TDMS Study 05211-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst EMODIN DATE: 01/25/01
EXPERIMENT: 05211 TEST: 05 TIME: 12:58:05
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-85216 ROUTE: DOSED FEED NTP C#: C62408
PATHOLOGIST: HEATH, JAMES CAS: 518-82-1
------------------------------------------------------------------------------------------------------------------------------------
FINAL#3;REVISION#1
REASONS FOR REMOVAL: 25022 Accidently Killed
25019 Moribund Sacrifice
25020 Natural Death
25021 Terminal Sacrifice
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst EMODIN DATE: 01/25/01
EXPERIMENT: 05211 TEST: 05 TIME: 12:58:05
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-85216 ROUTE: DOSED FEED NTP C#: C62408
PATHOLOGIST: HEATH, JAMES CAS: 518-82-1
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 Cortex
Adrenal Medulla
Brain
Clitoral/Preputial Gland
Islets, Pancreatic
Kidney
Liver
Lung
Nose
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Prostate
Salivary Glands
Spleen
Testes
Thymus
Thyroid Gland
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst EMODIN DATE: 01/25/01
EXPERIMENT: 05211 TEST: 05 TIME: 12:58:05
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-85216 ROUTE: DOSED FEED NTP C#: C62408
PATHOLOGIST: HEATH, JAMES CAS: 518-82-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF EMODIN
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Medulla Pheochromocytoma Benign
Islets, Pancreatic Carcinoma or Adenoma
Mesentery Sarcoma
Nose Squamous Cell Carcinoma
Testes Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Benign Tumors
Malignant Tumors
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Mammary Gland Carcinoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Zymbal's Gland Carcinoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Malignant Tumors
===============================================================
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 1
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 13/49 (27%) 6/50 (12%) 9/50 (18%) |1/47 (2%) 0/50 (0%) 4/50 (8%) 1/50 (2%) |
|POLY-3 RATE (b) | 7/41.06 13/40.68 6/40.39 9/43.31 |1/42.90 0/45.74 4/45.55 1/44.02 |
|POLY-3 PERCENT (g) | 17.1% 32.0% 14.9% 20.8% |2.3% 0.0% 8.8% 2.3% |
|TERMINAL (d) | 6/30 (20%) 2/20 (10%) 2/21 (10%) 7/30 (23%) |0/33 (0%) 0/39 (0%) 3/35 (9%) 1/34 (3%) |
|FIRST INCIDENCE | 686 511 638 539 |704 --- 665 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.407N P=0.036 * P=0.519 P=0.397 |P=0.556 P=0.479N P=0.205 P=0.760N |
|POLY 3 | P=0.465N P=0.091 P=0.513N P=0.437 |P=0.564 P=0.487N P=0.197 P=0.755N |
|POLY 1.5 | P=0.479N P=0.100 P=0.495N P=0.430 |P=0.573 P=0.488N P=0.196 P=0.752N |
|POLY 6 | P=0.453N P=0.077 P=0.547N P=0.437 |P=0.551 P=0.486N P=0.200 P=0.759N |
|LOGISTIC REGRESSION| P=0.465N P=0.075 P=0.563N P=0.419 |P=0.572 P=0.488N P=0.197 P=0.759N |
|COCH-ARM / FISHERS | P=0.520N P=0.096 P=0.500N P=0.393 |P=0.587 P=0.485N P=0.201 P=0.737N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 13/49 (27%) 7/50 (14%) 10/50 (20%) |2/47 (4%) 0/50 (0%) 4/50 (8%) 2/50 (4%) |
|POLY-3 RATE (b) | 8/41.37 13/40.68 7/40.39 10/43.31 |2/43.53 0/45.74 4/45.55 2/44.02 |
|POLY-3 PERCENT (g) | 19.3% 32.0% 17.3% 23.1% |4.6% 0.0% 8.8% 4.5% |
|TERMINAL (d) | 6/30 (20%) 2/20 (10%) 3/21 (14%) 8/30 (27%) |0/33 (0%) 0/39 (0%) 3/35 (9%) 2/34 (6%) |
|FIRST INCIDENCE | 646 511 638 539 |527 --- 665 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.440N P=0.062 P=0.489 P=0.403 |P=0.444 P=0.226N P=0.369 P=0.688N |
|POLY 3 | P=0.514N P=0.142 P=0.520N P=0.438 |P=0.450 P=0.226N P=0.358 P=0.690N |
|POLY 1.5 | P=0.527N P=0.156 P=0.497N P=0.434 |P=0.461 P=0.226N P=0.359 P=0.683N |
|POLY 6 | P=0.506N P=0.120 P=0.563N P=0.433 |P=0.435 P=0.225N P=0.360 P=0.690 |
|LOGISTIC REGRESSION| P=0.506N P=0.127 P=0.558N P=0.427 |P=0.484 P=0.165N P=0.383 P=0.644N |
|COCH-ARM / FISHERS | P=0.559 P=0.150 P=0.500N P=0.398 |P=0.477 P=0.232N P=0.369 P=0.668N |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 2
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Brain |
| Astrocytoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/40.89 1/40.19 0/39.45 0/42.44 |0/44.01 0/45.74 0/45.30 0/44.02 |
|POLY-3 PERCENT (g) | 4.9% 2.5% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/30 (7%) 0/21 (0%) 0/21 (0%) 0/30 (0%) |0/33 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 729 (T) 464 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.162N P=0.575N P=0.319N P=0.238N |(e) (e) (e) (e) |
|POLY 3 | P=0.164N P=0.506N P=0.245N P=0.229N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.167N P=0.496N P=0.238N P=0.229N |(e) (e) (e) (e) |
|POLY 6 | P=0.158N P=0.526N P=0.259N P=0.230N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.176N P=0.508N (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.170N P=0.500N P=0.247N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Brain |
| Oligodendroglioma, Glioma, or Astrocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/40.89 2/40.60 0/39.45 0/42.44 |0/44.01 0/45.74 1/45.30 0/44.02 |
|POLY-3 PERCENT (g) | 4.9% 4.9% 0.0% 0.0% |0.0% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 2/30 (7%) 0/21 (0%) 0/21 (0%) 0/30 (0%) |0/33 (0%) 0/39 (0%) 1/35 (3%) 0/34 (0%) |
|FIRST INCIDENCE | 729 (T) 464 --- --- |--- --- 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.119N P=0.637 P=0.319N P=0.238N |P=0.792N (e) P=0.512 (e) |
|POLY 3 | P=0.119N P=0.692 P=0.245N P=0.229N |P=0.787N (e) P=0.506 (e) |
|POLY 1.5 | P=0.121N P=0.688N P=0.238N P=0.229N |P=0.785N (e) P=0.504 (e) |
|POLY 6 | P=0.116N P=0.675 P=0.259N P=0.230N |P=0.790N (e) P=0.509 (e) |
|LOGISTIC REGRESSION| P=0.132N P=0.684 (e) (e) |(e) (e) P=0.512 (e) |
