TDMS Study 56348-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus CITRAL DATE: 06/01/00
EXPERIMENT: 56348 TEST: 03 TIME: 16:41:21
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55384 ROUTE: DOSED FEED NTP C#: C56348
PATHOLOGIST: SINGER, ALLEN CAS: 5392-40-5
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF CITRAL
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Heart Cardiomyopathy
Thrombosis
Liver Angiectasis
Pituitary Gland: Pars Distalis Hyperplasia
Prostate Inflammation Chronic
Skin Hyperkeratosis
Stomach, Forestomach: Epithelium Hyperplasia
Thyroid Gland: C-Cell Hyperplasia
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Hypertrophy
Clitoral Gland Hyperplasia
Inflammation
Heart Cardiomyopathy
Liver Basophilic Focus
Liver: Bile Duct Hyperplasia
Lymph Node, Mandibular Ectasia
Hyperplasia
Ovary Cyst
Stomach, Forestomach: Epithelium Hyperplasia
===============================================================
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.7% | 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/22 (0%) | 0/35 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- 639 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.225 | (e) |
|POLY 3 | P=0.234 | (e) |
|POLY 1.5 | P=0.235 | (e) |
|POLY 6 | P=0.231 | (e) |
|LOGISTIC REGRESSION| P=0.253 | (e) |
|COCH-ARM / FISHERS | P=0.247 | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 13/50 (26%) | 14/50 (28%) 16/50 (32%) |
|POLY-3 ADJUSTED (b)| 26.9% 30.0% | 30.6% 33.8% |
|TERMINAL (d) | 8/30 (27%) 6/22 (27%) | 12/35 (34%) 14/40 (35%) |
|FIRST INCIDENCE | 600 617 | 627 677 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.288 | P=0.584 |
|POLY 3 | P=0.469 | P=0.457 |
|POLY 1.5 | P=0.481 | P=0.428 |
|POLY 6 | P=0.452 | P=0.496 |
|LOGISTIC REGRESSION| P=0.460 | P=0.514 |
|COCH-ARM / FISHERS | P=0.500 | P=0.414 |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) | 10/50 (20%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% | 21.9% 8.5% |
|TERMINAL (d) | 0/30 (0%) 0/22 (0%) | 9/35 (26%) 4/40 (10%) |
|FIRST INCIDENCE | --- --- | 627 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.043N* |
|POLY 3 | (e) | P=0.062N |
|POLY 1.5 | (e) | P=0.069N |
|POLY 6 | (e) | P=0.054N |
|LOGISTIC REGRESSION| (e) | P=0.053N |
|COCH-ARM / FISHERS | (e) | P=0.074N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.8% 2.4% | 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/22 (0%) | 0/35 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 549 660 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.358N | (e) |
|POLY 3 | P=0.330N | (e) |
|POLY 1.5 | P=0.320N | (e) |
|POLY 6 | P=0.347N | (e) |
|LOGISTIC REGRESSION| P=0.278N | (e) |
|COCH-ARM / FISHERS | P=0.309N | (e) |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 7/50 (14%) | 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 9.1% 16.3% | 2.2% 4.2% |
|TERMINAL (d) | 1/30 (3%) 4/22 (18%) | 0/35 (0%) 2/40 (5%) |
|FIRST INCIDENCE | 660 509 | 622 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.179 | P=0.538 |
|POLY 3 | P=0.245 | P=0.508 |
|POLY 1.5 | P=0.253 | P=0.502 |
|POLY 6 | P=0.232 | P=0.515 |
|LOGISTIC REGRESSION| P=0.264 | P=0.500 |
|COCH-ARM / FISHERS | P=0.262 | P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 16/50 (32%) | 8/49 (16%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 27.3% 36.9% | 17.9% 6.3% |
|TERMINAL (d) | 9/30 (30%) 7/22 (32%) | 5/34 (15%) 1/40 (3%) |
|FIRST INCIDENCE | 674 623 | 627 697 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.101 | P=0.073N |
|POLY 3 | P=0.229 | P=0.081N |
|POLY 1.5 | P=0.237 | P=0.088N |
|POLY 6 | P=0.221 | P=0.072N |
|LOGISTIC REGRESSION| P=0.185 | P=0.091N |
|COCH-ARM / FISHERS | P=0.252 | P=0.094N |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Bone |
| Osteopetrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) | 3/50 (6%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% | 6.6% 6.3% |
|TERMINAL (d) | 0/30 (0%) 0/22 (0%) | 3/35 (9%) 1/40 (3%) |
|FIRST INCIDENCE | --- --- | 732 (T) 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.597N |
|POLY 3 | (e) | P=0.637N |
|POLY 1.5 | (e) | P=0.652N |
|POLY 6 | (e) | P=0.615N |
|LOGISTIC REGRESSION| (e) | P=0.648N |
|COCH-ARM / FISHERS | (e) | P=0.661N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 16/50 (32%) | 11/50 (22%) 9/50 (18%) |
|POLY-3 ADJUSTED (b)| 31.1% 36.0% | 23.5% 18.6% |
|TERMINAL (d) | 10/30 (33%) 9/22 (41%) | 5/35 (14%) 5/40 (13%) |
|FIRST INCIDENCE | 610 365 | 588 62 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.198 | P=0.333N |
|POLY 3 | P=0.396 | P=0.366N |
|POLY 1.5 | P=0.406 | P=0.381N |
|POLY 6 | P=0.371 | P=0.347N |
|LOGISTIC REGRESSION| P=0.416 | P=0.409N |
|COCH-ARM / FISHERS | P=0.414 | P=0.402N |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Bone Marrow |
| Myelofibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) | 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.5% 4.8% | 2.2% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/22 (0%) | 0/35 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 589 660 | 636 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.672 | P=0.473N |
|POLY 3 | P=0.681 | P=0.487N |
|POLY 1.5 | P=0.686 | P=0.496N |
|POLY 6 | P=0.673 | P=0.476N |
|LOGISTIC REGRESSION| P=0.663N | P=0.477N |
|COCH-ARM / FISHERS | P=0.691N | P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Brain |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 9/50 (18%) | 3/50 (6%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 11.3% 20.4% | 6.5% 4.2% |
|TERMINAL (d) | 0/30 (0%) 1/22 (5%) | 0/35 (0%) 1/40 (3%) |
|FIRST INCIDENCE | 674 610 | 508 677 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.160 | P=0.454N |
|POLY 3 | P=0.188 | P=0.491N |
|POLY 1.5 | P=0.190 | P=0.500N |
