P08 - Statistical Analysis of Primary Tumors (Rats)
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus ESTRAGOLE DATE: 10/08/03
EXPERIMENT: 60946 TEST: 01 TIME: 09:15:14
TEST TYPE: SUBCHRON 90-DAY CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-15460 ROUTE: GAVAGE NTP C#: C60946
PATHOLOGIST: MISSING CAS: 140-67-0
------------------------------------------------------------------------------------------------------------------------------------
FINAL/RATS
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus ESTRAGOLE DATE: 10/08/03
EXPERIMENT: 60946 TEST: 01 TIME: 09:15:14
TEST TYPE: SUBCHRON 90-DAY CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-15460 ROUTE: GAVAGE NTP C#: C60946
PATHOLOGIST: MISSING CAS: 140-67-0
Rats(FISCHER 344)
-----------------------------
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.
---------------
Liver
Lung
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus ESTRAGOLE DATE: 10/08/03
EXPERIMENT: 60946 TEST: 01 TIME: 09:15:14
TEST TYPE: SUBCHRON 90-DAY CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-15460 ROUTE: GAVAGE NTP C#: C60946
PATHOLOGIST: MISSING CAS: 140-67-0
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF ESTRAGOLE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Liver Cholangiocarcinoma
All Organs Malignant Tumors
Malignant and Benign Tumors
===============================================================
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 1
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Cholangiocarcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 2/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 20.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) |
|FIRST INCIDENCE | --- --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.011 * (e) (e) (e) (e) P=0.234 |
|POLY 3 | P=0.008 ** (e) (e) (e) (e) P=0.227 |
|POLY 1.5 | P=0.008 ** (e) (e) (e) (e) P=0.227 |
|POLY 6 | P=0.008 ** (e) (e) (e) (e) P=0.227 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.234 |
|COCH-ARM / FISHERS | P=0.010 * (e) (e) (e) (e) P=0.237 |
|ORDER RESTRICTED | P=0.007 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Cholangiocarcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (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) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 2
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 2/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 20.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) |
|FIRST INCIDENCE | --- --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.011 * (e) (e) (e) (e) P=0.234 |
|POLY 3 | P=0.008 ** (e) (e) (e) (e) P=0.227 |
|POLY 1.5 | P=0.008 ** (e) (e) (e) (e) P=0.227 |
|POLY 6 | P=0.008 ** (e) (e) (e) (e) P=0.227 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.234 |
|COCH-ARM / FISHERS | P=0.010 * (e) (e) (e) (e) P=0.237 |
|ORDER RESTRICTED | P=0.007 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (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) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 60946 TEST: 01 Page 3
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - ESTRAGOLE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) |
|POLY-3 RATE (b) | 0/10.00 1/10.00 0/10.00 0/10.00 0/10.00 3/10.00 |
|POLY-3 PERCENT (g) | 0.0% 10.0% 0.0% 0.0% 0.0% 30.0% |
|TERMINAL (d) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) |
|FIRST INCIDENCE | --- 93 (T) --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.011 * P=0.500 (e) (e) (e) P=0.111 |
|POLY 3 | P=0.008 ** P=0.500 (e) (e) (e) P=0.095 |
|POLY 1.5 | P=0.008 ** P=0.500 (e) (e) (e) P=0.095 |
|POLY 6 | P=0.008 ** P=0.500 (e) (e) (e) P=0.095 |
|LOGISTIC REGRESSION| (e) P=0.500 (e) (e) (e) P=0.111 |
|COCH-ARM / FISHERS | P=0.011 * P=0.500 (e) (e) (e) P=0.105 |
|ORDER RESTRICTED | P=0.003 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 37.5 75 150 300 600 |
| | MG/KG MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (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) |
|=================================================================================================================================|
(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).