TDMS Study 99039-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: BIORELIANCE TRANSGENIC MODEL EVALUATION II DATE: 02/21/03
EXPERIMENT: 99039 TEST: 02 TIME: 10:32:11
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/P53 +/- MICE
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: BIORELIANCE TRANSGENIC MODEL EVALUATION II DATE: 02/21/03
EXPERIMENT: 99039 TEST: 02 TIME: 10:32:11
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
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Thymus Atrophy Focal
===============================================================
Date: 02/21/03 EXPERIMENT: 99039 TEST: 02 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - TRANSGENIC MODEL EVALUATI
ON 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 |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 0/0 (0%) 0/0 (0%) 0/15 (0%) |2/15 (13%) 0/0 (0%) 0/0 (0%) 2/14 (14%) |
|POLY-3 RATE (b) | 0/14.33 0/0.00 0/0.00 0/14.55 |2/14.22 0/0.00 0/0.00 2/14.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |14.1% 0.0% 0.0% 14.3% |
|TERMINAL (d) | 0/14 (0%) 0/0 (0%) 0/0 (0%) 0/14 (0%) |2/14 (14%) 0/0 (0%) 0/0 (0%) 2/14 (14%) |
|FIRST INCIDENCE | --- --- --- --- |274 (T) --- --- 274 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.638 P=1.000 P=1.000 P=0.702 |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) P=0.693 |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) P=0.687 |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) P=0.698 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.638 (e) (e) P=0.702 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.612 P=1.000 P=1.000 P=0.674 |
|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: Subcapsular |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/15 (7%) 0/0 (0%) 0/0 (0%) 1/15 (7%) |13/15 (87%) 0/0 (0%) 0/0 (0%) 12/14 (86%) |
|POLY-3 RATE (b) | 1/14.33 0/0.00 0/0.00 1/14.55 |13/15.00 0/0.00 0/0.00 12/14.00 |
|POLY-3 PERCENT (g) | 7.0% 0.0% 0.0% 6.9% |86.7% 0.0% 0.0% 85.7% |
|TERMINAL (d) | 1/14 (7%) 0/0 (0%) 0/0 (0%) 1/14 (7%) |12/14 (86%) 0/0 (0%) 0/0 (0%) 12/14 (86%) |
|FIRST INCIDENCE | 274 (T) --- --- 274 (T) |166 --- --- 274 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.685 P=1.000N P=1.000N P=0.764 |P=0.493N P=0.514N P=0.514N P=0.506N |
|POLY 3 | (e) (e) (e) P=0.757N |(e) (e) (e) P=0.673N |
|POLY 1.5 | (e) (e) (e) P=0.758N |(e) (e) (e) P=0.673N |
|POLY 6 | (e) (e) (e) P=0.758N |(e) (e) (e) P=0.673N |
|LOGISTIC REGRESSION| P=0.685 (e) (e) P=0.764 |(e) (e) (e) P=0.506N |
|COCH-ARM / FISHERS | P=0.687 P=1.000 P=1.000 P=0.759N |P=0.612N P=1.000 P=1.000 P=0.674N |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/21/03 EXPERIMENT: 99039 TEST: 02 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - TRANSGENIC MODEL EVALUATIO
N 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 |
|=================================================================================================================================|
| |
|Harderian Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/15 (27%) 0/0 (0%) 0/0 (0%) 2/15 (13%) |1/15 (7%) 0/0 (0%) 0/0 (0%) 0/14 (0%) |
|POLY-3 RATE (b) | 4/14.33 0/0.00 0/0.00 2/15.00 |1/14.22 0/0.00 0/0.00 0/14.00 |