|POLY 6 | P=0.187 | P=0.479N |
|LOGISTIC REGRESSION| P=0.214 | P=0.461N |
|COCH-ARM / FISHERS | P=0.194 | P=0.500N |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | | 7/49 (14%) 17/49 (35%) |
|POLY-3 ADJUSTED (b)| | 15.7% 36.6% |
|TERMINAL (d) | | 7/35 (20%) 14/40 (35%) |
|FIRST INCIDENCE | | 732 (T) 694 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.040 * |
|POLY 3 | | P=0.019 * |
|POLY 1.5 | | P=0.016 * |
|POLY 6 | | P=0.024 * |
|LOGISTIC REGRESSION| | P=0.029 * |
|COCH-ARM / FISHERS | | P=0.017 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | | 13/49 (27%) 22/49 (45%) |
|POLY-3 ADJUSTED (b)| | 28.6% 46.8% |
|TERMINAL (d) | | 9/35 (26%) 20/40 (50%) |
|FIRST INCIDENCE | | 595 491 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.114 |
|POLY 3 | | P=0.052 |
|POLY 1.5 | | P=0.046 * |
|POLY 6 | | P=0.061 |
|LOGISTIC REGRESSION| | P=0.049 * |
|COCH-ARM / FISHERS | | P=0.046 * |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Clitoral Gland: Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | | 5/49 (10%) 5/49 (10%) |
|POLY-3 ADJUSTED (b)| | 11.2% 10.8% |
|TERMINAL (d) | | 4/35 (11%) 4/40 (10%) |
|FIRST INCIDENCE | | 719 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.549N |
|POLY 3 | | P=0.603N |
|POLY 1.5 | | P=0.621N |
|POLY 6 | | P=0.580N |
|LOGISTIC REGRESSION| | P=0.581N |
|COCH-ARM / FISHERS | | P=0.630N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Eye |
| Cataract |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/1 (100%) 3/3 (100%) | 2/2 (100%) 2/3 (67%) |
|POLY-3 ADJUSTED (b)| 100.0% 100.0% | 100.0% 68.9% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) | 2/2 (100%) 1/1 (100%) |
|FIRST INCIDENCE | 505 674 | 732 (T) 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.524 |
|POLY 3 | (e) | P=0.530N |
|POLY 1.5 | (e) | P=0.515N |
|POLY 6 | (e) | P=0.564N |
|LOGISTIC REGRESSION| (e) | P=0.821N |
|COCH-ARM / FISHERS | (e) | P=0.600N |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Eye: Retina |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/1 (100%) 3/3 (100%) | 2/2 (100%) 2/3 (67%) |
|POLY-3 ADJUSTED (b)| 100.0% 100.0% | 100.0% 68.9% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) | 2/2 (100%) 1/1 (100%) |
|FIRST INCIDENCE | 505 674 | 732 (T) 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.524 |
|POLY 3 | (e) | P=0.530N |
|POLY 1.5 | (e) | P=0.515N |
|POLY 6 | (e) | P=0.564N |
|LOGISTIC REGRESSION| (e) | P=0.821N |
|COCH-ARM / FISHERS | (e) | P=0.600N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 39/50 (78%) 43/50 (86%) | 41/50 (82%) 48/50 (96%) |
|POLY-3 ADJUSTED (b)| 81.1% 90.0% | 86.5% 98.0% |
|TERMINAL (d) | 26/30 (87%) 22/22 (100%) | 32/35 (91%) 39/40 (98%) |
|FIRST INCIDENCE | 450 365 | 508 491 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.029 * | P=0.456 |
|POLY 3 | P=0.151 | P=0.026 * |
|POLY 1.5 | P=0.180 | P=0.016 * |
|POLY 6 | P=0.111 | P=0.064 |
|LOGISTIC REGRESSION| P=0.181 | P=0.028 * |
|COCH-ARM / FISHERS | P=0.218 | P=0.026 * |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Heart |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.7% | 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/22 (0%) | 0/35 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- 365 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.245 | (e) |
|POLY 3 | P=0.235 | (e) |
|POLY 1.5 | P=0.236 | (e) |
|POLY 6 | P=0.233 | (e) |
|LOGISTIC REGRESSION| P=0.373 | (e) |
|COCH-ARM / FISHERS | P=0.247 | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Heart |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 6/50 (12%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 13.8% | 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/22 (0%) | 0/35 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- 365 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.016 * | (e) |
|POLY 3 | P=0.015 * | (e) |
|POLY 1.5 | P=0.015 * | (e) |
|POLY 6 | P=0.015 * | (e) |
|LOGISTIC REGRESSION| P=0.024 * | (e) |
|COCH-ARM / FISHERS | P=0.013 * | (e) |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Intestine Large, Cecum |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.3% 4.7% | 0.0% 0.0% |
|TERMINAL (d) | 1/30 (3%) 0/22 (0%) | 0/35 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 726 (T) 446 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.447 | (e) |
|POLY 3 | P=0.495 | (e) |
|POLY 1.5 | P=0.497 | (e) |
|POLY 6 | P=0.491 | (e) |
|LOGISTIC REGRESSION| P=0.557 | (e) |
|COCH-ARM / FISHERS | P=0.500 | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Intestine Large, Colon |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) | 2/50 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 9.2% 0.0% | 4.4% 4.2% |
|TERMINAL (d) | 3/30 (10%) 0/22 (0%) | 2/35 (6%) 1/40 (3%) |
|FIRST INCIDENCE | 660 --- | 732 (T) 694 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.099N | P=0.644N |
|POLY 3 | P=0.068N | P=0.674N |
|POLY 1.5 | P=0.065N | P=0.686N |
|POLY 6 | P=0.074N | P=0.657N |
|LOGISTIC REGRESSION| P=0.073N | P=0.674N |
|COCH-ARM / FISHERS | P=0.059N | P=0.691N |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Intestine Large, Rectum |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 3/50 (6%) | 7/50 (14%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 16.0% 7.2% | 15.3% 8.5% |
|TERMINAL (d) | 6/30 (20%) 3/22 (14%) | 6/35 (17%) 3/40 (8%) |
|FIRST INCIDENCE | 660 726 (T) | 588 708 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.292N | P=0.201N |
|POLY 3 | P=0.178N | P=0.241N |
|POLY 1.5 | P=0.169N | P=0.255N |
|POLY 6 | P=0.194N | P=0.223N |
|LOGISTIC REGRESSION| P=0.227N | P=0.246N |
|COCH-ARM / FISHERS | P=0.159N | P=0.262N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Intestine Small, Ileum |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.7% | 0.0% 2.1% |
