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: 12:19:53
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 MALES
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 0 MG/KG/DY
INCLUDE 002 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: 12:19:53
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
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Accessory Adrenal Cortical Nodule
Degeneration Fatty
Bone Marrow Hyperplasia
Epididymis Atypia Cellular
Heart Cardiomyopathy
Intestine Large, Cecum Edema
Kidney Nephropathy
Kidney: Renal Tubule Hyaline Droplet
Necrosis
Pigmentation
Liver Basophilic Focus
Clear Cell Focus
Degeneration Cystic
Eosinophilic Focus
Hematopoietic Cell Proliferation
Hemorrhage
Infiltration Cellular Mixed Cell
Mixed Cell Focus
Necrosis Focal
Liver: Bile Duct Hyperplasia
Liver: Hepatocyte Cytomegaly
Hyperplasia Regenerative
Vacuolization Cytoplasmic
Lung Edema
Hemorrhage
Infiltration Cellular Histiocyte
Lymph Node, Mediastinal Congestion
Hemorrhage
Pigmentation
Lymph Node, Mesenteric Congestion
Hemorrhage
Lymph Node: Renal Hemorrhage
Pigmentation
Mesentery: Fat Necrosis
Nose Foreign Body
Inflammation Chronic
Nose: Respiratory Epithelium Hyperplasia
Pancreas Atrophy
Pituitary Gland: Pars Distalis Hyperplasia Focal
Preputial Gland Inflammation Chronic
Prostate Inflammation Chronic
Skeletal Muscle Hemorrhage
Spleen Congestion
Hematopoietic Cell Proliferation
Stomach, Forestomach Ulcer
Stomach, Glandular Erosion
Ulcer
Testes Atrophy
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst RIDDELLIINE DATE: 12/15/00
EXPERIMENT: 05161 TEST: 05 TIME: 12:19:53
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
Testes: Interstitial Cell Hyperplasia
Thymus Hemorrhage
===============================================================
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Accessory Adrenal Cortical Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/49 (16%) 1/50 (2%) |
|POLY-3 RATE (b) | 8/48.84 1/28.57 |
|POLY-3 PERCENT (g) | 16.4% 3.5% |
|TERMINAL (d) | 8/48 (17%) 0/3 (0%) |
|FIRST INCIDENCE | 497 (T) 327 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.707 P=0.707 |
|POLY 3 | P=0.133N P=0.135N |
|POLY 1.5 | P=0.053N P=0.053N |
|POLY 6 | P=0.393N P=0.395N |
|LOGISTIC REGRESSION| P=0.093N P=0.093N |
|COCH-ARM / FISHERS | P=0.017N* P=0.014N* |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Degeneration Fatty |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/49 (10%) 4/50 (8%) |
|POLY-3 RATE (b) | 5/49.00 4/28.71 |
|POLY-3 PERCENT (g) | 10.2% 13.9% |
|TERMINAL (d) | 4/48 (8%) 1/3 (33%) |
|FIRST INCIDENCE | 468 424 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.513 P=0.514 |
|POLY 1.5 | P=0.626 P=0.627 |
|POLY 6 | P=0.394 P=0.396 |
|LOGISTIC REGRESSION| P=0.187 P=0.187 |
|COCH-ARM / FISHERS | P=0.487N P=0.487N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/49 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/48.84 1/27.85 |
|POLY-3 PERCENT (g) | 6.1% 3.6% |
|TERMINAL (d) | 3/48 (6%) 1/3 (33%) |
|FIRST INCIDENCE | 497 (T) 497 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.281 P=0.281 |
|POLY 3 | P=0.611N P=0.613N |
|POLY 1.5 | P=0.455N P=0.456N |
|POLY 6 | P=0.840N P=0.841N |
|LOGISTIC REGRESSION| P=0.281 P=0.281 |
|COCH-ARM / FISHERS | P=0.298N P=0.301N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 36/49 (73%) |
|POLY-3 RATE (b) | 1/50.00 36/41.84 |
|POLY-3 PERCENT (g) | 2.0% 86.1% |
|TERMINAL (d) | 0/49 (0%) 2/3 (67%) |
|FIRST INCIDENCE | 468 307 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Bone: Femur |
| Osteopetrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/49.84 2/29.03 |
|POLY-3 PERCENT (g) | 0.0% 6.9% |
|TERMINAL (d) | 0/49 (0%) 0/3 (0%) |
|FIRST INCIDENCE | --- 321 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.165 P=0.165 |
|POLY 3 | P=0.226 P=0.226 |
