TDMS Study 88122-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus ELMIRON DATE: 06/12/01
EXPERIMENT: 88122 TEST: 06 TIME: 09:18:57
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-55388 ROUTE: GAVAGE NTP C#: C88122
PATHOLOGIST: RYAN, MICHAEL CAS: 37319-17-8
------------------------------------------------------------------------------------------------------------------------------------
FINAL#1
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus ELMIRON DATE: 06/12/01
EXPERIMENT: 88122 TEST: 06 TIME: 09:18:57
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-55388 ROUTE: GAVAGE NTP C#: C88122
PATHOLOGIST: RYAN, MICHAEL CAS: 37319-17-8
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
Islets, Pancreatic
Liver
Lung
Nose
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Salivary Glands
Testes
Thyroid Gland
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus ELMIRON DATE: 06/12/01
EXPERIMENT: 88122 TEST: 06 TIME: 09:18:57
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-55388 ROUTE: GAVAGE NTP C#: C88122
PATHOLOGIST: RYAN, MICHAEL CAS: 37319-17-8
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF ELMIRON
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
All Organs Malignant and Benign Tumors
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
===============================================================
Date: 06/12/01 EXPERIMENT: 88122 TEST: 06 Page 1
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - ELMIRON
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 7/50 (14%) 3/50 (6%) 8/50 (16%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 3/50 (6%) |
|POLY-3 RATE (b) | 7/41.59 7/41.97 3/39.89 8/40.29 |2/41.96 1/42.89 0/41.46 3/39.33 |
|POLY-3 PERCENT (g) | 16.8% 16.7% 7.5% 19.9% |4.8% 2.3% 0.0% 7.6% |
|TERMINAL (d) | 4/26 (15%) 6/29 (21%) 3/25 (12%) 7/28 (25%) |1/30 (3%) 1/31 (3%) 0/28 (0%) 2/27 (7%) |
|FIRST INCIDENCE | 640 713 727 (T) 660 |722 728 (T) --- 727 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.425 P=0.537N P=0.191N P=0.544 |P=0.222 P=0.496N P=0.258N P=0.456 |
|POLY 3 | P=0.383 P=0.608N P=0.172N P=0.473 |P=0.238 P=0.492N P=0.240N P=0.470 |
|POLY 1.5 | P=0.382 P=0.612 P=0.162N P=0.468 |P=0.241 P=0.496N P=0.239N P=0.474 |
|POLY 6 | P=0.391 P=0.593N P=0.187N P=0.488 |P=0.235 P=0.488N P=0.240N P=0.469 |
|LOGISTIC REGRESSION| P=0.389 P=0.569N P=0.193N P=0.498 |P=0.220 P=0.486N P=0.247N P=0.458 |
|COCH-ARM / FISHERS | P=0.409 P=0.613N P=0.159N P=0.500 |P=0.257 P=0.500N P=0.247N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/41.22 0/41.91 3/40.86 1/40.04 |1/41.94 0/42.89 0/41.46 0/39.32 |
|POLY-3 PERCENT (g) | 2.4% 0.0% 7.3% 2.5% |2.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/26 (4%) 0/29 (0%) 1/25 (4%) 1/28 (4%) |1/30 (3%) 0/31 (0%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | 727 (T) --- 419 727 (T) |728 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.564 P=0.478N P=0.292 P=0.746N |P=0.490N P=0.493N P=0.514N P=0.521N |
|POLY 3 | P=0.544 P=0.497N P=0.301 P=0.755 |P=0.472N P=0.496N P=0.502N P=0.513N |
|POLY 1.5 | P=0.544 P=0.500N P=0.306 P=0.753 |P=0.471N P=0.498N P=0.502N P=0.511N |
|POLY 6 | P=0.547 P=0.491N P=0.294 P=0.759 |P=0.474N P=0.493N P=0.503N P=0.513N |
|LOGISTIC REGRESSION| P=0.566 (e) P=0.302 P=0.746N |P=0.490N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.564 P=0.500N P=0.309 P=0.753N |P=0.471N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 06/12/01 EXPERIMENT: 88122 TEST: 06 Page 2
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - ELMIRON
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 7/50 (14%) 6/50 (12%) 9/50 (18%) |3/50 (6%) 1/50 (2%) 0/50 (0%) 3/50 (6%) |
|POLY-3 RATE (b) | 7/41.59 7/41.97 6/40.86 9/40.29 |3/41.96 1/42.89 0/41.46 3/39.33 |
|POLY-3 PERCENT (g) | 16.8% 16.7% 14.7% 22.3% |7.2% 2.3% 0.0% 7.6% |
|TERMINAL (d) | 4/26 (15%) 6/29 (21%) 4/25 (16%) 8/28 (29%) |2/30 (7%) 1/31 (3%) 0/28 (0%) 2/27 (7%) |
|FIRST INCIDENCE | 640 713 419 660 |722 728 (T) --- 727 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.321 P=0.537N P=0.549N P=0.439 |P=0.357 P=0.300N P=0.137N P=0.616 |
|POLY 3 | P=0.276 P=0.608N P=0.514N P=0.363 |P=0.378 P=0.297N P=0.120N P=0.633 |
|POLY 1.5 | P=0.277 P=0.612 P=0.501N P=0.360 |P=0.382 P=0.301N P=0.120N P=0.636 |
|POLY 6 | P=0.283 P=0.593N P=0.536N P=0.377 |P=0.374 P=0.292N P=0.121N P=0.632 |
|LOGISTIC REGRESSION| P=0.283 P=0.569N P=0.522N P=0.388 |P=0.357 P=0.291N P=0.129N P=0.622 |
|COCH-ARM / FISHERS | P=0.307 P=0.613N P=0.500N P=0.393 |P=0.402 P=0.309N P=0.121N P=0.661N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |3/50 (6%) 0/50 (0%) 0/50 (0%) 4/49 (8%) |
|POLY-3 RATE (b) | 1/41.22 1/41.91 1/39.89 2/40.07 |3/42.38 0/42.89 0/41.46 4/38.41 |
|POLY-3 PERCENT (g) | 2.4% 2.4% 2.5% 5.0% |7.1% 0.0% 0.0% 10.4% |
|TERMINAL (d) | 1/26 (4%) 1/29 (3%) 1/25 (4%) 1/28 (4%) |2/30 (7%) 0/31 (0%) 0/28 (0%) 3/26 (12%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 727 (T) 720 |601 --- --- 706 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.369 P=0.738N P=0.754 P=0.513 |P=0.098 P=0.118N P=0.129N P=0.436 |
|POLY 3 | P=0.349 P=0.757N P=0.754 P=0.490 |P=0.108 P=0.116N P=0.122N P=0.446 |
|POLY 1.5 | P=0.348 P=0.760N P=0.758 P=0.487 |P=0.110 P=0.117N P=0.121N P=0.453 |
|POLY 6 | P=0.352 P=0.752N P=0.747 P=0.498 |P=0.105 P=0.115N P=0.124N P=0.442 |
|LOGISTIC REGRESSION| P=0.347 P=0.738N P=0.754 P=0.496 |P=0.103 P=0.119N P=0.122N P=0.451 |
|COCH-ARM / FISHERS | P=0.361 P=0.753N P=0.753N P=0.500 |P=0.124 P=0.121N P=0.121N P=0.489 |
|=================================================================================================================================|
Date: 06/12/01 EXPERIMENT: 88122 TEST: 06 Page 3
