TDMS Study 05180-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest GALLIUM ARSENIDE DATE: 02/17/99 EXPERIMENT: 05180 TEST: 06 TIME: 08:15:51 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 62033B PATHOLOGIST: GRUMBEIN, S. CAS: 1303-00-0000 ------------------------------------------------------------------------------------------------------------------------------------ 2 YEAR CHRONIC RATS REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest GALLIUM ARSENIDE DATE: 02/17/99 EXPERIMENT: 05180 TEST: 06 TIME: 08:15:51 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 62033B PATHOLOGIST: GRUMBEIN, S. CAS: 1303-00-0000 Rats(FISCHER 344) ----------------------------- 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 Medulla Brain Clitoral/Preputial Gland Heart Islets, Pancreatic Kidney Liver Lung Ovary Pancreas Pituitary Gland Prostate Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest GALLIUM ARSENIDE DATE: 02/17/99 EXPERIMENT: 05180 TEST: 06 TIME: 08:15:51 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 62033B PATHOLOGIST: GRUMBEIN, S. CAS: 1303-00-0000 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF GALLIUM ARSENIDE =============================================================== Male Rats ------------ Organ Morphology ----- ---------- Clitoral/Preputial Gland Adenoma All Organs Hemangioma Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Malignant Tumors =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma: Benign, Complex, Malignant, NOS Islets, Pancreatic Carcinoma or Adenoma Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Mammary Gland Fibroadenoma Fibroma, Fibroadenoma or Adenoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Thyroid Gland: C-Cell Adenoma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Malignant Tumors Malignant and Benign Tumors =============================================================== Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 1 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 16/50 (32%) 12/49 (24%) 22/49 (45%) 13/50 (26%) |4/50 (8%) 5/49 (10%) 6/50 (12%) 13/49 (27%) | |POLY-3 ADJUSTED (b)| 40.8% 33.0% 54.8% 35.3% |9.9% 13.3% 16.0% 36.0% | |TERMINAL (d) | 5/13 (39%) 4/13 (31%) 9/15 (60%) 7/13 (54%) |1/19 (5%) 2/16 (13%) 5/21 (24%) 4/11 (36%) | |FIRST INCIDENCE | 567 614 590 547 |506 695 674 564 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.347N P=0.342N P=0.284 P=0.376N |P<0.001 ** P=0.447 P=0.390 P=0.002 ** | |POLY 3 | P=0.297N P=0.314N P=0.140 P=0.395N |P<0.001 ** P=0.455 P=0.321 P=0.005 ** | |POLY 1.5 | P=0.271N P=0.303N P=0.133 P=0.368N |P=0.002 ** P=0.469 P=0.336 P=0.007 ** | |POLY 6 | P=0.344N P=0.316N P=0.162 P=0.434N |P<0.001 ** P=0.441 P=0.309 P=0.003 ** | |LOGISTIC REGRESSION| P=0.314N P=0.334N P=0.165 P=0.404N |P<0.001 ** P=0.463 P=0.329 P=0.007 ** | |COCH-ARM / FISHERS | P=0.251N P=0.272N P=0.133 P=0.330N |P=0.004 ** P=0.487 P=0.370 P=0.014 * | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/49 (0%) 3/49 (6%) 1/50 (2%) |0/50 (0%) 1/49 (2%) 0/50 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 5.4% 0.0% 8.0% 2.9% |0.0% 2.7% 0.0% 0.0% | |TERMINAL (d) | 1/13 (8%) 0/13 (0%) 2/15 (13%) 0/13 (0%) |0/19 (0%) 1/16 (6%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 671 --- 601 713 |--- 734 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.549N P=0.259N P=0.555 P=0.527N |P=0.768N P=0.466 (e) (e) | |POLY 3 | P=0.537N P=0.254N P=0.508 P=0.519N |P=0.682N P=0.489 (e) (e) | |POLY 1.5 | P=0.532N P=0.250N P=0.500 P=0.512N |P=0.677N P=0.492 (e) (e) | |POLY 6 | P=0.542N P=0.258N P=0.521 P=0.527N |P=0.689N P=0.485 (e) (e) | |LOGISTIC REGRESSION| P=0.554N P=0.256N P=0.517 P=0.524N |(e) P=0.466 (e) (e) | |COCH-ARM / FISHERS | P=0.528N P=0.253N P=0.490 P=0.500N |P=0.671N P=0.495 (e) (e) | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 2 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 16/50 (32%) 12/49 (24%) 23/49 (47%) 14/50 (28%) |4/50 (8%) 6/49 (12%) 6/50 (12%) 13/49 (27%) | |POLY-3 ADJUSTED (b)| 40.8% 33.0% 56.7% 38.0% |9.9% 16.0% 16.0% 36.0% | |TERMINAL (d) | 5/13 (39%) 4/13 (31%) 9/15 (60%) 7/13 (54%) |1/19 (5%) 3/16 (19%) 5/21 (24%) 4/11 (36%) | |FIRST INCIDENCE | 567 614 590 547 |506 695 674 564 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.418N P=0.342N P=0.233 P=0.459N |P<0.001 ** P=0.317 P=0.390 P=0.002 ** | |POLY 3 | P=0.380N P=0.314N P=0.103 P=0.492N |P=0.002 ** P=0.323 P=0.321 P=0.005 ** | |POLY 1.5 | P=0.347N P=0.303N P=0.096 P=0.459N |P=0.003 ** P=0.338 P=0.336 P=0.007 ** | |POLY 6 | P=0.438N P=0.316N P=0.127 P=0.536N |P=0.002 ** P=0.308 P=0.309 P=0.003 ** | |LOGISTIC REGRESSION| P=0.395N P=0.334N P=0.115 P=0.502N |P<0.001 ** P=0.328 P=0.329 P=0.007 ** | |COCH-ARM / FISHERS | P=0.318N P=0.272N P=0.094 P=0.414N |P=0.006 ** P=0.357 P=0.370 P=0.014 * | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Bone | | Osteosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.7% 0.0% 5.2% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 567 --- 562 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.427N P=0.510N P=0.512 P=0.515N |(e) (e) (e) (e) | |POLY 3 | P=0.402N P=0.517N P=0.511 P=0.513N |(e) (e) (e) (e) | |POLY 1.5 | P=0.400N P=0.512N P=0.506 P=0.508N |(e) (e) (e) (e) | |POLY 6 | P=0.406N P=0.523N P=0.521 P=0.519N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.395N P=0.454N P=0.489 P=0.466N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.400N P=0.500N P=0.500 P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 3 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/49 (4%) 3/50 (6%) 6/49 (12%) |8/50 (16%) 9/48 (19%) 7/47 (15%) 4/48 (8%) | |POLY-3 ADJUSTED (b)| 0.0% 5.9% 7.8% 16.7% |19.6% 23.5% 19.7% 11.9% | |TERMINAL (d) | 0/13 (0%) 1/13 (8%) 1/15 (7%) 3/13 (23%) |4/19 (21%) 4/16 (25%) 5/20 (25%) 0/10 (0%) | |FIRST INCIDENCE | --- 574 604 520 |581 590 631 632 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.017 * P=0.237 P=0.141 P=0.018 * |P=0.333N P=0.413 P=0.502N P=0.424N | |POLY 3 | P=0.016 * P=0.218 P=0.126 P=0.013 * |P=0.174N P=0.444 P=0.610 P=0.279N | |POLY 1.5 | P=0.016 * P=0.222 P=0.122 P=0.013 * |P=0.150N P=0.454 P=0.597N P=0.247N | |POLY 6 | P=0.015 * P=0.215 P=0.132 P=0.012 * |P=0.205N P=0.434 P=0.601 P=0.317N | |LOGISTIC REGRESSION| P=0.017 * P=0.224 P=0.120 P=0.015 * |P=0.178N P=0.445 P=0.605N P=0.265N | |COCH-ARM / FISHERS | P=0.017 * P=0.242 P=0.121 P=0.012 * |P=0.113N P=0.463 P=0.552N P=0.199N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 