TDMS Study 99036-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TRANSGENIC MODEL EVALUATION II (PHENOLPHTHALEIN) DATE: 04/21/04
EXPERIMENT: 99036 TEST: 01 TIME: 08:35:19
TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-65406 ROUTE: DOSED FEED NTP C#: C99036
PATHOLOGIST: MISSING CAS: 77-09-08
------------------------------------------------------------------------------------------------------------------------------------
FINAL #1 MICE
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TRANSGENIC MODEL EVALUATION II (PHENOLPHTHALEIN) DATE: 04/21/04
EXPERIMENT: 99036 TEST: 01 TIME: 08:35:19
TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-65406 ROUTE: DOSED FEED NTP C#: C99036
PATHOLOGIST: MISSING CAS: 77-09-08
Mice(P16(INK4A)/(+/-) (C57BL/6))
-----------------------------
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.
---------------
Adrenal Medulla
Date: 04/21/04 EXPERIMENT: 99036 TEST: 01 Page 1
Statistical Analysis of Primary Tumors in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (PHENOLP
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 1/15 (7%) 1/15 (7%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/13.07 0/15.00 1/15.00 1/13.01 0/15.00 0/14.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 6.7% 7.7% 0.0% 0.0% |
|TERMINAL (d) | 0/13 (0%) 0/15 (0%) 1/15 (7%) 1/13 (8%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- --- 183 (T) 183 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.512N (e) P=0.529 P=0.500 (e) (e) |
|POLY 3 | P=0.511N (e) P=0.527 P=0.499 (e) (e) |
|POLY 1.5 | P=0.512N (e) P=0.524 P=0.498 (e) (e) |
|POLY 6 | P=0.510N (e) P=0.528 P=0.500 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.529 P=0.500 (e) (e) |
|COCH-ARM / FISHERS | P=0.512N (e) P=0.500 P=0.500 (e) (e) |
|ORDER RESTRICTED | P=0.506N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/15 (0%) 1/15 (7%) 2/15 (13%) 1/15 (7%) 1/15 (7%) 1/15 (7%) |
|POLY-3 RATE (b) | 0/15.00 1/13.00 2/14.00 1/15.00 1/14.00 1/15.00 |
|POLY-3 PERCENT (g) | 0.0% 7.7% 14.3% 6.7% 7.1% 6.7% |
|TERMINAL (d) | 0/15 (0%) 1/13 (8%) 2/14 (14%) 1/15 (7%) 1/14 (7%) 1/15 (7%) |
|FIRST INCIDENCE | --- 184 (T) 184 (T) 184 (T) 184 (T) 184 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.664N P=0.471 P=0.221 P=0.500 P=0.486 P=0.500 |
|POLY 3 | P=0.668 P=0.472 P=0.216 P=0.500 P=0.486 P=0.500 |
|POLY 1.5 | P=0.668 P=0.472 P=0.216 P=0.500 P=0.487 P=0.500 |
|POLY 6 | P=0.668 P=0.471 P=0.216 P=0.500 P=0.486 P=0.500 |
|LOGISTIC REGRESSION| (e) P=0.471 P=0.221 P=0.500 P=0.486 P=0.500 |
|COCH-ARM / FISHERS | P=0.658 P=0.500 P=0.241 P=0.500 P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.317 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/21/04 EXPERIMENT: 99036 TEST: 01 Page 2
Statistical Analysis of Primary Tumors in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (PHENOLP
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 1/15 (7%) 0/15 (0%) 1/15 (7%) 1/15 (7%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 1/14.00 0/15.00 1/15.00 1/13.01 0/15.00 0/14.00 |
|POLY-3 PERCENT (g) | 7.1% 0.0% 6.7% 7.7% 0.0% 0.0% |
|TERMINAL (d) | 0/13 (0%) 0/15 (0%) 1/15 (7%) 1/13 (8%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 76 --- 183 (T) 183 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.366N P=0.486N P=0.737N P=0.752 P=0.486N P=0.500N |
