TDMS Study 99033-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: BIORELIANCE TRANSGENIC MODEL EVALUATION II (ASPARTAME) DATE: 03/05/03
EXPERIMENT: 99033 TEST: 01 TIME: 11:29:50
TEST TYPE: 26-39 WEEKS CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-65406 ROUTE: DOSED FEED NTP C#: C99033
PATHOLOGIST: LANNING, LYNDA CAS: 22839-47-0
------------------------------------------------------------------------------------------------------------------------------------
FINAL #3 TG.AC MICE
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 VEHICLE CONTROL
INCLUDE 002 3125 PPM
INCLUDE 003 6250 PPM
INCLUDE 004 12500 PPM
INCLUDE 005 25000 PPM
INCLUDE 006 50000 PPM
INCLUDE 008 VEHICLE CONTROL
INCLUDE 009 3125 PPM
INCLUDE 010 6250 PPM
INCLUDE 011 12500 PPM
INCLUDE 012 25000 PPM
INCLUDE 013 50000 PPM
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: BIORELIANCE TRANSGENIC MODEL EVALUATION II (ASPARTAME) DATE: 03/05/03
EXPERIMENT: 99033 TEST: 01 TIME: 11:29:50
TEST TYPE: 26-39 WEEKS CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-65406 ROUTE: DOSED FEED NTP C#: C99033
PATHOLOGIST: LANNING, LYNDA CAS: 22839-47-0
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF TRANSGENIC MODEL EVALUATION II (ASPA
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex Atrophy
Hypertrophy Focal
Bone Marrow Hyperplasia
Kidney Nephropathy
Liver Necrosis Focal
Lymph Node, Mandibular Necrosis
Spleen Hematopoietic Cell Proliferation
Thymus Atrophy Focal
Thyroid Gland: Follicle Cyst
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex Atrophy
Adrenal Cortex: Subcapsular Hyperplasia Focal
Liver Necrosis Focal
Liver: Hepatocyte Necrosis Focal
Pituitary Gland Cyst
Spleen Hematopoietic Cell Proliferation
===============================================================
Date: 03/05/03 EXPERIMENT: 99033 TEST: 01 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUATION I
I (ASPA
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/13 (77%) 12/15 (80%) 8/13 (62%) 9/14 (64%) 8/15 (53%) 6/13 (46%) |
|POLY-3 RATE (b) | 10/11.96 12/14.31 8/10.06 9/13.39 8/12.70 6/10.92 |
|POLY-3 PERCENT (g) | 83.6% 83.8% 79.5% 67.2% 63.0% 54.9% |
|TERMINAL (d) | 9/9 (100%) 12/12 (100%) 8/8 (100%) 9/12 (75%) 8/11 (73%) 6/9 (67%) |
|FIRST INCIDENCE | 271 274 (T) 274 (T) 274 (T) 274 (T) 274 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.006N** P=0.469N P=0.557N P=0.086N P=0.082N P=0.061N |
|POLY 3 | P=0.036N* P=0.697 P=0.625N P=0.311N P=0.237N P=0.138N |
|POLY 1.5 | P=0.030N* P=0.689N P=0.470N P=0.307N P=0.202N P=0.105N |
|POLY 6 | P=0.046N* P=0.675 P=0.694 P=0.329N P=0.275N P=0.187N |
|LOGISTIC REGRESSION| (e) P=0.469N P=0.557N P=0.086N P=0.082N P=0.061N |
|COCH-ARM / FISHERS | P=0.033N* P=0.600 P=0.336N P=0.385N P=0.184N P=0.113N |
|ORDER RESTRICTED | P=0.097N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/15 (20%) 2/12 (17%) 1/13 (8%) 4/13 (31%) 5/14 (36%) 5/15 (33%) |
|POLY-3 RATE (b) | 3/13.74 2/12.00 1/9.84 4/11.37 5/13.92 5/10.74 |
|POLY-3 PERCENT (g) | 21.8% 16.7% 10.2% 35.2% 35.9% 46.6% |
|TERMINAL (d) | 1/11 (9%) 0/10 (0%) 1/9 (11%) 3/9 (33%) 3/11 (27%) 3/8 (38%) |
|FIRST INCIDENCE | 200 198 275 (T) 165 269 184 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.039 * P=0.544N P=0.392N P=0.385 P=0.362 P=0.199 |
|POLY 3 | P=0.043 * P=0.565N P=0.428N P=0.387 P=0.348 P=0.198 |
|POLY 1.5 | P=0.053 P=0.576N P=0.412N P=0.398 P=0.336 P=0.228 |
|POLY 6 | P=0.040 * P=0.555N P=0.442N P=0.380 P=0.357 P=0.185 |
|LOGISTIC REGRESSION| P=0.074 P=0.698N P=0.373N P=0.423 P=0.281 P=0.253 |
|COCH-ARM / FISHERS | P=0.100 P=0.612N P=0.356N P=0.412 P=0.298 P=0.341 |
|ORDER RESTRICTED | P=0.083 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/05/03 EXPERIMENT: 99033 TEST: 01 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUATION II
(ASPA
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/13 (69%) 5/15 (33%) 5/13 (38%) 6/14 (43%) 7/15 (47%) 5/13 (38%) |
|POLY-3 RATE (b) | 9/11.92 5/14.31 5/10.06 6/13.39 7/12.70 5/10.92 |
|POLY-3 PERCENT (g) | 75.5% 34.9% 49.7% 44.8% 55.1% 45.8% |
|TERMINAL (d) | 9/9 (100%) 5/12 (42%) 5/8 (63%) 6/12 (50%) 7/11 (64%) 5/9 (56%) |
|FIRST INCIDENCE | 274 (T) 274 (T) 274 (T) 274 (T) 274 (T) 274 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.350N P=0.011N* P=0.089N P=0.024N* P=0.077N P=0.049N* |
|POLY 3 | P=0.415N P=0.038N* P=0.204N P=0.118N P=0.261N P=0.145N |
|POLY 1.5 | P=0.378N P=0.038N* P=0.149N P=0.118N P=0.231N P=0.116N |
|POLY 6 | P=0.454N P=0.039N* P=0.268N P=0.122N P=0.290N P=0.184N |
|LOGISTIC REGRESSION| P=0.350N P=0.011N* P=0.089N P=0.024N* P=0.077N P=0.049N* |
|COCH-ARM / FISHERS | P=0.334N P=0.064N P=0.119N P=0.161N P=0.207N P=0.119N |
|ORDER RESTRICTED | P=0.135N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/12 (0%) 0/13 (0%) 0/13 (0%) 0/14 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/13.08 0/11.33 0/9.84 0/10.59 0/13.80 0/9.98 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/11 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/11 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/05/03 EXPERIMENT: 99033 TEST: 01 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUATION II
(ASPA
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex: Subcapsular |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/13 (0%) 0/15 (0%) 0/13 (0%) 0/14 (0%) 0/15 (0%) 1/13 (8%) |
|POLY-3 RATE (b) | 0/11.92 0/14.31 0/10.06 0/13.39 0/12.70 1/10.92 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 9.2% |
|TERMINAL (d) | 0/9 (0%) 0/12 (0%) 0/8 (0%) 0/12 (0%) 0/11 (0%) 1/9 (11%) |
|FIRST INCIDENCE | --- --- --- --- --- 274 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.093 (e) (e) (e) (e) P=0.500 |