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - ELMIRON
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |3/50 (6%) 0/50 (0%) 0/50 (0%) 4/49 (8%) |
|POLY-3 RATE (b) | 2/41.94 1/41.91 1/39.89 2/40.07 |3/42.38 0/42.89 0/41.46 4/38.41 |
|POLY-3 PERCENT (g) | 4.8% 2.4% 2.5% 5.0% |7.1% 0.0% 0.0% 10.4% |
|TERMINAL (d) | 1/26 (4%) 1/29 (3%) 1/25 (4%) 1/28 (4%) |2/30 (7%) 0/31 (0%) 0/28 (0%) 3/26 (12%) |
|FIRST INCIDENCE | 475 727 (T) 727 (T) 720 |601 --- --- 706 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.523 P=0.480N P=0.511N P=0.691 |P=0.098 P=0.118N P=0.129N P=0.436 |
|POLY 3 | P=0.507 P=0.500N P=0.517N P=0.678 |P=0.108 P=0.116N P=0.122N P=0.446 |
|POLY 1.5 | P=0.508 P=0.503N P=0.508N P=0.677 |P=0.110 P=0.117N P=0.121N P=0.453 |
|POLY 6 | P=0.508 P=0.494N P=0.531N P=0.684 |P=0.105 P=0.115N P=0.124N P=0.442 |
|LOGISTIC REGRESSION| P=0.513 P=0.498N P=0.502N P=0.693 |P=0.103 P=0.119N P=0.122N P=0.451 |
|COCH-ARM / FISHERS | P=0.524 P=0.500N P=0.500N P=0.691N |P=0.124 P=0.121N P=0.121N P=0.489 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/41.22 1/42.00 1/40.49 0/40.04 |0/41.94 1/42.89 2/41.46 0/39.32 |
|POLY-3 PERCENT (g) | 2.4% 2.4% 2.5% 0.0% |0.0% 2.3% 4.8% 0.0% |
|TERMINAL (d) | 1/26 (4%) 0/29 (0%) 0/25 (0%) 0/28 (0%) |0/30 (0%) 1/31 (3%) 2/28 (7%) 0/27 (0%) |
|FIRST INCIDENCE | 727 (T) 705 533 --- |--- 728 (T) 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.330N P=0.735N P=0.758 P=0.485N |P=0.550N P=0.507 P=0.223 (e) |
|POLY 3 | P=0.332N P=0.757N P=0.757 P=0.506N |P=0.544N P=0.504 P=0.234 (e) |
|POLY 1.5 | P=0.333N P=0.760N P=0.760 P=0.507N |P=0.540N P=0.502 P=0.235 (e) |
|POLY 6 | P=0.330N P=0.751N P=0.752 P=0.502N |P=0.545N P=0.507 P=0.233 (e) |
|LOGISTIC REGRESSION| P=0.321N P=0.752N P=0.759 (e) |(e) P=0.507 P=0.223 (e) |
|COCH-ARM / FISHERS | P=0.323N P=0.753N P=0.753N P=0.500N |P=0.517N P=0.500 P=0.247 (e) |
|=================================================================================================================================|
Date: 06/12/01 EXPERIMENT: 88122 TEST: 06 Page 4
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - ELMIRON
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/41.22 2/42.00 1/40.49 0/40.04 |0/41.94 1/42.89 2/41.46 0/39.32 |
|POLY-3 PERCENT (g) | 2.4% 4.8% 2.5% 0.0% |0.0% 2.3% 4.8% 0.0% |
|TERMINAL (d) | 1/26 (4%) 1/29 (3%) 0/25 (0%) 0/28 (0%) |0/30 (0%) 1/31 (3%) 2/28 (7%) 0/27 (0%) |
|FIRST INCIDENCE | 727 (T) 705 533 --- |--- 728 (T) 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.239N P=0.539 P=0.758 P=0.485N |P=0.550N P=0.507 P=0.223 (e) |
|POLY 3 | P=0.242N P=0.507 P=0.757 P=0.506N |P=0.544N P=0.504 P=0.234 (e) |
|POLY 1.5 | P=0.244N P=0.501 P=0.760 P=0.507N |P=0.540N P=0.502 P=0.235 (e) |
|POLY 6 | P=0.238N P=0.516 P=0.752 P=0.502N |P=0.545N P=0.507 P=0.233 (e) |
|LOGISTIC REGRESSION| P=0.238N P=0.521 P=0.759 (e) |(e) P=0.507 P=0.223 (e) |
|COCH-ARM / FISHERS | P=0.235N P=0.500 P=0.753N P=0.500N |P=0.517N P=0.500 P=0.247 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/41.22 1/42.41 1/40.05 2/40.04 |0/41.94 0/42.89 0/41.46 0/39.32 |
|POLY-3 PERCENT (g) | 0.0% 2.4% 2.5% 5.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/26 (0%) 0/29 (0%) 0/25 (0%) 2/28 (7%) |0/30 (0%) 0/31 (0%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | --- 577 686 727 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.200 P=0.505 P=0.475 P=0.254 |(e) (e) (e) (e) |
|POLY 3 | P=0.183 P=0.506 P=0.494 P=0.230 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.183 P=0.502 P=0.498 P=0.229 |(e) (e) (e) (e) |
|POLY 6 | P=0.186 P=0.512 P=0.489 P=0.235 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.187 P=0.509 P=0.496 P=0.254 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.193 P=0.500 P=0.500 P=0.247 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/12/01 EXPERIMENT: 88122 TEST: 06 Page 5
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - ELMIRON
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/41.38 0/41.91 0/39.89 1/40.04 |0/41.94 1/42.89 0/41.46 0/39.32 |
|POLY-3 PERCENT (g) | 4.8% 0.0% 0.0% 2.5% |0.0% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 1/26 (4%) 0/29 (0%) 0/25 (0%) 1/28 (4%) |0/30 (0%) 1/31 (3%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | 685 --- --- 727 (T) |--- 728 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.642N P=0.225N P=0.258N P=0.486N |P=0.605N P=0.507 (e) (e) |
|POLY 3 | P=0.651N P=0.234N P=0.245N P=0.512N |P=0.585N P=0.504 (e) (e) |
|POLY 1.5 | P=0.649N P=0.237N P=0.240N P=0.513N |P=0.586N P=0.502 (e) (e) |
|POLY 6 | P=0.653N P=0.229N P=0.253N P=0.506N |P=0.584N P=0.507 (e) (e) |
|LOGISTIC REGRESSION| P=0.652N P=0.231N P=0.250N P=0.503N |(e) P=0.507 (e) (e) |
|COCH-ARM / FISHERS | P=0.646N P=0.247N P=0.247N P=0.500N |P=0.585N P=0.500 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 3/50 (6%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/41.38 1/42.41 1/40.05 3/40.04 |0/41.94 1/42.89 0/41.46 0/39.32 |
|POLY-3 PERCENT (g) | 4.8% 2.4% 2.5% 7.5% |0.0% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 1/26 (4%) 0/29 (0%) 0/25 (0%) 3/28 (11%) |0/30 (0%) 1/31 (3%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | 685 577 686 727 (T) |--- 728 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.290 P=0.481N P=0.533N P=0.524 |P=0.605N P=0.507 (e) (e) |
|POLY 3 | P=0.266 P=0.491N P=0.511N P=0.485 |P=0.585N P=0.504 (e) (e) |
|POLY 1.5 | P=0.268 P=0.498N P=0.504N P=0.483 |P=0.586N P=0.502 (e) (e) |
|POLY 6 | P=0.266 P=0.481N P=0.522N P=0.493 |P=0.584N P=0.507 (e) (e) |
|LOGISTIC REGRESSION| P=0.269 P=0.500N P=0.515N P=0.500 |(e) P=0.507 (e) (e) |
