TDMS Study 05211-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst EMODIN DATE: 01/25/01
EXPERIMENT: 05211 TEST: 05 TIME: 13:06:07
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 NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst EMODIN DATE: 01/25/01
EXPERIMENT: 05211 TEST: 05 TIME: 13:06:07
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 Cortex Accessory Adrenal Cortical Nodule
Adrenal Medulla Hyperplasia
Bone Marrow Hyperplasia
Heart Thrombosis
Intestine Large, Cecum Inflammation Chronic
Intestine Large, Cecum: Epithelium Hyperplasia
Islets, Pancreatic Hyperplasia
Kidney Hydronephrosis
Infarct
Inflammation Chronic
Nephropathy
Kidney: Renal Tubule Hyaline Droplet
Pigmentation
Liver Angiectasis
Liver: Bile Duct Hyperplasia
Lung Infiltration Cellular Histiocyte
Lymph Node, Mesenteric Ectasia
Mammary Gland Hyperplasia
Mesentery Accessory Spleen
Pituitary Gland: Pars Distalis Hyperplasia Focal
Prostate: Epithelium Hyperplasia
Spleen Fibrosis
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Atrophy
Brain Hydrocephalus
Kidney Infarct
Kidney: Renal Tubule Hyaline Droplet
Hyperplasia Oncocytic
Liver Angiectasis
Clear Cell Focus
Eosinophilic Focus
Necrosis Focal
Lymph Node, Mandibular Ectasia
Pigmentation
Nose: Respiratory Epithelium Hyperplasia
Pituitary Gland: Pars Distalis Cyst
Hyperplasia Focal
Spleen Fibrosis
Hematopoietic Cell Proliferation
Pigmentation
Thyroid Gland: C-Cell Hyperplasia
Uterus Hyperplasia Cystic
===============================================================
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 1
Statistical Analysis of Non-neoplastic Lesions 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 Cortex |
| Accessory Adrenal Cortical Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 18/50 (36%) 16/50 (32%) 10/50 (20%) |6/49 (12%) 4/50 (8%) 7/50 (14%) 10/50 (20%) |
|POLY-3 RATE (b) | 13/42.15 18/41.41 16/41.38 10/43.75 |6/44.80 4/46.19 7/46.17 10/44.85 |
|POLY-3 PERCENT (g) | 30.8% 43.5% 38.7% 22.9% |13.4% 8.7% 15.2% 22.3% |
|TERMINAL (d) | 10/30 (33%) 11/21 (52%) 9/21 (43%) 4/30 (13%) |3/33 (9%) 3/39 (8%) 5/35 (14%) 8/34 (24%) |
|FIRST INCIDENCE | 590 511 617 590 |610 600 527 602 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.070N P=0.041 * P=0.108 P=0.315N |P=0.066 P=0.305N P=0.541 P=0.219 |
|POLY 3 | P=0.076N P=0.161 P=0.299 P=0.276N |P=0.069 P=0.350N P=0.523 P=0.204 |
|POLY 1.5 | P=0.088N P=0.192 P=0.330 P=0.280N |P=0.073 P=0.354N P=0.517 P=0.210 |
|POLY 6 | P=0.064N P=0.115 P=0.249 P=0.278N |P=0.064 P=0.344N P=0.532 P=0.197 |
|LOGISTIC REGRESSION| P=0.083N P=0.146 P=0.278 P=0.285N |P=0.080 P=0.360N P=0.519 P=0.214 |
|COCH-ARM / FISHERS | P=0.119N P=0.194 P=0.330 P=0.318N |P=0.079 P=0.357N P=0.516 P=0.220 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/49 (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 |0/44.01 0/45.74 0/45.30 2/44.48 |
|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%) 1/34 (3%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 592 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.041 * (e) (e) P=0.245 |
|POLY 3 | (e) (e) (e) (e) |P=0.041 * (e) (e) P=0.239 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.041 * (e) (e) P=0.240 |
|POLY 6 | (e) (e) (e) (e) |P=0.040 * (e) (e) P=0.239 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.045 * (e) (e) P=0.257 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.042 * (e) (e) P=0.253 |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 2
Statistical Analysis of Non-neoplastic Lesions 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 Cortex |
| Degeneration Fatty |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 9/50 (18%) 10/50 (20%) 8/50 (16%) |12/49 (24%) 9/50 (18%) 14/50 (28%) 10/50 (20%) |
|POLY-3 RATE (b) | 7/41.44 9/41.31 10/40.09 8/42.44 |12/44.43 9/45.90 14/45.34 10/45.01 |
|POLY-3 PERCENT (g) | 16.9% 21.8% 25.0% 18.9% |27.0% 19.6% 30.9% 22.2% |
|TERMINAL (d) | 5/30 (17%) 2/21 (10%) 6/21 (29%) 8/30 (27%) |9/33 (27%) 8/39 (21%) 12/35 (34%) 7/34 (21%) |
|FIRST INCIDENCE | 599 506 644 729 (T) |648 690 725 603 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.449N P=0.230 P=0.118 P=0.504 |P=0.509N P=0.193N P=0.480 P=0.391N |
|POLY 3 | P=0.547N P=0.388 P=0.266 P=0.520 |P=0.458N P=0.280N P=0.432 P=0.390N |
|POLY 1.5 | P=0.550N P=0.406 P=0.293 P=0.524 |P=0.452N P=0.287N P=0.427 P=0.389N |
|POLY 6 | P=0.551N P=0.354 P=0.221 P=0.506 |P=0.465N P=0.268N P=0.439 P=0.389N |
|LOGISTIC REGRESSION| P=0.507N P=0.382 P=0.216 P=0.520 |P=0.499N P=0.251N P=0.474 P=0.406N |
|COCH-ARM / FISHERS | P=0.554 P=0.393 P=0.298 P=0.500 |P=0.442N P=0.294N P=0.433 P=0.384N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/40.89 2/39.60 1/39.86 1/42.86 |1/44.11 0/45.74 0/45.30 0/44.02 |
|POLY-3 PERCENT (g) | 0.0% 5.1% 2.5% 2.3% |2.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 1/21 (5%) 0/21 (0%) 0/30 (0%) |0/33 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- 690 609 607 |704 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.638 P=0.178 P=0.505 P=0.515 |P=0.486N P=0.484N P=0.495N P=0.511N |
|POLY 3 | P=0.633 P=0.230 P=0.495 P=0.509 |P=0.472N P=0.493N P=0.495N P=0.500N |
|POLY 1.5 | P=0.630 P=0.237 P=0.501 P=0.508 |P=0.471N P=0.494N P=0.496N P=0.499N |
|POLY 6 | P=0.633 P=0.216 P=0.484 P=0.509 |P=0.474N P=0.490N P=0.492N P=0.503N |
|LOGISTIC REGRESSION| P=0.610 P=0.211 P=0.487 P=0.474 |P=0.472N P=0.495N P=0.496N P=0.498N |
|COCH-ARM / FISHERS | P=0.614 P=0.247 P=0.500 P=0.500 |P=0.470N P=0.495N P=0.495N P=0.495N |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 3
Statistical Analysis of Non-neoplastic Lesions 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 Cortex |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 4/50 (8%) 2/50 (4%) |3/49 (6%) 3/50 (6%) 8/50 (16%) 7/50 (14%) |
|POLY-3 RATE (b) | 3/40.99 0/39.45 4/39.88 2/42.44 |3/44.03 3/46.09 8/46.01 7/44.65 |
|POLY-3 PERCENT (g) | 7.3% 0.0% 10.0% 4.7% |6.8% 6.5% 17.4% 15.7% |
|TERMINAL (d) | 2/30 (7%) 0/21 (0%) 3/21 (14%) 2/30 (7%) |2/33 (6%) 2/39 (5%) 3/35 (9%) 5/34 (15%) |
|FIRST INCIDENCE | 704 --- 605 729 (T) |725 634 665 610 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.570N P=0.184N P=0.347 P=0.500N |P=0.095 P=0.597N P=0.132 P=0.168 |
|POLY 3 | P=0.610N P=0.125N P=0.485 P=0.484N |P=0.103 P=0.641N P=0.112 P=0.162 |
|POLY 1.5 | P=0.610 P=0.119N P=0.501 P=0.484N |P=0.106 P=0.647N P=0.107 P=0.163 |
|POLY 6 | P=0.591N P=0.138N P=0.454 P=0.489N |P=0.098 P=0.631N P=0.121 P=0.162 |
|LOGISTIC REGRESSION| P=0.600N P=0.153N P=0.450 P=0.494N |P=0.105 P=0.646N P=0.109 P=0.157 |
|COCH-ARM / FISHERS | P=0.589 P=0.121N P=0.500 P=0.500N |P=0.113 P=0.651N P=0.106 P=0.167 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 9/50 (18%) 7/50 (14%) 3/50 (6%) |12/49 (24%) 7/50 (14%) 12/50 (24%) 10/50 (20%) |
|POLY-3 RATE (b) | 6/41.79 9/41.88 7/41.33 3/42.44 |12/45.06 7/46.42 12/45.46 10/44.94 |
|POLY-3 PERCENT (g) | 14.4% 21.5% 16.9% 7.1% |26.6% 15.1% 26.4% 22.3% |
|TERMINAL (d) | 4/30 (13%) 2/21 (10%) 2/21 (10%) 3/30 (10%) |9/33 (27%) 5/39 (13%) 9/35 (26%) 8/34 (24%) |
|FIRST INCIDENCE | 597 506 483 729 (T) |544 572 702 529 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.079N P=0.184 P=0.369 P=0.236N |P=0.517 P=0.095N P=0.533N P=0.386N |
|POLY 3 | P=0.086N P=0.285 P=0.491 P=0.233N |P=0.547 P=0.134N P=0.584N P=0.406N |
|POLY 1.5 | P=0.087N P=0.300 P=0.508 P=0.230N |P=0.560N P=0.138N P=0.583N P=0.398N |
|POLY 6 | P=0.088N P=0.258 P=0.458 P=0.242N |P=0.527 P=0.126N P=0.582N P=0.417N |
|LOGISTIC REGRESSION| P=0.096N P=0.288 P=0.501 P=0.226N |P=0.556 P=0.141N P=0.556N P=0.393N |
|COCH-ARM / FISHERS | P=0.097N P=0.288 P=0.500 P=0.243N |P=0.541N P=0.142N P=0.570N P=0.384N |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 4
Statistical Analysis of Non-neoplastic Lesions 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 Cortex |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/40.89 1/40.11 0/39.45 0/42.44 |0/44.01 2/46.62 0/45.30 0/44.02 |
|POLY-3 PERCENT (g) | 0.0% 2.5% 0.0% 0.0% |0.0% 4.3% 0.0% 0.0% |
|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 | --- 506 --- --- |--- 600 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.583N P=0.509 (e) (e) |P=0.389N P=0.247 (e) (e) |
|POLY 3 | P=0.586N P=0.496 (e) (e) |P=0.376N P=0.250 (e) (e) |
|POLY 1.5 | P=0.583N P=0.502 (e) (e) |P=0.378N P=0.246 (e) (e) |
|POLY 6 | P=0.591N P=0.485 (e) (e) |P=0.373N P=0.257 (e) (e) |
|LOGISTIC REGRESSION| P=0.654N P=0.407 (e) (e) |P=0.350N P=0.257 (e) (e) |
|COCH-ARM / FISHERS | P=0.587N P=0.500 (e) (e) |P=0.379N P=0.253 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 9/49 (18%) 7/50 (14%) 17/50 (34%) |2/47 (4%) 2/50 (4%) 2/50 (4%) 3/50 (6%) |
|POLY-3 RATE (b) | 10/41.49 9/39.51 7/40.01 17/43.51 |2/42.97 2/45.74 2/45.30 3/44.02 |
|POLY-3 PERCENT (g) | 24.1% 22.8% 17.5% 39.1% |4.7% 4.4% 4.4% 6.8% |
|TERMINAL (d) | 6/30 (20%) 4/20 (20%) 4/21 (19%) 11/30 (37%) |1/33 (3%) 2/39 (5%) 2/35 (6%) 3/34 (9%) |
|FIRST INCIDENCE | 617 596 638 605 |686 730 (T) 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.081 P=0.415 P=0.549N P=0.108 |P=0.372 P=0.641N P=0.675N P=0.508 |
|POLY 3 | P=0.030 * P=0.549N P=0.322N P=0.102 |P=0.393 P=0.671N P=0.675N P=0.511 |
|POLY 1.5 | P=0.028 * P=0.517N P=0.297N P=0.102 |P=0.401 P=0.672N P=0.675N P=0.518 |
|POLY 6 | P=0.034 * P=0.605 P=0.371N P=0.099 |P=0.382 P=0.669N P=0.674N P=0.503 |
|LOGISTIC REGRESSION| P=0.040 * P=0.602 P=0.380N P=0.097 |P=0.372 P=0.668N P=0.672N P=0.503 |
|COCH-ARM / FISHERS | P=0.025 * P=0.520N P=0.298N P=0.088 |P=0.411 P=0.668N P=0.668N P=0.530 |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 5
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 3/50 (6%) 11/50 (22%) |5/49 (10%) 3/50 (6%) 4/50 (8%) 6/50 (12%) |
|POLY-3 RATE (b) | 3/43.19 5/40.25 3/40.41 11/44.90 |5/44.64 3/46.58 4/46.35 6/46.26 |
|POLY-3 PERCENT (g) | 7.0% 12.4% 7.4% 24.5% |11.2% 6.4% 8.6% 13.0% |
|TERMINAL (d) | 0/30 (0%) 2/21 (10%) 0/21 (0%) 5/30 (17%) |2/33 (6%) 2/39 (5%) 2/35 (6%) 1/34 (3%) |
|FIRST INCIDENCE | 122 610 603 590 |630 396 232 360 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.017 * P=0.292 P=0.647 P=0.033 * |P=0.283 P=0.307N P=0.475N P=0.498 |
|POLY 3 | P=0.007 ** P=0.317 P=0.632 P=0.023 * |P=0.307 P=0.333N P=0.477N P=0.525 |
|POLY 1.5 | P=0.007 ** P=0.340 P=0.648 P=0.022 * |P=0.307 P=0.338N P=0.481N P=0.521 |
|POLY 6 | P=0.009 ** P=0.284 P=0.605 P=0.024 * |P=0.306 P=0.328N P=0.473N P=0.528 |
|LOGISTIC REGRESSION| P=0.003 ** P=0.253 P=0.525 P=0.009 ** |P=0.370 P=0.348N P=0.450N P=0.580 |
|COCH-ARM / FISHERS | P=0.006 ** P=0.357 P=0.661N P=0.020 * |P=0.305 P=0.346N P=0.487N P=0.514 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Bone Marrow |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 2/50 (4%) 4/50 (8%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/40.89 0/39.45 0/39.45 0/42.44 |0/44.01 2/45.74 4/45.70 2/44.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.4% 8.8% 4.5% |
|TERMINAL (d) | 0/30 (0%) 0/21 (0%) 0/21 (0%) 0/30 (0%) |0/33 (0%) 2/39 (5%) 3/35 (9%) 1/34 (3%) |
|FIRST INCIDENCE | --- --- --- --- |--- 730 (T) 617 689 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.359 P=0.276 P=0.072 P=0.243 |
|POLY 3 | (e) (e) (e) (e) |P=0.370 P=0.246 P=0.065 P=0.238 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.376 P=0.244 P=0.064 P=0.239 |
|POLY 6 | (e) (e) (e) (e) |P=0.364 P=0.249 P=0.067 P=0.237 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.373 P=0.276 P=0.065 P=0.238 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.385 P=0.253 P=0.061 P=0.253 |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 6
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Bone: Cranium |
| Osteopetrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |7/49 (14%) 5/50 (10%) 6/50 (12%) 8/50 (16%) |
|POLY-3 RATE (b) | 1/41.51 0/39.45 0/39.45 0/42.44 |7/45.09 5/45.74 6/46.98 8/44.17 |
|POLY-3 PERCENT (g) | 2.4% 0.0% 0.0% 0.0% |15.5% 10.9% 12.8% 18.1% |
|TERMINAL (d) | 0/30 (0%) 0/21 (0%) 0/21 (0%) 0/30 (0%) |4/33 (12%) 5/39 (13%) 2/35 (6%) 7/34 (21%) |
|FIRST INCIDENCE | 528 --- --- --- |610 730 (T) 539 690 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.465N P=0.500N P=0.496N P=0.491N |P=0.297 P=0.296N P=0.463N P=0.510 |
|POLY 3 | P=0.464N P=0.510N P=0.510N P=0.496N |P=0.304 P=0.369N P=0.468N P=0.483 |
|POLY 1.5 | P=0.471N P=0.502N P=0.502N P=0.495N |P=0.318 P=0.368N P=0.479N P=0.497 |
|POLY 6 | P=0.451N P=0.525N P=0.524N P=0.499N |P=0.287 P=0.369N P=0.455N P=0.463 |
|LOGISTIC REGRESSION| P=0.524N P=0.573N P=0.558N P=0.569N |P=0.337 P=0.362N P=0.461N P=0.504 |
