TDMS Study 61427-07 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest VANADIUM PENTOXIDE DATE: 11/19/01 EXPERIMENT: 61427 TEST: 07 TIME: 10:09:05 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 61427B PATHOLOGIST: RENNE, ROGER MILLER, RODNEY CAS: 1314-62-1 ------------------------------------------------------------------------------------------------------------------------------------ FINAL#2/RATS REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest VANADIUM PENTOXIDE DATE: 11/19/01 EXPERIMENT: 61427 TEST: 07 TIME: 10:09:05 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 61427B PATHOLOGIST: RENNE, ROGER MILLER, RODNEY CAS: 1314-62-1 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 Islets, Pancreatic Kidney Liver Lung Nose Ovary Pituitary Gland Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest VANADIUM PENTOXIDE DATE: 11/19/01 EXPERIMENT: 61427 TEST: 07 TIME: 10:09:05 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 61427B PATHOLOGIST: RENNE, ROGER MILLER, RODNEY CAS: 1314-62-1 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF VANADIUM PENTOXIDE =============================================================== Male Rats ------------ Organ Morphology ----- ---------- Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma: Benign, Complex, Malignant, NOS Skin Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma Testes Adenoma All Organs Benign Tumors =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Uterus Polyp Stromal Sarcoma Stromal or Polyp Stromal =============================================================== Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 1 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - VANADIUM PENTOXIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 11/50 (22%) 6/49 (12%) 6/50 (12%) |2/49 (4%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | |POLY-3 RATE (b) | 4/40.13 11/42.79 6/43.26 6/41.64 |2/42.75 2/42.05 1/42.55 1/42.54 | |POLY-3 PERCENT (g) | 10.0% 25.7% 13.9% 14.4% |4.7% 4.8% 2.4% 2.4% | |TERMINAL (d) | 3/20 (15%) 9/29 (31%) 4/26 (15%) 4/27 (15%) |2/33 (6%) 0/24 (0%) 1/29 (3%) 1/30 (3%) | |FIRST INCIDENCE | 652 694 653 533 |731 (T) 652 731 (T) 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.400N P=0.167 P=0.552 P=0.536 |P=0.349N P=0.612 P=0.545N P=0.533N | |POLY 3 | P=0.508N P=0.054 P=0.417 P=0.392 |P=0.337N P=0.688 P=0.502N P=0.502N | |POLY 1.5 | P=0.528N P=0.048 * P=0.389 P=0.379 |P=0.335N P=0.693N P=0.499N P=0.497N | |POLY 6 | P=0.469N P=0.071 P=0.464 P=0.420 |P=0.341N P=0.678 P=0.507N P=0.509N | |LOGISTIC REGRESSION| P=0.500N P=0.117 P=0.495 P=0.402 |P=0.339N P=0.685 P=0.545N P=0.533N | |COCH-ARM / FISHERS | P=0.544N P=0.045 * P=0.357 P=0.370 |P=0.332N P=0.684N P=0.492N P=0.492N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Complex | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/49 (4%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/39.84 0/42.57 2/43.62 0/40.96 |0/42.75 0/41.70 0/42.55 0/42.54 | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.6% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/20 (0%) 0/29 (0%) 0/26 (0%) 0/27 (0%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) | |FIRST INCIDENCE | --- --- 633 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.600 (e) P=0.289 (e) |(e) (e) (e) (e) | |POLY 3 | P=0.593 (e) P=0.258 (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.592 (e) P=0.246 (e) |(e) (e) (e) (e) | |POLY 6 | P=0.600 (e) P=0.278 (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.594 (e) P=0.199 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.594 (e) P=0.242 (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 2 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - VANADIUM PENTOXIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/49 (0%) 0/50 (0%) |0/49 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 1/39.93 2/42.62 0/42.93 0/40.96 |0/42.75 1/42.22 0/42.55 1/42.64 | |POLY-3 PERCENT (g) | 2.5% 4.7% 0.0% 0.0% |0.0% 2.4% 0.0% 2.4% | |TERMINAL (d) | 0/20 (0%) 1/29 (3%) 0/26 (0%) 0/27 (0%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) | |FIRST INCIDENCE | 708 716 --- --- |--- 571 --- 706 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.153N P=0.633 P=0.428N P=0.454N |P=0.402 P=0.500 (e) P=0.483 | |POLY 3 | P=0.180N P=0.523 P=0.486N P=0.495N |P=0.402 P=0.498 (e) P=0.499 | |POLY 1.5 | P=0.185N P=0.510 P=0.494N P=0.498N |P=0.405 P=0.501 (e) P=0.502 | |POLY 6 | P=0.172N P=0.547 P=0.472N P=0.487N |P=0.396 P=0.492 (e) P=0.496 | |LOGISTIC REGRESSION| P=0.167N P=0.585 P=0.469N P=0.482N |P=0.408 P=0.490 (e) P=0.500 | |COCH-ARM / FISHERS | P=0.189N P=0.500 P=0.505N P=0.500N |P=0.408 P=0.505 (e) P=0.505 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 13/50 (26%) 8/49 (16%) 6/50 (12%) |2/49 (4%) 3/50 (6%) 1/50 (2%) 2/50 (4%) | |POLY-3 RATE (b) | 5/40.21 13/42.84 8/43.95 6/41.64 |2/42.75 3/42.57 1/42.55 2/42.64 | |POLY-3 PERCENT (g) | 12.4% 30.4% 18.2% 14.4% |4.7% 7.1% 2.4% 4.7% | |TERMINAL (d) | 3/20 (15%) 10/29 (35%) 4/26 (15%) 4/27 (15%) |2/33 (6%) 0/24 (0%) 1/29 (3%) 1/30 (3%) | |FIRST INCIDENCE | 652 694 633 533 |731 (T) 571 731 (T) 706 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.263N P=0.160 P=0.476 P=0.578N |P=0.510N P=0.421 P=0.545N P=0.660 | |POLY 3 | P=0.357N P=0.040 * P=0.334 P=0.525 |P=0.501N P=0.498 P=0.502N P=0.693 | |POLY 1.5 | P=0.380N P=0.034 * P=0.300 P=0.510 |P=0.497N P=0.504 P=0.499N P=0.690N | |POLY 6 | P=0.317N P=0.054 P=0.393 P=0.556 |P=0.507N P=0.488 P=0.507N P=0.687 | |LOGISTIC REGRESSION| P=0.363N P=0.098 P=0.333 P=0.539 |P=0.496N P=0.510 P=0.545N P=0.679 | |COCH-ARM / FISHERS | P=0.399N P=0.033 * P=0.264 P=0.500 |P=0.493N P=0.510 P=0.492N P=0.684N | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 3 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - VANADIUM PENTOXIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Brain | | Astrocytoma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 2/50 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 0/39.84 0/42.57 0/42.93 0/40.96 |0/43.71 2/41.94 2/42.78 0/42.54 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.8% 4.7% 0.0% | |TERMINAL (d) | 0/20 (0%) 0/29 (0%) 0/26 (0%) 0/27 (0%) |0/33 (0%) 1/24 (4%) 0/29 (0%) 0/30 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 667 689 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.511N