TDMS Study 05161-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst RIDDELLIINE DATE: 12/15/00
EXPERIMENT: 05161 TEST: 05 TIME: 12:16:38
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-55393 ROUTE: GAVAGE NTP C#: 61358C
PATHOLOGIST: HEATH, JAMES E. CAS: 23246-96-0
------------------------------------------------------------------------------------------------------------------------------------
RATS/FINAL#1_FEMALES
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 003 0 MG/KG/DY
INCLUDE 004 0.01 MG/KG/DY
INCLUDE 005 0.033 MG/KG/DY
INCLUDE 006 0.1 MG/KG/DY
INCLUDE 007 0.33 MG/KG/DY
INCLUDE 008 1.0 MG/KG/DY
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst RIDDELLIINE DATE: 12/15/00
EXPERIMENT: 05161 TEST: 05 TIME: 12:16:38
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-55393 ROUTE: GAVAGE NTP C#: 61358C
PATHOLOGIST: HEATH, JAMES E. CAS: 23246-96-0
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF RIDDELLIINE
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Accessory Adrenal Cortical Nodule
Degeneration Fatty
Hyperplasia Focal
Hypertrophy Focal
Bone Marrow Hyperplasia
Bone: Cranium Osteopetrosis
Bone: Femur Osteopetrosis
Brain Compression
Hydrocephalus
Clitoral Gland Cyst
Hyperplasia
Inflammation Chronic
Heart Cardiomyopathy
Kidney Nephropathy
Kidney: Renal Tubule Hyaline Droplet
Necrosis
Pigmentation
Kidney: Transitional Epithelium Hyperplasia
Liver Angiectasis
Basophilic Focus
Clear Cell Focus
Eosinophilic Focus
Hematopoietic Cell Proliferation
Hemorrhage
Hepatodiaphragmatic Nodule
Infiltration Cellular Mixed Cell
Mixed Cell Focus
Necrosis Focal
Liver: Bile Duct Hyperplasia
Liver: Hepatocyte Cytomegaly
Hyperplasia Regenerative
Vacuolization Cytoplasmic
Liver: Kupffer Cell Pigmentation
Lung Congestion
Edema
Hemorrhage
Infiltration Cellular Histiocyte
Lung: Alveolar Epithelium Hyperplasia
Lymph Node, Mandibular Pigmentation
Lymph Node, Mediastinal Congestion
Hemorrhage
Pigmentation
Lymph Node, Mesenteric Hemorrhage
Pigmentation
Lymph Node: Pancreatic Hemorrhage
Pigmentation
Lymph Node: Renal Pigmentation
Mammary Gland Hyperplasia
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst RIDDELLIINE DATE: 12/15/00
EXPERIMENT: 05161 TEST: 05 TIME: 12:16:38
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-55393 ROUTE: GAVAGE NTP C#: 61358C
PATHOLOGIST: HEATH, JAMES E. CAS: 23246-96-0
Mesentery: Fat Necrosis
Nose: Respiratory Epithelium Hyperplasia
Ovary Cyst
Pancreas Atrophy
Pituitary Gland: Pars Distalis Angiectasis
Cyst
Hyperplasia Focal
Salivary Glands Atrophy
Skeletal Muscle Hemorrhage
Spleen Congestion
Hematopoietic Cell Proliferation
Pigmentation
Stomach, Forestomach: Epithelium Hyperplasia
Stomach, Glandular Erosion
Ulcer
Thymus Hemorrhage
Thyroid Gland Ultimobranchial Cyst
Thyroid Gland: C-Cell Hyperplasia
Uterus Hydrometra
Hyperplasia Cystic
===============================================================
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Accessory Adrenal Cortical Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/50 (12%) 2/50 (4%) 6/50 (12%) 4/50 (8%) 2/50 (4%) 7/50 (14%) |
|POLY-3 RATE (b) | 6/44.74 2/40.06 6/42.82 4/41.17 2/41.99 7/21.99 |
|POLY-3 PERCENT (g) | 13.4% 5.0% 14.0% 9.7% 4.8% 31.8% |
|TERMINAL (d) | 2/33 (6%) 1/22 (5%) 3/28 (11%) 2/22 (9%) 2/29 (7%) 0/0 (0%) |
|FIRST INCIDENCE | 437 698 571 646 729 (T) 426 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.229N P=0.560 P=0.512N P=0.169N P=0.005 ** |
|POLY 3 | P=0.085 P=0.170N P=0.590 P=0.422N P=0.153N P=0.092 |
|POLY 1.5 | P=0.117 P=0.153N P=0.604 P=0.404N P=0.143N P=0.228 |
|POLY 6 | P=0.107 P=0.200N P=0.568 P=0.452N P=0.172N P=0.023 * |
|LOGISTIC REGRESSION| P=0.338 P=0.117N P=0.616N P=0.348N P=0.137N P=0.470N |
|COCH-ARM / FISHERS | P=0.228 P=0.134N P=0.620N P=0.370N P=0.134N P=0.500 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Degeneration Fatty |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/50 (18%) 9/50 (18%) 12/50 (24%) 8/50 (16%) 13/50 (26%) 3/50 (6%) |
|POLY-3 RATE (b) | 9/43.20 9/40.47 12/43.77 8/41.95 13/44.52 3/18.97 |
|POLY-3 PERCENT (g) | 20.8% 22.2% 27.4% 19.1% 29.2% 15.8% |
|TERMINAL (d) | 8/33 (24%) 7/22 (32%) 7/28 (25%) 4/22 (18%) 7/29 (24%) 0/0 (0%) |
|FIRST INCIDENCE | 640 573 437 451 451 527 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.025 * P=0.272 P=0.214 P=0.426 P=0.172 P=0.002 ** |
|POLY 3 | P=0.519 P=0.544 P=0.320 P=0.527N P=0.254 P=0.461N |
|POLY 1.5 | P=0.249N P=0.573 P=0.321 P=0.518N P=0.251 P=0.220N |
|POLY 6 | P=0.246 P=0.491 P=0.309 P=0.550N P=0.247 P=0.443 |
|LOGISTIC REGRESSION| P=0.347N P=0.453 P=0.300 P=0.543N P=0.232 P=0.304 |
|COCH-ARM / FISHERS | P=0.033N* P=0.602N P=0.312 P=0.500N P=0.235 P=0.061N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.87 0/39.94 3/43.16 1/40.87 0/41.99 0/17.60 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 7.0% 2.5% 0.0% 0.0% |
|TERMINAL (d) | 0/33 (0%) 0/22 (0%) 0/28 (0%) 0/22 (0%) 0/29 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 437 707 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.496N (e) P=0.124 P=0.455 (e) (e) |
|POLY 3 | P=0.299N (e) P=0.119 P=0.490 (e) (e) |
|POLY 1.5 | P=0.288N (e) P=0.120 P=0.494 (e) (e) |
|POLY 6 | P=0.355N (e) P=0.117 P=0.484 (e) (e) |
|LOGISTIC REGRESSION| P=0.135N (e) P=0.090 P=0.487 (e) (e) |
|COCH-ARM / FISHERS | P=0.263N (e) P=0.121 P=0.500 (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 5/50 (10%) 6/50 (12%) 4/50 (8%) 9/50 (18%) 3/50 (6%) |
|POLY-3 RATE (b) | 4/43.99 5/40.06 6/42.38 4/41.21 9/42.53 3/19.64 |
|POLY-3 PERCENT (g) | 9.1% 12.5% 14.2% 9.7% 21.2% 15.3% |
|TERMINAL (d) | 2/33 (6%) 4/22 (18%) 5/28 (18%) 2/22 (9%) 7/29 (24%) 0/0 (0%) |
|FIRST INCIDENCE | 437 698 444 668 630 407 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** P=0.315 P=0.302 P=0.513 P=0.088 P=0.148 |
|POLY 3 | P=0.166 P=0.441 P=0.345 P=0.607 P=0.100 P=0.399 |
|POLY 1.5 | P=0.401 P=0.468 P=0.359 P=0.619 P=0.108 P=0.584 |
|POLY 6 | P=0.051 P=0.400 P=0.321 P=0.588 P=0.087 P=0.210 |
|LOGISTIC REGRESSION| P=0.388 P=0.487 P=0.374 P=0.638N P=0.116 P=0.285N |
|COCH-ARM / FISHERS | P=0.363N P=0.500 P=0.370 P=0.643N P=0.117 P=0.500N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/50 (18%) 5/50 (10%) 7/50 (14%) 2/50 (4%) 4/50 (8%) 2/50 (4%) |
|POLY-3 RATE (b) | 9/43.90 5/40.30 7/42.69 2/41.55 4/42.52 2/18.45 |
|POLY-3 PERCENT (g) | 20.5% 12.4% 16.4% 4.8% 9.4% 10.8% |
|TERMINAL (d) | 7/33 (21%) 3/22 (14%) 4/28 (14%) 1/22 (5%) 1/29 (3%) 0/0 (0%) |
|FIRST INCIDENCE | 483 643 532 451 671 528 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.369 P=0.416N P=0.498N P=0.079N P=0.170N P=0.157 |
|POLY 3 | P=0.203N P=0.240N P=0.415N P=0.030N* P=0.125N P=0.319N |
|POLY 1.5 | P=0.136N P=0.218N P=0.403N P=0.029N* P=0.120N P=0.123N |
|POLY 6 | P=0.231N P=0.281N P=0.438N P=0.035N* P=0.137N P=0.588 |
|LOGISTIC REGRESSION| P=0.188N P=0.230N P=0.399N P=0.027N* P=0.119N P=0.528N |
|COCH-ARM / FISHERS | P=0.051N P=0.194N P=0.393N P=0.026N* P=0.117N P=0.026N* |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 3/49 (6%) 0/50 (0%) 3/50 (6%) 3/50 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/42.87 3/40.69 0/41.60 3/41.16 3/42.15 0/17.60 |
|POLY-3 PERCENT (g) | 2.3% 7.4% 0.0% 7.3% 7.1% 0.0% |
|TERMINAL (d) | 1/33 (3%) 1/22 (5%) 0/28 (0%) 1/22 (5%) 2/29 (7%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 407 --- 651 686 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.615 P=0.239 P=0.533N P=0.219 P=0.263 P=1.000N |
|POLY 3 | P=0.535 P=0.286 P=0.506N P=0.290 P=0.299 P=0.650N |
|POLY 1.5 | P=0.431N P=0.293 P=0.503N P=0.295 P=0.304 P=0.586N |
|POLY 6 | P=0.314 P=0.272 P=0.513N P=0.281 P=0.288 P=0.716N |
|LOGISTIC REGRESSION| P=0.307N P=0.329 (e) P=0.284 P=0.275 (e) |
|COCH-ARM / FISHERS | P=0.233N P=0.301 P=0.500N P=0.309 P=0.309 P=0.500N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/50 (12%) 3/50 (6%) 8/50 (16%) 7/50 (14%) 10/50 (20%) 32/50 (64%) |
|POLY-3 RATE (b) | 6/45.97 3/41.67 8/43.74 7/42.19 10/44.09 32/38.51 |
|POLY-3 PERCENT (g) | 13.1% 7.2% 18.3% 16.6% 22.7% 83.1% |
|TERMINAL (d) | 1/33 (3%) 0/22 (0%) 3/28 (11%) 3/22 (14%) 4/29 (14%) 0/0 (0%) |
|FIRST INCIDENCE | 393 407 437 307 524 350 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.297N P=0.352 P=0.361 P=0.191 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.292N P=0.348 P=0.434 P=0.178 P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.271N P=0.364 P=0.457 P=0.190 P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.325N P=0.328 P=0.401 P=0.165 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.152N P=0.376 P=0.603 P=0.175 P=0.046 * |
|COCH-ARM / FISHERS | P<0.001 ** P=0.243N P=0.387 P=0.500 P=0.207 P<0.001 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Bone: Cranium |
| Osteopetrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/50 (20%) 10/50 (20%) 12/50 (24%) 6/50 (12%) 7/50 (14%) 0/50 (0%) |
|POLY-3 RATE (b) | 10/43.13 10/41.68 12/42.66 6/40.84 7/42.15 0/17.60 |
|POLY-3 PERCENT (g) | 23.2% 24.0% 28.1% 14.7% 16.6% 0.0% |