|TERMINAL (d) | 0/30 (0%) 1/22 (5%) | 0/35 (0%) 1/40 (3%) |
|FIRST INCIDENCE | --- 509 | --- 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.206 | P=0.527 |
|POLY 3 | P=0.234 | P=0.500 |
|POLY 1.5 | P=0.235 | P=0.500 |
|POLY 6 | P=0.231 | P=0.501 |
|LOGISTIC REGRESSION| P=0.272 | P=0.527 |
|COCH-ARM / FISHERS | P=0.247 | P=0.500 |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Intestine Small, Jejunum |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.3% 7.2% | 0.0% 0.0% |
|TERMINAL (d) | 1/30 (3%) 3/22 (14%) | 0/35 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 726 (T) 726 (T) | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.200 | (e) |
|POLY 3 | P=0.293 | (e) |
|POLY 1.5 | P=0.299 | (e) |
|POLY 6 | P=0.285 | (e) |
|LOGISTIC REGRESSION| P=0.200 | (e) |
|COCH-ARM / FISHERS | P=0.309 | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Kidney |
| Accumulation, Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.7% | 0.0% 2.1% |
|TERMINAL (d) | 0/30 (0%) 0/22 (0%) | 0/35 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- 365 | --- 697 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.225 | P=0.524 |
|POLY 3 | P=0.235 | P=0.500 |
|POLY 1.5 | P=0.236 | P=0.500 |
|POLY 6 | P=0.232 | P=0.501 |
|LOGISTIC REGRESSION| P=0.337 | P=0.500 |
|COCH-ARM / FISHERS | P=0.247 | P=0.500 |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Kidney |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 7.1% | 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/22 (0%) | 0/35 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- 610 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.116 | (e) |
|POLY 3 | P=0.116 | (e) |
|POLY 1.5 | P=0.117 | (e) |
|POLY 6 | P=0.114 | (e) |
|LOGISTIC REGRESSION| P=0.134 | (e) |
|COCH-ARM / FISHERS | P=0.121 | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 45/50 (90%) 42/50 (84%) | 41/50 (82%) 43/50 (86%) |
|POLY-3 ADJUSTED (b)| 92.5% 85.3% | 84.5% 86.0% |
|TERMINAL (d) | 29/30 (97%) 18/22 (82%) | 29/35 (83%) 33/40 (83%) |
|FIRST INCIDENCE | 450 365 | 519 62 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.242 | P=0.362N |
|POLY 3 | P=0.192N | P=0.528 |
|POLY 1.5 | P=0.227N | P=0.471 |
|POLY 6 | P=0.155N | P=0.598 |
|LOGISTIC REGRESSION| P=0.276N | P=0.393 |
|COCH-ARM / FISHERS | P=0.277N | P=0.393 |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 50/50 (100%) | 41/50 (82%) 44/50 (88%) |
|POLY-3 ADJUSTED (b)| 99.1% 100.0% | 87.3% 90.0% |
|TERMINAL (d) | 30/30 (100%) 22/22 (100%) | 34/35 (97%) 36/40 (90%) |
|FIRST INCIDENCE | 450 365 | 588 491 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.076 | P=0.383N |
|POLY 3 | P=0.901 | P=0.459 |
|POLY 1.5 | P=0.695 | P=0.334 |
|POLY 6 | P=1.000 | P=0.629N |
|LOGISTIC REGRESSION| P=0.407 | P=0.439 |
|COCH-ARM / FISHERS | P=0.500 | P=0.288 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Kidney |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) | 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 6.7% 4.8% | 4.4% 2.1% |
|TERMINAL (d) | 0/30 (0%) 0/22 (0%) | 0/35 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 450 660 | 650 652 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.539N | P=0.458N |
|POLY 3 | P=0.533N | P=0.482N |
|POLY 1.5 | P=0.519N | P=0.493N |
|POLY 6 | P=0.552N | P=0.467N |
|LOGISTIC REGRESSION| P=0.438N | P=0.490N |
|COCH-ARM / FISHERS | P=0.500N | P=0.500N |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Kidney |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.7% | 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/22 (0%) | 0/35 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- 610 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.230 | (e) |
|POLY 3 | P=0.234 | (e) |
|POLY 1.5 | P=0.235 | (e) |
|POLY 6 | P=0.232 | (e) |
|LOGISTIC REGRESSION| P=0.258 | (e) |
|COCH-ARM / FISHERS | P=0.247 | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 5/50 (10%) | 0/50 (0%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 12.0% | 0.0% 6.4% |
|TERMINAL (d) | 0/30 (0%) 4/22 (18%) | 0/35 (0%) 3/40 (8%) |
|FIRST INCIDENCE | --- 674 | --- 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.015 * | P=0.146 |
|POLY 3 | P=0.027 * | P=0.124 |
|POLY 1.5 | P=0.029 * | P=0.121 |
|POLY 6 | P=0.025 * | P=0.128 |
|LOGISTIC REGRESSION| P=0.022 * | P=0.146 |
|COCH-ARM / FISHERS | P=0.028 * | P=0.121 |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 33/50 (66%) 24/50 (48%) | 42/50 (84%) 48/50 (96%) |
|POLY-3 ADJUSTED (b)| 72.2% 54.8% | 89.6% 98.5% |
|TERMINAL (d) | 27/30 (90%) 18/22 (82%) | 34/35 (97%) 40/40 (100%) |
|FIRST INCIDENCE | 505 532 | 588 491 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.409N | P=0.554 |
|POLY 3 | P=0.057N | P=0.040 * |
|POLY 1.5 | P=0.055N | P=0.027 * |
|POLY 6 | P=0.061N | P=0.089 |
|LOGISTIC REGRESSION| P=0.077N | P=0.087 |
|COCH-ARM / FISHERS | P=0.053N | P=0.046 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 7/50 (14%) | 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 32.2% 16.8% | 0.0% 2.1% |
|TERMINAL (d) | 14/30 (47%) 7/22 (32%) | 0/35 (0%) 1/40 (3%) |
|FIRST INCIDENCE | 726 (T) 726 (T) | --- 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.216N | P=0.527 |
|POLY 3 | P=0.078N | P=0.500 |
|POLY 1.5 | P=0.074N | P=0.500 |
|POLY 6 | P=0.086N | P=0.501 |
|LOGISTIC REGRESSION| P=0.216N | P=0.527 |
|COCH-ARM / FISHERS | P=0.070N | P=0.500 |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) | 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 6.9% 4.8% | 2.2% 4.2% |
|TERMINAL (d) | 2/30 (7%) 1/22 (5%) | 1/35 (3%) 1/40 (3%) |
|FIRST INCIDENCE | 639 688 | 732 (T) 697 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.599N | P=0.545 |
|POLY 3 | P=0.526N | P=0.510 |
|POLY 1.5 | P=0.515N | P=0.504 |
