TDMS Study 88124-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest INDIUM PHOSPHIDE DATE: 10/28/99 EXPERIMENT: 88124 TEST: 03 TIME: 14:03:52 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C88124 PATHOLOGIST: GRUMBEIN, S. CAS: 22398-80-7 ------------------------------------------------------------------------------------------------------------------------------------ FINAL#1 CORE STUDY RATS REASONS FOR REMOVAL: 25022 Accidently Killed 25019 Moribund Sacrifice 25020 Natural Death 25021 Terminal Sacrifice REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest INDIUM PHOSPHIDE DATE: 10/28/99 EXPERIMENT: 88124 TEST: 03 TIME: 14:03:52 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C88124 PATHOLOGIST: GRUMBEIN, S. CAS: 22398-80-7 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 Cortex Adrenal Medulla Brain Clitoral/Preputial Gland Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Prostate Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest INDIUM PHOSPHIDE DATE: 10/28/99 EXPERIMENT: 88124 TEST: 03 TIME: 14:03:52 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C88124 PATHOLOGIST: GRUMBEIN, S. CAS: 22398-80-7 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF INDIUM PHOSPHIDE =============================================================== Male Rats ------------ Organ Morphology ----- ---------- Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma: Benign, Complex, Malignant, NOS Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Squamous Cell Carcinoma Pituitary Gland: Pars Distalis or Unspecified Site Carcinoma or Adenoma Skin Fibroma Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma Testes Adenoma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Malignant Tumors =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma: Benign, Complex, Malignant, NOS Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Mammary Gland Carcinoma Fibroadenoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma Oral Mucosa Squamous Cell Carcinoma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated =============================================================== Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 1 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/50 (20%) 22/50 (44%) 16/49 (33%) 23/50 (46%) |2/50 (4%) 6/48 (13%) 2/50 (4%) 9/49 (18%) | |POLY-3 ADJUSTED (b)| 23.8% 48.8% 38.0% 51.1% |4.6% 14.5% 4.5% 20.6% | |TERMINAL (d) | 6/27 (22%) 17/29 (59%) 11/28 (39%) 15/26 (58%) |1/34 (3%) 4/31 (13%) 2/36 (6%) 6/34 (18%) | |FIRST INCIDENCE | 537 635 537 525 |615 686 735 (T) 588 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.026 * P=0.022 * P=0.163 P=0.008 ** |P=0.031 * P=0.124 P=0.674N P=0.031 * | |POLY 3 | P=0.044 * P=0.011 * P=0.117 P=0.006 ** |P=0.026 * P=0.119 P=0.682N P=0.026 * | |POLY 1.5 | P=0.042 * P=0.010 * P=0.118 P=0.006 ** |P=0.027 * P=0.117 P=0.686N P=0.025 * | |POLY 6 | P=0.045 * P=0.013 * P=0.119 P=0.006 ** |P=0.026 * P=0.123 P=0.678N P=0.025 * | |LOGISTIC REGRESSION| P=0.038 * P=0.018 * P=0.123 P=0.007 ** |P=0.028 * P=0.120 P=0.687N P=0.027 * | |COCH-ARM / FISHERS | P=0.036 * P=0.009 ** P=0.115 P=0.005 ** |P=0.026 * P=0.121 P=0.691N P=0.023 * | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 3/49 (6%) 1/50 (2%) |0/50 (0%) 0/48 (0%) 0/50 (0%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 6.8% 7.4% 2.3% |0.0% 0.0% 0.0% 2.3% | |TERMINAL (d) | 0/27 (0%) 2/29 (7%) 2/28 (7%) 0/26 (0%) |0/34 (0%) 0/31 (0%) 0/36 (0%) 1/34 (3%) | |FIRST INCIDENCE | --- 628 698 684 |--- --- --- 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.576N P=0.142 P=0.129 P=0.506 |P=0.218 (e) (e) P=0.500 | |POLY 3 | P=0.526N P=0.136 P=0.119 P=0.511 |P=0.217 (e) (e) P=0.501 | |POLY 1.5 | P=0.531N P=0.130 P=0.118 P=0.508 |P=0.218 (e) (e) P=0.501 | |POLY 6 | P=0.524N P=0.144 P=0.120 P=0.513 |P=0.216 (e) (e) P=0.500 | |LOGISTIC REGRESSION| P=0.544N P=0.129 P=0.121 P=0.503 |(e) (e) (e) P=0.500 | |COCH-ARM / FISHERS | P=0.549N P=0.121 P=0.117 P=0.500 |P=0.213 (e) (e) P=0.495 | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 2 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/50 (20%) 26/50 (52%) 18/49 (37%) 24/50 (48%) |2/50 (4%) 6/48 (13%) 2/50 (4%) 9/49 (18%) | |POLY-3 ADJUSTED (b)| 23.8% 57.1% 42.6% 53.1% |4.6% 14.5% 4.5% 20.6% | |TERMINAL (d) | 6/27 (22%) 19/29 (66%) 12/28 (43%) 15/26 (58%) |1/34 (3%) 4/31 (13%) 2/36 (6%) 6/34 (18%) | |FIRST INCIDENCE | 537 628 537 525 |615 686 735 (T) 588 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.041 * P=0.004 ** P=0.086 P=0.005 ** |P=0.031 * P=0.124 P=0.674N P=0.031 * | |POLY 3 | P=0.070 P<0.001 ** P=0.051 P=0.003 ** |P=0.026 * P=0.119 P=0.682N P=0.026 * | |POLY 1.5 | P=0.065 P<0.001 ** P=0.052 P=0.003 ** |P=0.027 * P=0.117 P=0.686N P=0.025 * | |POLY 6 | P=0.074 P<0.001 ** P=0.052 P=0.003 ** |P=0.026 * P=0.123 P=0.678N P=0.025 * | |LOGISTIC REGRESSION| P=0.058 P=0.002 ** P=0.056 P=0.004 ** |P=0.028 * P=0.120 P=0.687N P=0.027 * | |COCH-ARM / FISHERS | P=0.055 P<0.001 ** P=0.052 P=0.003 ** |P=0.026 * P=0.121 P=0.691N P=0.023 * | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Bone | | Osteosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 7.2% 0.0% 2.4% 2.3% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/29 (0%) 0/26 (0%) |0/34 (0%) 0/31 (0%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | 408 --- 435 671 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.434N P=0.109N P=0.296N P=0.284N |(e) (e) (e) (e) | |POLY 3 | P=0.453N P=0.110N P=0.302N P=0.298N |(e) (e) (e) (e) | |POLY 1.5 | P=0.448N P=0.113N P=0.301N P=0.298N |(e) (e) (e) (e) | |POLY 6 | P=0.460N P=0.107N P=0.303N P=0.301N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.573N P=0.169N P=0.398N P=0.407N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.442N P=0.121N P=0.309N P=0.309N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 3 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Bone | | Osteosarcoma or Osteoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 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)| 7.2% 