADJUSTED (b)| 54.6% 76.1% 82.7% | 38.1% 50.1% 54.2% | |TERMINAL (d) | 19/37 (51%) 20/29 (69%) 22/27 (82%) | 16/42 (38%) 15/33 (46%) 8/21 (38%) | |FIRST INCIDENCE | 607 478 370 | 626 617 496 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.005 ** P<0.001 ** | P=0.002 ** P=0.046 * P=0.003 ** | |POLY 3 | P=0.003 ** P=0.019 * P=0.002 ** | P=0.096 P=0.163 P=0.090 | |POLY 1.5 | P=0.004 ** P=0.018 * P=0.003 ** | P=0.139 P=0.165 P=0.126 | |POLY 6 | P=0.002 ** P=0.021 * P<0.001 ** | P=0.063 P=0.156 P=0.061 | |LOGISTIC REGRESSION| P=0.007 ** P=0.022 * P=0.002 ** | P=0.110 P=0.148 P=0.092 | |COCH-ARM / FISHERS | P=0.009 ** P=0.019 * P=0.006 ** | P=0.241 P=0.156 P=0.208 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/50 (26%) 7/50 (14%) 13/50 (26%) | 3/50 (6%) 10/50 (20%) 7/50 (14%) | |POLY-3 ADJUSTED (b)| 28.2% 16.3% 30.7% | 6.4% 21.5% 18.0% | |TERMINAL (d) | 12/37 (32%) 4/29 (14%) 10/27 (37%) | 2/42 (5%) 6/33 (18%) 4/21 (19%) | |FIRST INCIDENCE | 726 657 562 | 699 658 608 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.189 P=0.252N P=0.256 | P=0.036 * P=0.019 * P=0.026 * | |POLY 3 | P=0.367 P=0.138N P=0.490 | P=0.128 P=0.033 * P=0.092 | |POLY 1.5 | P=0.395 P=0.124N P=0.530 | P=0.174 P=0.035 * P=0.116 | |POLY 6 | P=0.333 P=0.155N P=0.442 | P=0.083 P=0.029 * P=0.068 | |LOGISTIC REGRESSION| P=0.281 P=0.192N P=0.373 | P=0.146 P=0.035 * P=0.096 | |COCH-ARM / FISHERS | P=0.437 P=0.105N P=0.590N | P=0.260 P=0.036 * P=0.159 | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88124 TEST: 04 Page 9 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 22/50 (44%) 13/50 (26%) | 1/50 (2%) 5/50 (10%) 7/50 (14%) | |POLY-3 ADJUSTED (b)| 12.9% 48.6% 29.7% | 2.1% 10.8% 17.6% | |TERMINAL (d) | 4/37 (11%) 14/29 (48%) 6/27 (22%) | 1/42 (2%) 3/33 (9%) 1/21 (5%) | |FIRST INCIDENCE | 664 478 589 | 735 (T) 664 600 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.082 P<0.001 ** P=0.022 * | P=0.005 ** P=0.073 P=0.007 ** | |POLY 3 | P=0.134 P<0.001 ** P=0.042 * | P=0.017 * P=0.099 P=0.016 * | |POLY 1.5 | P=0.159 P<0.001 ** P=0.049 * | P=0.023 * P=0.102 P=0.021 * | |POLY 6 | P=0.112 P<0.001 ** P=0.036 * | P=0.012 * P=0.093 P=0.012 * | |LOGISTIC REGRESSION| P=0.225 P<0.001 ** P=0.066 | P=0.036 * P=0.103 P=0.032 * | |COCH-ARM / FISHERS | P=0.217 P<0.001 ** P=0.062 | P=0.037 * P=0.102 P=0.030 * | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 18/50 (36%) 24/50 (48%) 21/50 (42%) | 4/50 (8%) 15/50 (30%) 14/50 (28%) | |POLY-3 ADJUSTED (b)| 38.6% 52.6% 47.1% | 8.5% 31.9% 34.4% | |TERMINAL (d) | 15/37 (41%) 15/29 (52%) 12/27 (44%) | 3/42 (7%) 9/33 (27%) 5/21 (24%) | |FIRST INCIDENCE | 664 478 562 | 699 658 600 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.114 P=0.036 * P=0.082 | P<0.001 ** P=0.002 ** P<0.001 ** | |POLY 3 | P=0.312 P=0.122 P=0.270 | P=0.006 ** P=0.004 ** P=0.002 ** | |POLY 