|POLY 6 | P=0.544N | P=0.520 |
|LOGISTIC REGRESSION| P=0.525N | P=0.516 |
|COCH-ARM / FISHERS | P=0.500N | P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 3/50 (6%) | 8/50 (16%) 8/50 (16%) |
|POLY-3 ADJUSTED (b)| 13.8% 7.2% | 17.7% 17.0% |
|TERMINAL (d) | 6/30 (20%) 3/22 (14%) | 7/35 (20%) 8/40 (20%) |
|FIRST INCIDENCE | 726 (T) 726 (T) | 719 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.411N | P=0.499N |
|POLY 3 | P=0.265N | P=0.572N |
|POLY 1.5 | P=0.255N | P=0.594N |
|POLY 6 | P=0.281N | P=0.542N |
|LOGISTIC REGRESSION| P=0.411N | P=0.518N |
|COCH-ARM / FISHERS | P=0.243N | P=0.607N |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.5% 9.3% | 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 1/22 (5%) | 0/35 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 505 365 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.311 | (e) |
|POLY 3 | P=0.325 | (e) |
|POLY 1.5 | P=0.331 | (e) |
|POLY 6 | P=0.316 | (e) |
|LOGISTIC REGRESSION| P=0.444 | (e) |
|COCH-ARM / FISHERS | P=0.339 | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) | 1/50 (2%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 7.0% | 2.2% 6.2% |
|TERMINAL (d) | 0/30 (0%) 0/22 (0%) | 0/35 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- 365 | 719 62 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.106 | P=0.330 |
|POLY 3 | P=0.117 | P=0.324 |
|POLY 1.5 | P=0.118 | P=0.316 |
|POLY 6 | P=0.114 | P=0.335 |
|LOGISTIC REGRESSION| P=0.166 | P=0.394 |
|COCH-ARM / FISHERS | P=0.121 | P=0.309 |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 3/50 (6%) | 10/50 (20%) 8/50 (16%) |
|POLY-3 ADJUSTED (b)| 13.7% 7.0% | 21.7% 16.6% |
|TERMINAL (d) | 5/30 (17%) 0/22 (0%) | 8/35 (23%) 5/40 (13%) |
|FIRST INCIDENCE | 674 509 | 508 491 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.348N | P=0.304N |
|POLY 3 | P=0.247N | P=0.355N |
|POLY 1.5 | P=0.246N | P=0.381N |
|POLY 6 | P=0.253N | P=0.321N |
|LOGISTIC REGRESSION| P=0.224N | P=0.398N |
|COCH-ARM / FISHERS | P=0.243N | P=0.398N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 21/50 (42%) 22/50 (44%) | 40/50 (80%) 44/50 (88%) |
|POLY-3 ADJUSTED (b)| 46.8% 49.2% | 86.1% 90.3% |
|TERMINAL (d) | 18/30 (60%) 16/22 (73%) | 33/35 (94%) 36/40 (90%) |
|FIRST INCIDENCE | 505 365 | 588 491 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.125 | P=0.483N |
|POLY 3 | P=0.493 | P=0.358 |
|POLY 1.5 | P=0.499 | P=0.243 |
|POLY 6 | P=0.472 | P=0.566 |
|LOGISTIC REGRESSION| P=0.456 | P=0.428 |
|COCH-ARM / FISHERS | P=0.500 | P=0.207 |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 1/50 (2%) | 16/50 (32%) 18/50 (36%) |
|POLY-3 ADJUSTED (b)| 11.5% 2.4% | 35.4% 38.2% |
|TERMINAL (d) | 5/30 (17%) 1/22 (5%) | 15/35 (43%) 18/40 (45%) |
|FIRST INCIDENCE | 726 (T) 726 (T) | 719 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.183N | P=0.570N |
|POLY 3 | P=0.112N | P=0.470 |
|POLY 1.5 | P=0.108N | P=0.435 |
|POLY 6 | P=0.120N | P=0.518 |
|LOGISTIC REGRESSION| P=0.183N | P=0.571 |
|COCH-ARM / FISHERS | P=0.102N | P=0.417 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 6/50 (12%) | 5/50 (10%) 12/50 (24%) |
|POLY-3 ADJUSTED (b)| 16.1% 14.3% | 11.0% 25.4% |
|TERMINAL (d) | 7/30 (23%) 5/22 (23%) | 3/35 (9%) 11/40 (28%) |
|FIRST INCIDENCE | 726 (T) 660 | 622 697 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.516 | P=0.098 |
|POLY 3 | P=0.531N | P=0.060 |
|POLY 1.5 | P=0.518N | P=0.055 |
|POLY 6 | P=0.552N | P=0.068 |
|LOGISTIC REGRESSION| P=0.601 | P=0.071 |
|COCH-ARM / FISHERS | P=0.500N | P=0.054 |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 48/50 (96%) 45/50 (90%) | 25/50 (50%) 15/50 (30%) |
|POLY-3 ADJUSTED (b)| 96.0% 95.2% | 52.0% 30.9% |
|TERMINAL (d) | 28/30 (93%) 22/22 (100%) | 15/35 (43%) 11/40 (28%) |
|FIRST INCIDENCE | 450 532 | 519 62 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.210 | P=0.022N* |
|POLY 3 | P=0.639N | P=0.026N* |
|POLY 1.5 | P=0.449N | P=0.028N* |
|POLY 6 | P=0.637 | P=0.024N* |
|LOGISTIC REGRESSION| P=0.302N | P=0.037N* |
|COCH-ARM / FISHERS | P=0.218N | P=0.033N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 22/50 (44%) 19/50 (38%) | 5/50 (10%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 45.5% 41.4% | 10.7% 12.6% |
|TERMINAL (d) | 6/30 (20%) 2/22 (9%) | 0/35 (0%) 4/40 (10%) |
|FIRST INCIDENCE | 450 446 | 595 652 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.543N | P=0.583 |
|POLY 3 | P=0.425N | P=0.509 |
|POLY 1.5 | P=0.392N | P=0.500 |
|POLY 6 | P=0.470N | P=0.519 |
|LOGISTIC REGRESSION| P=0.266N | P=0.509 |
|COCH-ARM / FISHERS | P=0.342N | P=0.500 |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 2/50 (4%) | 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 13.7% 4.8% | 4.3% 0.0% |
|TERMINAL (d) | 4/30 (13%) 2/22 (9%) | 0/35 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 660 726 (T) | 508 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.230N | P=0.242N |
|POLY 3 | P=0.152N | P=0.232N |
|POLY 1.5 | P=0.144N | P=0.237N |
|POLY 6 | P=0.167N | P=0.225N |
|LOGISTIC REGRESSION| P=0.165N | P=0.149N |
|COCH-ARM / FISHERS | P=0.134N | P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 12/50 (24%) | 9/50 (18%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 26.9% 27.4% | 19.9% 14.9% |
|TERMINAL (d) | 8/30 (27%) 5/22 (23%) | 7/35 (20%) 7/40 (18%) |
|FIRST INCIDENCE | 617 365 | 719 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.384 | P=0.293N |
|POLY 3 | P=0.578 | P=0.358N |
|POLY 1.5 | P=0.585 | P=0.380N |
|POLY 6 | P=0.562 | P=0.329N |
|LOGISTIC REGRESSION| P=0.588 | P=0.302N |
|COCH-ARM / FISHERS | P=0.592N | P=0.393N |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.3% 7.0% | 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/22 (0%) | 0/35 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 712 365 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.280 | (e) |
