TDMS Study 99039-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: BIORELIANCE TRANSGENIC MODEL EVALUATION II DATE: 02/21/03
EXPERIMENT: 99039 TEST: 02 TIME: 10:30:52
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
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FINAL#3/P53 +/- MICE
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: BIORELIANCE TRANSGENIC MODEL EVALUATION II DATE: 02/21/03
EXPERIMENT: 99039 TEST: 02 TIME: 10:30:52
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
Mice(P53 Heterozygous Transgenic)
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FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE
BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS RATES
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.
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Date: 02/21/03 EXPERIMENT: 99039 TEST: 02 Page 1
Statistical Analysis of Primary Tumors in Mice(P53 Heterozygous Transgenic) - TRANSGENIC MODEL EVALUATION 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 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 1/15 (7%) 1/15 (7%) |1/15 (7%) 1/15 (7%) 1/15 (7%) 2/15 (13%) |
|POLY-3 RATE (b) | 0/14.33 0/15.00 1/15.00 1/15.00 |1/15.00 1/15.00 1/15.00 2/15.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 6.7% 6.7% |6.7% 6.7% 6.7% 13.3% |
|TERMINAL (d) | 0/14 (0%) 0/15 (0%) 1/15 (7%) 0/14 (0%) |0/14 (0%) 0/14 (0%) 0/14 (0%) 1/14 (7%) |
|FIRST INCIDENCE | --- --- 274 (T) 225 |166 176 127 243 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.303 (e) P=0.514 P=0.514 |P=0.370 P=0.753N P=0.753 P=0.508 |
|POLY 3 | P=0.312 (e) P=0.509 P=0.509 |P=0.360 P=0.760 P=0.760 P=0.500 |
|POLY 1.5 | P=0.309 (e) P=0.506 P=0.506 |P=0.360 P=0.760 P=0.760 P=0.500 |
|POLY 6 | P=0.315 (e) P=0.512 P=0.512 |P=0.360 P=0.760 P=0.760 P=0.500 |
|LOGISTIC REGRESSION| P=0.250 (e) P=0.514 P=0.321 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.301 (e) P=0.500 P=0.500 |P=0.356 P=0.759N P=0.759N P=0.500 |
|ORDER RESTRICTED | P=0.260 (e) (e) (e) |P=0.412 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE 0.3 % 1.0 % 3.0 % |VEHICLE 0.3 % 1.0 % 3.0 % |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 1/15 (7%) 1/15 (7%) |1/15 (7%) 1/15 (7%) 1/15 (7%) 2/15 (13%) |
|POLY-3 RATE (b) | 0/14.33 0/15.00 1/15.00 1/15.00 |1/15.00 1/15.00 1/15.00 2/15.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 6.7% 6.7% |6.7% 6.7% 6.7% 13.3% |
|TERMINAL (d) | 0/14 (0%) 0/15 (0%) 1/15 (7%) 0/14 (0%) |0/14 (0%) 0/14 (0%) 0/14 (0%) 1/14 (7%) |
|FIRST INCIDENCE | --- --- 274 (T) 225 |166 176 127 243 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.303 (e) P=0.514 P=0.514 |P=0.370 P=0.753N P=0.753 P=0.508 |
|POLY 3 | P=0.312 (e) P=0.509 P=0.509 |P=0.360 P=0.760 P=0.760 P=0.500 |
|POLY 1.5 | P=0.309 (e) P=0.506 P=0.506 |P=0.360 P=0.760 P=0.760 P=0.500 |
|POLY 6 | P=0.315 (e) P=0.512 P=0.512 |P=0.360 P=0.760 P=0.760 P=0.500 |
|LOGISTIC REGRESSION| P=0.250 (e) P=0.514 P=0.321 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.301 (e) P=0.500 P=0.500 |P=0.356 P=0.759N P=0.759N P=0.500 |
|ORDER RESTRICTED | P=0.260 (e) (e) (e) |P=0.412 (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).