|POLY 1.5 | P=0.218 P=0.218 |
|POLY 6 | P=0.308 P=0.308 |
|LOGISTIC REGRESSION| P=0.670 P=0.670 |
|COCH-ARM / FISHERS | P=0.238 P=0.247 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Brain |
| Compression |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/49.84 0/27.85 |
|POLY-3 PERCENT (g) | 4.0% 0.0% |
|TERMINAL (d) | 2/49 (4%) 0/3 (0%) |
|FIRST INCIDENCE | 497 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.881N P=0.881N |
|POLY 3 | P=0.520N P=0.520N |
|POLY 1.5 | P=0.368N P=0.368N |
|POLY 6 | P=0.794N P=0.794N |
|LOGISTIC REGRESSION| P=0.881N (e) |
|COCH-ARM / FISHERS | P=0.238N P=0.247N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Epididymis |
| Atypia Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/50 (18%) 9/50 (18%) |
|POLY-3 RATE (b) | 9/49.84 9/31.19 |
|POLY-3 PERCENT (g) | 18.1% 28.9% |
|TERMINAL (d) | 9/49 (18%) 1/3 (33%) |
|FIRST INCIDENCE | 497 (T) 373 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.232 P=0.232 |
|POLY 1.5 | P=0.379 P=0.379 |
|POLY 6 | P=0.104 P=0.104 |
|LOGISTIC REGRESSION| P=0.259 P=0.259 |
|COCH-ARM / FISHERS | P=0.603 P=0.602N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 32/50 (64%) 28/50 (56%) |
|POLY-3 RATE (b) | 32/49.84 28/40.39 |
|POLY-3 PERCENT (g) | 64.2% 69.3% |
|TERMINAL (d) | 32/49 (65%) 3/3 (100%) |
|FIRST INCIDENCE | 497 (T) 204 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.394 P=0.394 |
|POLY 1.5 | P=0.557N P=0.557N |
|POLY 6 | P=0.121 P=0.121 |
|LOGISTIC REGRESSION| P=0.297N P=0.297N |
|COCH-ARM / FISHERS | P=0.270N P=0.270N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Intestine Large, Cecum |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 3/49 (6%) |
|POLY-3 RATE (b) | 1/50.00 3/28.02 |
|POLY-3 PERCENT (g) | 2.0% 10.7% |
|TERMINAL (d) | 0/49 (0%) 0/3 (0%) |
|FIRST INCIDENCE | 468 412 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.018 * P=0.018 * |
|POLY 3 | P=0.210 P=0.208 |
|POLY 1.5 | P=0.236 P=0.235 |
|POLY 6 | P=0.223 P=0.220 |
|LOGISTIC REGRESSION| P=0.334 P=0.334 |
|COCH-ARM / FISHERS | P=0.298 P=0.301 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney |
| Hydronephrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/49.84 2/29.09 |
|POLY-3 PERCENT (g) | 0.0% 6.9% |
|TERMINAL (d) | 0/49 (0%) 0/3 (0%) |
|FIRST INCIDENCE | --- 204 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.103 P=0.103 |
|POLY 3 | P=0.226 P=0.226 |
|POLY 1.5 | P=0.218 P=0.218 |
|POLY 6 | P=0.310 P=0.310 |
|LOGISTIC REGRESSION| P=0.890 P=0.890 |
|COCH-ARM / FISHERS | P=0.238 P=0.247 |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 47/50 (94%) 38/50 (76%) |
|POLY-3 RATE (b) | 47/49.84 38/43.64 |
|POLY-3 PERCENT (g) | 94.3% 87.1% |
|TERMINAL (d) | 47/49 (96%) 3/3 (100%) |
|FIRST INCIDENCE | 497 (T) 266 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.169N P=0.169N |
|POLY 1.5 | P=0.056N P=0.056N |
|POLY 6 | P=0.475N P=0.475N |
|LOGISTIC REGRESSION| P=0.507N P=0.507N |
|COCH-ARM / FISHERS | P=0.013N* P=0.011N* |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/50.00 3/29.20 |
|POLY-3 PERCENT (g) | 2.0% 10.3% |
|TERMINAL (d) | 0/49 (0%) 0/3 (0%) |
|FIRST INCIDENCE | 468 373 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.045 * P=0.045 * |
|POLY 3 | P=0.212 P=0.212 |
|POLY 1.5 | P=0.241 P=0.241 |
|POLY 6 | P=0.217 P=0.217 |
|LOGISTIC REGRESSION| P=0.536 P=0.536 |
|COCH-ARM / FISHERS | P=0.305 P=0.309 |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 6/50 (12%) |
|POLY-3 RATE (b) | 0/49.84 6/30.56 |
|POLY-3 PERCENT (g) | 0.0% 19.6% |
|TERMINAL (d) | 0/49 (0%) 0/3 (0%) |
|FIRST INCIDENCE | --- 307 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.004 ** P=0.004 ** |
|POLY 1.5 | P=0.007 ** P=0.007 ** |
|POLY 6 | P=0.003 ** P=0.003 ** |
|LOGISTIC REGRESSION| P=0.064 P=0.064 |
|COCH-ARM / FISHERS | P=0.018 * P=0.013 * |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 4/50 (8%) |