0.0% 4.7% 2.3% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/29 (0%) 0/26 (0%) |0/34 (0%) 0/31 (0%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | 408 --- 435 671 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.428N P=0.109N P=0.487N P=0.284N |(e) (e) (e) (e) | |POLY 3 | P=0.447N P=0.110N P=0.494N P=0.298N |(e) (e) (e) (e) | |POLY 1.5 | P=0.441N P=0.113N P=0.494N P=0.298N |(e) (e) (e) (e) | |POLY 6 | P=0.455N P=0.107N P=0.494N P=0.301N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.550N P=0.169N P=0.596N P=0.407N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.437N P=0.121N P=0.500N P=0.309N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |5/49 (10%) 4/47 (9%) 4/47 (9%) 6/49 (12%) | |POLY-3 ADJUSTED (b)| 2.5% 4.5% 0.0% 0.0% |12.0% 10.2% 9.5% 14.0% | |TERMINAL (d) | 1/27 (4%) 2/29 (7%) 0/29 (0%) 0/26 (0%) |5/33 (15%) 4/29 (14%) 4/35 (11%) 6/34 (18%) | |FIRST INCIDENCE | 733 (T) 733 (T) --- --- |735 (T) 735 (T) 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.218N P=0.525 P=0.486N P=0.508N |P=0.411 P=0.582N P=0.463N P=0.521 | |POLY 3 | P=0.202N P=0.530 P=0.495N P=0.490N |P=0.395 P=0.538N P=0.492N P=0.520 | |POLY 1.5 | P=0.204N P=0.519 P=0.496N P=0.492N |P=0.394 P=0.539N P=0.505N P=0.518 | |POLY 6 | P=0.201N P=0.542 P=0.493N P=0.489N |P=0.392 P=0.538N P=0.477N P=0.520 | |LOGISTIC REGRESSION| P=0.218N P=0.525 (e) (e) |P=0.411 P=0.582N P=0.463N P=0.521 | |COCH-ARM / FISHERS | P=0.209N P=0.500 P=0.500N P=0.500N |P=0.371 P=0.527N P=0.527N P=0.500 | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 4 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/49 (0%) 3/47 (6%) 3/47 (6%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 4.8% 0.0% 2.4% 0.0% |0.0% 7.4% 7.1% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/29 (0%) 1/29 (3%) 0/26 (0%) |0/33 (0%) 1/29 (3%) 3/35 (9%) 0/34 (0%) | |FIRST INCIDENCE | 537 --- 733 (T) --- |--- 428 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.274N P=0.219N P=0.483N P=0.227N |P=0.274N P=0.116 P=0.131 (e) | |POLY 3 | P=0.280N P=0.223N P=0.499N P=0.231N |P=0.272N P=0.113 P=0.120 (e) | |POLY 1.5 | P=0.276N P=0.228N P=0.497N P=0.231N |P=0.273N P=0.111 P=0.117 (e) | |POLY 6 | P=0.286N P=0.219N P=0.501N P=0.233N |P=0.272N P=0.115 P=0.125 (e) | |LOGISTIC REGRESSION| P=0.289N P=0.287N P=0.519N P=0.292N |P=0.304N P=0.128 P=0.131 (e) | |COCH-ARM / FISHERS | P=0.271N P=0.247N P=0.500N P=0.247N |P=0.286N P=0.113 P=0.113 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |5/49 (10%) 7/47 (15%) 7/47 (15%) 6/49 (12%) | |POLY-3 ADJUSTED (b)| 7.3% 4.5% 2.4% 0.0% |12.0% 17.3% 16.6% 14.0% | |TERMINAL (d) | 1/27 (4%) 2/29 (7%) 1/29 (3%) 0/26 (0%) |5/33 (15%) 5/29 (17%) 7/35 (20%) 6/34 (18%) | |FIRST INCIDENCE | 537 733 (T) 733 (T) --- |735 (T) 428 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.091N P=0.464N P=0.289N P=0.119N |P=0.526N P=0.306 P=0.419 P=0.521 | |POLY 3 | P=0.087N P=0.471N P=0.304N P=0.113N |P=0.554N P=0.359 P=0.387 P=0.520 | |POLY 1.5 | P=0.086N P=0.480N P=0.302N P=0.114N |P=0.551N P=0.350 P=0.373 P=0.518 | |POLY 6 | P=0.089N P=0.463N P=0.305N P=0.115N |P=0.560N P=0.368 P=0.404 P=0.520 | |LOGISTIC REGRESSION| P=0.086N P=0.508N P=0.310N P=0.136N |P=0.545N P=0.340 P=0.419 P=0.521 | |COCH-ARM / FISHERS | P=0.086N P=0.500N P=0.309N P=0.121N |P=0.572 P=0.350 P=0.350 P=0.500 | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 5 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Heart | | Schwannoma Benign | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 2.5% 0.0% 0.0% 2.4% |0.0% 2.4% 0.0% 4.7% | |TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/29 (0%) 1/26 (4%) |0/34 (0%) 1/31 (3%) 0/36 (0%) 2/34 (6%) | |FIRST INCIDENCE | 672 --- --- 733 (T) |--- 735 (T) --- 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.529 P=0.463N P=0.506N P=0.755N |P=0.156 P=0.482 (e) P=0.238 | |POLY 3 | P=0.529 P=0.484N P=0.496N P=0.751N |P=0.151 P=0.498 (e) P=0.238 | |POLY 1.5 | P=0.533 P=0.489N P=0.497N P=0.753N |P=0.152 P=0.497 (e) P=0.238 | |POLY 6 | P=0.523 P=0.478N P=0.495N P=0.752N |P=0.150 P=0.498 (e) P=0.237 | |LOGISTIC REGRESSION| P=0.539 P=0.505N P=0.500N P=0.753N |(e) P=0.482 (e) P=0.238 | |COCH-ARM / FISHERS | P=0.536 P=0.500N P=0.500N P=0.753N |P=0.151 P=0.500 (e) P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 3/50 (6%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 2.5% 4.5% 4.8% 7.0% |2.3% 0.0% 0.0% 2.3% | |TERMINAL (d) | 1/27 (4%) 1/29 (3%) 2/29 (7%) 2/26 (8%) |1/34 (3%) 0/31 (0%) 0/36 (0%) 1/34 (3%) | |FIRST INCIDENCE | 733 (T) 701 733 (T) 658 |735 (T) --- --- 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.246 P=0.534 P=0.525 P=0.310 |P=0.544 P=0.518N P=0.489N P=0.762 | |POLY 3 | P=0.279 P=0.531 P=0.509 P=0.325 |P=0.539 P=0.502N P=0.491N P=0.760N | |POLY 1.5 | P=0.279 P=0.520 P=0.507 P=0.320 |P=0.539 P=0.503N P=0.494N P=0.760N | |POLY 6 | P=0.278 P=0.544 P=0.512 P=0.328 |P=0.537 P=0.502N P=0.488N P=0.760N | |LOGISTIC REGRESSION| P=0.266 P=0.547 P=0.525 P=0.323 |P=0.544 (e) (e) P=0.762 | |COCH-ARM / FISHERS | P=0.269 P=0.500 P=0.500 P=0.309 |P=0.532 P=0.500N P=0.500N P=0.747 | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 6 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 4/50 (8%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 4.9% 0.0% 9.5% 7.