1.5 | P=0.340 P=0.135 P=0.294 | P=0.011 * P=0.004 ** P=0.004 ** | |POLY 6 | P=0.291 P=0.109 P=0.252 | P=0.003 ** P=0.003 ** P<0.001 ** | |LOGISTIC REGRESSION| P=0.321 P=0.110 P=0.232 | P=0.013 * P=0.005 ** P=0.005 ** | |COCH-ARM / FISHERS | P=0.395 P=0.156 P=0.341 | P=0.029 * P=0.005 ** P=0.009 ** | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88124 TEST: 04 Page 10 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Ovary | | Granulosa Cell Tumor Benign | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 0/47 (0%) 2/44 (5%) 0/47 (0%) | |POLY-3 ADJUSTED (b)| | 0.0% 5.0% 0.0% | |TERMINAL (d) | | 0/39 (0%) 2/29 (7%) 0/20 (0%) | |FIRST INCIDENCE | | --- 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | | P=0.725N P=0.176 (e) | |POLY 3 | | P=0.641N P=0.217 (e) | |POLY 1.5 | | P=0.613N P=0.221 (e) | |POLY 6 | | P=0.677N P=0.209 (e) | |LOGISTIC REGRESSION| | (e) P=0.176 (e) | |COCH-ARM / FISHERS | | P=0.572N P=0.231 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/45 (0%) 0/50 (0%) | 10/50 (20%) 11/48 (23%) 7/49 (14%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 21.2% 24.8% 18.5% | |TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/27 (0%) | 9/42 (21%) 9/32 (28%) 4/21 (19%) | |FIRST INCIDENCE | --- --- --- | 664 687 619 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.335 P=0.264 P=0.364 | |POLY 3 | (e) (e) (e) | P=0.429N P=0.439 P=0.486N | |POLY 1.5 | (e) (e) (e) | P=0.350N P=0.454 P=0.412N | |POLY 6 | (e) (e) (e) | P=0.531N P=0.408 P=0.580N | |LOGISTIC REGRESSION| (e) (e) (e) | P=0.565N P=0.395 P=0.608N | |COCH-ARM / FISHERS | (e) (e) (e) | P=0.243N P=0.458 P=0.314N | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88124 TEST: 04 Page 11 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/45 (0%) 0/50 (0%) | 10/50 (20%) 12/48 (25%) 8/49 (16%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 21.2% 27.0% 21.1% | |TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/27 (0%) | 9/42 (21%) 9/32 (28%) 4/21 (19%) | |FIRST INCIDENCE | --- --- --- | 664 687 619 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.233 P=0.191 P=0.255 | |POLY 3 | (e) (e) (e) | P=0.532N P=0.344 P=0.598N | |POLY 1.5 | (e) (e) (e) | P=0.447N P=0.359 P=0.523N | |POLY 6 | (e) (e) (e) | P=0.484 P=0.314 P=0.519 | |LOGISTIC REGRESSION| (e) (e) (e) | P=0.476 P=0.300 P=0.510 | |COCH-ARM / FISHERS | (e) (e) (e) | P=0.324N P=0.363 P=0.416N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Pituitary Gland: Pars Intermedia | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 2/45 (4%) 1/50 (2%) | 0/50 (0%) 0/48 (0%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 5.2% 2.4% | 0.0% 0.0% 2.7% | |TERMINAL (d) | 0/36 (0%) 1/27 (4%) 1/27 (4%) | 0/42 (0%) 0/32 (0%) 1/21 (5%) | |FIRST INCIDENCE | --- 644 733 (T) | --- --- 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.435 