|COCH-ARM / FISHERS | P=0.472N P=0.500N P=0.500N P=0.500N |P=0.335 P=0.365N P=0.484N P=0.517 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Bone: Femur |
| Osteopetrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |6/49 (12%) 8/50 (16%) 7/50 (14%) 7/50 (14%) |
|POLY-3 RATE (b) | 0/40.89 0/39.45 0/39.45 0/42.44 |6/44.67 8/46.02 7/45.81 7/44.33 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |13.4% 17.4% 15.3% 15.8% |
|TERMINAL (d) | 0/30 (0%) 0/21 (0%) 0/21 (0%) 0/30 (0%) |4/33 (12%) 7/39 (18%) 5/35 (14%) 5/34 (15%) |
|FIRST INCIDENCE | --- --- --- --- |630 656 617 689 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.506 P=0.497 P=0.543 P=0.510 |
|POLY 3 | (e) (e) (e) (e) |P=0.527 P=0.409 P=0.519 P=0.494 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.539 P=0.405 P=0.514 P=0.502 |
|POLY 6 | (e) (e) (e) (e) |P=0.511 P=0.417 P=0.528 P=0.484 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.532 P=0.413 P=0.516 P=0.501 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.557 P=0.403 P=0.516 P=0.516 |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 7
Statistical Analysis of Non-neoplastic Lesions 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 |
| Compression |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 5/50 (10%) 5/50 (10%) |8/49 (16%) 7/50 (14%) 10/50 (20%) 7/50 (14%) |
|POLY-3 RATE (b) | 4/41.82 2/40.18 5/40.70 5/42.74 |8/45.84 7/46.96 10/46.31 7/45.26 |
|POLY-3 PERCENT (g) | 9.6% 5.0% 12.3% 11.7% |17.5% 14.9% 21.6% 15.5% |
|TERMINAL (d) | 1/30 (3%) 0/21 (0%) 1/21 (5%) 4/30 (13%) |3/33 (9%) 4/39 (10%) 6/35 (17%) 2/34 (6%) |
|FIRST INCIDENCE | 604 561 483 645 |497 572 648 610 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.378 P=0.404N P=0.406 P=0.510 |P=0.515N P=0.421N P=0.458 P=0.504N |
|POLY 3 | P=0.329 P=0.355N P=0.483 P=0.514 |P=0.502N P=0.480N P=0.406 P=0.511N |
|POLY 1.5 | P=0.320 P=0.338N P=0.502 P=0.517 |P=0.488N P=0.483N P=0.405 P=0.501N |
|POLY 6 | P=0.339 P=0.387N P=0.446 P=0.502 |P=0.518N P=0.472N P=0.413 P=0.520N |
|LOGISTIC REGRESSION| P=0.304 P=0.341N P=0.499 P=0.517 |P=0.439N P=0.501N P=0.424 P=0.444N |
|COCH-ARM / FISHERS | P=0.301 P=0.339N P=0.500 P=0.500 |P=0.466N P=0.483N P=0.416 P=0.483N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Brain |
| Hydrocephalus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |3/49 (6%) 0/50 (0%) 3/50 (6%) 7/50 (14%) |
|POLY-3 RATE (b) | 1/41.29 1/39.45 2/40.32 1/42.44 |3/44.77 0/45.74 3/45.76 7/44.86 |
|POLY-3 PERCENT (g) | 2.4% 2.5% 5.0% 2.4% |6.7% 0.0% 6.6% 15.6% |
|TERMINAL (d) | 0/30 (0%) 1/21 (5%) 1/21 (5%) 1/30 (3%) |1/33 (3%) 0/39 (0%) 1/35 (3%) 3/34 (9%) |
|FIRST INCIDENCE | 617 729 (T) 368 729 (T) |596 --- 665 610 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.597N P=0.718 P=0.466 P=0.755N |P=0.013 * P=0.110N P=0.628N P=0.171 |
|POLY 3 | P=0.621N P=0.751 P=0.492 P=0.755N |P=0.012 * P=0.115N P=0.652N P=0.157 |
|POLY 1.5 | P=0.626N P=0.760 P=0.502 P=0.754N |P=0.013 * P=0.115N P=0.655N P=0.161 |
|POLY 6 | P=0.616N P=0.734 P=0.470 P=0.758N |P=0.012 * P=0.114N P=0.648N P=0.154 |
|LOGISTIC REGRESSION| P=0.645 P=0.763N P=0.448 P=0.762N |P=0.016 * P=0.113N P=0.641N P=0.174 |
|COCH-ARM / FISHERS | P=0.639N P=0.753N P=0.500 P=0.753N |P=0.015 * P=0.117N P=0.651N P=0.167 |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 8
Statistical Analysis of Non-neoplastic Lesions 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 Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/49 (2%) 0/50 (0%) 4/49 (8%) 1/49 (2%) |
|POLY-3 RATE (b) | |1/44.32 0/45.74 4/44.41 1/43.02 |
|POLY-3 PERCENT (g) | |2.3% 0.0% 9.0% 2.3% |
|TERMINAL (d) | |0/33 (0%) 0/39 (0%) 3/34 (9%) 1/33 (3%) |
|FIRST INCIDENCE | |645 --- 702 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.547 P=0.495N P=0.196 P=0.758 |
|POLY 3 | |P=0.548 P=0.494N P=0.179 P=0.754 |
|POLY 1.5 | |P=0.557 P=0.495N P=0.178 P=0.757 |
|POLY 6 | |P=0.534 P=0.492N P=0.181 P=0.751 |
|LOGISTIC REGRESSION| |P=0.560 P=0.489N P=0.179 P=0.760N |
|COCH-ARM / FISHERS | |P=0.570 P=0.495N P=0.181 P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |3/49 (6%) 2/50 (4%) 6/49 (12%) 3/49 (6%) |
|POLY-3 RATE (b) | |3/44.01 2/45.74 6/44.30 3/43.17 |
|POLY-3 PERCENT (g) | |6.8% 4.4% 13.5% 7.0% |
|TERMINAL (d) | |3/33 (9%) 2/39 (5%) 6/34 (18%) 2/33 (6%) |
|FIRST INCIDENCE | |730 (T) 730 (T) 730 (T) 690 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.505 P=0.424N P=0.254 P=0.660 |
|POLY 3 | |P=0.522 P=0.482N P=0.244 P=0.654 |
|POLY 1.5 | |P=0.531 P=0.487N P=0.241 P=0.656 |
|POLY 6 | |P=0.511 P=0.475N P=0.250 P=0.651 |
|LOGISTIC REGRESSION| |P=0.497 P=0.424N P=0.254 P=0.645 |
|COCH-ARM / FISHERS | |P=0.544 P=0.490N P=0.243 P=0.661N |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 9
Statistical Analysis of Non-neoplastic Lesions 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 Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |5/49 (10%) 5/50 (10%) 6/49 (12%) 5/49 (10%) |
|POLY-3 RATE (b) | |5/44.49 5/45.74 6/44.77 5/43.02 |
|POLY-3 PERCENT (g) | |11.2% 10.9% 13.4% 11.6% |
|TERMINAL (d) | |3/33 (9%) 5/39 (13%) 5/34 (15%) 5/33 (15%) |
|FIRST INCIDENCE | |645 730 (T) 592 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.537 P=0.537N P=0.522 P=0.626 |
|POLY 3 | |P=0.549 P=0.613N P=0.504 P=0.609 |
|POLY 1.5 | |P=0.562 P=0.615N P=0.499 P=0.618 |
|POLY 6 | |P=0.530 P=0.609N P=0.511 P=0.597 |
|LOGISTIC REGRESSION| |P=0.547 P=0.601N P=0.500 P=0.611 |
|COCH-ARM / FISHERS | |P=0.578N P=0.617N P=0.500 P=0.630N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Epididymis |
| Atypia Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 29/50 (58%) 26/50 (52%) 25/50 (50%) 29/50 (58%) | |
|POLY-3 RATE (b) | 29/44.66 26/42.58 25/43.18 29/46.03 | |
|POLY-3 PERCENT (g) | 64.9% 61.1% 57.9% 63.0% | |
|TERMINAL (d) | 19/30 (63%) 15/21 (71%) 12/21 (57%) 19/30 (63%) | |
|FIRST INCIDENCE | 528 555 575 539 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.385N P=0.290 P=0.403 P=0.539N | |
|POLY 3 | P=0.552N P=0.437N P=0.319N P=0.511N | |
|POLY 1.5 | P=0.512 P=0.350N P=0.266N P=0.508N | |
|POLY 6 | P=0.508N P=0.594N P=0.415N P=0.536N | |
|LOGISTIC REGRESSION| P=0.532 P=0.367N P=0.280N P=0.507N | |
|COCH-ARM / FISHERS | P=0.423 P=0.344N P=0.274N P=0.580N | |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 10
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Eye |
| Cataract |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/3 (67%) 1/1 (100%) 1/1 (100%) 0/0 (0%) |4/5 (80%) 2/2 (100%) 3/4 (75%) 1/2 (50%) |
|POLY-3 RATE (b) | 2/3.00 1/1.00 1/1.00 0/0.00 |4/4.54 2/2.00 3/4.00 1/1.58 |
|POLY-3 PERCENT (g) | 66.7% 100.0% 100.0% 0.0% |88.0% 100.0% 75.0% 63.2% |
|TERMINAL (d) | 1/2 (50%) 0/0 (0%) 1/1 (100%) 0/0 (0%) |3/3 (100%) 2/2 (100%) 2/3 (67%) 0/0 (0%) |
|FIRST INCIDENCE | 679 631 729 (T) --- |646 730 (T) 725 603 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.373N P=0.700 P=0.736N P=0.507N |P=0.639 P=0.484N P=0.487N P=0.751 |
|POLY 3 | (e) P=0.691 P=0.691 (e) |P=0.442N P=0.885 P=0.649N P=0.703N |
|POLY 1.5 | (e) P=0.691 P=0.691 (e) |P=0.412N P=0.778 P=0.680N P=0.615N |
|POLY 6 | (e) P=0.691 P=0.691 (e) |P=0.487N P=0.995 P=0.593N P=0.903N |
|LOGISTIC REGRESSION| (e) (e) P=0.736N (e) |P=0.721N P=0.484N P=0.484N P=0.803 |
|COCH-ARM / FISHERS | P=0.983 P=0.750 P=0.750 P=1.000 |P=0.365N P=0.714 P=0.722N P=0.524N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Eye |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/3 (0%) 0/1 (0%) 0/1 (0%) 0/0 (0%) |0/5 (0%) 0/2 (0%) 2/4 (50%) 0/2 (0%) |
|POLY-3 RATE (b) | 0/2.81 0/0.65 0/1.00 0/0.00 |0/4.24 0/2.00 2/4.00 0/1.15 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 50.0% 0.0% |
|TERMINAL (d) | 0/2 (0%) 0/0 (0%) 0/1 (0%) 0/0 (0%) |0/3 (0%) 0/2 (0%) 1/3 (33%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 725 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.668 (e) P=0.249 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.403 (e) P=0.176 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.566 (e) P=0.158 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.201 (e) P=0.207 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.534 (e) P=0.254 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.688 (e) P=0.167 (e) |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 11
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Eye: Retina |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/3 (67%) 1/1 (100%) 1/1 (100%) 0/0 (0%) |4/5 (80%) 2/2 (100%) 3/4 (75%) 1/2 (50%) |
|POLY-3 RATE (b) | 2/3.00 1/1.00 1/1.00 0/0.00 |4/4.54 2/2.00 3/4.00 1/1.58 |
|POLY-3 PERCENT (g) | 66.7% 100.0% 100.0% 0.0% |88.0% 100.0% 75.0% 63.2% |
|TERMINAL (d) | 1/2 (50%) 0/0 (0%) 1/1 (100%) 0/0 (0%) |3/3 (100%) 2/2 (100%) 2/3 (67%) 0/0 (0%) |
|FIRST INCIDENCE | 679 631 729 (T) --- |646 730 (T) 725 603 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.373N P=0.700 P=0.736N P=0.507N |P=0.639 P=0.484N P=0.487N P=0.751 |
|POLY 3 | (e) P=0.691 P=0.691 (e) |P=0.442N P=0.885 P=0.649N P=0.703N |
|POLY 1.5 | (e) P=0.691 P=0.691 (e) |P=0.412N P=0.778 P=0.680N P=0.615N |
|POLY 6 | (e) P=0.691 P=0.691 (e) |P=0.487N P=0.995 P=0.593N P=0.903N |
|LOGISTIC REGRESSION| (e) (e) P=0.736N (e) |P=0.721N P=0.484N P=0.484N P=0.803 |
|COCH-ARM / FISHERS | P=0.983 P=0.750 P=0.750 P=1.000 |P=0.365N P=0.714 P=0.722N P=0.524N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 34/50 (68%) 31/50 (62%) 35/50 (70%) 36/50 (72%) |22/49 (45%) 16/50 (32%) 17/50 (34%) 16/50 (32%) |
|POLY-3 RATE (b) | 34/44.50 31/45.10 35/44.96 36/46.91 |22/45.58 16/47.00 17/46.09 16/44.61 |
|POLY-3 PERCENT (g) | 76.4% 68.7% 77.9% 76.7% |48.3% 34.0% 36.9% 35.9% |
|TERMINAL (d) | 25/30 (83%) 14/21 (67%) 17/21 (81%) 24/30 (80%) |17/33 (52%) 13/39 (33%) 12/35 (34%) 14/34 (41%) |
|FIRST INCIDENCE | 472 462 510 492 |610 572 665 603 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.463N P=0.242 P=0.073 P=0.459 |P=0.301N P=0.066N P=0.160N P=0.137N |
|POLY 3 | P=0.386 P=0.273N P=0.537 P=0.586 |P=0.278N P=0.116N P=0.184N P=0.160N |
|POLY 1.5 | P=0.339 P=0.255N P=0.564 P=0.551 |P=0.253N P=0.124N P=0.188N P=0.148N |
|POLY 6 | P=0.444 P=0.322N P=0.489 P=0.602N |P=0.316N P=0.107N P=0.177N P=0.181N |
|LOGISTIC REGRESSION| P=0.356 P=0.321N P=0.496 P=0.526 |P=0.258N P=0.124N P=0.169N P=0.148N |
|COCH-ARM / FISHERS | P=0.258 P=0.338N P=0.500 P=0.414 |P=0.224N P=0.133N P=0.183N P=0.133N |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 12
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Heart |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 4/50 (8%) 2/50 (4%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/40.89 2/39.74 4/40.31 2/42.47 |0/44.01 0/45.74 0/45.30 0/44.02 |
|POLY-3 PERCENT (g) | 0.0% 5.0% 9.9% 4.7% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/21 (0%) 1/21 (5%) 1/30 (3%) |0/33 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- 679 603 720 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.436 P=0.195 P=0.047 * P=0.240 |(e) (e) (e) (e) |
|POLY 3 | P=0.408 P=0.230 P=0.058 P=0.245 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.402 P=0.238 P=0.061 P=0.245 |(e) (e) (e) (e) |
|POLY 6 | P=0.412 P=0.218 P=0.052 P=0.244 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.398 P=0.230 P=0.063 P=0.239 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.379 P=0.247 P=0.059 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 |
|=================================================================================================================================|
| |
|Intestine Large, Cecum |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 2/50 (4%) 3/50 (6%) 2/49 (4%) |0/49 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/40.03 2/40.01 3/39.80 2/41.62 |0/44.01 0/45.74 1/44.62 0/44.02 |
|POLY-3 PERCENT (g) | 5.0% 5.0% 7.5% 4.8% |0.0% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/21 (0%) 0/21 (0%) 0/29 (0%) |0/33 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 700 632 689 700 |--- --- 702 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.547N P=0.618 P=0.386 P=0.687N |P=0.800N (e) P=0.511 (e) |
|POLY 3 | P=0.586N P=0.695 P=0.497 P=0.680N |P=0.787N (e) P=0.503 (e) |
|POLY 1.5 | P=0.593N P=0.684N P=0.510 P=0.681N |P=0.785N (e) P=0.500 (e) |
|POLY 6 | P=0.577N P=0.675 P=0.473 P=0.683N |P=0.789N (e) P=0.507 (e) |
|LOGISTIC REGRESSION| P=0.587N P=0.691N P=0.477 P=0.684N |P=0.784N (e) P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.610N P=0.684N P=0.510 P=0.691N |P=0.783N (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 13