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/29 (0%) 2/29 (7%) 1/26 (4%) |0/34 (0%) 0/31 (0%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | 617 --- 649 684 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.240 P=0.214N P=0.366 P=0.501 |(e) (e) (e) (e) | |POLY 3 | P=0.246 P=0.221N P=0.349 P=0.519 |(e) (e) (e) (e) | |POLY 1.5 | P=0.250 P=0.226N P=0.346 P=0.516 |(e) (e) (e) (e) | |POLY 6 | P=0.238 P=0.216N P=0.353 P=0.520 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.252 P=0.249N P=0.341 P=0.510 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.249 P=0.247N P=0.339 P=0.500 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 6/50 (12%) 6/50 (12%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 7.3% 4.5% 14.3% 14.0% |2.3% 0.0% 0.0% 2.3% | |TERMINAL (d) | 1/27 (4%) 1/29 (3%) 4/29 (14%) 3/26 (12%) |1/34 (3%) 0/31 (0%) 0/36 (0%) 1/34 (3%) | |FIRST INCIDENCE | 617 701 649 658 |735 (T) --- --- 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.113 P=0.452N P=0.278 P=0.253 |P=0.544 P=0.518N P=0.489N P=0.762 | |POLY 3 | P=0.126 P=0.465N P=0.253 P=0.265 |P=0.539 P=0.502N P=0.491N P=0.760N | |POLY 1.5 | P=0.128 P=0.477N P=0.251 P=0.260 |P=0.539 P=0.503N P=0.494N P=0.760N | |POLY 6 | P=0.122 P=0.454N P=0.257 P=0.267 |P=0.537 P=0.502N P=0.488N P=0.760N | |LOGISTIC REGRESSION| P=0.127 P=0.478N P=0.253 P=0.263 |P=0.544 (e) (e) P=0.762 | |COCH-ARM / FISHERS | P=0.124 P=0.500N P=0.243 P=0.243 |P=0.532 P=0.500N P=0.500N P=0.747 | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 7 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 13/50 (26%) 27/50 (54%) 30/50 (60%) |0/50 (0%) 7/50 (14%) 5/50 (10%) 19/50 (38%) | |POLY-3 ADJUSTED (b)| 14.8% 29.1% 62.9% 67.0% |0.0% 16.5% 11.2% 43.6% | |TERMINAL (d) | 4/27 (15%) 8/29 (28%) 21/29 (72%) 20/26 (77%) |0/34 (0%) 5/31 (16%) 5/36 (14%) 17/34 (50%) | |FIRST INCIDENCE | 697 685 644 525 |--- 694 735 (T) 610 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.106 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.008 ** P=0.038 * P<0.001 ** | |POLY 3 | P<0.001 ** P=0.090 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.007 ** P=0.034 * P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.078 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.007 ** P=0.033 * P<0.001 ** | |POLY 6 | P<0.001 ** P=0.105 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.007 ** P=0.036 * P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.106 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.009 ** P=0.038 * P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.062 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.006 ** P=0.028 * P<0.001 ** | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 10/50 (20%) 8/50 (16%) 16/50 (32%) |1/50 (2%) 3/50 (6%) 1/50 (2%) 11/50 (22%) | |POLY-3 ADJUSTED (b)| 2.5% 22.4% 19.3% 36.5% |2.3% 7.1% 2.2% 25.3% | |TERMINAL (d) | 0/27 (0%) 6/29 (21%) 7/29 (24%) 9/26 (35%) |1/34 (3%) 1/31 (3%) 1/36 (3%) 10/34 (29%) | |FIRST INCIDENCE | 639 635 710 621 |735 (T) 695 735 (T) 519 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.010 * P=0.024 * P<0.001 ** |P<0.001 ** P=0.289 P=0.749N P=0.003 ** | |POLY 3 | P<0.001 ** P=0.006 ** P=0.016 * P<0.001 ** |P<0.001 ** P=0.302 P=0.751N P=0.002 ** | |POLY 1.5 | P<0.001 ** P=0.005 ** P=0.016 * P<0.001 ** |P<0.001 ** P=0.300 P=0.754N P=0.002 ** | |POLY 6 | P<0.001 ** P=0.007 ** P=0.016 * P<0.001 ** |P<0.001 ** P=0.305 P=0.747N P=0.002 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.008 ** P=0.019 * P<0.001 ** |P<0.001 ** P=0.301 P=0.749N P=0.003 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.004 ** P=0.015 * P<0.001 ** |P<0.001 ** P=0.309 P=0.753N P=0.002 ** | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 8 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 22/50 (44%) 30/50 (60%) 35/50 (70%) |1/50 (2%) 10/50 (20%) 6/50 (12%) 26/50 (52%) | |POLY-3 ADJUSTED (b)| 17.1% 48.7% 69.8% 76.1% |2.3% 23.5% 13.5% 58.8% | |TERMINAL (d) | 4/27 (15%) 14/29 (48%) 24/29 (83%) 21/26 (81%) |1/34 (3%) 6/31 (19%) 6/36 (17%) 23/34 (68%) | |FIRST INCIDENCE | 639 635 644 525 |735 (T) 694 735 (T) 519 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.005 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.005 ** P=0.066 P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.004 ** P=0.063 P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.004 ** P=0.060 P<0.001 ** | |POLY 6 | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.004 ** P=0.065 P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.005 ** P=0.066 P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.004 ** P=0.056 P<0.001 ** | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Lung | | Squamous Cell Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 9.1% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/29 (0%) 0/26 (0%) |0/34 (0%) 0/31 (0%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | --- --- --- 545 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.002 ** (e) (e) P=0.075 |(e) (e) (e) (e) | |POLY 3 | P=0.002 ** (e) (e) P=0.071 |(e) (e) (e) (e) | |POLY 1.5 | P=0.002 ** (e) (e) P=0.068 |(e) (e) (e) (e) | |POLY 6 | P=0.002 ** (e) (e) P=0.075 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P<0.001 ** (e) (e) P=0.035 * |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.002 ** (e) (e) P=0.059 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 9 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 8/50 (16%) 3/50 (6%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.4% 2.4% |0.0% 18.9% 6.7% 4.7% | |TERMINAL (d) | 0/27 (0%) 0/29 (0%) 1/29 (3%) 1/26 (4%) |0/34 (0%) 6/31 (19%) 1/36 (3%) 2/34 (6%) | |FIRST INCIDENCE | --- --- 733 (T) 733 (T) |--- 683 714 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.285 (e) P=0.514 P=0.492 |P=0.336N P=0.004 ** P=0.136 P=0.238 | |POLY 3 | P=0.306 (e) P=0.505 P=0.510 |P=0.344N P=0.003 ** P=0.127 P=0.238 | |POLY 1.5 | P=0.308 (e) P=0.504 P=0.508 |P=0.344N P=0.003 ** P=0.124 P=0.238 | |POLY 6 | P=0.303 (e) P=0.507 P=0.511 |P=0.345N P=0.003 ** P=0.131 P=0.237 | |LOGISTIC REGRESSION| (e) (e) P=0.514 P=0.492 |P=0.346N P=0.004 ** P=0.130 P=0.238 | |COCH-ARM / FISHERS | P=0.303 (e) P=0.500 P=0.500 |P=0.350N P=0.003 ** P=0.121 P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |20/50 (40%) 19/50 (38%) 18/50 (36%) 12/50 (24%) | |POLY-3 ADJUSTED (b)| 5.0% 2.3% 0.0% 2.4% |46.1% 44.0% 38.8% 27.7% | |TERMINAL (d) | 2/27 (7%) 1/29 (3%) 0/29 (0%) 1/26 (4%) |18/34 (53%) 15/31 (48%) 12/36 (33%) 11/34 (32%) | |FIRST INCIDENCE | 733 (T) 733 (T) --- 733 (T) |590 580 566 593 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.523N P=0.475N P=0.222N P=0.513N |P=0.035N* P=0.533 P=0.328N P=0.059N | |POLY 3 | P=0.505N P=0.470N P=0.231N P=0.483N |P=0.036N* P=0.509N P=0.312N P=0.056N | |POLY 1.5 | P=0.502N P=0.481N P=0.233N P=0.487N |P=0.036N* P=0.519N P=0.354N P=0.058N | |POLY 6 | P=0.510N P=0.458N P=0.229N P=0.481N |P=0.038N* P=0.497N P=0.262N P=0.055N | |LOGISTIC REGRESSION| P=0.523N P=0.475N (e) P=0.513N |P=0.036N* P=0.513N P=0.353N P=0.058N | |COCH-ARM / FISHERS | P=0.500N P=0.500N P=0.247N P=0.500N |P=0.043N* P=0.500N P=0.418N P=0.066N | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 10 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |20/50 (40%) 26/50 (52%) 21/50 (42%) 13/50 (26%) | |POLY-3 ADJUSTED (b)| 5.0% 2.3% 2.4% 4.7% |46.1% 59.9% 45.1% 30.0% | |TERMINAL (d) | 2/27 (7%) 1/29 (3%) 1/29 (3%) 2/26 (8%) |18/34 (53%) 20/31 (65%) 13/36 (36%) 12/34 (35%) | |FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) 733 (T) |590 580 566 593 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.493 P=0.475N P=0.475N P=0.683 |P=0.014N* P=0.083 P=0.550N P=0.091N | |POLY 3 | P=0.520 P=0.470N P=0.491N P=0.677N |P=0.012N* P=0.136 P=0.547N P=0.088N | |POLY 1.5 | P=0.523 P=0.481N P=0.493N P=0.680N |P=0.012N* P=0.133 P=0.572 P=0.090N | |POLY 6 | P=0.513 P=0.458N P=0.488N P=0.675N |P=0.012N* P=0.143 P=0.482N P=0.088N | |LOGISTIC REGRESSION| P=0.493 P=0.475N P=0.475N P=0.683 |P=0.012N* P=0.132 P=0.572 P=0.090N | |COCH-ARM / FISHERS | P=0.521 P=0.500N P=0.500N P=0.691N |P=0.017N* P=0.158 P=0.500 P=0.101N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Papilloma Squamous or Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.5% 0.0% 7.2% 2.4% |0.0% 2.4% 0.0% 0.0% | |TERMINAL (d) | 1/27 (4%) 0/29 (0%) 2/29 (7%) 1/26 (4%) |0/34 (0%) 1/31 (3%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | 733 (T) --- 698 733 (T) |--- 735 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.531 P=0.486N P=0.328 P=0.754 |P=0.571N P=0.482 (e) (e) | |POLY 3 | P=0.558 P=0.483N P=0.315 P=0.750N |P=0.579N P=0.498 (e) (e) | |POLY 1.5 | P=0.562 P=0.489N P=0.313 P=0.752N |P=0.579N P=0.497 (e) (e) | |POLY 6 | P=0.550 P=0.476N P=0.319 P=0.749N |P=0.579N P=0.498 (e) (e) | |LOGISTIC REGRESSION| P=0.554 (e) P=0.318 P=0.754 |(e) P=0.482 (e) (e) | |COCH-ARM / FISHERS | P=0.558 P=0.500N P=0.309 P=0.753N |P=0.576N P=0.500 (e) (e) | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 11 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 2.2% 4.7% | |TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/29 (0%) 0/26 (0%) |0/34 (0%) 0/31 (0%) 1/36 (3%) 2/34 (6%) | |FIRST INCIDENCE | --- --- --- --- |--- --- 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.087 (e) P=0.511 P=0.238 | |POLY 3 | (e) (e) (e) (e) |P=0.085 (e) P=0.509 P=0.238 | |POLY 1.5 | (e) (e) (e) (e) |P=0.085 (e) P=0.506 P=0.238 | |POLY 6 | (e) (e) (e) (e) |P=0.084 (e) P=0.512 P=0.237 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) P=0.511 P=0.238 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.084 (e) P=0.500 P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 2.5% 0.0% 7.2% 2.4% |0.0% 2.4% 2.2% 4.7% | |TERMINAL (d) | 1/27 (4%) 0/29 (0%) 2/29 (7%) 1/26 (4%) |0/34 (0%) 1/31 (3%) 1/36 (3%) 2/34 (6%) | |FIRST INCIDENCE | 733 (T) --- 698 733 (T) |--- 735 (T) 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.531 P=0.486N P=0.328 P=0.754 |P=0.201 P=0.482 P=0.511 P=0.238 | |POLY 3 | P=0.558 P=0.483N P=0.315 P=0.750N |P=0.196 P=0.498 P=0.509 P=0.238 | |POLY 1.5 | P=0.562 P=0.489N P=0.313 P=0.752N |P=0.197 P=0.497 P=0.506 P=0.238 | |POLY 6 | P=0.550 P=0.476N P=0.319 P=0.749N |P=0.195 P=0.498 P=0.512 P=0.237 | |LOGISTIC REGRESSION| P=0.554 (e) P=0.318 P=0.754 |(e) P=0.482 P=0.511 P=0.238 | |COCH-ARM / FISHERS | P=0.558 P=0.500N P=0.309 P=0.753N |P=0.194 P=0.500 P=0.500 P=0.247 | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 12 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Oral Mucosa | | Squamous Cell Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.7% | |TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/29 (0%) 0/26 (0%) |0/34 (0%) 0/31 (0%) 0/36 (0%) 2/34 (6%) | |FIRST INCIDENCE | --- --- --- --- |--- --- --- 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.043 * (e) (e) P=0.238 | |POLY 3 | (e) (e) (e) (e) |P=0.041 * (e) (e) P=0.238 | |POLY 1.5 | (e) (e) (e) (e) |P=0.041 * (e) (e) P=0.238 | |POLY 6 | (e) (e) (e) (e) |P=0.041 * (e) (e) P=0.237 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) P=0.238 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.042 * (e) (e) P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Oral Mucosa | | Squamous Cell Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.5% 0.0% 7.2% 2.4% |0.0% 2.4% 0.0% 0.0% | |TERMINAL (d) | 1/27 (4%) 0/29 (0%) 2/29 (7%) 1/26 (4%) |0/34 (0%) 1/31 (3%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | 733 (T) --- 698 733 (T) |--- 735 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.531 P=0.486N P=0.328 P=0.754 |P=0.571N P=0.482 (e) (e) | |POLY 3 | P=0.558 P=0.483N P=0.315 P=0.750N |P=0.579N P=0.498 (e) (e) | |POLY 1.5 | P=0.562 P=0.489N P=0.313 P=0.752N |P=0.579N P=0.497 (e) (e) | |POLY 6 | P=0.550 P=0.476N P=0.319 P=0.749N |P=0.579N P=0.498 (e) (e) | |LOGISTIC REGRESSION| P=0.554 (e) P=0.318 P=0.754 |(e) P=0.482 (e) (e) | |COCH-ARM / FISHERS | P=0.558 P=0.500N P=0.309 P=0.753N |P=0.576N P=0.500 (e) (e) | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 13 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Ovary | | Granulosa Cell Tumor: Benign, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |1/50 (2%) 1/50 (2%) 2/50 (4%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| |2.3% 2.4% 4.4% 0.0% | |TERMINAL (d) | |1/34 (3%) 1/31 (3%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | |735 (T) 735 (T) 225 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.331N P=0.741 P=0.521 P=0.500N | |POLY 3 | |P=0.329N P=0.758 P=0.524 P=0.499N | |POLY 1.5 | |P=0.329N P=0.757 P=0.517 P=0.499N | |POLY 6 | |P=0.330N P=0.759 P=0.532 P=0.500N | |LOGISTIC REGRESSION| |P=0.391N P=0.741 P=0.440 (e) | |COCH-ARM / FISHERS | |P=0.338N P=0.753N P=0.500 P=0.505N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 36/49 (73%) 33/50 (66%) 31/50 (62%) 