|TERMINAL (d) | 7/33 (21%) 5/22 (23%) 8/28 (29%) 5/22 (23%) 6/29 (21%) 0/0 (0%) |
|FIRST INCIDENCE | 693 573 616 715 686 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.211N P=0.304 P=0.270 P=0.502N P=0.412N P=1.000N |
|POLY 3 | P=0.030N* P=0.567 P=0.390 P=0.237N P=0.312N P=0.057N |
|POLY 1.5 | P=0.007N** P=0.583 P=0.400 P=0.226N P=0.301N P=0.010N* |
|POLY 6 | P=0.104N P=0.535 P=0.369 P=0.262N P=0.339N P=0.270N |
|LOGISTIC REGRESSION| P=0.058N P=0.525 P=0.339 P=0.353N P=0.381N P=0.764N |
|COCH-ARM / FISHERS | P<0.001N** P=0.598N P=0.405 P=0.207N P=0.298N P<0.001N** |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Bone: Femur |
| Osteopetrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/50 (24%) 7/50 (14%) 9/50 (18%) 15/50 (30%) 14/50 (28%) 9/50 (18%) |
|POLY-3 RATE (b) | 12/44.10 7/40.61 9/42.66 15/42.67 14/43.45 9/23.00 |
|POLY-3 PERCENT (g) | 27.2% 17.2% 21.1% 35.2% 32.2% 39.1% |
|TERMINAL (d) | 8/33 (24%) 3/22 (14%) 5/28 (18%) 9/22 (41%) 9/29 (31%) 0/0 (0%) |
|FIRST INCIDENCE | 498 600 616 552 587 461 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.399N P=0.445N P=0.097 P=0.303 P<0.001 ** |
|POLY 3 | P=0.073 P=0.199N P=0.339N P=0.284 P=0.389 P=0.250 |
|POLY 1.5 | P=0.239 P=0.177N P=0.324N P=0.296 P=0.403 P=0.528 |
|POLY 6 | P=0.018 * P=0.242N P=0.366N P=0.260 P=0.363 P=0.059 |
|LOGISTIC REGRESSION| P=0.076 P=0.194N P=0.329N P=0.288 P=0.392 P=0.415 |
|COCH-ARM / FISHERS | P=0.441N P=0.154N P=0.312N P=0.326 P=0.410 P=0.312N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Brain |
| Compression |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/50 (18%) 11/50 (22%) 15/50 (30%) 6/50 (12%) 12/50 (24%) 2/50 (4%) |
|POLY-3 RATE (b) | 9/43.90 11/41.42 15/43.64 6/41.57 12/42.80 2/18.40 |
|POLY-3 PERCENT (g) | 20.5% 26.6% 34.4% 14.4% 28.0% 10.9% |
|TERMINAL (d) | 4/33 (12%) 7/22 (32%) 8/28 (29%) 2/22 (9%) 9/29 (31%) 0/0 (0%) |
|FIRST INCIDENCE | 545 520 518 664 570 552 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.129 P=0.171 P=0.081 P=0.497N P=0.225 P=0.067 |
|POLY 3 | P=0.286N P=0.342 P=0.109 P=0.326N P=0.284 P=0.320N |
|POLY 1.5 | P=0.081N P=0.371 P=0.116 P=0.313N P=0.301 P=0.124N |
|POLY 6 | P=0.485 P=0.293 P=0.096 P=0.350N P=0.251 P=0.584 |
|LOGISTIC REGRESSION| P=0.246N P=0.357 P=0.114 P=0.313N P=0.288 P=0.646N |
|COCH-ARM / FISHERS | P=0.006N** P=0.402 P=0.121 P=0.288N P=0.312 P=0.026N* |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Brain |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/42.87 1/40.38 0/41.60 3/41.98 0/41.99 0/17.60 |
|POLY-3 PERCENT (g) | 2.3% 2.5% 0.0% 7.2% 0.0% 0.0% |
|TERMINAL (d) | 1/33 (3%) 0/22 (0%) 0/28 (0%) 0/22 (0%) 0/29 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 600 --- 561 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.600N P=0.713 P=0.533N P=0.274 P=0.526N P=1.000N |
|POLY 3 | P=0.311N P=0.748 P=0.506N P=0.297 P=0.504N P=0.650N |
|POLY 1.5 | P=0.281N P=0.754 P=0.503N P=0.299 P=0.501N P=0.586N |
|POLY 6 | P=0.390N P=0.736 P=0.513N P=0.292 P=0.511N P=0.716N |
|LOGISTIC REGRESSION| P=0.158N P=0.759N (e) P=0.325 (e) (e) |
|COCH-ARM / FISHERS | P=0.230N P=0.753N P=0.500N P=0.309 P=0.500N P=0.500N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Brain |
| Hydrocephalus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 8/50 (16%) 1/50 (2%) 10/50 (20%) 3/50 (6%) |
|POLY-3 RATE (b) | 3/43.63 4/39.94 8/42.32 1/40.98 10/42.80 3/18.82 |
|POLY-3 PERCENT (g) | 6.9% 10.0% 18.9% 2.4% 23.4% 15.9% |
|TERMINAL (d) | 0/33 (0%) 4/22 (18%) 4/28 (14%) 0/22 (0%) 7/29 (24%) 0/0 (0%) |
|FIRST INCIDENCE | 545 729 (T) 591 678 570 552 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.330 P=0.076 P=0.374N P=0.028 * P=0.004 ** |
|POLY 3 | P=0.078 P=0.452 P=0.087 P=0.328N P=0.030 * P=0.289 |
|POLY 1.5 | P=0.266 P=0.475 P=0.093 P=0.320N P=0.033 * P=0.452 |
|POLY 6 | P=0.015 * P=0.414 P=0.077 P=0.342N P=0.025 * P=0.148 |
|LOGISTIC REGRESSION| P=0.045 * P=0.466 P=0.097 P=0.294N P=0.036 * P=0.374 |
|COCH-ARM / FISHERS | P=0.482N P=0.500 P=0.100 P=0.309N P=0.036 * P=0.661N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/49 (10%) 2/49 (4%) 3/49 (6%) 1/48 (2%) 4/49 (8%) 3/50 (6%) |
|POLY-3 RATE (b) | 5/42.09 2/39.53 3/41.12 1/40.25 4/41.85 3/19.08 |
|POLY-3 PERCENT (g) | 11.9% 5.1% 7.3% 2.5% 9.6% 15.7% |
|TERMINAL (d) | 4/33 (12%) 2/22 (9%) 3/28 (11%) 0/22 (0%) 2/29 (7%) 0/0 (0%) |
|FIRST INCIDENCE | 693 729 (T) 729 (T) 646 658 552 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.393N P=0.448N P=0.189N P=0.581N P<0.001 ** |
|POLY 3 | P=0.226 P=0.241N P=0.368N P=0.111N P=0.504N P=0.499 |
|POLY 1.5 | P=0.341 P=0.229N P=0.361N P=0.109N P=0.499N P=0.585N |
|POLY 6 | P=0.213 P=0.265N P=0.386N P=0.116N P=0.518N P=0.266 |
|LOGISTIC REGRESSION| P=0.063 P=0.314N P=0.413N P=0.117N P=0.526N P=0.227 |
|COCH-ARM / FISHERS | P=0.573 P=0.218N P=0.357N P=0.107N P=0.500N P=0.346N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/49 (6%) 5/49 (10%) 4/49 (8%) 2/48 (4%) 2/49 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/41.95 5/39.88 4/41.43 2/40.53 2/42.02 0/17.60 |
|POLY-3 PERCENT (g) | 7.2% 12.5% 9.7% 4.9% 4.8% 0.0% |
|TERMINAL (d) | 3/33 (9%) 3/22 (14%) 3/28 (11%) 0/22 (0%) 0/29 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 650 647 638 602 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.350N P=0.182 P=0.423 P=0.607N P=0.553N P=1.000N |
|POLY 3 | P=0.119N P=0.328 P=0.493 P=0.516N P=0.499N P=0.336N |
|POLY 1.5 | P=0.076N P=0.342 P=0.498 P=0.514N P=0.497N P=0.215N |
|POLY 6 | P=0.177N P=0.303 P=0.481 P=0.524N P=0.507N P=0.511N |
|LOGISTIC REGRESSION| P=0.117N P=0.268 P=0.465 P=0.519N P=0.503N (e) |
|COCH-ARM / FISHERS | P=0.031N* P=0.357 P=0.500 P=0.510N P=0.500N P=0.117N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/49 (8%) 5/49 (10%) 4/49 (8%) 3/48 (6%) 4/49 (8%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/42.79 5/39.82 4/41.40 3/40.76 4/42.59 0/17.60 |
|POLY-3 PERCENT (g) | 9.4% 12.6% 9.7% 7.4% 9.4% 0.0% |
|TERMINAL (d) | 3/33 (9%) 4/22 (18%) 3/28 (11%) 0/22 (0%) 1/29 (3%) 0/0 (0%) |
|FIRST INCIDENCE | 393 650 654 646 576 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.483N P=0.296 P=0.568 P=0.602N P=0.599 P=0.508N |
|POLY 3 | P=0.227N P=0.455 P=0.626 P=0.527N P=0.641 P=0.262N |
|POLY 1.5 | P=0.115N P=0.475 P=0.634 P=0.523N P=0.643 P=0.141N |
|POLY 6 | P=0.410N P=0.422 P=0.611 P=0.536N P=0.635 P=0.460N |
|LOGISTIC REGRESSION| P=0.060N P=0.491 P=0.643N P=0.494N P=0.629 P=0.072N |
|COCH-ARM / FISHERS | P=0.033N* P=0.500 P=0.643N P=0.512N P=0.643N P=0.056N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Esophagus |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/48 (0%) 2/50 (4%) 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/40.87 2/40.76 0/40.38 0/40.79 0/41.25 0/17.60 |
|POLY-3 PERCENT (g) | 0.0% 4.9% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/31 (0%) 0/22 (0%) 0/27 (0%) 0/22 (0%) 0/29 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 612 --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.731N P=0.232 (e) (e) (e) (e) |
|POLY 3 | P=0.335N P=0.236 (e) (e) (e) (e) |
|POLY 1.5 | P=0.366N P=0.241 (e) (e) (e) (e) |
|POLY 6 | P=0.372N P=0.227 (e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.294N P=0.263 (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.389N P=0.258 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/50 (24%) 15/50 (30%) 8/50 (16%) 13/50 (26%) 8/50 (16%) 6/50 (12%) |
|POLY-3 RATE (b) | 12/43.15 15/42.04 8/42.59 13/42.47 8/42.25 6/20.84 |
|POLY-3 PERCENT (g) | 27.8% 35.7% 18.8% 30.6% 18.9% 28.8% |
|TERMINAL (d) | 11/33 (33%) 8/22 (36%) 6/28 (21%) 7/22 (32%) 7/29 (24%) 0/0 (0%) |
|FIRST INCIDENCE | 654 519 572 561 658 440 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.076 P=0.346N P=0.188 P=0.321N P<0.001 ** |
|POLY 3 | P=0.337N P=0.290 P=0.230N P=0.481 P=0.236N P=0.578 |
|POLY 1.5 | P=0.178N P=0.308 P=0.226N P=0.482 P=0.228N P=0.338N |
|POLY 6 | P=0.484N P=0.257 P=0.246N P=0.472 P=0.260N P=0.229 |
|LOGISTIC REGRESSION| P=0.540 P=0.232 P=0.264N P=0.430 P=0.300N P=0.176 |
|COCH-ARM / FISHERS | P=0.035N* P=0.326 P=0.227N P=0.500 P=0.227N P=0.096N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 32/50 (64%) 32/50 (64%) 33/50 (66%) 30/50 (60%) 38/50 (76%) 28/50 (56%) |
|POLY-3 RATE (b) | 32/46.45 32/44.61 33/46.14 30/42.81 38/47.48 28/34.74 |
|POLY-3 PERCENT (g) | 68.9% 71.7% 71.5% 70.1% 80.0% 80.6% |
|TERMINAL (d) | 24/33 (73%) 19/22 (86%) 21/28 (75%) 20/22 (91%) 24/29 (83%) 0/0 (0%) |
|FIRST INCIDENCE | 393 407 437 561 463 350 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.055 P=0.234 P=0.096 P=0.072 P<0.001 ** |
|POLY 3 | P=0.089 P=0.471 P=0.479 P=0.545 P=0.147 P=0.153 |
|POLY 1.5 | P=0.334 P=0.526 P=0.495 P=0.565N P=0.145 P=0.461 |
|POLY 6 | P=0.013 * P=0.373 P=0.443 P=0.442 P=0.142 P=0.019 * |
|LOGISTIC REGRESSION| P=0.028 * P=0.507 P=0.482 P=0.508N P=0.134 P=0.245 |
|COCH-ARM / FISHERS | P=0.239N P=0.582N P=0.500 P=0.418N P=0.138 P=0.270N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/42.87 1/40.13 2/42.39 0/40.79 2/43.49 1/18.44 |