|COCH-ARM / FISHERS | P=0.124N P=0.691N P=0.247N P=0.247N |P=0.783N (e) P=0.505 (e) |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 3
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 1/50 (2%) 2/50 (4%) 3/50 (6%) |10/49 (20%) 12/50 (24%) 8/49 (16%) 10/49 (20%) |
|POLY-3 RATE (b) | 5/42.26 1/39.45 2/40.26 3/42.44 |10/45.28 12/46.07 8/44.55 10/44.11 |
|POLY-3 PERCENT (g) | 11.8% 2.5% 5.0% 7.1% |22.1% 26.1% 18.0% 22.7% |
|TERMINAL (d) | 2/30 (7%) 1/21 (5%) 0/21 (0%) 3/30 (10%) |8/33 (24%) 10/39 (26%) 7/34 (21%) 8/33 (24%) |
|FIRST INCIDENCE | 472 729 (T) 483 729 (T) |497 656 665 529 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.482N P=0.167N P=0.296N P=0.355N |P=0.548N P=0.559 P=0.369N P=0.593N |
|POLY 3 | P=0.517N P=0.117N P=0.235N P=0.353N |P=0.517N P=0.422 P=0.411N P=0.574 |
|POLY 1.5 | P=0.530N P=0.105N P=0.220N P=0.348N |P=0.506N P=0.420 P=0.411N P=0.582 |
|POLY 6 | P=0.498N P=0.138N P=0.262N P=0.365N |P=0.531N P=0.432 P=0.406N P=0.566 |
|LOGISTIC REGRESSION| P=0.549N P=0.104N P=0.229N P=0.354N |P=0.510N P=0.432 P=0.398N P=0.592N |
|COCH-ARM / FISHERS | P=0.544N P=0.102N P=0.218N P=0.357N |P=0.490N P=0.426 P=0.397N P=0.599N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 3/50 (6%) |2/49 (4%) 3/50 (6%) 2/49 (4%) 0/49 (0%) |
|POLY-3 RATE (b) | 3/41.36 2/39.60 1/39.45 3/43.22 |2/44.11 3/46.09 2/44.55 0/43.02 |
|POLY-3 PERCENT (g) | 7.3% 5.1% 2.5% 6.9% |4.5% 6.5% 4.5% 0.0% |
|TERMINAL (d) | 2/30 (7%) 0/21 (0%) 1/21 (5%) 1/30 (3%) |1/33 (3%) 2/39 (5%) 1/34 (3%) 0/33 (0%) |
|FIRST INCIDENCE | 590 704 729 (T) 617 |704 634 665 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.564 P=0.617N P=0.407N P=0.649N |P=0.131N P=0.556 P=0.674N P=0.246N |
|POLY 3 | P=0.541 P=0.520N P=0.322N P=0.642N |P=0.127N P=0.520 P=0.690N P=0.243N |
|POLY 1.5 | P=0.528 P=0.502N P=0.308N P=0.644N |P=0.124N P=0.514 P=0.694N P=0.241N |
|POLY 6 | P=0.558 P=0.551N P=0.347N P=0.643N |P=0.131N P=0.529 P=0.685N P=0.245N |
|LOGISTIC REGRESSION| P=0.525 P=0.515N P=0.316N P=0.663 |P=0.121N P=0.511 P=0.695N P=0.244N |
|COCH-ARM / FISHERS | P=0.509 P=0.500N P=0.309N P=0.661N |P=0.120N P=0.510 P=0.691N P=0.247N |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 4
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 3/50 (6%) 3/50 (6%) 5/50 (10%) |12/49 (24%) 15/50 (30%) 9/49 (18%) 10/49 (20%) |
|POLY-3 RATE (b) | 8/42.73 3/39.60 3/40.26 5/43.22 |12/45.38 15/46.42 9/44.55 10/44.11 |
|POLY-3 PERCENT (g) | 18.7% 7.6% 7.5% 11.6% |26.4% 32.3% 20.2% 22.7% |
|TERMINAL (d) | 4/30 (13%) 1/21 (5%) 1/21 (5%) 3/30 (10%) |9/33 (27%) 12/39 (31%) 8/34 (24%) 8/33 (24%) |
|FIRST INCIDENCE | 472 704 483 617 |497 634 665 529 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.379N P=0.204N P=0.187N P=0.274N |P=0.305N P=0.494 P=0.285N P=0.404N |
|POLY 3 | P=0.411N P=0.121N P=0.115N P=0.266N |P=0.275N P=0.349 P=0.326N P=0.433N |
|POLY 1.5 | P=0.429N P=0.105N P=0.102N P=0.262N |P=0.265N P=0.345 P=0.326N P=0.423N |
|POLY 6 | P=0.385N P=0.152N P=0.141N P=0.274N |P=0.289N P=0.363 P=0.323N P=0.445N |
|LOGISTIC REGRESSION| P=0.449N P=0.100N P=0.102N P=0.279N |P=0.268N P=0.355 P=0.311N P=0.401N |
|COCH-ARM / FISHERS | P=0.452N P=0.100N P=0.100N P=0.277N |P=0.251N P=0.349 P=0.312N P=0.405N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 5/50 (10%) 1/49 (2%) 1/50 (2%) |1/49 (2%) 1/50 (2%) 1/49 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/40.89 5/39.80 1/38.45 1/42.44 |1/44.01 1/45.74 1/44.58 0/44.02 |
|POLY-3 PERCENT (g) | 4.9% 12.6% 2.6% 2.4% |2.3% 2.2% 2.2% 0.0% |
|TERMINAL (d) | 2/30 (7%) 4/21 (19%) 1/20 (5%) 1/30 (3%) |1/33 (3%) 1/39 (3%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 729 (T) 630 729 (T) 729 (T) |730 (T) 730 (T) 711 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.152N P=0.110 P=0.641N P=0.500N |P=0.334N P=0.724N P=0.745N P=0.494N |
|POLY 3 | P=0.170N P=0.203 P=0.522N P=0.487N |P=0.328N P=0.752N P=0.758N P=0.500N |
|POLY 1.5 | P=0.172N P=0.217 P=0.509N P=0.488N |P=0.326N P=0.754N P=0.760N P=0.499N |
|POLY 6 | P=0.169N P=0.180 P=0.545N P=0.490N |P=0.332N P=0.748N P=0.754N P=0.502N |
|LOGISTIC REGRESSION| P=0.160N P=0.158 P=0.641N P=0.500N |P=0.333N P=0.724N P=0.756N (e) |
|COCH-ARM / FISHERS | P=0.184N P=0.218 P=0.508N P=0.500N |P=0.321N P=0.747N P=0.753N P=0.495N |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 5
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/49 (2%) 0/50 (0%) |0/49 (0%) 1/50 (2%) 1/49 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/40.89 1/39.50 1/38.86 0/42.44 |0/44.01 1/45.74 1/44.53 0/44.02 |
|POLY-3 PERCENT (g) | 7.3% 2.5% 2.6% 0.0% |0.0% 2.2% 2.3% 0.0% |
|TERMINAL (d) | 3/30 (10%) 0/21 (0%) 0/20 (0%) 0/30 (0%) |0/33 (0%) 1/39 (3%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 729 (T) 716 609 --- |--- 730 (T) 725 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.107N P=0.434N P=0.416N P=0.120N |P=0.555N P=0.533 P=0.511 (e) |
|POLY 3 | P=0.105N P=0.317N P=0.323N P=0.112N |P=0.543N P=0.508 P=0.502 (e) |
|POLY 1.5 | P=0.110N P=0.305N P=0.312N P=0.112N |P=0.541N P=0.506 P=0.500 (e) |
|POLY 6 | P=0.099N P=0.341N P=0.344N P=0.112N |P=0.545N P=0.511 P=0.506 (e) |
|LOGISTIC REGRESSION| P=0.108N P=0.400N P=0.332N (e) |P=0.555N P=0.533 P=0.509 (e) |
|COCH-ARM / FISHERS | P=0.116N P=0.309N P=0.316N P=0.121N |P=0.538N P=0.505 P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 6/50 (12%) 2/49 (4%) 1/50 (2%) |1/49 (2%) 2/50 (4%) 2/49 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 5/40.89 6/39.86 2/38.86 1/42.44 |1/44.01 2/45.74 2/44.60 0/44.02 |
|POLY-3 PERCENT (g) | 12.2% 15.1% 5.2% 2.4% |2.3% 4.4% 4.5% 0.0% |
