TDMS Study 99039-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: BIORELIANCE TRANSGENIC MODEL EVALUATION II DATE: 02/21/03
EXPERIMENT: 99039 TEST: 01 TIME: 10:25:14
TEST TYPE: 26-39 WEEKS CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-75408 ROUTE: DOSED FEED NTP C#: C99039
PATHOLOGIST: LANNING, LYNDA CAS: 55589-62-3
------------------------------------------------------------------------------------------------------------------------------------
FINAL#3/TG.AC MICE
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 VEHICLE CONTROL
INCLUDE 002 0.3%
INCLUDE 003 1.0 %
INCLUDE 004 3.0 %
INCLUDE 006 VEHICLE CONTROL
INCLUDE 007 0.3 %
INCLUDE 008 1.0%
INCLUDE 009 3.0%
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: BIORELIANCE TRANSGENIC MODEL EVALUATION II DATE: 02/21/03
EXPERIMENT: 99039 TEST: 01 TIME: 10:25:14
TEST TYPE: 26-39 WEEKS CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75408 ROUTE: DOSED FEED NTP C#: C99039
PATHOLOGIST: LANNING, LYNDA CAS: 55589-62-3
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF TRANSGENIC MODEL EVALUATION II
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Spleen Hematopoietic Cell Proliferation
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Mesentery: Fat Necrosis Focal
Uterus: Endometrium Hyperplasia Cystic
===============================================================
Date: 02/21/03 EXPERIMENT: 99039 TEST: 01 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUA
TION II
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE 0.3% 1.0 % 3.0 % |VEHICLE 0.3 % 1.0% 3.0% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/14 (71%) 0/0 (0%) 0/0 (0%) 11/15 (73%) |0/14 (0%) 0/1 (0%) 0/0 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 10/12.35 0/0.00 0/0.00 11/15.00 |0/13.31 0/0.02 0/0.00 0/13.60 |
|POLY-3 PERCENT (g) | 81.0% 0.0% 0.0% 73.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 10/12 (83%) 0/0 (0%) 0/0 (0%) 10/14 (71%) |0/12 (0%) 0/0 (0%) 0/0 (0%) 0/12 (0%) |
|FIRST INCIDENCE | 274 (T) --- --- 172 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.558N P=1.000 P=1.000 P=0.565N |(e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) P=0.493N |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) P=0.563N |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) P=0.450N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.556N (e) (e) P=0.614N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.565 P=1.000 P=1.000 P=0.617 |(e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE 0.3% 1.0 % 3.0 % |VEHICLE 0.3 % 1.0% 3.0% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/14 (64%) 0/0 (0%) 0/0 (0%) 5/15 (33%) |0/14 (0%) 0/1 (0%) 0/0 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 9/13.16 0/0.00 0/0.00 5/14.25 |0/13.31 0/0.02 0/0.00 0/13.60 |
|POLY-3 PERCENT (g) | 68.4% 0.0% 0.0% 35.1% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 8/12 (67%) 0/0 (0%) 0/0 (0%) 5/14 (36%) |0/12 (0%) 0/0 (0%) 0/0 (0%) 0/12 (0%) |
|FIRST INCIDENCE | 157 --- --- 274 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.066N P=0.515N P=0.486N P=0.073N |(e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) P=0.081N |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) P=0.083N |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) P=0.082N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.064N (e) (e) P=0.082N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.078N P=1.000 P=1.000 P=0.097N |(e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/21/03 EXPERIMENT: 99039 TEST: 01 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUAT
ION II
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE 0.3% 1.0 % 3.0 % |VEHICLE 0.3 % 1.0% 3.0% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex: Subcapsular |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/14 (0%) 0/0 (0%) 0/0 (0%) 0/15 (0%) |9/14 (64%) 0/1 (0%) 0/0 (0%) 6/15 (40%) |
|POLY-3 RATE (b) | 0/12.35 0/0.00 0/0.00 0/14.25 |9/13.64 0/0.02 0/0.00 6/13.99 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |66.0% 0.0% 0.0% 42.9% |
|TERMINAL (d) | 0/12 (0%) 0/0 (0%) 0/0 (0%) 0/14 (0%) |8/12 (67%) 0/0 (0%) 0/0 (0%) 5/12 (42%) |
|FIRST INCIDENCE | --- --- --- --- |240 --- --- 232 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.257N P=0.500N P=0.500N P=0.243N |
|POLY 3 | (e) (e) (e) (e) |(e) P=0.846N (e) P=0.201N |
|POLY 1.5 | (e) (e) (e) (e) |(e) P=0.800N (e) P=0.194N |
|POLY 6 | (e) (e) (e) (e) |(e) P=0.857N (e) P=0.202N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.174N (e) (e) P=0.201N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.186N P=0.400N P=1.000 P=0.175N |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE 0.3% 1.0 % 3.0 % |VEHICLE 0.3 % 1.0% 3.0% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex: Zona Reticularis |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/14 (0%) 0/0 (0%) 0/0 (0%) 0/15 (0%) |9/14 (64%) 0/1 (0%) 0/0 (0%) 10/15 (67%) |
|POLY-3 RATE (b) | 0/12.35 0/0.00 0/0.00 0/14.25 |9/13.67 0/0.02 0/0.00 10/13.60 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |65.8% 0.0% 0.0% 73.5% |
|TERMINAL (d) | 0/12 (0%) 0/0 (0%) 0/0 (0%) 0/14 (0%) |8/12 (67%) 0/0 (0%) 0/0 (0%) 10/12 (83%) |
|FIRST INCIDENCE | --- --- --- --- |236 --- --- 274 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.392 P=0.515N P=0.515N P=0.494 |
|POLY 3 | (e) (e) (e) (e) |(e) P=0.845N (e) P=0.491 |
|POLY 1.5 | (e) (e) (e) (e) |(e) P=0.799N (e) P=0.531 |
|POLY 6 | (e) (e) (e) (e) |(e) P=0.856N (e) P=0.451 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.471 (e) (e) P=0.528 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.469 P=0.400N P=1.000 P=0.600 |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/21/03 EXPERIMENT: 99039 TEST: 01 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUAT
ION II
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE 0.3% 1.0 % 3.0 % |VEHICLE 0.3 % 1.0% 3.0% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Eye: Retina |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 15/15 (100%) 0/0 (0%) 0/0 (0%) 14/15 (93%) |13/13 (100%) 0/0 (0%) 0/0 (0%) 14/14 (100%) |
|POLY-3 RATE (b) | 15/15.00 0/0.00 0/0.00 14/15.00 |13/13.00 0/0.00 0/0.00 14/14.00 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 0.0% 93.3% |100.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 13/13 (100%) 0/0 (0%) 0/0 (0%) 13/14 (93%) |12/12 (100%) 0/0 (0%) 0/0 (0%) 12/12 (100%) |
|FIRST INCIDENCE | 148 --- --- 172 |240 --- --- 156 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.370N (e) (e) P=0.296N |(e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) P=0.500N |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) P=0.500N |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) P=0.500N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.367N (e) (e) P=0.500N |(e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE 0.3% 1.0 % 3.0 % |VEHICLE 0.3 % 1.0% 3.0% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Dilatation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 0/1 (0%) 0/0 (0%) 2/15 (13%) |0/15 (0%) 0/1 (0%) 0/0 (0%) 1/15 (7%) |