|COCH-ARM / FISHERS | P=0.281 P=0.500N P=0.500N P=0.500 |P=0.585N P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 06/12/01 EXPERIMENT: 88122 TEST: 06 Page 6
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - ELMIRON
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/41.22 0/41.91 0/39.89 0/40.04 |1/42.02 1/43.09 1/41.46 3/39.52 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.4% 2.3% 2.4% 7.6% |
|TERMINAL (d) | 0/26 (0%) 0/29 (0%) 0/25 (0%) 0/28 (0%) |0/30 (0%) 0/31 (0%) 1/28 (4%) 2/27 (7%) |
|FIRST INCIDENCE | --- --- --- --- |707 678 728 (T) 678 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.127 P=0.748N P=0.746 P=0.271 |
|POLY 3 | (e) (e) (e) (e) |P=0.140 P=0.755N P=0.758 P=0.283 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.142 P=0.758N P=0.758 P=0.285 |
|POLY 6 | (e) (e) (e) (e) |P=0.138 P=0.752N P=0.757 P=0.283 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.135 P=0.760N P=0.759 P=0.281 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.156 P=0.753N P=0.753N P=0.309 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 2/50 (4%) 4/50 (8%) |
|POLY-3 RATE (b) | 1/41.22 0/41.91 0/39.89 0/40.04 |1/42.02 1/43.09 2/41.46 4/39.52 |
|POLY-3 PERCENT (g) | 2.4% 0.0% 0.0% 0.0% |2.4% 2.3% 4.8% 10.1% |
|TERMINAL (d) | 1/26 (4%) 0/29 (0%) 0/25 (0%) 0/28 (0%) |0/30 (0%) 0/31 (0%) 2/28 (7%) 3/27 (11%) |
|FIRST INCIDENCE | 727 (T) --- --- --- |707 678 728 (T) 678 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.467N P=0.478N P=0.508N P=0.485N |P=0.055 P=0.748N P=0.477 P=0.153 |
|POLY 3 | P=0.472N P=0.497N P=0.507N P=0.506N |P=0.061 P=0.755N P=0.495 P=0.159 |
|POLY 1.5 | P=0.470N P=0.500N P=0.502N P=0.507N |P=0.063 P=0.758N P=0.496 P=0.162 |
|POLY 6 | P=0.476N P=0.491N P=0.513N P=0.502N |P=0.060 P=0.752N P=0.493 P=0.159 |
|LOGISTIC REGRESSION| P=0.467N (e) (e) (e) |P=0.059 P=0.760N P=0.490 P=0.159 |
|COCH-ARM / FISHERS | P=0.471N P=0.500N P=0.500N P=0.500N |P=0.074 P=0.753N P=0.500 P=0.181 |
|=================================================================================================================================|
Date: 06/12/01 EXPERIMENT: 88122 TEST: 06 Page 7
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - ELMIRON
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 3/50 (6%) 5/50 (10%) |15/50 (30%) 23/50 (46%) 24/50 (48%) 21/50 (42%) |
|POLY-3 RATE (b) | 2/42.52 1/41.91 3/40.40 5/40.04 |15/42.95 23/44.70 24/42.93 21/40.67 |
|POLY-3 PERCENT (g) | 4.7% 2.4% 7.4% 12.5% |34.9% 51.5% 55.9% 51.6% |
|TERMINAL (d) | 0/26 (0%) 1/29 (3%) 2/25 (8%) 5/28 (18%) |11/30 (37%) 16/31 (52%) 17/28 (61%) 14/27 (52%) |
|FIRST INCIDENCE | 503 727 (T) 574 727 (T) |621 474 474 588 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.077 P=0.495N P=0.491 P=0.227 |P=0.171 P=0.111 P=0.036 * P=0.093 |
|POLY 3 | P=0.063 P=0.505N P=0.477 P=0.191 |P=0.186 P=0.085 P=0.036 * P=0.088 |
|POLY 1.5 | P=0.064 P=0.506N P=0.490 P=0.194 |P=0.205 P=0.078 P=0.039 * P=0.095 |
|POLY 6 | P=0.062 P=0.501N P=0.459 P=0.192 |P=0.179 P=0.094 P=0.032 * P=0.087 |
|LOGISTIC REGRESSION| P=0.070 P=0.486N P=0.481 P=0.212 |P=0.192 P=0.082 P=0.038 * P=0.088 |
|COCH-ARM / FISHERS | P=0.074 P=0.500N P=0.500 P=0.218 |P=0.322 P=0.074 P=0.050 P=0.149 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 3/50 (6%) 5/50 (10%) |15/50 (30%) 23/50 (46%) 24/50 (48%) 21/50 (42%) |
|POLY-3 RATE (b) | 4/42.52 1/41.91 3/40.40 5/40.04 |15/42.95 23/44.70 24/42.93 21/40.67 |
|POLY-3 PERCENT (g) | 9.4% 2.4% 7.4% 12.5% |34.9% 51.5% 55.9% 51.6% |
|TERMINAL (d) | 2/26 (8%) 1/29 (3%) 2/25 (8%) 5/28 (18%) |11/30 (37%) 16/31 (52%) 17/28 (61%) 14/27 (52%) |
|FIRST INCIDENCE | 503 727 (T) 574 727 (T) |621 474 474 588 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.218 P=0.167N P=0.513N P=0.520 |P=0.171 P=0.111 P=0.036 * P=0.093 |
|POLY 3 | P=0.189 P=0.182N P=0.528N P=0.462 |P=0.186 P=0.085 P=0.036 * P=0.088 |
|POLY 1.5 | P=0.193 P=0.184N P=0.512N P=0.466 |P=0.205 P=0.078 P=0.039 * P=0.095 |
|POLY 6 | P=0.188 P=0.178N P=0.549N P=0.466 |P=0.179 P=0.094 P=0.032 * P=0.087 |
|LOGISTIC REGRESSION| P=0.200 P=0.177N P=0.502N P=0.486 |P=0.192 P=0.082 P=0.038 * P=0.088 |
|COCH-ARM / FISHERS | P=0.212 P=0.181N P=0.500N P=0.500 |P=0.322 P=0.074 P=0.050 P=0.149 |
|=================================================================================================================================|
Date: 06/12/01 EXPERIMENT: 88122 TEST: 06 Page 8
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - ELMIRON
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 3/50 (6%) 5/50 (10%) |16/50 (32%) 24/50 (48%) 24/50 (48%) 24/50 (48%) |
|POLY-3 RATE (b) | 4/42.52 1/41.91 3/40.40 5/40.04 |16/43.03 24/44.89 24/42.93 24/40.86 |
|POLY-3 PERCENT (g) | 9.4% 2.4% 7.4% 12.5% |37.2% 53.5% 55.9% 58.7% |
|TERMINAL (d) | 2/26 (8%) 1/29 (3%) 2/25 (8%) 5/28 (18%) |11/30 (37%) 16/31 (52%) 17/28 (61%) 16/27 (59%) |
|FIRST INCIDENCE | 503 727 (T) 574 727 (T) |621 474 474 588 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.218 P=0.167N P=0.513N P=0.520 |P=0.079 P=0.121 P=0.058 P=0.045 * |
|POLY 3 | P=0.189 P=0.182N P=0.528N P=0.462 |P=0.077 P=0.089 P=0.058 P=0.034 * |
|POLY 1.5 | P=0.193 P=0.184N P=0.512N P=0.466 |P=0.089 P=0.081 P=0.063 P=0.039 * |
|POLY 6 | P=0.188 P=0.178N P=0.549N P=0.466 |P=0.072 P=0.101 P=0.052 P=0.034 * |
|LOGISTIC REGRESSION| P=0.200 P=0.177N P=0.502N P=0.486 |P=0.080 P=0.084 P=0.060 P=0.036 * |
|COCH-ARM / FISHERS | P=0.212 P=0.181N P=0.500N P=0.500 |P=0.174 P=0.076 P=0.076 P=0.076 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 19/50 (38%) 18/50 (36%) 18/50 (36%) 13/50 (26%) |21/50 (42%) 21/50 (42%) 26/50 (52%) 19/50 (38%) |
|POLY-3 RATE (b) | 19/44.60 18/44.62 18/42.45 13/41.07 |21/45.02 21/44.26 26/44.55 19/41.27 |