4/49 (8%) 5/50 (10%) 4/49 (8%) |3/50 (6%) 2/48 (4%) 2/47 (4%) 2/48 (4%) | |POLY-3 ADJUSTED (b)| 10.6% 11.7% 12.8% 11.1% |7.5% 5.3% 5.7% 6.1% | |TERMINAL (d) | 1/13 (8%) 2/13 (15%) 0/15 (0%) 1/13 (8%) |2/19 (11%) 1/16 (6%) 2/20 (10%) 1/10 (10%) | |FIRST INCIDENCE | 534 567 590 540 |582 559 734 (T) 684 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.601 P=0.616 P=0.549 P=0.605 |P=0.540 P=0.561N P=0.490N P=0.662 | |POLY 3 | P=0.582N P=0.592 P=0.525 P=0.621 |P=0.623N P=0.527N P=0.563N P=0.589N | |POLY 1.5 | P=0.577N P=0.603 P=0.512 P=0.624 |P=0.600N P=0.522N P=0.553N P=0.563N | |POLY 6 | P=0.589N P=0.582 P=0.550 P=0.622 |P=0.631 P=0.533N P=0.570N P=0.620N | |LOGISTIC REGRESSION| P=0.575N P=0.609 P=0.497 P=0.636 |P=0.636N P=0.520N P=0.559N P=0.601N | |COCH-ARM / FISHERS | P=0.575N P=0.631 P=0.500 P=0.631 |P=0.562N P=0.520N P=0.530N P=0.520N | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 4 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 6/49 (12%) 8/50 (16%) 10/49 (20%) |11/50 (22%) 11/48 (23%) 9/47 (19%) 6/48 (13%) | |POLY-3 ADJUSTED (b)| 10.6% 17.3% 20.0% 26.8% |26.7% 28.3% 25.3% 17.8% | |TERMINAL (d) | 1/13 (8%) 3/13 (23%) 1/15 (7%) 4/13 (31%) |6/19 (32%) 5/16 (31%) 7/20 (35%) 1/10 (10%) | |FIRST INCIDENCE | 534 567 590 520 |581 559 631 632 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.086 P=0.349 P=0.235 P=0.073 |P=0.410N P=0.482 P=0.398N P=0.446N | |POLY 3 | P=0.092 P=0.315 P=0.202 P=0.062 |P=0.193N P=0.536 P=0.552N P=0.260N | |POLY 1.5 | P=0.093 P=0.327 P=0.189 P=0.063 |P=0.161N P=0.545 P=0.523N P=0.221N | |POLY 6 | P=0.089 P=0.307 P=0.228 P=0.061 |P=0.233N P=0.528 P=0.577N P=0.307N | |LOGISTIC REGRESSION| P=0.092 P=0.330 P=0.176 P=0.067 |P=0.197N P=0.538 P=0.527N P=0.251N | |COCH-ARM / FISHERS | P=0.093 P=0.357 P=0.178 P=0.068 |P=0.116N P=0.553 P=0.463N P=0.165N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/48 (4%) 1/49 (2%) 2/50 (4%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 5.6% 2.9% 5.3% 5.6% |2.5% 0.0% 0.0% 5.8% | |TERMINAL (d) | 1/13 (8%) 1/13 (8%) 0/15 (0%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 671 733 (T) 704 601 |685 --- --- 691 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.539 P=0.520N P=0.661N P=0.660 |P=0.127 P=0.480N P=0.539N P=0.443 | |POLY 3 | P=0.572 P=0.517N P=0.676N P=0.695 |P=0.139 P=0.507N P=0.513N P=0.449 | |POLY 1.5 | P=0.573 P=0.508N P=0.677N P=0.690N |P=0.145 P=0.504N P=0.509N P=0.465 | |POLY 6 | P=0.573 P=0.528N P=0.674N P=0.692 |P=0.134 P=0.510N P=0.515N P=0.432 | |LOGISTIC REGRESSION| P=0.554 P=0.528N P=0.670N P=0.694N |P=0.130 P=0.504N P=0.509N P=0.445 | |COCH-ARM / FISHERS | P=0.577 P=0.492N P=0.676N P=0.676N |P=0.155 P=0.500N P=0.500N P=0.492 | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 5 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 3/49 (6%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 8.7% 0.0% 2.9% |0.0% 0.0% 0.0% 2.9% | |TERMINAL (d) | 0/13 (0%) 2/13 (15%) 0/15 (0%) 1/13 (8%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | --- 532 --- 733 (T) |--- --- --- 688 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.688N P=0.117 (e) P=0.500 |P=0.231 (e) (e) P=0.468 | |POLY 3 | P=0.691N P=0.112 (e) P=0.496 |P=0.237 (e) (e) P=0.471 | |POLY 1.5 | P=0.681N P=0.116 (e) P=0.501 |P=0.243 (e) (e) P=0.480 | |POLY 6 | P=0.702N P=0.109 (e) P=0.491 |P=0.231 (e) (e) P=0.461 | |LOGISTIC REGRESSION| P=0.682N P=0.115 (e) P=0.500 |P=0.234 (e) (e) P=0.469 | |COCH-ARM / FISHERS | P=0.664N P=0.125 (e) P=0.510 |P=0.253 (e) (e) P=0.495 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/48 (4%) 4/49 (8%) 2/50 (4%) 3/50 (6%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 3/49 (6%) | |POLY-3 ADJUSTED (b)| 5.6% 11.5% 5.3% 8.4% |2.5% 0.0% 0.0% 8.7% | |TERMINAL (d) | 1/13 (8%) 3/13 (23%) 0/15 (0%) 1/13 (8%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 671 532 704 601 |685 --- --- 688 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.547 P=0.317 P=0.661N P=0.468 |P=0.028 * P=0.480N P=0.539N P=0.252 | |POLY 3 | P=0.570 P=0.321 P=0.676N P=0.499 |P=0.032 * P=0.507N P=0.513N P=0.256 | |POLY 1.5 | P=0.577 P=0.329 P=0.677N P=0.506 |P=0.034 * P=0.504N P=0.509N P=0.270 | |POLY 6 | P=0.564 P=0.310 P=0.674N P=0.493 |P=0.030 * P=0.510N P=0.515N P=0.241 | |LOGISTIC REGRESSION| P=0.562 P=0.308 P=0.670N P=0.491 |P=0.028 * P=0.504N P=0.509N P=0.250 | |COCH-ARM / FISHERS | P=0.590 P=0.349 P=0.676N P=0.520 |P=0.039 * P=0.500N P=0.500N P=0.301 | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 6 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 0/50 (0%) 0/50 (0%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 5.4% 0.0% 0.0% 8.5% |0.0% 0.0% 2.7% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 2/13 (15%) |0/19 (0%) 0/17 (0%) 1/21 (5%) 0/11 (0%) | |FIRST INCIDENCE | 590 --- --- 604 |--- --- 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.099 P=0.257N P=0.227N P=0.488 |P=0.841N (e) P=0.520 (e) | |POLY 3 | P=0.103 P=0.253N P=0.231N P=0.481 |P=0.764N (e) P=0.488 (e) | |POLY 1.5 | P=0.104 P=0.246N P=0.232N P=0.493 |P=0.758N (e) P=0.491 (e) | |POLY 6 | P=0.101 P=0.261N P=0.231N P=0.469 |P=0.771N (e) P=0.487 (e) | |LOGISTIC REGRESSION| P=0.100 P=0.230N P=0.235N P=0.489 |(e) (e) P=0.520 (e) | |COCH-ARM / FISHERS | P=0.106 P=0.242N P=0.242N P=0.510 |P=0.747N (e) P=0.500 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.7% 2.9% 5.3% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 1/13 (8%) 1/15 (7%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 726 733 (T) 698 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.296N P=0.745 P=0.546 P=0.514N |(e) (e) (e) (e) | |POLY 3 | P=0.302N P=0.745 P=0.509 P=0.510N |(e) (e) (e) (e) | |POLY 1.5 | P=0.298N P=0.750 P=0.505 P=0.506N |(e) (e) (e) (e) | |POLY 6 | P=0.306N P=0.742 P=0.518 P=0.514N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.300N P=0.751 P=0.526 P=0.508N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.294N P=0.753N P=0.500 P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 7 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, | | or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.7% 2.9% 5.3% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 1/13 (8%) 1/15 (7%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 726 733 (T) 698 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.296N P=0.745 P=0.546 P=0.514N |(e) (e) (e) (e) | |POLY 3 | P=0.302N P=0.745 P=0.509 P=0.510N |(e) (e) (e) (e) | |POLY 