|POLY-3 RATE (b) | 1/50.00 4/29.26 |
|POLY-3 PERCENT (g) | 2.0% 13.7% |
|TERMINAL (d) | 0/49 (0%) 0/3 (0%) |
|FIRST INCIDENCE | 468 388 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.004 ** P=0.004 ** |
|POLY 3 | P=0.097 P=0.097 |
|POLY 1.5 | P=0.122 P=0.122 |
|POLY 6 | P=0.090 P=0.090 |
|LOGISTIC REGRESSION| P=0.190 P=0.190 |
|COCH-ARM / FISHERS | P=0.179 P=0.181 |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/49.84 2/28.72 |
|POLY-3 PERCENT (g) | 0.0% 7.0% |
|TERMINAL (d) | 0/49 (0%) 0/3 (0%) |
|FIRST INCIDENCE | --- 408 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.092 P=0.092 |
|POLY 3 | P=0.227 P=0.227 |
|POLY 1.5 | P=0.218 P=0.218 |
|POLY 6 | P=0.313 P=0.313 |
|LOGISTIC REGRESSION| P=0.383 P=0.383 |
|COCH-ARM / FISHERS | P=0.238 P=0.247 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 32/50 (64%) 21/50 (42%) |
|POLY-3 RATE (b) | 32/49.84 21/38.20 |
|POLY-3 PERCENT (g) | 64.2% 55.0% |
|TERMINAL (d) | 32/49 (65%) 1/3 (33%) |
|FIRST INCIDENCE | 497 (T) 204 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.261N P=0.261N |
|POLY 1.5 | P=0.098N P=0.098N |
|POLY 6 | P=0.605 P=0.605 |
|LOGISTIC REGRESSION| P=0.013N* P=0.013N* |
|COCH-ARM / FISHERS | P=0.023N* P=0.022N* |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) |
|POLY-3 RATE (b) | 3/49.84 5/29.69 |
|POLY-3 PERCENT (g) | 6.0% 16.8% |
|TERMINAL (d) | 3/49 (6%) 1/3 (33%) |
|FIRST INCIDENCE | 497 (T) 373 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** P=0.003 ** |
|POLY 3 | P=0.172 P=0.172 |
|POLY 1.5 | P=0.238 P=0.238 |
|POLY 6 | P=0.121 P=0.121 |
|LOGISTIC REGRESSION| P=0.256 P=0.256 |
|COCH-ARM / FISHERS | P=0.356 P=0.357 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/49.84 3/29.01 |
|POLY-3 PERCENT (g) | 2.0% 10.3% |
|TERMINAL (d) | 1/49 (2%) 0/3 (0%) |
|FIRST INCIDENCE | 497 (T) 414 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.019 * P=0.019 * |
|POLY 3 | P=0.212 P=0.212 |
|POLY 1.5 | P=0.241 P=0.241 |
|POLY 6 | P=0.217 P=0.217 |
|LOGISTIC REGRESSION| P=0.311 P=0.311 |
|COCH-ARM / FISHERS | P=0.305 P=0.309 |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 15/50 (30%) |
|POLY-3 RATE (b) | 3/49.84 15/33.98 |
|POLY-3 PERCENT (g) | 6.0% 44.2% |
|TERMINAL (d) | 3/49 (6%) 1/3 (33%) |
|FIRST INCIDENCE | 497 (T) 318 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.004 ** P=0.004 ** |
|COCH-ARM / FISHERS | P=0.002 ** P=0.002 ** |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/49.84 2/28.47 |
|POLY-3 PERCENT (g) | 0.0% 7.0% |
|TERMINAL (d) | 0/49 (0%) 0/3 (0%) |
|FIRST INCIDENCE | --- 440 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.022 * P=0.022 * |
|POLY 3 | P=0.228 P=0.228 |
|POLY 1.5 | P=0.218 P=0.218 |
|POLY 6 | P=0.319 P=0.319 |
|LOGISTIC REGRESSION| P=0.194 P=0.194 |
|COCH-ARM / FISHERS | P=0.238 P=0.247 |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) |
|POLY-3 RATE (b) | 0/49.84 4/30.00 |
|POLY-3 PERCENT (g) | 0.0% 13.3% |
|TERMINAL (d) | 0/49 (0%) 0/3 (0%) |
|FIRST INCIDENCE | --- 307 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.024 * P=0.024 * |
|POLY 3 | P=0.033 * P=0.033 * |
|POLY 1.5 | P=0.041 * P=0.041 * |
|POLY 6 | P=0.035 * P=0.035 * |
|LOGISTIC REGRESSION| P=0.301 P=0.301 |
|COCH-ARM / FISHERS | P=0.063 P=0.059 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 4/50 (8%) |
|POLY-3 RATE (b) | 4/49.84 4/30.12 |
|POLY-3 PERCENT (g) | 8.0% 13.3% |
|TERMINAL (d) | 4/49 (8%) 0/3 (0%) |
|FIRST INCIDENCE | 497 (T) 321 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.076 P=0.076 |
|POLY 3 | P=0.419 P=0.419 |
|POLY 1.5 | P=0.513 P=0.513 |
|POLY 6 | P=0.326 P=0.326 |
|LOGISTIC REGRESSION| P=0.457N P=0.457N |
|COCH-ARM / FISHERS | P=0.644 P=0.643N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/50 (16%) 0/50 (0%) |
|POLY-3 RATE (b) | 8/49.84 0/27.85 |
|POLY-3 PERCENT (g) | 16.1% 0.0% |