|POLY 3 | P=0.095 (e) (e) (e) (e) P=0.482 |
|POLY 1.5 | P=0.097 (e) (e) (e) (e) P=0.493 |
|POLY 6 | P=0.092 (e) (e) (e) (e) P=0.472 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.099 (e) (e) (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.052 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex: Subcapsular |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/15 (80%) 6/12 (50%) 6/13 (46%) 5/13 (38%) 6/14 (43%) 6/15 (40%) |
|POLY-3 RATE (b) | 12/14.06 6/11.37 6/11.03 5/10.59 6/13.80 6/10.68 |
|POLY-3 PERCENT (g) | 85.3% 52.8% 54.4% 47.2% 43.5% 56.2% |
|TERMINAL (d) | 9/11 (82%) 5/10 (50%) 4/9 (44%) 5/9 (56%) 6/11 (55%) 5/8 (63%) |
|FIRST INCIDENCE | 200 271 200 275 (T) 275 (T) 184 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.304N P=0.085N P=0.166N P=0.060N P=0.037N* P=0.222N |
|POLY 3 | P=0.149N P=0.078N P=0.100N P=0.046N* P=0.019N* P=0.117N |
|POLY 1.5 | P=0.130N P=0.077N P=0.098N P=0.030N* P=0.022N* P=0.073N |
|POLY 6 | P=0.166N P=0.088N P=0.099N P=0.066N P=0.020N* P=0.159N |
|LOGISTIC REGRESSION| P=0.176N P=0.065N P=0.114N P=0.036N* P=0.023N* P=0.101N |
|COCH-ARM / FISHERS | P=0.086N P=0.109N P=0.071N P=0.031N* P=0.046N* P=0.030N* |
|ORDER RESTRICTED | P=0.044N* (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/05/03 EXPERIMENT: 99033 TEST: 01 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUATION II
(ASPA
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex: Zona Reticularis |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/13 (0%) 0/15 (0%) 0/13 (0%) 0/14 (0%) 0/15 (0%) 0/13 (0%) |
|POLY-3 RATE (b) | 0/11.92 0/14.31 0/10.06 0/13.39 0/12.70 0/10.92 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/9 (0%) 0/12 (0%) 0/8 (0%) 0/12 (0%) 0/11 (0%) 0/9 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex: Zona Reticularis |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/15 (80%) 9/12 (75%) 6/13 (46%) 8/13 (62%) 9/14 (64%) 8/15 (53%) |
|POLY-3 RATE (b) | 12/13.45 9/11.33 6/9.84 8/10.59 9/13.85 8/12.10 |
|POLY-3 PERCENT (g) | 89.2% 79.4% 61.0% 75.6% 65.0% 66.1% |
|TERMINAL (d) | 10/11 (91%) 9/10 (90%) 6/9 (67%) 8/9 (89%) 8/11 (73%) 4/8 (50%) |
|FIRST INCIDENCE | 242 275 (T) 275 (T) 275 (T) 270 151 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.548 P=0.312N P=0.090N P=0.309N P=0.209N P=0.508N |
|POLY 3 | P=0.152N P=0.452N P=0.119N P=0.358N P=0.139N P=0.168N |
|POLY 1.5 | P=0.179N P=0.474N P=0.103N P=0.299N P=0.177N P=0.170N |
|POLY 6 | P=0.117N P=0.456N P=0.141N P=0.417N P=0.118N P=0.147N |
|LOGISTIC REGRESSION| P=0.423N P=0.361N P=0.115N P=0.338N P=0.088N P=0.313N |
|COCH-ARM / FISHERS | P=0.173N P=0.557N P=0.071N P=0.255N P=0.298N P=0.123N |
|ORDER RESTRICTED | P=0.125N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/05/03 EXPERIMENT: 99033 TEST: 01 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUATION II
(ASPA
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/14 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/14 (14%) |
|POLY-3 RATE (b) | 0/12.30 0/0.00 0/0.00 0/0.00 0/0.00 2/13.36 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 15.0% |
|TERMINAL (d) | 0/9 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 180 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.012 * (e) (e) (e) (e) P=0.252 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.250 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.246 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.252 |
|LOGISTIC REGRESSION| P=0.058 (e) (e) (e) (e) P=0.126 |
|COCH-ARM / FISHERS | P=0.136 (e) (e) (e) (e) P=0.241 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/12 (0%) |
|POLY-3 RATE (b) | 0/13.08 0/0.00 0/0.00 0/0.00 0/0.00 0/9.88 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/11 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/05/03 EXPERIMENT: 99033 TEST: 01 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUATION II
(ASPA
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Epididymis: Unilateral |
| Aspermia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/15 (7%) 3/15 (20%) 4/15 (27%) 2/15 (13%) 3/15 (20%) 2/15 (13%) |
|POLY-3 RATE (b) | 1/12.63 3/14.31 4/11.74 2/13.81 3/13.57 2/12.09 |
|POLY-3 PERCENT (g) | 7.9% 21.0% 34.1% 14.5% 22.1% 16.5% |
|TERMINAL (d) | 0/9 (0%) 3/12 (25%) 2/8 (25%) 1/12 (8%) 2/11 (18%) 1/10 (10%) |
|FIRST INCIDENCE | 271 274 (T) 78 271 138 271 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.531N P=0.398 P=0.146 P=0.552 P=0.334 P=0.492 |
|POLY 3 | P=0.570N P=0.345 P=0.133 P=0.532 P=0.323 P=0.484 |
|POLY 1.5 | P=0.552N P=0.333 P=0.143 P=0.526 P=0.315 P=0.494 |
|POLY 6 | P=0.565 P=0.353 P=0.129 P=0.534 P=0.329 P=0.476 |
|LOGISTIC REGRESSION| P=0.528N P=0.357 P=0.188 P=0.536 P=0.294 P=0.476 |
|COCH-ARM / FISHERS | P=0.531N P=0.299 P=0.165 P=0.500 P=0.299 P=0.500 |
|ORDER RESTRICTED | P=0.373 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Epididymis: Unilateral |
| Aspermia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 03/05/03 EXPERIMENT: 99033 TEST: 01 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUATION II
(ASPA
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Epididymis: Unilateral |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 2/15 (13%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/12.59 0/14.31 2/10.77 0/13.78 0/12.70 0/12.06 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 18.6% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/9 (0%) 0/12 (0%) 1/8 (13%) 0/12 (0%) 0/11 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- 207 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.384N (e) P=0.207 (e) (e) (e) |
|POLY 3 | P=0.431N (e) P=0.194 (e) (e) (e) |
|POLY 1.5 | P=0.418N (e) P=0.204 (e) (e) (e) |