1.5 | P=0.298N P=0.750 P=0.505 P=0.506N |(e) (e) (e) (e) | |POLY 6 | P=0.306N P=0.742 P=0.518 P=0.514N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.300N P=0.751 P=0.526 P=0.508N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.294N P=0.753N P=0.500 P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/49 (0%) 3/50 (6%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 7/50 (14%) | |POLY-3 ADJUSTED (b)| 2.7% 0.0% 8.0% 5.7% |0.0% 0.0% 5.3% 19.7% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 3/15 (20%) 2/13 (15%) |0/19 (0%) 0/17 (0%) 1/21 (5%) 2/11 (18%) | |FIRST INCIDENCE | 688 --- 733 (T) 733 (T) |--- --- 646 556 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.412 P=0.490N P=0.357 P=0.506 |P<0.001 ** (e) P=0.244 P=0.003 ** | |POLY 3 | P=0.421 P=0.516N P=0.310 P=0.481 |P<0.001 ** (e) P=0.225 P=0.004 ** | |POLY 1.5 | P=0.426 P=0.512N P=0.308 P=0.488 |P<0.001 ** (e) P=0.228 P=0.005 ** | |POLY 6 | P=0.416 P=0.520N P=0.314 P=0.473 |P<0.001 ** (e) P=0.225 P=0.003 ** | |LOGISTIC REGRESSION| P=0.410 P=0.517N P=0.328 P=0.480 |P<0.001 ** (e) P=0.226 P=0.005 ** | |COCH-ARM / FISHERS | P=0.431 P=0.505N P=0.309 P=0.500 |P<0.001 ** (e) P=0.247 P=0.006 ** | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 8 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/49 (0%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 5.4% 0.0% 5.3% 2.9% |0.0% 0.0% 5.4% 8.6% | |TERMINAL (d) | 1/13 (8%) 0/13 (0%) 1/15 (7%) 1/13 (8%) |0/19 (0%) 0/17 (0%) 2/21 (10%) 1/11 (9%) | |FIRST INCIDENCE | 567 --- 722 733 (T) |--- --- 734 (T) 677 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.629N P=0.245N P=0.659N P=0.509N |P=0.024 * (e) P=0.259 P=0.077 | |POLY 3 | P=0.617N P=0.256N P=0.692N P=0.523N |P=0.053 (e) P=0.224 P=0.097 | |POLY 1.5 | P=0.613N P=0.251N P=0.693N P=0.514N |P=0.059 (e) P=0.227 P=0.104 | |POLY 6 | P=0.623N P=0.261N P=0.689N P=0.533N |P=0.048 * (e) P=0.221 P=0.089 | |LOGISTIC REGRESSION| P=0.632N P=0.245N P=0.683N P=0.518N |P=0.037 * (e) P=0.259 P=0.087 | |COCH-ARM / FISHERS | P=0.609N P=0.253N P=0.691N P=0.500N |P=0.070 (e) P=0.247 P=0.121 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/49 (0%) 5/50 (10%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 4/50 (8%) 9/50 (18%) | |POLY-3 ADJUSTED (b)| 8.0% 0.0% 13.3% 8.6% |0.0% 0.0% 10.7% 25.0% | |TERMINAL (d) | 1/13 (8%) 0/13 (0%) 4/15 (27%) 3/13 (23%) |0/19 (0%) 0/17 (0%) 3/21 (14%) 2/11 (18%) | |FIRST INCIDENCE | 567 --- 722 733 (T) |--- --- 646 556 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.479 P=0.124N P=0.423 P=0.663 |P<0.001 ** (e) P=0.071 P<0.001 ** | |POLY 3 | P=0.490 P=0.134N P=0.357 P=0.632 |P<0.001 ** (e) P=0.053 P<0.001 ** | |POLY 1.5 | P=0.498 P=0.130N P=0.357 P=0.644 |P<0.001 ** (e) P=0.055 P<0.001 ** | |POLY 6 | P=0.480 P=0.139N P=0.357 P=0.617 |P<0.001 ** (e) P=0.052 P<0.001 ** | |LOGISTIC REGRESSION| P=0.471 P=0.130N P=0.387 P=0.634 |P<0.001 ** (e) P=0.054 P<0.001 ** | |COCH-ARM / FISHERS | P=0.505 P=0.125N P=0.357 P=0.661N |P<0.001 ** (e) P=0.059 P<0.001 ** | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 9 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |8/50 (16%) 3/50 (6%) 7/50 (14%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.9% |19.8% 7.7% 18.7% 14.2% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |4/19 (21%) 1/17 (6%) 6/21 (29%) 1/11 (9%) | |FIRST INCIDENCE | --- --- --- 668 |589 559 701 632 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.248 (e) (e) P=0.483 |P=0.446 P=0.130N P=0.477N P=0.523N | |POLY 3 | P=0.256 (e) (e) P=0.491 |P=0.549N P=0.105N P=0.569N P=0.368N | |POLY 1.5 | P=0.257 (e) (e) P=0.494 |P=0.516N P=0.102N P=0.546N P=0.333N | |POLY 6 | P=0.256 (e) (e) P=0.490 |P=0.588N P=0.108N P=0.594N P=0.411N | |LOGISTIC REGRESSION| P=0.252 (e) (e) P=0.492 |P=0.588N P=0.106N P=0.558N P=0.392N | |COCH-ARM / FISHERS | P=0.257 (e) (e) P=0.500 |P=0.457N P=0.100N P=0.500N P=0.277N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |8/50 (16%) 3/50 (6%) 7/50 (14%) 6/50 (12%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.9% |19.8% 7.7% 18.7% 16.9% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |4/19 (21%) 1/17 (6%) 6/21 (29%) 1/11 (9%) | |FIRST INCIDENCE | --- --- --- 668 |589 559 701 632 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.248 (e) (e) P=0.483 |P=0.292 P=0.130N P=0.477N P=0.579 | |POLY 3 | P=0.256 (e) (e) P=0.491 |P=0.488 P=0.105N P=0.569N P=0.491N | |POLY 1.5 | P=0.257 (e) (e) P=0.494 |P=0.520 P=0.102N P=0.546N P=0.453N | |POLY 6 | P=0.256 (e) (e) P=0.490 |P=0.454 P=0.108N P=0.594N P=0.534N | |LOGISTIC REGRESSION| P=0.252 (e) (e) P=0.492 |P=0.449 P=0.106N P=0.558N P=0.518N | |COCH-ARM / FISHERS | P=0.257 (e) (e) P=0.500 |P=0.578 P=0.100N P=0.500N P=0.387N | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 10 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 3/50 (6%) 2/50 (4%) |26/50 (52%) 31/50 (62%) 29/50 (58%) 31/50 (62%) | |POLY-3 ADJUSTED (b)| 0.0% 5.8% 7.9% 5.6% |59.2% 71.3% 68.0% 74.3% | |TERMINAL (d) | 0/13 (0%) 1/13 (8%) 0/15 (0%) 1/13 (8%) |11/19 (58%) 13/17 (77%) 16/21 (76%) 7/11 (64%) | |FIRST INCIDENCE | --- 660 601 422 |497 422 339 418 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.516 P=0.217 P=0.150 P=0.240 |P=0.018 * P=0.173 P=0.391 P=0.025 * | |POLY 3 | P=0.521 P=0.222 P=0.125 P=0.230 |P=0.184 P=0.152 P=0.252 P=0.090 | |POLY 1.5 | P=0.524 P=0.226 P=0.122 P=0.233 |P=0.223 P=0.178 P=0.280 P=0.122 | |POLY 6 | P=0.519 P=0.219 P=0.131 P=0.228 |P=0.158 P=0.128 P=0.223 P=0.069 | |LOGISTIC REGRESSION| P=0.524 P=0.217 P=0.122 P=0.266 |P=0.172 P=0.172 P=0.264 P=0.096 | |COCH-ARM / FISHERS | P=0.527 P=0.247 P=0.121 P=0.247 |P=0.329 P=0.210 P=0.344 P=0.210 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 3/50 (6%) 2/50 (4%) |26/50 (52%) 31/50 (62%) 29/50 (58%) 31/50 (62%) | |POLY-3 ADJUSTED (b)| 0.0% 5.8% 7.9% 5.6% |59.2% 71.3% 68.0% 74.3% | |TERMINAL (d) | 0/13 (0%) 1/13 (8%) 0/15 (0%) 1/13 (8%) |11/19 (58%) 13/17 (77%) 16/21 (76%) 7/11 (64%) | |FIRST INCIDENCE | --- 660 601 422 |497 422 339 418 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.516 P=0.217 P=0.150 P=0.240 |P=0.018 * P=0.173 P=0.391 P=0.025 * | |POLY 3 | P=0.521 P=0.222 P=0.125 P=0.230 |P=0.184 P=0.152 P=0.252 P=0.090 | |POLY 1.5 | P=0.524 P=0.226 P=0.122 P=0.233 |P=0.223 P=0.178 P=0.280 P=0.122 | |POLY 6 | P=0.519 P=0.219 P=0.131 P=0.228 |P=0.158 P=0.128 P=0.223 P=0.069 | |LOGISTIC REGRESSION| P=0.524 P=0.217 P=0.122 P=0.266 |P=0.172 P=0.172 P=0.264 P=0.096 | |COCH-ARM / FISHERS | P=0.527 P=0.247 P=0.121 P=0.247 |P=0.329 P=0.210 P=0.344 P=0.210 | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 11 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 3/50 (6%) 3/50 (6%) |29/50 (58%) 32/50 (64%) 31/50 (62%) 32/50 (64%) | |POLY-3 ADJUSTED (b)| 0.0% 5.8% 7.9% 8.4% |65.4% 72.7% 72.7% 76.0% | |TERMINAL (d) | 0/13 (0%) 1/13 (8%) 0/15 (0%) 1/13 (8%) |12/19 (63%) 13/17 (77%) 18/21 (86%) 7/11 (64%) | |FIRST INCIDENCE | --- 660 601 422 |497 422 339 418 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.278 P=0.217 P=0.150 P=0.119 |P=0.026 * P=0.269 P=0.453 P=0.045 * | |POLY 3 | P=0.283 P=0.222 P=0.125 P=0.113 |P=0.264 P=0.295 P=0.295 P=0.183 | |POLY 1.5 | P=0.286 P=0.226 P=0.122 P=0.115 |P=0.307 P=0.319 P=0.337 P=0.228 | |POLY 6 | P=0.282 P=0.219 P=0.131 P=0.112 |P=0.240 P=0.267 P=0.240 P=0.152 | |LOGISTIC REGRESSION| P=0.284 P=0.217 P=0.122 P=0.132 |P=0.232 P=0.296 P=0.312 P=0.171 | |COCH-ARM / FISHERS | P=0.288 P=0.247 P=0.121 P=0.121 |P=0.423 P=0.341 P=0.419 P=0.341 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Papilloma Squamous or Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 1/50 (2%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.7% 8.5% 2.7% 5.7% |2.5% 0.0% 2.7% 0.0% | |TERMINAL (d) | 0/13 (0%) 1/13 (8%) 0/15 (0%) 1/13 (8%) |0/19 (0%) 0/17 (0%) 1/21 (5%) 0/11 (0%) | |FIRST INCIDENCE | 662 524 702 702 |699 --- 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.584 P=0.272 P=0.738N P=0.494 |P=0.594N P=0.500N P=0.758 P=0.563N | |POLY 3 | P=0.572 P=0.286 P=0.757N P=0.481 |P=0.520N P=0.507N P=0.747 P=0.528N | |POLY 1.5 | P=0.581 P=0.291 P=0.759N P=0.488 |P=0.512N P=0.504N P=0.751 P=0.517N | |POLY 6 | P=0.561 P=0.284 P=0.754N P=0.474 |P=0.532N P=0.510N P=0.745 P=0.541N | |LOGISTIC REGRESSION| P=0.586 P=0.307 P=0.757N P=0.476 |P=0.553N P=0.507N P=0.749 P=0.537N | |COCH-ARM / FISHERS | P=0.595 P=0.309 P=0.753N P=0.500 |P=0.497N P=0.500N P=0.753N P=0.500N | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 12 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.7% 0.0% 0.0% 0.0% |0.0% 5.2% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 506 --- --- --- |--- 695 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.661N P=0.513N P=0.508N P=0.508N |P=0.499N P=0.244 (e) (e) | |POLY 3 | P=0.660N P=0.518N P=0.499N P=0.514N |P=0.463N P=0.231 (e) (e) | |POLY 1.5 | P=0.659N P=0.512N P=0.500N P=0.508N |P=0.454N P=0.234 (e) (e) | |POLY 6 | P=0.662N P=0.524N P=0.497N P=0.519N |P=0.473N P=0.230 (e) (e) | |LOGISTIC REGRESSION| P=0.667N P=0.403N P=0.521N P=0.437N |P=0.476N P=0.230 (e) (e) | |COCH-ARM / FISHERS | P=0.660N P=0.500N P=0.500N P=0.500N |P=0.443N P=0.247 (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 3/50 (6%) 1/50 (2%) 2/50 (4%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.3% 8.5% 2.7% 5.7% |2.5% 5.2% 2.7% 0.0% | |TERMINAL (d) | 0/13 (0%) 1/13 (8%) 0/15 (0%) 1/13 (8%) |0/19 (0%) 0/17 (0%) 1/21 (5%) 0/11 (0%) | |FIRST INCIDENCE | 506 524 702 702 |699 695 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.631N P=0.457 P=0.482N P=0.684 |P=0.336N P=0.504 P=0.758 P=0.563N | |POLY 3 | P=0.650N P=0.469 P=0.499N P=0.669 |P=0.288N P=0.491 P=0.747 P=0.528N | |POLY 1.5 | P=0.637N P=0.478 P=0.500N P=0.679 |P=0.276N P=0.495 P=0.751 P=0.517N | |POLY 6 | P=0.642 P=0.463 P=0.497N P=0.659 |P=0.303N P=0.488 P=0.745 P=0.541N | |LOGISTIC REGRESSION| P=0.624N P=0.538 P=0.507N P=0.691 |P=0.299N P=0.488 P=0.749 P=0.537N | |COCH-ARM / FISHERS | P=0.622N P=0.500 P=0.500N P=0.691N |P=0.258N P=0.500 P=0.753N P=0.500N | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 13 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Oral Mucosa | | Squamous Cell Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 5.2% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 695 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.499N P=0.244 (e) (e) | |POLY 3 | (e) (e) (e) (e) |P=0.463N P=0.231 (e) (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.454N P=0.234 (e) (e) | |POLY 6 | (e) (e) (e) (e) |P=0.473N P=0.230 (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.476N P=0.230 (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.443N P=0.247 (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Oral Mucosa | | Squamous Cell Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 8.5% 0.0% 2.9% |2.5% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 1/13 (8%) 0/15 (0%) 1/13 (8%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | --- 524 --- 733 (T) |699 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.692N P=0.114 (e) P=0.500 |P=0.714N P=0.500N P=0.524N P=0.563N | |POLY 3 | P=0.698N P=0.109 (e) P=0.490 |P=0.663N P=0.507N P=0.512N P=0.528N | |POLY 1.5 | P=0.689N P=0.112 (e) P=0.494 |P=0.661N P=0.504N P=0.509N P=0.517N | |POLY 6 | P=0.705N P=0.109 (e) P=0.487 |P=0.666N P=0.510N P=0.515N P=0.541N | |LOGISTIC REGRESSION| P=0.675N P=0.124 (e) P=0.500 |P=0.689N P=0.507N P=0.512N P=0.537N | |COCH-ARM / FISHERS | P=0.672N P=0.121 (e) P=0.500 |P=0.660N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 14 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Pancreas | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 1/49 (2%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 5.5% 2.9% 2.7% 2.9% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/13 (8%) 0/13 (0%) 1/15 (7%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 720 712 733 (T) 732 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.584N P=0.538N P=0.460N P=0.507N |(e) (e) (e) (e) | |POLY 3 | P=0.582N P=0.520N P=0.487N P=0.513N |(e) (e) (e) (e) | |POLY 1.5 | P=0.575N P=0.513N P=0.490N P=0.505N |(e) (e) (e) (e) | |POLY 6 | P=0.590N P=0.526N P=0.481N P=0.521N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.589N P=0.528N P=0.472N P=0.512N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.568N P=0.500N P=0.492N P=0.492N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 21/49 (43%) 22/49 (45%) 21/50 (42%) 19/50 (38%) |42/50 (84%) 43/50 (86%) 36/50 (72%) 31/49 (63%) | |POLY-3 ADJUSTED (b)| 49.6% 56.8% 50.9% 48.8% |92.3% 94.8% 81.3% 74.8% | |TERMINAL (d) | 4/13 (31%) 7/13 (54%) 7/15 (47%) 7/13 (54%) |19/19 (100%) 17/17 (100%) 19/21 (91%) 9/11 (82%) | |FIRST INCIDENCE | 338 574 513 539 |581 478 339 506 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.439N P=0.418 P=0.459N P=0.504N |P=0.451 P=0.339 P=0.208N P=0.479 | |POLY 3 | P=0.414N P=0.328 P=0.539 P=0.564N |P=0.004N** P=0.470 