|TERMINAL (d) | 5/30 (17%) 4/21 (19%) 1/20 (5%) 1/30 (3%) |1/33 (3%) 2/39 (5%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 729 (T) 630 609 729 (T) |730 (T) 730 (T) 711 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.034N* P=0.285 P=0.372N P=0.100N |P=0.261N P=0.558 P=0.523 P=0.494N |
|POLY 3 | P=0.036N* P=0.482 P=0.235N P=0.092N |P=0.253N P=0.513 P=0.505 P=0.500N |
|POLY 1.5 | P=0.038N* P=0.503 P=0.223N P=0.093N |P=0.250N P=0.510 P=0.501 P=0.499N |
|POLY 6 | P=0.034N* P=0.441 P=0.259N P=0.093N |P=0.258N P=0.519 P=0.511 P=0.502N |
|LOGISTIC REGRESSION| P=0.036N* P=0.375 P=0.276N P=0.100N |P=0.259N P=0.558 P=0.512 (e) |
|COCH-ARM / FISHERS | P=0.044N* P=0.500 P=0.226N P=0.102N |P=0.245N P=0.508 P=0.500 P=0.495N |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 6
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/40.89 1/39.45 1/39.45 2/42.44 |0/44.01 0/45.74 0/45.30 1/44.02 |
|POLY-3 PERCENT (g) | 2.5% 2.5% 2.5% 4.7% |0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 1/30 (3%) 1/21 (5%) 1/21 (5%) 2/30 (7%) |0/33 (0%) 0/39 (0%) 0/35 (0%) 1/34 (3%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |--- --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.420 P=0.681 P=0.681 P=0.500 |P=0.208 (e) (e) P=0.506 |
|POLY 3 | P=0.381 P=0.753 P=0.753 P=0.513 |P=0.213 (e) (e) P=0.500 |
|POLY 1.5 | P=0.375 P=0.761 P=0.760 P=0.512 |P=0.215 (e) (e) P=0.501 |
|POLY 6 | P=0.389 P=0.738 P=0.739 P=0.510 |P=0.210 (e) (e) P=0.498 |
|LOGISTIC REGRESSION| P=0.420 P=0.681 P=0.681 P=0.500 |(e) (e) (e) P=0.506 |
|COCH-ARM / FISHERS | P=0.361 P=0.753N P=0.753N P=0.500 |P=0.217 (e) (e) P=0.505 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 3/50 (6%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/40.89 3/39.70 3/39.91 0/42.44 |0/44.01 0/45.74 0/45.30 0/44.02 |
|POLY-3 PERCENT (g) | 0.0% 7.6% 7.5% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 1/21 (5%) 1/21 (5%) 0/30 (0%) |0/33 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- 690 605 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.266N P=0.080 P=0.090 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.277N P=0.113 P=0.114 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.278N P=0.119 P=0.119 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.279N P=0.102 P=0.104 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.281N P=0.101 P=0.118 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.297N P=0.121 P=0.121 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 7
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/50 (8%) 4/50 (8%) 2/50 (4%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/40.89 4/39.70 4/39.91 2/42.44 |0/44.01 0/45.74 0/45.30 1/44.02 |
|POLY-3 PERCENT (g) | 2.5% 10.1% 10.0% 4.7% |0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 1/30 (3%) 2/21 (10%) 2/21 (10%) 2/30 (7%) |0/33 (0%) 0/39 (0%) 0/35 (0%) 1/34 (3%) |
|FIRST INCIDENCE | 729 (T) 690 605 729 (T) |--- --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.468N P=0.103 P=0.112 P=0.500 |P=0.208 (e) (e) P=0.506 |
|POLY 3 | P=0.517N P=0.168 P=0.170 P=0.513 |P=0.213 (e) (e) P=0.500 |
|POLY 1.5 | P=0.522N P=0.179 P=0.179 P=0.512 |P=0.215 (e) (e) P=0.501 |
|POLY 6 | P=0.515N P=0.151 P=0.154 P=0.510 |P=0.210 (e) (e) P=0.498 |
|LOGISTIC REGRESSION| P=0.500N P=0.132 P=0.158 P=0.500 |(e) (e) (e) P=0.506 |
|COCH-ARM / FISHERS | P=0.544N P=0.181 P=0.181 P=0.500 |P=0.217 (e) (e) P=0.505 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/50 (8%) 4/50 (8%) 2/50 (4%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/40.89 4/39.70 4/39.91 2/42.44 |0/44.01 0/45.74 0/45.30 1/44.02 |
|POLY-3 PERCENT (g) | 2.5% 10.1% 10.0% 4.7% |0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 1/30 (3%) 2/21 (10%) 2/21 (10%) 2/30 (7%) |0/33 (0%) 0/39 (0%) 0/35 (0%) 1/34 (3%) |
|FIRST INCIDENCE | 729 (T) 690 605 729 (T) |--- --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.468N P=0.103 P=0.112 P=0.500 |P=0.208 (e) (e) P=0.506 |
|POLY 3 | P=0.517N P=0.168 P=0.170 P=0.513 |P=0.213 (e) (e) P=0.500 |
|POLY 1.5 | P=0.522N P=0.179 P=0.179 P=0.512 |P=0.215 (e) (e) P=0.501 |
|POLY 6 | P=0.515N P=0.151 P=0.154 P=0.510 |P=0.210 (e) (e) P=0.498 |
|LOGISTIC REGRESSION| P=0.500N P=0.132 P=0.158 P=0.500 |(e) (e) (e) P=0.506 |
|COCH-ARM / FISHERS | P=0.544N P=0.181 P=0.181 P=0.500 |P=0.217 (e) (e) P=0.505 |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 8
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/40.89 0/39.45 0/39.45 0/42.44 |0/44.24 0/45.74 0/45.30 2/44.02 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.5% |
|TERMINAL (d) | 0/30 (0%) 0/21 (0%) 0/21 (0%) 0/30 (0%) |0/33 (0%) 0/39 (0%) 0/35 (0%) 2/34 (6%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.038 * (e) (e) P=0.245 |
|POLY 3 | (e) (e) (e) (e) |P=0.040 * (e) (e) P=0.236 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.040 * (e) (e) P=0.236 |
|POLY 6 | (e) (e) (e) (e) |P=0.039 * (e) (e) P=0.235 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) P=0.245 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.042 * (e) (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 3/50 (6%) |23/50 (46%) 18/50 (36%) 20/50 (40%) 17/50 (34%) |
|POLY-3 RATE (b) | 1/40.89 2/39.45 2/39.74 3/42.55 |23/46.87 18/46.52 20/46.73 17/46.07 |
|POLY-3 PERCENT (g) | 2.5% 5.1% 5.0% 7.1% |49.1% 38.7% 42.8% 36.9% |
|TERMINAL (d) | 1/30 (3%) 2/21 (10%) 1/21 (5%) 2/30 (7%) |14/33 (42%) 15/39 (39%) 15/35 (43%) 11/34 (32%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 648 700 |596 634 592 529 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.336 P=0.376 P=0.401 P=0.309 |P=0.281N P=0.109N P=0.279N P=0.174N |
|POLY 3 | P=0.291 P=0.487 P=0.490 P=0.319 |P=0.220N P=0.210N P=0.343N P=0.162N |
|POLY 1.5 | P=0.285 P=0.500 P=0.500 P=0.318 |P=0.214N P=0.208N P=0.347N P=0.157N |