|TERMINAL (d) | 8/49 (16%) 0/3 (0%) |
|FIRST INCIDENCE | 497 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.525N P=0.525N |
|POLY 3 | P=0.060N P=0.060N |
|POLY 1.5 | P=0.018N* P=0.018N* |
|POLY 6 | P=0.258N P=0.258N |
|LOGISTIC REGRESSION| P=0.525N (e) |
|COCH-ARM / FISHERS | P=0.005N** P=0.003N** |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 7/50 (14%) |
|POLY-3 RATE (b) | 3/49.84 7/30.51 |
|POLY-3 PERCENT (g) | 6.0% 22.9% |
|TERMINAL (d) | 3/49 (6%) 1/3 (33%) |
|FIRST INCIDENCE | 497 (T) 314 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.046 * P=0.046 * |
|POLY 1.5 | P=0.080 P=0.080 |
|POLY 6 | P=0.024 * P=0.024 * |
|LOGISTIC REGRESSION| P=0.143 P=0.143 |
|COCH-ARM / FISHERS | P=0.159 P=0.159 |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 23/50 (46%) |
|POLY-3 RATE (b) | 0/49.84 23/38.52 |
|POLY-3 PERCENT (g) | 0.0% 59.7% |
|TERMINAL (d) | 0/49 (0%) 1/3 (33%) |
|FIRST INCIDENCE | --- 204 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 48/50 (96%) 37/50 (74%) |
|POLY-3 RATE (b) | 48/49.84 37/46.07 |
|POLY-3 PERCENT (g) | 96.3% 80.3% |
|TERMINAL (d) | 48/49 (98%) 2/3 (67%) |
|FIRST INCIDENCE | 497 (T) 204 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.007N** P=0.007N** |
|POLY 1.5 | P=0.004N** P=0.004N** |
|POLY 6 | P=0.024N* P=0.024N* |
|LOGISTIC REGRESSION| P<0.001N** P<0.001N** |
|COCH-ARM / FISHERS | P=0.003N** P=0.002N** |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Cytomegaly |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 32/50 (64%) |
|POLY-3 RATE (b) | 0/49.84 32/42.85 |
|POLY-3 PERCENT (g) | 0.0% 74.7% |
|TERMINAL (d) | 0/49 (0%) 1/3 (33%) |
|FIRST INCIDENCE | --- 266 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Hyperplasia Regenerative |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 49/50 (98%) |
|POLY-3 RATE (b) | 0/49.84 49/49.58 |
|POLY-3 PERCENT (g) | 0.0% 98.8% |
|TERMINAL (d) | 0/49 (0%) 3/3 (100%) |
|FIRST INCIDENCE | --- 204 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 30/50 (60%) 5/50 (10%) |
|POLY-3 RATE (b) | 30/49.84 5/30.96 |
|POLY-3 PERCENT (g) | 60.2% 16.2% |
|TERMINAL (d) | 30/49 (61%) 0/3 (0%) |
|FIRST INCIDENCE | 497 (T) 266 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.290 P=0.290 |
|POLY 3 | P<0.001N** P<0.001N** |
|POLY 1.5 | P<0.001N** P<0.001N** |
|POLY 6 | P=0.011N* P=0.011N* |
|LOGISTIC REGRESSION| P<0.001N** P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** P<0.001N** |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 5/50 (10%) |
|POLY-3 RATE (b) | 0/49.84 5/30.23 |
|POLY-3 PERCENT (g) | 0.0% 16.5% |
|TERMINAL (d) | 0/49 (0%) 0/3 (0%) |
|FIRST INCIDENCE | --- 364 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.004 ** P=0.004 ** |
|POLY 3 | P=0.012 * P=0.012 * |
|POLY 1.5 | P=0.017 * P=0.017 * |
|POLY 6 | P=0.011 * P=0.011 * |
|LOGISTIC REGRESSION| P=0.112 P=0.112 |
|COCH-ARM / FISHERS | P=0.033 * P=0.028 * |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 21/50 (42%) |
|POLY-3 RATE (b) | 1/49.84 21/36.82 |
|POLY-3 PERCENT (g) | 2.0% 57.0% |
|TERMINAL (d) | 1/49 (2%) 0/3 (0%) |
|FIRST INCIDENCE | 497 (T) 266 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 41/50 (82%) 32/50 (64%) |
|POLY-3 RATE (b) | 41/50.00 32/40.80 |
|POLY-3 PERCENT (g) | 82.0% 78.4% |
|TERMINAL (d) | 40/49 (82%) 2/3 (67%) |
|FIRST INCIDENCE | 468 321 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.446N P=0.446N |
|POLY 1.5 | P=0.192N P=0.192N |
|POLY 6 | P=0.472 P=0.472 |
|LOGISTIC REGRESSION| P=0.548 P=0.548 |
|COCH-ARM / FISHERS | P=0.036N* P=0.035N* |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Metaplasia Osseous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/50.00 1/28.08 |
|POLY-3 PERCENT (g) | 4.0% 3.6% |
|TERMINAL (d) | 1/49 (2%) 0/3 (0%) |
|FIRST INCIDENCE | 468 457 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.337 P=0.337 |