|POLY-3 PERCENT (g) | 0.0% 2.5% 4.7% 0.0% 4.6% 5.4% |
|TERMINAL (d) | 0/33 (0%) 0/22 (0%) 1/28 (4%) 0/22 (0%) 0/29 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 679 437 --- 451 400 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.328 P=0.457 P=0.224 (e) P=0.247 P=0.492 |
|POLY 3 | P=0.225 P=0.487 P=0.234 (e) P=0.240 P=0.354 |
|POLY 1.5 | P=0.341 P=0.493 P=0.237 (e) P=0.241 P=0.417 |
|POLY 6 | P=0.189 P=0.476 P=0.228 (e) P=0.236 P=0.288 |
|LOGISTIC REGRESSION| P=0.328N P=0.498 P=0.217 (e) P=0.053 P=0.894 |
|COCH-ARM / FISHERS | P=0.533 P=0.500 P=0.247 (e) P=0.247 P=0.500 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 33/50 (66%) 23/50 (46%) 30/50 (60%) 26/50 (52%) 26/50 (52%) 9/50 (18%) |
|POLY-3 RATE (b) | 33/44.89 23/41.49 30/43.44 26/43.64 26/43.29 9/22.68 |
|POLY-3 PERCENT (g) | 73.5% 55.4% 69.1% 59.6% 60.1% 39.7% |
|TERMINAL (d) | 28/33 (85%) 19/22 (86%) 23/28 (82%) 17/22 (77%) 22/29 (76%) 0/0 (0%) |
|FIRST INCIDENCE | 393 407 532 307 587 400 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.589 P=0.443 P=0.353 P=0.289N P<0.001 ** |
|POLY 3 | P=0.023N* P=0.048N* P=0.403N P=0.108N P=0.115N P=0.004N** |
|POLY 1.5 | P<0.001N** P=0.039N* P=0.372N P=0.115N P=0.110N P<0.001N** |
|POLY 6 | P=0.219N P=0.074N P=0.461N P=0.099N P=0.134N P=0.240N |
|LOGISTIC REGRESSION| P=0.518 P=0.072N P=0.424N P=0.145N P=0.126N P=0.307N |
|COCH-ARM / FISHERS | P<0.001N** P=0.035N* P=0.339N P=0.111N P=0.111N P<0.001N** |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 6/50 (12%) |
|POLY-3 RATE (b) | 0/42.87 0/39.94 0/41.60 1/40.87 1/42.62 6/21.40 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.5% 2.4% 28.0% |
|TERMINAL (d) | 0/33 (0%) 0/22 (0%) 0/28 (0%) 0/22 (0%) 0/29 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 707 524 405 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.455 P=0.513 P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) P=0.490 P=0.499 P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P=0.494 P=0.500 P=0.004 ** |
|POLY 6 | P<0.001 ** (e) (e) P=0.484 P=0.494 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.007 ** (e) (e) P=0.487 P=0.416 P=0.099 |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.500 P=0.500 P=0.013 * |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 38/50 (76%) 28/50 (56%) 31/50 (62%) 31/50 (62%) 41/50 (82%) 23/50 (46%) |
|POLY-3 RATE (b) | 38/46.67 28/41.67 31/44.23 31/44.46 41/47.58 23/31.54 |
|POLY-3 PERCENT (g) | 81.4% 67.2% 70.1% 69.7% 86.2% 72.9% |
|TERMINAL (d) | 29/33 (88%) 21/22 (96%) 21/28 (75%) 18/22 (82%) 26/29 (90%) 0/0 (0%) |
|FIRST INCIDENCE | 393 573 532 307 451 400 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.486 P=0.405N P=0.322 P=0.132 P<0.001 ** |
|POLY 3 | P=0.336 P=0.077N P=0.136N P=0.129N P=0.354 P=0.241N |
|POLY 1.5 | P=0.330N P=0.047N* P=0.115N P=0.121N P=0.339 P=0.034N* |
|POLY 6 | P=0.066 P=0.165N P=0.178N P=0.145N P=0.363 P=0.482 |
|LOGISTIC REGRESSION| P=0.019 * P=0.050N P=0.102N P=0.128N P=0.312 P=0.561N |
|COCH-ARM / FISHERS | P=0.024N* P=0.028N* P=0.097N P=0.097N P=0.312 P=0.002N** |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 5/50 (10%) |
|POLY-3 RATE (b) | 1/42.87 1/39.94 1/41.91 1/41.33 0/41.99 5/20.21 |
|POLY-3 PERCENT (g) | 2.3% 2.5% 2.4% 2.4% 0.0% 24.7% |
|TERMINAL (d) | 1/33 (3%) 1/22 (5%) 0/28 (0%) 0/22 (0%) 0/29 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 647 561 --- 516 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.669 P=0.742 P=0.719 P=0.526N P<0.001 ** |
|POLY 3 | P=0.004 ** P=0.745 P=0.756 P=0.753 P=0.504N P=0.015 * |
|POLY 1.5 | P=0.004 ** P=0.752 P=0.759 P=0.755 P=0.501N P=0.037 * |
|POLY 6 | P=0.022 * P=0.731 P=0.750 P=0.747 P=0.511N P=0.005 ** |
|LOGISTIC REGRESSION| P=0.021 * P=0.669 P=0.761 P=0.753N (e) P=0.027 * |
|COCH-ARM / FISHERS | P=0.007 ** P=0.753N P=0.753N P=0.753N P=0.500N P=0.102 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 0/50 (0%) 5/50 (10%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/43.56 1/39.94 2/42.07 0/40.79 5/42.80 1/17.83 |
|POLY-3 PERCENT (g) | 4.6% 2.5% 4.8% 0.0% 11.7% 5.6% |
|TERMINAL (d) | 0/33 (0%) 1/22 (5%) 1/28 (4%) 0/22 (0%) 2/29 (7%) 0/0 (0%) |
|FIRST INCIDENCE | 611 729 (T) 591 --- 630 668 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.004 ** P=0.581N P=0.661 P=0.246N P=0.197 P=0.159 |
|POLY 3 | P=0.123 P=0.530N P=0.682 P=0.252N P=0.208 P=0.657 |
|POLY 1.5 | P=0.302 P=0.516N P=0.689 P=0.246N P=0.214 P=0.650N |
|POLY 6 | P=0.039 * P=0.555N P=0.668 P=0.263N P=0.196 P=0.490 |
|LOGISTIC REGRESSION| P=0.370 P=0.493N P=0.694N P=0.217N P=0.216 P=0.844 |
|COCH-ARM / FISHERS | P=0.605 P=0.500N P=0.691N P=0.247N P=0.218 P=0.500N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 45/50 (90%) 46/50 (92%) 44/50 (88%) 42/50 (84%) 40/50 (80%) 20/50 (40%) |
|POLY-3 RATE (b) | 45/48.80 46/47.73 44/48.32 42/46.37 40/46.94 20/30.51 |
|POLY-3 PERCENT (g) | 92.2% 96.4% 91.1% 90.6% 85.2% 65.6% |
|TERMINAL (d) | 31/33 (94%) 22/22 (100%) 26/28 (93%) 22/22 (100%) 26/29 (90%) 0/0 (0%) |
|FIRST INCIDENCE | 437 407 444 252 451 407 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.020 * P=0.284 P=0.083 P=0.512N P<0.001 ** |
|POLY 3 | P<0.001N** P=0.312 P=0.568N P=0.536N P=0.205N P<0.001N** |
|POLY 1.5 | P<0.001N** P=0.387 P=0.534N P=0.411N P=0.159N P<0.001N** |
|POLY 6 | P=0.010N* P=0.227 P=0.613N P=0.639 P=0.298N P=0.102N |
|LOGISTIC REGRESSION| P<0.001N** P=0.426 P=0.504N P=0.358N P=0.116N P=0.002N** |
|COCH-ARM / FISHERS | P<0.001N** P=0.500 P=0.500N P=0.277N P=0.131N P<0.001N** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/50 (18%) 8/50 (16%) 9/50 (18%) 13/50 (26%) 22/50 (44%) 2/50 (4%) |
|POLY-3 RATE (b) | 9/43.47 8/40.81 9/42.52 13/41.33 22/43.03 2/19.24 |
|POLY-3 PERCENT (g) | 20.7% 19.6% 21.2% 31.5% 51.1% 10.4% |
|TERMINAL (d) | 7/33 (21%) 6/22 (27%) 7/28 (25%) 10/22 (46%) 19/29 (66%) 0/0 (0%) |
|FIRST INCIDENCE | 640 600 572 646 576 393 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.413 P=0.477 P=0.051 P<0.001 ** P=0.281 |
|POLY 3 | P=0.103 P=0.558N P=0.584 P=0.187 P=0.002 ** P=0.291N |
|POLY 1.5 | P=0.488N P=0.530N P=0.596 P=0.203 P=0.003 ** P=0.113N |
|POLY 6 | P<0.001 ** P=0.608N P=0.557 P=0.159 P<0.001 ** P=0.609N |
|LOGISTIC REGRESSION| P=0.074 P=0.586N P=0.570 P=0.153 P=0.002 ** P=0.208N |
|COCH-ARM / FISHERS | P=0.047N* P=0.500N P=0.602N P=0.235 P=0.004 ** P=0.026N* |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 6/50 (12%) 4/50 (8%) 12/50 (24%) 13/50 (26%) |
|POLY-3 RATE (b) | 1/42.87 2/39.94 6/42.86 4/41.06 12/42.82 13/25.89 |
|POLY-3 PERCENT (g) | 2.3% 5.0% 14.0% 9.7% 28.0% 50.2% |
|TERMINAL (d) | 1/33 (3%) 2/22 (9%) 3/28 (11%) 2/22 (9%) 9/29 (31%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 571 678 587 393 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.359 P=0.046 * P=0.099 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.475 P=0.055 P=0.165 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.487 P=0.056 P=0.169 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.455 P=0.052 P=0.156 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.359 P=0.059 P=0.146 P<0.001 ** P=0.013 * |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.056 P=0.181 P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 4/50 (8%) 0/50 (0%) 1/50 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 2/43.66 1/40.77 4/42.65 0/40.79 1/41.99 3/19.82 |
|POLY-3 PERCENT (g) | 4.6% 2.5% 9.4% 0.0% 2.4% 15.1% |
|TERMINAL (d) | 1/33 (3%) 0/22 (0%) 1/28 (4%) 0/22 (0%) 1/29 (3%) 0/0 (0%) |
|FIRST INCIDENCE | 437 407 591 --- 729 (T) 447 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.042 * P=0.549N P=0.311 P=0.289N P=0.528N P=0.219 |
|POLY 3 | P=0.217 P=0.524N P=0.326 P=0.252N P=0.514N P=0.205 |
|POLY 1.5 | P=0.247 P=0.512N P=0.332 P=0.247N P=0.506N P=0.322 |
|POLY 6 | P=0.327 P=0.544N P=0.317 P=0.261N P=0.527N P=0.108 |
|LOGISTIC REGRESSION| P=0.439N P=0.434N P=0.334 P=0.187N P=0.515N P=0.433N |
|COCH-ARM / FISHERS | P=0.353 P=0.500N P=0.339 P=0.247N P=0.500N P=0.500 |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) 7/50 (14%) |
|POLY-3 RATE (b) | 0/42.87 0/39.94 2/42.28 0/40.79 1/42.62 7/22.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.7% 0.0% 2.4% 31.6% |
|TERMINAL (d) | 0/33 (0%) 0/22 (0%) 0/28 (0%) 0/22 (0%) 0/29 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 617 --- 524 393 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.226 (e) P=0.513 P<0.001 ** |
|POLY 3 | P<0.001 ** (e) P=0.234 (e) P=0.499 P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) P=0.236 (e) P=0.500 P<0.001 ** |
|POLY 6 | P<0.001 ** (e) P=0.229 (e) P=0.494 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.010 * (e) P=0.236 (e) P=0.416 P=0.075 |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.247 (e) P=0.500 P=0.006 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 13/50 (26%) 8/50 (16%) 9/50 (18%) 6/50 (12%) 4/50 (8%) 5/50 (10%) |