|POLY 6 | P=0.297 P=0.464 P=0.471 P=0.317 |P=0.236N P=0.217N P=0.346N P=0.177N |
|LOGISTIC REGRESSION| P=0.308 P=0.376 P=0.478 P=0.310 |P=0.219N P=0.187N P=0.333N P=0.154N |
|COCH-ARM / FISHERS | P=0.268 P=0.500 P=0.500 P=0.309 |P=0.209N P=0.208N P=0.343N P=0.154N |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 9
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 3/50 (6%) |23/50 (46%) 18/50 (36%) 20/50 (40%) 18/50 (36%) |
|POLY-3 RATE (b) | 1/40.89 2/39.45 2/39.74 3/42.55 |23/46.87 18/46.52 20/46.73 18/46.07 |
|POLY-3 PERCENT (g) | 2.5% 5.1% 5.0% 7.1% |49.1% 38.7% 42.8% 39.1% |
|TERMINAL (d) | 1/30 (3%) 2/21 (10%) 1/21 (5%) 2/30 (7%) |14/33 (42%) 15/39 (39%) 15/35 (43%) 12/34 (35%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 648 700 |596 634 592 529 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.336 P=0.376 P=0.401 P=0.309 |P=0.361N P=0.109N P=0.279N P=0.224N |
|POLY 3 | P=0.291 P=0.487 P=0.490 P=0.319 |P=0.300N P=0.210N P=0.343N P=0.221N |
|POLY 1.5 | P=0.285 P=0.500 P=0.500 P=0.318 |P=0.292N P=0.208N P=0.347N P=0.214N |
|POLY 6 | P=0.297 P=0.464 P=0.471 P=0.317 |P=0.320N P=0.217N P=0.346N P=0.240N |
|LOGISTIC REGRESSION| P=0.308 P=0.376 P=0.478 P=0.310 |P=0.297N P=0.187N P=0.333N P=0.209N |
|COCH-ARM / FISHERS | P=0.268 P=0.500 P=0.500 P=0.309 |P=0.284N P=0.208N P=0.343N P=0.208N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Mesentery |
| Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/40.89 0/39.45 0/39.45 2/42.44 |0/44.24 0/45.74 0/45.30 0/44.02 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.7% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/21 (0%) 0/21 (0%) 2/30 (7%) |0/33 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.062 (e) (e) P=0.238 |(e) (e) (e) (e) |
|POLY 3 | P=0.044 * (e) (e) P=0.245 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.043 * (e) (e) P=0.245 |(e) (e) (e) (e) |
|POLY 6 | P=0.045 * (e) (e) P=0.243 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.238 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.042 * (e) (e) P=0.247 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 10
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Nose |
| Squamous Cell Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/40.89 0/39.45 0/39.45 2/43.13 |0/44.01 0/45.74 0/45.30 0/44.02 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.6% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/21 (0%) 0/21 (0%) 1/30 (3%) |0/33 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- --- 492 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.054 (e) (e) P=0.247 |(e) (e) (e) (e) |
|POLY 3 | P=0.045 * (e) (e) P=0.249 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.043 * (e) (e) P=0.247 |(e) (e) (e) (e) |
|POLY 6 | P=0.047 * (e) (e) P=0.249 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.033 * (e) (e) P=0.207 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.042 * (e) (e) P=0.247 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Pancreas |
| Mixed Tumor Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/41.51 0/39.45 0/39.45 0/42.44 |0/44.01 0/45.74 0/44.51 0/44.02 |
|POLY-3 PERCENT (g) | 4.8% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/30 (3%) 0/21 (0%) 0/21 (0%) 0/30 (0%) |0/33 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 528 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.230N P=0.279N P=0.276N P=0.235N |(e) (e) (e) (e) |
|POLY 3 | P=0.226N P=0.248N P=0.248N P=0.232N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.234N P=0.239N P=0.240N P=0.231N |(e) (e) (e) (e) |
|POLY 6 | P=0.213N P=0.265N P=0.264N P=0.235N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.248N P=0.245N P=0.243N P=0.251N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.239N P=0.247N P=0.247N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 11
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 15/49 (31%) 9/50 (18%) 10/48 (21%) 13/50 (26%) |15/49 (31%) 21/50 (42%) 25/49 (51%) 25/49 (51%) |
|POLY-3 RATE (b) | 15/41.14 9/41.29 10/39.69 13/42.98 |15/46.31 21/47.49 25/45.54 25/46.10 |
|POLY-3 PERCENT (g) | 36.5% 21.8% 25.2% 30.3% |32.4% 44.2% 54.9% 54.2% |
|TERMINAL (d) | 10/29 (35%) 4/21 (19%) 5/20 (25%) 11/30 (37%) |8/33 (24%) 16/39 (41%) 20/35 (57%) 15/33 (46%) |
|FIRST INCIDENCE | 604 511 483 645 |497 600 648 590 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.439N P=0.315N P=0.443N P=0.378N |P=0.044 * P=0.302 P=0.072 P=0.054 |
|POLY 3 | P=0.556 P=0.107N P=0.193N P=0.353N |P=0.042 * P=0.166 P=0.022 * P=0.025 * |
|POLY 1.5 | P=0.541 P=0.096N P=0.177N P=0.350N |P=0.044 * P=0.164 P=0.023 * P=0.026 * |
|POLY 6 | P=0.550N P=0.134N P=0.234N P=0.373N |P=0.041 * P=0.174 P=0.021 * P=0.025 * |
|LOGISTIC REGRESSION| P=0.533N P=0.117N P=0.206N P=0.337N |P=0.047 * P=0.162 P=0.032 * P=0.034 * |
|COCH-ARM / FISHERS | P=0.512 P=0.109N P=0.193N P=0.387N |P=0.052 P=0.166 P=0.032 * P=0.032 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Prostate |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 3/50 (6%) | |
|POLY-3 RATE (b) | 1/40.89 0/39.45 1/39.45 3/42.44 | |
|POLY-3 PERCENT (g) | 2.5% 0.0% 2.5% 7.1% | |
|TERMINAL (d) | 1/30 (3%) 0/21 (0%) 1/21 (5%) 3/30 (10%) | |
|FIRST INCIDENCE | 729 (T) --- 729 (T) 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.119 P=0.571N P=0.681 P=0.304 | |
|POLY 3 | P=0.090 P=0.507N P=0.753 P=0.318 | |
|POLY 1.5 | P=0.087 P=0.500N P=0.760 P=0.318 | |
|POLY 6 | P=0.095 P=0.520N P=0.739 P=0.315 | |
|LOGISTIC REGRESSION| P=0.119 (e) P=0.681 P=0.304 | |
|COCH-ARM / FISHERS | P=0.082 P=0.500N P=0.753N P=0.309 | |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 12
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous |
| Tumor (benign, malignant or NOS), or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/40.89 2/39.45 0/39.45 2/42.91 |0/44.24 0/45.74 0/45.30 1/44.02 |
|POLY-3 PERCENT (g) | 2.5% 5.1% 0.0% 4.7% |0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 1/30 (3%) 2/21 (10%) 0/21 (0%) 1/30 (3%) |0/33 (0%) 0/39 (0%) 0/35 (0%) 1/34 (3%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 590 |--- --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.511 P=0.376 P=0.571N P=0.505 |P=0.208 (e) (e) P=0.506 |
|POLY 3 | P=0.480 P=0.487 P=0.507N P=0.517 |P=0.213 (e) (e) P=0.499 |
|POLY 1.5 | P=0.474 P=0.500 P=0.501N P=0.514 |P=0.214 (e) (e) P=0.499 |
|POLY 6 | P=0.485 P=0.464 P=0.520N P=0.517 |P=0.210 (e) (e) P=0.498 |
|LOGISTIC REGRESSION| P=0.483 P=0.376 (e) P=0.506 |(e) (e) (e) P=0.506 |
|COCH-ARM / FISHERS | P=0.460 P=0.500 P=0.500N P=0.500 |P=0.215 (e) (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|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%) 6/50 (12%) 3/50 (6%) 8/50 (16%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 4/40.99 6/39.97 3/39.45 8/43.01 |1/44.24 0/45.74 0/45.30 1/44.02 |
|POLY-3 PERCENT (g) | 9.8% 15.0% 7.6% 18.6% |2.3% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 3/30 (10%) 4/21 (19%) 3/21 (14%) 6/30 (20%) |1/33 (3%) 0/39 (0%) 0/35 (0%) 1/34 (3%) |
|FIRST INCIDENCE | 704 638 729 (T) 590 |730 (T) --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.233 P=0.201 P=0.626 P=0.183 |P=0.532 P=0.467N P=0.488N P=0.755N |
|POLY 3 | P=0.172 P=0.352 P=0.521N P=0.198 |P=0.533 P=0.493N P=0.495N P=0.760 |
|POLY 1.5 | P=0.164 P=0.372 P=0.502N P=0.196 |P=0.537 P=0.496N P=0.498N P=0.760 |
|POLY 6 | P=0.180 P=0.316 P=0.557N P=0.196 |P=0.528 P=0.489N P=0.492N P=0.759 |
|LOGISTIC REGRESSION| P=0.193 P=0.289 P=0.639N P=0.190 |P=0.532 (e) (e) P=0.755N |
|COCH-ARM / FISHERS | P=0.149 P=0.370 P=0.500N P=0.178 |P=0.541 P=0.500N P=0.500N P=0.753N |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 13
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 2/50 (4%) 5/50 (10%) |2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/40.99 3/40.48 2/39.91 5/43.17 |2/44.26 0/45.74 1/45.38 0/44.02 |
|POLY-3 PERCENT (g) | 2.4% 7.4% 5.0% 11.6% |4.5% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/21 (0%) 0/21 (0%) 3/30 (10%) |1/33 (3%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 704 584 631 605 |725 --- 711 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.128 P=0.266 P=0.439 P=0.113 |P=0.277N P=0.210N P=0.477N P=0.240N |
|POLY 3 | P=0.100 P=0.300 P=0.491 P=0.113 |P=0.274N P=0.230N P=0.491N P=0.238N |
|POLY 1.5 | P=0.096 P=0.309 P=0.501 P=0.111 |P=0.270N P=0.233N P=0.496N P=0.238N |
|POLY 6 | P=0.104 P=0.283 P=0.472 P=0.113 |P=0.279N P=0.225N P=0.485N P=0.239N |
|LOGISTIC REGRESSION| P=0.088 P=0.301 P=0.498 P=0.109 |P=0.272N P=0.217N P=0.483N P=0.241N |
|COCH-ARM / FISHERS | P=0.088 P=0.309 P=0.500 P=0.102 |P=0.266N P=0.247N P=0.500N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 2/50 (4%) 5/50 (10%) |2/50 (4%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/41.99 4/40.67 2/39.91 5/43.17 |2/44.26 1/45.74 2/46.35 0/44.02 |
|POLY-3 PERCENT (g) | 4.8% 9.8% 5.0% 11.6% |4.5% 2.2% 4.3% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/21 (0%) 0/21 (0%) 3/30 (10%) |1/33 (3%) 1/39 (3%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 122 584 631 605 |725 730 (T) 232 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.267 P=0.292 P=0.644 P=0.230 |P=0.219N P=0.449N P=0.674N P=0.240N |
|POLY 3 | P=0.227 P=0.322 P=0.676 P=0.226 |P=0.216N P=0.489N P=0.677N P=0.238N |
|POLY 1.5 | P=0.222 P=0.334 P=0.687 P=0.225 |P=0.213N P=0.494N P=0.684N P=0.238N |
|POLY 6 | P=0.233 P=0.301 P=0.656 P=0.226 |P=0.220N P=0.482N P=0.670N P=0.239N |
|LOGISTIC REGRESSION| P=0.175 P=0.243 P=0.619 P=0.166 |P=0.191N P=0.465N P=0.664N P=0.241N |
|COCH-ARM / FISHERS | P=0.211 P=0.339 P=0.691N P=0.218 |P=0.208N P=0.500N P=0.691N P=0.247N |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 14
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 3/50 (6%) 3/50 (6%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/40.99 3/39.97 3/39.45 3/42.44 |1/44.24 0/45.74 0/45.30 0/44.02 |
|POLY-3 PERCENT (g) | 7.3% 7.5% 7.6% 7.1% |2.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/30 (7%) 1/21 (5%) 3/21 (14%) 3/30 (10%) |1/33 (3%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 704 638 729 (T) 729 (T) |730 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.522N P=0.534 P=0.497 P=0.663 |P=0.479N P=0.467N P=0.488N P=0.494N |
|POLY 3 | P=0.575N P=0.652 P=0.645 P=0.647N |P=0.477N P=0.493N P=0.495N P=0.501N |
|POLY 1.5 | P=0.583N P=0.660N P=0.661 P=0.647N |P=0.475N P=0.496N P=0.498N P=0.501N |
|POLY 6 | P=0.567N P=0.626 P=0.615 P=0.652N |P=0.480N P=0.489N P=0.492N P=0.502N |
|LOGISTIC REGRESSION| P=0.550N P=0.636 P=0.548 P=0.660N |P=0.479N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.601N P=0.661N P=0.661N P=0.661N |P=0.472N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Carcinoma, Basal Cell Carcinoma, Basosquamous |
| Tumor (malignant or NOS), or Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/40.89 1/39.45 0/39.45 2/42.44 |0/44.24 0/45.74 0/45.30 0/44.02 |
|POLY-3 PERCENT (g) | 0.0% 2.5% 0.0% 4.7% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 1/21 (5%) 0/21 (0%) 2/30 (7%) |0/33 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.190 P=0.429 (e) P=0.238 |(e) (e) (e) (e) |
|POLY 3 | P=0.156 P=0.493 (e) P=0.245 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.154 P=0.500 (e) P=0.245 |(e) (e) (e) (e) |
|POLY 6 | P=0.156 P=0.480 (e) P=0.243 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.429 (e) P=0.238 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.149 P=0.500 (e) P=0.247 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 15