|POLY-3 PERCENT (g) | 27.9% 0.0% 0.0% 13.3% |7.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 4/14 (29%) 0/0 (0%) 0/0 (0%) 1/14 (7%) |1/14 (7%) 0/0 (0%) 0/0 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 274 (T) --- --- 225 |274 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.315N P=1.000N P=1.000N P=0.326N |P=0.369N P=1.000 P=1.000 P=0.500N |
|POLY 3 | (e) (e) (e) P=0.305N |(e) (e) (e) P=0.503N |
|POLY 1.5 | (e) (e) (e) P=0.313N |(e) (e) (e) P=0.507N |
|POLY 6 | (e) (e) (e) P=0.297N |(e) (e) (e) P=0.501N |
|LOGISTIC REGRESSION| P=0.285N (e) (e) P=0.339N |P=0.369N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.271N P=1.000 P=1.000 P=0.326N |P=0.380N P=1.000 P=1.000 P=0.517N |
|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) | 1/15 (7%) 0/0 (0%) 0/0 (0%) 2/15 (13%) |6/15 (40%) 0/0 (0%) 0/0 (0%) 2/14 (14%) |
|POLY-3 RATE (b) | 1/14.33 0/0.00 0/0.00 2/14.55 |6/15.00 0/0.00 0/0.00 2/14.00 |
|POLY-3 PERCENT (g) | 7.0% 0.0% 0.0% 13.7% |40.0% 0.0% 0.0% 14.3% |
|TERMINAL (d) | 1/14 (7%) 0/0 (0%) 0/0 (0%) 2/14 (14%) |5/14 (36%) 0/0 (0%) 0/0 (0%) 2/14 (14%) |
|FIRST INCIDENCE | 274 (T) --- --- 274 (T) |166 --- --- 274 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.421 P=1.000N P=1.000N P=0.500 |P=0.108N P=0.514N P=0.514N P=0.121N |
|POLY 3 | (e) (e) (e) P=0.505 |(e) (e) (e) P=0.127N |
|POLY 1.5 | (e) (e) (e) P=0.504 |(e) (e) (e) P=0.127N |
|POLY 6 | (e) (e) (e) P=0.505 |(e) (e) (e) P=0.127N |
|LOGISTIC REGRESSION| P=0.421 (e) (e) P=0.500 |(e) (e) (e) P=0.121N |
|COCH-ARM / FISHERS | P=0.420 P=1.000 P=1.000 P=0.500 |P=0.102N P=1.000 P=1.000 P=0.129N |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/21/03 EXPERIMENT: 99039 TEST: 02 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - TRANSGENIC MODEL EVALUATIO
N 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 |
| Infiltration Cellular Focal Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 0/0 (0%) 0/0 (0%) 0/15 (0%) |2/15 (13%) 0/0 (0%) 0/0 (0%) 1/14 (7%) |
|POLY-3 RATE (b) | 0/14.33 0/0.00 0/0.00 0/14.55 |2/14.22 0/0.00 0/0.00 1/14.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |14.1% 0.0% 0.0% 7.1% |
|TERMINAL (d) | 0/14 (0%) 0/0 (0%) 0/0 (0%) 0/14 (0%) |2/14 (14%) 0/0 (0%) 0/0 (0%) 1/14 (7%) |
|FIRST INCIDENCE | --- --- --- --- |274 (T) --- --- 274 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.421N P=1.000 P=1.000 P=0.500N |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) P=0.506N |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) P=0.512N |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) P=0.501N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.421N (e) (e) P=0.500N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.444N P=1.000 P=1.000 P=0.527N |
|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 |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/15 (7%) 0/0 (0%) 0/0 (0%) 5/15 (33%) |6/15 (40%) 0/0 (0%) 0/0 (0%) 7/14 (50%) |
|POLY-3 RATE (b) | 1/14.33 0/0.00 0/0.00 5/14.55 |6/14.22 0/0.00 0/0.00 7/14.00 |
|POLY-3 PERCENT (g) | 7.0% 0.0% 0.0% 34.4% |42.2% 0.0% 0.0% 50.0% |
|TERMINAL (d) | 1/14 (7%) 0/0 (0%) 0/0 (0%) 5/14 (36%) |6/14 (43%) 0/0 (0%) 0/0 (0%) 7/14 (50%) |
|FIRST INCIDENCE | 274 (T) --- --- 274 (T) |274 (T) --- --- 274 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.066 P=1.000N P=1.000N P=0.087 |P=0.451 P=1.000 P=1.000 P=0.500 |