|POLY 3 | P=0.303 | (e) |
|POLY 1.5 | P=0.304 | (e) |
|POLY 6 | P=0.299 | (e) |
|LOGISTIC REGRESSION| P=0.395 | (e) |
|COCH-ARM / FISHERS | P=0.309 | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 6/50 (12%) | 9/50 (18%) 10/50 (20%) |
|POLY-3 ADJUSTED (b)| 16.0% 14.0% | 19.9% 21.2% |
|TERMINAL (d) | 6/30 (20%) 2/22 (9%) | 8/35 (23%) 10/40 (25%) |
|FIRST INCIDENCE | 674 532 | 722 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.572 | P=0.577N |
|POLY 3 | P=0.512N | P=0.537 |
|POLY 1.5 | P=0.508N | P=0.513 |
|POLY 6 | P=0.520N | P=0.568 |
|LOGISTIC REGRESSION| P=0.519N | P=0.604 |
|COCH-ARM / FISHERS | P=0.500N | P=0.500 |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/49 (6%) | 0/50 (0%) 10/50 (20%) |
|POLY-3 ADJUSTED (b)| 9.1% 7.3% | 0.0% 21.0% |
|TERMINAL (d) | 3/30 (10%) 3/22 (14%) | 0/35 (0%) 7/40 (18%) |
|FIRST INCIDENCE | 639 726 (T) | --- 652 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.647N | P=0.003 ** |
|POLY 3 | P=0.542N | P<0.001 ** |
|POLY 1.5 | P=0.529N | P<0.001 ** |
|POLY 6 | P=0.562N | P<0.001 ** |
|LOGISTIC REGRESSION| P=0.567N | P<0.001 ** |
|COCH-ARM / FISHERS | P=0.511N | P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 17/50 (34%) 14/49 (29%) | 6/50 (12%) 17/50 (34%) |
|POLY-3 ADJUSTED (b)| 37.1% 31.9% | 13.2% 35.8% |
|TERMINAL (d) | 10/30 (33%) 7/22 (32%) | 5/35 (14%) 14/40 (35%) |
|FIRST INCIDENCE | 505 509 | 635 652 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.574N | P=0.023 * |
|POLY 3 | P=0.385N | P=0.009 ** |
|POLY 1.5 | P=0.375N | P=0.008 ** |
|POLY 6 | P=0.402N | P=0.012 * |
|LOGISTIC REGRESSION| P=0.340N | P=0.012 * |
|COCH-ARM / FISHERS | P=0.358N | P=0.008 ** |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.8% | 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/22 (0%) | 0/35 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- 688 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.199 | (e) |
|POLY 3 | P=0.233 | (e) |
|POLY 1.5 | P=0.235 | (e) |
|POLY 6 | P=0.230 | (e) |
|LOGISTIC REGRESSION| P=0.226 | (e) |
|COCH-ARM / FISHERS | P=0.247 | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.9% 2.4% | 0.0% 0.0% |
|TERMINAL (d) | 3/30 (10%) 0/22 (0%) | 0/35 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 726 (T) 509 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.391N | (e) |
|POLY 3 | P=0.317N | (e) |
|POLY 1.5 | P=0.312N | (e) |
|POLY 6 | P=0.327N | (e) |
|LOGISTIC REGRESSION| P=0.295N | (e) |
|COCH-ARM / FISHERS | P=0.309N | (e) |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Galactocele |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) | 3/50 (6%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% | 6.5% 2.1% |
|TERMINAL (d) | 0/30 (0%) 0/22 (0%) | 1/35 (3%) 1/40 (3%) |
|FIRST INCIDENCE | --- --- | 627 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.264N |
|POLY 3 | (e) | P=0.294N |
|POLY 1.5 | (e) | P=0.302N |
|POLY 6 | (e) | P=0.284N |
|LOGISTIC REGRESSION| (e) | P=0.300N |
|COCH-ARM / FISHERS | (e) | P=0.309N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 7/50 (14%) | 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 6.9% 16.5% | 0.0% 2.1% |
|TERMINAL (d) | 2/30 (7%) 3/22 (14%) | 0/35 (0%) 1/40 (3%) |
|FIRST INCIDENCE | 674 660 | --- 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.094 | P=0.527 |
|POLY 3 | P=0.144 | P=0.500 |
|POLY 1.5 | P=0.150 | P=0.500 |
|POLY 6 | P=0.136 | P=0.501 |
|LOGISTIC REGRESSION| P=0.134 | P=0.527 |
|COCH-ARM / FISHERS | P=0.159 | P=0.500 |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) | 4/50 (8%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% | 8.8% 10.6% |
|TERMINAL (d) | 0/30 (0%) 0/22 (0%) | 3/35 (9%) 5/40 (13%) |
|FIRST INCIDENCE | --- --- | 719 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.576 |
|POLY 3 | (e) | P=0.522 |
|POLY 1.5 | (e) | P=0.508 |
|POLY 6 | (e) | P=0.541 |
|LOGISTIC REGRESSION| (e) | P=0.568 |
|COCH-ARM / FISHERS | (e) | P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Mesentery |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/8 (0%) 1/13 (8%) | 0/10 (0%) 2/5 (40%) |
|POLY-3 ADJUSTED (b)| 0.0% 9.3% | 0.0% 40.8% |
|TERMINAL (d) | 0/4 (0%) 0/3 (0%) | 0/8 (0%) 1/3 (33%) |
|FIRST INCIDENCE | --- 707 | --- 652 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.457 | P=0.149 |
|POLY 3 | P=0.495 | P=0.115 |
|POLY 1.5 | P=0.497 | P=0.114 |
|POLY 6 | P=0.492 | P=0.115 |
|LOGISTIC REGRESSION| P=0.549 | P=0.080 |
|COCH-ARM / FISHERS | P=0.619 | P=0.095 |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/8 (88%) 11/13 (85%) | 8/10 (80%) 3/5 (60%) |
|POLY-3 ADJUSTED (b)| 88.1% 85.6% | 86.3% 63.7% |
|TERMINAL (d) | 4/4 (100%) 3/3 (100%) | 8/8 (100%) 2/3 (67%) |
|FIRST INCIDENCE | 610 532 | 732 (T) 708 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.088 | P=0.636N |
|POLY 3 | P=0.630N | P=0.473N |
|POLY 1.5 | P=0.622N | P=0.486N |
|POLY 6 | P=0.646N | P=0.455N |
|LOGISTIC REGRESSION| P=0.579N | P=0.455N |
|COCH-ARM / FISHERS | P=0.684N | P=0.407N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Nose |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 7/50 (14%) | 3/50 (6%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 15.6% 16.5% | 6.6% 2.1% |
|TERMINAL (d) | 3/30 (10%) 4/22 (18%) | 3/35 (9%) 1/40 (3%) |
|FIRST INCIDENCE | 505 610 | 732 (T) 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.468 | P=0.258N |
|POLY 3 | P=0.573 | P=0.287N |
|POLY 1.5 | P=0.589 | P=0.299N |
|POLY 6 | P=0.547 | P=0.273N |
|LOGISTIC REGRESSION| P=0.612N | P=0.258N |
|COCH-ARM / FISHERS | P=0.613N | P=0.309N |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 11/50 (22%) | 4/50 (8%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 28.1% 24.8% | 8.8% 10.6% |