P=0.081N P=0.014N* | |POLY 1.5 | P=0.365N P=0.383 P=0.567 P=0.494N |P=0.005N** P=0.497 P=0.094N P=0.015N* | |POLY 6 | P=0.478N P=0.283 P=0.510 P=0.555 |P=0.002N** P=0.437 P=0.068N P=0.013N* | |LOGISTIC REGRESSION| P=0.344N P=0.464 P=0.541N P=0.407N |P=0.028N* P=0.238 P=0.204N P=0.068N | |COCH-ARM / FISHERS | P=0.305N P=0.500 P=0.547N P=0.387N |P=0.007N** P=0.500 P=0.114N P=0.017N* | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 15 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Prostate | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/48 (4%) 0/50 (0%) 0/50 (0%) | | |POLY-3 ADJUSTED (b)| 0.0% 5.9% 0.0% 0.0% | | |TERMINAL (d) | 0/13 (0%) 2/13 (15%) 0/15 (0%) 0/13 (0%) | | |FIRST INCIDENCE | --- 733 (T) --- --- | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.451N P=0.235 (e) (e) | | |POLY 3 | P=0.459N P=0.220 (e) (e) | | |POLY 1.5 | P=0.451N P=0.223 (e) (e) | | |POLY 6 | P=0.468N P=0.215 (e) (e) | | |LOGISTIC REGRESSION| (e) P=0.235 (e) (e) | | |COCH-ARM / FISHERS | P=0.439N P=0.237 (e) (e) | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Skin | | Basal Cell Adenoma, Basosquamous Tumor Benign, or | | Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.7% 0.0% 0.0% 5.7% |0.0% 0.0% 0.0% 2.9% | |TERMINAL (d) | 1/13 (8%) 0/13 (0%) 0/15 (0%) 1/13 (8%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 1/11 (9%) | |FIRST INCIDENCE | 733 (T) --- --- 702 |--- --- --- 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.158 P=0.500N P=0.471N P=0.513 |P=0.159 (e) (e) P=0.391 | |POLY 3 | P=0.156 P=0.514N P=0.495N P=0.483 |P=0.239 (e) (e) P=0.473 | |POLY 1.5 | P=0.158 P=0.510N P=0.498N P=0.489 |P=0.245 (e) (e) P=0.483 | |POLY 6 | P=0.154 P=0.518N P=0.491N P=0.479 |P=0.231 (e) (e) P=0.461 | |LOGISTIC REGRESSION| P=0.147 (e) (e) P=0.483 |(e) (e) (e) P=0.391 | |COCH-ARM / FISHERS | P=0.160 P=0.500N P=0.500N P=0.500 |P=0.257 (e) (e) P=0.500 | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 16 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Skin | | Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous | | Tumor (benign, malignant or NOS), or Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.7% 0.0% 0.0% 5.7% |0.0% 0.0% 2.7% 2.9% | |TERMINAL (d) | 1/13 (8%) 0/13 (0%) 0/15 (0%) 1/13 (8%) |0/19 (0%) 0/17 (0%) 1/21 (5%) 1/11 (9%) | |FIRST INCIDENCE | 733 (T) --- --- 702 |--- --- 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.158 P=0.500N P=0.471N P=0.513 |P=0.302 (e) P=0.520 P=0.391 | |POLY 3 | P=0.156 P=0.514N P=0.495N P=0.483 |P=0.399 (e) P=0.488 P=0.473 | |POLY 1.5 | P=0.158 P=0.510N P=0.498N P=0.489 |P=0.412 (e) P=0.491 P=0.483 | |POLY 6 | P=0.154 P=0.518N P=0.491N P=0.479 |P=0.384 (e) P=0.487 P=0.461 | |LOGISTIC REGRESSION| P=0.147 (e) (e) P=0.483 |(e) (e) P=0.520 P=0.391 | |COCH-ARM / FISHERS | P=0.160 P=0.500N P=0.500N P=0.500 |P=0.436 (e) P=0.500 P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Skin | | Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor | | (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 4/50 (8%) 5/50 (10%) 6/50 (12%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 10.9% 11.4% 13.3% 16.5% |0.0% 0.0% 5.4% 2.9% | |TERMINAL (d) | 3/13 (23%) 2/13 (15%) 3/15 (20%) 2/13 (15%) |0/19 (0%) 0/17 (0%) 2/21 (10%) 1/11 (9%) | |FIRST INCIDENCE | 671 594 702 519 |--- --- 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.295 P=0.617 P=0.582 P=0.354 |P=0.393 (e) P=0.259 P=0.391 | |POLY 3 | P=0.317 P=0.616 P=0.514 P=0.358 |P=0.498 (e) P=0.224 P=0.473 | |POLY 1.5 | P=0.318 P=0.622 P=0.507 P=0.360 |P=0.514 (e) P=0.227 P=0.483 | |POLY 6 | P=0.321 P=0.619 P=0.527 P=0.364 |P=0.478 (e) P=0.221 P=0.461 | |LOGISTIC REGRESSION| P=0.284 P=0.596 P=0.550 P=0.334 |(e) (e) P=0.259 P=0.391 | |COCH-ARM / FISHERS | P=0.319 P=0.643N P=0.500 P=0.370 |P=0.546 (e) P=0.247 P=0.500 | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 17 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Skin | | Fibroma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 8.0% 2.9% 5.3% 2.8% |2.5% 0.0% 5.3% 2.9% | |TERMINAL (d) | 0/13 (0%) 1/13 (8%) 1/15 (7%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 1/21 (5%) 0/11 (0%) | |FIRST INCIDENCE | 566 733 (T) 674 618 |607 --- 684 709 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.420N P=0.337N P=0.474N P=0.336N |P=0.587 P=0.516N P=0.484 P=0.698 | |POLY 3 | P=0.404N P=0.340N P=0.499N P=0.328N |P=0.624 P=0.508N P=0.477 P=0.728 | |POLY 1.5 | P=0.400N P=0.328N P=0.500N P=0.319N |P=0.639 P=0.504N P=0.484 P=0.741 | |POLY 6 | P=0.408N P=0.354N P=0.497N P=0.338N |P=0.605 P=0.512N P=0.473 P=0.712 | |LOGISTIC REGRESSION| P=0.405N P=0.316N P=0.499N P=0.291N |P=0.642 P=0.496N P=0.489 P=0.757 | |COCH-ARM / FISHERS | P=0.398N P=0.309N P=0.500N P=0.309N |P=0.668 P=0.500N P=0.500 P=0.753N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, | | or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 4/50 (8%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 3/50 (6%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 8.0% 5.8% 10.6% 2.8% |2.5% 0.0% 8.0% 2.9% | |TERMINAL (d) | 0/13 (0%) 1/13 (8%) 3/15 (20%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 1/21 (5%) 0/11 (0%) | |FIRST INCIDENCE | 566 548 674 618 |607 --- 647 709 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.264N P=0.530N P=0.544 P=0.336N |P=0.643 P=0.516N P=0.286 P=0.698 | |POLY 3 | P=0.253N P=0.538N P=0.501 P=0.328N |P=0.672 P=0.508N P=0.284 P=0.728 | |POLY 1.5 | P=0.247N P=0.526N P=0.500 P=0.319N |P=0.683N P=0.504N P=0.290 P=0.741 | |POLY 6 | P=0.259N P=0.551N P=0.503 P=0.338N |P=0.651 P=0.512N P=0.282 P=0.712 | |LOGISTIC REGRESSION| P=0.249N P=0.493N P=0.514 P=0.291N |P=0.682N P=0.496N P=0.297 P=0.757 | |COCH-ARM / FISHERS | P=0.242N P=0.500N P=0.500 P=0.309N |P=0.652N P=0.500N P=0.309 P=0.753N | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 18 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Skin | | Fibrosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.9% 5.3% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 2/15 (13%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | --- 548 733 (T) --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.420N P=0.495 P=0.268 (e) |(e) (e) (e) (e) | |POLY 3 | P=0.417N P=0.489 P=0.241 (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.412N P=0.492 P=0.239 (e) |(e) (e) (e) (e) | |POLY 6 | P=0.422N P=0.488 P=0.245 (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.412N P=0.561 P=0.268 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.405N P=0.500 P=0.247 (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.9% 5.3% 0.0% |0.0% 0.0% 2.7% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 2/15 (13%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | --- 548 733 (T) --- |--- --- 647 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.420N P=0.495 P=0.268 (e) |P=0.771N (e) P=0.477 (e) | |POLY 3 | P=0.417N P=0.489 P=0.241 (e) |P=0.761N (e) P=0.490 (e) | |POLY 1.5 | P=0.412N P=0.492 P=0.239 (e) |P=0.754N (e) P=0.492 (e) | |POLY 6 | P=0.422N P=0.488 P=0.245 (e) |P=0.769N (e) P=0.490 (e) | |LOGISTIC REGRESSION| P=0.412N P=0.561 P=0.268 (e) |P=0.744N (e) P=0.503 (e) | |COCH-ARM / FISHERS | P=0.405N P=0.500 P=0.247 (e) |P=0.743N (e) P=0.500 (e) | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 19 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 4/50 (8%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 8.1% 5.8% 10.6% 8.