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/40.89 1/39.45 0/39.45 2/42.54 |0/44.24 0/45.74 0/45.30 0/44.02 |
|POLY-3 PERCENT (g) | 0.0% 2.5% 0.0% 4.7% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 1/21 (5%) 0/21 (0%) 1/30 (3%) |0/33 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- 702 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.190 P=0.429 (e) P=0.243 |(e) (e) (e) (e) |
|POLY 3 | P=0.156 P=0.493 (e) P=0.246 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.155 P=0.500 (e) P=0.245 |(e) (e) (e) (e) |
|POLY 6 | P=0.157 P=0.480 (e) P=0.244 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.174 P=0.429 (e) P=0.243 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.149 P=0.500 (e) P=0.247 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell |
| Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 3/50 (6%) 6/50 (12%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/40.99 4/39.97 3/39.45 6/42.54 |1/44.24 0/45.74 0/45.30 0/44.02 |
|POLY-3 PERCENT (g) | 7.3% 10.0% 7.6% 14.1% |2.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/30 (7%) 2/21 (10%) 3/21 (14%) 5/30 (17%) |1/33 (3%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 704 638 729 (T) 702 |730 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.267 P=0.353 P=0.497 P=0.245 |P=0.479N P=0.467N P=0.488N P=0.494N |
|POLY 3 | P=0.206 P=0.486 P=0.645 P=0.259 |P=0.477N P=0.493N P=0.495N P=0.501N |
|POLY 1.5 | P=0.200 P=0.503 P=0.661 P=0.259 |P=0.475N P=0.496N P=0.498N P=0.501N |
|POLY 6 | P=0.211 P=0.455 P=0.615 P=0.254 |P=0.480N P=0.489N P=0.492N P=0.502N |
|LOGISTIC REGRESSION| P=0.234 P=0.455 P=0.548 P=0.246 |P=0.479N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.185 P=0.500 P=0.661N P=0.243 |P=0.472N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 16
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 3/50 (6%) 5/50 (10%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/40.99 4/39.97 3/39.45 5/42.54 |1/44.24 0/45.74 0/45.30 0/44.02 |
|POLY-3 PERCENT (g) | 7.3% 10.0% 7.6% 11.8% |2.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/30 (7%) 2/21 (10%) 3/21 (14%) 4/30 (13%) |1/33 (3%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 704 638 729 (T) 702 |730 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.405 P=0.353 P=0.497 P=0.359 |P=0.479N P=0.467N P=0.488N P=0.494N |
|POLY 3 | P=0.343 P=0.486 P=0.645 P=0.376 |P=0.477N P=0.493N P=0.495N P=0.501N |
|POLY 1.5 | P=0.336 P=0.503 P=0.661 P=0.376 |P=0.475N P=0.496N P=0.498N P=0.501N |
|POLY 6 | P=0.351 P=0.455 P=0.615 P=0.371 |P=0.480N P=0.489N P=0.492N P=0.502N |
|LOGISTIC REGRESSION| P=0.372 P=0.455 P=0.548 P=0.363 |P=0.479N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.315 P=0.500 P=0.661N P=0.357 |P=0.472N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 41/50 (82%) 43/50 (86%) 44/50 (88%) 48/50 (96%) | |
|POLY-3 RATE (b) | 41/44.33 43/45.66 44/47.50 48/48.74 | |
|POLY-3 PERCENT (g) | 92.5% 94.2% 92.6% 98.5% | |
|TERMINAL (d) | 29/30 (97%) 21/21 (100%) 20/21 (95%) 30/30 (100%)| |
|FIRST INCIDENCE | 528 555 510 449 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.488 P=0.020 * P=0.022 * P=0.165 | |
|POLY 3 | P=0.099 P=0.553 P=0.662 P=0.135 | |
|POLY 1.5 | P=0.049 * P=0.563 P=0.542 P=0.071 | |
|POLY 6 | P=0.221 P=0.472 P=0.578N P=0.249 | |
|LOGISTIC REGRESSION| P=0.028 * P=0.309 P=0.320 P=0.044 * | |
|COCH-ARM / FISHERS | P=0.023 * P=0.393 P=0.288 P=0.026 * | |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 17
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 3/50 (6%) 3/50 (6%) |4/49 (8%) 6/50 (12%) 4/50 (8%) 3/50 (6%) |
|POLY-3 RATE (b) | 3/40.89 5/39.80 3/40.37 3/42.44 |4/44.63 6/46.09 4/45.77 3/44.02 |
|POLY-3 PERCENT (g) | 7.3% 12.6% 7.4% 7.1% |9.0% 13.0% 8.7% 6.8% |
|TERMINAL (d) | 3/30 (10%) 4/21 (19%) 0/21 (0%) 3/30 (10%) |3/33 (9%) 5/39 (13%) 3/35 (9%) 3/34 (9%) |
|FIRST INCIDENCE | 729 (T) 632 575 729 (T) |527 634 592 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.377N P=0.196 P=0.553 P=0.665 |P=0.320N P=0.461 P=0.615N P=0.484N |
|POLY 3 | P=0.426N P=0.340 P=0.657 P=0.646N |P=0.315N P=0.390 P=0.630N P=0.508N |
|POLY 1.5 | P=0.433N P=0.358 P=0.658N P=0.646N |P=0.307N P=0.385 P=0.633N P=0.501N |
|POLY 6 | P=0.420N P=0.308 P=0.637 P=0.650N |P=0.327N P=0.399 P=0.622N P=0.516N |
|LOGISTIC REGRESSION| P=0.414N P=0.268 P=0.658 P=0.665 |P=0.298N P=0.381 P=0.628N P=0.493N |
|COCH-ARM / FISHERS | P=0.453N P=0.357 P=0.661N P=0.661N |P=0.293N P=0.383 P=0.631N P=0.489N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |2/49 (4%) 2/50 (4%) 0/50 (0%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/40.97 1/39.45 1/39.45 1/42.83 |2/44.01 2/45.74 0/45.30 3/44.38 |
|POLY-3 PERCENT (g) | 2.4% 2.5% 2.5% 2.3% |4.5% 4.4% 0.0% 6.8% |
|TERMINAL (d) | 0/30 (0%) 1/21 (5%) 1/21 (5%) 0/30 (0%) |2/33 (6%) 2/39 (5%) 0/35 (0%) 1/34 (3%) |
|FIRST INCIDENCE | 711 729 (T) 729 (T) 617 |730 (T) 730 (T) --- 646 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.620N P=0.687 P=0.682 P=0.751N |P=0.342 P=0.634N P=0.225N P=0.508 |
|POLY 3 | P=0.650N P=0.753 P=0.753 P=0.751N |P=0.358 P=0.680N P=0.231N P=0.504 |
|POLY 1.5 | P=0.656N P=0.761 P=0.760 P=0.752N |P=0.360 P=0.683N P=0.233N P=0.505 |
|POLY 6 | P=0.643N P=0.737 P=0.738 P=0.752N |P=0.354 P=0.674N P=0.227N P=0.503 |
|LOGISTIC REGRESSION| P=0.650N P=0.722 P=0.723 P=0.762 |P=0.348 P=0.634N (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.668 P=0.753N P=0.753N P=0.753N |P=0.364 P=0.684N P=0.242N P=0.510 |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 18
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 6/50 (12%) 4/50 (8%) 4/50 (8%) |6/49 (12%) 8/50 (16%) 4/50 (8%) 6/50 (12%) |