|POLY-3 RATE (b) | 0/13.35 0/0.97 0/0.00 2/14.25 |0/13.86 0/0.02 0/0.00 1/13.60 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 14.0% |0.0% 0.0% 0.0% 7.4% |
|TERMINAL (d) | 0/13 (0%) 0/0 (0%) 0/0 (0%) 2/14 (14%) |0/12 (0%) 0/0 (0%) 0/0 (0%) 1/12 (8%) |
|FIRST INCIDENCE | --- --- --- 274 (T) |--- --- --- 274 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.182 (e) (e) P=0.252 |P=0.369 (e) (e) P=0.500 |
|POLY 3 | (e) (e) (e) P=0.246 |(e) (e) (e) P=0.496 |
|POLY 1.5 | (e) (e) (e) P=0.242 |(e) (e) (e) P=0.496 |
|POLY 6 | (e) (e) (e) P=0.248 |(e) (e) (e) P=0.498 |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.252 |(e) (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.154 (e) (e) P=0.241 |P=0.357 (e) (e) P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/21/03 EXPERIMENT: 99039 TEST: 01 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUAT
ION II
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE 0.3% 1.0 % 3.0 % |VEHICLE 0.3 % 1.0% 3.0% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/15 (7%) 0/0 (0%) 0/1 (0%) 0/15 (0%) |2/15 (13%) 0/2 (0%) 0/0 (0%) 3/15 (20%) |
|POLY-3 RATE (b) | 1/14.16 0/0.00 0/0.34 0/14.25 |2/13.86 0/0.39 0/0.00 3/14.41 |
|POLY-3 PERCENT (g) | 7.1% 0.0% 0.0% 0.0% |14.4% 0.0% 0.0% 20.8% |
|TERMINAL (d) | 0/13 (0%) 0/0 (0%) 0/0 (0%) 0/14 (0%) |2/12 (17%) 0/0 (0%) 0/0 (0%) 2/12 (17%) |
|FIRST INCIDENCE | 157 --- --- --- |274 (T) --- --- 156 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.459N P=0.515N P=0.486N P=0.486N |P=0.382 P=1.000 P=1.000 P=0.500 |
|POLY 3 | (e) (e) P=0.970N P=0.499N |(e) P=0.831N (e) P=0.519 |
|POLY 1.5 | (e) (e) P=0.967N P=0.499N |(e) P=0.808N (e) P=0.510 |
|POLY 6 | (e) (e) P=0.973N P=0.499N |(e) P=0.847N (e) P=0.530 |
|LOGISTIC REGRESSION| P=0.739N (e) P=0.972N P=0.861N |P=0.373 (e) (e) P=0.558 |
|COCH-ARM / FISHERS | P=0.370N P=1.000 P=0.937N P=0.500N |P=0.387 P=0.772N P=1.000 P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE 0.3% 1.0 % 3.0 % |VEHICLE 0.3 % 1.0% 3.0% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/15 (7%) 0/0 (0%) 0/1 (0%) 0/15 (0%) |2/15 (13%) 0/2 (0%) 0/0 (0%) 3/15 (20%) |
|POLY-3 RATE (b) | 1/13.35 0/0.00 0/0.34 0/14.25 |2/13.86 0/0.39 0/0.00 3/13.60 |
|POLY-3 PERCENT (g) | 7.5% 0.0% 0.0% 0.0% |14.4% 0.0% 0.0% 22.1% |
|TERMINAL (d) | 1/13 (8%) 0/0 (0%) 0/0 (0%) 0/14 (0%) |2/12 (17%) 0/0 (0%) 0/0 (0%) 3/12 (25%) |
|FIRST INCIDENCE | 274 (T) --- --- --- |274 (T) --- --- 274 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.355N P=1.000 P=1.000 P=0.485N |P=0.435 P=1.000 P=1.000 P=0.500 |
|POLY 3 | (e) (e) P=0.970N P=0.487N |(e) P=0.831N (e) P=0.491 |
|POLY 1.5 | (e) (e) P=0.967N P=0.491N |(e) P=0.808N (e) P=0.492 |
|POLY 6 | (e) (e) P=0.973N P=0.485N |(e) P=0.847N (e) P=0.496 |
|LOGISTIC REGRESSION| P=0.355N (e) (e) (e) |P=0.435 (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.370N P=1.000 P=0.937N P=0.500N |P=0.387 P=0.772N P=1.000 P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/21/03 EXPERIMENT: 99039 TEST: 01 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUAT
ION II
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE 0.3% 1.0 % 3.0 % |VEHICLE 0.3 % 1.0% 3.0% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/14 (14%) 0/0 (0%) 0/0 (0%) 2/15 (13%) |1/12 (8%) 0/1 (0%) 0/0 (0%) 3/15 (20%) |
|POLY-3 RATE (b) | 2/13.16 0/0.00 0/0.00 2/14.25 |1/11.67 0/0.02 0/0.00 3/14.81 |