P=0.199 P=0.443 | P=0.193 (e) P=0.362 | |POLY 3 | P=0.460 P=0.205 P=0.485 | P=0.259 (e) P=0.455 | |POLY 1.5 | P=0.483 P=0.212 P=0.495 | P=0.273 (e) P=0.472 | |POLY 6 | P=0.431 P=0.197 P=0.474 | P=0.242 (e) P=0.434 | |LOGISTIC REGRESSION| P=0.497 P=0.232 P=0.443 | (e) (e) P=0.362 | |COCH-ARM / FISHERS | P=0.517 P=0.231 P=0.510 | P=0.295 (e) P=0.495 | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88124 TEST: 04 Page 12 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Skin | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.4% | 4.2% 0.0% 0.0% | |TERMINAL (d) | 0/37 (0%) 0/29 (0%) 0/27 (0%) | 1/42 (2%) 0/33 (0%) 0/21 (0%) | |FIRST INCIDENCE | --- --- 687 | 664 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.275 (e) P=0.461 | P=0.247N P=0.269N P=0.368N | |POLY 3 | P=0.278 (e) P=0.479 | P=0.177N P=0.243N P=0.288N | |POLY 1.5 | P=0.285 (e) P=0.488 | P=0.175N P=0.239N P=0.266N | |POLY 6 | P=0.269 (e) P=0.469 | P=0.178N P=0.252N P=0.319N | |LOGISTIC REGRESSION| P=0.297 (e) P=0.511 | P=0.167N P=0.239N P=0.252N | |COCH-ARM / FISHERS | P=0.296 (e) P=0.500 | P=0.171N P=0.247N P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/48 (2%) 0/48 (0%) | 1/50 (2%) 1/50 (2%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 4.3% 2.4% 0.0% | 2.1% 2.2% 0.0% | |TERMINAL (d) | 1/37 (3%) 0/29 (0%) 0/27 (0%) | 0/42 (0%) 1/33 (3%) 0/21 (0%) | |FIRST INCIDENCE | 669 681 --- | 664 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.223N P=0.573N P=0.302N | P=0.472N P=0.731 P=0.585N | |POLY 3 | P=0.194N P=0.541N P=0.268N | P=0.396N P=0.754 P=0.544N | |POLY 1.5 | P=0.189N P=0.530N P=0.259N | P=0.381N P=0.759 P=0.527N | |POLY 6 | P=0.201N P=0.554N P=0.281N | P=0.417N P=0.746 P=0.566N | |LOGISTIC REGRESSION| P=0.179N P=0.504N P=0.247N | P=0.360N P=0.761 P=0.482N | |COCH-ARM / FISHERS | P=0.182N P=0.515N P=0.258N | P=0.356N P=0.753N P=0.505N | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88124 TEST: 04 Page 13 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma or Papilloma Squamous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.3% 4.7% 0.0% | 2.1% 2.2% 0.0% | |TERMINAL (d) | 2/37 (5%) 2/29 (7%) 0/27 (0%) | 0/42 (0%) 1/33 (3%) 0/21 (0%) | |FIRST INCIDENCE | 733 (T) 733 (T) --- | 678 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.238N P=0.605 P=0.310N | P=0.473N P=0.726 P=0.588N | |POLY 3 | P=0.194N P=0.661 P=0.262N | P=0.394N P=0.755 P=0.542N | |POLY 1.5 | P=0.185N P=0.675 P=0.252N | P=0.378N P=0.759 P=0.525N | |POLY 6 | P=0.207N P=0.643 P=0.275N | P=0.415N P=0.746 P=0.565N | |LOGISTIC REGRESSION| P=0.238N P=0.605 (e) | P=0.374N P=0.762 P=0.494N | |COCH-ARM / FISHERS | P=0.172N P=0.691N P=0.247N | P=0.352N P=0.753N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.2% 4.7% 0.0% | 0.0% 2.2% 0.0% | |TERMINAL (d) | 1/37 (3%) 2/29 (7%) 0/27 (0%) | 0/42 (0%) 1/33 (3%) 