|POLY 6 | P=0.437N (e) P=0.190 (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.379N (e) P=0.222 (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.381N (e) P=0.241 (e) (e) (e) |
|ORDER RESTRICTED | P=0.364N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Epididymis: Unilateral |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 03/05/03 EXPERIMENT: 99033 TEST: 01 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUATION II
(ASPA
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Eye: Retina |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/12 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 14/14 (100%) |
|POLY-3 RATE (b) | 12/12.00 0/0.00 0/0.00 0/0.00 0/0.00 14/14.00 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 9/9 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%) |
|FIRST INCIDENCE | 271 --- --- --- --- 180 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Eye: Retina |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 15/15 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%) |
|POLY-3 RATE (b) | 15/15.00 0/0.00 0/0.00 0/0.00 0/0.00 10/10.00 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 11/11 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 8/8 (100%) |
|FIRST INCIDENCE | 109 --- --- --- --- 184 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/05/03 EXPERIMENT: 99033 TEST: 01 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUATION II
(ASPA
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/15 (20%) 0/15 (0%) 0/13 (0%) 0/15 (0%) 0/14 (0%) 1/15 (7%) |
|POLY-3 RATE (b) | 3/12.66 0/14.31 0/10.06 0/13.78 0/12.66 1/12.06 |
|POLY-3 PERCENT (g) | 23.7% 0.0% 0.0% 0.0% 0.0% 8.3% |
|TERMINAL (d) | 1/9 (11%) 0/12 (0%) 0/8 (0%) 0/12 (0%) 0/11 (0%) 1/10 (10%) |
|FIRST INCIDENCE | 271 --- --- --- --- 274 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.485N P=0.088N P=0.164N P=0.096N P=0.118N P=0.300N |
|POLY 3 | P=0.473N P=0.083N P=0.147N P=0.089N P=0.103N P=0.313N |
|POLY 1.5 | P=0.476N P=0.088N P=0.139N P=0.092N P=0.106N P=0.302N |
|POLY 6 | P=0.469N P=0.080N P=0.156N P=0.088N P=0.101N P=0.323N |
|LOGISTIC REGRESSION| P=0.494N P=0.086N P=0.156N P=0.094N P=0.107N P=0.317N |
|COCH-ARM / FISHERS | P=0.470N P=0.112N P=0.139N P=0.112N P=0.125N P=0.299N |
|ORDER RESTRICTED | P=0.008N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/15 (7%) 0/12 (0%) 0/13 (0%) 0/14 (0%) 0/14 (0%) 1/14 (7%) |
|POLY-3 RATE (b) | 1/13.08 0/11.33 0/9.84 0/10.80 0/13.80 1/9.94 |
|POLY-3 PERCENT (g) | 7.7% 0.0% 0.0% 0.0% 0.0% 10.1% |
|TERMINAL (d) | 1/11 (9%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/11 (0%) 1/8 (13%) |
|FIRST INCIDENCE | 275 (T) --- --- --- --- 275 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.375 P=0.519N P=0.540N P=0.540N P=0.500N P=0.693 |
|POLY 3 | P=0.410 P=0.529N P=0.556N P=0.538N P=0.489N P=0.698 |
|POLY 1.5 | P=0.413 P=0.533N P=0.552N P=0.529N P=0.497N P=0.711 |
|POLY 6 | P=0.408 P=0.525N P=0.558N P=0.542N P=0.483N P=0.691 |
|LOGISTIC REGRESSION| P=0.375 (e) (e) (e) (e) P=0.693 |
|COCH-ARM / FISHERS | P=0.422 P=0.556N P=0.536N P=0.517N P=0.517N P=0.741 |
|ORDER RESTRICTED | P=0.217 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/05/03 EXPERIMENT: 99033 TEST: 01 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUATION II
(ASPA
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Dilatation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/15 (7%) 0/15 (0%) 1/13 (8%) 0/15 (0%) 0/14 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 1/12.59 0/14.31 1/10.06 0/13.78 0/12.66 0/12.06 |
|POLY-3 PERCENT (g) | 7.9% 0.0% 9.9% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/9 (11%) 0/12 (0%) 1/8 (13%) 0/12 (0%) 0/11 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 274 (T) --- 274 (T) --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.278N P=0.443N P=0.741 P=0.443N P=0.460N P=0.479N |
|POLY 3 | P=0.300N P=0.474N P=0.711 P=0.482N P=0.499N P=0.509N |
|POLY 1.5 | P=0.297N P=0.481N P=0.720 P=0.485N P=0.502N P=0.503N |
|POLY 6 | P=0.302N P=0.470N P=0.703 P=0.481N P=0.497N P=0.513N |
|LOGISTIC REGRESSION| P=0.278N (e) P=0.741 (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.285N P=0.500N P=0.722 P=0.500N P=0.517N P=0.500N |
|ORDER RESTRICTED | P=0.198N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Dilatation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/15 (7%) 2/12 (17%) 1/13 (8%) 0/14 (0%) 0/14 (0%) 1/14 (7%) |
|POLY-3 RATE (b) | 1/13.08 2/11.33 1/9.84 0/10.80 0/13.80 1/9.94 |
|POLY-3 PERCENT (g) | 7.7% 17.7% 10.2% 0.0% 0.0% 10.1% |
|TERMINAL (d) | 1/11 (9%) 2/10 (20%) 1/9 (11%) 0/9 (0%) 0/11 (0%) 1/8 (13%) |
|FIRST INCIDENCE | 275 (T) 275 (T) 275 (T) --- --- 275 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.495N P=0.465 P=0.720 P=0.540N P=0.500N P=0.693 |
|POLY 3 | P=0.369N P=0.448 P=0.696 P=0.538N P=0.489N P=0.698 |
|POLY 1.5 | P=0.389N P=0.441 P=0.701 P=0.529N P=0.497N P=0.711 |
|POLY 6 | P=0.354N P=0.455 P=0.694 P=0.542N P=0.483N P=0.691 |
|LOGISTIC REGRESSION| P=0.495N P=0.465 P=0.720 (e) (e) P=0.693 |
|COCH-ARM / FISHERS | P=0.427N P=0.414 P=0.722 P=0.517N P=0.517N P=0.741 |
|ORDER RESTRICTED | P=0.364N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/05/03 EXPERIMENT: 99033 TEST: 01 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUATION II
(ASPA
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Acute Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/15 (7%) 0/15 (0%) 0/14 (0%) 0/15 (0%) 0/14 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 1/12.59 0/14.31 0/10.17 0/13.78 0/12.66 0/12.06 |