|TERMINAL (d) | 5/30 (17%) 3/22 (14%) | 3/35 (9%) 3/40 (8%) |
|FIRST INCIDENCE | 505 446 | 719 708 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.563N | P=0.566 |
|POLY 3 | P=0.454N | P=0.524 |
|POLY 1.5 | P=0.434N | P=0.509 |
|POLY 6 | P=0.490N | P=0.545 |
|LOGISTIC REGRESSION| P=0.339N | P=0.557 |
|COCH-ARM / FISHERS | P=0.408N | P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | | 3/50 (6%) 11/50 (22%) |
|POLY-3 ADJUSTED (b)| | 6.6% 23.0% |
|TERMINAL (d) | | 1/35 (3%) 8/40 (20%) |
|FIRST INCIDENCE | | 636 652 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.047 * |
|POLY 3 | | P=0.024 * |
|POLY 1.5 | | P=0.021 * |
|POLY 6 | | P=0.029 * |
|LOGISTIC REGRESSION| | P=0.022 * |
|COCH-ARM / FISHERS | | P=0.020 * |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Pancreas |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 22/50 (44%) 18/50 (36%) | 8/50 (16%) 12/50 (24%) |
|POLY-3 ADJUSTED (b)| 48.2% 40.5% | 17.6% 25.1% |
|TERMINAL (d) | 15/30 (50%) 9/22 (41%) | 7/35 (20%) 8/40 (20%) |
|FIRST INCIDENCE | 450 365 | 627 652 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.548 | P=0.343 |
|POLY 3 | P=0.298N | P=0.261 |
|POLY 1.5 | P=0.287N | P=0.239 |
|POLY 6 | P=0.317N | P=0.294 |
|LOGISTIC REGRESSION| P=0.286N | P=0.244 |
|COCH-ARM / FISHERS | P=0.270N | P=0.227 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Pancreas |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% | 0.0% 4.2% |
|TERMINAL (d) | 0/30 (0%) 0/22 (0%) | 0/35 (0%) 1/40 (3%) |
|FIRST INCIDENCE | --- --- | --- 652 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.275 |
|POLY 3 | (e) | P=0.243 |
|POLY 1.5 | (e) | P=0.239 |
|POLY 6 | (e) | P=0.248 |
|LOGISTIC REGRESSION| (e) | P=0.238 |
|COCH-ARM / FISHERS | (e) | P=0.247 |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Pancreas |
| Cytoplasmic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) | 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.3% 4.8% | 4.4% 2.1% |
|TERMINAL (d) | 1/30 (3%) 2/22 (9%) | 1/35 (3%) 1/40 (3%) |
|FIRST INCIDENCE | 726 (T) 726 (T) | 719 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.392 | P=0.466N |
|POLY 3 | P=0.490 | P=0.482N |
|POLY 1.5 | P=0.494 | P=0.493N |
|POLY 6 | P=0.484 | P=0.467N |
|LOGISTIC REGRESSION| P=0.392 | P=0.465N |
|COCH-ARM / FISHERS | P=0.500 | P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Pancreas |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) | 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 6.9% 4.8% | 2.2% 4.2% |
|TERMINAL (d) | 3/30 (10%) 2/22 (9%) | 1/35 (3%) 2/40 (5%) |
|FIRST INCIDENCE | 726 (T) 726 (T) | 732 (T) 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.642N | P=0.547 |
|POLY 3 | P=0.524N | P=0.510 |
|POLY 1.5 | P=0.514N | P=0.503 |
|POLY 6 | P=0.541N | P=0.518 |
|LOGISTIC REGRESSION| P=0.642N | P=0.547 |
|COCH-ARM / FISHERS | P=0.500N | P=0.500 |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Pancreas |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) | 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.6% 2.4% | 2.2% 0.0% |
|TERMINAL (d) | 2/30 (7%) 1/22 (5%) | 1/35 (3%) 0/40 (0%) |
|FIRST INCIDENCE | 726 (T) 726 (T) | 732 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.608N | P=0.473N |
|POLY 3 | P=0.520N | P=0.484N |
|POLY 1.5 | P=0.512N | P=0.494N |
|POLY 6 | P=0.535N | P=0.471N |
|LOGISTIC REGRESSION| P=0.608N | (e) |
|COCH-ARM / FISHERS | P=0.500N | P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 4/50 (8%) | 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 11.4% 9.4% | 2.2% 0.0% |
|TERMINAL (d) | 3/30 (10%) 2/22 (9%) | 1/35 (3%) 0/40 (0%) |
|FIRST INCIDENCE | 660 509 | 732 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.618N | P=0.473N |
|POLY 3 | P=0.521N | P=0.484N |
|POLY 1.5 | P=0.512N | P=0.494N |
|POLY 6 | P=0.539N | P=0.471N |
|LOGISTIC REGRESSION| P=0.496N | (e) |
|COCH-ARM / FISHERS | P=0.500N | P=0.500N |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 22/50 (44%) | 27/50 (54%) 29/50 (58%) |
|POLY-3 ADJUSTED (b)| 33.6% 49.2% | 56.8% 59.5% |
|TERMINAL (d) | 11/30 (37%) 10/22 (46%) | 20/35 (57%) 22/40 (55%) |
|FIRST INCIDENCE | 589 532 | 588 491 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.032 * | P=0.469N |
|POLY 3 | P=0.095 | P=0.472 |
|POLY 1.5 | P=0.098 | P=0.433 |
|POLY 6 | P=0.093 | P=0.520 |
|LOGISTIC REGRESSION| P=0.084 | P=0.430 |
|COCH-ARM / FISHERS | P=0.107 | P=0.420 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Preputial Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) | |
|POLY-3 ADJUSTED (b)| 4.6% 4.8% | |
|TERMINAL (d) | 1/30 (3%) 1/22 (5%) | |
|FIRST INCIDENCE | 695 695 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.605 | |
|POLY 3 | P=0.683 | |
|POLY 1.5 | P=0.687 | |
|POLY 6 | P=0.676 | |
|LOGISTIC REGRESSION| P=0.661 | |
|COCH-ARM / FISHERS | P=0.691N | |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 47/50 (94%) 48/50 (96%) | |
|POLY-3 ADJUSTED (b)| 94.7% 97.7% | |
|TERMINAL (d) | 28/30 (93%) 21/22 (96%) | |
|FIRST INCIDENCE | 450 446 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.089 | |
|POLY 3 | P=0.400 | |
|POLY 1.5 | P=0.416 | |
|POLY 6 | P=0.422 | |
|LOGISTIC REGRESSION| P=0.440 | |
|COCH-ARM / FISHERS | P=0.500 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Prostate |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) | |
|POLY-3 ADJUSTED (b)| 9.0% 2.4% | |
|TERMINAL (d) | 1/30 (3%) 0/22 (0%) | |
|FIRST INCIDENCE | 589 637 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.218N | |
|POLY 3 | P=0.200N | |
|POLY 1.5 | P=0.191N | |
|POLY 6 | P=0.216N | |
|LOGISTIC REGRESSION| P=0.153N | |
|COCH-ARM / FISHERS | P=0.181N | |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Prostate |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) | |