|POLY-3 RATE (b) | 13/44.34 8/41.50 9/43.56 6/41.12 4/42.44 5/21.21 |
|POLY-3 PERCENT (g) | 29.3% 19.3% 20.7% 14.6% 9.4% 23.6% |
|TERMINAL (d) | 9/33 (27%) 4/22 (18%) 6/28 (21%) 4/22 (18%) 2/29 (7%) 0/0 (0%) |
|FIRST INCIDENCE | 468 573 444 660 657 352 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.083 P=0.406N P=0.344N P=0.217N P=0.034N* P=0.046 * |
|POLY 3 | P=0.231N P=0.201N P=0.244N P=0.082N P=0.017N* P=0.431N |
|POLY 1.5 | P=0.162N P=0.183N P=0.235N P=0.074N P=0.015N* P=0.170N |
|POLY 6 | P=0.245N P=0.237N P=0.269N P=0.098N P=0.021N* P=0.388 |
|LOGISTIC REGRESSION| P=0.095N P=0.179N P=0.233N P=0.075N P=0.017N* P=0.117N |
|COCH-ARM / FISHERS | P=0.060N P=0.163N P=0.235N P=0.062N P=0.016N* P=0.033N* |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/50 (18%) 7/50 (14%) 9/50 (18%) 8/50 (16%) 15/50 (30%) 3/50 (6%) |
|POLY-3 RATE (b) | 9/42.91 7/41.10 9/42.34 8/43.14 15/42.64 3/19.63 |
|POLY-3 PERCENT (g) | 21.0% 17.0% 21.3% 18.5% 35.2% 15.3% |
|TERMINAL (d) | 8/33 (24%) 3/22 (14%) 6/28 (21%) 4/22 (18%) 13/29 (45%) 0/0 (0%) |
|FIRST INCIDENCE | 720 520 647 252 570 393 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** P=0.533 P=0.468 P=0.429 P=0.058 P=0.023 * |
|POLY 3 | P=0.247 P=0.428N P=0.592 P=0.495N P=0.107 P=0.435N |
|POLY 1.5 | P=0.465N P=0.410N P=0.600 P=0.494N P=0.115 P=0.209N |
|POLY 6 | P=0.039 * P=0.461N P=0.576 P=0.511N P=0.090 P=0.473 |
|LOGISTIC REGRESSION| P=0.571N P=0.482N P=0.529 P=0.490N P=0.066 P=0.714 |
|COCH-ARM / FISHERS | P=0.092N P=0.393N P=0.602N P=0.500N P=0.121 P=0.061N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/50 (16%) 10/50 (20%) 10/50 (20%) 11/50 (22%) 23/50 (46%) 5/50 (10%) |
|POLY-3 RATE (b) | 8/43.21 10/40.68 10/43.30 11/41.98 23/43.73 5/20.88 |
|POLY-3 PERCENT (g) | 18.5% 24.6% 23.1% 26.2% 52.6% 24.0% |
|TERMINAL (d) | 7/33 (21%) 8/22 (36%) 5/28 (18%) 4/22 (18%) 18/29 (62%) 0/0 (0%) |
|FIRST INCIDENCE | 636 613 444 646 570 407 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.133 P=0.292 P=0.120 P<0.001 ** P=0.004 ** |
|POLY 3 | P=0.029 * P=0.340 P=0.397 P=0.276 P<0.001 ** P=0.437 |
|POLY 1.5 | P=0.282 P=0.367 P=0.402 P=0.284 P<0.001 ** P=0.557N |
|POLY 6 | P<0.001 ** P=0.295 P=0.383 P=0.263 P<0.001 ** P=0.180 |
|LOGISTIC REGRESSION| P=0.046 * P=0.273 P=0.383 P=0.250 P<0.001 ** P=0.592 |
|COCH-ARM / FISHERS | P=0.219N P=0.398 P=0.398 P=0.306 P<0.001 ** P=0.277N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 3/50 (6%) 4/50 (8%) 4/50 (8%) 15/50 (30%) |
|POLY-3 RATE (b) | 4/44.16 2/40.27 3/42.40 4/41.32 4/43.17 15/27.82 |
|POLY-3 PERCENT (g) | 9.1% 5.0% 7.1% 9.7% 9.3% 53.9% |
|TERMINAL (d) | 0/33 (0%) 1/22 (5%) 1/28 (4%) 0/22 (0%) 1/29 (3%) 0/0 (0%) |
|FIRST INCIDENCE | 545 638 572 638 524 393 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.426N P=0.544N P=0.556 P=0.601 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.380N P=0.522N P=0.607 P=0.631 P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.360N P=0.510N P=0.620 P=0.639 P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.415N P=0.544N P=0.584 P=0.613 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.005 ** P=0.316N P=0.498N P=0.635N P=0.631 P=0.283 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.339N P=0.500N P=0.643N P=0.643N P=0.005 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 4/50 (8%) 4/50 (8%) 3/50 (6%) 10/50 (20%) |
|POLY-3 RATE (b) | 2/42.87 1/40.16 4/43.05 4/41.72 3/42.74 10/23.86 |
|POLY-3 PERCENT (g) | 4.7% 2.5% 9.3% 9.6% 7.0% 41.9% |
|TERMINAL (d) | 2/33 (6%) 0/22 (0%) 1/28 (4%) 1/22 (5%) 1/29 (3%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 672 444 561 524 400 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.616N P=0.299 P=0.241 P=0.457 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.523N P=0.338 P=0.324 P=0.499 P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.512N P=0.341 P=0.327 P=0.502 P=0.002 ** |
|POLY 6 | P<0.001 ** P=0.541N P=0.330 P=0.315 P=0.489 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.026 * P=0.545N P=0.338 P=0.329 P=0.500 P=0.045 * |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500N P=0.339 P=0.339 P=0.500 P=0.014 * |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Cytomegaly |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 7/50 (14%) 23/50 (46%) 32/50 (64%) 29/50 (58%) |
|POLY-3 RATE (b) | 0/42.87 0/39.94 7/42.54 23/42.07 32/45.36 29/36.57 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 16.5% 54.7% 70.5% 79.3% |
|TERMINAL (d) | 0/33 (0%) 0/22 (0%) 4/28 (14%) 16/22 (73%) 24/29 (83%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 572 650 451 350 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.007 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) P=0.007 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) P=0.007 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) P=0.006 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) P=0.009 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.006 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Hyperplasia Regenerative |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 8/50 (16%) 50/50 (100%) |
|POLY-3 RATE (b) | 0/42.87 0/39.94 0/41.60 0/40.79 8/42.53 50/50.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 18.8% 100.0% |
|TERMINAL (d) | 0/33 (0%) 0/22 (0%) 0/28 (0%) 0/22 (0%) 6/29 (21%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 656 350 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.003 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) P=0.003 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.004 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) P=0.003 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) P=0.004 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.003 ** P<0.001 ** |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 5/50 (10%) 7/50 (14%) 4/50 (8%) 3/50 (6%) 5/50 (10%) |
|POLY-3 RATE (b) | 4/43.89 5/41.01 7/43.76 4/41.57 3/42.62 5/20.97 |
|POLY-3 PERCENT (g) | 9.1% 12.2% 16.0% 9.6% 7.0% 23.9% |
|TERMINAL (d) | 1/33 (3%) 1/22 (5%) 2/28 (7%) 0/22 (0%) 2/29 (7%) 0/0 (0%) |
|FIRST INCIDENCE | 393 573 437 651 524 460 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.006 ** P=0.361 P=0.228 P=0.527 P=0.550N P=0.031 * |
|POLY 3 | P=0.299 P=0.457 P=0.258 P=0.614 P=0.516N P=0.137 |
|POLY 1.5 | P=0.401 P=0.476 P=0.261 P=0.622 P=0.507N P=0.269 |
|POLY 6 | P=0.310 P=0.428 P=0.249 P=0.600 P=0.535N P=0.049 * |
|LOGISTIC REGRESSION| P=0.274N P=0.525 P=0.258 P=0.626N P=0.510N P=0.529N |
|COCH-ARM / FISHERS | P=0.529N P=0.500 P=0.262 P=0.643N P=0.500N P=0.500 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver: Kupffer Cell |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 3/50 (6%) 2/50 (4%) 6/50 (12%) 4/50 (8%) |
|POLY-3 RATE (b) | 0/42.87 2/40.76 3/42.41 2/42.26 6/44.30 4/20.52 |
|POLY-3 PERCENT (g) | 0.0% 4.9% 7.1% 4.7% 13.5% 19.5% |
|TERMINAL (d) | 0/33 (0%) 0/22 (0%) 0/28 (0%) 0/22 (0%) 1/29 (3%) 0/0 (0%) |
|FIRST INCIDENCE | --- 573 562 307 463 459 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.221 P=0.113 P=0.238 P=0.018 * P=0.031 * |
|POLY 3 | P=0.005 ** P=0.226 P=0.116 P=0.234 P=0.017 * P=0.013 * |
|POLY 1.5 | P=0.022 * P=0.231 P=0.118 P=0.235 P=0.017 * P=0.026 * |
|POLY 6 | P=0.002 ** P=0.216 P=0.112 P=0.229 P=0.016 * P=0.006 ** |
|LOGISTIC REGRESSION| P=0.543N P=0.258 P=0.121 P=0.396 P=0.011 * P=0.359 |
|COCH-ARM / FISHERS | P=0.104 P=0.247 P=0.121 P=0.247 P=0.013 * P=0.059 |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 7/50 (14%) 2/50 (4%) 8/50 (16%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 4/44.42 7/42.43 2/42.54 8/42.96 1/41.99 1/18.32 |
|POLY-3 PERCENT (g) | 9.0% 16.5% 4.7% 18.6% 2.4% 5.5% |
|TERMINAL (d) | 0/33 (0%) 0/22 (0%) 0/28 (0%) 0/22 (0%) 1/29 (3%) 0/0 (0%) |
|FIRST INCIDENCE | 468 519 444 293 729 (T) 478 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.373N P=0.209 P=0.370N P=0.144 P=0.203N P=0.705 |
|POLY 3 | P=0.125N P=0.234 P=0.357N P=0.159 P=0.196N P=0.514N |
|POLY 1.5 | P=0.082N P=0.247 P=0.346N P=0.166 P=0.187N P=0.346N |
|POLY 6 | P=0.160N P=0.212 P=0.378N P=0.147 P=0.213N P=0.597 |
|LOGISTIC REGRESSION| P=0.003N** P=0.310 P=0.348N P=0.218 P=0.187N P=0.058N |
|COCH-ARM / FISHERS | P=0.032N* P=0.262 P=0.339N P=0.178 P=0.181N P=0.181N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/42.87 0/39.94 0/41.60 0/40.79 1/42.62 2/19.23 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 2.4% 10.4% |
|TERMINAL (d) | 0/33 (0%) 0/22 (0%) 0/28 (0%) 0/22 (0%) 0/29 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 524 405 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.009 ** (e) (e) (e) P=0.513 P=0.221 |
|POLY 3 | P=0.005 ** (e) (e) (e) P=0.499 P=0.115 |
|POLY 1.5 | P=0.008 ** (e) (e) (e) P=0.500 P=0.160 |
|POLY 6 | P=0.014 * (e) (e) (e) P=0.494 P=0.080 |
|LOGISTIC REGRESSION| P=0.214 (e) (e) (e) P=0.416 P=0.706 |
|COCH-ARM / FISHERS | P=0.020 * (e) (e) (e) P=0.500 P=0.247 |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 7/50 (14%) 1/50 (2%) 3/50 (6%) 5/50 (10%) 19/50 (38%) |