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Intestine Large, Cecum |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) |0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/39.89 0/39.45 0/39.45 2/41.44 |0/44.01 0/45.74 0/44.51 0/44.02 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/21 (0%) 0/21 (0%) 2/29 (7%) |0/33 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.060 (e) (e) P=0.238 |(e) (e) (e) (e) |
|POLY 3 | P=0.043 * (e) (e) P=0.245 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.042 * (e) (e) P=0.245 |(e) (e) (e) (e) |
|POLY 6 | P=0.044 * (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=0.041 * (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 |
|=================================================================================================================================|
| |
|Intestine Large, Cecum: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) |0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/39.89 0/39.45 0/39.45 2/41.44 |0/44.01 0/45.74 0/44.51 0/44.02 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/21 (0%) 0/21 (0%) 2/29 (7%) |0/33 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.060 (e) (e) P=0.238 |(e) (e) (e) (e) |
|POLY 3 | P=0.043 * (e) (e) P=0.245 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.042 * (e) (e) P=0.245 |(e) (e) (e) (e) |
|POLY 6 | P=0.044 * (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=0.041 * (e) (e) P=0.247 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 14
Statistical Analysis of Non-neoplastic Lesions 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 |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 0/50 (0%) 1/49 (2%) 2/50 (4%) |0/49 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 5/42.19 0/39.45 1/38.88 2/42.44 |0/44.01 1/45.74 0/44.51 0/44.02 |
|POLY-3 PERCENT (g) | 11.9% 0.0% 2.6% 4.7% |0.0% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 3/30 (10%) 0/21 (0%) 0/20 (0%) 2/30 (7%) |0/33 (0%) 1/39 (3%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 406 --- 602 729 (T) |--- 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.370N P=0.057N P=0.155N P=0.214N |P=0.595N P=0.533 (e) (e) |
|POLY 3 | P=0.387N P=0.036N* P=0.120N P=0.213N |P=0.584N P=0.508 (e) (e) |
|POLY 1.5 | P=0.404N P=0.032N* P=0.110N P=0.209N |P=0.584N P=0.506 (e) (e) |
|POLY 6 | P=0.363N P=0.044N* P=0.138N P=0.220N |P=0.582N P=0.511 (e) (e) |
|LOGISTIC REGRESSION| P=0.427N P=0.035N* P=0.112N P=0.220N |(e) P=0.533 (e) (e) |
|COCH-ARM / FISHERS | P=0.418N P=0.028N* P=0.107N P=0.218N |P=0.585N P=0.505 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |0/49 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/40.89 1/39.45 2/39.46 1/42.44 |0/44.01 0/45.74 1/44.51 0/44.02 |
|POLY-3 PERCENT (g) | 0.0% 2.5% 5.1% 2.4% |0.0% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 0/30 (0%) 1/21 (5%) 1/21 (5%) 1/30 (3%) |0/33 (0%) 0/39 (0%) 1/35 (3%) 0/34 (0%) |
|FIRST INCIDENCE | --- 729 (T) 725 729 (T) |--- --- 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.545 P=0.429 P=0.167 P=0.500 |P=0.792N (e) P=0.512 (e) |
|POLY 3 | P=0.524 P=0.493 P=0.229 P=0.507 |P=0.787N (e) P=0.502 (e) |
|POLY 1.5 | P=0.519 P=0.500 P=0.236 P=0.507 |P=0.785N (e) P=0.500 (e) |
|POLY 6 | P=0.526 P=0.480 P=0.215 P=0.506 |P=0.789N (e) P=0.506 (e) |
|LOGISTIC REGRESSION| P=0.543 P=0.429 P=0.175 P=0.500 |(e) (e) P=0.512 (e) |
|COCH-ARM / FISHERS | P=0.501 P=0.500 P=0.247 P=0.500 |P=0.783N (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 15
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Kidney |
| Hydronephrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/49 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/40.89 0/39.45 0/39.45 2/42.83 |0/44.01 0/45.74 1/44.75 0/44.02 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.7% |0.0% 0.0% 2.2% 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 | --- --- --- 617 |--- --- 665 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.055 (e) (e) P=0.245 |P=0.792N (e) P=0.524 (e) |
|POLY 3 | P=0.044 * (e) (e) P=0.247 |P=0.787N (e) P=0.503 (e) |
|POLY 1.5 | P=0.043 * (e) (e) P=0.246 |P=0.785N (e) P=0.501 (e) |
|POLY 6 | P=0.046 * (e) (e) P=0.247 |P=0.789N (e) P=0.508 (e) |
|LOGISTIC REGRESSION| P=0.042 * (e) (e) P=0.238 |P=0.777N (e) P=0.511 (e) |
|COCH-ARM / FISHERS | P=0.042 * (e) (e) P=0.247 |P=0.783N (e) P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) |0/49 (0%) 0/50 (0%) 2/49 (4%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/40.89 0/39.45 0/39.45 3/42.44 |0/44.01 0/45.74 2/45.47 3/44.70 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 7.1% |0.0% 0.0% 4.4% 6.7% |
|TERMINAL (d) | 0/30 (0%) 0/21 (0%) 0/21 (0%) 3/30 (10%) |0/33 (0%) 0/39 (0%) 1/35 (3%) 1/34 (3%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |--- --- 232 592 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.017 * (e) (e) P=0.120 |P=0.036 * (e) P=0.246 P=0.126 |
|POLY 3 | P=0.009 ** (e) (e) P=0.125 |P=0.037 * (e) P=0.244 P=0.121 |
|POLY 1.5 | P=0.009 ** (e) (e) P=0.125 |P=0.037 * (e) P=0.241 P=0.122 |
|POLY 6 | P=0.009 ** (e) (e) P=0.123 |P=0.036 * (e) P=0.249 P=0.121 |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.120 |P=0.045 * (e) P=0.371 P=0.133 |
|COCH-ARM / FISHERS | P=0.009 ** (e) (e) P=0.121 |P=0.039 * (e) P=0.247 P=0.125 |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 16
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 11/50 (22%) 13/50 (26%) 25/50 (50%) |0/49 (0%) 1/50 (2%) 1/49 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 13/41.29 11/39.50 13/40.86 25/43.92 |0/44.01 1/45.74 1/44.58 3/44.02 |
|POLY-3 PERCENT (g) | 31.5% 27.9% 31.8% 56.9% |0.0% 2.2% 2.2% 6.8% |
|TERMINAL (d) | 12/30 (40%) 10/21 (48%) 9/21 (43%) 21/30 (70%) |0/33 (0%) 1/39 (3%) 0/35 (0%) 3/34 (9%) |
|FIRST INCIDENCE | 617 716 575 602 |--- 730 (T) 711 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.004 ** P=0.391 P=0.248 P=0.008 ** |P=0.057 P=0.533 P=0.516 P=0.126 |
|POLY 3 | P<0.001 ** P=0.454N P=0.582 P=0.012 * |P=0.062 P=0.508 P=0.503 P=0.118 |
|POLY 1.5 | P<0.001 ** P=0.410N P=0.580N P=0.013 * |P=0.063 P=0.506 P=0.500 P=0.120 |
|POLY 6 | P<0.001 ** P=0.539N P=0.533 P=0.012 * |P=0.060 P=0.511 P=0.506 P=0.117 |
|LOGISTIC REGRESSION| P=0.002 ** P=0.532 P=0.481 P=0.011 * |P=0.054 P=0.533 P=0.502 P=0.126 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.408N P=0.590N P=0.011 * |P=0.066 P=0.505 P=0.500 P=0.125 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 48/50 (96%) 50/50 (100%) 50/50 (100%) 50/50 (100%)|46/49 (94%) 43/50 (86%) 45/49 (92%) 49/50 (98%) |
|POLY-3 RATE (b) | 48/48.57 50/50.00 50/50.00 50/50.00 |46/48.69 43/49.04 45/47.82 49/49.53 |
|POLY-3 PERCENT (g) | 98.8% 100.0% 100.0% 100.0% |94.5% 87.7% 94.1% 98.9% |
|TERMINAL (d) | 30/30 (100%) 21/21 (100%) 21/21 (100%) 30/30 (100%)|31/33 (94%) 35/39 (90%) 33/35 (94%) 34/34 (100%) |
|FIRST INCIDENCE | 216 462 368 266 |497 396 527 360 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.252N P=0.037 * P=0.040 * P=0.482 |P=0.115 P=0.065N P=0.325N P=0.413 |
|POLY 3 | P=0.723 P=0.768 P=0.768 P=0.768 |P=0.061 P=0.195N P=0.644N P=0.235 |
|POLY 1.5 | P=0.555 P=0.587 P=0.587 P=0.587 |P=0.068 P=0.180N P=0.622N P=0.261 |
|POLY 6 | P=0.960 P=0.980 P=0.980 P=0.980 |P=0.058 P=0.224N P=0.649N P=0.209 |
|LOGISTIC REGRESSION| P=0.375 P=0.498 P=0.439 P=0.424 |P=0.068 P=0.164N P=0.550N P=0.281 |
|COCH-ARM / FISHERS | P=0.239 P=0.247 P=0.247 P=0.247 |P=0.084 P=0.167N P=0.500N P=0.301 |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 17
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 45/50 (90%) 43/50 (86%) 43/50 (86%) |22/49 (45%) 49/50 (98%) 49/49 (100%) 50/50 (100%) |
|POLY-3 RATE (b) | 3/40.97 45/48.49 43/47.80 43/48.49 |22/46.01 49/49.73 49/49.00 50/50.00 |
|POLY-3 PERCENT (g) | 7.3% 92.8% 90.0% 88.7% |47.8% 98.5% 100.0% 100.0% |
|TERMINAL (d) | 2/30 (7%) 19/21 (91%) 21/21 (100%) 26/30 (87%) |16/33 (49%) 39/39 (100%) 35/35 (100%) 34/34 (100%) |
|FIRST INCIDENCE | 711 462 368 266 |497 396 232 360 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia Oncocytic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/49 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/40.89 0/39.45 0/39.45 0/42.44 |0/44.01 0/45.74 0/44.51 2/44.43 |
|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%) 1/34 (3%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 610 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.038 * (e) (e) P=0.238 |
|POLY 3 | (e) (e) (e) (e) |P=0.041 * (e) (e) P=0.239 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.041 * (e) (e) P=0.240 |
|POLY 6 | (e) (e) (e) (e) |P=0.040 * (e) (e) P=0.239 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.045 * (e) (e) P=0.252 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.043 * (e) (e) P=0.253 |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 18
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 35/50 (70%) 47/50 (94%) 49/50 (98%) 50/50 (100%)|45/49 (92%) 49/50 (98%) 49/49 (100%) 50/50 (100%) |
|POLY-3 RATE (b) | 35/46.22 47/49.26 49/50.00 50/50.00 |45/48.36 49/49.73 49/49.00 50/50.00 |
|POLY-3 PERCENT (g) | 75.7% 95.4% 98.0% 100.0% |93.1% 98.5% 100.0% 100.0% |
|TERMINAL (d) | 21/30 (70%) 20/21 (95%) 20/21 (95%) 30/30 (100%)|31/33 (94%) 39/39 (100%) 35/35 (100%) 34/34 (100%) |
|FIRST INCIDENCE | 216 462 368 266 |497 396 232 360 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.261 P=0.002 ** P<0.001 ** P=0.019 * |P=0.153 P=0.392N P=0.470 P=0.283 |
|POLY 3 | P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** |P=0.071 P=0.183 P=0.083 P=0.080 |
|POLY 1.5 | P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |P=0.061 P=0.180 P=0.071 P=0.068 |
|POLY 6 | P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** |P=0.089 P=0.178 P=0.102 P=0.099 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P=0.052 P=0.174 P=0.059 P=0.055 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P=0.055 P=0.175 P=0.059 P=0.056 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 4/50 (8%) 3/50 (6%) 2/50 (4%) |2/49 (4%) 0/50 (0%) 1/49 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 4/40.89 4/39.69 3/39.56 2/42.78 |2/44.37 0/45.74 1/44.51 1/44.02 |
|POLY-3 PERCENT (g) | 9.8% 10.1% 7.6% 4.7% |4.5% 0.0% 2.3% 2.3% |
|TERMINAL (d) | 4/30 (13%) 3/21 (14%) 2/21 (10%) 1/30 (3%) |1/33 (3%) 0/39 (0%) 1/35 (3%) 1/34 (3%) |
|FIRST INCIDENCE | 729 (T) 665 700 634 |630 --- 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.199N P=0.456 P=0.630 P=0.333N |P=0.630N P=0.221N P=0.484N P=0.501N |
|POLY 3 | P=0.222N P=0.628 P=0.518N P=0.316N |P=0.618N P=0.230N P=0.499N P=0.503N |
|POLY 1.5 | P=0.232N P=0.642N P=0.501N P=0.319N |P=0.614N P=0.232N P=0.501N P=0.499N |
|POLY 6 | P=0.210N P=0.595 P=0.550N P=0.316N |P=0.624N P=0.228N P=0.495N P=0.508N |
|LOGISTIC REGRESSION| P=0.213N P=0.533 P=0.634N P=0.322N |P=0.613N P=0.234N P=0.500N P=0.493N |
|COCH-ARM / FISHERS | P=0.249N P=0.643N P=0.500N P=0.339N |P=0.610N P=0.242N P=0.500N P=0.492N |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 19
Statistical Analysis of Non-neoplastic Lesions 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 |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 5/50 (10%) 0/50 (0%) 11/50 (22%) |0/49 (0%) 0/50 (0%) 2/50 (4%) 4/50 (8%) |
|POLY-3 RATE (b) | 5/41.29 5/39.64 0/39.45 11/42.78 |0/44.01 0/45.74 2/45.30 4/44.43 |
|POLY-3 PERCENT (g) | 12.1% 12.6% 0.0% 25.7% |0.0% 0.0% 4.4% 9.0% |
|TERMINAL (d) | 4/30 (13%) 4/21 (19%) 0/21 (0%) 10/30 (33%) |0/33 (0%) 0/39 (0%) 2/35 (6%) 3/34 (9%) |
|FIRST INCIDENCE | 617 679 --- 634 |--- --- 730 (T) 610 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.034 * P=0.430 P=0.063N P=0.084 |P=0.009 ** (e) P=0.251 P=0.066 |
|POLY 3 | P=0.015 * P=0.606 P=0.034N* P=0.092 |P=0.009 ** (e) P=0.244 P=0.061 |
|POLY 1.5 | P=0.014 * P=0.629 P=0.031N* P=0.094 |P=0.010 * (e) P=0.242 P=0.062 |
|POLY 6 | P=0.016 * P=0.562 P=0.040N* P=0.087 |P=0.009 ** (e) P=0.247 P=0.061 |
|LOGISTIC REGRESSION| P=0.025 * P=0.550 P=0.039N* P=0.091 |P=0.010 * (e) P=0.251 P=0.065 |
|COCH-ARM / FISHERS | P=0.015 * P=0.630N P=0.028N* P=0.086 |P=0.011 * (e) P=0.253 P=0.061 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 20/50 (40%) 18/50 (36%) 18/50 (36%) 23/50 (46%) |39/49 (80%) 44/50 (88%) 41/50 (82%) 45/50 (90%) |
|POLY-3 RATE (b) | 20/41.39 18/40.07 18/39.60 23/42.95 |39/46.33 44/47.60 41/47.15 45/47.78 |
|POLY-3 PERCENT (g) | 48.3% 44.9% 45.5% 53.6% |84.2% 92.4% 87.0% 94.2% |
|TERMINAL (d) | 18/30 (60%) 15/21 (71%) 16/21 (76%) 21/30 (70%) |30/33 (91%) 38/39 (97%) 32/35 (91%) 34/34 (100%) |
|FIRST INCIDENCE | 617 610 700 617 |527 572 592 529 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.453 P=0.215 P=0.191 P=0.323 |P=0.093 P=0.488N P=0.554N P=0.192 |