|POLY-3 PERCENT (g) | 15.2% 0.0% 0.0% 14.0% |8.6% 0.0% 0.0% 20.3% |
|TERMINAL (d) | 1/12 (8%) 0/0 (0%) 0/0 (0%) 2/14 (14%) |0/10 (0%) 0/0 (0%) 0/0 (0%) 1/12 (8%) |
|FIRST INCIDENCE | 157 --- --- 274 (T) |236 --- --- 156 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.637 P=0.515N P=0.486N P=0.648N |P=0.111 P=0.515N P=0.515N P=0.324 |
|POLY 3 | (e) (e) (e) P=0.670N |(e) P=0.958N (e) P=0.389 |
|POLY 1.5 | (e) (e) (e) P=0.670N |(e) P=0.956N (e) P=0.387 |
|POLY 6 | (e) (e) (e) P=0.671N |(e) P=0.959N (e) P=0.393 |
|LOGISTIC REGRESSION| P=0.609 (e) (e) P=0.679 |P=0.227 (e) (e) P=0.439 |
|COCH-ARM / FISHERS | P=0.612N P=1.000 P=1.000 P=0.674N |P=0.289 P=0.923N P=1.000 P=0.389 |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE 0.3% 1.0 % 3.0 % |VEHICLE 0.3 % 1.0% 3.0% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/2 (100%) 0/0 (0%) 0/0 (0%) 2/2 (100%) |2/2 (100%) 0/0 (0%) 0/1 (0%) 0/0 (0%) |
|POLY-3 RATE (b) | 2/2.00 0/0.00 0/0.00 2/2.00 |2/2.00 0/0.00 0/0.96 0/0.00 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 0.0% 100.0% |100.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/2 (100%) 0/0 (0%) 0/0 (0%) 2/2 (100%) |2/2 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 274 (T) --- --- 274 (T) |274 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=1.000N (e) P=1.000 (e) |
|POLY 3 | (e) (e) (e) (e) |(e) (e) P<0.001N** (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) P<0.001N** (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) P=1.000N (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=1.000N (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.807N (e) P=0.333N (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/21/03 EXPERIMENT: 99039 TEST: 01 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUAT
ION II
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE 0.3% 1.0 % 3.0 % |VEHICLE 0.3 % 1.0% 3.0% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/15 (67%) 1/1 (100%) 0/1 (0%) 7/15 (47%) |12/15 (80%) 0/0 (0%) 3/3 (100%) 13/15 (87%) |
|POLY-3 RATE (b) | 10/13.35 1/1.00 0/0.34 7/14.25 |12/14.19 0/0.00 3/3.00 13/14.81 |
|POLY-3 PERCENT (g) | 74.9% 100.0% 0.0% 49.1% |84.6% 0.0% 100.0% 87.8% |
|TERMINAL (d) | 10/13 (77%) 0/0 (0%) 0/0 (0%) 7/14 (50%) |11/12 (92%) 0/0 (0%) 2/2 (100%) 11/12 (92%) |
|FIRST INCIDENCE | 274 (T) 271 --- 274 (T) |240 --- 270 156 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.095N P=0.484 P=1.000 P=0.152N |P=0.305 P=0.500N P=0.684 P=0.500 |
|POLY 3 | P=0.098N P=0.750 P=0.732N P=0.155N |(e) (e) P=0.597 P=0.618 |
|POLY 1.5 | P=0.120N P=0.722 P=0.589N P=0.175N |(e) (e) P=0.549 P=0.563 |
|POLY 6 | P=0.087N P=0.764 P=0.846N P=0.147N |(e) (e) P=0.677 P=0.697 |
|LOGISTIC REGRESSION| P=0.095N P=0.735 (e) P=0.152N |P=0.403 (e) P=0.783 P=0.452 |
|COCH-ARM / FISHERS | P=0.182N P=0.688 P=0.375N P=0.231N |P=0.463 P=1.000 P=0.558 P=0.500 |
|ORDER RESTRICTED | P=0.019N* (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE 0.3% 1.0 % 3.0 % |VEHICLE 0.3 % 1.0% 3.0% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 0/1 (0%) 0/1 (0%) 0/15 (0%) |3/15 (20%) 0/0 (0%) 0/3 (0%) 2/15 (13%) |
|POLY-3 RATE (b) | 0/13.35 0/0.97 0/0.34 0/14.25 |3/13.86 0/0.00 0/2.96 2/13.60 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |21.7% 0.0% 0.0% 14.7% |
|TERMINAL (d) | 0/13 (0%) 0/0 (0%) 0/0 (0%) 0/14 (0%) |3/12 (25%) 0/0 (0%) 0/2 (0%) 2/12 (17%) |
|FIRST INCIDENCE | --- --- --- --- |274 (T) --- --- 274 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.459N P=1.000 P=0.551N P=0.500N |