|POLY-3 PERCENT (g) | 42.6% 40.3% 42.4% 31.7% |46.7% 47.5% 58.4% 46.0% |
|TERMINAL (d) | 12/26 (46%) 10/29 (35%) 11/25 (44%) 8/28 (29%) |9/30 (30%) 16/31 (52%) 14/28 (50%) 11/27 (41%) |
|FIRST INCIDENCE | 503 313 462 629 |462 526 474 525 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.124N P=0.397N P=0.568N P=0.131N |P=0.540 P=0.533N P=0.202 P=0.560N |
|POLY 3 | P=0.170N P=0.499N P=0.580N P=0.203N |P=0.510N P=0.555 P=0.181 P=0.564N |
|POLY 1.5 | P=0.159N P=0.507N P=0.536N P=0.193N |P=0.481N P=0.567 P=0.188 P=0.535N |
|POLY 6 | P=0.170N P=0.484N P=0.546 P=0.199N |P=0.528N P=0.530 P=0.170 P=0.587 |
|LOGISTIC REGRESSION| P=0.125N P=0.501N P=0.509N P=0.161N |P=0.461N P=0.560N P=0.198 P=0.504N |
|COCH-ARM / FISHERS | P=0.107N P=0.500N P=0.500N P=0.142N |P=0.345N P=0.580N P=0.212 P=0.419N |
|=================================================================================================================================|
Date: 06/12/01 EXPERIMENT: 88122 TEST: 06 Page 9
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - ELMIRON
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 20/50 (40%) 18/50 (36%) 18/50 (36%) 13/50 (26%) |21/50 (42%) 21/50 (42%) 26/50 (52%) 19/50 (38%) |
|POLY-3 RATE (b) | 20/44.92 18/44.62 18/42.45 13/41.07 |21/45.02 21/44.26 26/44.55 19/41.27 |
|POLY-3 PERCENT (g) | 44.5% 40.3% 42.4% 31.7% |46.7% 47.5% 58.4% 46.0% |
|TERMINAL (d) | 12/26 (46%) 10/29 (35%) 11/25 (44%) 8/28 (29%) |9/30 (30%) 16/31 (52%) 14/28 (50%) 11/27 (41%) |
|FIRST INCIDENCE | 503 313 462 629 |462 526 474 525 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.102N P=0.327N P=0.496N P=0.097N |P=0.540 P=0.533N P=0.202 P=0.560N |
|POLY 3 | P=0.141N P=0.425N P=0.506N P=0.155N |P=0.510N P=0.555 P=0.181 P=0.564N |
|POLY 1.5 | P=0.129N P=0.429N P=0.458N P=0.144N |P=0.481N P=0.567 P=0.188 P=0.535N |
|POLY 6 | P=0.143N P=0.418N P=0.569N P=0.156N |P=0.528N P=0.530 P=0.170 P=0.587 |
|LOGISTIC REGRESSION| P=0.099N P=0.419N P=0.426N P=0.116N |P=0.461N P=0.560N P=0.198 P=0.504N |
|COCH-ARM / FISHERS | P=0.085N P=0.418N P=0.418N P=0.101N |P=0.345N P=0.580N P=0.212 P=0.419N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Salivary Glands |
| Schwannoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/49 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/41.37 2/42.42 1/39.36 1/40.12 |0/41.94 0/42.89 0/41.46 0/39.32 |
|POLY-3 PERCENT (g) | 2.4% 4.7% 2.5% 2.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/26 (0%) 0/29 (0%) 0/25 (0%) 0/28 (0%) |0/30 (0%) 0/31 (0%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | 686 645 630 707 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.544N P=0.528 P=0.741 P=0.760 |(e) (e) (e) (e) |
|POLY 3 | P=0.549N P=0.509 P=0.750 P=0.754 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.550N P=0.502 P=0.754 P=0.752 |(e) (e) (e) (e) |
|POLY 6 | P=0.545N P=0.520 P=0.744 P=0.759 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.542N P=0.500 P=0.758 P=0.757 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.538N P=0.500 P=0.747 P=0.753N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/12/01 EXPERIMENT: 88122 TEST: 06 Page 10
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - ELMIRON
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor |
| (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 4/50 (8%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/41.22 3/42.14 4/40.53 1/40.18 |1/41.94 0/42.89 1/41.46 0/39.32 |
|POLY-3 PERCENT (g) | 9.7% 7.1% 9.9% 2.5% |2.4% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 4/26 (15%) 2/29 (7%) 1/25 (4%) 0/28 (0%) |1/30 (3%) 0/31 (0%) 1/28 (4%) 0/27 (0%) |
|FIRST INCIDENCE | 727 (T) 668 630 691 |728 (T) --- 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.157N P=0.442N P=0.605 P=0.163N |P=0.486N P=0.493N P=0.747 P=0.521N |
|POLY 3 | P=0.165N P=0.488N P=0.635 P=0.185N |P=0.476N P=0.496N P=0.758 P=0.513N |
|POLY 1.5 | P=0.166N P=0.498N P=0.642 P=0.189N |P=0.473N P=0.498N P=0.759 P=0.511N |
|POLY 6 | P=0.160N P=0.471N P=0.627 P=0.177N |P=0.479N P=0.493N P=0.758 P=0.513N |
|LOGISTIC REGRESSION| P=0.162N P=0.468N P=0.613 P=0.177N |P=0.486N (e) P=0.747 (e) |
|COCH-ARM / FISHERS | P=0.153N P=0.500N P=0.643N P=0.181N |P=0.459N P=0.500N P=0.753N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 3/50 (6%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/41.22 1/41.91 3/40.09 1/40.04 |1/42.15 0/42.89 2/41.48 0/39.32 |
|POLY-3 PERCENT (g) | 2.4% 2.4% 7.5% 2.5% |2.4% 0.0% 4.8% 0.0% |
|TERMINAL (d) | 1/26 (4%) 1/29 (3%) 2/25 (8%) 1/28 (4%) |0/30 (0%) 0/31 (0%) 1/28 (4%) 0/27 (0%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 674 727 (T) |673 --- 723 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.607N P=0.738N P=0.293 P=0.746N |P=0.479N P=0.489N P=0.481 P=0.523N |
|POLY 3 | P=0.633N P=0.757N P=0.295 P=0.755 |P=0.478N P=0.497N P=0.494 P=0.514N |
|POLY 1.5 | P=0.633N P=0.760N P=0.302 P=0.753 |P=0.473N P=0.498N P=0.496 P=0.512N |
|POLY 6 | P=0.629N P=0.752N P=0.285 P=0.759 |P=0.482N P=0.495N P=0.492 P=0.515N |
|LOGISTIC REGRESSION| P=0.625N P=0.738N P=0.275 P=0.746N |P=0.470N P=0.500N P=0.495 P=0.505N |
|COCH-ARM / FISHERS | P=0.617N P=0.753N P=0.309 P=0.753N |P=0.450N P=0.500N P=0.500 P=0.500N |
|=================================================================================================================================|
Date: 06/12/01 EXPERIMENT: 88122 TEST: 06 Page 11
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - ELMIRON
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 4/50 (8%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 3/50 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/41.46 3/41.91 4/40.09 2/40.29 |1/42.15 0/42.89 3/41.71 0/39.32 |