|POLY-3 PERCENT (g) | 7.9% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/9 (11%) 0/12 (0%) 0/8 (0%) 0/12 (0%) 0/11 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 274 (T) --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.410N P=0.443N P=0.523N P=0.443N P=0.460N P=0.479N |
|POLY 3 | P=0.403N P=0.474N P=0.542N P=0.482N P=0.499N P=0.509N |
|POLY 1.5 | P=0.411N P=0.481N P=0.531N P=0.485N P=0.502N P=0.503N |
|POLY 6 | P=0.398N P=0.470N P=0.551N P=0.481N P=0.497N P=0.513N |
|LOGISTIC REGRESSION| P=0.410N (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.416N P=0.500N P=0.517N P=0.500N P=0.517N P=0.500N |
|ORDER RESTRICTED | P=0.069N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Acute Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/15 (7%) 0/15 (0%) 0/14 (0%) 0/15 (0%) 1/14 (7%) 2/14 (14%) |
|POLY-3 RATE (b) | 1/13.08 0/12.12 0/9.99 0/10.85 1/13.88 2/11.62 |
|POLY-3 PERCENT (g) | 7.7% 0.0% 0.0% 0.0% 7.2% 17.2% |
|TERMINAL (d) | 1/11 (9%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/11 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 275 (T) --- --- --- 267 79 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.066 P=0.519N P=0.540N P=0.540N P=0.743N P=0.436 |
|POLY 3 | P=0.080 P=0.515N P=0.553N P=0.537N P=0.747N P=0.458 |
|POLY 1.5 | P=0.076 P=0.510N P=0.545N P=0.526N P=0.756N P=0.461 |
|POLY 6 | P=0.084 P=0.519N P=0.557N P=0.542N P=0.739N P=0.458 |
|LOGISTIC REGRESSION| P=0.084 (e) (e) (e) P=0.763N P=0.677 |
|COCH-ARM / FISHERS | P=0.068 P=0.500N P=0.517N P=0.500N P=0.741 P=0.473 |
|ORDER RESTRICTED | P=0.079 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/05/03 EXPERIMENT: 99033 TEST: 01 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUATION II
(ASPA
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/14 (0%) 0/15 (0%) 0/14 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/12.59 0/14.31 0/10.17 0/13.78 0/12.66 0/12.06 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/9 (0%) 0/12 (0%) 0/8 (0%) 0/12 (0%) 0/11 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/15 (13%) 0/15 (0%) 0/14 (0%) 0/15 (0%) 1/14 (7%) 1/14 (7%) |
|POLY-3 RATE (b) | 2/13.74 0/12.12 0/9.99 0/10.85 1/13.86 1/9.94 |
|POLY-3 PERCENT (g) | 14.6% 0.0% 0.0% 0.0% 7.2% 10.1% |
|TERMINAL (d) | 0/11 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/11 (0%) 1/8 (13%) |
|FIRST INCIDENCE | 200 --- --- --- 269 275 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.476 P=0.267N P=0.300N P=0.298N P=0.491N P=0.621N |
|POLY 3 | P=0.500 P=0.260N P=0.309N P=0.288N P=0.497N P=0.613N |
|POLY 1.5 | P=0.501 P=0.250N P=0.293N P=0.269N P=0.504N P=0.588N |
|POLY 6 | P=0.503 P=0.272N P=0.321N P=0.301N P=0.493N P=0.630N |
|LOGISTIC REGRESSION| P=0.500 P=0.215N P=0.228N P=0.209N P=0.636N P=0.543N |
|COCH-ARM / FISHERS | P=0.507 P=0.241N P=0.259N P=0.241N P=0.527N P=0.527N |
|ORDER RESTRICTED | P=0.233N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/05/03 EXPERIMENT: 99033 TEST: 01 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUATION II
(ASPA
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/14 (0%) 0/15 (0%) 0/14 (0%) 2/15 (13%) |
|POLY-3 RATE (b) | 0/12.59 0/14.31 0/10.17 0/13.78 0/12.66 2/12.06 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 16.6% |
|TERMINAL (d) | 0/9 (0%) 0/12 (0%) 0/8 (0%) 0/12 (0%) 0/11 (0%) 2/10 (20%) |
|FIRST INCIDENCE | --- --- --- --- --- 274 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.010 * (e) (e) (e) (e) P=0.257 |
|POLY 3 | P=0.009 ** (e) (e) (e) (e) P=0.219 |
|POLY 1.5 | P=0.009 ** (e) (e) (e) (e) P=0.226 |
|POLY 6 | P=0.009 ** (e) (e) (e) (e) P=0.214 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.257 |
|COCH-ARM / FISHERS | P=0.011 * (e) (e) (e) (e) P=0.241 |
|ORDER RESTRICTED | P=0.006 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/15 (7%) 0/15 (0%) 0/14 (0%) 0/15 (0%) 0/14 (0%) 4/14 (29%) |
|POLY-3 RATE (b) | 1/13.08 0/12.12 0/9.99 0/10.85 0/13.80 4/10.90 |
|POLY-3 PERCENT (g) | 7.7% 0.0% 0.0% 0.0% 0.0% 36.7% |
|TERMINAL (d) | 1/11 (9%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/11 (0%) 3/8 (38%) |
|FIRST INCIDENCE | 275 (T) --- --- --- --- 92 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.519N P=0.540N P=0.540N P=0.500N P=0.095 |
|POLY 3 | P<0.001 ** P=0.515N P=0.553N P=0.537N P=0.489N P=0.103 |
|POLY 1.5 | P<0.001 ** P=0.510N P=0.545N P=0.526N P=0.497N P=0.113 |
|POLY 6 | P<0.001 ** P=0.519N P=0.557N P=0.542N P=0.483N P=0.097 |
|LOGISTIC REGRESSION| P=0.002 ** (e) (e) (e) (e) P=0.144 |
|COCH-ARM / FISHERS | P=0.002 ** P=0.500N P=0.517N P=0.500N P=0.517N P=0.143 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/05/03 EXPERIMENT: 99033 TEST: 01 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUATION II
(ASPA
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/14 (0%) 0/15 (0%) 0/14 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/12.59 0/14.31 0/10.17 0/13.78 0/12.66 0/12.06 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/9 (0%) 0/12 (0%) 0/8 (0%) 0/12 (0%) 0/11 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 1/15 (7%) 0/14 (0%) 4/15 (27%) 1/14 (7%) 0/14 (0%) |
|POLY-3 RATE (b) | 0/13.08 1/12.12 0/9.99 4/11.68 1/13.80 0/9.94 |
|POLY-3 PERCENT (g) | 0.0% 8.3% 0.0% 34.3% 7.3% 0.0% |
|TERMINAL (d) | 0/11 (0%) 1/10 (10%) 0/9 (0%) 2/9 (22%) 1/11 (9%) 0/8 (0%) |
|FIRST INCIDENCE | --- 275 (T) --- 165 275 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.502N P=0.481 (e) P=0.048 * P=0.500 (e) |
|POLY 3 | P=0.488N P=0.485 (e) P=0.030 * P=0.511 (e) |
|POLY 1.5 | P=0.483N P=0.490 (e) P=0.033 * P=0.503 (e) |
|POLY 6 | P=0.486N P=0.480 (e) P=0.029 * P=0.517 (e) |
|LOGISTIC REGRESSION| P=0.470N P=0.481 (e) P=0.048 * P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.460N P=0.500 (e) P=0.050 P=0.483 (e) |