|POLY 3 | P=0.775N P=0.775N |
|POLY 1.5 | P=0.651N P=0.651N |
|POLY 6 | P=0.842 P=0.842 |
|LOGISTIC REGRESSION| P=0.820 P=0.820 |
|COCH-ARM / FISHERS | P=0.500N P=0.500N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/49.84 1/28.30 |
|POLY-3 PERCENT (g) | 6.0% 3.5% |
|TERMINAL (d) | 3/49 (6%) 0/3 (0%) |
|FIRST INCIDENCE | 497 (T) 407 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.521 P=0.521 |
|POLY 3 | P=0.614N P=0.614N |
|POLY 1.5 | P=0.462N P=0.462N |
|POLY 6 | P=0.832N P=0.832N |
|LOGISTIC REGRESSION| P=0.654N P=0.654N |
|COCH-ARM / FISHERS | P=0.305N P=0.309N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/49.84 1/28.32 |
|POLY-3 PERCENT (g) | 4.0% 3.5% |
|TERMINAL (d) | 2/49 (4%) 0/3 (0%) |
|FIRST INCIDENCE | 497 (T) 402 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.499 P=0.499 |
|POLY 3 | P=0.770N P=0.770N |
|POLY 1.5 | P=0.648N P=0.648N |
|POLY 6 | P=0.839 P=0.839 |
|LOGISTIC REGRESSION| P=0.733N P=0.733N |
|COCH-ARM / FISHERS | P=0.500N P=0.500N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 11/50 (22%) |
|POLY-3 RATE (b) | 3/49.84 11/31.82 |
|POLY-3 PERCENT (g) | 6.0% 34.6% |
|TERMINAL (d) | 3/49 (6%) 1/3 (33%) |
|FIRST INCIDENCE | 497 (T) 373 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.002 ** P=0.002 ** |
|POLY 1.5 | P=0.005 ** P=0.005 ** |
|POLY 6 | P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.006 ** P=0.006 ** |
|COCH-ARM / FISHERS | P=0.022 * P=0.020 * |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 20/50 (40%) |
|POLY-3 RATE (b) | 3/49.84 20/36.43 |
|POLY-3 PERCENT (g) | 6.0% 54.9% |
|TERMINAL (d) | 3/49 (6%) 1/3 (33%) |
|FIRST INCIDENCE | 497 (T) 307 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/50 (20%) 20/50 (40%) |
|POLY-3 RATE (b) | 10/49.84 20/35.37 |
|POLY-3 PERCENT (g) | 20.1% 56.6% |
|TERMINAL (d) | 10/49 (20%) 2/3 (67%) |
|FIRST INCIDENCE | 497 (T) 314 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.003 ** P=0.003 ** |
|POLY 6 | P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.003 ** P=0.003 ** |
|COCH-ARM / FISHERS | P=0.025 * P=0.024 * |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) |
|POLY-3 RATE (b) | 0/49.84 4/29.37 |
|POLY-3 PERCENT (g) | 0.0% 13.6% |
|TERMINAL (d) | 0/49 (0%) 0/3 (0%) |
|FIRST INCIDENCE | --- 407 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.004 ** P=0.004 ** |
|POLY 3 | P=0.033 * P=0.033 * |
|POLY 1.5 | P=0.040 * P=0.040 * |
|POLY 6 | P=0.036 * P=0.036 * |
|LOGISTIC REGRESSION| P=0.070 P=0.070 |
|COCH-ARM / FISHERS | P=0.063 P=0.059 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 8/50 (16%) |
|POLY-3 RATE (b) | 1/49.84 8/31.08 |
|POLY-3 PERCENT (g) | 2.0% 25.7% |
|TERMINAL (d) | 1/49 (2%) 1/3 (33%) |
|FIRST INCIDENCE | 497 (T) 327 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.003 ** P=0.003 ** |
|POLY 1.5 | P=0.006 ** P=0.006 ** |
|POLY 6 | P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.034 * P=0.034 * |
|COCH-ARM / FISHERS | P=0.018 * P=0.015 * |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/13 (0%) 2/39 (5%) |
|POLY-3 RATE (b) | 0/13.00 2/22.87 |
|POLY-3 PERCENT (g) | 0.0% 8.8% |
|TERMINAL (d) | 0/13 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- 373 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.069 P=0.069 |
|POLY 3 | P=0.337 P=0.252 |
|POLY 1.5 | P=0.395 P=0.287 |
|POLY 6 | P=0.253 P=0.224 |
|LOGISTIC REGRESSION| P=0.606 P=0.606 |
|COCH-ARM / FISHERS | P=0.500 P=0.559 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/13 (0%) 2/39 (5%) |
|POLY-3 RATE (b) | 0/13.00 2/22.87 |
|POLY-3 PERCENT (g) | 0.0% 8.8% |
|TERMINAL (d) | 0/13 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- 373 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.069 P=0.069 |
|POLY 3 | P=0.337 P=0.252 |
|POLY 1.5 | P=0.395 P=0.287 |
|POLY 6 | P=0.253 P=0.224 |
|LOGISTIC REGRESSION| P=0.606 P=0.606 |