|POLY-3 PERCENT (g) | 7.2% 7.2% 10.0% 5.0% |2.4% 0.0% 7.2% 0.0% |
|TERMINAL (d) | 2/26 (8%) 3/29 (10%) 3/25 (12%) 1/28 (4%) |0/30 (0%) 0/31 (0%) 1/28 (4%) 0/27 (0%) |
|FIRST INCIDENCE | 661 727 (T) 674 661 |673 --- 667 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.387N P=0.616N P=0.478 P=0.475N |P=0.475N P=0.489N P=0.297 P=0.523N |
|POLY 3 | P=0.418N P=0.658N P=0.482 P=0.513N |P=0.478N P=0.497N P=0.301 P=0.514N |
|POLY 1.5 | P=0.420N P=0.662 P=0.494 P=0.516N |P=0.472N P=0.498N P=0.302 P=0.512N |
|POLY 6 | P=0.410N P=0.649N P=0.464 P=0.504N |P=0.483N P=0.495N P=0.300 P=0.515N |
|LOGISTIC REGRESSION| P=0.412N P=0.641N P=0.462 P=0.511N |P=0.462N P=0.500N P=0.301 P=0.505N |
|COCH-ARM / FISHERS | P=0.399N P=0.661N P=0.500 P=0.500N |P=0.442N P=0.500N P=0.309 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/41.46 2/41.91 1/39.89 1/40.29 |0/41.94 0/42.89 0/41.46 0/39.32 |
|POLY-3 PERCENT (g) | 4.8% 4.8% 2.5% 2.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/26 (4%) 2/29 (7%) 1/25 (4%) 0/28 (0%) |0/30 (0%) 0/31 (0%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | 661 727 (T) 727 (T) 661 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.376N P=0.659N P=0.516N P=0.485N |(e) (e) (e) (e) |
|POLY 3 | P=0.393N P=0.691N P=0.514N P=0.510N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.395N P=0.693 P=0.505N P=0.513N |(e) (e) (e) (e) |
|POLY 6 | P=0.388N P=0.684N P=0.526N P=0.503N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.394N P=0.683N P=0.520N P=0.508N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.383N P=0.691N P=0.500N P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/12/01 EXPERIMENT: 88122 TEST: 06 Page 12
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - ELMIRON
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/41.46 2/41.91 1/39.89 1/40.29 |0/41.94 0/42.89 1/41.69 0/39.32 |
|POLY-3 PERCENT (g) | 4.8% 4.8% 2.5% 2.5% |0.0% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 1/26 (4%) 2/29 (7%) 1/25 (4%) 0/28 (0%) |0/30 (0%) 0/31 (0%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | 661 727 (T) 727 (T) 661 |--- --- 667 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.376N P=0.659N P=0.516N P=0.485N |P=0.800N (e) P=0.505 (e) |
|POLY 3 | P=0.393N P=0.691N P=0.514N P=0.510N |P=0.796N (e) P=0.499 (e) |
|POLY 1.5 | P=0.395N P=0.693 P=0.505N P=0.513N |P=0.794N (e) P=0.499 (e) |
|POLY 6 | P=0.388N P=0.684N P=0.526N P=0.503N |P=0.797N (e) P=0.499 (e) |
|LOGISTIC REGRESSION| P=0.394N P=0.683N P=0.520N P=0.508N |P=0.787N (e) P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.383N P=0.691N P=0.500N P=0.500N |P=0.785N (e) P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 3/50 (6%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/41.22 3/42.14 3/40.53 1/40.18 |0/41.94 0/42.89 1/41.46 0/39.32 |
|POLY-3 PERCENT (g) | 4.9% 7.1% 7.4% 2.5% |0.0% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 2/26 (8%) 2/29 (7%) 0/25 (0%) 0/28 (0%) |0/30 (0%) 0/31 (0%) 1/28 (4%) 0/27 (0%) |
|FIRST INCIDENCE | 727 (T) 668 630 691 |--- --- 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.309N P=0.547 P=0.463 P=0.483N |P=0.802N (e) P=0.486 (e) |
|POLY 3 | P=0.319N P=0.510 P=0.492 P=0.509N |P=0.796N (e) P=0.498 (e) |
|POLY 1.5 | P=0.321N P=0.502 P=0.498 P=0.512N |P=0.794N (e) P=0.498 (e) |
|POLY 6 | P=0.311N P=0.524 P=0.485 P=0.500N |P=0.797N (e) P=0.497 (e) |
|LOGISTIC REGRESSION| P=0.317N P=0.522 P=0.486 P=0.502N |(e) (e) P=0.486 (e) |
|COCH-ARM / FISHERS | P=0.304N P=0.500 P=0.500 P=0.500N |P=0.785N (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 06/12/01 EXPERIMENT: 88122 TEST: 06 Page 13
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - ELMIRON
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell |
| Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 4/50 (8%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/41.22 3/42.14 4/40.53 1/40.18 |0/41.94 0/42.89 1/41.46 0/39.32 |
|POLY-3 PERCENT (g) | 7.3% 7.1% 9.9% 2.5% |0.0% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 3/26 (12%) 2/29 (7%) 1/25 (4%) 0/28 (0%) |0/30 (0%) 0/31 (0%) 1/28 (4%) 0/27 (0%) |
|FIRST INCIDENCE | 727 (T) 668 630 691 |--- --- 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.222N P=0.614N P=0.462 P=0.286N |P=0.802N (e) P=0.486 (e) |
|POLY 3 | P=0.233N P=0.653N P=0.491 P=0.314N |P=0.796N (e) P=0.498 (e) |
|POLY 1.5 | P=0.235N P=0.661N P=0.498 P=0.317N |P=0.794N (e) P=0.498 (e) |
|POLY 6 | P=0.227N P=0.639N P=0.482 P=0.305N |P=0.797N (e) P=0.497 (e) |
|LOGISTIC REGRESSION| P=0.229N P=0.639N P=0.473 P=0.304N |(e) (e) P=0.486 (e) |
|COCH-ARM / FISHERS | P=0.218N P=0.661N P=0.500 P=0.309N |P=0.785N (e) P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 3/50 (6%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/41.22 3/42.14 3/40.53 1/40.18 |0/41.94 0/42.89 1/41.46 0/39.32 |
|POLY-3 PERCENT (g) | 7.3% 7.1% 7.4% 2.5% |0.0% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 3/26 (12%) 2/29 (7%) 0/25 (0%) 0/28 (0%) |0/30 (0%) 0/31 (0%) 1/28 (4%) 0/27 (0%) |
|FIRST INCIDENCE | 727 (T) 668 630 691 |--- --- 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.220N P=0.614N P=0.625 P=0.286N |P=0.802N (e) P=0.486 (e) |
|POLY 3 | P=0.228N P=0.653N P=0.655 P=0.314N |P=0.796N (e) P=0.498 (e) |
|POLY 1.5 | P=0.229N P=0.661N P=0.661 P=0.317N |P=0.794N (e) P=0.498 (e) |
|POLY 6 | P=0.222N P=0.639N P=0.649 P=0.305N |P=0.797N (e) P=0.497 (e) |
|LOGISTIC REGRESSION| P=0.225N P=0.639N P=0.645 P=0.304N |(e) (e) P=0.486 (e) |
|COCH-ARM / FISHERS | P=0.215N P=0.661N P=0.661N P=0.309N |P=0.785N (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 06/12/01 EXPERIMENT: 88122 TEST: 06 Page 14
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - ELMIRON