|ORDER RESTRICTED | P=0.191 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/05/03 EXPERIMENT: 99033 TEST: 01 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUATION II
(ASPA
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/14 (0%) 3/15 (20%) 0/14 (0%) 0/15 (0%) 1/14 (7%) 0/14 (0%) |
|POLY-3 RATE (b) | 0/12.30 3/14.94 0/10.17 0/13.78 1/12.79 0/11.92 |
|POLY-3 PERCENT (g) | 0.0% 20.1% 0.0% 0.0% 7.8% 0.0% |
|TERMINAL (d) | 0/9 (0%) 2/12 (17%) 0/8 (0%) 0/12 (0%) 0/11 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- 198 --- --- 261 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.303N P=0.171 (e) (e) P=0.500 (e) |
|POLY 3 | P=0.258N P=0.144 (e) (e) P=0.508 (e) |
|POLY 1.5 | P=0.267N P=0.138 (e) (e) P=0.507 (e) |
|POLY 6 | P=0.253N P=0.150 (e) (e) P=0.508 (e) |
|LOGISTIC REGRESSION| P=0.307N P=0.093 (e) (e) P=0.502 (e) |
|COCH-ARM / FISHERS | P=0.305N P=0.125 (e) (e) P=0.500 (e) |
|ORDER RESTRICTED | P=0.192N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/15 (7%) 0/14 (0%) 0/14 (0%) 0/15 (0%) 0/14 (0%) 0/14 (0%) |
|POLY-3 RATE (b) | 1/13.08 0/12.09 0/9.99 0/10.85 0/13.80 0/9.94 |
|POLY-3 PERCENT (g) | 7.7% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/11 (9%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/11 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 275 (T) --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.437N P=0.519N P=0.540N P=0.540N P=0.500N P=0.564N |
|POLY 3 | P=0.332N P=0.516N P=0.553N P=0.537N P=0.489N P=0.554N |
|POLY 1.5 | P=0.359N P=0.513N P=0.545N P=0.526N P=0.497N P=0.544N |
|POLY 6 | P=0.314N P=0.520N P=0.557N P=0.542N P=0.483N P=0.560N |
|LOGISTIC REGRESSION| P=0.437N (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.420N P=0.517N P=0.517N P=0.500N P=0.517N P=0.517N |
|ORDER RESTRICTED | P=0.112N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/05/03 EXPERIMENT: 99033 TEST: 01 Page 16
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUATION II
(ASPA
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/12 (8%) 2/15 (13%) 0/13 (0%) 2/14 (14%) 0/14 (0%) 1/14 (7%) |
|POLY-3 RATE (b) | 1/10.96 2/14.97 0/9.17 2/13.97 0/12.66 1/12.64 |
|POLY-3 PERCENT (g) | 9.1% 13.4% 0.0% 14.3% 0.0% 7.9% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/7 (0%) 1/12 (8%) 0/11 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 271 198 --- 199 --- 180 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.477N P=0.562 P=0.557N P=0.581 P=0.517N P=0.759 |
|POLY 3 | P=0.419N P=0.609 P=0.535N P=0.585 P=0.471N P=0.730N |
|POLY 1.5 | P=0.424N P=0.604 P=0.514N P=0.581 P=0.467N P=0.724N |
|POLY 6 | P=0.421N P=0.611 P=0.552N P=0.587 P=0.477N P=0.737N |
|LOGISTIC REGRESSION| P=0.470N P=0.531 P=0.551N P=0.512 P=0.471N P=0.759N |
|COCH-ARM / FISHERS | P=0.448N P=0.586 P=0.480N P=0.560 P=0.462N P=0.720N |
|ORDER RESTRICTED | P=0.472N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/15 (13%) 2/14 (14%) 0/12 (0%) 2/12 (17%) 2/14 (14%) 1/12 (8%) |
|POLY-3 RATE (b) | 2/13.74 2/12.72 0/9.18 2/11.07 2/13.95 1/10.14 |
|POLY-3 PERCENT (g) | 14.6% 15.7% 0.0% 18.1% 14.3% 9.9% |
|TERMINAL (d) | 0/11 (0%) 1/10 (10%) 0/9 (0%) 1/9 (11%) 0/11 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 200 198 --- 184 267 184 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.554N P=0.655 P=0.311N P=0.604 P=0.671N P=0.612N |
|POLY 3 | P=0.522N P=0.671 P=0.329N P=0.619 P=0.694N P=0.607N |
|POLY 1.5 | P=0.525N P=0.676 P=0.323N P=0.618 P=0.696 P=0.601N |
|POLY 6 | P=0.518N P=0.664 P=0.328N P=0.622 P=0.688N P=0.608N |
|LOGISTIC REGRESSION| P=0.533N P=0.658 P=0.261N P=0.627 P=0.605 P=0.518N |
|COCH-ARM / FISHERS | P=0.541N P=0.674 P=0.299N P=0.611 P=0.674 P=0.586N |
|ORDER RESTRICTED | P=0.639N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/05/03 EXPERIMENT: 99033 TEST: 01 Page 17
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUATION II
(ASPA
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/12 (17%) 0/15 (0%) 0/13 (0%) 0/14 (0%) 0/14 (0%) 0/14 (0%) |
|POLY-3 RATE (b) | 2/10.99 0/14.31 0/9.17 0/13.35 0/12.66 0/11.92 |
|POLY-3 PERCENT (g) | 18.2% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/7 (0%) 0/12 (0%) 0/11 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 271 --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.217N P=0.202N P=0.300N P=0.217N P=0.254N P=0.254N |
|POLY 3 | P=0.171N P=0.170N P=0.272N P=0.185N P=0.196N P=0.209N |
|POLY 1.5 | P=0.180N P=0.169N P=0.245N P=0.184N P=0.192N P=0.198N |
|POLY 6 | P=0.162N P=0.174N P=0.297N P=0.188N P=0.203N P=0.221N |
|LOGISTIC REGRESSION| P=0.200N P=0.174N P=0.283N P=0.188N P=0.199N P=0.215N |
|COCH-ARM / FISHERS | P=0.197N P=0.188N P=0.220N P=0.203N P=0.203N P=0.203N |
|ORDER RESTRICTED | P=0.005N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 0/14 (0%) 0/12 (0%) |
|POLY-3 RATE (b) | 0/13.08 0/12.09 0/9.18 0/10.37 0/13.80 0/9.44 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/11 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/11 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/05/03 EXPERIMENT: 99033 TEST: 01 Page 18
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUATION II
(ASPA
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Ovary |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Ovary |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/15 (13%) 0/15 (0%) 1/13 (8%) 0/14 (0%) 0/14 (0%) 0/14 (0%) |
|POLY-3 RATE (b) | 2/13.45 0/12.12 1/10.45 0/10.63 0/13.80 0/9.94 |
|POLY-3 PERCENT (g) | 14.9% 0.0% 9.6% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/11 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/11 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 242 --- 200 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.173N P=0.268N P=0.602N P=0.290N P=0.232N P=0.328N |