0/21 (0%) | |FIRST INCIDENCE | 733 (T) 733 (T) --- | --- 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.398N P=0.415 P=0.563N | P=0.809 P=0.452 (e) | |POLY 3 | P=0.353N P=0.469 P=0.522N | P=0.740N P=0.496 (e) | |POLY 1.5 | P=0.339N P=0.482 P=0.513N | P=0.725N P=0.499 (e) | |POLY 6 | P=0.371N P=0.452 P=0.533N | P=0.757N P=0.489 (e) | |LOGISTIC REGRESSION| P=0.398N P=0.415 (e) | (e) P=0.452 (e) | |COCH-ARM / FISHERS | P=0.320N P=0.500 P=0.500N | P=0.704N P=0.500 (e) | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88124 TEST: 04 Page 14 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Testes | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) | | |POLY-3 ADJUSTED (b)| 4.3% 2.4% 0.0% | | |TERMINAL (d) | 2/37 (5%) 1/29 (3%) 0/27 (0%) | | |FIRST INCIDENCE | 733 (T) 733 (T) --- | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.232N P=0.585N P=0.310N | | |POLY 3 | P=0.188N P=0.531N P=0.262N | | |POLY 1.5 | P=0.182N P=0.518N P=0.252N | | |POLY 6 | P=0.195N P=0.548N P=0.275N | | |LOGISTIC REGRESSION| P=0.232N P=0.585N (e) | | |COCH-ARM / FISHERS | P=0.175N P=0.500N P=0.247N | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | | 0/50 (0%) 2/50 (4%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| | 0.0% 4.4% 5.3% | |TERMINAL (d) | | 0/42 (0%) 2/33 (6%) 2/21 (10%) | |FIRST INCIDENCE | | --- 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | | P=0.092 P=0.187 P=0.104 | |POLY 3 | | P=0.178 P=0.232 P=0.194 | |POLY 1.5 | | P=0.206 P=0.236 P=0.211 | |POLY 6 | | P=0.146 P=0.225 P=0.174 | |LOGISTIC REGRESSION| | (e) P=0.187 P=0.104 | |COCH-ARM / FISHERS | | P=0.249 P=0.247 P=0.247 | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88124 TEST: 04 Page 15 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |All Organs | | Hemangioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 4.7% 0.0% | 2.1% 2.2% 0.0% | |TERMINAL (d) | 0/37 (0%) 2/29 (7%) 0/27 (0%) | 1/42 (2%) 0/33 (0%) 0/21 (0%) | |FIRST INCIDENCE | --- 733 (T) --- | 735 (T) 672 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.643N P=0.186 (e) | P=0.473N P=0.731 P=0.638N | |POLY 3 | P=0.615N P=0.218 (e) | P=0.394N P=0.757 P=0.541N | |POLY 1.5 | P=0.599N P=0.226 (e) | P=0.377N P=0.760 P=0.524N | |POLY 6 | P=0.635N P=0.207 (e) | P=0.414N P=0.750 P=0.563N | |LOGISTIC REGRESSION| (e) P=0.186 (e) | P=0.367N P=0.762 (e) | |COCH-ARM / FISHERS | P=0.575N P=0.247 (e) | P=0.352N P=0.753N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 3/50 (6%) | 3/50 (6%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 6.5% 2.4% 7.2% | 6.4% 2.2% 2.6% | |TERMINAL (d) | 2/37 (5%) 0/29 (0%) 2/27 (7%) | 2/42 (5%) 1/33 (3%) 0/21 (0%) | |FIRST INCIDENCE | 669 681 687 | 664 735 (T) 727 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.431 P=0.388N P=0.527 | P=0.476N P=0.375N P=0.535N | |POLY 3 | P=0.505 P=0.338N P=0.611 | P=0.320N P=0.315N P=0.386N | |POLY 1.5 | P=0.520 P=0.325N P=0.632 | P=0.301N P=0.308N P=0.351N | |POLY 6 | P=0.486 P=0.357N P=0.584 | P=0.342N P=0.329N P=0.432N | |LOGISTIC REGRESSION| P=0.495 P=0.317N P=0.601 | P=0.357N P=0.307N P=0.394N | |COCH-ARM / FISHERS | P=0.541 P=0.309N P=0.661N | P=0.272N P=0.309N P=0.309N | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88124 TEST: 04 Page 16 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 3/50 (6%) 3/50 (6%) | 4/50 (8%) 2/50 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 6.5% 7.1% 7.2% | 8.5% 4.3% 2.6% | |TERMINAL (d) | 2/37 (5%) 2/29 (7%) 2/27 (7%) | 3/42 (7%) 1/33 (3%) 0/21 (0%) | |FIRST INCIDENCE | 669 681 687 | 664 672 727 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.478 P=0.553 P=0.527 | P=0.338N P=0.418N P=0.407N | |POLY 3 | P=0.554 P=0.620 P=0.611 | P=0.202N P=0.348N P=0.251N | |POLY 1.5 | P=0.576 P=0.637 P=0.632 | P=0.181N P=0.340N P=0.219N | |POLY 6 | P=0.525 P=0.597 P=0.584 | P=0.230N P=0.363N P=0.296N | |LOGISTIC REGRESSION| P=0.542 P=0.617 P=0.601 | P=0.201N P=0.337N P=0.270N | |COCH-ARM / FISHERS | P=0.609 P=0.661N P=0.661N | P=0.150N P=0.339N P=0.181N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) | 1/50 (2%) 1/50 (2%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.4% | 2.1% 2.2% 7.7% | |TERMINAL (d) | 0/37 (0%) 0/29 (0%) 0/27 (0%) | 1/42 (2%) 0/33 (0%) 0/21 (0%) | |FIRST INCIDENCE | --- --- 471 | 735 (T) 691 512 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.293 (e) P=0.496 | P=0.105 P=0.717 P=0.185 | |POLY 3 | P=0.281 (e) P=0.482 | P=0.154 P=0.757 P=0.245 | |POLY 1.5 | P=0.287 (e) P=0.489 | P=0.171 P=0.760 P=0.269 | |POLY 6 | P=0.272 (e) P=0.472 | P=0.136 P=0.750 P=0.216 | |LOGISTIC REGRESSION| P=0.569 (e) P=0.906 | P=0.280 P=0.762 P=0.379 | |COCH-ARM / FISHERS | P=0.296 (e) P=0.500 | P=0.197 P=0.753N P=0.309 | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88124 TEST: 04 Page 17 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 2/50 (4%) | 8/50 (16%) 10/50 (20%) 13/50 (26%) | |POLY-3 ADJUSTED (b)| 2.2% 7.0% 4.7% | 17.0% 20.9% 33.2% | |TERMINAL (d) | 0/37 (0%) 1/29 (3%) 0/27 (0%) | 7/42 (17%) 5/33 (15%) 7/21 (33%) | |FIRST INCIDENCE | 686 657 562 | 699 547 600 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.431 P=0.232 P=0.457 | P=0.006 ** P=0.265 P=0.006 ** | |POLY 3 | P=0.453 P=0.276 P=0.470 | P=0.053 P=0.413 P=0.066 | |POLY 1.5 | P=0.472 P=0.288 P=0.482 | P=0.080 P=0.412 P=0.098 | |POLY 6 | P=0.430 P=0.262 P=0.454 | P=0.031 * P=0.403 P=0.039 * | |LOGISTIC REGRESSION| P=0.598 P=0.320 P=0.711 | P=0.072 P=0.392 P=0.033 * | |COCH-ARM / FISHERS | P=0.500 P=0.309 P=0.500 | P=0.141 P=0.398 P=0.163 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 29/50 (58%) 31/50 (62%) 35/50 (70%) | 25/50 (50%) 36/50 (72%) 26/50 (52%) | |POLY-3 ADJUSTED (b)| 61.0% 68.2% 76.4% | 