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin: Sebaceous Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/41.22 1/41.91 1/39.89 2/40.30 |0/41.94 0/42.89 0/41.46 0/39.32 |
|POLY-3 PERCENT (g) | 2.4% 2.4% 2.5% 5.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/26 (4%) 1/29 (3%) 1/25 (4%) 0/28 (0%) |0/30 (0%) 0/31 (0%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 727 (T) 679 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.367 P=0.738N P=0.754 P=0.509 |(e) (e) (e) (e) |
|POLY 3 | P=0.351 P=0.757N P=0.754 P=0.492 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.349 P=0.760N P=0.758 P=0.488 |(e) (e) (e) (e) |
|POLY 6 | P=0.357 P=0.752N P=0.747 P=0.502 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.353 P=0.738N P=0.754 P=0.493 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.361 P=0.753N P=0.753N P=0.500 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin: Sebaceous Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/41.22 1/41.91 2/40.24 3/40.30 |0/41.94 0/42.89 0/41.46 0/39.32 |
|POLY-3 PERCENT (g) | 2.4% 2.4% 5.0% 7.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/26 (4%) 1/29 (3%) 1/25 (4%) 1/28 (4%) |0/30 (0%) 0/31 (0%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 630 679 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.189 P=0.738N P=0.485 P=0.321 |(e) (e) (e) (e) |
|POLY 3 | P=0.172 P=0.757N P=0.492 P=0.297 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.171 P=0.760N P=0.498 P=0.293 |(e) (e) (e) (e) |
|POLY 6 | P=0.177 P=0.752N P=0.483 P=0.306 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.172 P=0.738N P=0.488 P=0.299 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.182 P=0.753N P=0.500 P=0.309 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/12/01 EXPERIMENT: 88122 TEST: 06 Page 15
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - ELMIRON
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 44/50 (88%) 43/50 (86%) 43/50 (86%) 40/50 (80%) | |
|POLY-3 RATE (b) | 44/47.31 43/46.30 43/47.00 40/44.46 | |
|POLY-3 PERCENT (g) | 93.0% 92.9% 91.5% 90.0% | |
|TERMINAL (d) | 26/26 (100%) 28/29 (97%) 24/25 (96%) 26/28 (93%) | |
|FIRST INCIDENCE | 475 503 484 433 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.250N P=0.262N P=0.491 P=0.211N | |
|POLY 3 | P=0.346N P=0.658N P=0.550N P=0.435N | |
|POLY 1.5 | P=0.310N P=0.644N P=0.493N P=0.393N | |
|POLY 6 | P=0.353N P=0.615N P=0.613N P=0.427N | |
|LOGISTIC REGRESSION| P=0.342N P=0.581N P=0.508N P=0.388N | |
|COCH-ARM / FISHERS | P=0.160N P=0.500N P=0.500N P=0.207N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 8/50 (16%) 8/50 (16%) 7/50 (14%) |11/50 (22%) 8/50 (16%) 10/50 (20%) 9/50 (18%) |
|POLY-3 RATE (b) | 8/42.32 8/42.22 8/40.54 7/40.22 |11/42.19 8/42.98 10/41.91 9/40.05 |
|POLY-3 PERCENT (g) | 18.9% 19.0% 19.7% 17.4% |26.1% 18.6% 23.9% 22.5% |
|TERMINAL (d) | 6/26 (23%) 7/29 (24%) 6/25 (24%) 5/28 (18%) |9/30 (30%) 6/31 (19%) 6/28 (21%) 5/27 (19%) |
|FIRST INCIDENCE | 519 645 582 689 |673 715 673 651 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.417N P=0.526N P=0.571 P=0.459N |P=0.534 P=0.282N P=0.567N P=0.494N |
|POLY 3 | P=0.486N P=0.607 P=0.573 P=0.543N |P=0.536N P=0.285N P=0.507N P=0.451N |
|POLY 1.5 | P=0.482N P=0.600 P=0.593 P=0.541N |P=0.530N P=0.294N P=0.507N P=0.450N |
|POLY 6 | P=0.482N P=0.598N P=0.544 P=0.535N |P=0.531N P=0.275N P=0.506N P=0.441N |
|LOGISTIC REGRESSION| P=0.465N P=0.595N P=0.583 P=0.521N |P=0.562N P=0.260N P=0.522N P=0.464N |
|COCH-ARM / FISHERS | P=0.439N P=0.607N P=0.607N P=0.500N |P=0.469N P=0.306N P=0.500N P=0.402N |
|=================================================================================================================================|
Date: 06/12/01 EXPERIMENT: 88122 TEST: 06 Page 16
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - ELMIRON
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/42.07 1/42.19 0/39.89 1/40.04 |0/41.94 0/42.89 0/41.46 0/39.32 |
|POLY-3 PERCENT (g) | 4.8% 2.4% 0.0% 2.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/26 (0%) 0/29 (0%) 0/25 (0%) 1/28 (4%) |0/30 (0%) 0/31 (0%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | 573 654 --- 727 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.498N P=0.482N P=0.246N P=0.491N |(e) (e) (e) (e) |
|POLY 3 | P=0.507N P=0.499N P=0.249N P=0.517N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.506N P=0.502N P=0.242N P=0.516N |(e) (e) (e) (e) |
|POLY 6 | P=0.508N P=0.493N P=0.259N P=0.515N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.493N P=0.494N P=0.248N P=0.495N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.500N P=0.500N P=0.247N P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 9/50 (18%) 8/50 (16%) 8/50 (16%) |11/50 (22%) 8/50 (16%) 10/50 (20%) 9/50 (18%) |
|POLY-3 RATE (b) | 10/43.18 9/42.49 8/40.54 8/40.22 |11/42.19 8/42.98 10/41.91 9/40.05 |
|POLY-3 PERCENT (g) | 23.2% 21.2% 19.7% 19.9% |26.1% 18.6% 23.9% 22.5% |
|TERMINAL (d) | 6/26 (23%) 7/29 (24%) 6/25 (24%) 6/28 (21%) |9/30 (30%) 6/31 (19%) 6/28 (21%) 5/27 (19%) |
|FIRST INCIDENCE | 519 645 582 689 |673 715 673 651 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.361N P=0.417N P=0.436N P=0.360N |P=0.534 P=0.282N P=0.567N P=0.494N |
|POLY 3 | P=0.440N P=0.516N P=0.454N P=0.462N |P=0.536N P=0.285N P=0.507N P=0.451N |
|POLY 1.5 | P=0.429N P=0.517N P=0.423N P=0.452N |P=0.530N P=0.294N P=0.507N P=0.450N |
|POLY 6 | P=0.446N P=0.507N P=0.499N P=0.465N |P=0.531N P=0.275N P=0.506N P=0.441N |
|LOGISTIC REGRESSION| P=0.410N P=0.497N P=0.410N P=0.422N |P=0.562N P=0.260N P=0.522N P=0.464N |
|COCH-ARM / FISHERS | P=0.380N P=0.500N P=0.398N P=0.398N |P=0.469N P=0.306N P=0.500N P=0.402N |