|POLY-3 RATE (b) | 4/44.66 7/42.41 1/41.87 3/41.59 5/43.43 19/29.60 |
|POLY-3 PERCENT (g) | 9.0% 16.5% 2.4% 7.2% 11.5% 64.2% |
|TERMINAL (d) | 0/33 (0%) 0/22 (0%) 0/28 (0%) 0/22 (0%) 1/29 (3%) 0/0 (0%) |
|FIRST INCIDENCE | 468 573 658 642 524 350 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.229 P=0.204N P=0.514N P=0.479 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.231 P=0.198N P=0.539N P=0.482 P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.244 P=0.189N P=0.525N P=0.493 P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.211 P=0.215N P=0.561N P=0.462 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.310 P=0.182N P=0.441N P=0.469 P=0.046 * |
|COCH-ARM / FISHERS | P<0.001 ** P=0.262 P=0.181N P=0.500N P=0.500 P<0.001 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 45/50 (90%) 41/50 (82%) 47/50 (94%) 44/50 (88%) 49/50 (98%) 42/50 (84%) |
|POLY-3 RATE (b) | 45/48.81 41/46.78 47/48.64 44/45.77 49/49.65 42/44.19 |
|POLY-3 PERCENT (g) | 92.2% 87.7% 96.6% 96.1% 98.7% 95.0% |
|TERMINAL (d) | 32/33 (97%) 22/22 (100%) 28/28 (100%) 22/22 (100%) 29/29 (100%) 0/0 (0%) |
|FIRST INCIDENCE | 393 407 437 552 451 350 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.094 P=0.123 P=0.037 * P=0.099 P<0.001 ** |
|POLY 3 | P=0.245 P=0.329N P=0.277 P=0.332 P=0.112 P=0.434 |
|POLY 1.5 | P=0.496 P=0.276N P=0.311 P=0.449 P=0.106 P=0.654N |
|POLY 6 | P=0.094 P=0.386N P=0.243 P=0.284 P=0.133 P=0.236 |
|LOGISTIC REGRESSION| P=0.027 * P=0.234N P=0.353 P=0.625 P=0.104 P=0.498 |
|COCH-ARM / FISHERS | P=0.313N P=0.194N P=0.357 P=0.500N P=0.102 P=0.277N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Metaplasia Osseous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.87 2/40.70 0/41.60 0/40.79 0/41.99 0/17.60 |
|POLY-3 PERCENT (g) | 0.0% 4.9% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/33 (0%) 0/22 (0%) 0/28 (0%) 0/22 (0%) 0/29 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 520 --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.608N P=0.214 (e) (e) (e) (e) |
|POLY 3 | P=0.337N P=0.225 (e) (e) (e) (e) |
|POLY 1.5 | P=0.369N P=0.231 (e) (e) (e) (e) |
|POLY 6 | P=0.376N P=0.215 (e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.293N P=0.258 (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.393N P=0.247 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/50 (10%) 4/50 (8%) 10/50 (20%) 5/50 (10%) 5/50 (10%) 7/50 (14%) |
|POLY-3 RATE (b) | 5/42.87 4/40.29 10/42.37 5/40.79 5/41.99 7/21.20 |
|POLY-3 PERCENT (g) | 11.7% 9.9% 23.6% 12.3% 11.9% 33.0% |
|TERMINAL (d) | 5/33 (15%) 3/22 (14%) 8/28 (29%) 5/22 (23%) 5/29 (17%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 631 591 729 (T) 729 (T) 459 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.554 P=0.074 P=0.362 P=0.548 P<0.001 ** |
|POLY 3 | P=0.114 P=0.539N P=0.120 P=0.599 P=0.618 P=0.057 |
|POLY 1.5 | P=0.200 P=0.520N P=0.126 P=0.610 P=0.627 P=0.154 |
|POLY 6 | P=0.095 P=0.571N P=0.110 P=0.578 P=0.598 P=0.013 * |
|LOGISTIC REGRESSION| P=0.004 ** P=0.619N P=0.098 P=0.362 P=0.548 P=0.017 * |
|COCH-ARM / FISHERS | P=0.431 P=0.500N P=0.131 P=0.630N P=0.630N P=0.380 |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/48 (0%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.87 0/39.58 0/40.38 3/41.07 0/41.99 0/17.60 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 7.3% 0.0% 0.0% |
|TERMINAL (d) | 0/33 (0%) 0/22 (0%) 0/27 (0%) 2/22 (9%) 0/29 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 651 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.919N (e) (e) P=0.078 (e) (e) |
|POLY 3 | P=0.543N (e) (e) P=0.111 (e) (e) |
|POLY 1.5 | P=0.492N (e) (e) P=0.113 (e) (e) |
|POLY 6 | P=0.686N (e) (e) P=0.106 (e) (e) |
|LOGISTIC REGRESSION| P=0.763N (e) (e) P=0.110 (e) (e) |
|COCH-ARM / FISHERS | P=0.430N (e) (e) P=0.121 (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 3/49 (6%) 1/48 (2%) 5/50 (10%) 5/50 (10%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/42.87 3/39.89 1/40.38 5/40.89 5/42.27 0/17.60 |
|POLY-3 PERCENT (g) | 4.7% 7.5% 2.5% 12.2% 11.8% 0.0% |
|TERMINAL (d) | 2/33 (6%) 2/22 (9%) 1/27 (4%) 3/22 (14%) 4/29 (14%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 644 729 (T) 715 654 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.268 P=0.343 P=0.570N P=0.094 P=0.174 P=1.000N |
|POLY 3 | P=0.460 P=0.467 P=0.521N P=0.196 P=0.209 P=0.457N |
|POLY 1.5 | P=0.401N P=0.479 P=0.516N P=0.203 P=0.215 P=0.349N |
|POLY 6 | P=0.179 P=0.446 P=0.532N P=0.183 P=0.197 P=0.589N |
|LOGISTIC REGRESSION| P=0.382 P=0.435 P=0.570N P=0.124 P=0.183 (e) |
|COCH-ARM / FISHERS | P=0.154N P=0.490 P=0.515N P=0.218 P=0.218 P=0.247N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/50 (10%) 2/49 (4%) 2/48 (4%) 11/50 (22%) 3/50 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 5/42.87 2/39.77 2/40.44 11/41.92 3/42.48 0/17.60 |
|POLY-3 PERCENT (g) | 11.7% 5.0% 5.0% 26.2% 7.1% 0.0% |
|TERMINAL (d) | 5/33 (15%) 1/22 (5%) 1/27 (4%) 5/22 (23%) 2/29 (7%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 679 715 638 581 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.652N P=0.391N P=0.299N P=0.023 * P=0.418N P=1.000N |
|POLY 3 | P=0.221N P=0.246N P=0.239N P=0.072 P=0.361N P=0.203N |
|POLY 1.5 | P=0.100N P=0.236N P=0.234N P=0.075 P=0.356N P=0.093N |
|POLY 6 | P=0.441N P=0.267N P=0.252N P=0.067 P=0.374N P=0.416N |
|LOGISTIC REGRESSION| P=0.320N P=0.312N P=0.290N P=0.060 P=0.380N (e) |
|COCH-ARM / FISHERS | P=0.026N* P=0.226N P=0.235N P=0.086 P=0.357N P=0.028N* |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 3/50 (6%) 3/50 (6%) 1/50 (2%) 9/50 (18%) |
|POLY-3 RATE (b) | 4/42.87 3/40.88 3/42.54 3/41.79 1/42.15 9/23.79 |
|POLY-3 PERCENT (g) | 9.3% 7.3% 7.1% 7.2% 2.4% 37.8% |
|TERMINAL (d) | 4/33 (12%) 0/22 (0%) 1/28 (4%) 0/22 (0%) 0/29 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 636 444 552 686 393 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.650N P=0.571N P=0.641N P=0.221N P<0.001 ** |
|POLY 3 | P=0.003 ** P=0.526N P=0.504N P=0.514N P=0.183N P=0.008 ** |
|POLY 1.5 | P=0.004 ** P=0.514N P=0.500N P=0.511N P=0.180N P=0.030 * |
|POLY 6 | P=0.005 ** P=0.547N P=0.517N P=0.524N P=0.191N P<0.001 ** |
|LOGISTIC REGRESSION| P=0.140 P=0.526N P=0.501N P=0.511N P=0.206N P=0.248 |
|COCH-ARM / FISHERS | P=0.011 * P=0.500N P=0.500N P=0.500N P=0.181N P=0.117 |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/50 (10%) 8/50 (16%) 9/50 (18%) 5/50 (10%) 7/50 (14%) 25/50 (50%) |
|POLY-3 RATE (b) | 5/44.55 8/40.81 9/42.41 5/40.87 7/42.46 25/32.79 |
|POLY-3 PERCENT (g) | 11.2% 19.6% 21.2% 12.2% 16.5% 76.3% |
|TERMINAL (d) | 1/33 (3%) 5/22 (23%) 6/28 (21%) 4/22 (18%) 6/29 (21%) 0/0 (0%) |
|FIRST INCIDENCE | 483 613 591 707 590 405 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.153 P=0.147 P=0.478 P=0.320 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.219 P=0.163 P=0.575 P=0.345 P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.244 P=0.178 P=0.596 P=0.363 P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.182 P=0.141 P=0.540 P=0.311 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.280 P=0.195 P=0.630 P=0.380 P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.277 P=0.194 P=0.630N P=0.380 P<0.001 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 23/50 (46%) 22/50 (44%) 32/50 (64%) 15/50 (30%) 16/50 (32%) 31/50 (62%) |
|POLY-3 RATE (b) | 23/47.15 22/43.02 32/45.35 15/42.50 16/44.30 31/37.24 |
|POLY-3 PERCENT (g) | 48.8% 51.1% 70.6% 35.3% 36.1% 83.3% |
|TERMINAL (d) | 12/33 (36%) 12/22 (55%) 22/28 (79%) 8/22 (36%) 9/29 (31%) 0/0 (0%) |
|FIRST INCIDENCE | 393 573 444 552 570 405 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.230 P=0.029 * P=0.363N P=0.236N P<0.001 ** |
|POLY 3 | P=0.003 ** P=0.495 P=0.022 * P=0.137N P=0.152N P<0.001 ** |
|POLY 1.5 | P=0.012 * P=0.562 P=0.033 * P=0.112N P=0.131N P=0.005 ** |
|POLY 6 | P<0.001 ** P=0.407 P=0.012 * P=0.181N P=0.190N P<0.001 ** |
|LOGISTIC REGRESSION| P=0.026 * P=0.515N P=0.053 P=0.078N P=0.108N P=0.300 |
|COCH-ARM / FISHERS | P=0.067 P=0.500N P=0.054 P=0.074N P=0.109N P=0.080 |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 3/50 (6%) 4/47 (9%) 0/49 (0%) 6/49 (12%) |
|POLY-3 RATE (b) | 1/43.28 2/40.35 3/42.35 4/40.25 0/40.99 6/21.44 |
|POLY-3 PERCENT (g) | 2.3% 5.0% 7.1% 9.9% 0.0% 28.0% |
|TERMINAL (d) | 0/33 (0%) 1/22 (5%) 1/28 (4%) 2/22 (9%) 0/28 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 611 613 591 618 --- 405 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.440 P=0.279 P=0.138 P=0.514N P=0.002 ** |
|POLY 3 | P=0.021 * P=0.475 P=0.297 P=0.156 P=0.511N P=0.006 ** |
|POLY 1.5 | P=0.025 * P=0.487 P=0.302 P=0.158 P=0.507N P=0.016 * |
|POLY 6 | P=0.041 * P=0.455 P=0.287 P=0.151 P=0.519N P<0.001 ** |
|LOGISTIC REGRESSION| P=0.237 P=0.515 P=0.306 P=0.163 P=0.520N P=0.319 |
|COCH-ARM / FISHERS | P=0.050 P=0.500 P=0.309 P=0.162 P=0.505N P=0.053 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 2/50 (4%) 2/47 (4%) 3/49 (6%) 2/49 (4%) |