|POLY 3 | P=0.268 P=0.465N P=0.485N P=0.393 |P=0.126 P=0.150 P=0.462 P=0.081 |
|POLY 1.5 | P=0.249 P=0.411N P=0.425N P=0.395 |P=0.137 P=0.163 P=0.447 P=0.092 |
|POLY 6 | P=0.293 P=0.575N P=0.587 P=0.374 |P=0.118 P=0.144 P=0.505 P=0.072 |
|LOGISTIC REGRESSION| P=0.357 P=0.451 P=0.372 P=0.353 |P=0.072 P=0.216 P=0.538 P=0.064 |
|COCH-ARM / FISHERS | P=0.212 P=0.418N P=0.418N P=0.343 |P=0.167 P=0.194 P=0.480 P=0.122 |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 20
Statistical Analysis of Non-neoplastic Lesions 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 |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 7/50 (14%) 9/50 (18%) 13/50 (26%) |2/49 (4%) 10/50 (20%) 4/50 (8%) 11/50 (22%) |
|POLY-3 RATE (b) | 7/40.89 7/39.45 9/39.45 13/42.98 |2/44.01 10/45.74 4/45.30 11/44.63 |
|POLY-3 PERCENT (g) | 17.1% 17.7% 22.8% 30.3% |4.5% 21.9% 8.8% 24.7% |
|TERMINAL (d) | 7/30 (23%) 7/21 (33%) 9/21 (43%) 11/30 (37%) |2/33 (6%) 10/39 (26%) 4/35 (11%) 8/34 (24%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 590 |730 (T) 730 (T) 730 (T) 618 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.106 P=0.321 P=0.123 P=0.099 |P=0.027 * P=0.029 * P=0.363 P=0.010 * |
|POLY 3 | P=0.067 P=0.587 P=0.359 P=0.121 |P=0.033 * P=0.016 * P=0.350 P=0.007 ** |
|POLY 1.5 | P=0.061 P=0.614 P=0.389 P=0.121 |P=0.034 * P=0.015 * P=0.347 P=0.007 ** |
|POLY 6 | P=0.075 P=0.534 P=0.305 P=0.119 |P=0.032 * P=0.017 * P=0.357 P=0.007 ** |
|LOGISTIC REGRESSION| P=0.088 P=0.321 P=0.123 P=0.106 |P=0.025 * P=0.029 * P=0.363 P=0.008 ** |
|COCH-ARM / FISHERS | P=0.051 P=0.613N P=0.393 P=0.105 |P=0.038 * P=0.015 * P=0.349 P=0.008 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 10/50 (20%) 11/50 (22%) 10/50 (20%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 7/41.06 10/40.30 11/40.92 10/42.69 |0/44.01 0/45.74 0/45.30 0/44.02 |
|POLY-3 PERCENT (g) | 17.1% 24.8% 26.9% 23.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 6/30 (20%) 5/21 (24%) 6/21 (29%) 7/30 (23%) |0/33 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 686 631 575 702 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.519 P=0.116 P=0.080 P=0.303 |(e) (e) (e) (e) |
|POLY 3 | P=0.420 P=0.277 P=0.207 P=0.325 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.406 P=0.301 P=0.223 P=0.324 |(e) (e) (e) (e) |
|POLY 6 | P=0.433 P=0.237 P=0.179 P=0.319 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.450 P=0.196 P=0.170 P=0.304 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.369 P=0.298 P=0.218 P=0.298 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 21
Statistical Analysis of Non-neoplastic Lesions 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 |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 8/50 (16%) 6/50 (12%) 10/50 (20%) |18/49 (37%) 10/50 (20%) 18/50 (36%) 27/50 (54%) |
|POLY-3 RATE (b) | 6/40.89 8/39.70 6/39.45 10/42.83 |18/46.11 10/46.17 18/45.66 27/45.13 |
|POLY-3 PERCENT (g) | 14.7% 20.2% 15.2% 23.4% |39.0% 21.7% 39.4% 59.8% |
|TERMINAL (d) | 6/30 (20%) 6/21 (29%) 6/21 (29%) 9/30 (30%) |12/33 (36%) 8/39 (21%) 16/35 (46%) 22/34 (65%) |
|FIRST INCIDENCE | 729 (T) 679 729 (T) 617 |497 656 665 610 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.302 P=0.158 P=0.355 P=0.199 |P=0.002 ** P=0.031N* P=0.498N P=0.076 |
|POLY 3 | P=0.225 P=0.361 P=0.597 P=0.231 |P<0.001 ** P=0.053N P=0.570 P=0.033 * |
|POLY 1.5 | P=0.213 P=0.388 P=0.620 P=0.230 |P<0.001 ** P=0.053N P=0.580 P=0.043 * |
|POLY 6 | P=0.238 P=0.314 P=0.552 P=0.228 |P<0.001 ** P=0.052N P=0.563 P=0.025 * |
|LOGISTIC REGRESSION| P=0.267 P=0.209 P=0.355 P=0.210 |P=0.002 ** P=0.052N P=0.549N P=0.052 |
|COCH-ARM / FISHERS | P=0.189 P=0.387 P=0.620N P=0.207 |P=0.003 ** P=0.052N P=0.553N P=0.064 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/49 (4%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/42.72 0/39.45 0/39.45 0/42.44 |2/44.11 0/45.74 2/46.27 2/44.76 |
|POLY-3 PERCENT (g) | 4.7% 0.0% 0.0% 0.0% |4.5% 0.0% 4.3% 4.5% |
|TERMINAL (d) | 0/30 (0%) 0/21 (0%) 0/21 (0%) 0/30 (0%) |1/33 (3%) 0/39 (0%) 1/35 (3%) 0/34 (0%) |
|FIRST INCIDENCE | 122 --- --- --- |704 --- 232 592 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.238N P=0.233N P=0.237N P=0.235N |P=0.420 P=0.213N P=0.679N P=0.690N |
|POLY 3 | P=0.222N P=0.255N P=0.255N P=0.238N |P=0.427 P=0.229N P=0.677N P=0.689N |
|POLY 1.5 | P=0.231N P=0.245N P=0.245N P=0.237N |P=0.430 P=0.231N P=0.681N P=0.688N |
|POLY 6 | P=0.210N P=0.272N P=0.271N P=0.241N |P=0.423 P=0.226N P=0.672N P=0.689N |
|LOGISTIC REGRESSION| P=0.450N P=0.762N P=0.635N P=0.540N |P=0.485 P=0.227N P=0.618N P=0.671N |
|COCH-ARM / FISHERS | P=0.239N P=0.247N P=0.247N P=0.247N |P=0.435 P=0.242N P=0.684N P=0.684N |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 22
Statistical Analysis of Non-neoplastic Lesions 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 |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 2/50 (4%) 4/50 (8%) |3/49 (6%) 9/50 (18%) 7/50 (14%) 7/50 (14%) |
|POLY-3 RATE (b) | 3/41.84 5/40.43 2/39.56 4/43.12 |3/44.62 9/46.23 7/45.75 7/44.56 |
|POLY-3 PERCENT (g) | 7.2% 12.4% 5.1% 9.3% |6.7% 19.5% 15.3% 15.7% |
|TERMINAL (d) | 2/30 (7%) 2/21 (10%) 1/21 (5%) 2/30 (7%) |1/33 (3%) 7/39 (18%) 4/35 (11%) 4/34 (12%) |
|FIRST INCIDENCE | 284 610 700 597 |544 605 674 657 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.568N P=0.259 P=0.612N P=0.507 |P=0.338 P=0.105 P=0.190 P=0.173 |
|POLY 3 | P=0.573 P=0.336 P=0.526N P=0.517 |P=0.355 P=0.067 P=0.167 P=0.156 |
|POLY 1.5 | P=0.565 P=0.353 P=0.508N P=0.515 |P=0.364 P=0.066 P=0.165 P=0.160 |
|POLY 6 | P=0.584 P=0.310 P=0.554N P=0.517 |P=0.346 P=0.070 P=0.173 P=0.153 |
|LOGISTIC REGRESSION| P=0.541 P=0.343 P=0.510N P=0.469 |P=0.366 P=0.067 P=0.167 P=0.166 |
|COCH-ARM / FISHERS | P=0.547 P=0.357 P=0.500N P=0.500 |P=0.380 P=0.065 P=0.167 P=0.167 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |15/49 (31%) 12/50 (24%) 9/50 (18%) 11/50 (22%) |
|POLY-3 RATE (b) | 0/40.89 2/39.45 2/40.63 2/42.74 |15/45.32 12/46.02 9/45.30 11/45.12 |
|POLY-3 PERCENT (g) | 0.0% 5.1% 4.9% 4.7% |33.1% 26.1% 19.9% 24.4% |
|TERMINAL (d) | 0/30 (0%) 2/21 (10%) 0/21 (0%) 1/30 (3%) |11/33 (33%) 11/39 (28%) 9/35 (26%) 7/34 (21%) |
|FIRST INCIDENCE | --- 729 (T) 368 645 |497 656 730 (T) 590 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.387 P=0.163 P=0.237 P=0.243 |P=0.331N P=0.189N P=0.091N P=0.241N |
|POLY 3 | P=0.364 P=0.229 P=0.235 P=0.247 |P=0.293N P=0.306N P=0.115N P=0.246N |
|POLY 1.5 | P=0.358 P=0.237 P=0.240 P=0.246 |P=0.286N P=0.308N P=0.115N P=0.241N |
|POLY 6 | P=0.367 P=0.214 P=0.224 P=0.246 |P=0.301N P=0.300N P=0.114N P=0.251N |
|LOGISTIC REGRESSION| P=0.319 P=0.163 P=0.150 P=0.242 |P=0.304N P=0.286N P=0.103N P=0.236N |
|COCH-ARM / FISHERS | P=0.339 P=0.247 P=0.247 P=0.247 |P=0.275N P=0.304N P=0.109N P=0.228N |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 23
Statistical Analysis of Non-neoplastic Lesions 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 |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 4/50 (8%) 3/50 (6%) 9/50 (18%) |4/49 (8%) 5/50 (10%) 6/50 (12%) 1/50 (2%) |
|POLY-3 RATE (b) | 6/41.29 4/39.45 3/39.45 9/42.86 |4/44.62 5/45.74 6/45.85 1/44.17 |
|POLY-3 PERCENT (g) | 14.5% 10.1% 7.6% 21.0% |9.0% 10.9% 13.1% 2.3% |
|TERMINAL (d) | 5/30 (17%) 4/21 (19%) 3/21 (14%) 8/30 (27%) |2/33 (6%) 5/39 (13%) 4/35 (11%) 0/34 (0%) |
|FIRST INCIDENCE | 617 729 (T) 729 (T) 607 |646 730 (T) 648 690 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.172 P=0.583N P=0.416N P=0.291 |P=0.114N P=0.586 P=0.423 P=0.183N |
|POLY 3 | P=0.121 P=0.397N P=0.263N P=0.312 |P=0.108N P=0.516 P=0.387 P=0.181N |
|POLY 1.5 | P=0.113 P=0.372N P=0.245N P=0.312 |P=0.104N P=0.514 P=0.382 P=0.178N |
|POLY 6 | P=0.131 P=0.445N P=0.298N P=0.305 |P=0.114N P=0.519 P=0.394 P=0.186N |
|LOGISTIC REGRESSION| P=0.145 P=0.476N P=0.317N P=0.306 |P=0.103N P=0.522 P=0.382 P=0.169N |
|COCH-ARM / FISHERS | P=0.103 P=0.370N P=0.243N P=0.288 |P=0.099N P=0.513 P=0.383 P=0.175N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |4/49 (8%) 4/50 (8%) 3/50 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/41.87 2/39.79 2/40.57 0/42.44 |4/44.01 4/46.19 3/45.30 0/44.02 |
|POLY-3 PERCENT (g) | 4.8% 5.0% 4.9% 0.0% |9.1% 8.7% 6.6% 0.0% |
|TERMINAL (d) | 1/30 (3%) 0/21 (0%) 0/21 (0%) 0/30 (0%) |4/33 (12%) 3/39 (8%) 3/35 (9%) 0/34 (0%) |
|FIRST INCIDENCE | 216 638 483 --- |730 (T) 600 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.149N P=0.620 P=0.670 P=0.238N |P=0.042N* P=0.558N P=0.467N P=0.059N |
|POLY 3 | P=0.148N P=0.676 P=0.683 P=0.234N |P=0.041N* P=0.617N P=0.484N P=0.060N |
|POLY 1.5 | P=0.151N P=0.689 P=0.692 P=0.233N |P=0.040N* P=0.624N P=0.489N P=0.059N |
|POLY 6 | P=0.145N P=0.654 P=0.666 P=0.236N |P=0.043N* P=0.604N P=0.477N P=0.061N |
|LOGISTIC REGRESSION| P=0.200N P=0.640 P=0.588 P=0.336N |P=0.041N* P=0.622N P=0.467N (e) |
|COCH-ARM / FISHERS | P=0.156N P=0.691N P=0.691N P=0.247N |P=0.038N* P=0.631N P=0.489N P=0.056N |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 24
Statistical Analysis of Non-neoplastic Lesions 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: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 33/50 (66%) 24/50 (48%) 20/50 (40%) 14/50 (28%) |1/49 (2%) 0/50 (0%) 4/50 (8%) 1/50 (2%) |
|POLY-3 RATE (b) | 33/44.89 24/42.29 20/41.95 14/44.20 |1/44.11 0/45.74 4/46.60 1/44.26 |
|POLY-3 PERCENT (g) | 73.5% 56.8% 47.7% 31.7% |2.3% 0.0% 8.6% 2.3% |
|TERMINAL (d) | 24/30 (80%) 12/21 (57%) 10/21 (48%) 7/30 (23%) |0/33 (0%) 0/39 (0%) 1/35 (3%) 0/34 (0%) |
|FIRST INCIDENCE | 216 506 533 607 |704 --- 232 665 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001N** P=0.487N P=0.186N P<0.001N** |P=0.554 P=0.484N P=0.198 P=0.754 |
|POLY 3 | P<0.001N** P=0.064N P=0.008N** P<0.001N** |P=0.563 P=0.493N P=0.196 P=0.760N |
|POLY 1.5 | P<0.001N** P=0.049N* P=0.006N** P<0.001N** |P=0.569 P=0.494N P=0.191 P=0.759N |
|POLY 6 | P<0.001N** P=0.102N P=0.013N* P<0.001N** |P=0.554 P=0.490N P=0.202 P=0.760 |
|LOGISTIC REGRESSION| P<0.001N** P=0.048N* P=0.007N** P<0.001N** |P=0.624 P=0.495N P=0.227 P=0.754N |
|COCH-ARM / FISHERS | P<0.001N** P=0.053N P=0.008N** P<0.001N** |P=0.577 P=0.495N P=0.187 P=0.747N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 4/50 (8%) 2/50 (4%) |3/49 (6%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 3/41.22 3/39.83 4/40.42 2/42.59 |3/44.64 2/46.39 2/45.63 2/44.70 |
|POLY-3 PERCENT (g) | 7.3% 7.5% 9.9% 4.7% |6.7% 4.3% 4.4% 4.5% |
|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 | 679 679 602 700 |630 634 674 603 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.350N P=0.541 P=0.403 P=0.500N |P=0.517N P=0.478N P=0.482N P=0.516N |
|POLY 3 | P=0.371N P=0.647 P=0.489 P=0.485N |P=0.497N P=0.482N P=0.490N P=0.499N |
|POLY 1.5 | P=0.379N P=0.662N P=0.503 P=0.485N |P=0.492N P=0.487N P=0.492N P=0.496N |
|POLY 6 | P=0.362N P=0.618 P=0.462 P=0.490N |P=0.505N P=0.476N P=0.486N P=0.504N |
|LOGISTIC REGRESSION| P=0.379N P=0.641 P=0.498 P=0.485N |P=0.456N P=0.491N P=0.481N P=0.453N |
|COCH-ARM / FISHERS | P=0.399N P=0.661N P=0.500 P=0.500N |P=0.485N P=0.490N P=0.490N P=0.490N |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 25
Statistical Analysis of Non-neoplastic Lesions 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: Kupffer Cell |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 4/50 (8%) |2/49 (4%) 2/50 (4%) 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/40.89 1/39.86 2/39.94 4/43.24 |2/44.54 2/46.05 3/45.55 1/44.26 |
|POLY-3 PERCENT (g) | 2.5% 2.5% 5.0% 9.3% |4.5% 4.3% 6.6% 2.3% |
|TERMINAL (d) | 1/30 (3%) 0/21 (0%) 0/21 (0%) 1/30 (3%) |0/33 (0%) 1/39 (3%) 2/35 (6%) 0/34 (0%) |
|FIRST INCIDENCE | 729 (T) 610 617 607 |630 646 665 665 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.105 P=0.724 P=0.427 P=0.192 |P=0.396N P=0.666N P=0.526 P=0.511N |
|POLY 3 | P=0.086 P=0.755 P=0.492 P=0.195 |P=0.389N P=0.682N P=0.510 P=0.502N |
|POLY 1.5 | P=0.082 P=0.760N P=0.501 P=0.193 |P=0.382N P=0.684N P=0.508 P=0.499N |
|POLY 6 | P=0.093 P=0.743 P=0.474 P=0.197 |P=0.397N P=0.678N P=0.514 P=0.507N |
|LOGISTIC REGRESSION| P=0.074 P=0.762N P=0.496 P=0.185 |P=0.363N P=0.691N P=0.513 P=0.466N |
|COCH-ARM / FISHERS | P=0.074 P=0.753N P=0.500 P=0.181 |P=0.373N P=0.684N P=0.510 P=0.492N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |3/49 (6%) 1/50 (2%) 2/50 (4%) 5/50 (10%) |
|POLY-3 RATE (b) | 0/40.89 1/40.19 2/40.27 1/42.51 |3/44.47 1/46.58 2/46.27 5/44.02 |
|POLY-3 PERCENT (g) | 0.0% 2.5% 5.0% 2.4% |6.8% 2.2% 4.3% 11.4% |
|TERMINAL (d) | 0/30 (0%) 0/21 (0%) 0/21 (0%) 0/30 (0%) |2/33 (6%) 0/39 (0%) 1/35 (3%) 5/34 (15%) |