|=================================================================================================================================|
Date: 06/12/01 EXPERIMENT: 88122 TEST: 06 Page 17
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - ELMIRON
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/41.22 1/41.91 1/39.89 3/40.12 |0/41.94 0/42.89 0/41.46 0/39.32 |
|POLY-3 PERCENT (g) | 0.0% 2.4% 2.5% 7.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/26 (0%) 1/29 (3%) 1/25 (4%) 2/28 (7%) |0/30 (0%) 0/31 (0%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | --- 727 (T) 727 (T) 707 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.069 P=0.522 P=0.492 P=0.131 |(e) (e) (e) (e) |
|POLY 3 | P=0.059 P=0.503 P=0.493 P=0.113 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.059 P=0.500 P=0.498 P=0.112 |(e) (e) (e) (e) |
|POLY 6 | P=0.061 P=0.509 P=0.487 P=0.117 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.061 P=0.522 P=0.492 P=0.119 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.064 P=0.500 P=0.500 P=0.121 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/41.22 1/42.48 0/39.89 1/40.04 |1/41.94 0/42.89 0/41.46 1/39.32 |
|POLY-3 PERCENT (g) | 4.9% 2.4% 0.0% 2.5% |2.4% 0.0% 0.0% 2.5% |
|TERMINAL (d) | 2/26 (8%) 0/29 (0%) 0/25 (0%) 1/28 (4%) |1/30 (3%) 0/31 (0%) 0/28 (0%) 1/27 (4%) |
|FIRST INCIDENCE | 727 (T) 551 --- 727 (T) |728 (T) --- --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.494N P=0.469N P=0.246N P=0.474N |P=0.514 P=0.493N P=0.514N P=0.739 |
|POLY 3 | P=0.508N P=0.489N P=0.244N P=0.510N |P=0.524 P=0.496N P=0.502N P=0.746 |
|POLY 1.5 | P=0.507N P=0.497N P=0.240N P=0.513N |P=0.527 P=0.498N P=0.502N P=0.748 |
|POLY 6 | P=0.509N P=0.478N P=0.251N P=0.503N |P=0.521 P=0.493N P=0.503N P=0.746 |
|LOGISTIC REGRESSION| P=0.508N P=0.500N (e) P=0.474N |P=0.514 (e) (e) P=0.739 |
|COCH-ARM / FISHERS | P=0.500N P=0.500N P=0.247N P=0.500N |P=0.541 P=0.500N P=0.500N P=0.753N |
|=================================================================================================================================|
Date: 06/12/01 EXPERIMENT: 88122 TEST: 06 Page 18
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - ELMIRON
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 4/50 (8%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/41.22 2/42.48 1/39.89 4/40.12 |1/41.94 0/42.89 0/41.46 1/39.32 |
|POLY-3 PERCENT (g) | 4.9% 4.7% 2.5% 10.0% |2.4% 0.0% 0.0% 2.5% |
|TERMINAL (d) | 2/26 (8%) 1/29 (3%) 1/25 (4%) 3/28 (11%) |1/30 (3%) 0/31 (0%) 0/28 (0%) 1/27 (4%) |
|FIRST INCIDENCE | 727 (T) 551 727 (T) 707 |728 (T) --- --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.206 P=0.660N P=0.514N P=0.365 |P=0.514 P=0.493N P=0.514N P=0.739 |
|POLY 3 | P=0.184 P=0.683N P=0.511N P=0.324 |P=0.524 P=0.496N P=0.502N P=0.746 |
|POLY 1.5 | P=0.184 P=0.691N P=0.504N P=0.321 |P=0.527 P=0.498N P=0.502N P=0.748 |
|POLY 6 | P=0.186 P=0.672N P=0.522N P=0.334 |P=0.521 P=0.493N P=0.503N P=0.746 |
|LOGISTIC REGRESSION| P=0.186 P=0.694N P=0.514N P=0.331 |P=0.514 (e) (e) P=0.739 |
|COCH-ARM / FISHERS | P=0.196 P=0.691N P=0.500N P=0.339 |P=0.541 P=0.500N P=0.500N P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |7/50 (14%) 8/50 (16%) 7/50 (14%) 6/50 (12%) |
|POLY-3 RATE (b) | |7/42.67 8/42.99 7/42.31 6/39.59 |
|POLY-3 PERCENT (g) | |16.4% 18.6% 16.6% 15.2% |
|TERMINAL (d) | |5/30 (17%) 6/31 (19%) 4/28 (14%) 5/27 (19%) |
|FIRST INCIDENCE | |621 716 559 656 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.481N P=0.529 P=0.578 P=0.565N |
|POLY 3 | |P=0.453N P=0.506 P=0.608 P=0.558N |
|POLY 1.5 | |P=0.442N P=0.504 P=0.608 P=0.549N |
|POLY 6 | |P=0.461N P=0.508 P=0.607 P=0.565N |
|LOGISTIC REGRESSION| |P=0.450N P=0.526 P=0.607 P=0.549N |
|COCH-ARM / FISHERS | |P=0.385N P=0.500 P=0.613N P=0.500N |
|=================================================================================================================================|
Date: 06/12/01 EXPERIMENT: 88122 TEST: 06 Page 19
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - ELMIRON
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |7/50 (14%) 8/50 (16%) 7/50 (14%) 7/50 (14%) |
|POLY-3 RATE (b) | |7/42.67 8/42.99 7/42.31 7/39.88 |
|POLY-3 PERCENT (g) | |16.4% 18.6% 16.6% 17.6% |
|TERMINAL (d) | |5/30 (17%) 6/31 (19%) 4/28 (14%) 5/27 (19%) |
|FIRST INCIDENCE | |621 716 559 651 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.524 P=0.529 P=0.578 P=0.551 |
|POLY 3 | |P=0.554 P=0.506 P=0.608 P=0.561 |
|POLY 1.5 | |P=0.562 P=0.504 P=0.608 P=0.567 |
|POLY 6 | |P=0.551 P=0.508 P=0.607 P=0.560 |
|LOGISTIC REGRESSION| |P=0.554 P=0.526 P=0.607 P=0.567 |
|COCH-ARM / FISHERS | |P=0.517N P=0.500 P=0.613N P=0.613N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or |
| Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 16/50 (32%) 12/50 (24%) 16/50 (32%) |7/50 (14%) 14/50 (28%) 8/50 (16%) 10/50 (20%) |
|POLY-3 RATE (b) | 15/44.05 16/45.08 12/42.28 16/42.12 |7/43.03 14/45.28 8/43.35 10/41.99 |
|POLY-3 PERCENT (g) | 34.1% 35.5% 28.4% 38.0% |16.3% 30.9% 18.5% 23.8% |
|TERMINAL (d) | 5/26 (19%) 4/29 (14%) 4/25 (16%) 8/28 (29%) |4/30 (13%) 6/31 (19%) 2/28 (7%) 2/27 (7%) |
|FIRST INCIDENCE | 519 313 526 484 |596 510 491 495 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.470 P=0.567N P=0.411N P=0.529 |P=0.444 P=0.101 P=0.491 P=0.264 |
|POLY 3 | P=0.401 P=0.532 P=0.368N P=0.438 |P=0.493 P=0.084 P=0.506 P=0.275 |
|POLY 1.5 | P=0.408 P=0.511 P=0.342N P=0.438 |P=0.489 P=0.076 P=0.501 P=0.269 |
|POLY 6 | P=0.408 P=0.563 P=0.403N P=0.457 |P=0.507 P=0.094 P=0.513 P=0.288 |
|LOGISTIC REGRESSION| P=0.454 P=0.500 P=0.328N P=0.468 |P=0.529 P=0.071 P=0.500 P=0.288 |