|POLY 3 | P=0.120N P=0.255N P=0.589N P=0.287N P=0.225N P=0.304N |
|POLY 1.5 | P=0.132N P=0.246N P=0.586N P=0.274N P=0.230N P=0.287N |
|POLY 6 | P=0.111N P=0.265N P=0.590N P=0.295N P=0.223N P=0.318N |
|LOGISTIC REGRESSION| P=0.158N P=0.235N P=0.535N P=0.258N P=0.266N P=0.268N |
|COCH-ARM / FISHERS | P=0.160N P=0.241N P=0.556N P=0.259N P=0.259N P=0.259N |
|ORDER RESTRICTED | P=0.064N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/05/03 EXPERIMENT: 99033 TEST: 01 Page 19
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUATION II
(ASPA
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/9 (0%) 0/13 (0%) 0/6 (0%) 0/11 (0%) 0/13 (0%) 0/9 (0%) |
|POLY-3 RATE (b) | 0/8.90 0/12.35 0/4.80 0/10.39 0/11.66 0/8.25 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/6 (0%) 0/11 (0%) 0/4 (0%) 0/9 (0%) 0/10 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/13 (15%) 0/11 (0%) 0/12 (0%) 0/10 (0%) 0/11 (0%) 0/9 (0%) |
|POLY-3 RATE (b) | 2/11.69 0/9.37 0/9.83 0/8.47 0/10.85 0/8.24 |
|POLY-3 PERCENT (g) | 17.1% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/10 (20%) 0/9 (0%) 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 275 (T) --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.232N P=0.257N P=0.257N P=0.316N P=0.257N P=0.316N |
|POLY 3 | P=0.200N P=0.281N P=0.270N P=0.306N P=0.245N P=0.312N |
|POLY 1.5 | P=0.208N P=0.279N P=0.264N P=0.299N P=0.251N P=0.311N |
|POLY 6 | P=0.195N P=0.281N P=0.276N P=0.312N P=0.241N P=0.313N |
|LOGISTIC REGRESSION| P=0.232N (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.233N P=0.283N P=0.260N P=0.308N P=0.283N P=0.338N |
|ORDER RESTRICTED | P=0.026N* (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/05/03 EXPERIMENT: 99033 TEST: 01 Page 20
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUATION II
(ASPA
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/14 (21%) 3/15 (20%) 8/13 (62%) 2/15 (13%) 8/14 (57%) 4/14 (29%) |
|POLY-3 RATE (b) | 3/12.36 3/14.35 8/11.50 2/13.78 8/13.66 4/13.36 |
|POLY-3 PERCENT (g) | 24.3% 20.9% 69.6% 14.5% 58.6% 30.0% |
|TERMINAL (d) | 1/9 (11%) 2/12 (17%) 6/8 (75%) 2/12 (17%) 6/11 (55%) 2/10 (20%) |
|FIRST INCIDENCE | 271 271 138 274 (T) 138 180 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.407 P=0.558N P=0.046 * P=0.406N P=0.125 P=0.523 |
|POLY 3 | P=0.422 P=0.598N P=0.026 * P=0.448N P=0.079 P=0.546 |
|POLY 1.5 | P=0.414 P=0.605N P=0.030 * P=0.446N P=0.074 P=0.539 |
|POLY 6 | P=0.426 P=0.596N P=0.022 * P=0.455N P=0.081 P=0.548 |
|LOGISTIC REGRESSION| P=0.384 P=0.597N P=0.035 * P=0.449N P=0.062 P=0.494 |
|COCH-ARM / FISHERS | P=0.383 P=0.639N P=0.041 * P=0.465N P=0.060 P=0.500 |
|ORDER RESTRICTED | P=0.196 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/15 (67%) 4/14 (29%) 7/14 (50%) 6/12 (50%) 8/14 (57%) 5/14 (36%) |
|POLY-3 RATE (b) | 10/14.06 4/12.09 7/10.98 6/12.00 8/14.00 5/10.00 |
|POLY-3 PERCENT (g) | 71.1% 33.1% 63.8% 50.0% 57.1% 50.0% |
|TERMINAL (d) | 7/11 (64%) 4/10 (40%) 6/9 (67%) 3/9 (33%) 5/11 (46%) 4/8 (50%) |
|FIRST INCIDENCE | 200 275 (T) 67 165 267 269 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.440N P=0.071N P=0.470N P=0.335N P=0.367N P=0.296N |
|POLY 3 | P=0.417N P=0.051N P=0.516N P=0.244N P=0.356N P=0.268N |
|POLY 1.5 | P=0.390N P=0.041N* P=0.437N P=0.258N P=0.374N P=0.195N |
|POLY 6 | P=0.422N P=0.072N P=0.593N P=0.240N P=0.351N P=0.335N |
|LOGISTIC REGRESSION| P=0.320N P=0.042N* P=0.424N P=0.292N P=0.374N P=0.201N |
|COCH-ARM / FISHERS | P=0.272N P=0.046N* P=0.297N P=0.315N P=0.442N P=0.097N |
|ORDER RESTRICTED | P=0.282N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/05/03 EXPERIMENT: 99033 TEST: 01 Page 21
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUATION II
(ASPA
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/14 (64%) 12/15 (80%) 8/13 (62%) 12/15 (80%) 13/14 (93%) 11/14 (79%) |
|POLY-3 RATE (b) | 9/12.33 12/14.35 8/10.90 12/13.81 13/14.00 11/13.28 |
|POLY-3 PERCENT (g) | 73.0% 83.7% 73.4% 86.9% 92.9% 82.8% |
|TERMINAL (d) | 8/9 (89%) 11/12 (92%) 7/8 (88%) 11/12 (92%) 10/11 (91%) 8/10 (80%) |
|FIRST INCIDENCE | 271 271 150 271 138 180 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.261 P=0.673 P=0.677 P=0.659 P=0.310 P=0.468 |
|POLY 3 | P=0.328 P=0.422 P=0.676 P=0.338 P=0.193 P=0.451 |
|POLY 1.5 | P=0.284 P=0.398 P=0.637N P=0.351 P=0.151 P=0.430 |
|POLY 6 | P=0.383 P=0.434 P=0.633 P=0.310 P=0.234 P=0.471 |
|LOGISTIC REGRESSION| P=0.163 (e) P=0.574 (e) P=0.093 P=0.316 |
|COCH-ARM / FISHERS | P=0.202 P=0.298 P=0.598N P=0.298 P=0.082 P=0.339 |
|ORDER RESTRICTED | P=0.270 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/15 (67%) 10/14 (71%) 11/14 (79%) 10/12 (83%) 11/14 (79%) 9/14 (64%) |
|POLY-3 RATE (b) | 10/13.39 10/12.09 11/12.58 10/11.22 11/13.80 9/10.00 |
|POLY-3 PERCENT (g) | 74.7% 82.7% 87.4% 89.2% 79.7% 90.0% |
|TERMINAL (d) | 9/11 (82%) 10/10 (100%) 8/9 (89%) 8/9 (89%) 11/11 (100%) 8/8 (100%) |
|FIRST INCIDENCE | 242 275 (T) 61 165 275 (T) 269 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.399 P=0.503 P=0.214 P=0.339 P=0.509 P=0.302 |
|POLY 3 | P=0.355 P=0.495 P=0.367 P=0.341 P=0.557 P=0.333 |
|POLY 1.5 | P=0.442 P=0.543 P=0.382 P=0.327 P=0.507 P=0.463 |
|POLY 6 | P=0.309 P=0.414 P=0.352 P=0.358 P=0.583 P=0.239 |
|LOGISTIC REGRESSION| P=0.572N P=0.466 P=0.271 P=0.214 P=0.675N P=0.271 |
|COCH-ARM / FISHERS | P=0.410N P=0.550 P=0.383 P=0.298 P=0.383 P=0.600N |
|ORDER RESTRICTED | P=0.277 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/05/03 EXPERIMENT: 99033 TEST: 01 Page 22
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUATION II
(ASPA