|POLY-3 RATE (b) | 3/43.28 1/39.94 2/41.60 2/39.99 3/40.99 2/18.48 |
|POLY-3 PERCENT (g) | 6.9% 2.5% 4.8% 5.0% 7.3% 10.8% |
|TERMINAL (d) | 2/33 (6%) 1/22 (5%) 2/28 (7%) 1/22 (5%) 3/28 (11%) 0/0 (0%) |
|FIRST INCIDENCE | 611 729 (T) 729 (T) 618 729 (T) 447 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** P=0.426N P=0.566N P=0.604N P=0.592 P=0.059 |
|POLY 3 | P=0.233 P=0.334N P=0.518N P=0.536N P=0.638 P=0.499 |
|POLY 1.5 | P=0.358 P=0.320N P=0.508N P=0.533N P=0.647 P=0.658 |
|POLY 6 | P=0.194 P=0.359N P=0.536N P=0.546N P=0.618 P=0.310 |
|LOGISTIC REGRESSION| P=0.193 P=0.330N P=0.518N P=0.529N P=0.632 P=0.694 |
|COCH-ARM / FISHERS | P=0.577 P=0.309N P=0.500N P=0.530N P=0.651 P=0.510N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/26 (0%) 0/24 (0%) 0/36 (0%) 0/19 (0%) 0/21 (0%) 2/40 (5%) |
|POLY-3 RATE (b) | 0/21.36 0/20.27 0/31.39 0/16.17 0/17.48 2/16.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 12.4% |
|TERMINAL (d) | 0/14 (0%) 0/13 (0%) 0/23 (0%) 0/9 (0%) 0/12 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 352 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.005 ** (e) (e) (e) (e) P=0.189 |
|POLY 3 | P=0.014 * (e) (e) (e) (e) P=0.182 |
|POLY 1.5 | P=0.019 * (e) (e) (e) (e) P=0.248 |
|POLY 6 | P=0.043 * (e) (e) (e) (e) P=0.118 |
|LOGISTIC REGRESSION| P=0.435 (e) (e) (e) (e) P=0.664 |
|COCH-ARM / FISHERS | P=0.032 * (e) (e) (e) (e) P=0.364 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/26 (0%) 1/24 (4%) 2/36 (6%) 0/19 (0%) 4/21 (19%) 1/40 (3%) |
|POLY-3 RATE (b) | 0/21.36 1/20.27 2/31.87 0/16.17 4/17.65 1/15.29 |
|POLY-3 PERCENT (g) | 0.0% 4.9% 6.3% 0.0% 22.7% 6.5% |
|TERMINAL (d) | 0/14 (0%) 1/13 (8%) 0/23 (0%) 0/9 (0%) 3/12 (25%) 0/0 (0%) |
|FIRST INCIDENCE | --- 729 (T) 654 --- 686 472 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** P=0.485 P=0.219 (e) P=0.044 * P=0.410 |
|POLY 3 | P=0.116 P=0.490 P=0.330 (e) P=0.030 * P=0.436 |
|POLY 1.5 | P=0.321 P=0.489 P=0.323 (e) P=0.031 * P=0.508 |
|POLY 6 | P=0.017 * P=0.486 P=0.338 (e) P=0.029 * P=0.345 |
|LOGISTIC REGRESSION| P=0.296 P=0.485 P=0.297 (e) P=0.033 * P=0.819 |
|COCH-ARM / FISHERS | P=0.609N P=0.480 P=0.333 (e) P=0.034 * P=0.606 |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node: Renal |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/26 (0%) 0/24 (0%) 2/36 (6%) 0/19 (0%) 2/21 (10%) 1/40 (3%) |
|POLY-3 RATE (b) | 0/21.36 0/20.27 2/31.44 0/16.17 2/18.13 1/15.39 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 6.4% 0.0% 11.0% 6.5% |
|TERMINAL (d) | 0/14 (0%) 0/13 (0%) 1/23 (4%) 0/9 (0%) 0/12 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 715 --- 587 407 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.046 * (e) P=0.278 (e) P=0.227 P=0.483 |
|POLY 3 | P=0.180 (e) P=0.326 (e) P=0.196 P=0.438 |
|POLY 1.5 | P=0.334 (e) P=0.321 (e) P=0.193 P=0.509 |
|POLY 6 | P=0.090 (e) P=0.332 (e) P=0.199 P=0.346 |
|LOGISTIC REGRESSION| P=0.679 (e) P=0.334 (e) P=0.175 P=0.851 |
|COCH-ARM / FISHERS | P=0.555 (e) P=0.333 (e) P=0.194 P=0.606 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 48/50 (96%) 46/50 (92%) 46/50 (92%) 45/50 (90%) 44/49 (90%) 43/49 (88%) |
|POLY-3 RATE (b) | 48/49.22 46/47.77 46/48.31 45/46.59 44/48.22 43/44.25 |
|POLY-3 PERCENT (g) | 97.5% 96.3% 95.2% 96.6% 91.2% 97.2% |
|TERMINAL (d) | 33/33 (100%) 22/22 (100%) 27/28 (96%) 22/22 (100%) 26/29 (90%) 0/0 (0%) |
|FIRST INCIDENCE | 393 407 437 451 451 350 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.046 * P=0.320 P=0.077 P=0.535 P<0.001 ** |
|POLY 3 | P=0.612N P=0.613N P=0.468N P=0.654N P=0.165N P=0.771N |
|POLY 1.5 | P=0.398N P=0.483N P=0.400N P=0.502N P=0.176N P=0.405N |
|POLY 6 | P=0.522 P=0.804N P=0.573N P=0.786N P=0.169N P=0.686 |
|LOGISTIC REGRESSION| P=0.082 P=0.394N P=0.311N P=0.361N P=0.203N P=0.494 |
|COCH-ARM / FISHERS | P=0.165N P=0.339N P=0.339N P=0.218N P=0.210N P=0.128N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Mesentery |
| Accessory Spleen |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 0/10 (0%) 1/18 (6%) 2/14 (14%) 1/13 (8%) 0/5 (0%) |
|POLY-3 RATE (b) | 2/9.48 0/8.66 1/15.81 2/12.97 1/9.97 0/2.17 |
|POLY-3 PERCENT (g) | 21.1% 0.0% 6.3% 15.4% 10.0% 0.0% |
|TERMINAL (d) | 2/7 (29%) 0/6 (0%) 1/11 (9%) 1/8 (13%) 1/5 (20%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) 638 729 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.838 P=0.265N P=0.337N P=0.659N P=0.627N P=1.000N |
|POLY 3 | P=0.530N P=0.246N P=0.317N P=0.581N P=0.482N P=0.576N |
|POLY 1.5 | P=0.503N P=0.237N P=0.307N P=0.575N P=0.448N P=0.497N |
|POLY 6 | P=0.625 P=0.262N P=0.328N P=0.592N P=0.531N P=0.670N |
|LOGISTIC REGRESSION| P=0.849N (e) P=0.337N P=0.569N P=0.627N (e) |
|COCH-ARM / FISHERS | P=0.449N P=0.237N P=0.284N P=0.563N P=0.398N P=0.429N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/10 (80%) 10/10 (100%) 18/18 (100%) 12/14 (86%) 9/13 (69%) 3/5 (60%) |
|POLY-3 RATE (b) | 8/10.00 10/10.00 18/18.00 12/14.00 9/12.56 3/3.87 |
|POLY-3 PERCENT (g) | 80.0% 100.0% 100.0% 85.7% 71.6% 77.6% |
|TERMINAL (d) | 5/7 (71%) 6/6 (100%) 11/11 (100%) 6/8 (75%) 2/5 (40%) 0/0 (0%) |
|FIRST INCIDENCE | 611 573 518 638 463 522 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.033 * P=0.194 P=0.044 * P=0.198 P=0.339 P=0.007 ** |
|POLY 3 | P=0.113N P=0.227 P=0.106 P=0.571 P=0.513N P=0.727N |
|POLY 1.5 | P=0.055N P=0.227 P=0.106 P=0.571 P=0.490N P=0.595N |
|POLY 6 | P=0.224N P=0.227 P=0.106 P=0.571 P=0.546N P=0.659 |
|LOGISTIC REGRESSION| P=0.006N** (e) (e) (e) P=0.278N P=0.780N |
|COCH-ARM / FISHERS | P=0.020N* P=0.237 P=0.119 P=0.563 P=0.463N P=0.407N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Nose |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/49 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/43.61 0/39.94 1/41.91 1/41.28 0/41.99 1/18.32 |
|POLY-3 PERCENT (g) | 4.6% 0.0% 2.4% 2.4% 0.0% 5.5% |
|TERMINAL (d) | 1/33 (3%) 0/22 (0%) 0/28 (0%) 0/22 (0%) 0/29 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 468 --- 647 307 --- 475 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.542 P=0.284N P=0.519N P=0.556N P=0.254N P=0.681 |
|POLY 3 | P=0.597N P=0.257N P=0.514N P=0.519N P=0.245N P=0.664 |
|POLY 1.5 | P=0.627 P=0.248N P=0.507N P=0.515N P=0.241N P=0.647N |
|POLY 6 | P=0.523N P=0.272N P=0.525N P=0.530N P=0.254N P=0.501 |
|LOGISTIC REGRESSION| P=0.245N P=0.211N P=0.508N P=0.348N P=0.258N P=0.295N |
|COCH-ARM / FISHERS | P=0.619N P=0.247N P=0.500N P=0.508N P=0.247N P=0.500N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Nose |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 2/49 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/43.61 0/39.94 0/41.60 2/41.28 0/41.99 1/18.23 |
|POLY-3 PERCENT (g) | 6.9% 0.0% 0.0% 4.9% 0.0% 5.5% |
|TERMINAL (d) | 2/33 (6%) 0/22 (0%) 0/28 (0%) 1/22 (5%) 0/29 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 468 --- --- 307 --- 522 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.540 P=0.173N P=0.143N P=0.616N P=0.138N P=0.648 |
|POLY 3 | P=0.533N P=0.135N P=0.127N P=0.525N P=0.125N P=0.620N |
|POLY 1.5 | P=0.558N P=0.127N P=0.123N P=0.519N P=0.122N P=0.477N |
|POLY 6 | P=0.466N P=0.148N P=0.134N P=0.539N P=0.132N P=0.557 |
|LOGISTIC REGRESSION| P=0.258N P=0.110N P=0.119N P=0.434N P=0.123N P=0.335N |
|COCH-ARM / FISHERS | P=0.527N P=0.121N P=0.121N P=0.510N P=0.121N P=0.309N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/42.87 0/39.94 1/41.91 0/40.35 0/41.99 3/19.52 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 2.4% 0.0% 0.0% 15.4% |
|TERMINAL (d) | 1/33 (3%) 0/22 (0%) 0/28 (0%) 0/22 (0%) 0/29 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) --- 647 --- --- 475 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.581N P=0.742 P=0.581N P=0.526N P=0.032 * |
|POLY 3 | P=0.026 * P=0.514N P=0.756 P=0.512N P=0.504N P=0.110 |
|POLY 1.5 | P=0.022 * P=0.507N P=0.759 P=0.510N P=0.501N P=0.180 |
|POLY 6 | P=0.108 P=0.526N P=0.750 P=0.518N P=0.511N P=0.059 |
|LOGISTIC REGRESSION| P=0.123 (e) P=0.761 (e) (e) P=0.381 |
|COCH-ARM / FISHERS | P=0.031 * P=0.500N P=0.753N P=0.505N P=0.500N P=0.309 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 11/50 (22%) 7/49 (14%) 8/50 (16%) 9/50 (18%) 6/50 (12%) 9/50 (18%) |
|POLY-3 RATE (b) | 11/44.55 7/40.72 8/44.26 9/42.25 6/42.94 9/23.66 |
|POLY-3 PERCENT (g) | 24.7% 17.2% 18.1% 21.3% 14.0% 38.0% |
|TERMINAL (d) | 8/33 (24%) 3/21 (14%) 2/28 (7%) 4/22 (18%) 4/29 (14%) 0/0 (0%) |
|FIRST INCIDENCE | 498 328 518 293 587 440 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.469N P=0.393N P=0.520 P=0.201N P=0.002 ** |
|POLY 3 | P=0.179 P=0.280N P=0.308N P=0.452N P=0.158N P=0.206 |
|POLY 1.5 | P=0.299 P=0.254N P=0.304N P=0.432N P=0.149N P=0.454 |
|POLY 6 | P=0.131 P=0.328N P=0.318N P=0.489N P=0.177N P=0.047 * |
|LOGISTIC REGRESSION| P=0.285N P=0.214N P=0.295N P=0.400N P=0.143N P=0.449N |
|COCH-ARM / FISHERS | P=0.541N P=0.232N P=0.306N P=0.402N P=0.143N P=0.402N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Pancreas |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/50 (20%) 3/50 (6%) 9/50 (18%) 8/46 (17%) 4/50 (8%) 4/50 (8%) |