|COCH-ARM / FISHERS | P=0.478 P=0.500 P=0.326N P=0.500 |P=0.536 P=0.070 P=0.500 P=0.298 |
|=================================================================================================================================|
Date: 06/12/01 EXPERIMENT: 88122 TEST: 06 Page 20
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - ELMIRON
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/41.35 0/41.91 2/39.89 4/40.84 |0/41.94 0/42.89 0/41.46 0/39.32 |
|POLY-3 PERCENT (g) | 4.8% 0.0% 5.0% 9.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/26 (0%) 0/29 (0%) 2/25 (8%) 2/28 (7%) |0/30 (0%) 0/31 (0%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | 699 --- 727 (T) 604 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.097 P=0.230N P=0.651 P=0.354 |(e) (e) (e) (e) |
|POLY 3 | P=0.084 P=0.234N P=0.682 P=0.331 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.083 P=0.237N P=0.690 P=0.324 |(e) (e) (e) (e) |
|POLY 6 | P=0.087 P=0.229N P=0.669 P=0.345 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.083 P=0.229N P=0.661 P=0.325 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.090 P=0.247N P=0.691N P=0.339 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/41.35 0/41.91 2/39.89 4/40.84 |0/41.94 0/42.89 0/41.46 0/39.32 |
|POLY-3 PERCENT (g) | 4.8% 0.0% 5.0% 9.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/26 (0%) 0/29 (0%) 2/25 (8%) 2/28 (7%) |0/30 (0%) 0/31 (0%) 0/28 (0%) 0/27 (0%) |
|FIRST INCIDENCE | 699 --- 727 (T) 604 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.097 P=0.230N P=0.651 P=0.354 |(e) (e) (e) (e) |
|POLY 3 | P=0.084 P=0.234N P=0.682 P=0.331 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.083 P=0.237N P=0.690 P=0.324 |(e) (e) (e) (e) |
|POLY 6 | P=0.087 P=0.229N P=0.669 P=0.345 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.083 P=0.229N P=0.661 P=0.325 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.090 P=0.247N P=0.691N P=0.339 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/12/01 EXPERIMENT: 88122 TEST: 06 Page 21
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - ELMIRON
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 47/50 (94%) 49/50 (98%) 45/50 (90%) |37/50 (74%) 41/50 (82%) 41/50 (82%) 35/50 (70%) |
|POLY-3 RATE (b) | 49/49.00 47/47.99 49/49.19 45/45.21 |37/46.19 41/46.12 41/45.50 35/42.20 |
|POLY-3 PERCENT (g) | 100.0% 97.9% 99.6% 99.5% |80.1% 88.9% 90.1% 83.0% |
|TERMINAL (d) | 26/26 (100%) 29/29 (100%) 25/25 (100%) 28/28 (100%)|22/30 (73%) 28/31 (90%) 26/28 (93%) 22/27 (82%) |
|FIRST INCIDENCE | 475 313 462 433 |462 474 474 525 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.300N P=0.225N P=0.408 P=0.233N |P=0.522 P=0.385 P=0.211 P=0.483 |
|POLY 3 | P=0.721 P=0.500N P=1.000N P=1.000N |P=0.532N P=0.176 P=0.132 P=0.471 |
|POLY 1.5 | P=0.551N P=0.429N P=0.920N P=0.600N |P=0.444N P=0.195 P=0.159 P=0.539 |
|POLY 6 | P=0.630 P=0.530N P=1.000N P=1.000N |P=0.566 P=0.152 P=0.103 P=0.421 |
|LOGISTIC REGRESSION| P=0.476N P=0.454N (e) (e) |P=0.424N P=0.251 P=0.179 P=0.574 |
|COCH-ARM / FISHERS | P=0.075N P=0.309N P=0.753N P=0.102N |P=0.187N P=0.235 P=0.235 P=0.412N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 29/50 (58%) 25/50 (50%) 22/50 (44%) 25/50 (50%) |12/50 (24%) 17/50 (34%) 14/50 (28%) 15/50 (30%) |
|POLY-3 RATE (b) | 29/45.98 25/46.62 22/44.55 25/43.17 |12/44.49 17/45.47 14/45.00 15/43.17 |
|POLY-3 PERCENT (g) | 63.1% 53.6% 49.4% 57.9% |27.0% 37.4% 31.1% 34.8% |
|TERMINAL (d) | 11/26 (42%) 9/29 (31%) 9/25 (36%) 14/28 (50%) |6/30 (20%) 8/31 (26%) 4/28 (14%) 4/27 (15%) |
|FIRST INCIDENCE | 475 313 419 484 |406 510 483 379 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.390N P=0.234N P=0.254N P=0.280N |P=0.348 P=0.244 P=0.394 P=0.275 |
|POLY 3 | P=0.499N P=0.237N P=0.129N P=0.388N |P=0.398 P=0.202 P=0.422 P=0.288 |
|POLY 1.5 | P=0.474N P=0.259N P=0.112N P=0.375N |P=0.394 P=0.194 P=0.411 P=0.283 |
|POLY 6 | P=0.505N P=0.209N P=0.162N P=0.378N |P=0.411 P=0.217 P=0.439 P=0.304 |
|LOGISTIC REGRESSION| P=0.396N P=0.274N P=0.116N P=0.326N |P=0.466 P=0.188 P=0.417 P=0.334 |
|COCH-ARM / FISHERS | P=0.354N P=0.274N P=0.115N P=0.274N |P=0.456 P=0.189 P=0.410 P=0.326 |
|=================================================================================================================================|
Date: 06/12/01 EXPERIMENT: 88122 TEST: 06 Page 22
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - ELMIRON
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 14 MG/KG 42 MG/KG 126 |0 MG/KG 28 MG/KG 84 MG/KG 252 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 48/50 (96%) 50/50 (100%) 45/50 (90%) |42/50 (84%) 45/50 (90%) 44/50 (88%) 40/50 (80%) |
|POLY-3 RATE (b) | 49/49.00 48/48.04 50/50.00 45/45.21 |42/47.56 45/47.52 44/46.73 40/45.18 |
|POLY-3 PERCENT (g) | 100.0% 99.9% 100.0% 99.5% |88.3% 94.7% 94.2% 88.5% |
|TERMINAL (d) | 26/26 (100%) 29/29 (100%) 25/25 (100%) 28/28 (100%)|25/30 (83%) 29/31 (94%) 26/28 (93%) 22/27 (82%) |
|FIRST INCIDENCE | 475 313 419 433 |406 474 474 379 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.277N P=0.277N P=0.354 P=0.233N |P=0.463 P=0.458 P=0.316 P=0.463 |
|POLY 3 | P=1.000N P=1.000N P=1.000 P=1.000N |P=0.396N P=0.218 P=0.251 P=0.616 |
|POLY 1.5 | P=0.176N P=1.000N P=1.000 P=0.600N |P=0.387N P=0.224 P=0.281 P=0.622 |
|POLY 6 | P=1.000N P=1.000N P=1.000 P=1.000N |P=0.363N P=0.219 P=0.234 P=0.618N |
|LOGISTIC REGRESSION| P=0.195N (e) (e) (e) |P=0.465N P=0.284 P=0.331 P=0.602 |
|COCH-ARM / FISHERS | P=0.031N* P=0.500N P=0.500 P=0.102N |P=0.182N P=0.277 P=0.387 P=0.398N |
|=================================================================================================================================|
(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).