52.9% 74.9% 61.7% | |TERMINAL (d) | 24/37 (65%) 22/29 (76%) 22/27 (82%) | 23/42 (55%) 25/33 (76%) 13/21 (62%) | |FIRST INCIDENCE | 561 481 370 | 664 617 496 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.007 ** P=0.076 P=0.007 ** | P=0.003 ** P<0.001 ** P=0.003 ** | |POLY 3 | P=0.065 P=0.300 P=0.074 | P=0.332 P=0.018 * P=0.263 | |POLY 1.5 | P=0.088 P=0.348 P=0.100 | P=0.459 P=0.019 * P=0.353 | |POLY 6 | P=0.043 * P=0.246 P=0.049 * | P=0.203 P=0.016 * P=0.172 | |LOGISTIC REGRESSION| P=0.052 P=0.249 P=0.061 | P=0.222 P=0.012 * P=0.179 | |COCH-ARM / FISHERS | P=0.129 P=0.419 P=0.149 | P=0.447N P=0.020 * P=0.500 | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88124 TEST: 04 Page 18 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 21/50 (42%) 40/50 (80%) 30/50 (60%) | 20/50 (40%) 25/50 (50%) 27/50 (54%) | |POLY-3 ADJUSTED (b)| 43.2% 81.2% 63.0% | 41.7% 51.2% 62.6% | |TERMINAL (d) | 11/37 (30%) 20/29 (69%) 14/27 (52%) | 15/42 (36%) 14/33 (42%) 9/21 (43%) | |FIRST INCIDENCE | 561 478 471 | 626 547 512 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.040 * P<0.001 ** P=0.014 * | P<0.001 ** P=0.085 P<0.001 ** | |POLY 3 | P=0.100 P<0.001 ** P=0.039 * | P=0.033 * P=0.234 P=0.035 * | |POLY 1.5 | P=0.112 P<0.001 ** P=0.043 * | P=0.054 P=0.233 P=0.055 | |POLY 6 | P=0.089 P<0.001 ** P=0.035 * | P=0.020 * P=0.224 P=0.021 * | |LOGISTIC REGRESSION| P=0.250 P<0.001 ** P=0.111 | P=0.069 P=0.211 P=0.045 * | |COCH-ARM / FISHERS | P=0.152 P<0.001 ** P=0.055 | P=0.119 P=0.211 P=0.115 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 41/50 (82%) 46/50 (92%) 45/50 (90%) | 35/50 (70%) 45/50 (90%) 40/50 (80%) | |POLY-3 ADJUSTED (b)| 83.7% 93.4% 91.9% | 73.0% 90.0% 89.0% | |TERMINAL (d) | 30/37 (81%) 26/29 (90%) 24/27 (89%) | 30/42 (71%) 28/33 (85%) 18/21 (86%) | |FIRST INCIDENCE | 561 478 370 | 626 547 496 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.020 * P=0.018 * P=0.013 * | P<0.001 ** P=0.002 ** P<0.001 ** | |POLY 3 | P=0.181 P=0.112 P=0.170 | P=0.045 * P=0.025 * P=0.038 * | |POLY 1.5 | P=0.191 P=0.109 P=0.178 | P=0.088 P=0.019 * P=0.069 | |POLY 6 | P=0.171 P=0.125 P=0.164 | P=0.025 * P=0.032 * P=0.023 * | |LOGISTIC REGRESSION| P=0.183 P=0.091 P=0.161 | P=0.030 * P=0.012 * P=0.013 * | |COCH-ARM / FISHERS | P=0.210 P=0.117 P=0.194 | P=0.256 P=0.011 * P=0.178 | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Poly-3 adjusted lifetime tumor incidence. (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. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fishers exact tests compare directly the overall incidence rates For all tests a negative trend is indicated by N (e) Value of Statistic cannot be computed. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01). --multipart-boundary Content-type: text/plain Range: bytes 146643-146643/146643 --multipart-boundary--