|POLY-3 ADJUSTED (b)| 4.6% 7.2% | |
|TERMINAL (d) | 2/30 (7%) 3/22 (14%) | |
|FIRST INCIDENCE | 726 (T) 726 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.358 | |
|POLY 3 | P=0.484 | |
|POLY 1.5 | P=0.491 | |
|POLY 6 | P=0.474 | |
|LOGISTIC REGRESSION| P=0.358 | |
|COCH-ARM / FISHERS | P=0.500 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 22/50 (44%) 33/50 (66%) | |
|POLY-3 ADJUSTED (b)| 46.9% 70.9% | |
|TERMINAL (d) | 14/30 (47%) 18/22 (82%) | |
|FIRST INCIDENCE | 450 365 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.005 ** | |
|POLY 3 | P=0.012 * | |
|POLY 1.5 | P=0.015 * | |
|POLY 6 | P=0.009 ** | |
|LOGISTIC REGRESSION| P=0.023 * | |
|COCH-ARM / FISHERS | P=0.022 * | |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Salivary Glands |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) | 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.3% 2.4% | 4.4% 0.0% |
|TERMINAL (d) | 1/30 (3%) 0/22 (0%) | 1/35 (3%) 0/40 (0%) |
|FIRST INCIDENCE | 726 (T) 532 | 588 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.724 | P=0.225N |
|POLY 3 | P=0.758 | P=0.227N |
|POLY 1.5 | P=0.759 | P=0.234N |
|POLY 6 | P=0.756 | P=0.218N |
|LOGISTIC REGRESSION| P=0.735N | P=0.222N |
|COCH-ARM / FISHERS | P=0.753N | P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Salivary Glands |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% | 0.0% 4.2% |
|TERMINAL (d) | 0/30 (0%) 0/22 (0%) | 0/35 (0%) 1/40 (3%) |
|FIRST INCIDENCE | --- --- | --- 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.273 |
|POLY 3 | (e) | P=0.243 |
|POLY 1.5 | (e) | P=0.239 |
|POLY 6 | (e) | P=0.247 |
|LOGISTIC REGRESSION| (e) | P=0.238 |
|COCH-ARM / FISHERS | (e) | P=0.247 |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) | 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 9.5% | 2.2% 0.0% |
|TERMINAL (d) | 0/30 (0%) 3/22 (14%) | 1/35 (3%) 0/40 (0%) |
|FIRST INCIDENCE | --- 639 | 732 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.037 * | P=0.473N |
|POLY 3 | P=0.056 | P=0.484N |
|POLY 1.5 | P=0.058 | P=0.494N |
|POLY 6 | P=0.054 | P=0.471N |
|LOGISTIC REGRESSION| P=0.054 | (e) |
|COCH-ARM / FISHERS | P=0.059 | P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) | 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 7.2% | 2.2% 0.0% |
|TERMINAL (d) | 0/30 (0%) 3/22 (14%) | 1/35 (3%) 0/40 (0%) |
|FIRST INCIDENCE | --- 726 (T) | 732 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.071 | P=0.473N |
|POLY 3 | P=0.113 | P=0.484N |
|POLY 1.5 | P=0.116 | P=0.494N |
|POLY 6 | P=0.109 | P=0.471N |
|LOGISTIC REGRESSION| P=0.071 | (e) |
|COCH-ARM / FISHERS | P=0.121 | P=0.500N |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 38
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Skin: Epidermis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.6% 2.4% | 0.0% 0.0% |
|TERMINAL (d) | 1/30 (3%) 1/22 (5%) | 0/35 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 653 726 (T) | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.577N | (e) |
|POLY 3 | P=0.523N | (e) |
|POLY 1.5 | P=0.513N | (e) |
|POLY 6 | P=0.540N | (e) |
|LOGISTIC REGRESSION| P=0.520N | (e) |
|COCH-ARM / FISHERS | P=0.500N | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Spinal Cord |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 2/2 (100%) | 0/0 (0%) 0/0 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 100.0% | 0.0% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 623 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | (e) |
|POLY 3 | (e) | (e) |
|POLY 1.5 | (e) | (e) |
|POLY 6 | (e) | (e) |
|LOGISTIC REGRESSION| (e) | (e) |
|COCH-ARM / FISHERS | (e) | (e) |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 39
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) | 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 4.6% 4.8% | 2.2% 2.1% |
|TERMINAL (d) | 2/30 (7%) 2/22 (9%) | 0/35 (0%) 1/40 (3%) |
|FIRST INCIDENCE | 726 (T) 726 (T) | 650 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.580 | P=0.728N |
|POLY 3 | P=0.683 | P=0.749N |
|POLY 1.5 | P=0.687 | P=0.757N |
|POLY 6 | P=0.676 | P=0.740N |
|LOGISTIC REGRESSION| P=0.580 | P=0.762N |
|COCH-ARM / FISHERS | P=0.691N | P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 8/50 (16%) | 11/50 (22%) 11/50 (22%) |
|POLY-3 ADJUSTED (b)| 6.8% 17.9% | 23.9% 22.7% |
|TERMINAL (d) | 2/30 (7%) 0/22 (0%) | 7/35 (20%) 6/40 (15%) |
|FIRST INCIDENCE | 610 365 | 609 62 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.090 | P=0.480N |
|POLY 3 | P=0.103 | P=0.537N |
|POLY 1.5 | P=0.102 | P=0.562N |
|POLY 6 | P=0.104 | P=0.504N |
|LOGISTIC REGRESSION| P=0.137 | P=0.594 |
|COCH-ARM / FISHERS | P=0.100 | P=0.595N |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 40
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Spleen |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) | 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.6% 4.8% | 2.2% 0.0% |
|TERMINAL (d) | 1/30 (3%) 0/22 (0%) | 0/35 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 600 674 | 650 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.630 | P=0.469N |
|POLY 3 | P=0.682 | P=0.487N |
|POLY 1.5 | P=0.687 | P=0.495N |
|POLY 6 | P=0.674 | P=0.475N |
|LOGISTIC REGRESSION| P=0.692N | P=0.484N |
|COCH-ARM / FISHERS | P=0.691N | P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Spleen |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.8% | 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/22 (0%) | 0/35 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- 674 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.217 | (e) |
|POLY 3 | P=0.233 | (e) |
|POLY 1.5 | P=0.235 | (e) |
|POLY 6 | P=0.231 | (e) |
|LOGISTIC REGRESSION| P=0.240 | (e) |
|COCH-ARM / FISHERS | P=0.247 | (e) |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 41