|FIRST INCIDENCE | --- 464 533 711 |596 396 232 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.523 P=0.513 P=0.224 P=0.506 |P=0.111 P=0.275N P=0.484N P=0.371 |
|POLY 3 | P=0.522 P=0.497 P=0.233 P=0.508 |P=0.110 P=0.289N P=0.482N P=0.350 |
|POLY 1.5 | P=0.518 P=0.502 P=0.239 P=0.507 |P=0.115 P=0.293N P=0.486N P=0.357 |
|POLY 6 | P=0.526 P=0.485 P=0.223 P=0.507 |P=0.104 P=0.284N P=0.478N P=0.342 |
|LOGISTIC REGRESSION| P=0.452 P=0.365 P=0.217 P=0.506 |P=0.145 P=0.271N P=0.406N P=0.354 |
|COCH-ARM / FISHERS | P=0.501 P=0.500 P=0.247 P=0.500 |P=0.123 P=0.301N P=0.490N P=0.369 |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 26
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 26/50 (52%) 28/50 (56%) 27/50 (54%) 35/50 (70%) |38/49 (78%) 37/50 (74%) 34/50 (68%) 32/50 (64%) |
|POLY-3 RATE (b) | 26/41.59 28/43.53 27/44.61 35/45.67 |38/47.29 37/48.27 34/47.56 32/47.03 |
|POLY-3 PERCENT (g) | 62.5% 64.3% 60.5% 76.6% |80.4% 76.7% 71.5% 68.1% |
|TERMINAL (d) | 21/30 (70%) 14/21 (67%) 12/21 (57%) 24/30 (80%) |26/33 (79%) 32/39 (82%) 27/35 (77%) 24/34 (71%) |
|FIRST INCIDENCE | 617 584 373 449 |497 396 539 529 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.221 P=0.059 P=0.106 P=0.069 |P=0.217N P=0.162N P=0.184N P=0.164N |
|POLY 3 | P=0.060 P=0.521 P=0.513N P=0.101 |P=0.106N P=0.422N P=0.215N P=0.120N |
|POLY 1.5 | P=0.050 P=0.511 P=0.544N P=0.083 |P=0.099N P=0.423N P=0.219N P=0.114N |
|POLY 6 | P=0.078 P=0.524 P=0.494N P=0.126 |P=0.116N P=0.430N P=0.206N P=0.131N |
|LOGISTIC REGRESSION| P=0.058 P=0.273 P=0.449 P=0.055 |P=0.103N P=0.416N P=0.200N P=0.116N |
|COCH-ARM / FISHERS | P=0.035 * P=0.421 P=0.500 P=0.050 |P=0.086N P=0.430N P=0.200N P=0.104N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |1/49 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/41.89 0/39.45 0/39.45 2/42.44 |1/44.01 1/45.90 1/45.30 0/44.02 |
|POLY-3 PERCENT (g) | 2.4% 0.0% 0.0% 4.7% |2.3% 2.2% 2.2% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/21 (0%) 0/21 (0%) 2/30 (7%) |1/33 (3%) 0/39 (0%) 1/35 (3%) 0/34 (0%) |
|FIRST INCIDENCE | 122 --- --- 729 (T) |730 (T) 690 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.222 P=0.500N P=0.500N P=0.500 |P=0.335N P=0.730N P=0.749N P=0.494N |
|POLY 3 | P=0.201 P=0.512N P=0.512N P=0.505 |P=0.328N P=0.751N P=0.754N P=0.500N |
|POLY 1.5 | P=0.196 P=0.504N P=0.505N P=0.505 |P=0.326N P=0.754N P=0.756N P=0.499N |
|POLY 6 | P=0.209 P=0.526N P=0.525N P=0.501 |P=0.332N P=0.747N P=0.751N P=0.502N |
|LOGISTIC REGRESSION| P=0.123 (e) (e) P=0.382 |P=0.328N P=0.756N P=0.749N (e) |
|COCH-ARM / FISHERS | P=0.191 P=0.500N P=0.500N P=0.500 |P=0.321N P=0.747N P=0.747N P=0.495N |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 27
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 1/50 (2%) 2/50 (4%) 5/50 (10%) |3/49 (6%) 4/50 (8%) 0/50 (0%) 4/50 (8%) |
|POLY-3 RATE (b) | 5/41.61 1/39.45 2/39.76 5/42.55 |3/44.18 4/46.05 0/45.30 4/44.02 |
|POLY-3 PERCENT (g) | 12.0% 2.5% 5.0% 11.8% |6.8% 8.7% 0.0% 9.1% |
|TERMINAL (d) | 3/30 (10%) 1/21 (5%) 0/21 (0%) 4/30 (13%) |2/33 (6%) 3/39 (8%) 0/35 (0%) 4/34 (12%) |
|FIRST INCIDENCE | 528 729 (T) 673 700 |685 646 --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.369 P=0.180N P=0.333N P=0.624N |P=0.431 P=0.571 P=0.116N P=0.510 |
|POLY 3 | P=0.318 P=0.112N P=0.233N P=0.617N |P=0.448 P=0.523 P=0.114N P=0.498 |
|POLY 1.5 | P=0.305 P=0.103N P=0.219N P=0.614N |P=0.453 P=0.517 P=0.115N P=0.503 |
|POLY 6 | P=0.337 P=0.132N P=0.260N P=0.627N |P=0.440 P=0.532 P=0.112N P=0.491 |
|LOGISTIC REGRESSION| P=0.326 P=0.108N P=0.221N P=0.610N |P=0.437 P=0.519 P=0.114N P=0.491 |
|COCH-ARM / FISHERS | P=0.290 P=0.102N P=0.218N P=0.630N |P=0.461 P=0.511 P=0.117N P=0.511 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 3/50 (6%) 2/48 (4%) 1/50 (2%) |1/49 (2%) 2/50 (4%) 6/50 (12%) 6/50 (12%) |
|POLY-3 RATE (b) | 0/39.89 3/39.64 2/38.55 1/42.44 |1/44.01 2/46.05 6/45.41 6/44.64 |
|POLY-3 PERCENT (g) | 0.0% 7.6% 5.2% 2.4% |2.3% 4.3% 13.2% 13.4% |
|TERMINAL (d) | 0/29 (0%) 2/21 (10%) 0/20 (0%) 1/30 (3%) |1/33 (3%) 1/39 (3%) 5/35 (14%) 3/34 (9%) |
|FIRST INCIDENCE | --- 679 624 729 (T) |730 (T) 646 702 646 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.520N P=0.078 P=0.230 P=0.507 |P=0.038 * P=0.544 P=0.069 P=0.065 |
|POLY 3 | P=0.546N P=0.117 P=0.229 P=0.512 |P=0.041 * P=0.516 P=0.061 P=0.058 |
|POLY 1.5 | P=0.548N P=0.123 P=0.234 P=0.512 |P=0.042 * P=0.511 P=0.059 P=0.058 |
|POLY 6 | P=0.549N P=0.106 P=0.219 P=0.511 |P=0.039 * P=0.523 P=0.063 P=0.058 |
|LOGISTIC REGRESSION| P=0.548N P=0.100 P=0.227 P=0.507 |P=0.041 * P=0.507 P=0.066 P=0.059 |
|COCH-ARM / FISHERS | P=0.566N P=0.125 P=0.242 P=0.505 |P=0.046 * P=0.508 P=0.059 P=0.059 |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 28
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 1/48 (2%) 2/50 (4%) |2/49 (4%) 4/50 (8%) 4/50 (8%) 4/50 (8%) |
|POLY-3 RATE (b) | 0/39.89 0/39.45 1/38.57 2/42.44 |2/45.15 4/45.74 4/46.52 4/44.02 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.6% 4.7% |4.4% 8.8% 8.6% 9.1% |
|TERMINAL (d) | 0/29 (0%) 0/21 (0%) 0/20 (0%) 2/30 (7%) |0/33 (0%) 4/39 (10%) 2/35 (6%) 4/34 (12%) |
|FIRST INCIDENCE | --- --- 483 729 (T) |497 730 (T) 232 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.113 (e) P=0.513 P=0.245 |P=0.372 P=0.393 P=0.359 P=0.348 |
|POLY 3 | P=0.096 (e) P=0.493 P=0.251 |P=0.369 P=0.343 P=0.351 P=0.325 |
|POLY 1.5 | P=0.093 (e) P=0.498 P=0.250 |P=0.380 P=0.344 P=0.349 P=0.334 |
|POLY 6 | P=0.099 (e) P=0.483 P=0.249 |P=0.354 P=0.345 P=0.354 P=0.315 |
|LOGISTIC REGRESSION| P=0.081 (e) P=0.406 P=0.245 |P=0.430 P=0.342 P=0.400 P=0.370 |
|COCH-ARM / FISHERS | P=0.088 (e) P=0.495 P=0.253 |P=0.398 P=0.349 P=0.349 P=0.349 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 0/50 (0%) 1/48 (2%) 0/50 (0%) |1/49 (2%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/39.89 0/39.45 1/37.86 0/42.44 |1/44.01 0/45.74 2/46.27 1/44.90 |
|POLY-3 PERCENT (g) | 2.5% 0.0% 2.6% 0.0% |2.3% 0.0% 4.3% 2.2% |
|TERMINAL (d) | 1/29 (3%) 0/21 (0%) 1/20 (5%) 0/30 (0%) |1/33 (3%) 0/39 (0%) 1/35 (3%) 0/34 (0%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) --- |730 (T) --- 232 360 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.423N P=0.564N P=0.677 P=0.493N |P=0.552 P=0.467N P=0.514 P=0.757N |
|POLY 3 | P=0.441N P=0.502N P=0.749 P=0.488N |P=0.558 P=0.492N P=0.517 P=0.756N |
|POLY 1.5 | P=0.449N P=0.495N P=0.756 P=0.488N |P=0.561 P=0.494N P=0.513 P=0.756N |
|POLY 6 | P=0.430N P=0.515N P=0.736 P=0.489N |P=0.551 P=0.489N P=0.523 P=0.757N |
|LOGISTIC REGRESSION| P=0.423N (e) P=0.677 (e) |P=0.662 (e) P=0.630 P=0.667N |
|COCH-ARM / FISHERS | P=0.456N P=0.495N P=0.747 P=0.495N |P=0.563 P=0.495N P=0.508 P=0.747N |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 29
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 2/50 (4%) 0/48 (0%) 2/50 (4%) |18/49 (37%) 19/50 (38%) 21/50 (42%) 25/50 (50%) |
|POLY-3 RATE (b) | 0/39.89 2/39.45 0/37.86 2/42.67 |18/45.06 19/45.74 21/46.01 25/44.54 |
|POLY-3 PERCENT (g) | 0.0% 5.1% 0.0% 4.7% |40.0% 41.5% 45.6% 56.1% |
|TERMINAL (d) | 0/29 (0%) 2/21 (10%) 0/20 (0%) 1/30 (3%) |12/33 (36%) 19/39 (49%) 16/35 (46%) 22/34 (65%) |
|FIRST INCIDENCE | --- 729 (T) --- 668 |630 730 (T) 665 646 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.335 P=0.170 (e) P=0.243 |P=0.052 P=0.437N P=0.435 P=0.136 |
|POLY 3 | P=0.299 P=0.234 (e) P=0.252 |P=0.057 P=0.524 P=0.367 P=0.087 |
|POLY 1.5 | P=0.297 P=0.242 (e) P=0.251 |P=0.068 P=0.526 P=0.362 P=0.103 |
|POLY 6 | P=0.298 P=0.220 (e) P=0.252 |P=0.044 * P=0.519 P=0.378 P=0.069 |
|LOGISTIC REGRESSION| P=0.316 P=0.170 (e) P=0.250 |P=0.042 * P=0.575N P=0.398 P=0.088 |
|COCH-ARM / FISHERS | P=0.285 P=0.253 (e) P=0.253 |P=0.088 P=0.531 P=0.371 P=0.129 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/41.72 1/40.19 2/40.19 4/42.47 |0/44.24 0/45.74 2/46.27 1/44.48 |
|POLY-3 PERCENT (g) | 2.4% 2.5% 5.0% 9.4% |0.0% 0.0% 4.3% 2.3% |
|TERMINAL (d) | 0/30 (0%) 0/21 (0%) 0/21 (0%) 3/30 (10%) |0/33 (0%) 0/39 (0%) 1/35 (3%) 0/34 (0%) |
|FIRST INCIDENCE | 406 464 603 720 |--- --- 232 592 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.104 P=0.746N P=0.498 P=0.186 |P=0.353 (e) P=0.246 P=0.504 |
|POLY 3 | P=0.080 P=0.753 P=0.487 P=0.183 |P=0.352 (e) P=0.247 P=0.501 |
|POLY 1.5 | P=0.078 P=0.760 P=0.498 P=0.185 |P=0.353 (e) P=0.243 P=0.501 |
|POLY 6 | P=0.082 P=0.738 P=0.469 P=0.179 |P=0.349 (e) P=0.252 P=0.502 |
|LOGISTIC REGRESSION| P=0.059 P=0.611 P=0.428 P=0.175 |P=0.384 (e) P=0.318 P=0.525 |
|COCH-ARM / FISHERS | P=0.074 P=0.753N P=0.500 P=0.181 |P=0.355 (e) P=0.247 P=0.500 |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 30
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 4/50 (8%) 2/50 (4%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/40.89 2/40.14 4/40.60 2/42.44 |1/44.24 1/46.09 1/45.30 0/44.02 |
|POLY-3 PERCENT (g) | 0.0% 5.0% 9.9% 4.7% |2.3% 2.2% 2.2% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/21 (0%) 0/21 (0%) 2/30 (7%) |1/33 (3%) 0/39 (0%) 1/35 (3%) 0/34 (0%) |
|FIRST INCIDENCE | --- 631 603 729 (T) |730 (T) 634 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.430 P=0.228 P=0.054 P=0.238 |P=0.333N P=0.737N P=0.749N P=0.494N |
|POLY 3 | P=0.406 P=0.232 P=0.059 P=0.245 |P=0.330N P=0.752N P=0.755N P=0.501N |
|POLY 1.5 | P=0.401 P=0.239 P=0.061 P=0.245 |P=0.328N P=0.756N P=0.758N P=0.501N |
|POLY 6 | P=0.408 P=0.221 P=0.054 P=0.243 |P=0.333N P=0.746N P=0.752N P=0.502N |
|LOGISTIC REGRESSION| P=0.378 P=0.228 P=0.062 P=0.238 |P=0.324N P=0.756 P=0.749N (e) |
|COCH-ARM / FISHERS | P=0.379 P=0.247 P=0.059 P=0.247 |P=0.324N P=0.753N P=0.753N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 6/50 (12%) |0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/40.89 0/39.45 0/39.45 6/43.89 |0/44.01 0/45.74 0/44.51 0/44.02 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 13.7% |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 | --- --- --- 602 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.023 * |(e) (e) (e) (e) |
|POLY 3 | P<0.001 ** (e) (e) P=0.019 * |(e) (e) (e) (e) |
|POLY 1.5 | P<0.001 ** (e) (e) P=0.018 * |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** (e) (e) P=0.020 * |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) P=0.016 * |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.013 * |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 31
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |2/49 (4%) 5/50 (10%) 2/49 (4%) 4/50 (8%) |
|POLY-3 RATE (b) | 2/41.06 2/40.19 2/39.88 2/42.47 |2/44.37 5/46.19 2/45.49 4/44.73 |
|POLY-3 PERCENT (g) | 4.9% 5.0% 5.0% 4.7% |4.5% 10.8% 4.4% 8.9% |
|TERMINAL (d) | 1/30 (3%) 1/21 (5%) 1/21 (5%) 1/30 (3%) |1/33 (3%) 4/39 (10%) 0/35 (0%) 1/34 (3%) |
|FIRST INCIDENCE | 686 464 603 720 |630 600 232 602 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.563N P=0.610 P=0.615 P=0.692 |P=0.419 P=0.273 P=0.679N P=0.338 |
|POLY 3 | P=0.603N P=0.687 P=0.684 P=0.682N |P=0.439 P=0.233 P=0.685N P=0.341 |
|POLY 1.5 | P=0.608N P=0.691N P=0.694N P=0.682N |P=0.443 P=0.229 P=0.688N P=0.343 |
|POLY 6 | P=0.596N P=0.665 P=0.664 P=0.686N |P=0.436 P=0.239 P=0.680N P=0.339 |
|LOGISTIC REGRESSION| P=0.616N P=0.693 P=0.690 P=0.686N |P=0.486 P=0.223 P=0.611N P=0.359 |
|COCH-ARM / FISHERS | P=0.622 P=0.691N P=0.691N P=0.691N |P=0.450 P=0.226 P=0.691N P=0.349 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/49 (4%) 2/50 (4%) 0/49 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/40.89 0/39.45 0/39.45 0/42.44 |2/44.01 2/45.74 0/44.51 2/44.02 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.5% 4.4% 0.0% 4.5% |
|TERMINAL (d) | 0/30 (0%) 0/21 (0%) 0/21 (0%) 0/30 (0%) |2/33 (6%) 2/39 (5%) 0/35 (0%) 2/34 (6%) |
|FIRST INCIDENCE | --- --- --- --- |730 (T) 730 (T) --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.602 P=0.634N P=0.225N P=0.685N |
|POLY 3 | (e) (e) (e) (e) |P=0.612 P=0.680N P=0.235N P=0.694N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.615 P=0.683N P=0.237N P=0.691N |
|POLY 6 | (e) (e) (e) (e) |P=0.607 P=0.674N P=0.231N P=0.691 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.602 P=0.634N (e) P=0.685N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.621 P=0.684N P=0.247N P=0.684N |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 32
Statistical Analysis of Non-neoplastic Lesions 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 |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 14/49 (29%) 23/47 (49%) 10/49 (20%) 13/49 (27%) |44/49 (90%) 44/50 (88%) 42/50 (84%) 42/50 (84%) |