|POLY-3 RATE (b) | 10/45.06 3/40.30 9/43.27 8/40.12 4/41.99 4/20.41 |
|POLY-3 PERCENT (g) | 22.2% 7.4% 20.8% 19.9% 9.5% 19.6% |
|TERMINAL (d) | 6/33 (18%) 1/22 (5%) 5/28 (18%) 6/22 (27%) 4/29 (14%) 0/0 (0%) |
|FIRST INCIDENCE | 393 643 437 646 729 (T) 405 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.078 P=0.111N P=0.591 P=0.550 P=0.114N P=0.191 |
|POLY 3 | P=0.376N P=0.053N P=0.540N P=0.505N P=0.092N P=0.531N |
|POLY 1.5 | P=0.261N P=0.045N* P=0.520N P=0.492N P=0.083N P=0.269N |
|POLY 6 | P=0.452N P=0.070N P=0.572N P=0.533N P=0.110N P=0.359 |
|LOGISTIC REGRESSION| P=0.145N P=0.033N* P=0.491N P=0.475N P=0.074N P=0.031N* |
|COCH-ARM / FISHERS | P=0.101N P=0.036N* P=0.500N P=0.475N P=0.074N P=0.074N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/50 (0%) 0/46 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/42.87 1/39.94 0/41.60 0/39.53 1/41.99 0/17.60 |
|POLY-3 PERCENT (g) | 7.0% 2.5% 0.0% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 3/33 (9%) 1/22 (5%) 0/28 (0%) 0/22 (0%) 1/29 (3%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- 729 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.755N P=0.458N P=0.151N P=0.200N P=0.352N P=1.000N |
|POLY 3 | P=0.332N P=0.331N P=0.124N P=0.133N P=0.312N P=0.342N |
|POLY 1.5 | P=0.296N P=0.318N P=0.121N P=0.133N P=0.307N P=0.221N |
|POLY 6 | P=0.413N P=0.352N P=0.130N P=0.137N P=0.324N P=0.514N |
|LOGISTIC REGRESSION| P=0.755N P=0.458N (e) (e) P=0.352N (e) |
|COCH-ARM / FISHERS | P=0.239N P=0.309N P=0.121N P=0.137N P=0.309N P=0.121N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/50 (12%) 6/48 (13%) 8/50 (16%) 8/49 (16%) 9/50 (18%) 7/49 (14%) |
|POLY-3 RATE (b) | 6/43.61 6/39.53 8/42.78 8/41.54 9/43.64 7/21.98 |
|POLY-3 PERCENT (g) | 13.8% 15.2% 18.7% 19.3% 20.6% 31.9% |
|TERMINAL (d) | 5/33 (15%) 1/21 (5%) 6/28 (21%) 4/22 (18%) 5/29 (17%) 0/0 (0%) |
|FIRST INCIDENCE | 468 605 437 638 463 400 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.405 P=0.291 P=0.214 P=0.229 P=0.003 ** |
|POLY 3 | P=0.082 P=0.551 P=0.370 P=0.348 P=0.286 P=0.097 |
|POLY 1.5 | P=0.200 P=0.569 P=0.381 P=0.352 P=0.290 P=0.231 |
|POLY 6 | P=0.036 * P=0.525 P=0.349 P=0.339 P=0.273 P=0.024 * |
|LOGISTIC REGRESSION| P=0.471 P=0.586 P=0.386 P=0.358 P=0.288 P=0.665N |
|COCH-ARM / FISHERS | P=0.504 P=0.591 P=0.387 P=0.371 P=0.288 P=0.484 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 16/50 (32%) 11/48 (23%) 19/50 (38%) 16/49 (33%) 17/50 (34%) 19/49 (39%) |
|POLY-3 RATE (b) | 16/43.90 11/39.85 19/45.73 16/41.52 17/45.37 19/29.81 |
|POLY-3 PERCENT (g) | 36.4% 27.6% 41.6% 38.5% 37.5% 63.7% |
|TERMINAL (d) | 14/33 (42%) 5/21 (24%) 10/28 (36%) 10/22 (46%) 8/29 (28%) 0/0 (0%) |
|FIRST INCIDENCE | 483 541 437 618 463 350 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.570N P=0.212 P=0.181 P=0.373 P<0.001 ** |
|POLY 3 | P=0.010 * P=0.262N P=0.389 P=0.510 P=0.548 P=0.016 * |
|POLY 1.5 | P=0.038 * P=0.241N P=0.373 P=0.521 P=0.532 P=0.080 |
|POLY 6 | P=0.002 ** P=0.299N P=0.399 P=0.486 P=0.559 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.099 P=0.283N P=0.336 P=0.492 P=0.496 P=0.235 |
|COCH-ARM / FISHERS | P=0.183 P=0.218N P=0.338 P=0.558 P=0.500 P=0.310 |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/50 (20%) 8/48 (17%) 9/50 (18%) 11/49 (22%) 7/50 (14%) 6/49 (12%) |
|POLY-3 RATE (b) | 10/42.87 8/40.66 9/42.54 11/41.23 7/42.94 6/20.85 |
|POLY-3 PERCENT (g) | 23.3% 19.7% 21.2% 26.7% 16.3% 28.8% |
|TERMINAL (d) | 10/33 (30%) 1/21 (5%) 7/28 (25%) 8/22 (36%) 4/29 (14%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 513 562 638 581 469 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.512 P=0.563 P=0.176 P=0.391N P<0.001 ** |
|POLY 3 | P=0.493 P=0.445N P=0.508N P=0.459 P=0.292N P=0.441 |
|POLY 1.5 | P=0.408N P=0.439N P=0.501N P=0.461 P=0.291N P=0.515N |
|POLY 6 | P=0.395 P=0.460N P=0.526N P=0.448 P=0.302N P=0.166 |
|LOGISTIC REGRESSION| P=0.539 P=0.467N P=0.567N P=0.372 P=0.338N P=0.214 |
|COCH-ARM / FISHERS | P=0.151N P=0.435N P=0.500N P=0.479 P=0.298N P=0.220N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Salivary Glands |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/42.87 0/39.94 0/41.60 1/40.79 0/41.99 2/18.79 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.5% 0.0% 10.7% |
|TERMINAL (d) | 0/33 (0%) 0/22 (0%) 0/28 (0%) 1/22 (5%) 0/29 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) --- 527 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.419 (e) P=0.076 |
|POLY 3 | P=0.030 * (e) (e) P=0.490 (e) P=0.113 |
|POLY 1.5 | P=0.030 * (e) (e) P=0.493 (e) P=0.158 |
|POLY 6 | P=0.104 (e) (e) P=0.483 (e) P=0.079 |
|LOGISTIC REGRESSION| P=0.093 (e) (e) P=0.419 (e) P=0.357 |
|COCH-ARM / FISHERS | P=0.047 * (e) (e) P=0.500 (e) P=0.247 |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Skeletal Muscle |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/0 (0%) 0/1 (0%) 0/1 (0%) 0/2 (0%) 0/0 (0%) 4/6 (67%) |
|POLY-3 RATE (b) | 0/0.00 0/0.88 0/0.53 0/0.68 0/0.00 4/4.68 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 85.5% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 476 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.005 ** |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.057 (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.051 (e) (e) (e) (e) P=1.000 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.87 0/39.94 0/40.60 2/41.23 0/41.99 0/17.60 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.9% 0.0% 0.0% |
|TERMINAL (d) | 0/33 (0%) 0/22 (0%) 0/27 (0%) 0/22 (0%) 0/29 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 618 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.949N (e) (e) P=0.211 (e) (e) |
|POLY 3 | P=0.591N (e) (e) P=0.228 (e) (e) |
|POLY 1.5 | P=0.563N (e) (e) P=0.231 (e) (e) |
|POLY 6 | P=0.724N (e) (e) P=0.223 (e) (e) |
|LOGISTIC REGRESSION| P=0.629N (e) (e) P=0.239 (e) (e) |
|COCH-ARM / FISHERS | P=0.534N (e) (e) P=0.247 (e) (e) |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Spleen |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 3/50 (6%) 7/50 (14%) |
|POLY-3 RATE (b) | 0/42.87 0/39.94 0/41.60 1/41.09 3/42.47 7/22.30 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.4% 7.1% 31.4% |
|TERMINAL (d) | 0/33 (0%) 0/22 (0%) 0/28 (0%) 0/22 (0%) 2/29 (7%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 646 587 393 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.505 P=0.108 P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) P=0.492 P=0.116 P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P=0.494 P=0.119 P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) P=0.486 P=0.112 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.003 ** (e) (e) P=0.511 P=0.120 P=0.109 |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.500 P=0.121 P=0.006 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/42.87 1/40.16 2/41.60 0/40.79 2/42.47 0/17.60 |
|POLY-3 PERCENT (g) | 2.3% 2.5% 4.8% 0.0% 4.7% 0.0% |
|TERMINAL (d) | 1/33 (3%) 0/22 (0%) 2/28 (7%) 0/22 (0%) 1/29 (3%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 672 729 (T) --- 587 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.721 P=0.692 P=0.442 P=0.581N P=0.470 P=1.000N |
|POLY 3 | P=0.581N P=0.746 P=0.490 P=0.510N P=0.497 P=0.650N |
|POLY 1.5 | P=0.457N P=0.753 P=0.496 P=0.507N P=0.500 P=0.586N |
|POLY 6 | P=0.488 P=0.734 P=0.478 P=0.517N P=0.488 P=0.716N |
|LOGISTIC REGRESSION| P=0.647N P=0.747 P=0.442 (e) P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.321N P=0.753N P=0.500 P=0.500N P=0.500 P=0.500N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 24/50 (48%) 33/50 (66%) 25/50 (50%) 26/50 (52%) 27/50 (54%) 34/50 (68%) |
|POLY-3 RATE (b) | 24/46.90 33/46.20 25/46.39 26/44.48 27/44.37 34/38.85 |
|POLY-3 PERCENT (g) | 51.2% 71.4% 53.9% 58.5% 60.9% 87.5% |
|TERMINAL (d) | 16/33 (49%) 15/22 (68%) 14/28 (50%) 12/22 (55%) 19/29 (66%) 0/0 (0%) |
|FIRST INCIDENCE | 393 328 437 307 524 350 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.006 ** P=0.322 P=0.100 P=0.203 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.031 * P=0.478 P=0.310 P=0.230 P<0.001 ** |
|POLY 1.5 | P=0.005 ** P=0.038 * P=0.486 P=0.341 P=0.277 P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.024 * P=0.469 P=0.280 P=0.175 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.024 * P=0.058 P=0.515 P=0.408 P=0.339 P=0.088 |
|COCH-ARM / FISHERS | P=0.057 P=0.053 P=0.500 P=0.421 P=0.345 P=0.034 * |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 37/50 (74%) 41/50 (82%) 35/50 (70%) 34/50 (68%) 35/50 (70%) 29/50 (58%) |
|POLY-3 RATE (b) | 37/46.55 41/46.41 35/46.77 34/46.15 35/45.40 29/36.54 |
|POLY-3 PERCENT (g) | 79.5% 88.3% 74.8% 73.7% 77.1% 79.4% |
|TERMINAL (d) | 27/33 (82%) 21/22 (96%) 20/28 (71%) 16/22 (73%) 25/29 (86%) 0/0 (0%) |
|FIRST INCIDENCE | 468 328 444 252 524 393 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.007 ** P=0.396 P=0.168 P=0.444 P<0.001 ** |