|POLY 3 | (e) (e) (e) P=0.082 |(e) (e) (e) P=0.485 |
|POLY 1.5 | (e) (e) (e) P=0.082 |(e) (e) (e) P=0.469 |
|POLY 6 | (e) (e) (e) P=0.081 |(e) (e) (e) P=0.497 |
|LOGISTIC REGRESSION| P=0.066 (e) (e) P=0.087 |P=0.451 (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.064 P=1.000 P=1.000 P=0.084 |P=0.385 P=1.000 P=1.000 P=0.434 |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/21/03 EXPERIMENT: 99039 TEST: 02 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - TRANSGENIC MODEL EVALUATIO
N 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) | 0/15 (0%) 0/0 (0%) 0/0 (0%) 2/15 (13%) |1/15 (7%) 0/0 (0%) 0/0 (0%) 0/14 (0%) |
|POLY-3 RATE (b) | 0/14.33 0/0.00 0/0.00 2/15.00 |1/14.22 0/0.00 0/0.00 0/14.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 13.3% |7.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/14 (0%) 0/0 (0%) 0/0 (0%) 1/14 (7%) |1/14 (7%) 0/0 (0%) 0/0 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- --- --- 225 |274 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.103 (e) (e) P=0.247 |P=0.369N P=1.000N P=1.000N P=0.500N |
|POLY 3 | (e) (e) (e) P=0.242 |(e) (e) (e) P=0.503N |
|POLY 1.5 | (e) (e) (e) P=0.238 |(e) (e) (e) P=0.507N |
|POLY 6 | (e) (e) (e) P=0.246 |(e) (e) (e) P=0.501N |
|LOGISTIC REGRESSION| P=0.105 (e) (e) P=0.161 |P=0.369N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.165 (e) (e) P=0.241 |P=0.380N P=1.000 P=1.000 P=0.517N |
|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 |
|=================================================================================================================================|
| |
|Salivary Glands |
| Infiltration Cellular Focal Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/15 (67%) 0/0 (0%) 0/0 (0%) 8/15 (53%) |10/15 (67%) 0/0 (0%) 0/0 (0%) 9/14 (64%) |
|POLY-3 RATE (b) | 10/14.33 0/0.00 0/0.00 8/15.00 |10/14.22 0/0.00 0/0.00 9/14.00 |
|POLY-3 PERCENT (g) | 69.8% 0.0% 0.0% 53.3% |70.3% 0.0% 0.0% 64.3% |
|TERMINAL (d) | 10/14 (71%) 0/0 (0%) 0/0 (0%) 7/14 (50%) |10/14 (71%) 0/0 (0%) 0/0 (0%) 9/14 (64%) |
|FIRST INCIDENCE | 274 (T) --- --- 225 |274 (T) --- --- 274 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.349N P=1.000N P=1.000N P=0.357N |P=0.447N P=1.000 P=1.000N P=0.500N |
|POLY 3 | (e) (e) (e) P=0.299N |(e) (e) (e) P=0.523N |
|POLY 1.5 | (e) (e) (e) P=0.321N |(e) (e) (e) P=0.549N |
|POLY 6 | (e) (e) (e) P=0.280N |(e) (e) (e) P=0.505N |
|LOGISTIC REGRESSION| P=0.293N (e) (e) P=0.337N |P=0.447N (e) (e) P=0.500N |
|COCH-ARM / FISHERS | P=0.310N P=1.000 P=1.000 P=0.355N |P=0.550N P=1.000 P=1.000 P=0.600N |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/21/03 EXPERIMENT: 99039 TEST: 02 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - TRANSGENIC MODEL EVALUATIO
N 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) | 1/15 (7%) 0/0 (0%) 0/0 (0%) 1/15 (7%) |2/15 (13%) 0/0 (0%) 0/0 (0%) 1/14 (7%) |
|POLY-3 RATE (b) | 1/14.33 0/0.00 0/0.00 1/15.00 |2/15.00 0/0.00 0/0.00 1/14.00 |
|POLY-3 PERCENT (g) | 7.0% 0.0% 0.0% 6.7% |13.3% 0.0% 0.0% 7.1% |
|TERMINAL (d) | 1/14 (7%) 0/0 (0%) 0/0 (0%) 0/14 (0%) |1/14 (7%) 0/0 (0%) 0/0 (0%) 1/14 (7%) |