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.8% | 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/22 (0%) | 0/35 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- 663 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.221 | (e) |
|POLY 3 | P=0.233 | (e) |
|POLY 1.5 | P=0.235 | (e) |
|POLY 6 | P=0.231 | (e) |
|LOGISTIC REGRESSION| P=0.242 | (e) |
|COCH-ARM / FISHERS | P=0.247 | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) | 2/50 (4%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 2.3% 7.1% | 4.3% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/22 (0%) | 0/35 (0%) 0/39 (0%) |
|FIRST INCIDENCE | 695 628 | 508 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.289 | P=0.227N |
|POLY 3 | P=0.298 | P=0.238N |
|POLY 1.5 | P=0.301 | P=0.243N |
|POLY 6 | P=0.294 | P=0.230N |
|LOGISTIC REGRESSION| P=0.328 | P=0.171N |
|COCH-ARM / FISHERS | P=0.309 | P=0.253N |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 42
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 6/50 (12%) | 6/50 (12%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 2.3% 13.9% | 12.6% 2.2% |
|TERMINAL (d) | 0/30 (0%) 1/22 (5%) | 0/35 (0%) 0/39 (0%) |
|FIRST INCIDENCE | 674 532 | 508 697 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.048 * | P=0.053N |
|POLY 3 | P=0.053 | P=0.062N |
|POLY 1.5 | P=0.054 | P=0.063N |
|POLY 6 | P=0.051 | P=0.061N |
|LOGISTIC REGRESSION| P=0.066 | P=0.040N* |
|COCH-ARM / FISHERS | P=0.056 | P=0.059N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 7/50 (14%) | 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 4.6% 16.3% | 4.4% 2.1% |
|TERMINAL (d) | 0/30 (0%) 1/22 (5%) | 0/35 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 674 610 | 622 715 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.062 | P=0.477N |
|POLY 3 | P=0.074 | P=0.488N |
|POLY 1.5 | P=0.076 | P=0.497N |
|POLY 6 | P=0.071 | P=0.477N |
|LOGISTIC REGRESSION| P=0.084 | P=0.477N |
|COCH-ARM / FISHERS | P=0.080 | P=0.500N |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 43
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.8% 9.5% | 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 1/22 (5%) | 0/35 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 653 660 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.425 | (e) |
|POLY 3 | P=0.481 | (e) |
|POLY 1.5 | P=0.489 | (e) |
|POLY 6 | P=0.468 | (e) |
|LOGISTIC REGRESSION| P=0.495 | (e) |
|COCH-ARM / FISHERS | P=0.500 | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Testes |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) | |
|POLY-3 ADJUSTED (b)| 4.6% 4.7% | |
|TERMINAL (d) | 1/30 (3%) 0/22 (0%) | |
|FIRST INCIDENCE | 660 637 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.653 | |
|POLY 3 | P=0.685 | |
|POLY 1.5 | P=0.688 | |
|POLY 6 | P=0.679 | |
|LOGISTIC REGRESSION| P=0.686N | |
|COCH-ARM / FISHERS | P=0.691N | |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 44
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 7/50 (14%) | |
|POLY-3 ADJUSTED (b)| 8.8% 16.0% | |
|TERMINAL (d) | 1/30 (3%) 2/22 (9%) | |
|FIRST INCIDENCE | 450 365 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.213 | |
|POLY 3 | P=0.241 | |
|POLY 1.5 | P=0.250 | |
|POLY 6 | P=0.229 | |
|LOGISTIC REGRESSION| P=0.357 | |
|COCH-ARM / FISHERS | P=0.262 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 45/50 (90%) 38/47 (81%) | 45/49 (92%) 46/47 (98%) |
|POLY-3 ADJUSTED (b)| 93.3% 84.9% | 95.7% 100.0% |
|TERMINAL (d) | 30/30 (100%) 19/22 (86%) | 35/35 (100%) 37/37 (100%) |
|FIRST INCIDENCE | 450 365 | 588 491 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.435 | P=0.423N |
|POLY 3 | P=0.139N | P=0.175 |
|POLY 1.5 | P=0.152N | P=0.111 |
|POLY 6 | P=0.118N | P=0.436 |
|LOGISTIC REGRESSION| P=0.195N | P=0.109 |
|COCH-ARM / FISHERS | P=0.161N | P=0.194 |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 45
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 32/50 (64%) 38/50 (76%) | 45/50 (90%) 45/50 (90%) |
|POLY-3 ADJUSTED (b)| 66.9% 81.3% | 92.2% 91.8% |
|TERMINAL (d) | 19/30 (63%) 18/22 (82%) | 33/35 (94%) 36/40 (90%) |
|FIRST INCIDENCE | 450 509 | 519 491 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.034 * | P=0.194N |
|POLY 3 | P=0.076 | P=0.624N |
|POLY 1.5 | P=0.093 | P=0.610 |
|POLY 6 | P=0.065 | P=0.542N |
|LOGISTIC REGRESSION| P=0.114 | P=0.624 |
|COCH-ARM / FISHERS | P=0.138 | P=0.630N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.3% 4.8% | 0.0% 2.1% |
|TERMINAL (d) | 1/30 (3%) 2/22 (9%) | 0/35 (0%) 1/40 (3%) |
|FIRST INCIDENCE | 726 (T) 726 (T) | --- 732 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.392 | P=0.527 |
|POLY 3 | P=0.490 | P=0.500 |
|POLY 1.5 | P=0.494 | P=0.500 |
|POLY 6 | P=0.484 | P=0.501 |
|LOGISTIC REGRESSION| P=0.392 | P=0.527 |
|COCH-ARM / FISHERS | P=0.500 | P=0.500 |
|=================================================================================================================================|
Date: 06/01/00 EXPERIMENT: 56348 TEST: 03 Page 46
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CITRAL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT VEHICLE | UNTREAT VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | | 9/50 (18%) 12/50 (24%) |
|POLY-3 ADJUSTED (b)| | 19.5% 25.3% |
|TERMINAL (d) | | 5/35 (14%) 10/40 (25%) |
|FIRST INCIDENCE | | 595 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.432 |
|POLY 3 | | P=0.331 |
|POLY 1.5 | | P=0.316 |
|POLY 6 | | P=0.351 |
|LOGISTIC REGRESSION| | P=0.324 |
|COCH-ARM / FISHERS | | P=0.312 |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Poly-3 adjusted lifetime tumor incidence.
(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.
(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).