30/50 (60%) |30/50 (60%) 27/50 (54%) 29/48 (60%) 25/49 (51%) | |POLY-3 ADJUSTED (b)| 79.6% 69.2% 67.6% 64.0% |64.2% 60.6% 65.7% 56.8% | |TERMINAL (d) | 21/27 (78%) 20/29 (69%) 19/29 (66%) 16/26 (62%) |20/34 (59%) 20/31 (65%) 23/34 (68%) 21/34 (62%) | |FIRST INCIDENCE | 495 526 435 525 |397 551 448 610 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.298N P=0.193N P=0.173N P=0.204N |P=0.194N P=0.491N P=0.466N P=0.237N | |POLY 3 | P=0.110N P=0.175N P=0.135N P=0.067N |P=0.288N P=0.444N P=0.529 P=0.302N | |POLY 1.5 | P=0.108N P=0.199N P=0.128N P=0.072N |P=0.249N P=0.424N P=0.548 P=0.262N | |POLY 6 | P=0.123N P=0.160N P=0.155N P=0.073N |P=0.349N P=0.460N P=0.507 P=0.362N | |LOGISTIC REGRESSION| P=0.121N P=0.193N P=0.132N P=0.083N |P=0.199N P=0.367N P=0.556N P=0.204N | |COCH-ARM / FISHERS | P=0.138N P=0.278N P=0.157N P=0.113N |P=0.261N P=0.343N P=0.565 P=0.243N | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 14 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 37/49 (76%) 34/50 (68%) 31/50 (62%) 30/50 (60%) |30/50 (60%) 27/50 (54%) 30/48 (63%) 25/49 (51%) | |POLY-3 ADJUSTED (b)| 81.8% 71.2% 67.6% 64.0% |64.2% 60.6% 67.3% 56.8% | |TERMINAL (d) | 22/27 (82%) 20/29 (69%) 19/29 (66%) 16/26 (62%) |20/34 (59%) 20/31 (65%) 23/34 (68%) 21/34 (62%) | |FIRST INCIDENCE | 495 526 435 525 |397 551 448 610 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.240N P=0.190N P=0.132N P=0.162N |P=0.194N P=0.491N P=0.533N P=0.237N | |POLY 3 | P=0.065N P=0.161N P=0.083N P=0.038N* |P=0.286N P=0.444N P=0.465 P=0.302N | |POLY 1.5 | P=0.066N P=0.188N P=0.081N P=0.042N* |P=0.247N P=0.424N P=0.475 P=0.262N | |POLY 6 | P=0.074N P=0.144N P=0.096N P=0.040N* |P=0.348N P=0.460N P=0.457 P=0.362N | |LOGISTIC REGRESSION| P=0.076N P=0.178N P=0.087N P=0.051N |P=0.198N P=0.367N P=0.522 P=0.204N | |COCH-ARM / FISHERS | P=0.091N P=0.272N P=0.109N P=0.075N |P=0.258N P=0.343N P=0.482 P=0.243N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Prostate | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 2/50 (4%) | | |POLY-3 ADJUSTED (b)| 2.5% 4.5% 4.8% 4.7% | | |TERMINAL (d) | 1/27 (4%) 2/29 (7%) 2/29 (7%) 2/26 (8%) | | |FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) 733 (T) | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.459 P=0.525 P=0.525 P=0.487 | | |POLY 3 | P=0.501 P=0.530 P=0.509 P=0.517 | | |POLY 1.5 | P=0.500 P=0.519 P=0.507 P=0.513 | | |POLY 6 | P=0.497 P=0.542 P=0.512 P=0.519 | | |LOGISTIC REGRESSION| P=0.459 P=0.525 P=0.525 P=0.487 | | |COCH-ARM / FISHERS | P=0.490 P=0.500 P=0.500 P=0.500 | | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 15 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |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) | 2/50 (4%) 4/50 (8%) 6/50 (12%) 3/50 (6%) |1/50 (2%) 0/50 (0%) 3/50 (6%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.0% 9.0% 14.5% 7.0% |2.3% 0.0% 6.7% 0.0% | |TERMINAL (d) | 2/27 (7%) 3/29 (10%) 6/29 (21%) 2/26 (8%) |0/34 (0%) 0/31 (0%) 3/36 (8%) 0/34 (0%) | |FIRST INCIDENCE | 733 (T) 576 733 (T) 560 |566 --- 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.547 P=0.375 P=0.152 P=0.493 |P=0.436N P=0.505N P=0.328 P=0.491N | |POLY 3 | P=0.577N P=0.383 P=0.139 P=0.528 |P=0.445N P=0.505N P=0.316 P=0.501N | |POLY 1.5 | P=0.579N P=0.366 P=0.138 P=0.521 |P=0.443N P=0.504N P=0.313 P=0.500N | |POLY 6 | P=0.579N P=0.402 P=0.140 P=0.534 |P=0.448N P=0.506N P=0.320 P=0.503N | |LOGISTIC REGRESSION| P=0.589 P=0.376 P=0.152 P=0.519 |P=0.447N P=0.476N P=0.306 P=0.514N | |COCH-ARM / FISHERS | P=0.584 P=0.339 P=0.134 P=0.500 |P=0.448N P=0.500N P=0.309 P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Skin | | Fibroma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 4/50 (8%) 7/50 (14%) 3/50 (6%) |3/50 (6%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.5% 9.0% 16.8% 7.0% |7.0% 0.0% 2.2% 0.0% | |TERMINAL (d) | 0/27 (0%) 2/29 (7%) 6/29 (21%) 1/26 (4%) |3/34 (9%) 0/31 (0%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | 672 686 665 672 |735 (T) --- 716 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.466 P=0.224 P=0.040 * P=0.326 |P=0.154N P=0.137N P=0.287N P=0.121N | |POLY 3 | P=0.514 P=0.206 P=0.032 * P=0.323 |P=0.156N P=0.120N P=0.289N P=0.117N | |POLY 1.5 | P=0.512 P=0.196 P=0.032 * P=0.319 |P=0.155N P=0.121N P=0.295N P=0.118N | |POLY 6 | P=0.508 P=0.216 P=0.032 * P=0.324 |P=0.157N P=0.119N P=0.282N P=0.117N | |LOGISTIC REGRESSION| P=0.494 P=0.205 P=0.035 * P=0.320 |P=0.157N (e) P=0.279N (e) | |COCH-ARM / FISHERS | P=0.493 P=0.181 P=0.030 * P=0.309 |P=0.160N P=0.121N P=0.309N P=0.121N | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 16 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, | | or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 4/50 (8%) 8/50 (16%) 4/50 (8%) |3/50 (6%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 4.9% 9.0% 19.2% 9.3% |7.0% 0.0% 2.2% 2.3% | |TERMINAL (d) | 1/27 (4%) 2/29 (7%) 7/29 (24%) 1/26 (4%) |3/34 (9%) 0/31 (0%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | 672 686 665 671 |735 (T) --- 716 726 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.401 P=0.395 P=0.058 P=0.362 |P=0.427N P=0.137N P=0.287N P=0.304N | |POLY 3 | P=0.449 P=0.378 P=0.047 * P=0.362 |P=0.438N P=0.120N P=0.289N P=0.303N | |POLY 1.5 | P=0.448 P=0.363 P=0.048 * P=0.356 |P=0.437N P=0.121N P=0.295N P=0.303N | |POLY 6 | P=0.446 P=0.394 P=0.047 * P=0.366 |P=0.440N P=0.119N P=0.282N P=0.303N | |LOGISTIC REGRESSION| P=0.430 P=0.385 P=0.051 P=0.357 |P=0.441N (e) P=0.279N P=0.302N | |COCH-ARM / FISHERS | P=0.429 P=0.339 P=0.046 * P=0.339 |P=0.442N P=0.121N P=0.309N P=0.309N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Skin | | Fibrosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 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)| 2.5% 4.5% 2.4% 2.3% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/27 (4%) 0/29 (0%) 1/29 (3%) 0/26 (0%) |0/34 (0%) 0/31 (0%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | 733 (T) 686 733 (T) 671 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.549N P=0.543 