|POLY 3 | (e) (e) (e) (e) |(e) (e) P=0.482N P=0.509N |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) P=0.490N P=0.508N |
|POLY 6 | (e) (e) (e) (e) |(e) (e) P=0.471N P=0.504N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.459N (e) (e) P=0.500N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.463N P=1.000 P=0.558N P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/21/03 EXPERIMENT: 99039 TEST: 01 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUAT
ION II
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE 0.3% 1.0 % 3.0 % |VEHICLE 0.3 % 1.0% 3.0% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/15 (20%) 0/0 (0%) 0/0 (0%) 2/14 (14%) |1/11 (9%) 0/1 (0%) 0/0 (0%) 1/14 (7%) |
|POLY-3 RATE (b) | 3/15.00 0/0.00 0/0.00 2/13.25 |1/11.00 0/0.02 0/0.00 1/13.61 |
|POLY-3 PERCENT (g) | 20.0% 0.0% 0.0% 15.1% |9.1% 0.0% 0.0% 7.4% |
|TERMINAL (d) | 1/13 (8%) 0/0 (0%) 0/0 (0%) 2/13 (15%) |0/10 (0%) 0/0 (0%) 0/0 (0%) 0/12 (0%) |
|FIRST INCIDENCE | 148 --- --- 274 (T) |240 --- --- 156 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.537N P=0.264N P=0.232N P=0.494N |P=0.542 P=0.516N P=0.516N P=0.759 |
|POLY 3 | (e) (e) (e) P=0.559N |(e) P=0.951N (e) P=0.713N |
|POLY 1.5 | (e) (e) (e) P=0.550N |(e) P=0.949N (e) P=0.710N |
|POLY 6 | (e) (e) (e) P=0.565N |(e) P=0.951N (e) P=0.717N |
|LOGISTIC REGRESSION| P=0.613N (e) (e) P=0.683N |P=0.684 (e) (e) P=0.367N |
|COCH-ARM / FISHERS | P=0.468N P=1.000 P=1.000 P=0.535N |P=0.644N P=0.917N P=1.000 P=0.697N |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE 0.3% 1.0 % 3.0 % |VEHICLE 0.3 % 1.0% 3.0% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/15 (13%) 0/0 (0%) 0/0 (0%) 0/14 (0%) |0/11 (0%) 0/1 (0%) 0/0 (0%) 0/14 (0%) |
|POLY-3 RATE (b) | 2/13.35 0/0.00 0/0.00 0/13.25 |0/10.67 0/0.02 0/0.00 0/12.79 |
|POLY-3 PERCENT (g) | 15.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/13 (15%) 0/0 (0%) 0/0 (0%) 0/13 (0%) |0/10 (0%) 0/0 (0%) 0/0 (0%) 0/12 (0%) |
|FIRST INCIDENCE | 274 (T) --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.168N P=1.000N P=1.000 P=0.235N |(e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) P=0.232N |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) P=0.236N |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) P=0.230N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.168N (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.177N P=1.000 P=1.000 P=0.259N |(e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/21/03 EXPERIMENT: 99039 TEST: 01 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRANSGENIC MODEL EVALUAT
ION II
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE 0.3% 1.0 % 3.0 % |VEHICLE 0.3 % 1.0% 3.0% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |7/13 (54%) 2/2 (100%) 1/1 (100%) 10/14 (71%) |
|POLY-3 RATE (b) | |7/12.67 2/2.00 1/1.00 10/13.19 |
|POLY-3 PERCENT (g) | |55.2% 100.0% 100.0% 75.9% |
|TERMINAL (d) | |7/12 (58%) 2/2 (100%) 1/1 (100%) 9/12 (75%) |
|FIRST INCIDENCE | |274 (T) 274 (T) 274 (T) 232 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.207 P=0.371 P=0.594 P=0.222 |
|POLY 3 | |P=0.285 P=0.334 P=0.569 P=0.245 |
|POLY 1.5 | |P=0.298 P=0.329 P=0.564 P=0.256 |
|POLY 6 | |P=0.290 P=0.343 P=0.578 P=0.250 |
|LOGISTIC REGRESSION| |P=0.233 P=0.371 P=0.594 P=0.207 |
|COCH-ARM / FISHERS | |P=0.342 P=0.343 P=0.571 P=0.293 |
|ORDER RESTRICTED | |P=0.044 * (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).