P=0.205 P=0.218 (e) | |POLY 3 | (e) (e) (e) (e) |P=0.513N P=0.228 P=0.232 (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.506N P=0.233 P=0.234 (e) | |POLY 6 | (e) (e) (e) (e) |P=0.523N P=0.221 P=0.230 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.503N P=0.231 P=0.234 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.500N P=0.247 P=0.247 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Brain | | Oligodendroglioma, Glioma, or Astrocytoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 2/50 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 0/39.84 1/42.99 0/42.93 0/40.96 |0/43.71 2/41.94 2/42.78 0/42.54 | |POLY-3 PERCENT (g) | 0.0% 2.3% 0.0% 0.0% |0.0% 4.8% 4.7% 0.0% | |TERMINAL (d) | 0/20 (0%) 0/29 (0%) 0/26 (0%) 0/27 (0%) |0/33 (0%) 1/24 (4%) 0/29 (0%) 0/30 (0%) | |FIRST INCIDENCE | --- 608 --- --- |--- 667 689 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.574N P=0.500 (e) (e) |P=0.511N P=0.205 P=0.218 (e) | |POLY 3 | P=0.552N P=0.515 (e) (e) |P=0.513N P=0.228 P=0.232 (e) | |POLY 1.5 | P=0.560N P=0.507 (e) (e) |P=0.506N P=0.233 P=0.234 (e) | |POLY 6 | P=0.538N P=0.531 (e) (e) |P=0.523N P=0.221 P=0.230 (e) | |LOGISTIC REGRESSION| P=0.563N P=0.505 (e) (e) |P=0.503N P=0.231 P=0.234 (e) | |COCH-ARM / FISHERS | P=0.567N P=0.500 (e) (e) |P=0.500N P=0.247 P=0.247 (e) | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 4 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - VANADIUM PENTOXIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 3/49 (6%) 0/50 (0%) | |POLY-3 RATE (b) | 0/39.84 0/42.57 0/42.93 0/40.96 |2/43.71 0/41.70 3/42.20 0/42.54 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.6% 0.0% 7.1% 0.0% | |TERMINAL (d) | 0/20 (0%) 0/29 (0%) 0/26 (0%) 0/27 (0%) |2/33 (6%) 0/24 (0%) 2/29 (7%) 0/30 (0%) | |FIRST INCIDENCE | --- --- --- --- |731 (T) --- 698 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.308N P=0.311N P=0.446 P=0.259N | |POLY 3 | (e) (e) (e) (e) |P=0.296N P=0.248N P=0.484 P=0.243N | |POLY 1.5 | (e) (e) (e) (e) |P=0.296N P=0.242N P=0.486 P=0.240N | |POLY 6 | (e) (e) (e) (e) |P=0.297N P=0.256N P=0.480 P=0.248N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.308N (e) P=0.468 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.297N P=0.247N P=0.490 P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 2/49 (4%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 2/49 (4%) 3/50 (6%) | |POLY-3 RATE (b) | 0/39.84 2/43.91 2/43.12 2/41.21 |0/43.71 1/41.84 2/42.10 3/42.95 | |POLY-3 PERCENT (g) | 0.0% 4.6% 4.6% 4.9% |0.0% 2.4% 4.8% 7.0% | |TERMINAL (d) | 0/20 (0%) 0/29 (0%) 1/26 (4%) 1/27 (4%) |0/33 (0%) 0/24 (0%) 1/29 (3%) 2/30 (7%) | |FIRST INCIDENCE | --- 311 680 661 |--- 696 725 612 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.266 P=0.240 P=0.313 P=0.283 |P=0.065 P=0.472 P=0.215 P=0.109 | |POLY 3 | P=0.252 P=0.259 P=0.255 P=0.244 |P=0.060 P=0.491 P=0.229 P=0.115 | |POLY 1.5 | P=0.245 P=0.248 P=0.244 P=0.240 |P=0.061 P=0.496 P=0.230 P=0.117 | |POLY 6 | P=0.267 P=0.279 P=0.273 P=0.255 |P=0.059 P=0.484 P=0.226 P=0.113 | |LOGISTIC REGRESSION| P=0.247 P=0.318 P=0.262 P=0.245 |P=0.061 P=0.496 P=0.216 P=0.120 | |COCH-ARM / FISHERS | P=0.242 P=0.247 P=0.242 P=0.247 |P=0.062 P=0.500 P=0.242 P=0.121 | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 5 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - VANADIUM PENTOXIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 2/49 (4%) 2/50 (4%) |2/50 (4%) 1/50 (2%) 5/49 (10%) 3/50 (6%) | |POLY-3 RATE (b) | 0/39.84 2/43.91 2/43.12 2/41.21 |2/43.71 1/41.84 5/42.22 3/42.95 | |POLY-3 PERCENT (g) | 0.0% 4.6% 4.6% 4.9% |4.6% 2.4% 11.8% 7.0% | |TERMINAL (d) | 0/20 (0%) 0/29 (0%) 1/26 (4%) 1/27 (4%) |2/33 (6%) 0/24 (0%) 3/29 (10%) 2/30 (7%) | |FIRST INCIDENCE | --- 311 680 661 |731 (T) 696 698 612 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.266 P=0.240 P=0.313 P=0.283 |P=0.279 P=0.590N P=0.175 P=0.461 | |POLY 3 | P=0.252 P=0.259 P=0.255 P=0.244 |P=0.280 P=0.515N P=0.201 P=0.492 | |POLY 1.5 | P=0.245 P=0.248 P=0.244 P=0.240 |P=0.281 P=0.507N P=0.203 P=0.496 | |POLY 6 | P=0.267 P=0.279 P=0.273 P=0.255 |P=0.278 P=0.527N P=0.198 P=0.486 | |LOGISTIC REGRESSION| P=0.247 P=0.318 P=0.262 P=0.245 |P=0.273 P=0.537N P=0.185 P=0.489 | |COCH-ARM / FISHERS | P=0.242 P=0.247 P=0.242 P=0.247 |P=0.282 P=0.500N P=0.210 P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 1/49 (2%) 2/50 (4%) |1/49 (2%) 1/50 (2%) 1/49 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 1/39.84 3/42.57 1/42.98 2/40.96 |1/42.75 1/41.70 1/42.34 0/42.54 | |POLY-3 PERCENT (g) | 2.5% 7.1% 2.3% 4.9% |2.3% 2.4% 2.4% 0.0% | |TERMINAL (d) | 1/20 (5%) 3/29 (10%) 0/26 (0%) 2/27 (7%) |1/33 (3%) 1/24 (4%) 1/29 (3%) 0/30 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 717 729 (T) |731 (T) 731 (T) 731 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.605 P=0.445 P=0.685N P=0.605 |P=0.320N P=0.689 P=0.733 P=0.519N | |POLY 3 | P=0.539 P=0.329 P=0.744N P=0.510 |P=0.312N P=0.755 P=0.759 P=0.501N | |POLY 1.5 | P=0.531 P=0.315 P=0.754N P=0.503 |P=0.311N P=0.760 P=0.759 P=0.498N | |POLY 6 | P=0.557 P=0.355 P=0.727N P=0.525 |P=0.315N P=0.747 P=0.756 P=0.505N | |LOGISTIC REGRESSION| P=0.597 P=0.445 P=0.695N P=0.605 |P=0.320N P=0.689 P=0.733 (e) | |COCH-ARM / FISHERS | P=0.525 P=0.309 P=0.747 P=0.500 |P=0.309N P=0.747N P=0.753N P=0.495N | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 6 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - VANADIUM PENTOXIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 4/50 (8%) 3/49 (6%) 0/50 (0%) |1/49 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/39.84 4/42.63 3/42.96 0/40.96 |1/42.75 0/41.70 0/42.34 0/42.54 | |POLY-3 PERCENT (g) | 2.5% 9.4% 7.0% 0.0% |2.