|POLY-3 RATE (b) | 14/42.09 23/40.45 10/39.80 13/42.47 |44/47.69 44/48.57 42/47.34 42/47.58 |
|POLY-3 PERCENT (g) | 33.3% 56.9% 25.1% 30.6% |92.3% 90.6% 88.7% 88.3% |
|TERMINAL (d) | 9/30 (30%) 9/21 (43%) 5/20 (25%) 8/30 (27%) |30/33 (91%) 36/39 (92%) 31/35 (89%) 30/34 (88%) |
|FIRST INCIDENCE | 216 584 483 645 |544 572 617 590 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.105N P=0.010 * P=0.549N P=0.495N |P=0.532N P=0.166N P=0.267N P=0.387N |
|POLY 3 | P=0.121N P=0.022 * P=0.284N P=0.489N |P=0.337N P=0.529N P=0.400N P=0.371N |
|POLY 1.5 | P=0.127N P=0.028 * P=0.252N P=0.483N |P=0.303N P=0.527N P=0.366N P=0.337N |
|POLY 6 | P=0.118N P=0.017 * P=0.347N P=0.501N |P=0.383N P=0.538N P=0.438N P=0.417N |
|LOGISTIC REGRESSION| P=0.116N P=0.030 * P=0.249N P=0.466N |P=0.339N P=0.490N P=0.253N P=0.339N |
|COCH-ARM / FISHERS | P=0.151N P=0.033 * P=0.241N P=0.500N |P=0.261N P=0.514N P=0.290N P=0.290N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Mesentery |
| Accessory Spleen |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/8 (50%) 2/7 (29%) 2/13 (15%) 0/15 (0%) |0/1 (0%) 2/6 (33%) 0/1 (0%) 2/6 (33%) |
|POLY-3 RATE (b) | 4/7.89 2/6.24 2/10.24 0/12.57 |0/0.90 2/5.66 0/0.98 2/5.61 |
|POLY-3 PERCENT (g) | 50.7% 32.1% 19.5% 0.0% |0.0% 35.4% 0.0% 35.7% |
|TERMINAL (d) | 0/3 (0%) 1/4 (25%) 0/4 (0%) 0/9 (0%) |0/0 (0%) 2/5 (40%) 0/0 (0%) 2/5 (40%) |
|FIRST INCIDENCE | 528 725 510 --- |--- 730 (T) --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.044N* P=0.412N P=0.423N P=0.067N |P=0.677 P=1.000 (e) P=1.000 |
|POLY 3 | P=0.005N** P=0.438N P=0.176N P=0.003N** |P=0.556 P=0.686 (e) P=0.685 |
|POLY 1.5 | P=0.005N** P=0.412N P=0.144N P=0.002N** |P=0.554 P=0.679 (e) P=0.679 |
|POLY 6 | P=0.005N** P=0.478N P=0.231N P=0.004N** |P=0.564 P=0.700 (e) P=0.699 |
|LOGISTIC REGRESSION| P=0.007N** P=0.424N P=0.071N P=0.006N** |(e) P=1.000 (e) P=1.000 |
|COCH-ARM / FISHERS | P=0.008N** P=0.378N P=0.115N P=0.008N** |P=0.560 P=0.714 (e) P=0.714 |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 33
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/8 (63%) 6/7 (86%) 11/13 (85%) 12/15 (80%) |1/1 (100%) 4/6 (67%) 1/1 (100%) 5/6 (83%) |
|POLY-3 RATE (b) | 5/6.88 6/6.98 11/12.24 12/14.93 |1/1.00 4/6.00 1/1.00 5/6.00 |
|POLY-3 PERCENT (g) | 72.6% 85.9% 89.9% 80.4% |100.0% 66.7% 100.0% 83.3% |
|TERMINAL (d) | 3/3 (100%) 4/4 (100%) 4/4 (100%) 7/9 (78%) |0/0 (0%) 3/5 (60%) 0/0 (0%) 4/5 (80%) |
|FIRST INCIDENCE | 700 610 373 266 |704 634 725 618 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.428 P=0.623 P=0.063 P=0.386 |P=0.442 P=0.740N (e) P=0.754 |
|POLY 3 | P=0.599N P=0.522 P=0.355 P=0.559 |P=0.530 P=0.673N (e) P=0.828N |
|POLY 1.5 | P=0.587 P=0.431 P=0.303 P=0.459 |P=0.530 P=0.673N (e) P=0.828N |
|POLY 6 | P=0.491N P=0.671 P=0.486 P=0.702 |P=0.530 P=0.673N (e) P=0.828N |
|LOGISTIC REGRESSION| P=0.461 P=0.396 P=0.170 P=0.338 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.464 P=0.338 P=0.262 P=0.334 |P=0.534 P=0.714N (e) P=0.857N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Nose |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 1/50 (2%) 2/50 (4%) |1/49 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 4/41.21 3/40.66 1/39.78 2/42.44 |1/44.60 0/45.74 1/45.30 2/44.02 |
|POLY-3 PERCENT (g) | 9.7% 7.4% 2.5% 4.7% |2.2% 0.0% 2.2% 4.5% |
|TERMINAL (d) | 2/30 (7%) 1/21 (5%) 0/21 (0%) 2/30 (7%) |0/33 (0%) 0/39 (0%) 1/35 (3%) 2/34 (6%) |
|FIRST INCIDENCE | 646 506 638 729 (T) |544 --- 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.268N P=0.615N P=0.268N P=0.341N |P=0.227 P=0.492N P=0.754N P=0.509 |
|POLY 3 | P=0.290N P=0.507N P=0.188N P=0.323N |P=0.229 P=0.495N P=0.757N P=0.495 |
|POLY 1.5 | P=0.296N P=0.493N P=0.179N P=0.322N |P=0.233 P=0.496N P=0.758N P=0.500 |
|POLY 6 | P=0.283N P=0.538N P=0.207N P=0.329N |P=0.223 P=0.493N P=0.756N P=0.490 |
|LOGISTIC REGRESSION| P=0.301N P=0.500N P=0.187N P=0.323N |P=0.245 P=0.417N P=0.736N P=0.527 |
|COCH-ARM / FISHERS | P=0.305N P=0.500N P=0.181N P=0.339N |P=0.238 P=0.495N P=0.747N P=0.508 |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 34
Statistical Analysis of Non-neoplastic Lesions 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 |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 8/50 (16%) 9/50 (18%) 8/50 (16%) |6/49 (12%) 3/50 (6%) 5/50 (10%) 5/50 (10%) |
|POLY-3 RATE (b) | 9/42.23 8/41.06 9/42.78 8/42.58 |6/44.72 3/46.26 5/45.91 5/44.02 |
|POLY-3 PERCENT (g) | 21.3% 19.5% 21.0% 18.8% |13.4% 6.5% 10.9% 11.4% |
|TERMINAL (d) | 5/30 (17%) 4/21 (19%) 1/21 (5%) 6/30 (20%) |3/33 (9%) 2/39 (5%) 3/35 (9%) 5/34 (15%) |
|FIRST INCIDENCE | 406 506 533 711 |544 572 617 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.382N P=0.498 P=0.463 P=0.494N |P=0.518 P=0.192N P=0.466N P=0.489N |
|POLY 3 | P=0.469N P=0.526N P=0.593N P=0.492N |P=0.525 P=0.225N P=0.482N P=0.511N |
|POLY 1.5 | P=0.473N P=0.498N P=0.585N P=0.484N |P=0.538 P=0.229N P=0.487N P=0.501N |
|POLY 6 | P=0.466N P=0.577N P=0.603 P=0.510N |P=0.506 P=0.218N P=0.471N P=0.524N |
|LOGISTIC REGRESSION| P=0.481N P=0.499N P=0.598 P=0.470N |P=0.554 P=0.236N P=0.484N P=0.500N |
|COCH-ARM / FISHERS | P=0.489N P=0.500N P=0.602N P=0.500N |P=0.557 P=0.233N P=0.486N P=0.486N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 7/50 (14%) 8/50 (16%) 5/50 (10%) |6/49 (12%) 4/50 (8%) 4/50 (8%) 1/50 (2%) |
|POLY-3 RATE (b) | 6/41.27 7/40.77 8/42.80 5/42.58 |6/45.06 4/45.74 4/45.70 1/44.29 |
|POLY-3 PERCENT (g) | 14.5% 17.2% 18.7% 11.7% |13.3% 8.8% 8.8% 2.3% |
|TERMINAL (d) | 4/30 (13%) 3/21 (14%) 0/21 (0%) 3/30 (10%) |3/33 (9%) 4/39 (10%) 3/35 (9%) 0/34 (0%) |
|FIRST INCIDENCE | 646 506 533 711 |544 730 (T) 617 657 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.296N P=0.309 P=0.297 P=0.494N |P=0.064N P=0.296N P=0.346N P=0.064N |
|POLY 3 | P=0.338N P=0.490 P=0.414 P=0.478N |P=0.058N P=0.360N P=0.360N P=0.058N |
|POLY 1.5 | P=0.346N P=0.510 P=0.414 P=0.477N |P=0.056N P=0.360N P=0.362N P=0.056N |
|POLY 6 | P=0.331N P=0.449 P=0.406 P=0.486N |P=0.061N P=0.358N P=0.357N P=0.061N |
|LOGISTIC REGRESSION| P=0.365N P=0.485 P=0.383 P=0.481N |P=0.052N P=0.358N P=0.351N P=0.048N* |
|COCH-ARM / FISHERS | P=0.370N P=0.500 P=0.387 P=0.500N |P=0.053N P=0.357N P=0.357N P=0.053N |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 35
Statistical Analysis of Non-neoplastic Lesions 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: Respiratory Epithelium |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 5/50 (10%) 1/50 (2%) |1/49 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 4/41.84 3/39.50 5/41.23 1/42.51 |1/44.01 1/45.74 0/45.30 2/44.02 |
|POLY-3 PERCENT (g) | 9.6% 7.6% 12.1% 2.4% |2.3% 2.2% 0.0% 4.5% |
|TERMINAL (d) | 1/30 (3%) 2/21 (10%) 1/21 (5%) 0/30 (0%) |1/33 (3%) 1/39 (3%) 0/35 (0%) 2/34 (6%) |
|FIRST INCIDENCE | 406 716 533 711 |730 (T) 730 (T) --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.137N P=0.641N P=0.409 P=0.183N |P=0.317 P=0.724N P=0.488N P=0.510 |
|POLY 3 | P=0.138N P=0.532N P=0.491 P=0.173N |P=0.329 P=0.752N P=0.494N P=0.500 |
|POLY 1.5 | P=0.145N P=0.508N P=0.504 P=0.172N |P=0.332 P=0.754N P=0.496N P=0.503 |
|POLY 6 | P=0.131N P=0.571N P=0.467 P=0.176N |P=0.324 P=0.748N P=0.491N P=0.497 |
|LOGISTIC REGRESSION| P=0.161N P=0.501N P=0.484 P=0.185N |P=0.317 P=0.724N (e) P=0.510 |
|COCH-ARM / FISHERS | P=0.157N P=0.500N P=0.500 P=0.181N |P=0.335 P=0.747N P=0.495N P=0.508 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |10/49 (20%) 6/50 (12%) 6/50 (12%) 7/50 (14%) |
|POLY-3 RATE (b) | |10/45.60 6/45.74 6/46.54 7/44.51 |
|POLY-3 PERCENT (g) | |21.9% 13.1% 12.9% 15.7% |
|TERMINAL (d) | |5/33 (15%) 6/39 (15%) 3/35 (9%) 5/34 (15%) |
|FIRST INCIDENCE | |497 730 (T) 232 603 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.445N P=0.146N P=0.193N P=0.304N |
|POLY 3 | |P=0.422N P=0.202N P=0.192N P=0.315N |
|POLY 1.5 | |P=0.410N P=0.200N P=0.193N P=0.302N |
|POLY 6 | |P=0.437N P=0.204N P=0.191N P=0.332N |
|LOGISTIC REGRESSION| |P=0.378N P=0.195N P=0.174N P=0.277N |
|COCH-ARM / FISHERS | |P=0.393N P=0.194N P=0.194N P=0.282N |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 36
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Pancreas |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 19/50 (38%) 16/50 (32%) 23/50 (46%) |13/49 (27%) 15/50 (30%) 18/49 (37%) 13/50 (26%) |
|POLY-3 RATE (b) | 23/43.83 19/41.67 16/41.97 23/44.93 |13/44.62 15/47.10 18/45.86 13/44.68 |
|POLY-3 PERCENT (g) | 52.5% 45.6% 38.1% 51.2% |29.1% 31.9% 39.3% 29.1% |
|TERMINAL (d) | 17/30 (57%) 10/21 (48%) 9/21 (43%) 16/30 (53%) |11/33 (33%) 11/39 (28%) 12/35 (34%) 11/34 (32%) |
|FIRST INCIDENCE | 406 584 550 590 |544 572 592 597 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.486N P=0.453 P=0.410N P=0.551N |P=0.507N P=0.580N P=0.262 P=0.562N |
|POLY 3 | P=0.458 P=0.333N P=0.125N P=0.537N |P=0.484N P=0.478 P=0.213 P=0.591N |
|POLY 1.5 | P=0.426 P=0.279N P=0.105N P=0.535N |P=0.463N P=0.457 P=0.197 P=0.583N |
|POLY 6 | P=0.503 P=0.425N P=0.165N P=0.542N |P=0.510N P=0.513 P=0.244 P=0.590 |
|LOGISTIC REGRESSION| P=0.454 P=0.291N P=0.112N P=0.523N |P=0.464N P=0.448 P=0.198 P=0.585 |
|COCH-ARM / FISHERS | P=0.374 P=0.272N P=0.109N P=0.579N |P=0.433N P=0.437 P=0.193 P=0.567N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 0/50 (0%) 1/48 (2%) 1/50 (2%) |9/49 (18%) 10/50 (20%) 6/49 (12%) 5/49 (10%) |
|POLY-3 RATE (b) | 1/39.89 0/39.45 1/38.39 1/42.44 |9/44.68 10/45.74 6/44.59 5/43.29 |
|POLY-3 PERCENT (g) | 2.5% 0.0% 2.6% 2.4% |20.1% 21.9% 13.5% 11.6% |
|TERMINAL (d) | 1/29 (3%) 0/21 (0%) 0/20 (0%) 1/30 (3%) |7/33 (21%) 10/39 (26%) 5/35 (14%) 4/33 (12%) |
|FIRST INCIDENCE | 729 (T) --- 624 729 (T) |630 730 (T) 711 657 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.585 P=0.564N P=0.720 P=0.755N |P=0.140N P=0.559N P=0.249N P=0.199N |
|POLY 3 | P=0.576 P=0.502N P=0.753 P=0.747N |P=0.127N P=0.523 P=0.287N P=0.209N |
|POLY 1.5 | P=0.567 P=0.495N P=0.758 P=0.748N |P=0.122N P=0.520 P=0.291N P=0.203N |
|POLY 6 | P=0.588 P=0.515N P=0.742 P=0.749N |P=0.134N P=0.528 P=0.281N P=0.217N |
|LOGISTIC REGRESSION| P=0.568 (e) P=0.758 P=0.755N |P=0.135N P=0.555 P=0.272N P=0.206N |
|COCH-ARM / FISHERS | P=0.554 P=0.495N P=0.747 P=0.747N |P=0.115N P=0.520 P=0.288N P=0.194N |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 37
Statistical Analysis of Non-neoplastic Lesions 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 |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/49 (14%) 9/50 (18%) 5/48 (10%) 3/50 (6%) |22/49 (45%) 11/50 (22%) 13/49 (27%) 16/49 (33%) |
|POLY-3 RATE (b) | 7/40.81 9/41.23 5/39.12 3/42.55 |22/45.25 11/46.05 13/46.82 16/44.46 |
|POLY-3 PERCENT (g) | 17.2% 21.8% 12.8% 7.1% |48.6% 23.9% 27.8% 36.0% |
|TERMINAL (d) | 4/29 (14%) 3/21 (14%) 1/20 (5%) 2/30 (7%) |16/33 (49%) 10/39 (26%) 9/35 (26%) 12/33 (36%) |
|FIRST INCIDENCE | 406 561 605 700 |610 646 232 590 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.054N P=0.238 P=0.552N P=0.154N |P=0.515N P=0.006N** P=0.041N* P=0.170N |
|POLY 3 | P=0.054N P=0.399 P=0.408N P=0.138N |P=0.457N P=0.010N* P=0.029N* P=0.156N |
|POLY 1.5 | P=0.057N P=0.418 P=0.391N P=0.138N |P=0.448N P=0.011N* P=0.035N* P=0.154N |
|POLY 6 | P=0.052N P=0.366 P=0.436N P=0.141N |P=0.469N P=0.009N** P=0.025N* P=0.160N |
|LOGISTIC REGRESSION| P=0.059N P=0.410 P=0.393N P=0.138N |P=0.442N P=0.010N* P=0.045N* P=0.168N |
|COCH-ARM / FISHERS | P=0.065N P=0.410 P=0.394N P=0.151N |P=0.434N P=0.013N* P=0.046N* P=0.150N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/49 (12%) 3/50 (6%) 5/48 (10%) 1/50 (2%) |13/49 (27%) 10/50 (20%) 3/49 (6%) 5/49 (10%) |
|POLY-3 RATE (b) | 6/40.55 3/40.00 5/38.76 1/42.44 |13/45.15 10/45.74 3/44.52 5/43.02 |
|POLY-3 PERCENT (g) | 14.8% 7.5% 12.9% 2.4% |28.8% 21.9% 6.7% 11.6% |
|TERMINAL (d) | 3/29 (10%) 2/21 (10%) 3/20 (15%) 1/30 (3%) |10/33 (30%) 10/39 (26%) 3/35 (9%) 5/33 (15%) |
|FIRST INCIDENCE | 590 557 602 729 (T) |527 730 (T) 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.057N P=0.380N P=0.573 P=0.057N |P=0.038N* P=0.187N P=0.005N** P=0.035N* |
|POLY 3 | P=0.059N P=0.246N P=0.532N P=0.048N* |P=0.033N* P=0.302N P=0.006N** P=0.039N* |
|POLY 1.5 | P=0.064N P=0.230N P=0.512N P=0.048N* |P=0.031N* P=0.302N P=0.006N** P=0.036N* |
|POLY 6 | P=0.054N P=0.280N P=0.571N P=0.050N |P=0.036N* P=0.299N P=0.005N** P=0.043N* |
|LOGISTIC REGRESSION| P=0.064N P=0.240N P=0.530N P=0.049N* |P=0.036N* P=0.276N P=0.007N** P=0.037N* |
|COCH-ARM / FISHERS | P=0.072N P=0.233N P=0.515N P=0.053N |P=0.031N* P=0.298N P=0.006N** P=0.033N* |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 38
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 17/50 (34%) 20/50 (40%) 13/50 (26%) 20/50 (40%) | |