|COCH-ARM / FISHERS | P=0.500 P=0.559 |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node: Renal |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/13 (0%) 3/39 (8%) |
|POLY-3 RATE (b) | 0/13.00 3/23.51 |
|POLY-3 PERCENT (g) | 0.0% 12.8% |
|TERMINAL (d) | 0/13 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- 321 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.030 * P=0.030 * |
|POLY 3 | P=0.226 P=0.149 |
|POLY 1.5 | P=0.290 P=0.189 |
|POLY 6 | P=0.136 P=0.110 |
|LOGISTIC REGRESSION| P=0.591 P=0.591 |
|COCH-ARM / FISHERS | P=0.366 P=0.414 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node: Renal |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/13 (0%) 3/39 (8%) |
|POLY-3 RATE (b) | 0/13.00 3/23.51 |
|POLY-3 PERCENT (g) | 0.0% 12.8% |
|TERMINAL (d) | 0/13 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- 321 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.030 * P=0.030 * |
|POLY 3 | P=0.226 P=0.149 |
|POLY 1.5 | P=0.290 P=0.189 |
|POLY 6 | P=0.136 P=0.110 |
|LOGISTIC REGRESSION| P=0.591 P=0.591 |
|COCH-ARM / FISHERS | P=0.366 P=0.414 |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/42 (12%) 2/38 (5%) |
|POLY-3 RATE (b) | 5/41.84 2/22.02 |
|POLY-3 PERCENT (g) | 12.0% 9.1% |
|TERMINAL (d) | 5/41 (12%) 0/2 (0%) |
|FIRST INCIDENCE | 497 (T) 321 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.307 P=0.307 |
|POLY 3 | P=0.614N P=0.609N |
|POLY 1.5 | P=0.447N P=0.443N |
|POLY 6 | P=0.767 P=0.761 |
|LOGISTIC REGRESSION| P=0.287N P=0.287N |
|COCH-ARM / FISHERS | P=0.257N P=0.259N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/8 (88%) 3/9 (33%) |
|POLY-3 RATE (b) | 7/8.00 3/6.53 |
|POLY-3 PERCENT (g) | 87.5% 46.0% |
|TERMINAL (d) | 6/7 (86%) 0/0 (0%) |
|FIRST INCIDENCE | 468 397 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.068 P=0.068 |
|POLY 3 | P=0.110N P=0.113N |
|POLY 1.5 | P=0.051N P=0.052N |
|POLY 6 | P=0.309N P=0.318N |
|LOGISTIC REGRESSION| P=0.201N P=0.201N |
|COCH-ARM / FISHERS | P=0.038N* P=0.036N* |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Nose |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/50 (10%) 5/50 (10%) |
|POLY-3 RATE (b) | 5/49.84 5/30.11 |
|POLY-3 PERCENT (g) | 10.0% 16.6% |
|TERMINAL (d) | 5/49 (10%) 0/3 (0%) |
|FIRST INCIDENCE | 497 (T) 364 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.014 * P=0.014 * |
|POLY 3 | P=0.364 P=0.364 |
|POLY 1.5 | P=0.474 P=0.474 |
|POLY 6 | P=0.254 P=0.254 |
|LOGISTIC REGRESSION| P=0.638 P=0.638 |
|COCH-ARM / FISHERS | P=0.631 P=0.630N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Nose |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/49.84 2/28.84 |
|POLY-3 PERCENT (g) | 2.0% 6.9% |
|TERMINAL (d) | 1/49 (2%) 0/3 (0%) |
|FIRST INCIDENCE | 497 (T) 364 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.136 P=0.136 |
|POLY 3 | P=0.424 P=0.424 |
|POLY 1.5 | P=0.444 P=0.444 |
|POLY 6 | P=0.461 P=0.461 |
|LOGISTIC REGRESSION| P=0.714 P=0.714 |
|COCH-ARM / FISHERS | P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Nose |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/50 (14%) 5/50 (10%) |
|POLY-3 RATE (b) | 7/50.00 5/29.81 |
|POLY-3 PERCENT (g) | 14.0% 16.8% |
|TERMINAL (d) | 6/49 (12%) 0/3 (0%) |
|FIRST INCIDENCE | 468 400 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.011 * P=0.011 * |
|POLY 3 | P=0.547 P=0.547 |
|POLY 1.5 | P=0.607N P=0.607N |
|POLY 6 | P=0.390 P=0.390 |
|LOGISTIC REGRESSION| P=0.655 P=0.655 |
|COCH-ARM / FISHERS | P=0.379N P=0.380N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/50 (14%) 6/50 (12%) |
|POLY-3 RATE (b) | 7/49.84 6/30.62 |
|POLY-3 PERCENT (g) | 14.1% 19.6% |
|TERMINAL (d) | 7/49 (14%) 0/3 (0%) |
|FIRST INCIDENCE | 497 (T) 364 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.010 * P=0.010 * |
|POLY 3 | P=0.416 P=0.416 |
|POLY 1.5 | P=0.551 P=0.551 |
|POLY 6 | P=0.267 P=0.267 |