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Testes: Bilateral, Germinal Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 2/15 (13%) 0/15 (0%) 1/14 (7%) 0/15 (0%) 1/15 (7%) |
|POLY-3 RATE (b) | 0/12.59 2/14.31 0/10.20 1/13.39 0/12.70 1/12.06 |
|POLY-3 PERCENT (g) | 0.0% 14.0% 0.0% 7.5% 0.0% 8.3% |
|TERMINAL (d) | 0/9 (0%) 2/12 (17%) 0/8 (0%) 1/12 (8%) 0/11 (0%) 1/10 (10%) |
|FIRST INCIDENCE | --- 274 (T) --- 274 (T) --- 274 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.609 P=0.300 (e) P=0.557 (e) P=0.521 |
|POLY 3 | P=0.623 P=0.261 (e) P=0.512 (e) P=0.491 |
|POLY 1.5 | P=0.621 P=0.254 (e) P=0.506 (e) P=0.497 |
|POLY 6 | P=0.622 P=0.267 (e) P=0.517 (e) P=0.487 |
|LOGISTIC REGRESSION| (e) P=0.300 (e) P=0.557 (e) P=0.521 |
|COCH-ARM / FISHERS | P=0.600 P=0.241 (e) P=0.483 (e) P=0.500 |
|ORDER RESTRICTED | P=0.329 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Testes: Bilateral, Germinal Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 03/05/03 EXPERIMENT: 99033 TEST: 01 Page 23
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUATION II
(ASPA
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 2/15 (13%) 0/15 (0%) 1/14 (7%) 0/15 (0%) 1/15 (7%) |
|POLY-3 RATE (b) | 0/12.59 2/14.31 0/10.20 1/13.39 0/12.70 1/12.06 |
|POLY-3 PERCENT (g) | 0.0% 14.0% 0.0% 7.5% 0.0% 8.3% |
|TERMINAL (d) | 0/9 (0%) 2/12 (17%) 0/8 (0%) 1/12 (8%) 0/11 (0%) 1/10 (10%) |
|FIRST INCIDENCE | --- 274 (T) --- 274 (T) --- 274 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.609 P=0.300 (e) P=0.557 (e) P=0.521 |
|POLY 3 | P=0.623 P=0.261 (e) P=0.512 (e) P=0.491 |
|POLY 1.5 | P=0.621 P=0.254 (e) P=0.506 (e) P=0.497 |
|POLY 6 | P=0.622 P=0.267 (e) P=0.517 (e) P=0.487 |
|LOGISTIC REGRESSION| (e) P=0.300 (e) P=0.557 (e) P=0.521 |
|COCH-ARM / FISHERS | P=0.600 P=0.241 (e) P=0.483 (e) P=0.500 |
|ORDER RESTRICTED | P=0.329 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 03/05/03 EXPERIMENT: 99033 TEST: 01 Page 24
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUATION II
(ASPA
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Testes: Unilateral |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/15 (7%) 2/15 (13%) 3/15 (20%) 2/14 (14%) 2/15 (13%) 1/15 (7%) |
|POLY-3 RATE (b) | 1/12.63 2/14.31 3/11.17 2/13.43 2/12.70 1/12.06 |
|POLY-3 PERCENT (g) | 7.9% 14.0% 26.9% 14.9% 15.8% 8.3% |
|TERMINAL (d) | 0/9 (0%) 2/12 (17%) 2/8 (25%) 1/12 (8%) 2/11 (18%) 1/10 (10%) |
|FIRST INCIDENCE | 271 274 (T) 78 271 274 (T) 274 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.386N P=0.585 P=0.266 P=0.552 P=0.537 P=0.758N |
|POLY 3 | P=0.432N P=0.544 P=0.249 P=0.522 P=0.502 P=0.752 |
|POLY 1.5 | P=0.413N P=0.533 P=0.268 P=0.510 P=0.501 P=0.758 |
|POLY 6 | P=0.448N P=0.552 P=0.235 P=0.530 P=0.503 P=0.747 |
|LOGISTIC REGRESSION| P=0.389N P=0.559 P=0.321 P=0.530 P=0.502 P=0.755 |
|COCH-ARM / FISHERS | P=0.386N P=0.500 P=0.299 P=0.473 P=0.500 P=0.759N |
|ORDER RESTRICTED | P=0.520 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Testes: Unilateral |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 03/05/03 EXPERIMENT: 99033 TEST: 01 Page 25
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUATION II
(ASPA
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Testes: Unilateral, Germinal Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/15 (7%) 2/15 (13%) 4/15 (27%) 2/14 (14%) 3/15 (20%) 3/15 (20%) |
|POLY-3 RATE (b) | 1/12.63 2/14.31 4/11.74 2/13.43 3/13.57 3/12.09 |
|POLY-3 PERCENT (g) | 7.9% 14.0% 34.1% 14.9% 22.1% 24.8% |
|TERMINAL (d) | 0/9 (0%) 2/12 (17%) 2/8 (25%) 1/12 (8%) 2/11 (18%) 2/10 (20%) |
|FIRST INCIDENCE | 271 274 (T) 78 271 138 271 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.335 P=0.585 P=0.146 P=0.552 P=0.334 P=0.307 |
|POLY 3 | P=0.282 P=0.544 P=0.133 P=0.522 P=0.323 P=0.278 |
|POLY 1.5 | P=0.305 P=0.533 P=0.143 P=0.510 P=0.315 P=0.289 |
|POLY 6 | P=0.265 P=0.552 P=0.129 P=0.530 P=0.329 P=0.269 |
|LOGISTIC REGRESSION| P=0.338 P=0.559 P=0.188 P=0.530 P=0.294 P=0.267 |
|COCH-ARM / FISHERS | P=0.335 P=0.500 P=0.165 P=0.473 P=0.299 P=0.299 |
|ORDER RESTRICTED | P=0.271 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Testes: Unilateral, Germinal Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 03/05/03 EXPERIMENT: 99033 TEST: 01 Page 26
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUATION II
(ASPA
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/12 (8%) 0/14 (0%) 1/12 (8%) 0/13 (0%) 4/14 (29%) 0/12 (0%) |
|POLY-3 RATE (b) | 1/11.94 0/13.94 1/10.47 0/12.97 4/14.00 0/11.36 |
|POLY-3 PERCENT (g) | 8.4% 0.0% 9.6% 0.0% 28.6% 0.0% |
|TERMINAL (d) | 0/9 (0%) 0/12 (0%) 0/8 (0%) 0/12 (0%) 1/11 (9%) 0/10 (0%) |
|FIRST INCIDENCE | 271 --- 150 --- 138 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.510 P=0.469N P=0.719 P=0.484N P=0.197 P=0.517N |
|POLY 3 | P=0.490 P=0.469N P=0.731 P=0.483N P=0.213 P=0.510N |
|POLY 1.5 | P=0.504 P=0.469N P=0.741 P=0.484N P=0.212 P=0.506N |
|POLY 6 | P=0.474 P=0.469N P=0.724 P=0.483N P=0.215 P=0.514N |
|LOGISTIC REGRESSION| P=0.526 (e) P=0.538N (e) (e) P=0.503N |
|COCH-ARM / FISHERS | P=0.522 P=0.462N P=0.761N P=0.480N P=0.213 P=0.500N |
|ORDER RESTRICTED | P=0.252 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/15 (20%) 1/13 (8%) 1/12 (8%) 2/12 (17%) 2/13 (15%) 2/11 (18%) |
|POLY-3 RATE (b) | 3/14.39 1/12.38 1/10.44 2/11.96 2/13.00 2/10.02 |
|POLY-3 PERCENT (g) | 20.9% 8.1% 9.6% 16.7% 15.4% 20.0% |
|TERMINAL (d) | 0/11 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/11 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 109 192 67 165 269 184 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.472 P=0.344N P=0.403N P=0.587N P=0.499N P=0.641N |