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/20 (5%) 3/29 (10%) 2/26 (8%) 0/27 (0%) |1/33 (3%) 0/24 (0%) 0/29 (0%) 0/30 (0%) | |FIRST INCIDENCE | 729 (T) 714 722 --- |731 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.168N P=0.312 P=0.414 P=0.440N |P=0.313N P=0.564N P=0.526N P=0.519N | |POLY 3 | P=0.218N P=0.199 P=0.332 P=0.494N |P=0.298N P=0.505N P=0.502N P=0.501N | |POLY 1.5 | P=0.227N P=0.187 P=0.316 P=0.498N |P=0.301N P=0.500N P=0.501N P=0.498N | |POLY 6 | P=0.199N P=0.223 P=0.359 P=0.486N |P=0.293N P=0.512N P=0.504N P=0.505N | |LOGISTIC REGRESSION| P=0.174N P=0.293 P=0.432 (e) |P=0.313N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.233N P=0.181 P=0.301 P=0.500N |P=0.304N P=0.495N P=0.500N P=0.495N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 7/50 (14%) 4/49 (8%) 2/50 (4%) |2/49 (4%) 1/50 (2%) 1/49 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 2/39.84 7/42.63 4/43.00 2/40.96 |2/42.75 1/41.70 1/42.34 0/42.54 | |POLY-3 PERCENT (g) | 5.0% 16.4% 9.3% 4.9% |4.7% 2.4% 2.4% 0.0% | |TERMINAL (d) | 2/20 (10%) 6/29 (21%) 2/26 (8%) 2/27 (7%) |2/33 (6%) 1/24 (4%) 1/29 (3%) 0/30 (0%) | |FIRST INCIDENCE | 729 (T) 714 717 729 (T) |731 (T) 731 (T) 731 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.236N P=0.200 P=0.484 P=0.584N |P=0.162N P=0.611N P=0.545N P=0.259N | |POLY 3 | P=0.319N P=0.094 P=0.372 P=0.685N |P=0.152N P=0.509N P=0.503N P=0.238N | |POLY 1.5 | P=0.333N P=0.085 P=0.351 P=0.691N |P=0.152N P=0.500N P=0.502N P=0.235N | |POLY 6 | P=0.291N P=0.113 P=0.408 P=0.670N |P=0.152N P=0.522N P=0.508N P=0.242N | |LOGISTIC REGRESSION| P=0.246N P=0.189 P=0.497 P=0.584N |P=0.162N P=0.611N P=0.545N (e) | |COCH-ARM / FISHERS | P=0.343N P=0.080 P=0.329 P=0.691N |P=0.151N P=0.492N P=0.500N P=0.242N | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 7 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - VANADIUM PENTOXIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 8/49 (16%) 5/48 (10%) 6/50 (12%) |0/49 (0%) 3/49 (6%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 4/39.84 8/42.69 5/42.92 6/42.22 |0/43.46 3/41.03 1/42.55 0/42.54 | |POLY-3 PERCENT (g) | 10.0% 18.7% 11.7% 14.2% |0.0% 7.3% 2.4% 0.0% | |TERMINAL (d) | 4/20 (20%) 7/29 (24%) 3/26 (12%) 3/27 (11%) |0/33 (0%) 2/24 (8%) 1/29 (3%) 0/30 (0%) | |FIRST INCIDENCE | 729 (T) 608 694 558 |--- 675 731 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.555N P=0.375 P=0.606N P=0.507 |P=0.375N P=0.085 P=0.474 (e) | |POLY 3 | P=0.500 P=0.209 P=0.547 P=0.405 |P=0.381N P=0.108 P=0.496 (e) | |POLY 1.5 | P=0.478 P=0.186 P=0.515 P=0.386 |P=0.371N P=0.113 P=0.499 (e) | |POLY 6 | P=0.541 P=0.255 P=0.596 P=0.446 |P=0.395N P=0.102 P=0.492 (e) | |LOGISTIC REGRESSION| P=0.475 P=0.315 P=0.584N P=0.385 |P=0.372N P=0.105 P=0.474 (e) | |COCH-ARM / FISHERS | P=0.457 P=0.168 P=0.474 P=0.370 |P=0.360N P=0.121 P=0.505 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/49 (6%) 1/48 (2%) 3/50 (6%) |0/49 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 0/39.84 3/42.56 1/42.77 3/40.96 |0/43.46 0/40.82 0/42.55 1/42.54 | |POLY-3 PERCENT (g) | 0.0% 7.1% 2.3% 7.3% |0.0% 0.0% 0.0% 2.4% | |TERMINAL (d) | 0/20 (0%) 2/29 (7%) 1/26 (4%) 3/27 (11%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 1/30 (3%) | |FIRST INCIDENCE | --- 652 729 (T) 729 (T) |--- --- --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.202 P=0.185 P=0.552 P=0.177 |P=0.204 (e) (e) P=0.481 | |POLY 3 | P=0.177 P=0.130 P=0.514 P=0.123 |P=0.199 (e) (e) P=0.496 | |POLY 1.5 | P=0.171 P=0.122 P=0.504 P=0.120 |P=0.200 (e) (e) P=0.500 | |POLY 6 | P=0.190 P=0.147 P=0.529 P=0.130 |P=0.198 (e) (e) P=0.491 | |LOGISTIC REGRESSION| P=0.176 P=0.135 P=0.552 P=0.177 |(e) (e) (e) P=0.481 | |COCH-ARM / FISHERS | P=0.167 P=0.117 P=0.490 P=0.121 |P=0.201 (e) (e) P=0.505 | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 8 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - VANADIUM PENTOXIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 10/49 (20%) 6/48 (13%) 9/50 (18%) |0/49 (0%) 3/49 (6%) 1/50 (2%) 1/50 (2%) | |POLY-3 RATE (b) | 4/39.84 10/42.98 6/42.92 9/42.22 |0/43.46 3/41.03 1/42.55 1/42.54 | |POLY-3 PERCENT (g) | 10.0% 23.3% 14.0% 21.3% |0.0% 7.3% 2.4% 2.4% | |TERMINAL (d) | 4/20 (20%) 8/29 (28%) 4/26 (15%) 6/27 (22%) |0/33 (0%) 2/24 (8%) 1/29 (3%) 1/30 (3%) | |FIRST INCIDENCE | 729 (T) 608 694 558 |--- 675 731 (T) 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.294 P=0.208 P=0.550 P=0.224 |P=0.582 P=0.085 P=0.474 P=0.481 | |POLY 3 | P=0.232 P=0.092 P=0.416 P=0.134 |P=0.575 P=0.108 P=0.496 P=0.496 | |POLY 1.5 | P=0.215 P=0.078 P=0.384 P=0.123 |P=0.586 P=0.113 P=0.499 P=0.500 | |POLY 6 | P=0.265 P=0.124 P=0.468 P=0.160 |P=0.560 P=0.102 P=0.492 P=0.491 | |LOGISTIC REGRESSION| P=0.212 P=0.140 P=0.584 P=0.134 |P=0.583 P=0.105 P=0.474 P=0.481 | |COCH-ARM / FISHERS | P=0.201 P=0.068 P=0.344 P=0.117 |P=0.598 P=0.121 P=0.505 P=0.505 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 2/50 (4%) 2/50 (4%) 3/50 (6%) | |POLY-3 RATE (b) | 0/39.84 1/42.57 0/43.82 0/40.96 |2/44.68 2/41.91 2/42.62 3/42.77 | |POLY-3 PERCENT (g) | 0.0% 2.4% 0.0% 0.0% |4.5% 4.8% 4.7% 7.0% | |TERMINAL (d) | 0/20 (0%) 1/29 (3%) 0/26 (0%) 0/27 (0%) |1/33 (3%) 1/24 (4%) 1/29 (3%) 2/30 (7%) | |FIRST INCIDENCE | --- 729 (T) --- --- |234 675 712 668 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.540N P=0.574 (e) (e) |P=0.382 P=0.630 P=0.654 P=0.472 | |POLY 3 | P=0.553N P=0.513 (e) (e) |P=0.374 P=0.671 P=0.677 P=0.480 | |POLY 1.5 | P=0.560N P=0.506 (e) (e) |P=0.379 P=0.680 P=0.682 P=0.487 | |POLY 6 | P=0.539N P=0.527 (e) (e) |P=0.370 P=0.658 P=0.671 P=0.472 | |LOGISTIC REGRESSION| (e) P=0.574 (e) (e) |P=0.388 P=0.697 P=0.670N P=0.500 | |COCH-ARM / FISHERS | P=0.567N P=0.500 (e) (e) |P=0.387 P=0.691N P=0.691N P=0.500 | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 9 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - VANADIUM PENTOXIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 2/50 (4%) 2/50 (4%) 3/50 (6%) | |POLY-3 RATE (b) | 0/39.84 1/42.57 0/43.82 0/40.96 |3/44.68 2/41.91 2/42.62 3/42.77 | |POLY-3 PERCENT (g) | 0.0% 2.4% 0.0% 0.0% |6.7% 4.8% 4.7% 7.0% | |TERMINAL (d) | 0/20 (0%) 1/29 (3%) 0/26 (0%) 0/27 (0%) |2/33 (6%) 1/24 (4%) 1/29 (3%) 2/30 (7%) | |FIRST INCIDENCE | --- 729 (T) --- --- |234 675 712 668 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.540N P=0.574 (e) (e) |P=0.534 P=0.590N P=0.550N P=0.630 | |POLY 3 | P=0.553N P=0.513 (e) (e) |P=0.533 P=0.529N P=0.521N P=0.642 | |POLY 1.5 | P=0.560N P=0.506 (e) (e) |P=0.536 P=0.517N P=0.516N P=0.649 | |POLY 6 | P=0.539N P=0.527 (e) (e) |P=0.529 P=0.545N P=0.529N P=0.635 | |LOGISTIC REGRESSION| (e) P=0.574 (e) (e) |P=0.546 P=0.494N P=0.476N P=0.662N | |COCH-ARM / FISHERS | P=0.567N P=0.500 (e) (e) |P=0.544 P=0.500N P=0.500N P=0.661N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |16/50 (32%) 13/50 (26%) 20/50 (40%) 21/50 (42%) | |POLY-3 RATE (b) | 2/39.84 2/42.65 1/43.82 0/40.96 |16/44.85 13/43.11 20/44.11 21/43.44 | |POLY-3 PERCENT (g) | 5.0% 4.7% 2.3% 