|FIRST INCIDENCE | 274 (T) --- --- 225 |166 --- --- 274 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.622 P=1.000N P=1.000N P=0.753N |P=0.491N P=0.514N P=0.514N P=0.508N |
|POLY 3 | (e) (e) (e) P=0.750N |(e) (e) (e) P=0.524N |
|POLY 1.5 | (e) (e) (e) P=0.754N |(e) (e) (e) P=0.524N |
|POLY 6 | (e) (e) (e) P=0.747N |(e) (e) (e) P=0.524N |
|LOGISTIC REGRESSION| P=0.628 (e) (e) P=0.722 |(e) (e) (e) P=0.508N |
|COCH-ARM / FISHERS | P=0.687 P=1.000 P=1.000 P=0.759N |P=0.444N P=1.000 P=1.000 P=0.527N |
|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 |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/15 (13%) 0/0 (0%) 0/0 (0%) 2/14 (14%) |6/15 (40%) 0/0 (0%) 0/0 (0%) 2/14 (14%) |
|POLY-3 RATE (b) | 2/14.33 0/0.00 0/0.00 2/13.55 |6/14.22 0/0.00 0/0.00 2/13.70 |
|POLY-3 PERCENT (g) | 14.0% 0.0% 0.0% 14.8% |42.2% 0.0% 0.0% 14.6% |
|TERMINAL (d) | 2/14 (14%) 0/0 (0%) 0/0 (0%) 2/13 (15%) |6/14 (43%) 0/0 (0%) 0/0 (0%) 2/13 (15%) |
|FIRST INCIDENCE | 274 (T) --- --- 274 (T) |274 (T) --- --- 274 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.609 P=1.000N P=1.000N P=0.675 |P=0.104N P=1.000 P=1.000N P=0.132N |
|POLY 3 | (e) (e) (e) P=0.679 |(e) (e) (e) P=0.113N |
|POLY 1.5 | (e) (e) (e) P=0.677 |(e) (e) (e) P=0.116N |
|POLY 6 | (e) (e) (e) P=0.678 |(e) (e) (e) P=0.114N |
|LOGISTIC REGRESSION| P=0.609 (e) (e) P=0.675 |P=0.104N (e) (e) P=0.132N |
|COCH-ARM / FISHERS | P=0.612 P=1.000 P=1.000 P=0.674 |P=0.102N P=1.000 P=1.000 P=0.129N |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/21/03 EXPERIMENT: 99039 TEST: 02 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - TRANSGENIC MODEL EVALUATIO
N 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 Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 0/0 (0%) 0/0 (0%) 1/14 (7%) |0/15 (0%) 0/0 (0%) 0/0 (0%) 4/14 (29%) |
|POLY-3 RATE (b) | 0/14.33 0/0.00 0/0.00 1/13.55 |0/14.22 0/0.00 0/0.00 4/13.70 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 7.4% |0.0% 0.0% 0.0% 29.2% |
|TERMINAL (d) | 0/14 (0%) 0/0 (0%) 0/0 (0%) 1/13 (8%) |0/14 (0%) 0/0 (0%) 0/0 (0%) 4/13 (31%) |
|FIRST INCIDENCE | --- --- --- 274 (T) |--- --- --- 274 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.355 (e) (e) P=0.485 |P=0.032 * (e) (e) P=0.047 * |
|POLY 3 | (e) (e) (e) P=0.489 |(e) (e) (e) P=0.039 * |
|POLY 1.5 | (e) (e) (e) P=0.488 |(e) (e) (e) P=0.039 * |
|POLY 6 | (e) (e) (e) P=0.488 |(e) (e) (e) P=0.039 * |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.485 |(e) (e) (e) P=0.047 * |
|COCH-ARM / FISHERS | P=0.354 (e) (e) P=0.483 |P=0.031 * (e) (e) P=0.042 * |
|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 |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |13/15 (87%) 0/0 (0%) 1/1 (100%) 13/14 (93%) |
|POLY-3 RATE (b) | |13/14.22 0/0.00 1/1.00 13/14.00 |
|POLY-3 PERCENT (g) | |91.4% 0.0% 100.0% 92.9% |
|TERMINAL (d) | |13/14 (93%) 0/0 (0%) 1/1 (100%) 13/14 (93%) |
|FIRST INCIDENCE | |274 (T) --- 274 (T) 274 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.681N P=1.000 P=0.959 P=0.764 |
|POLY 3 | |(e) (e) P=0.950 P=0.711 |
|POLY 1.5 | |(e) (e) P=0.931 P=0.650 |
|POLY 6 | |(e) (e) P=0.958 P=0.750 |
|LOGISTIC REGRESSION| |P=0.681N (e) P=0.959 P=0.764 |
|COCH-ARM / FISHERS | |P=0.451 P=1.000 P=0.875 P=0.527 |
|ORDER RESTRICTED | |(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).