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/13 (15%) 1/13 (8%) 2/15 (13%) 1/13 (8%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 671 621 702 519 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.580 P=0.527N P=0.568 P=0.642 |(e) (e) (e) (e) | |POLY 3 | P=0.603 P=0.531N P=0.512 P=0.652 |(e) (e) (e) (e) | |POLY 1.5 | P=0.602 P=0.522N P=0.506 P=0.654 |(e) (e) (e) (e) | |POLY 6 | P=0.606 P=0.537N P=0.523 P=0.654 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.578 P=0.541N P=0.542 P=0.646 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.601 P=0.500N P=0.500 P=0.661N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 5.8% 2.7% 2.8% |0.0% 0.0% 2.7% 0.0% | |TERMINAL (d) | 0/13 (0%) 1/13 (8%) 1/15 (7%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 1/21 (5%) 0/11 (0%) | |FIRST INCIDENCE | --- 594 733 (T) 621 |--- --- 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.693 P=0.228 P=0.529 P=0.475 |P=0.841N (e) P=0.520 (e) | |POLY 3 | P=0.690 P=0.223 P=0.505 P=0.492 |P=0.761N (e) P=0.488 (e) | |POLY 1.5 | P=0.694 P=0.227 P=0.502 P=0.495 |P=0.754N (e) P=0.491 (e) | |POLY 6 | P=0.688 P=0.221 P=0.509 P=0.491 |P=0.769N (e) P=0.487 (e) | |LOGISTIC REGRESSION| P=0.696 P=0.226 P=0.529 P=0.509 |(e) (e) P=0.520 (e) | |COCH-ARM / FISHERS | P=0.702 P=0.247 P=0.500 P=0.500 |P=0.743N (e) P=0.500 (e) | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 20 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 4/50 (8%) 5/50 (10%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 8.1% 11.4% 13.3% 11.0% |0.0% 0.0% 2.7% 0.0% | |TERMINAL (d) | 2/13 (15%) 2/13 (15%) 3/15 (20%) 1/13 (8%) |0/19 (0%) 0/17 (0%) 1/21 (5%) 0/11 (0%) | |FIRST INCIDENCE | 671 594 702 519 |--- --- 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.561 P=0.468 P=0.428 P=0.471 |P=0.841N (e) P=0.520 (e) | |POLY 3 | P=0.587 P=0.471 P=0.366 P=0.491 |P=0.761N (e) P=0.488 (e) | |POLY 1.5 | P=0.586 P=0.477 P=0.361 P=0.492 |P=0.754N (e) P=0.491 (e) | |POLY 6 | P=0.594 P=0.470 P=0.374 P=0.497 |P=0.769N (e) P=0.487 (e) | |LOGISTIC REGRESSION| P=0.561 P=0.454 P=0.393 P=0.484 |(e) (e) P=0.520 (e) | |COCH-ARM / FISHERS | P=0.586 P=0.500 P=0.357 P=0.500 |P=0.743N (e) P=0.500 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, or Keratoacanthoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 4/50 (8%) 5/50 (10%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 8.1% 11.4% 13.3% 11.0% |0.0% 0.0% 2.7% 0.0% | |TERMINAL (d) | 2/13 (15%) 2/13 (15%) 3/15 (20%) 1/13 (8%) |0/19 (0%) 0/17 (0%) 1/21 (5%) 0/11 (0%) | |FIRST INCIDENCE | 671 594 702 519 |--- --- 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.561 P=0.468 P=0.428 P=0.471 |P=0.841N (e) P=0.520 (e) | |POLY 3 | P=0.587 P=0.471 P=0.366 P=0.491 |P=0.761N (e) P=0.488 (e) | |POLY 1.5 | P=0.586 P=0.477 P=0.361 P=0.492 |P=0.754N (e) P=0.491 (e) | |POLY 6 | P=0.594 P=0.470 P=0.374 P=0.497 |P=0.769N (e) P=0.487 (e) | |LOGISTIC REGRESSION| P=0.561 P=0.454 P=0.393 P=0.484 |(e) (e) P=0.520 (e) | |COCH-ARM / FISHERS | P=0.586 P=0.500 P=0.357 P=0.500 |P=0.743N (e) P=0.500 (e) | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 21 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Testes | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 45/50 (90%) 40/50 (80%) 46/50 (92%) 41/50 (82%) | | |POLY-3 ADJUSTED (b)| 95.5% 90.1% 95.5% 90.9% | | |TERMINAL (d) | 13/13 (100%) 12/13 (92%) 15/15 (100%) 13/13 (100%)| | |FIRST INCIDENCE | 506 524 394 422 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.516N P=0.443N P=0.409N P=0.465N | | |POLY 3 | P=0.345N P=0.227N P=0.742N P=0.269N | | |POLY 1.5 | P=0.284N P=0.199N P=0.643 P=0.228N | | |POLY 6 | P=0.473N P=0.237N P=0.841N P=0.357N | | |LOGISTIC REGRESSION| P=0.321N P=0.314N P=0.511 P=0.337N | | |COCH-ARM / FISHERS | P=0.267N P=0.131N P=0.500 P=0.194N | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/46 (7%) 5/46 (11%) 6/49 (12%) 2/50 (4%) |7/50 (14%) 4/49 (8%) 4/48 (8%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 8.7% 14.6% 15.5% 5.7% |17.5% 10.5% 10.8% 2.9% | |TERMINAL (d) | 1/13 (8%) 1/13 (8%) 2/15 (13%) 0/13 (0%) |3/19 (16%) 2/17 (12%) 2/21 (10%) 0/11 (0%) | |FIRST INCIDENCE | 645 393 562 645 |677 700 630 703 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.227N P=0.334 P=0.290 P=0.523N |P=0.137N P=0.300N P=0.271N P=0.101N | |POLY 3 | P=0.202N P=0.350 P=0.299 P=0.489N |P=0.078N P=0.286N P=0.306N P=0.048N* | |POLY 1.5 | P=0.189N P=0.351 P=0.287 P=0.478N |P=0.069N P=0.280N P=0.302N P=0.042N* | |POLY 6 | P=0.217N P=0.350 P=0.318 P=0.501N |P=0.091N P=0.293N P=0.306N P=0.058N | |LOGISTIC REGRESSION| P=0.179N P=0.347 P=0.278 P=0.502N |P=0.086N P=0.283N P=0.312N P=0.062N | |COCH-ARM / FISHERS | P=0.172N P=0.357 P=0.276 P=0.460N |P=0.057N P=0.274N P=0.286N P=0.032N* | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 22 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/46 (0%) 3/46 (7%) 2/49 (4%) 1/50 (2%) |2/50 (4%) 1/49 (2%) 2/48 (4%) 3/49 (6%) | |POLY-3 ADJUSTED (b)| 0.0% 9.0% 5.4% 2.8% |5.0% 2.6% 5.5% 8.7% | |TERMINAL (d) | 0/13 (0%) 1/13 (8%) 0/15 (0%) 0/13 (0%) |1/19 (5%) 1/17 (6%) 1/21 (5%) 1/11 (9%) | |FIRST INCIDENCE | --- 614 660 615 |684 734 (T) 605 632 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.530N P=0.110 P=0.258 P=0.482 |P=0.179 P=0.518N P=0.692 P=0.353 | |POLY 3 | P=0.503N P=0.112 P=0.257 P=0.507 |P=0.275 P=0.516N P=0.667 P=0.436 | |POLY 1.5 | P=0.493N P=0.114 P=0.254 P=0.510 |P=0.291 P=0.512N P=0.669 P=0.455 | |POLY 6 | P=0.513N P=0.111 P=0.261 