0.0% |35.7% 30.2% 45.3% 48.4% | |TERMINAL (d) | 2/20 (10%) 1/29 (3%) 1/26 (4%) 0/27 (0%) |13/33 (39%) 7/24 (29%) 13/29 (45%) 18/30 (60%) | |FIRST INCIDENCE | 729 (T) 708 729 (T) --- |458 608 570 617 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.093N P=0.553N P=0.408N P=0.174N |P=0.083 P=0.528 P=0.161 P=0.113 | |POLY 3 | P=0.122N P=0.670N P=0.467N P=0.230N |P=0.065 P=0.372N P=0.235 P=0.156 | |POLY 1.5 | P=0.124N P=0.683N P=0.482N P=0.235N |P=0.073 P=0.352N P=0.243 P=0.176 | |POLY 6 | P=0.117N P=0.642N P=0.442N P=0.221N |P=0.056 P=0.399N P=0.231 P=0.135 | |LOGISTIC REGRESSION| P=0.093N P=0.578N P=0.408N (e) |P=0.072 P=0.374N P=0.233 P=0.158 | |COCH-ARM / FISHERS | P=0.125N P=0.691N P=0.500N P=0.247N |P=0.088 P=0.330N P=0.266 P=0.204 | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 10 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - VANADIUM PENTOXIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |17/50 (34%) 13/50 (26%) 20/50 (40%) 21/50 (42%) | |POLY-3 RATE (b) | 2/39.84 2/42.65 1/43.82 0/40.96 |17/44.85 13/43.11 20/44.11 21/43.44 | |POLY-3 PERCENT (g) | 5.0% 4.7% 2.3% 0.0% |37.9% 30.2% 45.3% 48.4% | |TERMINAL (d) | 2/20 (10%) 1/29 (3%) 1/26 (4%) 0/27 (0%) |14/33 (42%) 7/24 (29%) 13/29 (45%) 18/30 (60%) | |FIRST INCIDENCE | 729 (T) 708 729 (T) --- |458 608 570 617 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.093N P=0.553N P=0.408N P=0.174N |P=0.112 P=0.570N P=0.211 P=0.157 | |POLY 3 | P=0.122N P=0.670N P=0.467N P=0.230N |P=0.092 P=0.293N P=0.308 P=0.215 | |POLY 1.5 | P=0.124N P=0.683N P=0.482N P=0.235N |P=0.103 P=0.275N P=0.315 P=0.238 | |POLY 6 | P=0.117N P=0.642N P=0.442N P=0.221N |P=0.082 P=0.316N P=0.304 P=0.190 | |LOGISTIC REGRESSION| P=0.093N P=0.578N P=0.408N (e) |P=0.100 P=0.298N P=0.301 P=0.214 | |COCH-ARM / FISHERS | P=0.125N P=0.691N P=0.500N P=0.247N |P=0.120 P=0.257N P=0.339 P=0.268 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |19/50 (38%) 14/50 (28%) 22/50 (44%) 22/50 (44%) | |POLY-3 RATE (b) | 2/39.84 2/42.65 1/43.82 0/40.96 |19/45.82 14/43.32 22/44.18 22/43.68 | |POLY-3 PERCENT (g) | 5.0% 4.7% 2.3% 0.0% |41.5% 32.3% 49.8% 50.4% | |TERMINAL (d) | 2/20 (10%) 1/29 (3%) 1/26 (4%) 0/27 (0%) |15/33 (46%) 7/24 (29%) 14/29 (48%) 18/30 (60%) | |FIRST INCIDENCE | 729 (T) 708 729 (T) --- |234 608 570 617 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.093N P=0.553N P=0.408N P=0.174N |P=0.150 P=0.501N P=0.209 P=0.220 | |POLY 3 | P=0.122N P=0.670N P=0.467N P=0.230N |P=0.112 P=0.248N P=0.278 P=0.260 | |POLY 1.5 | P=0.124N P=0.683N P=0.482N P=0.235N |P=0.126 P=0.229N P=0.291 P=0.288 | |POLY 6 | P=0.117N P=0.642N P=0.442N P=0.221N |P=0.101 P=0.267N P=0.273 P=0.235 | |LOGISTIC REGRESSION| P=0.093N P=0.578N P=0.408N (e) |P=0.141 P=0.207N P=0.320 P=0.317 | |COCH-ARM / FISHERS | P=0.125N P=0.691N P=0.500N P=0.247N |P=0.157 P=0.198N P=0.342 P=0.342 | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 11 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - VANADIUM PENTOXIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | 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) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 0/39.84 2/43.09 0/43.82 1/41.46 |0/43.71 2/42.37 1/42.74 0/42.54 | |POLY-3 PERCENT (g) | 0.0% 4.6% 0.0% 2.4% |0.0% 4.7% 2.3% 0.0% | |TERMINAL (d) | 0/20 (0%) 1/29 (3%) 0/26 (0%) 0/27 (0%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) | |FIRST INCIDENCE | --- 571 --- 578 |--- 571 680 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.542 P=0.278 (e) P=0.482 |P=0.471N P=0.228 P=0.500 (e) | |POLY 3 | P=0.560 P=0.255 (e) P=0.508 |P=0.472N P=0.230 P=0.496 (e) | |POLY 1.5 | P=0.548 P=0.245 (e) P=0.503 |P=0.466N P=0.234 P=0.497 (e) | |POLY 6 | P=0.582 P=0.273 (e) P=0.518 |P=0.481N P=0.224 P=0.493 (e) | |LOGISTIC REGRESSION| P=0.541 P=0.234 (e) P=0.519 |P=0.459N P=0.239 P=0.501 (e) | |COCH-ARM / FISHERS | P=0.539 P=0.247 (e) P=0.500 |P=0.461N P=0.247 P=0.500 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | 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) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 3/50 (6%) 2/50 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 0/39.84 2/43.09 0/43.82 2/41.67 |0/43.71 3/42.37 2/43.42 0/42.54 | |POLY-3 PERCENT (g) | 0.0% 4.6% 0.0% 4.8% |0.0% 7.1% 4.6% 0.0% | |TERMINAL (d) | 0/20 (0%) 1/29 (3%) 0/26 (0%) 0/27 (0%) |0/33 (0%) 1/24 (4%) 0/29 (0%) 0/30 (0%) | |FIRST INCIDENCE | --- 571 --- 578 |--- 571 499 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.255 P=0.278 (e) P=0.254 |P=0.420N P=0.100 P=0.240 (e) | |POLY 3 | P=0.263 P=0.255 (e) P=0.247 |P=0.423N P=0.113 P=0.236 (e) | |POLY 1.5 | P=0.254 P=0.245 (e) P=0.241 |P=0.416N P=0.116 P=0.236 (e) | |POLY 6 | P=0.280 P=0.273 (e) P=0.259 |P=0.434N P=0.108 P=0.234 (e) | |LOGISTIC REGRESSION| P=0.251 P=0.234 (e) P=0.241 |P=0.406N P=0.123 P=0.255 (e) | |COCH-ARM / FISHERS | P=0.247 P=0.247 (e) P=0.247 |P=0.409N P=0.121 P=0.247 (e) | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 12 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - VANADIUM PENTOXIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Oral Mucosa | | Squamous Cell Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/39.84 2/43.09 0/43.82 0/40.96 |0/43.71 1/42.22 0/42.55 0/42.54 | |POLY-3 PERCENT (g) | 0.0% 4.6% 0.0% 0.0% |0.0% 2.4% 0.0% 0.0% | |TERMINAL (d) | 0/20 (0%) 1/29 (3%) 0/26 (0%) 0/27 (0%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) | |FIRST INCIDENCE | --- 571 --- --- |--- 571 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.393N P=0.278 (e) (e) |P=0.567N P=0.500 (e) (e) | |POLY 3 | P=0.383N P=0.255 (e) (e) |P=0.574N P=0.493 (e) (e) | |POLY 1.5 | P=0.395N P=0.245 (e) (e) |P=0.570N P=0.497 (e) (e) | |POLY 6 | P=0.362N P=0.273 (e) (e) |P=0.579N P=0.487 (e) (e) | |LOGISTIC REGRESSION| P=0.406N P=0.234 (e) (e) |P=0.570N P=0.488 (e) (e) | |COCH-ARM / FISHERS | P=0.405N P=0.247 (e) (e) |P=0.567N P=0.500 (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 35/50 (70%) 35/50 (70%) 39/50 (78%) 32/50 (64%) |31/49 (63%) 29/50 (58%) 24/49 (49%) 30/50 (60%) | |POLY-3 RATE (b) | 35/45.87 35/45.18 39/48.10 32/45.64 |31/45.50 29/45.48 24/43.58 30/45.10 | |POLY-3 PERCENT (g) | 76.3% 77.5% 81.1% 70.1% |68.1% 63.8% 55.1% 66.5% | |TERMINAL (d) | 14/20 (70%) 24/29 (83%) 20/26 (77%) 19/27 (70%) |24/33 (73%) 15/24 (63%) 18/29 (62%) 19/30 (63%) | |FIRST INCIDENCE | 477 