P=0.746N P=0.752N |(e) (e) (e) (e) | |POLY 3 | P=0.524N P=0.532 P=0.755N P=0.749N |(e) (e) (e) (e) | |POLY 1.5 | P=0.526N P=0.520 P=0.756N P=0.752N |(e) (e) (e) (e) | |POLY 6 | P=0.524N P=0.546 P=0.754N P=0.747N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.532N P=0.535 P=0.746N P=0.753N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.535N P=0.500 P=0.753N P=0.753N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 17 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.5% 4.5% 2.4% 2.3% |0.0% 0.0% 0.0% 2.3% | |TERMINAL (d) | 1/27 (4%) 0/29 (0%) 1/29 (3%) 0/26 (0%) |0/34 (0%) 0/31 (0%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | 733 (T) 686 733 (T) 671 |--- --- --- 726 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.549N P=0.543 P=0.746N P=0.752N |P=0.224 (e) (e) P=0.506 | |POLY 3 | P=0.524N P=0.532 P=0.755N P=0.749N |P=0.216 (e) (e) P=0.501 | |POLY 1.5 | P=0.526N P=0.520 P=0.756N P=0.752N |P=0.216 (e) (e) P=0.501 | |POLY 6 | P=0.524N P=0.546 P=0.754N P=0.747N |P=0.215 (e) (e) P=0.501 | |LOGISTIC REGRESSION| P=0.532N P=0.535 P=0.746N P=0.753N |P=0.212 (e) (e) P=0.500 | |COCH-ARM / FISHERS | P=0.535N P=0.500 P=0.753N P=0.753N |P=0.214 (e) (e) P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 4/50 (8%) 5/50 (10%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.0% 9.0% 12.1% 4.7% |0.0% 0.0% 4.5% 0.0% | |TERMINAL (d) | 2/27 (7%) 3/29 (10%) 5/29 (17%) 2/26 (8%) |0/34 (0%) 0/31 (0%) 2/36 (6%) 0/34 (0%) | |FIRST INCIDENCE | 733 (T) 576 733 (T) 733 (T) |--- --- 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.462N P=0.375 P=0.242 P=0.683 |P=0.690N (e) P=0.251 (e) | |POLY 3 | P=0.412N P=0.383 P=0.225 P=0.677N |P=0.695N (e) P=0.247 (e) | |POLY 1.5 | P=0.412N P=0.366 P=0.224 P=0.680N |P=0.694N (e) P=0.243 (e) | |POLY 6 | P=0.418N P=0.402 P=0.227 P=0.675N |P=0.696N (e) P=0.251 (e) | |LOGISTIC REGRESSION| P=0.427N P=0.376 P=0.242 P=0.683 |(e) (e) P=0.251 (e) | |COCH-ARM / FISHERS | P=0.425N P=0.339 P=0.218 P=0.691N |P=0.697N (e) P=0.247 (e) | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 18 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Skin | | Lipoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.5% 2.3% 4.8% 2.3% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/27 (4%) 1/29 (3%) 1/29 (3%) 0/26 (0%) |0/34 (0%) 0/31 (0%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | 733 (T) 733 (T) 698 547 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.643 P=0.746N P=0.520 P=0.760N |(e) (e) (e) (e) | |POLY 3 | P=0.631N P=0.741N P=0.510 P=0.747N |(e) (e) (e) (e) | |POLY 1.5 | P=0.631N P=0.748N P=0.508 P=0.750N |(e) (e) (e) (e) | |POLY 6 | P=0.632N P=0.734N P=0.514 P=0.744N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.638N P=0.746N P=0.514 P=0.744 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.640N P=0.753N P=0.500 P=0.753N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 4/50 (8%) 5/50 (10%) 3/50 (6%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.0% 9.0% 12.1% 7.0% |2.3% 0.0% 4.5% 0.0% | |TERMINAL (d) | 2/27 (7%) 3/29 (10%) 5/29 (17%) 2/26 (8%) |0/34 (0%) 0/31 (0%) 2/36 (6%) 0/34 (0%) | |FIRST INCIDENCE | 733 (T) 576 733 (T) 560 |566 --- 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.544 P=0.375 P=0.242 P=0.493 |P=0.445N P=0.505N P=0.521 P=0.491N | |POLY 3 | P=0.587N P=0.383 P=0.225 P=0.528 |P=0.452N P=0.505N P=0.511 P=0.501N | |POLY 1.5 | P=0.590N P=0.366 P=0.224 P=0.521 |P=0.451N P=0.504N P=0.507 P=0.500N | |POLY 6 | P=0.589N P=0.402 P=0.227 P=0.534 |P=0.455N P=0.506N P=0.515 P=0.503N | |LOGISTIC REGRESSION| P=0.585 P=0.376 P=0.242 P=0.519 |P=0.456N P=0.476N P=0.495 P=0.514N | |COCH-ARM / FISHERS | P=0.580 P=0.339 P=0.218 P=0.500 |P=0.455N P=0.500N P=0.500 P=0.500N | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 19 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, or Keratoacanthoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 4/50 (8%) 5/50 (10%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.0% 9.0% 12.1% 7.0% |0.0% 0.0% 4.5% 0.0% | |TERMINAL (d) | 2/27 (7%) 3/29 (10%) 5/29 (17%) 2/26 (8%) |0/34 (0%) 0/31 (0%) 2/36 (6%) 0/34 (0%) | |FIRST INCIDENCE | 733 (T) 576 733 (T) 560 |--- --- 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.544 P=0.375 P=0.242 P=0.493 |P=0.690N (e) P=0.251 (e) | |POLY 3 | P=0.587N P=0.383 P=0.225 P=0.528 |P=0.695N (e) P=0.247 (e) | |POLY 1.5 | P=0.590N P=0.366 P=0.224 P=0.521 |P=0.694N (e) P=0.243 (e) | |POLY 6 | P=0.589N P=0.402 P=0.227 P=0.534 |P=0.696N (e) P=0.251 (e) | |LOGISTIC REGRESSION| P=0.585 P=0.376 P=0.242 P=0.519 |(e) (e) P=0.251 (e) | |COCH-ARM / FISHERS | P=0.580 P=0.339 P=0.218 P=0.500 |P=0.697N (e) P=0.247 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Testes | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 40/50 (80%) 35/50 (70%) 41/50 (82%) 33/50 (66%) | | |POLY-3 ADJUSTED (b)| 86.1% 76.4% 91.3% 73.9% | | |TERMINAL (d) | 24/27 (89%) 26/29 (90%) 29/29 (100%) 23/26 (89%) | | |FIRST INCIDENCE | 408 586 552 532 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.272N P=0.091N P=0.474N P=0.154N | | |POLY 3 | P=0.121N P=0.157N P=0.301 P=0.092N | | |POLY 1.5 | P=0.099N P=0.152N P=0.405 P=0.075N | | |POLY 6 | P=0.190N P=0.177N P=0.206 P=0.146N | | |LOGISTIC REGRESSION| P=0.063N P=0.056N P=0.591 P=0.030N* | | |COCH-ARM / FISHERS | P=0.114N P=0.178N P=0.500 P=0.088N | | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 20 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/49 (10%) 8/49 (16%) 4/48 (8%) 9/48 (19%) |6/47 (13%) 6/47 (13%) 6/50 (12%) 2/47 (4%) | |POLY-3 ADJUSTED (b)| 12.6% 18.3% 9.9% 21.5% |14.6% 15.0% 13.3% 4.9% | |TERMINAL (d) | 4/27 (15%) 6/28 (21%) 4/29 (14%) 6/26 (23%) |6/34 (18%) 4/31 (13%) 3/36 (8%) 2/33 (6%) | |FIRST INCIDENCE | 697 635 733 (T) 525 |735 (T) 686 672 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.184 P=0.319 P=0.460N P=0.192 |P=0.089N P=0.569 P=0.568N P=0.141N | |POLY 3 | P=0.219 P=0.336 P=0.489N P=0.218 |P=0.083N P=0.602 P=0.556N P=0.132N | |POLY 1.5 | P=0.215 P=0.314 P=0.496N P=0.208 |P=0.081N P=0.601 