P=0.503 |P=0.258 P=0.520N P=0.667 P=0.415 | |LOGISTIC REGRESSION| P=0.498N P=0.112 P=0.257 P=0.529 |P=0.260 P=0.515N P=0.667 P=0.417 | |COCH-ARM / FISHERS | P=0.477N P=0.121 P=0.263 P=0.521 |P=0.320 P=0.508N P=0.676 P=0.490 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/46 (7%) 8/46 (17%) 8/49 (16%) 3/50 (6%) |9/50 (18%) 5/49 (10%) 6/48 (13%) 4/49 (8%) | |POLY-3 ADJUSTED (b)| 8.7% 23.0% 20.5% 8.4% |22.4% 13.1% 16.1% 11.6% | |TERMINAL (d) | 1/13 (8%) 2/13 (15%) 2/15 (13%) 0/13 (0%) |4/19 (21%) 3/17 (18%) 3/21 (14%) 1/11 (9%) | |FIRST INCIDENCE | 645 393 562 615 |677 700 605 632 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.201N P=0.093 P=0.139 P=0.633 |P=0.456N P=0.232N P=0.299N P=0.316N | |POLY 3 | P=0.161N P=0.093 P=0.136 P=0.649N |P=0.277N P=0.218N P=0.338N P=0.176N | |POLY 1.5 | P=0.151N P=0.094 P=0.128 P=0.639N |P=0.252N P=0.211N P=0.335N P=0.156N | |POLY 6 | P=0.173N P=0.092 P=0.151 P=0.658N |P=0.308N P=0.226N P=0.336N P=0.202N | |LOGISTIC REGRESSION| P=0.148N P=0.091 P=0.124 P=0.656N |P=0.309N P=0.211N P=0.351N P=0.210N | |COCH-ARM / FISHERS | P=0.137N P=0.099 P=0.120 P=0.621N |P=0.211N P=0.205N P=0.318N P=0.125N | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 23 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/46 (2%) 0/46 (0%) 0/49 (0%) 0/50 (0%) |2/50 (4%) 0/49 (0%) 0/48 (0%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 2.9% 0.0% 0.0% 0.0% |5.0% 0.0% 0.0% 2.9% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |1/19 (5%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 688 --- --- --- |660 --- --- 631 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.662N P=0.490N P=0.471N P=0.490N |P=0.596 P=0.262N P=0.242N P=0.597N | |POLY 3 | P=0.653N P=0.508N P=0.484N P=0.497N |P=0.630 P=0.247N P=0.257N P=0.551N | |POLY 1.5 | P=0.650N P=0.505N P=0.486N P=0.491N |P=0.637 P=0.245N P=0.254N P=0.535N | |POLY 6 | P=0.656N P=0.513N P=0.483N P=0.504N |P=0.621 P=0.250N P=0.260N P=0.569N | |LOGISTIC REGRESSION| P=0.662N P=0.509N P=0.482N P=0.500N |P=0.636 P=0.247N P=0.256N P=0.538N | |COCH-ARM / FISHERS | P=0.647N P=0.500N P=0.484N P=0.479N |P=0.652 P=0.253N P=0.258N P=0.508N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/46 (2%) 0/46 (0%) 0/49 (0%) 0/50 (0%) |2/50 (4%) 1/49 (2%) 1/48 (2%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 2.9% 0.0% 0.0% 0.0% |5.0% 2.6% 2.8% 5.8% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |1/19 (5%) 1/17 (6%) 1/21 (5%) 0/11 (0%) | |FIRST INCIDENCE | 688 --- --- --- |660 734 (T) 734 (T) 631 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.662N P=0.490N P=0.471N P=0.490N |P=0.372 P=0.536N P=0.491N P=0.600 | |POLY 3 | P=0.653N P=0.508N P=0.484N P=0.497N |P=0.461 P=0.517N P=0.532N P=0.643 | |POLY 1.5 | P=0.650N P=0.505N P=0.486N P=0.491N |P=0.475 P=0.512N P=0.527N P=0.658 | |POLY 6 | P=0.656N P=0.513N P=0.483N P=0.504N |P=0.446 P=0.522N P=0.537N P=0.626 | |LOGISTIC REGRESSION| P=0.662N P=0.509N P=0.482N P=0.500N |P=0.443 P=0.516N P=0.531N P=0.654 | |COCH-ARM / FISHERS | P=0.647N P=0.500N P=0.484N P=0.479N |P=0.501 P=0.508N P=0.515N P=0.684 | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 24 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Tongue | | Squamous Cell Carcinoma or Papilloma Squamous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.3% 0.0% 2.7% 2.9% |0.0% 0.0% 2.7% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 1/21 (5%) 0/11 (0%) | |FIRST INCIDENCE | 506 --- 702 702 |--- --- 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.698N P=0.275N P=0.482N P=0.510N |P=0.841N (e) P=0.520 (e) | |POLY 3 | P=0.704N P=0.258N P=0.499N P=0.525N |P=0.761N (e) P=0.488 (e) | |POLY 1.5 | P=0.702N P=0.251N P=0.500N P=0.515N |P=0.754N (e) P=0.491 (e) | |POLY 6 | P=0.708N P=0.266N P=0.497N P=0.536N |P=0.769N (e) P=0.487 (e) | |LOGISTIC REGRESSION| P=0.702N P=0.196N P=0.507N P=0.486N |(e) (e) P=0.520 (e) | |COCH-ARM / FISHERS | P=0.702N P=0.247N P=0.500N P=0.500N |P=0.743N (e) P=0.500 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |7/50 (14%) 6/50 (12%) 6/50 (12%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| |17.4% 15.1% 15.6% 5.7% | |TERMINAL (d) | |3/19 (16%) 1/17 (6%) 3/21 (14%) 1/11 (9%) | |FIRST INCIDENCE | |589 585 534 422 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.164N P=0.533N P=0.494N P=0.210N | |POLY 3 | |P=0.098N P=0.512N P=0.536N P=0.111N | |POLY 1.5 | |P=0.085N P=0.507N P=0.528N P=0.098N | |POLY 6 | |P=0.121N P=0.510N P=0.538N P=0.131N | |LOGISTIC REGRESSION| |P=0.080N P=0.517N P=0.537N P=0.100N | |COCH-ARM / FISHERS | |P=0.067N P=0.500N P=0.500N P=0.080N | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 25 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |All Organs | | Hemangioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 5.7% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | --- --- --- 668 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.042 * (e) (e) P=0.224 |(e) (e) (e) (e) | |POLY 3 | P=0.043 * (e) (e) P=0.227 |(e) (e) (e) (e) | |POLY 1.5 | P=0.044 * (e) (e) P=0.230 |(e) (e) (e) (e) | |POLY 6 | P=0.043 * (e) (e) P=0.225 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.041 * (e) (e) P=0.223 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.046 * (e) (e) P=0.247 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.7% 5.7% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | --- --- 678 668 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.119 (e) P=0.508 P=0.224 |(e) (e) (e) (e) | |POLY 3 | P=0.126 (e) P=0.506 P=0.227 |(e) (e) (e) (e) | |POLY 1.5 | P=0.127 (e) P=0.503 P=0.230 |(e) (e) (e) (e) | |POLY 6 | P=0.126 (e) P=0.511 P=0.225 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.118 (e) P=0.505 P=0.223 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.128 (e) P=0.500 P=0.247 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 26 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.6% 0.0% |0.0% 5.1% 2.7% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | --- --- 443 --- |--- 559 678 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.746N (e) P=0.500 (e) |P=0.396N P=0.223 P=0.465 (e) | |POLY 3 | P=0.745N (e) P=0.509 (e) |P=0.390N P=0.236 P=0.489 (e) | |POLY 1.5 | P=0.743N (e) P=0.505 (e) |P=0.377N P=0.237 P=0.492 (e) | |POLY 6 | P=0.746N (e) P=0.515 (e) |P=0.405N P=0.237 P=0.489 (e) | |LOGISTIC REGRESSION| P=0.769N (e) P=0.454 (e) |P=0.327N P=0.236 P=0.493 (e) | |COCH-ARM / FISHERS | P=0.743N (e) P=0.500 (e) |P=0.358N P=0.247 