485 519 332 |458 408 617 569 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.124N P=0.069N P=0.268N P=0.105N |P=0.497N P=0.236 P=0.281N P=0.461 | |POLY 3 | P=0.263N P=0.550 P=0.371 P=0.324N |P=0.469N P=0.411N P=0.140N P=0.525N | |POLY 1.5 | P=0.279N P=0.553 P=0.310 P=0.330N |P=0.445N P=0.383N P=0.126N P=0.491N | |POLY 6 | P=0.238N P=0.560 P=0.470 P=0.311N |P=0.489N P=0.455N P=0.166N P=0.555N | |LOGISTIC REGRESSION| P=0.297N P=0.492N P=0.352 P=0.322N |P=0.426N P=0.412N P=0.108N P=0.491N | |COCH-ARM / FISHERS | P=0.309N P=0.586N P=0.247 P=0.335N |P=0.409N P=0.371N P=0.111N P=0.449N | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 13 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - VANADIUM PENTOXIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Skin | | Basal Cell Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/39.84 2/42.65 1/43.82 0/40.96 |0/43.71 0/41.70 0/42.55 0/42.54 | |POLY-3 PERCENT (g) | 0.0% 4.7% 2.3% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/20 (0%) 1/29 (3%) 1/26 (4%) 0/27 (0%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) | |FIRST INCIDENCE | --- 708 729 (T) --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.417N P=0.327 P=0.552 (e) |(e) (e) (e) (e) | |POLY 3 | P=0.444N P=0.252 P=0.519 (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.454N P=0.244 P=0.510 (e) |(e) (e) (e) (e) | |POLY 6 | P=0.425N P=0.270 P=0.533 (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.430N P=0.291 P=0.552 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.461N P=0.247 P=0.500 (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | 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) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/39.84 2/42.65 1/43.82 1/40.96 |0/43.71 0/41.70 0/42.55 0/42.54 | |POLY-3 PERCENT (g) | 0.0% 4.7% 2.3% 2.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/20 (0%) 1/29 (3%) 1/26 (4%) 1/27 (4%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) | |FIRST INCIDENCE | --- 708 729 (T) 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.552 P=0.327 P=0.552 P=0.560 |(e) (e) (e) (e) | |POLY 3 | P=0.514 P=0.252 P=0.519 P=0.506 |(e) (e) (e) (e) | |POLY 1.5 | P=0.505 P=0.244 P=0.510 P=0.502 |(e) (e) (e) (e) | |POLY 6 | P=0.534 P=0.270 P=0.533 P=0.514 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.539 P=0.291 P=0.552 P=0.560 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.500 P=0.247 P=0.500 P=0.500 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 14 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - VANADIUM PENTOXIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | 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) | 0/50 (0%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/39.84 2/42.65 2/43.82 2/41.21 |0/43.71 0/41.70 0/42.55 0/42.54 | |POLY-3 PERCENT (g) | 0.0% 4.7% 4.6% 4.9% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/20 (0%) 1/29 (3%) 2/26 (8%) 1/27 (4%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) | |FIRST INCIDENCE | --- 708 729 (T) 661 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.284 P=0.327 P=0.297 P=0.283 |(e) (e) (e) (e) | |POLY 3 | P=0.254 P=0.252 P=0.259 P=0.244 |(e) (e) (e) (e) | |POLY 1.5 | P=0.247 P=0.244 P=0.249 P=0.240 |(e) (e) (e) (e) | |POLY 6 | P=0.270 P=0.270 P=0.276 P=0.255 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.253 P=0.291 P=0.297 P=0.245 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.242 P=0.247 P=0.247 P=0.247 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | 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) | 5/50 (10%) 8/50 (16%) 4/50 (8%) 4/50 (8%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 5/40.28 8/42.87 4/44.35 4/41.85 |0/43.71 1/42.30 0/42.55 0/42.54 | |POLY-3 PERCENT (g) | 12.4% 18.7% 9.0% 9.6% |0.0% 2.4% 0.0% 0.0% | |TERMINAL (d) | 3/20 (15%) 6/29 (21%) 2/26 (8%) 1/27 (4%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) | |FIRST INCIDENCE | 666 673 655 552 |--- 540 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.200N P=0.535 P=0.342N P=0.375N |P=0.567N P=0.500 (e) (e) | |POLY 3 | P=0.254N P=0.315 P=0.440N P=0.476N |P=0.573N P=0.493 (e) (e) | |POLY 1.5 | P=0.267N P=0.292 P=0.468N P=0.490N |P=0.570N P=0.497 (e) (e) | |POLY 6 | P=0.230N P=0.361 P=0.396N P=0.446N |P=0.578N P=0.487 (e) (e) | |LOGISTIC REGRESSION| P=0.264N P=0.414 P=0.427N P=0.488N |P=0.573N P=0.476 (e) (e) | |COCH-ARM / FISHERS | P=0.279N P=0.277 P=0.500N P=0.500N |P=0.567N P=0.500 (e) (e) | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 15 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - VANADIUM PENTOXIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Skin | | Fibroma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 4/50 (8%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | |POLY-3 RATE (b) | 2/40.22 0/42.57 4/43.85 2/40.96 |1/43.95 0/41.70 1/42.63 1/42.54 | |POLY-3 PERCENT (g) | 5.0% 0.0% 9.1% 4.9% |2.3% 0.0% 2.4% 2.4% | |TERMINAL (d) | 1/20 (5%) 0/29 (0%) 3/26 (12%) 2/27 (7%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 1/30 (3%) | |FIRST INCIDENCE | 624 --- 722 729 (T) |666 --- 710 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.476 P=0.192N P=0.465 P=0.609N |P=0.527 P=0.510N P=0.742 P=0.741 | |POLY 3 | P=0.396 P=0.224N P=0.377 P=0.688N |P=0.537 P=0.510N P=0.754 P=0.754 | |POLY 1.5 | P=0.399 P=0.232N P=0.359 P=0.692N |P=0.538 P=0.505N P=0.756 P=0.757 | |POLY 6 | P=0.396 P=0.211N P=0.408 P=0.676N |P=0.536 P=0.519N P=0.750 P=0.748 | |LOGISTIC REGRESSION| P=0.428 P=0.236N P=0.428 P=0.673N |P=0.536 P=0.497N P=0.762 P=0.760 | |COCH-ARM / FISHERS | P=0.404 P=0.247N P=0.339 P=0.691N |P=0.539 P=0.500N P=0.753N P=0.753N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | 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) | 6/50 (12%) 1/50 (2%) 5/50 (10%) 3/50 (6%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | |POLY-3 RATE (b) | 6/41.38 1/42.65 5/44.13 3/41.81 |1/43.95 1/41.76 1/42.63 1/42.54 | |POLY-3 PERCENT (g) | 14.5% 2.3% 11.3% 7.2% |2.3% 2.4% 2.4% 2.4% | |TERMINAL (d) | 1/20 (5%) 0/29 (0%) 3/26 (12%) 2/27 (7%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 1/30 (3%) | |FIRST INCIDENCE | 612 708 655 390 |666 717 710 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.285N P=0.035N* P=0.338N P=0.194N |P=0.617 P=0.727 P=0.742 P=0.741 | |POLY 3 | P=0.341N P=0.050N P=0.455N P=0.235N |P=0.626 P=0.749 P=0.754 P=0.754 | |POLY 1.5 | P=0.340N P=0.054N P=0.475N P=0.239N |P=0.629 P=0.755 P=0.756 P=0.757 | |POLY 6 | P=0.345N P=0.043N* P=0.424N P=0.226N |P=0.620 P=0.740 P=0.750 P=0.748 | |LOGISTIC REGRESSION| P=0.343N P=0.060N P=0.489N P=0.241N |P=0.629 P=0.760 P=0.762 P=0.760 | |COCH-ARM / FISHERS | P=0.341N P=0.056N P=0.500N P=0.243N |P=0.634 P=0.753N P=0.753N P=0.753N | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 16 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - VANADIUM PENTOXIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 4/41.00 1/42.65 1/44.10 1/41.81 |0/43.71 1/41.76 0/42.55 0/42.54 | |POLY-3 PERCENT (g) | 9.8% 2.3% 2.3% 2.4% |0.0% 2.4% 0.0% 0.0% | |TERMINAL (d) | 0/20 (0%) 0/29 (0%) 0/26 (0%) 0/27 (0%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) | |FIRST INCIDENCE | 612 708 655 390 |--- 717 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.124N P=0.127N P=0.124N P=0.173N |P=0.575N P=0.450 (e) (e) | |POLY 3 | P=0.133N P=0.166N P=0.157N P=0.171N |P=0.575N P=0.491 (e) (e) | |POLY 1.5 | P=0.133N P=0.174N P=0.167N P=0.176N |P=0.571N P=0.496 (e) (e) | |POLY 6 | P=0.134N P=0.151N P=0.142N P=0.164N |P=0.580N P=0.484 (e) (e) | |LOGISTIC REGRESSION| P=0.134N P=0.183N P=0.209N P=0.158N |P=0.571N P=0.482 (e) (e) | |COCH-ARM / FISHERS | P=0.134N P=0.181N P=0.181N P=0.181N |P=0.567N P=0.500 (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Skin | | Fibrous Histiocytoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/40.31 0/42.57 0/43.82 0/40.96 |0/43.71 0/41.70 0/42.55 0/42.54 | |POLY-3 PERCENT (g) | 5.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/20 (0%) 0/29 (0%) 0/26 (0%) 0/27 (0%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) | |FIRST INCIDENCE | 638 --- --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.103N P=0.191N P=0.184N P=0.221N |(e) (e) (e) (e) | |POLY 3 | P=0.116N P=0.225N P=0.219N P=0.233N |(e) (e) (e) (e) | |POLY 1.5 | P=0.114N P=0.232N P=0.227N P=0.236N |(e) (e) (e) (e) | |POLY 6 | P=0.120N P=0.212N P=0.206N P=0.226N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.116N P=0.239N P=0.247N P=0.238N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 17 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - VANADIUM PENTOXIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 6/50 (12%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 4/40.08 6/42.78 2/44.35 2/41.59 |0/43.71 1/42.30 0/42.55 0/42.54 | |POLY-3 PERCENT (g) | 10.0% 14.0% 4.5% 4.8% |0.0% 2.4% 0.0% 0.0% | |TERMINAL (d) | 3/20 (15%) 5/29 (17%) 0/26 (0%) 0/27 (0%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) | |FIRST INCIDENCE | 666 673 655 552 |--- 540 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.107N P=0.601 P=0.233N P=0.248N |P=0.567N P=0.500 (e) (e) | |POLY 3 | P=0.136N P=0.410 P=0.291N P=0.319N |P=0.573N P=0.493 (e) (e) | |POLY 1.5 | P=0.144N P=0.387 P=0.312N P=0.330N |P=0.570N P=0.497 (e) (e) | |POLY 6 | P=0.123N P=0.456 P=0.258N P=0.297N |P=0.578N P=0.487 (e) (e) | |LOGISTIC REGRESSION| P=0.144N P=0.522 P=0.298N P=0.328N |P=0.573N P=0.476 (e) (e) | |COCH-ARM / FISHERS | P=0.151N P=0.370 P=0.339N P=0.339N |P=0.567N P=0.500 (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Skin | | Lipoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/39.95 0/42.57 3/44.10 1/40.96 |0/43.71 0/41.70 0/42.55 0/42.54 | |POLY-3 PERCENT (g) | 5.0% 0.0% 6.8% 2.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/20 (5%) 0/29 (0%) 2/26 (8%) 1/27 (4%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) | |FIRST INCIDENCE | 701 --- 655 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.503N P=0.169N P=0.622 P=0.414N |(e) (e) (e) (e) | |POLY 3 | P=0.561N P=0.223N P=0.545 P=0.491N |(e) (e) (e) (e) | |POLY 1.5 | P=0.558N P=0.231N P=0.524 P=0.497N |(e) (e) (e) (e) | |POLY 6 | P=0.563N P=0.208N P=0.578 P=0.478N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.538N P=0.188N P=0.583 P=0.439N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.556N P=0.247N P=0.500 P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 18 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - VANADIUM PENTOXIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | 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) | 5/50 (10%) 7/50 (14%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 5/40.28 7/42.78 2/44.35 2/41.59 |0/43.71 1/42.30 0/42.55 0/42.54 | |POLY-3 PERCENT (g) | 12.4% 16.4% 4.5% 4.8% |0.0% 2.4% 0.0% 0.0% | |TERMINAL (d) | 3/20 (15%) 6/29 (21%) 0/26 (0%) 0/27 (0%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) | |FIRST INCIDENCE | 666 673 655 552 |--- 540 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.051N P=0.611N P=0.131N P=0.146N |P=0.567N P=0.500 (e) (e) | |POLY 3 | P=0.068N P=0.421 P=0.178N P=0.201N |P=0.573N P=0.493 (e) (e) | |POLY 1.5 | P=0.073N P=0.397 P=0.195N P=0.210N |P=0.570N P=0.497 (e) (e) | |POLY 6 | P=0.060N P=0.469 P=0.152N P=0.184N |P=0.578N P=0.487 (e) (e) | |LOGISTIC REGRESSION| P=0.073N P=0.529 P=0.188N P=0.210N |P=0.573N P=0.476 (e) (e) | |COCH-ARM / FISHERS | P=0.079N P=0.380 P=0.218N P=0.218N |P=0.567N P=0.500 (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, or Keratoacanthoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 7/50 (14%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 5/40.28 7/42.78 2/44.35 2/41.59 |0/43.71 1/42.30 0/42.55 0/42.54 | |POLY-3 PERCENT (g) | 12.4% 16.4% 4.5% 4.8% |0.0% 2.4% 0.0% 0.0% | |TERMINAL (d) | 3/20 (15%) 6/29 (21%) 0/26 (0%) 0/27 (0%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) | |FIRST INCIDENCE | 666 673 655 552 |--- 540 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.051N P=0.611N P=0.131N P=0.146N |P=0.567N P=0.500 (e) (e) | |POLY 3 | P=0.068N P=0.421 P=0.178N P=0.201N |P=0.573N P=0.493 (e) (e) | |POLY 1.5 | P=0.073N P=0.397 P=0.195N P=0.210N |P=0.570N P=0.497 (e) (e) | |POLY 6 | P=0.060N P=0.469 P=0.152N P=0.184N |P=0.578N P=0.487 (e) (e) | |LOGISTIC REGRESSION| P=0.073N P=0.529 P=0.188N P=0.210N |P=0.573N P=0.476 (e) (e) | |COCH-ARM / FISHERS | P=0.079N P=0.380 P=0.218N P=0.218N |P=0.567N P=0.500 (e) (e) | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 19 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - VANADIUM PENTOXIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Testes | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 36/50 (72%) 