|POLY-3 RATE (b) | 17/43.04 20/42.86 13/42.91 20/44.92 | |
|POLY-3 PERCENT (g) | 39.5% 46.7% 30.3% 44.5% | |
|TERMINAL (d) | 12/30 (40%) 10/21 (48%) 5/21 (24%) 12/30 (40%) | |
|FIRST INCIDENCE | 122 464 368 539 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.537N P=0.101 P=0.548N P=0.370 | |
|POLY 3 | P=0.423 P=0.322 P=0.249N P=0.396 | |
|POLY 1.5 | P=0.396 P=0.346 P=0.237N P=0.380 | |
|POLY 6 | P=0.459 P=0.278 P=0.289N P=0.408 | |
|LOGISTIC REGRESSION| P=0.377 P=0.340 P=0.258N P=0.368 | |
|COCH-ARM / FISHERS | P=0.358 P=0.339 P=0.257N P=0.339 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Prostate |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 5/50 (10%) 4/50 (8%) 6/50 (12%) | |
|POLY-3 RATE (b) | 5/41.30 5/40.59 4/39.55 6/42.51 | |
|POLY-3 PERCENT (g) | 12.1% 12.3% 10.1% 14.1% | |
|TERMINAL (d) | 3/30 (10%) 3/21 (14%) 3/21 (14%) 5/30 (17%) | |
|FIRST INCIDENCE | 617 511 704 711 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.522 P=0.467 P=0.588 P=0.503 | |
|POLY 3 | P=0.448 P=0.621 P=0.527N P=0.520 | |
|POLY 1.5 | P=0.440 P=0.624N P=0.504N P=0.522 | |
|POLY 6 | P=0.456 P=0.585 P=0.569N P=0.511 | |
|LOGISTIC REGRESSION| P=0.468 P=0.627 P=0.580N P=0.518 | |
|COCH-ARM / FISHERS | P=0.420 P=0.630N P=0.500N P=0.500 | |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 39
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 26/50 (52%) 24/50 (48%) 28/50 (56%) 29/50 (58%) | |
|POLY-3 RATE (b) | 26/45.50 24/44.58 28/46.88 29/48.61 | |
|POLY-3 PERCENT (g) | 57.1% 53.8% 59.7% 59.7% | |
|TERMINAL (d) | 15/30 (50%) 9/21 (43%) 8/21 (38%) 15/30 (50%) | |
|FIRST INCIDENCE | 122 491 368 266 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.483 P=0.336 P=0.169 P=0.406 | |
|POLY 3 | P=0.386 P=0.458N P=0.483 P=0.485 | |
|POLY 1.5 | P=0.328 P=0.422N P=0.479 P=0.446 | |
|POLY 6 | P=0.451 P=0.521N P=0.469 P=0.514 | |
|LOGISTIC REGRESSION| P=0.195 P=0.420N P=0.417 P=0.313 | |
|COCH-ARM / FISHERS | P=0.230 P=0.421N P=0.421 P=0.344 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Prostate: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 3/50 (6%) 10/50 (20%) 9/50 (18%) | |
|POLY-3 RATE (b) | 12/41.52 3/39.60 10/41.10 9/43.28 | |
|POLY-3 PERCENT (g) | 28.9% 7.6% 24.3% 20.8% | |
|TERMINAL (d) | 10/30 (33%) 2/21 (10%) 4/21 (19%) 6/30 (20%) | |
|FIRST INCIDENCE | 604 690 617 605 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.500N P=0.051N P=0.509 P=0.304N | |
|POLY 3 | P=0.566N P=0.012N* P=0.412N P=0.269N | |
|POLY 1.5 | P=0.536 P=0.010N* P=0.392N P=0.275N | |
|POLY 6 | P=0.521N P=0.017N* P=0.451N P=0.270N | |
|LOGISTIC REGRESSION| P=0.556 P=0.021N* P=0.456N P=0.278N | |
|COCH-ARM / FISHERS | P=0.491 P=0.011N* P=0.405N P=0.312N | |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 40
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Salivary Glands |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |1/49 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/40.89 0/39.45 0/39.45 0/41.51 |1/44.01 0/45.74 1/45.32 2/44.32 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.3% 0.0% 2.2% 4.5% |
|TERMINAL (d) | 0/30 (0%) 0/21 (0%) 0/21 (0%) 0/30 (0%) |1/33 (3%) 0/39 (0%) 0/35 (0%) 1/34 (3%) |
|FIRST INCIDENCE | --- --- --- --- |730 (T) --- 725 646 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.222 P=0.467N P=0.748N P=0.507 |
|POLY 3 | (e) (e) (e) (e) |P=0.232 P=0.492N P=0.754N P=0.502 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.235 P=0.494N P=0.756N P=0.504 |
|POLY 6 | (e) (e) (e) (e) |P=0.228 P=0.489N P=0.751N P=0.501 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.233 (e) P=0.750N P=0.504 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.238 P=0.495N P=0.747N P=0.508 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Skin |
| Cyst Epithelial Inclusion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 3/49 (6%) 2/49 (4%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/40.89 0/39.45 3/39.03 2/41.47 |0/44.01 0/45.74 0/45.30 0/44.02 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 7.7% 4.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/21 (0%) 0/21 (0%) 1/29 (3%) |0/33 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- 689 720 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.202 (e) P=0.082 P=0.236 |(e) (e) (e) (e) |
|POLY 3 | P=0.169 (e) P=0.110 P=0.240 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.164 (e) P=0.115 P=0.240 |(e) (e) (e) (e) |
|POLY 6 | P=0.174 (e) P=0.101 P=0.238 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.177 (e) P=0.102 P=0.233 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.154 (e) P=0.117 P=0.242 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 41
Statistical Analysis of Non-neoplastic Lesions 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 |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 1/49 (2%) 0/49 (0%) |1/49 (2%) 1/50 (2%) 1/50 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 2/41.09 3/39.53 1/39.06 0/41.44 |1/44.01 1/45.74 1/45.30 3/44.02 |
|POLY-3 PERCENT (g) | 4.9% 7.6% 2.6% 0.0% |2.3% 2.2% 2.2% 6.8% |
|TERMINAL (d) | 1/30 (3%) 1/21 (5%) 0/21 (0%) 0/29 (0%) |1/33 (3%) 1/39 (3%) 1/35 (3%) 3/34 (9%) |
|FIRST INCIDENCE | 679 714 644 --- |730 (T) 730 (T) 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.103N P=0.368 P=0.575N P=0.247N |P=0.143 P=0.724N P=0.749N P=0.315 |
|POLY 3 | P=0.103N P=0.482 P=0.518N P=0.235N |P=0.153 P=0.752N P=0.754N P=0.305 |
|POLY 1.5 | P=0.104N P=0.499 P=0.507N P=0.235N |P=0.156 P=0.754N P=0.756N P=0.308 |
|POLY 6 | P=0.102N P=0.451 P=0.537N P=0.238N |P=0.149 P=0.748N P=0.751N P=0.302 |
|LOGISTIC REGRESSION| P=0.103N P=0.432 P=0.511N P=0.235N |P=0.143 P=0.724N P=0.749N P=0.315 |
|COCH-ARM / FISHERS | P=0.110N P=0.500 P=0.508N P=0.253N |P=0.159 P=0.747N P=0.747N P=0.316 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Skin |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/49 (0%) 1/49 (2%) |1/49 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/41.09 2/39.62 0/38.75 1/42.20 |1/44.01 0/45.74 1/45.30 0/44.02 |
|POLY-3 PERCENT (g) | 4.9% 5.1% 0.0% 2.4% |2.3% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 1/30 (3%) 0/21 (0%) 0/21 (0%) 0/29 (0%) |1/33 (3%) 0/39 (0%) 1/35 (3%) 0/34 (0%) |
|FIRST INCIDENCE | 679 690 --- 449 |730 (T) --- 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.363N P=0.590 P=0.304N P=0.500N |P=0.468N P=0.467N P=0.749N P=0.494N |
|POLY 3 | P=0.378N P=0.682 P=0.250N P=0.491N |P=0.464N P=0.492N P=0.754N P=0.500N |
|POLY 1.5 | P=0.384N P=0.694 P=0.242N P=0.492N |P=0.461N P=0.494N P=0.756N P=0.499N |
|POLY 6 | P=0.372N P=0.658 P=0.264N P=0.493N |P=0.469N P=0.489N P=0.751N P=0.502N |
|LOGISTIC REGRESSION| P=0.400N P=0.666 P=0.255N P=0.540N |P=0.468N (e) P=0.749N (e) |
|COCH-ARM / FISHERS | P=0.393N P=0.691N P=0.253N P=0.508N |P=0.457N P=0.495N P=0.747N P=0.495N |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 42
Statistical Analysis of Non-neoplastic Lesions 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 |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/49 (0%) 0/49 (0%) |2/49 (4%) 1/50 (2%) 4/50 (8%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/40.89 2/40.01 0/38.75 0/41.44 |2/44.01 1/45.74 4/45.30 3/44.64 |
|POLY-3 PERCENT (g) | 0.0% 5.0% 0.0% 0.0% |4.5% 2.2% 8.8% 6.7% |
|TERMINAL (d) | 0/30 (0%) 0/21 (0%) 0/21 (0%) 0/29 (0%) |2/33 (6%) 1/39 (3%) 4/35 (11%) 2/34 (6%) |
|FIRST INCIDENCE | --- 610 --- --- |730 (T) 730 (T) 730 (T) 529 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.367N P=0.217 (e) (e) |P=0.320 P=0.442N P=0.363 P=0.515 |
|POLY 3 | P=0.382N P=0.232 (e) (e) |P=0.336 P=0.487N P=0.350 P=0.506 |
|POLY 1.5 | P=0.379N P=0.239 (e) (e) |P=0.340 P=0.490N P=0.347 P=0.507 |
|POLY 6 | P=0.391N P=0.220 (e) (e) |P=0.329 P=0.481N P=0.357 P=0.506 |
|LOGISTIC REGRESSION| P=0.391N P=0.235 (e) (e) |P=0.333 P=0.442N P=0.363 P=0.514 |
|COCH-ARM / FISHERS | P=0.386N P=0.247 (e) (e) |P=0.345 P=0.492N P=0.349 P=0.510 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Skin: Epidermis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 0/49 (0%) 0/49 (0%) |4/49 (8%) 2/50 (4%) 5/50 (10%) 5/50 (10%) |
|POLY-3 RATE (b) | 1/40.89 3/39.62 0/38.75 0/41.44 |4/44.01 2/45.74 5/45.30 5/44.64 |
|POLY-3 PERCENT (g) | 2.5% 7.6% 0.0% 0.0% |9.1% 4.4% 11.0% 11.2% |
|TERMINAL (d) | 1/30 (3%) 1/21 (5%) 0/21 (0%) 0/29 (0%) |4/33 (12%) 2/39 (5%) 5/35 (14%) 4/34 (12%) |
|FIRST INCIDENCE | 729 (T) 690 --- --- |730 (T) 730 (T) 730 (T) 529 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.149N P=0.202 P=0.571N P=0.507N |P=0.276 P=0.262N P=0.537 P=0.520 |
|POLY 3 | P=0.154N P=0.293 P=0.511N P=0.497N |P=0.298 P=0.319N P=0.518 P=0.509 |
|POLY 1.5 | P=0.153N P=0.306 P=0.504N P=0.497N |P=0.303 P=0.324N P=0.513 P=0.510 |
|POLY 6 | P=0.157N P=0.271 P=0.522N P=0.499N |P=0.290 P=0.311N P=0.527 P=0.508 |
|LOGISTIC REGRESSION| P=0.150N P=0.242 (e) (e) |P=0.283 P=0.262N P=0.537 P=0.503 |
|COCH-ARM / FISHERS | P=0.160N P=0.309 P=0.505N P=0.505N |P=0.308 P=0.329N P=0.513 P=0.513 |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 43
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 9/50 (18%) 3/50 (6%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 8/40.89 9/40.67 3/39.98 3/43.03 |0/44.24 0/45.74 0/45.30 2/44.45 |
|POLY-3 PERCENT (g) | 19.6% 22.1% 7.5% 7.0% |0.0% 0.0% 0.0% 4.5% |
|TERMINAL (d) | 8/30 (27%) 5/21 (24%) 1/21 (5%) 2/30 (7%) |0/33 (0%) 0/39 (0%) 0/35 (0%) 1/34 (3%) |
|FIRST INCIDENCE | 729 (T) 610 603 539 |--- --- --- 603 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.032N* P=0.253 P=0.226N P=0.095N |P=0.039 * (e) (e) P=0.241 |
|POLY 3 | P=0.032N* P=0.495 P=0.102N P=0.081N |P=0.040 * (e) (e) P=0.238 |
|POLY 1.5 | P=0.036N* P=0.514 P=0.095N P=0.084N |P=0.041 * (e) (e) P=0.238 |
|POLY 6 | P=0.029N* P=0.458 P=0.117N P=0.079N |P=0.040 * (e) (e) P=0.238 |
|LOGISTIC REGRESSION| P=0.036N* P=0.408 P=0.143N P=0.089N |P=0.043 * (e) (e) P=0.240 |
|COCH-ARM / FISHERS | P=0.045N* P=0.500 P=0.100N P=0.100N |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 |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 4/50 (8%) 8/50 (16%) |27/50 (54%) 24/50 (48%) 31/50 (62%) 40/50 (80%) |
|POLY-3 RATE (b) | 3/43.19 5/40.68 4/40.74 8/43.30 |27/47.19 24/47.08 31/47.89 40/48.43 |
|POLY-3 PERCENT (g) | 7.0% 12.3% 9.8% 18.5% |57.2% 51.0% 64.7% 82.6% |
|TERMINAL (d) | 0/30 (0%) 2/21 (10%) 0/21 (0%) 5/30 (17%) |18/33 (55%) 21/39 (54%) 23/35 (66%) 29/34 (85%) |
|FIRST INCIDENCE | 122 464 603 617 |497 396 232 360 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.128 P=0.299 P=0.484 P=0.116 |P<0.001 ** P=0.157N P=0.406 P=0.026 * |
|POLY 3 | P=0.082 P=0.323 P=0.468 P=0.097 |P<0.001 ** P=0.342N P=0.291 P=0.004 ** |
|POLY 1.5 | P=0.080 P=0.343 P=0.486 P=0.100 |P<0.001 ** P=0.340N P=0.285 P=0.004 ** |
|POLY 6 | P=0.084 P=0.290 P=0.441 P=0.094 |P<0.001 ** P=0.354N P=0.296 P=0.004 ** |
|LOGISTIC REGRESSION| P=0.054 P=0.221 P=0.364 P=0.064 |P<0.001 ** P=0.327N P=0.274 P=0.005 ** |
|COCH-ARM / FISHERS | P=0.078 P=0.357 P=0.500 P=0.100 |P<0.001 ** P=0.345N P=0.272 P=0.005 ** |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 44
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Spleen |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/41.06 1/39.60 2/40.41 1/42.51 |1/44.41 1/46.19 0/45.30 0/44.02 |
|POLY-3 PERCENT (g) | 2.4% 2.5% 5.0% 2.4% |2.3% 2.2% 0.0% 0.0% |
|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 | 686 690 373 711 |686 600 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.597N P=0.705 P=0.451 P=0.757N |P=0.313N P=0.747N P=0.495N P=0.505N |
|POLY 3 | P=0.620N P=0.753 P=0.494 P=0.753N |P=0.309N P=0.752N P=0.496N P=0.502N |
|POLY 1.5 | P=0.626N P=0.761 P=0.504 P=0.753N |P=0.308N P=0.756N P=0.498N P=0.501N |
|POLY 6 | P=0.614N P=0.738 P=0.475 P=0.756N |P=0.311N P=0.747N P=0.493N P=0.503N |
|LOGISTIC REGRESSION| P=0.644 P=0.759 P=0.462 P=0.756N |P=0.297N P=0.749 P=0.500N P=0.499N |
|COCH-ARM / FISHERS | P=0.639N P=0.753N P=0.500 P=0.753N |P=0.306N P=0.753N 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 |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 4/50 (8%) 4/50 (8%) |30/50 (60%) 30/50 (60%) 35/50 (70%) 43/50 (86%) |
|POLY-3 RATE (b) | 1/40.89 2/40.19 4/40.66 4/43.17 |30/46.81 30/46.75 35/46.35 43/47.35 |
|POLY-3 PERCENT (g) | 2.5% 5.0% 9.8% 9.3% |64.1% 64.2% 75.5% 90.8% |
|TERMINAL (d) | 1/30 (3%) 1/21 (5%) 1/21 (5%) 2/30 (7%) |23/33 (70%) 26/39 (67%) 29/35 (83%) 33/34 (97%) |
|FIRST INCIDENCE | 729 (T) 462 483 607 |497 572 648 529 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.212 P=0.427 P=0.135 P=0.189 |P<0.001 ** P=0.254N P=0.341 P=0.014 * |