|POLY 3 | P=0.484N P=0.171 P=0.382N P=0.332N P=0.489N P=0.615N |
|POLY 1.5 | P=0.173N P=0.203 P=0.381N P=0.325N P=0.438N P=0.279N |
|POLY 6 | P=0.239 P=0.122 P=0.409N P=0.370N P=0.598N P=0.215 |
|LOGISTIC REGRESSION| P=0.547 P=0.154 P=0.431N P=0.389N P=0.417N P=0.615N |
|COCH-ARM / FISHERS | P=0.017N* P=0.235 P=0.412N P=0.330N P=0.412N P=0.069N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 38
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.87 0/39.94 2/41.66 0/40.71 0/40.99 0/17.60 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.8% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/33 (0%) 0/22 (0%) 1/28 (4%) 0/22 (0%) 0/28 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 715 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.887N (e) P=0.209 (e) (e) (e) |
|POLY 3 | P=0.396N (e) P=0.230 (e) (e) (e) |
|POLY 1.5 | P=0.414N (e) P=0.234 (e) (e) (e) |
|POLY 6 | P=0.458N (e) P=0.223 (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.854N (e) P=0.213 (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.429N (e) P=0.247 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 5/50 (10%) 1/49 (2%) 1/49 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/42.87 1/40.38 5/43.05 1/40.91 1/41.42 3/19.34 |
|POLY-3 PERCENT (g) | 0.0% 2.5% 11.6% 2.4% 2.4% 15.5% |
|TERMINAL (d) | 0/33 (0%) 0/22 (0%) 1/28 (4%) 0/22 (0%) 0/28 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 600 437 678 602 488 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** P=0.495 P=0.030 * P=0.477 P=0.491 P=0.009 ** |
|POLY 3 | P=0.162 P=0.488 P=0.030 * P=0.491 P=0.493 P=0.037 * |
|POLY 1.5 | P=0.197 P=0.494 P=0.031 * P=0.493 P=0.495 P=0.062 |
|POLY 6 | P=0.239 P=0.478 P=0.029 * P=0.485 P=0.488 P=0.022 * |
|LOGISTIC REGRESSION| P=0.587 P=0.522 P=0.032 * P=0.496 P=0.476 P=0.184 |
|COCH-ARM / FISHERS | P=0.313 P=0.500 P=0.028 * P=0.495 P=0.495 P=0.121 |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 39
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) 1/49 (2%) 9/50 (18%) |
|POLY-3 RATE (b) | 0/42.87 0/39.94 0/41.60 2/41.81 1/41.42 9/23.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.8% 2.4% 39.1% |
|TERMINAL (d) | 0/33 (0%) 0/22 (0%) 0/28 (0%) 0/22 (0%) 0/28 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 451 602 405 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.245 P=0.491 P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) P=0.231 P=0.493 P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P=0.232 P=0.495 P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) P=0.227 P=0.488 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) P=0.278 P=0.476 P=0.014 * |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.242 P=0.495 P<0.001 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) 0/49 (0%) 7/50 (14%) |
|POLY-3 RATE (b) | 0/42.87 0/39.94 0/41.60 2/42.19 0/40.99 7/21.66 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.7% 0.0% 32.3% |
|TERMINAL (d) | 0/33 (0%) 0/22 (0%) 0/28 (0%) 0/22 (0%) 0/28 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 307 --- 405 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.238 (e) P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) P=0.233 (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P=0.234 (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) P=0.228 (e) P<0.001 ** |
|LOGISTIC REGRESSION| P=0.012 * (e) (e) P=0.347 (e) P=0.021 * |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.242 (e) P=0.006 ** |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 40
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Thymus |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/48 (0%) 2/48 (4%) 0/46 (0%) 0/48 (0%) 0/50 (0%) 2/49 (4%) |
|POLY-3 RATE (b) | 0/41.55 2/39.43 0/37.91 0/39.12 0/41.99 2/18.39 |
|POLY-3 PERCENT (g) | 0.0% 5.1% 0.0% 0.0% 0.0% 10.9% |
|TERMINAL (d) | 0/32 (0%) 0/21 (0%) 0/25 (0%) 0/22 (0%) 0/29 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 519 --- --- --- 393 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.028 * P=0.242 (e) (e) (e) P=0.096 |
|POLY 3 | P=0.141 P=0.225 (e) (e) (e) P=0.115 |
|POLY 1.5 | P=0.130 P=0.231 (e) (e) (e) P=0.160 |
|POLY 6 | P=0.336 P=0.216 (e) (e) (e) P=0.079 |
|LOGISTIC REGRESSION| P=0.514 P=0.278 (e) (e) (e) P=0.581 |
|COCH-ARM / FISHERS | P=0.167 P=0.247 (e) (e) (e) P=0.253 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Ultimobranchial Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/49 (2%) 2/50 (4%) 0/49 (0%) 0/49 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/42.28 2/40.37 0/41.38 0/40.72 1/42.75 2/18.68 |
|POLY-3 PERCENT (g) | 2.4% 5.0% 0.0% 0.0% 2.3% 10.7% |
|TERMINAL (d) | 0/32 (0%) 1/22 (5%) 0/28 (0%) 0/22 (0%) 0/29 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 611 605 --- --- 451 552 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.013 * P=0.444 P=0.514N P=0.500N P=0.757 P=0.053 |
|POLY 3 | P=0.153 P=0.484 P=0.504N P=0.508N P=0.758N P=0.261 |
|POLY 1.5 | P=0.178 P=0.495 P=0.501N P=0.504N P=0.756N P=0.363 |
|POLY 6 | P=0.248 P=0.464 P=0.511N P=0.515N P=0.757 P=0.168 |
|LOGISTIC REGRESSION| P=0.558 P=0.522 P=0.524N P=0.482N P=0.698 P=0.595 |
|COCH-ARM / FISHERS | P=0.270 P=0.508 P=0.500N P=0.500N P=0.747N P=0.508 |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 41
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 22/49 (45%) 9/50 (18%) 24/49 (49%) 15/49 (31%) 20/50 (40%) 10/50 (20%) |
|POLY-3 RATE (b) | 22/43.58 9/40.81 24/42.74 15/42.19 20/43.90 10/23.16 |
|POLY-3 PERCENT (g) | 50.5% 22.1% 56.2% 35.6% 45.6% 43.2% |
|TERMINAL (d) | 19/32 (59%) 6/22 (27%) 19/28 (68%) 8/22 (36%) 15/29 (52%) 0/0 (0%) |
|FIRST INCIDENCE | 393 573 518 561 463 352 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.056N P=0.211 P=0.475N P=0.570N P<0.001 ** |
|POLY 3 | P=0.449 P=0.004N** P=0.373 P=0.113N P=0.400N P=0.381N |
|POLY 1.5 | P=0.281N P=0.004N** P=0.398 P=0.113N P=0.391N P=0.090N |
|POLY 6 | P=0.181 P=0.006N** P=0.330 P=0.116N P=0.422N P=0.313 |
|LOGISTIC REGRESSION| P=0.138 P=0.006N** P=0.390 P=0.117N P=0.402N P=0.625N |
|COCH-ARM / FISHERS | P=0.031N* P=0.004N** P=0.420 P=0.105N P=0.386N P=0.007N** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Uterus |
| Hydrometra |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/50 (10%) 7/50 (14%) 0/50 (0%) 6/50 (12%) 6/50 (12%) 6/50 (12%) |
|POLY-3 RATE (b) | 5/43.24 7/41.97 0/41.60 6/41.89 6/42.56 6/21.54 |
|POLY-3 PERCENT (g) | 11.6% 16.7% 0.0% 14.3% 14.1% 27.9% |
|TERMINAL (d) | 4/33 (12%) 0/22 (0%) 0/28 (0%) 3/22 (14%) 3/29 (10%) 0/0 (0%) |
|FIRST INCIDENCE | 626 541 --- 451 654 407 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.245 P=0.048N* P=0.313 P=0.424 P=0.002 ** |
|POLY 3 | P=0.048 * P=0.357 P=0.033N* P=0.478 P=0.489 P=0.119 |
|POLY 1.5 | P=0.111 P=0.368 P=0.032N* P=0.485 P=0.497 P=0.258 |
|POLY 6 | P=0.029 * P=0.339 P=0.037N* P=0.459 P=0.470 P=0.035 * |
|LOGISTIC REGRESSION| P=0.320 P=0.382 P=0.037N* P=0.486 P=0.478 P=0.519 |
|COCH-ARM / FISHERS | P=0.304 P=0.380 P=0.028N* P=0.500 P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 42
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Uterus |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 7/50 (14%) 5/50 (10%) 2/50 (4%) 9/50 (18%) |
|POLY-3 RATE (b) | 4/42.87 3/39.99 7/42.39 5/41.10 2/42.34 9/23.06 |
|POLY-3 PERCENT (g) | 9.3% 7.5% 16.5% 12.2% 4.7% 39.0% |
|TERMINAL (d) | 4/33 (12%) 2/22 (9%) 6/28 (21%) 3/22 (14%) 1/29 (3%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 718 437 660 630 472 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.603 P=0.180 P=0.288 P=0.390N P<0.001 ** |
|POLY 3 | P=0.017 * P=0.538N P=0.252 P=0.473 P=0.342N P=0.007 ** |
|POLY 1.5 | P=0.027 * P=0.520N P=0.260 P=0.482 P=0.338N P=0.028 * |
|POLY 6 | P=0.021 * P=0.570N P=0.236 P=0.456 P=0.354N P<0.001 ** |
|LOGISTIC REGRESSION| P=0.017 * P=0.648 P=0.242 P=0.405 P=0.360N P=0.043 * |
|COCH-ARM / FISHERS | P=0.070 P=0.500N P=0.262 P=0.500 P=0.339N P=0.117 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 0.01 0.033 0.1 0.33 1.0 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Uterus |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.87 0/39.94 2/41.60 0/40.79 1/42.25 0/17.60 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.8% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 0/33 (0%) 0/22 (0%) 2/28 (7%) 0/22 (0%) 0/29 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) --- 658 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.842 (e) P=0.202 (e) P=0.484 (e) |
|POLY 3 | P=0.620 (e) P=0.230 (e) P=0.497 (e) |
|POLY 1.5 | P=0.578N (e) P=0.234 (e) P=0.499 (e) |
|POLY 6 | P=0.544 (e) P=0.223 (e) P=0.492 (e) |
|LOGISTIC REGRESSION| P=0.846 (e) P=0.202 (e) P=0.498 (e) |
|COCH-ARM / FISHERS | P=0.496N (e) P=0.247 (e) P=0.500 (e) |
|=================================================================================================================================|
(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).
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