|POLY-3 RATE (b) | 4/40.97 6/39.80 4/40.37 4/42.83 |6/44.63 8/46.09 4/45.77 6/44.38 |
|POLY-3 PERCENT (g) | 9.8% 15.1% 9.9% 9.3% |13.4% 17.4% 8.7% 13.5% |
|TERMINAL (d) | 3/30 (10%) 5/21 (24%) 1/21 (5%) 3/30 (10%) |5/33 (15%) 7/39 (18%) 3/35 (9%) 4/34 (12%) |
|FIRST INCIDENCE | 711 632 575 617 |527 634 592 646 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.371N P=0.190 P=0.497 P=0.637N |P=0.507N P=0.504 P=0.339N P=0.602N |
|POLY 3 | P=0.420N P=0.350 P=0.636 P=0.619N |P=0.489N P=0.411 P=0.354N P=0.617 |
|POLY 1.5 | P=0.431N P=0.371 P=0.639N P=0.622N |P=0.480N P=0.406 P=0.359N P=0.618N |
|POLY 6 | P=0.408N P=0.311 P=0.611 P=0.621N |P=0.499N P=0.423 P=0.345N P=0.612 |
|LOGISTIC REGRESSION| P=0.415N P=0.266 P=0.628 P=0.628N |P=0.481N P=0.409 P=0.356N P=0.616N |
|COCH-ARM / FISHERS | P=0.458N P=0.370 P=0.643N P=0.643N |P=0.467N P=0.403 P=0.357N P=0.606N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |0/49 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/40.89 2/39.46 2/39.46 0/42.44 |0/44.01 1/45.74 1/45.30 0/44.02 |
|POLY-3 PERCENT (g) | 0.0% 5.1% 5.1% 0.0% |0.0% 2.2% 2.2% 0.0% |
|TERMINAL (d) | 0/30 (0%) 1/21 (5%) 1/21 (5%) 0/30 (0%) |0/33 (0%) 1/39 (3%) 1/35 (3%) 0/34 (0%) |
|FIRST INCIDENCE | --- 725 725 --- |--- 730 (T) 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.354N P=0.167 P=0.167 (e) |P=0.551N P=0.533 P=0.512 (e) |
|POLY 3 | P=0.370N P=0.229 P=0.229 (e) |P=0.543N P=0.508 P=0.506 (e) |
|POLY 1.5 | P=0.372N P=0.237 P=0.236 (e) |P=0.541N P=0.506 P=0.504 (e) |
|POLY 6 | P=0.373N P=0.214 P=0.215 (e) |P=0.546N P=0.511 P=0.509 (e) |
|LOGISTIC REGRESSION| P=0.353N P=0.175 P=0.175 (e) |(e) P=0.533 P=0.512 (e) |
|COCH-ARM / FISHERS | P=0.386N P=0.247 P=0.247 (e) |P=0.538N P=0.505 P=0.505 (e) |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 19
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 2/50 (4%) 0/50 (0%) |0/49 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/40.89 3/39.46 2/39.46 0/42.44 |0/44.01 2/45.74 1/45.30 1/44.02 |
|POLY-3 PERCENT (g) | 2.5% 7.6% 5.1% 0.0% |0.0% 4.4% 2.2% 2.3% |
|TERMINAL (d) | 1/30 (3%) 2/21 (10%) 1/21 (5%) 0/30 (0%) |0/33 (0%) 2/39 (5%) 1/35 (3%) 1/34 (3%) |
|FIRST INCIDENCE | 729 (T) 725 725 --- |--- 730 (T) 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.167N P=0.190 P=0.379 P=0.500N |P=0.602 P=0.276 P=0.512 P=0.506 |
|POLY 3 | P=0.174N P=0.292 P=0.488 P=0.493N |P=0.609 P=0.246 P=0.506 P=0.500 |
|POLY 1.5 | P=0.176N P=0.305 P=0.499 P=0.493N |P=0.612 P=0.244 P=0.504 P=0.501 |
|POLY 6 | P=0.173N P=0.268 P=0.466 P=0.494N |P=0.605 P=0.249 P=0.509 P=0.498 |
|LOGISTIC REGRESSION| P=0.163N P=0.198 P=0.395 (e) |(e) P=0.276 P=0.512 P=0.506 |
|COCH-ARM / FISHERS | P=0.187N P=0.309 P=0.500 P=0.500N |P=0.617 P=0.253 P=0.505 P=0.505 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |10/50 (20%) 8/50 (16%) 7/50 (14%) 10/50 (20%) |
|POLY-3 RATE (b) | |10/45.55 8/45.74 7/46.22 10/44.48 |
|POLY-3 PERCENT (g) | |22.0% 17.5% 15.2% 22.5% |
|TERMINAL (d) | |5/33 (15%) 8/39 (21%) 4/35 (11%) 9/34 (27%) |
|FIRST INCIDENCE | |630 730 (T) 527 592 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.411 P=0.291N P=0.268N P=0.583N |
|POLY 3 | |P=0.425 P=0.393N P=0.285N P=0.576 |
|POLY 1.5 | |P=0.438 P=0.394N P=0.292N P=0.587 |
|POLY 6 | |P=0.405 P=0.395N P=0.279N P=0.555 |
|LOGISTIC REGRESSION| |P=0.439 P=0.374N P=0.299N P=0.595 |
|COCH-ARM / FISHERS | |P=0.452 P=0.398N P=0.298N P=0.598N |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 20
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |11/50 (22%) 8/50 (16%) 7/50 (14%) 10/50 (20%) |
|POLY-3 RATE (b) | |11/45.57 8/45.74 7/46.22 10/44.48 |
|POLY-3 PERCENT (g) | |24.1% 17.5% 15.2% 22.5% |
|TERMINAL (d) | |5/33 (15%) 8/39 (21%) 4/35 (11%) 9/34 (27%) |
|FIRST INCIDENCE | |630 730 (T) 527 592 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.477 P=0.214N P=0.197N P=0.489N |
|POLY 3 | |P=0.494 P=0.300N P=0.205N P=0.525N |
|POLY 1.5 | |P=0.506 P=0.302N P=0.212N P=0.513N |
|POLY 6 | |P=0.474 P=0.302N P=0.201N P=0.549N |
|LOGISTIC REGRESSION| |P=0.507 P=0.281N P=0.218N P=0.504N |
|COCH-ARM / FISHERS | |P=0.521 P=0.306N P=0.218N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/40.89 1/40.19 0/39.45 1/42.44 |0/44.24 0/45.74 0/45.30 3/45.82 |
|POLY-3 PERCENT (g) | 0.0% 2.5% 0.0% 2.4% |0.0% 0.0% 0.0% 6.6% |
|TERMINAL (d) | 0/30 (0%) 0/21 (0%) 0/21 (0%) 1/30 (3%) |0/33 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- 462 --- 729 (T) |--- --- --- 360 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.479 P=0.517 (e) P=0.500 |P=0.010 * (e) (e) P=0.128 |
|POLY 3 | P=0.469 P=0.497 (e) P=0.507 |P=0.008 ** (e) (e) P=0.125 |
|POLY 1.5 | P=0.469 P=0.502 (e) P=0.507 |P=0.008 ** (e) (e) P=0.123 |
|POLY 6 | P=0.468 P=0.485 (e) P=0.506 |P=0.008 ** (e) (e) P=0.127 |
|LOGISTIC REGRESSION| P=0.424 P=0.363 (e) P=0.500 |P=0.007 ** (e) (e) P=0.093 |
|COCH-ARM / FISHERS | P=0.459 P=0.500 (e) P=0.500 |P=0.009 ** (e) (e) P=0.121 |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 21
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or |
| Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 28/50 (56%) 31/50 (62%) 29/50 (58%) 18/50 (36%) |14/50 (28%) 17/50 (34%) 16/50 (32%) 3/50 (6%) |
|POLY-3 RATE (b) | 28/45.54 31/47.64 29/45.54 18/46.53 |14/46.56 17/47.71 16/47.73 3/44.70 |
|POLY-3 PERCENT (g) | 61.5% 65.1% 63.7% 38.7% |30.1% 35.6% 33.5% 6.7% |
|TERMINAL (d) | 16/30 (53%) 7/21 (33%) 11/21 (52%) 6/30 (20%) |7/33 (21%) 12/39 (31%) 9/35 (26%) 1/34 (3%) |
|FIRST INCIDENCE | 284 491 373 266 |448 575 527 603 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.012N* P=0.129 P=0.174 P=0.063N |P=0.002N** P=0.487 P=0.477 P=0.006N** |
|POLY 3 | P=0.003N** P=0.442 P=0.500 P=0.021N* |P<0.001N** P=0.361 P=0.445 P=0.003N** |