P=0.564N P=0.130N | |POLY 6 | P=0.220 P=0.361 P=0.483N P=0.227 |P=0.086N P=0.607 P=0.541N P=0.134N | |LOGISTIC REGRESSION| P=0.201 P=0.347 P=0.472N P=0.206 |P=0.084N P=0.599 P=0.563N P=0.141N | |COCH-ARM / FISHERS | P=0.198 P=0.276 P=0.513N P=0.182 |P=0.087N P=0.621N P=0.576N P=0.134N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 4/49 (8%) 3/48 (6%) 1/48 (2%) |3/47 (6%) 2/47 (4%) 2/50 (4%) 1/47 (2%) | |POLY-3 ADJUSTED (b)| 2.5% 9.3% 7.4% 2.5% |7.3% 5.0% 4.5% 2.4% | |TERMINAL (d) | 0/27 (0%) 3/28 (11%) 3/29 (10%) 1/26 (4%) |3/34 (9%) 2/31 (7%) 2/36 (6%) 1/33 (3%) | |FIRST INCIDENCE | 672 702 733 (T) 733 (T) |735 (T) 735 (T) 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.353N P=0.209 P=0.323 P=0.755N |P=0.264N P=0.542N P=0.474N P=0.315N | |POLY 3 | P=0.326N P=0.202 P=0.310 P=0.756N |P=0.263N P=0.516N P=0.465N P=0.305N | |POLY 1.5 | P=0.328N P=0.194 P=0.307 P=0.757N |P=0.261N P=0.515N P=0.467N P=0.303N | |POLY 6 | P=0.329N P=0.210 P=0.312 P=0.757N |P=0.267N P=0.516N P=0.461N P=0.309N | |LOGISTIC REGRESSION| P=0.342N P=0.210 P=0.317 P=0.758N |P=0.264N P=0.542N P=0.474N P=0.315N | |COCH-ARM / FISHERS | P=0.342N P=0.181 P=0.301 P=0.747 |P=0.268N P=0.500N P=0.470N P=0.308N | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 21 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/49 (12%) 11/49 (22%) 7/48 (15%) 10/48 (21%) |8/47 (17%) 8/47 (17%) 8/50 (16%) 3/47 (6%) | |POLY-3 ADJUSTED (b)| 15.0% 25.1% 17.3% 23.9% |19.4% 20.0% 17.7% 7.3% | |TERMINAL (d) | 4/27 (15%) 8/28 (29%) 7/29 (24%) 7/26 (27%) |8/34 (24%) 6/31 (19%) 5/36 (14%) 3/33 (9%) | |FIRST INCIDENCE | 672 635 733 (T) 525 |735 (T) 686 672 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.288 P=0.187 P=0.545 P=0.208 |P=0.062N P=0.542 P=0.548N P=0.105N | |POLY 3 | P=0.343 P=0.188 P=0.509 P=0.230 |P=0.057N P=0.585 P=0.530N P=0.096N | |POLY 1.5 | P=0.337 P=0.171 P=0.503 P=0.221 |P=0.056N P=0.584 P=0.540N P=0.095N | |POLY 6 | P=0.343 P=0.206 P=0.512 P=0.236 |P=0.060N P=0.591 P=0.513N P=0.098N | |LOGISTIC REGRESSION| P=0.312 P=0.199 P=0.534 P=0.221 |P=0.059N P=0.582 P=0.535N P=0.105N | |COCH-ARM / FISHERS | P=0.309 P=0.143 P=0.484 P=0.194 |P=0.062N P=0.608N P=0.554N P=0.099N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |10/50 (20%) 4/50 (8%) 10/50 (20%) 10/50 (20%) | |POLY-3 ADJUSTED (b)| |23.5% 9.5% 22.5% 22.6% | |TERMINAL (d) | |10/34 (29%) 3/31 (10%) 10/36 (28%) 7/34 (21%) | |FIRST INCIDENCE | |735 (T) 728 735 (T) 535 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.305 P=0.099N P=0.545N P=0.597N | |POLY 3 | |P=0.315 P=0.073N P=0.557N P=0.563N | |POLY 1.5 | |P=0.305 P=0.075N P=0.572N P=0.576N | |POLY 6 | |P=0.327 P=0.070N P=0.539N P=0.547N | |LOGISTIC REGRESSION| |P=0.278 P=0.083N P=0.545N P=0.595N | |COCH-ARM / FISHERS | |P=0.278 P=0.074N P=0.598N P=0.598N | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 22 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |10/50 (20%) 5/50 (10%) 10/50 (20%) 10/50 (20%) | |POLY-3 ADJUSTED (b)| |23.5% 11.8% 22.5% 22.6% | |TERMINAL (d) | |10/34 (29%) 3/31 (10%) 10/36 (28%) 7/34 (21%) | |FIRST INCIDENCE | |735 (T) 695 735 (T) 535 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.352 P=0.170N P=0.545N P=0.597N | |POLY 3 | |P=0.362 P=0.129N P=0.557N P=0.563N | |POLY 1.5 | |P=0.352 P=0.134N P=0.572N P=0.576N | |POLY 6 | |P=0.373 P=0.124N P=0.539N P=0.547N | |LOGISTIC REGRESSION| |P=0.325 P=0.130N P=0.545N P=0.595N | |COCH-ARM / FISHERS | |P=0.324 P=0.131N P=0.598N P=0.598N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 6.6% 0.0% 0.0% |0.0% 0.0% 0.0% 2.3% | |TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/29 (0%) 0/26 (0%) |0/34 (0%) 0/31 (0%) 0/36 (0%) 1/34 (3%) | |FIRST INCIDENCE | --- 285 --- --- |--- --- --- 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.256N P=0.154 (e) (e) |P=0.218 (e) (e) P=0.500 | |POLY 3 | P=0.227N P=0.141 (e) (e) |P=0.216 (e) (e) P=0.501 | |POLY 1.5 | P=0.234N P=0.133 (e) (e) |P=0.216 (e) (e) P=0.501 | |POLY 6 | P=0.220N P=0.150 (e) (e) |P=0.215 (e) (e) P=0.500 | |LOGISTIC REGRESSION| P=0.337N P=0.055 (e) (e) |(e) (e) (e) P=0.500 | |COCH-ARM / FISHERS | P=0.255N P=0.121 (e) (e) |P=0.214 (e) (e) P=0.500 | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 23 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or | | Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 16/50 (32%) 23/50 (46%) 29/50 (58%) 25/50 (50%) |14/50 (28%) 21/50 (42%) 14/50 (28%) 24/50 (48%) | |POLY-3 ADJUSTED (b)| 37.0% 49.6% 61.6% 55.8% |31.6% 46.3% 30.7% 51.0% | |TERMINAL (d) | 9/27 (33%) 14/29 (48%) 14/29 (48%) 14/26 (54%) |10/34 (29%) 11/31 (36%) 9/36 (25%) 14/34 (41%) | |FIRST INCIDENCE | 135 586 403 532 |504 428 595 411 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.118 P=0.228 P=0.035 * P=0.080 |P=0.090 P=0.092 P=0.513N P=0.051 | |POLY 3 | P=0.103 P=0.157 P=0.013 * P=0.053 |P=0.072 P=0.110 P=0.555N P=0.044 * | |POLY 1.5 | P=0.109 P=0.131 P=0.009 ** P=0.052 |P=0.064 P=0.102 P=0.567N P=0.038 * | |POLY 6 | P=0.094 P=0.196 P=0.024 * P=0.054 |P=0.083 P=0.121 P=0.536N P=0.054 | |LOGISTIC REGRESSION| P=0.120 P=0.117 P=0.007 ** P=0.061 |P=0.055 P=0.099 P=0.561N P=0.032 * | |COCH-ARM / FISHERS | P=0.114 P=0.109 P=0.008 ** P=0.052 |P=0.054 P=0.104 P=0.588N P=0.032 * | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Benign, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.9% 0.0% 2.4% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/27 (4%) 0/29 (0%) 0/29 (0%) 0/26 (0%) |0/34 (0%) 0/31 (0%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | 714 --- 656 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.272N P=0.218N P=0.481N P=0.240N |(e) (e) (e) (e) | |POLY 3 | P=0.282N P=0.218N P=0.489N P=0.226N |(e) (e) (e) (e) | |POLY 1.5 | P=0.277N P=0.225N P=0.492N P=0.229N |(e) (e) (e) (e) | |POLY 6 | P=0.288N P=0.212N P=0.485N P=0.225N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.269N P=0.208N P=0.491N P=0.226N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.271N P=0.247N P=0.500N P=0.247N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 24 