32/50 (64%) 34/50 (68%) 34/50 (68%) | | |POLY-3 RATE (b) | 36/45.75 32/45.25 34/45.67 34/43.31 | | |POLY-3 PERCENT (g) | 78.7% 70.7% 74.5% 78.5% | | |TERMINAL (d) | 18/20 (90%) 21/29 (72%) 23/26 (89%) 25/27 (93%) | | |FIRST INCIDENCE | 502 571 584 533 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.148N P=0.017N* P=0.046N* P=0.060N | | |POLY 3 | P=0.460 P=0.252N P=0.402N P=0.604N | | |POLY 1.5 | P=0.536 P=0.268N P=0.406N P=0.519N | | |POLY 6 | P=0.349 P=0.202N P=0.397N P=0.538 | | |LOGISTIC REGRESSION| P=0.429N P=0.174N P=0.182N P=0.362N | | |COCH-ARM / FISHERS | P=0.459N P=0.260N P=0.414N P=0.414N | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 4/50 (8%) 4/49 (8%) 2/50 (4%) |2/50 (4%) 4/50 (8%) 4/50 (8%) 3/50 (6%) | |POLY-3 RATE (b) | 1/40.17 4/42.85 4/43.04 2/41.13 |2/44.04 4/41.76 4/42.84 3/42.56 | |POLY-3 PERCENT (g) | 2.5% 9.3% 9.3% 4.9% |4.5% 9.6% 9.3% 7.1% | |TERMINAL (d) | 0/20 (0%) 3/29 (10%) 2/26 (8%) 1/27 (4%) |1/33 (3%) 3/24 (13%) 3/29 (10%) 2/30 (7%) | |FIRST INCIDENCE | 638 652 712 684 |638 717 652 725 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.566N P=0.281 P=0.291 P=0.565 |P=0.470 P=0.224 P=0.301 P=0.462 | |POLY 3 | P=0.532 P=0.198 P=0.199 P=0.508 |P=0.462 P=0.312 P=0.324 P=0.484 | |POLY 1.5 | P=0.524 P=0.187 P=0.187 P=0.503 |P=0.472 P=0.325 P=0.329 P=0.492 | |POLY 6 | P=0.554 P=0.221 P=0.221 P=0.522 |P=0.448 P=0.293 P=0.316 P=0.473 | |LOGISTIC REGRESSION| P=0.538 P=0.196 P=0.216 P=0.505 |P=0.466 P=0.303 P=0.328 P=0.485 | |COCH-ARM / FISHERS | P=0.520 P=0.181 P=0.175 P=0.500 |P=0.481 P=0.339 P=0.339 P=0.500 | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 20 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - VANADIUM PENTOXIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 4/50 (8%) 5/49 (10%) 3/50 (6%) |3/50 (6%) 5/50 (10%) 4/50 (8%) 3/50 (6%) | |POLY-3 RATE (b) | 1/40.17 4/42.85 5/43.61 3/41.13 |3/44.42 5/41.76 4/42.84 3/42.56 | |POLY-3 PERCENT (g) | 2.5% 9.3% 11.5% 7.3% |6.8% 12.0% 9.3% 7.1% | |TERMINAL (d) | 0/20 (0%) 3/29 (10%) 2/26 (8%) 2/27 (7%) |1/33 (3%) 4/24 (17%) 3/29 (10%) 2/30 (7%) | |FIRST INCIDENCE | 638 652 551 684 |625 717 652 725 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.408 P=0.281 P=0.180 P=0.387 |P=0.495N P=0.231 P=0.457 P=0.622 | |POLY 3 | P=0.340 P=0.198 P=0.120 P=0.313 |P=0.504N P=0.322 P=0.480 P=0.643 | |POLY 1.5 | P=0.333 P=0.187 P=0.109 P=0.308 |P=0.493N P=0.340 P=0.488 P=0.653 | |POLY 6 | P=0.359 P=0.221 P=0.140 P=0.327 |P=0.521N P=0.296 P=0.468 P=0.628 | |LOGISTIC REGRESSION| P=0.336 P=0.196 P=0.096 P=0.318 |P=0.494N P=0.333 P=0.496 P=0.659 | |COCH-ARM / FISHERS | P=0.331 P=0.181 P=0.098 P=0.309 |P=0.482N P=0.357 P=0.500 P=0.661N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/39.84 0/42.57 1/42.93 0/40.96 |2/43.74 0/41.70 0/42.55 0/42.54 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.3% 0.0% |4.6% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/20 (0%) 0/29 (0%) 1/26 (4%) 0/27 (0%) |1/33 (3%) 0/24 (0%) 0/29 (0%) 0/30 (0%) | |FIRST INCIDENCE | --- --- 729 (T) --- |722 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.722 (e) P=0.552 (e) |P=0.124N P=0.311N P=0.268N P=0.261N | |POLY 3 | P=0.693 (e) P=0.515 (e) |P=0.110N P=0.248N P=0.243N P=0.243N | |POLY 1.5 | P=0.691 (e) P=0.506 (e) |P=0.112N P=0.242N P=0.241N P=0.240N | |POLY 6 | P=0.699 (e) P=0.529 (e) |P=0.107N P=0.257N P=0.247N P=0.248N | |LOGISTIC REGRESSION| (e) (e) P=0.552 (e) |P=0.121N P=0.274N P=0.255N P=0.254N | |COCH-ARM / FISHERS | P=0.694 (e) P=0.495 (e) |P=0.115N P=0.247N P=0.247N P=0.247N | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 21 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - VANADIUM PENTOXIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Tongue | | Squamous Cell Carcinoma or Papilloma Squamous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 0/39.84 0/42.57 0/43.82 1/41.46 |0/43.71 2/41.84 1/42.74 0/42.54 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.4% |0.0% 4.8% 2.3% 0.0% | |TERMINAL (d) | 0/20 (0%) 0/29 (0%) 0/26 (0%) 0/27 (0%) |0/33 (0%) 1/24 (4%) 0/29 (0%) 0/30 (0%) | |FIRST INCIDENCE | --- --- --- 578 |--- 695 680 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.189 (e) (e) P=0.482 |P=0.473N P=0.194 P=0.500 (e) | |POLY 3 | P=0.201 (e) (e) P=0.508 |P=0.473N P=0.227 P=0.496 (e) | |POLY 1.5 | P=0.200 (e) (e) P=0.503 |P=0.467N P=0.232 P=0.497 (e) | |POLY 6 | P=0.203 (e) (e) P=0.518 |P=0.482N P=0.220 P=0.493 (e) | |LOGISTIC REGRESSION| P=0.207 (e) (e) P=0.519 |P=0.464N P=0.221 P=0.501 (e) | |COCH-ARM / FISHERS | P=0.198 (e) (e) P=0.500 |P=0.461N P=0.247 P=0.500 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |6/50 (12%) 3/50 (6%) 7/50 (14%) 13/50 (26%) | |POLY-3 RATE (b) | |6/44.18 3/41.90 7/44.02 13/43.28 | |POLY-3 PERCENT (g) | |13.6% 7.2% 15.9% 30.0% | |TERMINAL (d) | |4/33 (12%) 1/24 (4%) 5/29 (17%) 8/30 (27%) | |FIRST INCIDENCE | |624 694 433 612 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.011 * P=0.379N P=0.419 P=0.047 * | |POLY 3 | |P=0.008 ** P=0.268N P=0.497 P=0.051 | |POLY 1.5 | |P=0.008 ** P=0.255N P=0.499 P=0.056 | |POLY 6 | |P=0.008 ** P=0.289N P=0.487 P=0.046 * | |LOGISTIC REGRESSION| |P=0.009 ** P=0.272N P=0.502 P=0.050 | |COCH-ARM / FISHERS | |P=0.010 * P=0.243N P=0.500 P=0.062 | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 22 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - VANADIUM PENTOXIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |6/50 (12%) 3/50 (6%) 7/50 (14%) 14/50 (28%) | |POLY-3 RATE (b) | |6/44.18 3/41.90 7/44.02 14/43.80 | |POLY-3 PERCENT (g) | |13.6% 7.2% 15.9% 32.0% | |TERMINAL (d) | |4/33 (12%) 1/24 (4%) 5/29 (17%) 8/30 (27%) | |FIRST INCIDENCE | |624 694 433 569 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.006 ** P=0.379N P=0.419 P=0.031 * | |POLY 3 | |P=0.004 ** P=0.268N P=0.497 P=0.033 * | |POLY 1.5 | |P=0.004 ** P=0.255N P=0.499 P=0.035 * | |POLY 6 | |P=0.004 ** P=0.289N P=0.487 P=0.030 * | |LOGISTIC REGRESSION| |P=0.004 ** P=0.272N P=0.502 P=0.034 * | |COCH-ARM / FISHERS | |P=0.005 ** P=0.243N P=0.500 P=0.039 * | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or | | Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 22/50 (44%) 21/50 (42%) 19/50 (38%) 17/50 (34%) |21/50 (42%) 23/50 (46%) 22/50 (44%) 15/50 (30%) | |POLY-3 RATE (b) | 22/46.05 21/44.98 19/46.40 17/43.33 |21/46.50 23/45.82 22/46.05 15/44.82 | |POLY-3 