|POLY 1.5 | P=0.003N** P=0.425 P=0.528 P=0.021N* |P<0.001N** P=0.347 P=0.426 P=0.003N** |
|POLY 6 | P=0.003N** P=0.460 P=0.455 P=0.021N* |P<0.001N** P=0.385 P=0.471 P=0.004N** |
|LOGISTIC REGRESSION| P=0.007N** P=0.341 P=0.505 P=0.037N* |P<0.001N** P=0.304 P=0.401 P=0.004N** |
|COCH-ARM / FISHERS | P=0.006N** P=0.342 P=0.500 P=0.035N* |P<0.001N** P=0.333 P=0.414 P=0.003N** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 3/50 (6%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/41.52 1/39.78 3/40.35 1/42.83 |0/44.24 0/45.74 0/45.30 1/44.17 |
|POLY-3 PERCENT (g) | 4.8% 2.5% 7.4% 2.3% |0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 0/30 (0%) 0/21 (0%) 0/21 (0%) 0/30 (0%) |0/33 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 604 636 603 617 |--- --- --- 690 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.436N P=0.531N P=0.466 P=0.489N |P=0.203 (e) (e) P=0.495 |
|POLY 3 | P=0.440N P=0.515N P=0.487 P=0.489N |P=0.213 (e) (e) P=0.500 |
|POLY 1.5 | P=0.450N P=0.501N P=0.500 P=0.489N |P=0.214 (e) (e) P=0.500 |
|POLY 6 | P=0.429N P=0.539N P=0.462 P=0.493N |P=0.211 (e) (e) P=0.499 |
|LOGISTIC REGRESSION| P=0.489N P=0.508N P=0.495 P=0.524N |P=0.216 (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.466N P=0.500N P=0.500 P=0.500N |P=0.215 (e) (e) P=0.500 |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 22
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 3/50 (6%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/41.52 1/39.78 3/40.35 1/42.83 |0/44.24 0/45.74 0/45.30 1/44.17 |
|POLY-3 PERCENT (g) | 4.8% 2.5% 7.4% 2.3% |0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 0/30 (0%) 0/21 (0%) 0/21 (0%) 0/30 (0%) |0/33 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 604 636 603 617 |--- --- --- 690 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.436N P=0.531N P=0.466 P=0.489N |P=0.203 (e) (e) P=0.495 |
|POLY 3 | P=0.440N P=0.515N P=0.487 P=0.489N |P=0.213 (e) (e) P=0.500 |
|POLY 1.5 | P=0.450N P=0.501N P=0.500 P=0.489N |P=0.214 (e) (e) P=0.500 |
|POLY 6 | P=0.429N P=0.539N P=0.462 P=0.493N |P=0.211 (e) (e) P=0.499 |
|LOGISTIC REGRESSION| P=0.489N P=0.508N P=0.495 P=0.524N |P=0.216 (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.466N P=0.500N P=0.500 P=0.500N |P=0.215 (e) (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 45/50 (90%) 46/50 (92%) 47/50 (94%) 49/50 (98%) |41/50 (82%) 39/50 (78%) 41/50 (82%) 37/50 (74%) |
|POLY-3 RATE (b) | 45/45.79 46/47.15 47/48.25 49/49.05 |41/49.13 39/47.70 41/48.10 37/47.72 |
|POLY-3 PERCENT (g) | 98.3% 97.6% 97.4% 99.9% |83.5% 81.8% 85.2% 77.5% |
|TERMINAL (d) | 30/30 (100%) 21/21 (100%) 21/21 (100%) 30/30 (100%)|26/33 (79%) 32/39 (82%) 31/35 (89%) 26/34 (77%) |
|FIRST INCIDENCE | 472 511 483 449 |497 600 527 529 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.391N P=0.036 * P=0.031 * P=0.344 |P=0.405N P=0.134N P=0.411N P=0.280N |
|POLY 3 | P=0.292 P=0.792N P=0.698N P=0.656 |P=0.260N P=0.520N P=0.515 P=0.313N |
|POLY 1.5 | P=0.148 P=0.648N P=0.752N P=0.313 |P=0.240N P=0.470N P=0.538 P=0.278N |
|POLY 6 | P=0.589 P=0.998N P=0.636N P=0.991 |P=0.296N P=0.578N P=0.487 P=0.367N |
|LOGISTIC REGRESSION| P=0.099 P=0.634N P=0.629 P=0.281 |P=0.242N P=0.355N P=0.597N P=0.237N |
|COCH-ARM / FISHERS | P=0.078 P=0.500 P=0.357 P=0.102 |P=0.220N P=0.402N P=0.602N P=0.235N |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 23
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - EMODIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 36/50 (72%) 38/50 (76%) 36/50 (72%) 28/50 (56%) |22/50 (44%) 24/50 (48%) 22/50 (44%) 15/50 (30%) |
|POLY-3 RATE (b) | 36/48.14 38/49.51 36/47.55 28/48.03 |22/47.70 24/49.57 22/48.96 15/47.76 |
|POLY-3 PERCENT (g) | 74.8% 76.8% 75.7% 58.3% |46.1% 48.4% 44.9% 31.4% |
|TERMINAL (d) | 20/30 (67%) 10/21 (48%) 13/21 (62%) 12/30 (40%) |12/33 (36%) 15/39 (39%) 12/35 (34%) 5/34 (15%) |
|FIRST INCIDENCE | 122 462 368 266 |448 396 232 360 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.034N* P=0.134 P=0.182 P=0.134N |P=0.096N P=0.522N P=0.496N P=0.142N |
|POLY 3 | P=0.018N* P=0.504 P=0.553 P=0.063N |P=0.047N* P=0.491 P=0.535N P=0.101N |
|POLY 1.5 | P=0.017N* P=0.480 P=0.583 P=0.062N |P=0.045N* P=0.461 P=0.553N P=0.103N |
|POLY 6 | P=0.020N* P=0.530 P=0.513 P=0.066N |P=0.050N P=0.529 P=0.513N P=0.098N |
|LOGISTIC REGRESSION| P=0.027N* P=0.443 P=0.588N P=0.086N |P=0.025N* P=0.336 P=0.528 P=0.094N |
|COCH-ARM / FISHERS | P=0.019N* P=0.410 P=0.588N P=0.072N |P=0.043N* P=0.421 P=0.580N P=0.107N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 50/50 (100%) 50/50 (100%) 50/50 (100%)|45/50 (90%) 47/50 (94%) 48/50 (96%) 43/50 (86%) |
|POLY-3 RATE (b) | 49/49.03 50/50.00 50/50.00 50/50.00 |45/50.00 47/50.00 48/50.00 43/50.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 100.0% |90.0% 94.0% 96.0% 86.0% |
|TERMINAL (d) | 30/30 (100%) 21/21 (100%) 21/21 (100%) 30/30 (100%)|28/33 (85%) 36/39 (92%) 33/35 (94%) 27/34 (79%) |
|FIRST INCIDENCE | 122 462 368 266 |448 396 232 360 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.224N P=0.052 P=0.056 P=0.548 |P=0.450N P=0.308N P=0.533 P=0.404N |
|POLY 3 | P=1.000 P=1.000 P=1.000 P=1.000 |P=0.159N P=0.357 P=0.217 P=0.380N |
|POLY 1.5 | P=1.000 P=1.000 P=1.000 P=1.000 |P=0.159N P=0.357 P=0.217 P=0.380N |
|POLY 6 | P=1.000 P=1.000 P=1.000 P=1.000 |P=0.159N P=0.357 P=0.217 P=0.380N |
|LOGISTIC REGRESSION| P=0.754 P=0.987 P=0.949 P=0.860 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.472 P=0.500 P=0.500 P=0.500 |P=0.159N P=0.357 P=0.218 P=0.380N |
|=================================================================================================================================|
(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).