|POLY 3 | P=0.184 P=0.494 P=0.176 P=0.195 |P<0.001 ** P=0.584 P=0.155 P<0.001 ** |
|POLY 1.5 | P=0.176 P=0.504 P=0.182 P=0.192 |P<0.001 ** P=0.580 P=0.165 P<0.001 ** |
|POLY 6 | P=0.195 P=0.474 P=0.162 P=0.196 |P<0.001 ** P=0.586N P=0.150 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.147 P=0.492 P=0.178 P=0.186 |P<0.001 ** P=0.510N P=0.243 P=0.002 ** |
|COCH-ARM / FISHERS | P=0.159 P=0.500 P=0.181 P=0.181 |P<0.001 ** P=0.581N P=0.201 P=0.003 ** |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 45
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 2/49 (4%) 5/48 (10%) |1/49 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/42.59 3/40.07 2/39.67 5/41.61 |1/44.37 1/46.05 1/46.27 0/44.02 |
|POLY-3 PERCENT (g) | 9.4% 7.5% 5.0% 12.0% |2.3% 2.2% 2.2% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/21 (0%) 0/20 (0%) 1/29 (3%) |0/33 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 284 638 368 597 |630 646 232 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.386 P=0.572N P=0.366N P=0.516 |P=0.331N P=0.755N P=0.758N P=0.514N |
|POLY 3 | P=0.331 P=0.533N P=0.370N P=0.485 |P=0.330N P=0.752N P=0.751N P=0.502N |
|POLY 1.5 | P=0.322 P=0.510N P=0.352N P=0.487 |P=0.327N P=0.754N P=0.753N P=0.499N |
|POLY 6 | P=0.344 P=0.571N P=0.403N P=0.480 |P=0.335N P=0.749N P=0.749N P=0.505N |
|LOGISTIC REGRESSION| P=0.254 P=0.540N P=0.432N P=0.424 |P=0.236N P=0.753N P=0.591N P=0.460N |
|COCH-ARM / FISHERS | P=0.307 P=0.500N P=0.349N P=0.474 |P=0.321N P=0.747N P=0.747N P=0.495N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 2/50 (4%) 4/49 (8%) 4/48 (8%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 6/43.28 2/39.97 4/39.48 4/41.49 |0/44.01 0/45.74 0/45.30 0/44.02 |
|POLY-3 PERCENT (g) | 13.9% 5.0% 10.1% 9.6% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/21 (0%) 0/20 (0%) 0/29 (0%) |0/33 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 284 638 603 597 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.473N P=0.190N P=0.439N P=0.362N |(e) (e) (e) (e) |
|POLY 3 | P=0.525N P=0.158N P=0.428N P=0.396N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.539N P=0.142N P=0.400N P=0.390N |(e) (e) (e) (e) |
|POLY 6 | P=0.506N P=0.188N P=0.472N P=0.406N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.583 P=0.159N P=0.409N P=0.455N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.557N P=0.134N P=0.383N P=0.397N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 46
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 4/50 (8%) 7/49 (14%) 5/48 (10%) |1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 5/42.17 4/40.84 7/40.77 5/41.00 |1/44.70 0/45.74 0/45.30 0/44.02 |
|POLY-3 PERCENT (g) | 11.9% 9.8% 17.2% 12.2% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/30 (3%) 1/21 (5%) 0/20 (0%) 2/29 (7%) |0/33 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 528 464 550 634 |497 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.549N P=0.594N P=0.312 P=0.623N |P=0.472N P=0.500N P=0.500N P=0.500N |
|POLY 3 | P=0.526 P=0.520N P=0.354 P=0.613 |P=0.470N P=0.495N P=0.497N P=0.503N |
|POLY 1.5 | P=0.520 P=0.499N P=0.370 P=0.618 |P=0.470N P=0.496N P=0.498N P=0.500N |
|POLY 6 | P=0.533 P=0.560N P=0.327 P=0.602 |P=0.471N P=0.493N P=0.496N P=0.506N |
|LOGISTIC REGRESSION| P=0.483 P=0.517N P=0.357 P=0.613 |P=0.431N P=0.353N P=0.346N P=0.316N |
|COCH-ARM / FISHERS | P=0.502 P=0.500N P=0.365 P=0.603 |P=0.470N P=0.495N P=0.495N P=0.495N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 0/49 (0%) 0/48 (0%) |0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/41.01 3/39.79 0/38.45 0/40.55 |0/44.01 0/45.74 1/46.27 0/44.02 |
|POLY-3 PERCENT (g) | 2.4% 7.5% 0.0% 0.0% |0.0% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 0/30 (0%) 1/21 (5%) 0/20 (0%) 0/29 (0%) |0/33 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 700 679 --- --- |--- --- 232 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.151N P=0.222 P=0.546N P=0.500N |P=0.784N (e) P=0.500 (e) |
|POLY 3 | P=0.157N P=0.294 P=0.513N P=0.502N |P=0.787N (e) P=0.510 (e) |
|POLY 1.5 | P=0.157N P=0.306 P=0.505N P=0.502N |P=0.785N (e) P=0.507 (e) |
|POLY 6 | P=0.160N P=0.272 P=0.527N P=0.505N |P=0.790N (e) P=0.513 (e) |
|LOGISTIC REGRESSION| P=0.156N P=0.284 P=0.517N P=0.503N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.163N P=0.309 P=0.505N P=0.510N |P=0.783N (e) P=0.505 (e) |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 47
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 3/49 (6%) 1/48 (2%) |0/49 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/41.72 2/39.86 3/39.11 1/40.97 |0/44.01 1/46.12 1/45.32 1/44.29 |
|POLY-3 PERCENT (g) | 2.4% 5.0% 7.7% 2.4% |0.0% 2.2% 2.2% 2.3% |
|TERMINAL (d) | 0/30 (0%) 0/21 (0%) 0/20 (0%) 0/29 (0%) |0/33 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 406 630 603 607 |--- 624 725 657 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.476N P=0.478 P=0.274 P=0.747N |P=0.469 P=0.504 P=0.511 P=0.505 |
|POLY 3 | P=0.510N P=0.484 P=0.282 P=0.757 |P=0.480 P=0.509 P=0.506 P=0.501 |
|POLY 1.5 | P=0.514N P=0.497 P=0.294 P=0.757 |P=0.482 P=0.507 P=0.504 P=0.502 |
|POLY 6 | P=0.505N P=0.463 P=0.262 P=0.756 |P=0.477 P=0.514 P=0.509 P=0.501 |
|LOGISTIC REGRESSION| P=0.563N P=0.445 P=0.270 P=0.680 |P=0.500 P=0.521 P=0.511 P=0.522 |
|COCH-ARM / FISHERS | P=0.528N P=0.500 P=0.301 P=0.742 |P=0.487 P=0.505 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 |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 1/49 (2%) 1/48 (2%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/41.03 3/39.86 1/38.75 1/40.66 |0/44.01 0/45.74 0/45.30 0/44.02 |
|POLY-3 PERCENT (g) | 4.9% 7.5% 2.6% 2.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/21 (0%) 0/20 (0%) 0/29 (0%) |0/33 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 700 636 645 702 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.274N P=0.385 P=0.579N P=0.500N |(e) (e) (e) (e) |
|POLY 3 | P=0.302N P=0.487 P=0.520N P=0.503N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.306N P=0.502 P=0.508N P=0.503N |(e) (e) (e) (e) |
|POLY 6 | P=0.299N P=0.460 P=0.541N P=0.507N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.301N P=0.474 P=0.517N P=0.505N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.316N P=0.500 P=0.508N P=0.515N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 48
Statistical Analysis of Non-neoplastic Lesions 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 |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 12/50 (24%) 3/50 (6%) 8/50 (16%) | |
|POLY-3 RATE (b) | 7/43.00 12/43.46 3/39.90 8/43.03 | |
|POLY-3 PERCENT (g) | 16.3% 27.6% 7.5% 18.6% | |
|TERMINAL (d) | 2/30 (7%) 3/21 (14%) 1/21 (5%) 7/30 (23%) | |
|FIRST INCIDENCE | 406 462 603 539 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.384N P=0.109 P=0.252N P=0.514 | |
|POLY 3 | P=0.463N P=0.154 P=0.187N P=0.501 | |
|POLY 1.5 | P=0.458N P=0.165 P=0.167N P=0.512 | |
|POLY 6 | P=0.477N P=0.132 P=0.224N P=0.478 | |
|LOGISTIC REGRESSION| P=0.493N P=0.130 P=0.161N P=0.501 | |
|COCH-ARM / FISHERS | P=0.468N P=0.154 P=0.159N P=0.500 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 8/50 (16%) 3/50 (6%) 5/50 (10%) | |
|POLY-3 RATE (b) | 4/42.02 8/42.52 3/40.29 5/43.37 | |
|POLY-3 PERCENT (g) | 9.5% 18.8% 7.5% 11.5% | |
|TERMINAL (d) | 2/30 (7%) 2/21 (10%) 0/21 (0%) 2/30 (7%) | |
|FIRST INCIDENCE | 472 464 603 602 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.435N P=0.139 P=0.569N P=0.521 | |
|POLY 3 | P=0.477N P=0.180 P=0.523N P=0.520 | |
|POLY 1.5 | P=0.482N P=0.189 P=0.504N P=0.520 | |
|POLY 6 | P=0.473N P=0.161 P=0.555N P=0.517 | |
|LOGISTIC REGRESSION| P=0.547N P=0.146 P=0.507N P=0.488 | |
|COCH-ARM / FISHERS | P=0.501N P=0.178 P=0.500N P=0.500 | |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 49
Statistical Analysis of Non-neoplastic Lesions 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 |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 2/50 (4%) 7/50 (14%) 4/50 (8%) |21/49 (43%) 9/50 (18%) 11/50 (22%) 12/50 (24%) |
|POLY-3 RATE (b) | 7/42.02 2/39.69 7/40.17 4/42.54 |21/44.65 9/46.26 11/45.40 12/45.09 |
|POLY-3 PERCENT (g) | 16.7% 5.0% 17.4% 9.4% |47.0% 19.5% 24.2% 26.6% |
|TERMINAL (d) | 5/30 (17%) 1/21 (5%) 5/21 (24%) 3/30 (10%) |17/33 (52%) 8/39 (21%) 9/35 (26%) 9/34 (27%) |
|FIRST INCIDENCE | 472 665 609 702 |610 572 711 590 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.334N P=0.157N P=0.411 P=0.258N |P=0.229N P=0.002N** P=0.018N* P=0.042N* |
|POLY 3 | P=0.379N P=0.091N P=0.580 P=0.252N |P=0.184N P=0.004N** P=0.018N* P=0.033N* |
|POLY 1.5 | P=0.395N P=0.081N P=0.607 P=0.248N |P=0.180N P=0.004N** P=0.020N* P=0.035N* |
|POLY 6 | P=0.358N P=0.111N P=0.532 P=0.261N |P=0.190N P=0.003N** P=0.015N* P=0.032N* |
|LOGISTIC REGRESSION| P=0.381N P=0.082N P=0.601 P=0.244N |P=0.209N P=0.004N** P=0.014N* P=0.042N* |
|COCH-ARM / FISHERS | P=0.419N P=0.080N P=0.613N P=0.262N |P=0.178N P=0.006N** P=0.022N* P=0.037N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 1/50 (2%) 1/50 (2%) |1/49 (2%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/40.89 3/39.45 1/39.45 1/42.44 |1/44.01 1/45.74 2/45.30 2/44.02 |
|POLY-3 PERCENT (g) | 2.5% 7.6% 2.5% 2.4% |2.3% 2.2% 4.4% 4.5% |
|TERMINAL (d) | 1/30 (3%) 3/21 (14%) 1/21 (5%) 1/30 (3%) |1/33 (3%) 1/39 (3%) 2/35 (6%) 2/34 (6%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |730 (T) 730 (T) 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.376N P=0.186 P=0.681 P=0.762 |P=0.366 P=0.724N P=0.521 P=0.510 |
|POLY 3 | P=0.415N P=0.292 P=0.753 P=0.753N |P=0.376 P=0.752N P=0.510 P=0.500 |
|POLY 1.5 | P=0.418N P=0.305 P=0.760 P=0.753N |P=0.382 P=0.754N P=0.507 P=0.503 |
|POLY 6 | P=0.416N P=0.268 P=0.739 P=0.755N |P=0.369 P=0.748N P=0.515 P=0.497 |
|LOGISTIC REGRESSION| P=0.376N P=0.186 P=0.681 P=0.762 |P=0.366 P=0.724N P=0.521 P=0.510 |
|COCH-ARM / FISHERS | P=0.430N P=0.309 P=0.753N P=0.753N |P=0.388 P=0.747N P=0.508 P=0.508 |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 50
Statistical Analysis of Non-neoplastic Lesions 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 |
| Hydrometra |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |5/49 (10%) 3/50 (6%) 5/50 (10%) 6/50 (12%) |
|POLY-3 RATE (b) | |5/44.18 3/46.05 5/45.32 6/44.29 |
|POLY-3 PERCENT (g) | |11.3% 6.5% 11.0% 13.6% |
|TERMINAL (d) | |4/33 (12%) 2/39 (5%) 4/35 (11%) 4/34 (12%) |
|FIRST INCIDENCE | |685 646 725 674 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.280 P=0.286N P=0.596N P=0.510 |
|POLY 3 | |P=0.297 P=0.334N P=0.614N P=0.502 |
|POLY 1.5 | |P=0.305 P=0.340N P=0.618N P=0.506 |
|POLY 6 | |P=0.285 P=0.324N P=0.608N P=0.497 |
|LOGISTIC REGRESSION| |P=0.285 P=0.334N P=0.597N P=0.492 |
|COCH-ARM / FISHERS | |P=0.316 P=0.346N P=0.617N P=0.514 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Uterus |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/49 (2%) 5/50 (10%) 4/50 (8%) 7/50 (14%) |
|POLY-3 RATE (b) | |1/44.37 5/45.74 4/45.32 7/44.94 |
|POLY-3 PERCENT (g) | |2.3% 10.9% 8.8% 15.6% |
|TERMINAL (d) | |0/33 (0%) 5/39 (13%) 3/35 (9%) 5/34 (15%) |
|FIRST INCIDENCE | |630 730 (T) 725 590 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.049 * P=0.139 P=0.199 P=0.038 * |
|POLY 3 | |P=0.055 P=0.108 P=0.185 P=0.031 * |
|POLY 1.5 | |P=0.057 P=0.107 P=0.184 P=0.032 * |
|POLY 6 | |P=0.054 P=0.110 P=0.187 P=0.030 * |
|LOGISTIC REGRESSION| |P=0.055 P=0.112 P=0.186 P=0.037 * |
|COCH-ARM / FISHERS | |P=0.059 P=0.107 P=0.187 P=0.032 * |
|=================================================================================================================================|
Date: 01/25/01 EXPERIMENT: 05211 TEST: 05 Page 51
Statistical Analysis of Non-neoplastic Lesions 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 |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/49 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | |1/44.37 0/45.74 1/45.30 2/44.02 |
|POLY-3 PERCENT (g) | |2.3% 0.0% 2.2% 4.5% |
|TERMINAL (d) | |0/33 (0%) 0/39 (0%) 1/35 (3%) 2/34 (6%) |
|FIRST INCIDENCE | |630 --- 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.221 P=0.500N P=0.751N P=0.499 |
|POLY 3 | |P=0.229 P=0.494N P=0.756N P=0.497 |
|POLY 1.5 | |P=0.234 P=0.495N P=0.757N P=0.501 |
|POLY 6 | |P=0.223 P=0.492N P=0.754N P=0.492 |
|LOGISTIC REGRESSION| |P=0.235 P=0.482N P=0.754N P=0.507 |
|COCH-ARM / FISHERS | |P=0.238 P=0.495N P=0.747N P=0.508 |
|=================================================================================================================================|
(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).