PERCENT (g) | 47.8% 46.7% 41.0% 39.2% |45.2% 50.2% 47.8% 33.5% | |TERMINAL (d) | 4/20 (20%) 13/29 (45%) 6/26 (23%) 9/27 (33%) |11/33 (33%) 8/24 (33%) 10/29 (35%) 8/30 (27%) | |FIRST INCIDENCE | 502 493 528 552 |519 366 421 514 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.105N P=0.207N P=0.146N P=0.128N |P=0.159N P=0.183 P=0.372 P=0.263N | |POLY 3 | P=0.205N P=0.543N P=0.324N P=0.271N |P=0.108N P=0.391 P=0.483 P=0.175N | |POLY 1.5 | P=0.185N P=0.533N P=0.332N P=0.245N |P=0.098N P=0.414 P=0.492 P=0.159N | |POLY 6 | P=0.228N P=0.542N P=0.312N P=0.301N |P=0.129N P=0.348 P=0.457 P=0.204N | |LOGISTIC REGRESSION| P=0.157N P=0.509N P=0.431N P=0.208N |P=0.090N P=0.420 P=0.496 P=0.151N | |COCH-ARM / FISHERS | P=0.158N P=0.500N P=0.342N P=0.206N |P=0.090N P=0.420 P=0.500 P=0.149N | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 23 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - VANADIUM PENTOXIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Benign, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 3/50 (6%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/40.13 0/42.57 3/43.89 0/40.96 |0/43.71 0/41.70 0/42.55 0/42.54 | |POLY-3 PERCENT (g) | 2.5% 0.0% 6.8% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/20 (0%) 0/29 (0%) 2/26 (8%) 0/27 (0%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) | |FIRST INCIDENCE | 650 --- 712 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.453N P=0.463N P=0.421 P=0.494N |(e) (e) (e) (e) | |POLY 3 | P=0.505N P=0.488N P=0.338 P=0.496N |(e) (e) (e) (e) | |POLY 1.5 | P=0.503N P=0.495N P=0.323 P=0.499N |(e) (e) (e) (e) | |POLY 6 | P=0.504N P=0.475N P=0.362 P=0.489N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.491N P=0.503N P=0.357 P=0.500N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.500N P=0.500N P=0.309 P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 3/50 (6%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/40.13 0/42.57 3/43.89 0/40.96 |0/43.71 0/41.70 0/42.55 0/42.54 | |POLY-3 PERCENT (g) | 2.5% 0.0% 6.8% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/20 (0%) 0/29 (0%) 2/26 (8%) 0/27 (0%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) | |FIRST INCIDENCE | 650 --- 712 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.453N P=0.463N P=0.421 P=0.494N |(e) (e) (e) (e) | |POLY 3 | P=0.505N P=0.488N P=0.338 P=0.496N |(e) (e) (e) (e) | |POLY 1.5 | P=0.503N P=0.495N P=0.323 P=0.499N |(e) (e) (e) (e) | |POLY 6 | P=0.504N P=0.475N P=0.362 P=0.489N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.491N P=0.503N P=0.357 P=0.500N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.500N P=0.500N P=0.309 P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 24 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - VANADIUM PENTOXIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 48/50 (96%) 47/50 (94%) 49/50 (98%) 46/50 (92%) |41/50 (82%) 39/50 (78%) 41/50 (82%) 39/50 (78%) | |POLY-3 RATE (b) | 48/48.66 47/47.50 49/49.16 46/48.35 |41/47.98 39/47.44 41/47.44 39/45.97 | |POLY-3 PERCENT (g) | 98.6% 99.0% 99.7% 95.1% |85.5% 82.2% 86.4% 84.8% | |TERMINAL (d) | 20/20 (100%) 29/29 (100%) 26/26 (100%) 26/27 (96%) |29/33 (88%) 19/24 (79%) 25/29 (86%) 25/30 (83%) | |FIRST INCIDENCE | 477 485 519 332 |458 408 433 569 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.124N P=0.024N* P=0.083N P=0.087N |P=0.504N P=0.164 P=0.295 P=0.472 | |POLY 3 | P=0.104N P=0.905 P=0.805 P=0.315N |P=0.522 P=0.437N P=0.565 P=0.585N | |POLY 1.5 | P=0.155N P=0.796N P=0.628 P=0.314N |P=0.515N P=0.409N P=0.570 P=0.504N | |POLY 6 | P=0.085N P=0.997 P=0.995 P=0.332N |P=0.463 P=0.471N P=0.559 P=0.593 | |LOGISTIC REGRESSION| P=0.305N P=0.757N P=0.659 P=0.382N |P=0.421N P=0.432N P=0.561 P=0.440N | |COCH-ARM / FISHERS | P=0.292N P=0.500N P=0.500 P=0.339N |P=0.406N P=0.402N P=0.602N P=0.402N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 28/50 (56%) 31/50 (62%) 30/50 (60%) 24/50 (48%) |28/50 (56%) 29/50 (58%) 27/50 (54%) 22/50 (44%) | |POLY-3 RATE (b) | 28/48.04 31/47.82 30/47.78 24/45.03 |28/47.92 29/46.72 27/47.10 22/46.91 | |POLY-3 PERCENT (g) | 58.3% 64.8% 62.8% 53.3% |58.4% 62.1% 57.3% 46.9% | |TERMINAL (d) | 5/20 (25%) 16/29 (55%) 13/26 (50%) 12/27 (44%) |14/33 (42%) 11/24 (46%) 12/29 (41%) 11/30 (37%) | |FIRST INCIDENCE | 373 311 528 390 |234 366 421 332 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.118N P=0.351N P=0.315N P=0.165N |P=0.195N P=0.191 P=0.469 P=0.315N | |POLY 3 | P=0.284N P=0.325 P=0.404 P=0.390N |P=0.104N P=0.439 P=0.540N P=0.177N | |POLY 1.5 | P=0.238N P=0.331 P=0.406 P=0.344N |P=0.100N P=0.467 P=0.531N P=0.166N | |POLY 6 | P=0.338N P=0.327 P=0.410 P=0.442N |P=0.117N P=0.395 P=0.563N P=0.201N | |LOGISTIC REGRESSION| P=0.176N P=0.237 P=0.271 P=0.286N |P=0.095N P=0.514 P=0.490N P=0.146N | |COCH-ARM / FISHERS | P=0.174N P=0.342 P=0.420 P=0.274N |P=0.098N P=0.500 P=0.500N P=0.159N | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 25 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - VANADIUM PENTOXIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 | | | 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%) 50/50 (100%) 49/50 (98%) 49/50 (98%) |47/50 (94%) 47/50 (94%) 46/50 (92%) 45/50 (90%) | |POLY-3 RATE (b) | 50/50.00 50/50.00 49/49.16 49/49.40 |47/50.00 47/49.48 46/49.01 45/48.46 | |POLY-3 PERCENT (g) | 100.0% 100.0% 99.7% 99.2% |94.0% 95.0% 93.9% 92.9% | |TERMINAL (d) | 20/20 (100%) 29/29 (100%) 26/26 (100%) 27/27 (100%)|30/33 (91%) 22/24 (92%) 26/29 (90%) 27/30 (90%) | |FIRST INCIDENCE | 373 311 519 332 |234 366 421 332 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.146N (e) P=0.051N P=0.113N |P=0.459N P=0.083 P=0.347 P=0.456 | |POLY 3 | P=0.530N (e) P=1.000N P=0.930N |P=0.448N P=0.589 P=0.651N P=0.572N | |POLY 1.5 | P=0.316N (e) P=0.936N P=0.716N |P=0.378N P=0.621 P=0.640N P=0.495N | |POLY 6 | P=0.995N (e) P=1.000N P=1.000N |P=0.496N P=0.548 P=0.652N P=0.627N | |LOGISTIC REGRESSION| P=0.252N (e) P=0.398N P=0.538N |P=0.249N P=0.645N P=0.519N P=0.360N | |COCH-ARM / FISHERS | P=0.236N (e) P=0.500N P=0.500N |P=0.248N P=0.661N P=0.500N P=0.357N | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Number of tumor-bearing animals / Poly-3 number (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. (g) Poly-3 adjusted lifetime tumor incidence. (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).