|LOGISTIC REGRESSION| P=0.643N P=0.643N |
|COCH-ARM / FISHERS | P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Pancreas |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/50 (14%) 7/50 (14%) |
|POLY-3 RATE (b) | 7/49.84 7/30.71 |
|POLY-3 PERCENT (g) | 14.1% 22.8% |
|TERMINAL (d) | 7/49 (14%) 1/3 (33%) |
|FIRST INCIDENCE | 497 (T) 266 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.288 P=0.288 |
|POLY 1.5 | P=0.423 P=0.423 |
|POLY 6 | P=0.158 P=0.158 |
|LOGISTIC REGRESSION| P=0.569 P=0.569 |
|COCH-ARM / FISHERS | P=0.613 P=0.613N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 2/49 (4%) |
|POLY-3 RATE (b) | 4/49.84 2/28.19 |
|POLY-3 PERCENT (g) | 8.0% 7.1% |
|TERMINAL (d) | 4/49 (8%) 0/3 (0%) |
|FIRST INCIDENCE | 497 (T) 373 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.253 P=0.253 |
|POLY 3 | P=0.681N P=0.680N |
|POLY 1.5 | P=0.527N P=0.527N |
|POLY 6 | P=0.718 P=0.716 |
|LOGISTIC REGRESSION| P=0.535N P=0.535N |
|COCH-ARM / FISHERS | P=0.346N P=0.349N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/50 (10%) 4/49 (8%) |
|POLY-3 RATE (b) | 5/49.84 4/28.94 |
|POLY-3 PERCENT (g) | 10.0% 13.8% |
|TERMINAL (d) | 5/49 (10%) 0/3 (0%) |
|FIRST INCIDENCE | 497 (T) 375 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.033 * P=0.033 * |
|POLY 3 | P=0.509 P=0.509 |
|POLY 1.5 | P=0.614 P=0.614 |
|POLY 6 | P=0.399 P=0.397 |
|LOGISTIC REGRESSION| P=0.686 P=0.686 |
|COCH-ARM / FISHERS | P=0.513N P=0.513N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 24/50 (48%) 16/50 (32%) |
|POLY-3 RATE (b) | 24/50.00 16/34.36 |
|POLY-3 PERCENT (g) | 48.0% 46.6% |
|TERMINAL (d) | 23/49 (47%) 0/3 (0%) |
|FIRST INCIDENCE | 468 297 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.560N P=0.560N |
|POLY 1.5 | P=0.290N P=0.290N |
|POLY 6 | P=0.332 P=0.332 |
|LOGISTIC REGRESSION| P=0.532N P=0.532N |
|COCH-ARM / FISHERS | P=0.077N P=0.076N |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 18/50 (36%) 15/50 (30%) |
|POLY-3 RATE (b) | 18/49.84 15/34.35 |
|POLY-3 PERCENT (g) | 36.1% 43.7% |
|TERMINAL (d) | 18/49 (37%) 1/3 (33%) |
|FIRST INCIDENCE | 497 (T) 307 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.343 P=0.343 |
|POLY 1.5 | P=0.557 P=0.557 |
|POLY 6 | P=0.127 P=0.127 |
|LOGISTIC REGRESSION| P=0.601N P=0.601N |
|COCH-ARM / FISHERS | P=0.335N P=0.335N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Salivary Glands |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/49.84 2/29.13 |
|POLY-3 PERCENT (g) | 0.0% 6.9% |
|TERMINAL (d) | 0/49 (0%) 0/3 (0%) |
|FIRST INCIDENCE | --- 297 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.194 P=0.194 |
|POLY 3 | P=0.226 P=0.226 |
|POLY 1.5 | P=0.218 P=0.218 |
|POLY 6 | P=0.307 P=0.307 |
|LOGISTIC REGRESSION| P=0.762 P=0.762 |
|COCH-ARM / FISHERS | P=0.238 P=0.247 |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Skeletal Muscle |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/1 (0%) 3/5 (60%) |
|POLY-3 RATE (b) | 0/0.84 3/3.91 |
|POLY-3 PERCENT (g) | 0.0% 76.8% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 388 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.017 * P=0.017 * |
|POLY 3 | P=1.000 P=0.146 |
|POLY 1.5 | P=1.000 P=0.188 |
|POLY 6 | P=1.000 P=0.102 |
|LOGISTIC REGRESSION| P=0.488 P=0.488 |
|COCH-ARM / FISHERS | P=0.500 P=0.500 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Spleen |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 24/49 (49%) |
|POLY-3 RATE (b) | 0/49.84 24/38.55 |
|POLY-3 PERCENT (g) | 0.0% 62.3% |
|TERMINAL (d) | 0/49 (0%) 1/3 (33%) |
|FIRST INCIDENCE | --- 266 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 23/49 (47%) |
|POLY-3 RATE (b) | 1/49.84 23/36.96 |
|POLY-3 PERCENT (g) | 2.0% 62.2% |
|TERMINAL (d) | 1/49 (2%) 1/3 (33%) |
|FIRST INCIDENCE | 497 (T) 307 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/49.84 2/28.93 |