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.9% 0.0% 2.4% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/27 (4%) 0/29 (0%) 0/29 (0%) 0/26 (0%) |0/34 (0%) 0/31 (0%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | 714 --- 656 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.272N P=0.218N P=0.481N P=0.240N |(e) (e) (e) (e) | |POLY 3 | P=0.282N P=0.218N P=0.489N P=0.226N |(e) (e) (e) (e) | |POLY 1.5 | P=0.277N P=0.225N P=0.492N P=0.229N |(e) (e) (e) (e) | |POLY 6 | P=0.288N P=0.212N P=0.485N P=0.225N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.269N P=0.208N P=0.491N P=0.226N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.271N P=0.247N P=0.500N P=0.247N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |All Organs | | Osteosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 7.2% 0.0% 2.4% 2.3% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/29 (0%) 0/26 (0%) |0/34 (0%) 0/31 (0%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | 408 --- 435 671 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.434N P=0.109N P=0.296N P=0.284N |(e) (e) (e) (e) | |POLY 3 | P=0.453N P=0.110N P=0.302N P=0.298N |(e) (e) (e) (e) | |POLY 1.5 | P=0.448N P=0.113N P=0.301N P=0.298N |(e) (e) (e) (e) | |POLY 6 | P=0.460N P=0.107N P=0.303N P=0.301N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.573N P=0.169N P=0.398N P=0.407N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.442N P=0.121N P=0.309N P=0.309N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 25 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |All Organs | | Osteosarcoma or Osteoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 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)| 7.2% 0.0% 4.7% 2.3% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/29 (0%) 0/26 (0%) |0/34 (0%) 0/31 (0%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | 408 --- 435 671 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.428N P=0.109N P=0.487N P=0.284N |(e) (e) (e) (e) | |POLY 3 | P=0.447N P=0.110N P=0.494N P=0.298N |(e) (e) (e) (e) | |POLY 1.5 | P=0.441N P=0.113N P=0.494N P=0.298N |(e) (e) (e) (e) | |POLY 6 | P=0.455N P=0.107N P=0.494N P=0.301N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.550N P=0.169N P=0.596N P=0.407N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.437N P=0.121N P=0.500N P=0.309N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 47/50 (94%) 48/50 (96%) 48/50 (96%) 48/50 (96%) |44/50 (88%) 39/50 (78%) 44/50 (88%) 40/50 (80%) | |POLY-3 ADJUSTED (b)| 97.0% 97.9% 99.1% 98.0% |92.4% 86.7% 90.6% 86.5% | |TERMINAL (d) | 26/27 (96%) 29/29 (100%) 29/29 (100%) 26/26 (100%)|32/34 (94%) 28/31 (90%) 32/36 (89%) 31/34 (91%) | |FIRST INCIDENCE | 408 526 435 525 |397 551 436 535 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.365 P=0.341N P=0.462N P=0.521 |P=0.290N P=0.411N P=0.381N P=0.280N | |POLY 3 | P=0.603 P=0.654 P=0.494 P=0.657 |P=0.313N P=0.275N P=0.521N P=0.261N | |POLY 1.5 | P=0.633 P=0.620 P=0.550 P=0.659 |P=0.285N P=0.234N P=0.556N P=0.225N | |POLY 6 | P=0.483 P=0.702 P=0.465 P=0.607 |P=0.354N P=0.314N P=0.468N P=0.306N | |LOGISTIC REGRESSION| P=0.501N P=0.685N P=0.652 P=0.628N |P=0.243N P=0.151N P=0.548N P=0.157N | |COCH-ARM / FISHERS | P=0.491 P=0.500 P=0.500 P=0.500 |P=0.323N P=0.143N P=0.620N P=0.207N | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 26 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 26/50 (52%) 37/50 (74%) 42/50 (84%) 37/50 (74%) |25/50 (50%) 30/50 (60%) 24/50 (48%) 32/50 (64%) | |POLY-3 ADJUSTED (b)| 56.0% 76.6% 85.6% 78.5% |54.0% 64.6% 51.1% 68.0% | |TERMINAL (d) | 11/27 (41%) 19/29 (66%) 23/29 (79%) 19/26 (73%) |17/34 (50%) 16/31 (52%) 17/36 (47%) 21/34 (62%) | |FIRST INCIDENCE | 135 285 403 532 |476 428 225 411 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.128 P=0.161 P=0.028 * P=0.079 |P=0.230 P=0.183 P=0.403N P=0.160 | |POLY 3 | P=0.059 P=0.024 * P<0.001 ** P=0.014 * |P=0.153 P=0.203 P=0.467N P=0.117 | |POLY 1.5 | P=0.065 P=0.020 * P<0.001 ** P=0.015 * |P=0.155 P=0.192 P=0.468N P=0.115 | |POLY 6 | P=0.053 P=0.031 * P<0.001 ** P=0.013 * |P=0.153 P=0.220 P=0.465N P=0.121 | |LOGISTIC REGRESSION| P=0.080 P=0.014 * P<0.001 ** P=0.018 * |P=0.151 P=0.197 P=0.492N P=0.115 | |COCH-ARM / FISHERS | P=0.082 P=0.019 * P<0.001 ** P=0.019 * |P=0.146 P=0.211 P=0.500N P=0.113 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.03 0.1MG/M3 0.3MG/M3 |CONTROL 0.03 0.1MG/M3 0.3MG/M3 | | | MG/M3 STOP STOP | MG/M3 STOP STOP | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 49/50 (98%) 50/50 (100%) 50/50 (100%) 50/50 (100%)|49/50 (98%) 47/50 (94%) 48/50 (96%) 46/50 (92%) | |POLY-3 ADJUSTED (b)| 99.1% 100.0% 100.0% 100.0% |100.0% 97.9% 96.0% 94.8% | |TERMINAL (d) | 27/27 (100%) 29/29 (100%) 29/29 (100%) 26/26 (100%)|34/34 (100%) 30/31 (97%) 34/36 (94%) 32/34 (94%) | |FIRST INCIDENCE | 135 285 403 525 |397 428 225 411 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.371 P=0.339N P=0.460N P=0.523 |P=0.286N P=0.498 P=0.303N P=0.364N | |POLY 3 | P=0.864 P=0.910 P=0.910 P=0.910 |P=0.133N P=0.496N P=0.243N P=0.150N | |POLY 1.5 | P=0.654 P=0.702 P=0.702 P=0.702 |P=0.105N P=0.494N P=0.258N P=0.127N | |POLY 6 | P=1.000 P=1.000 P=1.000 P=1.000 |P=0.173N P=0.496N P=0.242N P=0.184N | |LOGISTIC REGRESSION| P=0.540 P=0.571 P=0.553 P=0.594 |P=0.102N P=0.462N P=0.433N P=0.119N | |COCH-ARM / FISHERS | P=0.474 P=0.500 P=0.500 P=0.500 |P=0.191N P=0.309N P=0.500N P=0.181N | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Poly-3 adjusted lifetime tumor incidence. (d) Observed incidence at terminal kill. (f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between the controls and that dosed group. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fishers exact tests compare directly the overall incidence rates For all tests a negative trend is indicated by N (e) Value of Statistic cannot be computed. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01). --multipart-boundary Content-type: text/plain Range: bytes 206998-206998/206998 --multipart-boundary--