P=0.500 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or | | Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 19/50 (38%) 28/50 (56%) 33/50 (66%) 28/50 (56%) |22/50 (44%) 21/50 (42%) 18/50 (36%) 33/50 (66%) | |POLY-3 ADJUSTED (b)| 45.6% 65.9% 73.1% 66.4% |51.7% 48.2% 42.2% 73.7% | |TERMINAL (d) | 4/13 (31%) 7/13 (54%) 12/15 (80%) 7/13 (54%) |11/19 (58%) 5/17 (29%) 5/21 (24%) 6/11 (55%) | |FIRST INCIDENCE | 506 350 450 520 |506 497 310 418 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.309 P=0.070 P=0.047 * P=0.077 |P<0.001 ** P=0.540 P=0.317N P=0.003 ** | |POLY 3 | P=0.288 P=0.038 * P=0.004 ** P=0.034 * |P<0.001 ** P=0.456N P=0.248N P=0.021 * | |POLY 1.5 | P=0.306 P=0.040 * P=0.004 ** P=0.039 * |P<0.001 ** P=0.475N P=0.263N P=0.017 * | |POLY 6 | P=0.294 P=0.039 * P=0.006 ** P=0.036 * |P=0.002 ** P=0.417N P=0.221N P=0.033 * | |LOGISTIC REGRESSION| P=0.327 P=0.047 * P=0.005 ** P=0.043 * |P=0.002 ** P=0.520N P=0.290N P=0.012 * | |COCH-ARM / FISHERS | P=0.347 P=0.054 P=0.004 ** P=0.054 |P=0.002 ** P=0.500N P=0.270N P=0.022 * | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 27 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Benign, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.3% 5.8% 2.7% 2.9% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 1/13 (8%) 0/15 (0%) 1/13 (8%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 599 534 680 733 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.489N P=0.659 P=0.484N P=0.523N |(e) (e) (e) (e) | |POLY 3 | P=0.485N P=0.668 P=0.497N P=0.525N |(e) (e) (e) (e) | |POLY 1.5 | P=0.475N P=0.676 P=0.499N P=0.515N |(e) (e) (e) (e) | |POLY 6 | P=0.498N P=0.661 P=0.495N P=0.538N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.466N P=0.686N P=0.503N P=0.509N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.463N P=0.691N P=0.500N P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |All Organs | | Osteosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.7% 0.0% 5.2% 2.9% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 1/13 (8%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 567 --- 562 733 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.643 P=0.510N P=0.512 P=0.752 |(e) (e) (e) (e) | |POLY 3 | P=0.666 P=0.517N P=0.511 P=0.747 |(e) (e) (e) (e) | |POLY 1.5 | P=0.668 P=0.512N P=0.506 P=0.752 |(e) (e) (e) (e) | |POLY 6 | P=0.663 P=0.523N P=0.521 P=0.742 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.671 P=0.454N P=0.489 P=0.761 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.668 P=0.500N P=0.500 P=0.753N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 28 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |All Organs | | Osteosarcoma or Osteoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.7% 0.0% 5.2% 2.9% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 1/13 (8%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 567 --- 562 733 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.643 P=0.510N P=0.512 P=0.752 |(e) (e) (e) (e) | |POLY 3 | P=0.666 P=0.517N P=0.511 P=0.747 |(e) (e) (e) (e) | |POLY 1.5 | P=0.668 P=0.512N P=0.506 P=0.752 |(e) (e) (e) (e) | |POLY 6 | P=0.663 P=0.523N P=0.521 P=0.742 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.671 P=0.454N P=0.489 P=0.761 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.668 P=0.500N P=0.500 P=0.753N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 50/50 (100%) 47/50 (94%) 49/50 (98%) 46/50 (92%) |48/50 (96%) 46/50 (92%) 43/50 (86%) 43/50 (86%) | |POLY-3 ADJUSTED (b)| 100.0% 99.6% 99.1% 96.8% |99.7% 97.7% 93.9% 94.2% | |TERMINAL (d) | 13/13 (100%) 13/13 (100%) 15/15 (100%) 13/13 (100%)|19/19 (100%) 17/17 (100%) 21/21 (100%) 10/11 (91%) | |FIRST INCIDENCE | 338 393 394 422 |497 422 339 418 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.518N P=0.531 P=0.319N P=0.488N |P=0.064 P=0.493 P=0.288N P=0.136 | |POLY 3 | P=0.116N P=1.000N P=0.891N P=0.276N |P=0.205N P=0.533N P=0.104N P=0.123N | |POLY 1.5 | P=0.073N P=0.700N P=0.689N P=0.141N |P=0.193N P=0.331N P=0.074N P=0.084N | |POLY 6 | P=0.258N P=1.000N P=1.000N P=0.498N |P=0.215N P=1.000N P=0.179N P=0.211N | |LOGISTIC REGRESSION| P=0.066N P=0.395N P=0.489N P=0.089N |P=0.459N P=0.331N P=0.164N P=0.247N | |COCH-ARM / FISHERS | P=0.104N P=0.121N P=0.500N P=0.059N |P=0.164N P=0.339N P=0.080N P=0.080N | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 29 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 30/50 (60%) 38/50 (76%) 41/50 (82%) 34/50 (68%) |28/50 (56%) 28/50 (56%) 32/50 (64%) 38/50 (76%) | |POLY-3 ADJUSTED (b)| 67.2% 81.8% 85.9% 77.8% |63.9% 61.5% 72.4% 82.6% | |TERMINAL (d) | 8/13 (62%) 10/13 (77%) 12/15 (80%) 9/13 (69%) |13/19 (68%) 8/17 (47%) 15/21 (71%) 7/11 (64%) | |FIRST INCIDENCE | 506 204 443 520 |506 478 310 418 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.534N P=0.109 P=0.171 P=0.261 |P<0.001 ** P=0.452 P=0.315 P=0.004 ** | |POLY 3 | P=0.567 P=0.070 P=0.020 * P=0.171 |P=0.014 * P=0.495N P=0.251 P=0.028 * | |POLY 1.5 | P=0.521N P=0.065 P=0.015 * P=0.200 |P=0.011 * P=0.530N P=0.250 P=0.021 * | |POLY 6 | P=0.516 P=0.078 P=0.032 * P=0.159 |P=0.023 * P=0.443N P=0.269 P=0.051 | |LOGISTIC REGRESSION| P=0.401N P=0.070 P=0.014 * P=0.220 |P=0.010 * P=0.565 P=0.204 P=0.012 * | |COCH-ARM / FISHERS | P=0.389N P=0.066 P=0.013 * P=0.266 |P=0.017 * P=0.580N P=0.270 P=0.028 * | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 50/50 (100%) 49/50 (98%) 50/50 (100%) 48/50 (96%) |48/50 (96%) 49/50 (98%) 49/50 (98%) 47/50 (94%) | |POLY-3 ADJUSTED (b)| 100.0% 99.9% 100.0% 99.4% |99.7% 99.8% 100.0% 99.7% | |TERMINAL (d) | 13/13 (100%) 13/13 (100%) 15/15 (100%) 13/13 (100%)|19/19 (100%) 17/17 (100%) 21/21 (100%) 11/11 (100%) | |FIRST INCIDENCE | 338 204 394 422 |497 422 310 418 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.495 P=0.436 (e) P=0.512 |P=0.041 * P=0.342 P=0.485 P=0.050 | |POLY 3 | P=0.999N P=1.000N (e) P=1.000N |P=1.000N P=1.000 P=1.000 P=1.000 | |POLY 1.5 | P=0.506N P=0.996N (e) P=0.705N |P=0.809N P=0.937 P=0.927 P=0.948N | |POLY 6 | P=1.000N P=1.000N (e) P=1.000N |P=1.000N P=1.000 P=1.000 P=1.000 | |LOGISTIC REGRESSION| P=0.075N P=0.848N (e) P=0.294N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.156N P=0.500N (e) P=0.247N |P=0.255N P=0.500 P=0.500 P=0.500N | |=================================================================================================================================| (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).