|POLY-3 PERCENT (g) | 0.0% 6.9% |
|TERMINAL (d) | 0/49 (0%) 0/3 (0%) |
|FIRST INCIDENCE | --- 318 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.106 P=0.106 |
|POLY 3 | P=0.227 P=0.227 |
|POLY 1.5 | P=0.218 P=0.218 |
|POLY 6 | P=0.310 P=0.310 |
|LOGISTIC REGRESSION| P=0.604 P=0.604 |
|COCH-ARM / FISHERS | P=0.238 P=0.247 |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/49.84 3/28.97 |
|POLY-3 PERCENT (g) | 0.0% 10.4% |
|TERMINAL (d) | 0/49 (0%) 0/3 (0%) |
|FIRST INCIDENCE | --- 373 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.009 ** P=0.009 ** |
|POLY 3 | P=0.088 P=0.088 |
|POLY 1.5 | P=0.093 P=0.093 |
|POLY 6 | P=0.111 P=0.111 |
|LOGISTIC REGRESSION| P=0.147 P=0.147 |
|COCH-ARM / FISHERS | P=0.121 P=0.121 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 10/50 (20%) |
|POLY-3 RATE (b) | 0/49.84 10/32.85 |
|POLY-3 PERCENT (g) | 0.0% 30.4% |
|TERMINAL (d) | 0/49 (0%) 0/3 (0%) |
|FIRST INCIDENCE | --- 297 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.034 * P=0.034 * |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 6/50 (12%) |
|POLY-3 RATE (b) | 0/49.84 6/30.82 |
|POLY-3 PERCENT (g) | 0.0% 19.5% |
|TERMINAL (d) | 0/49 (0%) 0/3 (0%) |
|FIRST INCIDENCE | --- 297 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** P=0.002 ** |
|POLY 3 | P=0.005 ** P=0.005 ** |
|POLY 1.5 | P=0.007 ** P=0.007 ** |
|POLY 6 | P=0.003 ** P=0.003 ** |
|LOGISTIC REGRESSION| P=0.110 P=0.110 |
|COCH-ARM / FISHERS | P=0.018 * P=0.013 * |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Testes |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 6/50 (12%) |
|POLY-3 RATE (b) | 3/49.84 6/30.05 |
|POLY-3 PERCENT (g) | 6.0% 20.0% |
|TERMINAL (d) | 3/49 (6%) 1/3 (33%) |
|FIRST INCIDENCE | 497 (T) 398 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.092 P=0.092 |
|POLY 1.5 | P=0.141 P=0.141 |
|POLY 6 | P=0.056 P=0.056 |
|LOGISTIC REGRESSION| P=0.150 P=0.150 |
|COCH-ARM / FISHERS | P=0.242 P=0.243 |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 22/50 (44%) 12/50 (24%) |
|POLY-3 RATE (b) | 22/50.00 12/30.56 |
|POLY-3 PERCENT (g) | 44.0% 39.3% |
|TERMINAL (d) | 21/49 (43%) 2/3 (67%) |
|FIRST INCIDENCE | 468 411 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.464N P=0.464N |
|POLY 1.5 | P=0.176N P=0.176N |
|POLY 6 | P=0.395 P=0.395 |
|LOGISTIC REGRESSION| P=0.023 * P=0.023 * |
|COCH-ARM / FISHERS | P=0.029N* P=0.028N* |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Thymus |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 4/49 (8%) |
|POLY-3 RATE (b) | 0/48.84 4/29.62 |
|POLY-3 PERCENT (g) | 0.0% 13.5% |
|TERMINAL (d) | 0/48 (0%) 0/3 (0%) |
|FIRST INCIDENCE | --- 266 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.021 * P=0.021 * |
|POLY 3 | P=0.033 * P=0.033 * |
|POLY 1.5 | P=0.041 * P=0.041 * |
|POLY 6 | P=0.035 * P=0.035 * |
|LOGISTIC REGRESSION| P=0.417 P=0.417 |
|COCH-ARM / FISHERS | P=0.063 P=0.059 |
|=================================================================================================================================|
Date: 12/15/00 EXPERIMENT: 05161 TEST: 05 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - RIDDELLIINE
Terminal Sacrifice at 71 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 1.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) |
|POLY-3 RATE (b) | 4/49.84 1/28.43 |
|POLY-3 PERCENT (g) | 8.0% 3.5% |
|TERMINAL (d) | 4/49 (8%) 0/3 (0%) |
|FIRST INCIDENCE | 497 (T) 373 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.603 P=0.603 |
|POLY 3 | P=0.473N P=0.473N |
|POLY 1.5 | P=0.317N P=0.317N |
|POLY 6 | P=0.736N P=0.736N |
|LOGISTIC REGRESSION| P=0.390N P=0.390N |
|COCH-ARM / FISHERS | P=0.179N P=0.181N |
|=================================================================================================================================|
(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).