|POLY 3 | P=0.445 P=0.355N P=0.423N P=0.588N P=0.548N P=0.669N |
|POLY 1.5 | P=0.439 P=0.353N P=0.417N P=0.595N P=0.556N P=0.670N |
|POLY 6 | P=0.455 P=0.357N P=0.426N P=0.582N P=0.540N P=0.663N |
|LOGISTIC REGRESSION| P=0.445 P=0.410N P=0.167N P=0.585N P=0.574 P=0.598N |
|COCH-ARM / FISHERS | P=0.447 P=0.356N P=0.389N P=0.612N P=0.572N P=0.654N |
|ORDER RESTRICTED | P=0.589N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/05/03 EXPERIMENT: 99033 TEST: 01 Page 27
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUATION II
(ASPA
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 1/13 (8%) 2/14 (14%) 2/12 (17%) |
|POLY-3 RATE (b) | 0/11.90 0/13.94 0/9.63 1/12.97 2/12.66 2/11.39 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 7.7% 15.8% 17.6% |
|TERMINAL (d) | 0/9 (0%) 0/12 (0%) 0/8 (0%) 1/12 (8%) 2/11 (18%) 1/10 (10%) |
|FIRST INCIDENCE | --- --- --- 274 (T) 274 (T) 271 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.031 * (e) (e) P=0.557 P=0.280 P=0.242 |
|POLY 3 | P=0.027 * (e) (e) P=0.517 P=0.243 P=0.218 |
|POLY 1.5 | P=0.027 * (e) (e) P=0.517 P=0.251 P=0.222 |
|POLY 6 | P=0.026 * (e) (e) P=0.518 P=0.236 P=0.215 |
|LOGISTIC REGRESSION| P=0.025 * (e) (e) P=0.557 P=0.280 P=0.217 |
|COCH-ARM / FISHERS | P=0.027 * (e) (e) P=0.520 P=0.280 P=0.239 |
|ORDER RESTRICTED | P=0.078 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/15 (13%) 1/13 (8%) 1/12 (8%) 0/12 (0%) 0/13 (0%) 1/11 (9%) |
|POLY-3 RATE (b) | 2/13.08 1/11.72 1/10.03 0/10.47 0/12.88 1/9.26 |
|POLY-3 PERCENT (g) | 15.3% 8.5% 10.0% 0.0% 0.0% 10.8% |
|TERMINAL (d) | 2/11 (18%) 1/10 (10%) 0/9 (0%) 0/9 (0%) 0/11 (0%) 1/8 (13%) |
|FIRST INCIDENCE | 275 (T) 275 (T) 207 --- --- 275 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.459N P=0.535N P=0.577N P=0.280N P=0.234N P=0.616N |
|POLY 3 | P=0.430N P=0.539N P=0.594N P=0.282N P=0.233N P=0.622N |
|POLY 1.5 | P=0.440N P=0.540N P=0.602N P=0.281N P=0.243N P=0.622N |
|POLY 6 | P=0.424N P=0.539N P=0.580N P=0.281N P=0.225N P=0.618N |
|LOGISTIC REGRESSION| P=0.464N P=0.535N P=0.594N (e) (e) P=0.616N |
|COCH-ARM / FISHERS | P=0.465N P=0.556N P=0.586N P=0.299N P=0.278N P=0.619N |
|ORDER RESTRICTED | P=0.265N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/05/03 EXPERIMENT: 99033 TEST: 01 Page 28
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUATION II
(ASPA
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/13 (15%) 0/15 (0%) 0/13 (0%) 0/14 (0%) 0/14 (0%) 0/14 (0%) |
|POLY-3 RATE (b) | 2/12.94 0/14.31 0/10.06 0/13.39 0/12.66 0/11.92 |
|POLY-3 PERCENT (g) | 15.5% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/9 (0%) 0/12 (0%) 0/8 (0%) 0/12 (0%) 0/11 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 197 --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.217N P=0.208N P=0.291N P=0.216N P=0.249N P=0.258N |
|POLY 3 | P=0.166N P=0.207N P=0.292N P=0.222N P=0.235N P=0.249N |
|POLY 1.5 | P=0.175N P=0.203N P=0.269N P=0.218N P=0.227N P=0.235N |
|POLY 6 | P=0.158N P=0.210N P=0.311N P=0.226N P=0.242N P=0.263N |
|LOGISTIC REGRESSION| P=0.183N P=0.188N P=0.133N P=0.216N P=0.142N P=0.114N |
|COCH-ARM / FISHERS | P=0.201N P=0.206N P=0.240N P=0.222N P=0.222N P=0.222N |
|ORDER RESTRICTED | P=0.010N* (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/15 (7%) 0/13 (0%) 0/12 (0%) 0/15 (0%) 0/14 (0%) 0/11 (0%) |
|POLY-3 RATE (b) | 1/13.39 0/11.67 0/8.84 0/10.85 0/13.80 0/8.74 |
|POLY-3 PERCENT (g) | 7.5% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/11 (0%) 0/10 (0%) 0/8 (0%) 0/9 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 242 --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.430N P=0.533N P=0.573N P=0.552N P=0.485N P=0.573N |
|POLY 3 | P=0.373N P=0.527N P=0.581N P=0.542N P=0.494N P=0.584N |
|POLY 1.5 | P=0.392N P=0.526N P=0.574N P=0.528N P=0.499N P=0.577N |
|POLY 6 | P=0.355N P=0.531N P=0.587N P=0.550N P=0.492N P=0.591N |
|LOGISTIC REGRESSION| P=0.438N P=0.550N P=0.544N P=0.496N P=0.591N P=0.555N |
|COCH-ARM / FISHERS | P=0.437N P=0.536N P=0.556N P=0.500N P=0.517N P=0.577N |
|ORDER RESTRICTED | P=0.152N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/05/03 EXPERIMENT: 99033 TEST: 01 Page 29
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUATION II
(ASPA
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
| | |
| | Females |
|Dose | VEHICLE 3125 PPM 6250 PPM 12500 25000 50000 |
| | CONTROL PPM PPM PPM |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/15 (67%) 8/13 (62%) 9/13 (69%) 10/12 (83%) 10/14 (71%) 10/14 (71%) |
|POLY-3 RATE (b) | 10/14.06 8/11.67 9/9.84 10/10.33 10/13.85 10/10.84 |
|POLY-3 PERCENT (g) | 71.1% 68.6% 91.5% 96.8% 72.2% 92.3% |
|TERMINAL (d) | 7/11 (64%) 8/10 (80%) 9/9 (100%) 9/9 (100%) 9/11 (82%) 8/8 (100%) |
|FIRST INCIDENCE | 200 275 (T) 275 (T) 184 270 92 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.090 P=0.494N P=0.493 P=0.341 P=0.630N P=0.231 |
|POLY 3 | P=0.201 P=0.613N P=0.237 P=0.126 P=0.636 P=0.201 |
|POLY 1.5 | P=0.256 P=0.568N P=0.332 P=0.177 P=0.622 P=0.300 |
|POLY 6 | P=0.162 P=0.663 P=0.161 P=0.099 P=0.628 P=0.133 |
|LOGISTIC REGRESSION| P=0.171 P=0.507N P=0.361 P=0.173 P=0.664N P=0.283 |
|COCH-ARM / FISHERS | P=0.425 P=0.544N P=0.604 P=0.298 P=0.550 P=0.550 |
|ORDER RESTRICTED | P=0.104 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Number of tumor-bearing animals / Poly-3 number
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death.
Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fishers exact tests compare directly the overall incidence rates
For all tests a negative trend is indicated by N
(e) Value of Statistic cannot be computed.
(g) Poly-3 adjusted lifetime tumor incidence.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).