|POLY 3 | P=0.374N P=0.486N P=0.745N P=0.745 P=0.486N P=0.500N |
|POLY 1.5 | P=0.373N P=0.487N P=0.745N P=0.746 P=0.487N P=0.499N |
|POLY 6 | P=0.374N P=0.486N P=0.745N P=0.744 P=0.486N P=0.500N |
|LOGISTIC REGRESSION| P=0.360N P=0.896N P=0.626 P=0.763N P=0.896N P=0.572N |
|COCH-ARM / FISHERS | P=0.364N P=0.500N P=0.759N P=0.759N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.282N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/15 (0%) 1/15 (7%) 2/15 (13%) 1/15 (7%) 1/15 (7%) 1/15 (7%) |
|POLY-3 RATE (b) | 0/15.00 1/13.00 2/14.00 1/15.00 1/14.00 1/15.00 |
|POLY-3 PERCENT (g) | 0.0% 7.7% 14.3% 6.7% 7.1% 6.7% |
|TERMINAL (d) | 0/15 (0%) 1/13 (8%) 2/14 (14%) 1/15 (7%) 1/14 (7%) 1/15 (7%) |
|FIRST INCIDENCE | --- 184 (T) 184 (T) 184 (T) 184 (T) 184 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.664N P=0.471 P=0.221 P=0.500 P=0.486 P=0.500 |
|POLY 3 | P=0.668 P=0.472 P=0.216 P=0.500 P=0.486 P=0.500 |
|POLY 1.5 | P=0.668 P=0.472 P=0.216 P=0.500 P=0.487 P=0.500 |
|POLY 6 | P=0.668 P=0.471 P=0.216 P=0.500 P=0.486 P=0.500 |
|LOGISTIC REGRESSION| (e) P=0.471 P=0.221 P=0.500 P=0.486 P=0.500 |
|COCH-ARM / FISHERS | P=0.658 P=0.500 P=0.241 P=0.500 P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.317 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/21/04 EXPERIMENT: 99036 TEST: 01 Page 3
Statistical Analysis of Primary Tumors in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (PHENOLP
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 1/15 (7%) 0/15 (0%) 1/15 (7%) 1/15 (7%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 1/14.00 0/15.00 1/15.00 1/13.01 0/15.00 0/14.00 |
|POLY-3 PERCENT (g) | 7.1% 0.0% 6.7% 7.7% 0.0% 0.0% |
|TERMINAL (d) | 0/13 (0%) 0/15 (0%) 1/15 (7%) 1/13 (8%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 76 --- 183 (T) 183 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.366N P=0.486N P=0.737N P=0.752 P=0.486N P=0.500N |
|POLY 3 | P=0.374N P=0.486N P=0.745N P=0.745 P=0.486N P=0.500N |
|POLY 1.5 | P=0.373N P=0.487N P=0.745N P=0.746 P=0.487N P=0.499N |
|POLY 6 | P=0.374N P=0.486N P=0.745N P=0.744 P=0.486N P=0.500N |
|LOGISTIC REGRESSION| P=0.360N P=0.896N P=0.626 P=0.763N P=0.896N P=0.572N |
|COCH-ARM / FISHERS | P=0.364N P=0.500N P=0.759N P=0.759N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.282N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/15 (0%) 1/15 (7%) 2/15 (13%) 1/15 (7%) 2/15 (13%) 1/15 (7%) |
|POLY-3 RATE (b) | 0/15.00 1/13.00 2/14.00 1/15.00 2/14.00 1/15.00 |
|POLY-3 PERCENT (g) | 0.0% 7.7% 14.3% 6.7% 14.3% 6.7% |
|TERMINAL (d) | 0/15 (0%) 1/13 (8%) 2/14 (14%) 1/15 (7%) 2/14 (14%) 1/15 (7%) |
|FIRST INCIDENCE | --- 184 (T) 184 (T) 184 (T) 184 (T) 184 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.655 P=0.471 P=0.221 P=0.500 P=0.221 P=0.500 |
|POLY 3 | P=0.654 P=0.472 P=0.216 P=0.500 P=0.216 P=0.500 |
|POLY 1.5 | P=0.653 P=0.472 P=0.216 P=0.500 P=0.216 P=0.500 |
|POLY 6 | P=0.654 P=0.471 P=0.216 P=0.500 P=0.216 P=0.500 |
|LOGISTIC REGRESSION| P=0.656 P=0.471 P=0.221 P=0.500 P=0.221 P=0.500 |
|COCH-ARM / FISHERS | P=0.639 P=0.500 P=0.241 P=0.500 P=0.241 P=0.500 |
|ORDER RESTRICTED | P=0.264 (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).