TDMS Study 89029-11 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest MAGNETIC FIELDS + DMBA INITIATION PROMOTION DATE: 12/19/97
EXPERIMENT: 89029 TEST: 11 TIME: 14:14:04
TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-65397 ROUTE: MAGNETIC FIELDS NTP C#: 89029D
PATHOLOGIST: GRUMBEIN, SONDRA CAS: EMF+DMBA
------------------------------------------------------------------------------------------------------------------------------------
10(10MGX1)DMBA VS 60HZ/1G 10MG(10MGX1)DMBA
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 10 DMBA CONTROL
INCLUDE 004 60 HZ/1G 10 DMBA
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest MAGNETIC FIELDS + DMBA INITIATION PROMOTION DATE: 12/18/97
EXPERIMENT: 89029 TEST: 11 TIME: 13:29:36
TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-65397 ROUTE: MAGNETIC FIELDS NTP C#: 89029D
PATHOLOGIST: GRUMBEIN, SONDRA CAS: EMF+DMBA
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF A MAGNETIC FIELDS + DMBA INITIATION PRO
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Lung Hyperplasia
====================================================================================================
DATE: 12/18/97 EXPERIMENT: 89029 TEST: 11 PAGE 1
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN FEMALE RATS(SPRAGUE-DAWLEY) -- A MAGNETIC FIELDS + DMBA INITIATION PRO
TERMINAL SACRIFICE AT 27 WEEKS
|==============================================================================|
|DOSE | 10 DMBA 60 HZ/1G |
| | CONTROL 10 DMBA |
|==============================================================================|
| |
|Kidney |
| Mineralization |
| |
|------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/100 (1%) 3/100 (3%) |
|ADJUSTED (b) | 1.1% 3.2% |
|TERMINAL (d) | 0/88 (0%) 3/94 (3%) |
|FIRST INCIDENCE (DAYS) | 173 183 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.328 |
|INCIDENTAL TUMOR | P=0.265 |
|LOGISTIC REGRESSION | P=0.310 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.311 |
|==============================================================================|
| |
|Kidney |
| Nephropathy |
| |
|------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 24/100 (24%) 25/100 (25%) |
|ADJUSTED (b) | 26.6% 26.0% |
|TERMINAL (d) | 22/88 (25%) 23/94 (24%) |
|FIRST INCIDENCE (DAYS) | 113 162 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.530N |
|INCIDENTAL TUMOR | P=0.510 |
|LOGISTIC REGRESSION | P=0.517 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.500 |
|==============================================================================|
DATE: 12/18/97 EXPERIMENT: 89029 TEST: 11 PAGE 2
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN FEMALE RATS(SPRAGUE-DAWLEY) -- A MAGNETIC FIELDS + DMBA INITIATION PRO
TERMINAL SACRIFICE AT 27 WEEKS
|==============================================================================|
|DOSE | 10 DMBA 60 HZ/1G |
| | CONTROL 10 DMBA |
|==============================================================================|
| |
|Liver |
| Angiectasis |
| |
|------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/98 (6%) 3/100 (3%) |
|ADJUSTED (b) | 6.8% 3.2% |
|TERMINAL (d) | 6/88 (7%) 3/94 (3%) |
|FIRST INCIDENCE (DAYS) | 183 (T) 183 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.217N |
|INCIDENTAL TUMOR | P=0.217N |
|LOGISTIC REGRESSION | P=0.217N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.239N |
|==============================================================================|
| |
|Liver |
| Basophilic Focus |
| |
|------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/98 (4%) 7/100 (7%) |
|ADJUSTED (b) | 4.5% 7.4% |
|TERMINAL (d) | 4/88 (5%) 7/94 (7%) |
|FIRST INCIDENCE (DAYS) | 183 (T) 183 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.306 |
|INCIDENTAL TUMOR | P=0.306 |
|LOGISTIC REGRESSION | P=0.306 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.280 |
|==============================================================================|
DATE: 12/18/97 EXPERIMENT: 89029 TEST: 11 PAGE 3
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN FEMALE RATS(SPRAGUE-DAWLEY) -- A MAGNETIC FIELDS + DMBA INITIATION PRO
TERMINAL SACRIFICE AT 27 WEEKS
|==============================================================================|
|DOSE | 10 DMBA 60 HZ/1G |
| | CONTROL 10 DMBA |
|==============================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
|------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/98 (8%) 5/100 (5%) |
|ADJUSTED (b) | 9.1% 5.3% |
|TERMINAL (d) | 8/88 (9%) 5/94 (5%) |
|FIRST INCIDENCE (DAYS) | 183 (T) 183 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.243N |
|INCIDENTAL TUMOR | P=0.243N |
|LOGISTIC REGRESSION | P=0.243N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.271N |
|==============================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
|------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/98 (7%) 4/100 (4%) |
|ADJUSTED (b) | 7.8% 4.3% |
|TERMINAL (d) | 6/88 (7%) 4/94 (4%) |
|FIRST INCIDENCE (DAYS) | 176 183 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.234N |
|INCIDENTAL TUMOR | P=0.260N |
|LOGISTIC REGRESSION | P=0.244N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.257N |
|==============================================================================|
DATE: 12/18/97 EXPERIMENT: 89029 TEST: 11 PAGE 4
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN FEMALE RATS(SPRAGUE-DAWLEY) -- A MAGNETIC FIELDS + DMBA INITIATION PRO
TERMINAL SACRIFICE AT 27 WEEKS
|==============================================================================|
|DOSE | 10 DMBA 60 HZ/1G |
| | CONTROL 10 DMBA |
|==============================================================================|
| |
|Liver: Centrilobular |
| Necrosis |
| |
|------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/98 (4%) 1/100 (1%) |
|ADJUSTED (b) | 4.2% 1.0% |
|TERMINAL (d) | 1/88 (1%) 0/94 (0%) |
|FIRST INCIDENCE (DAYS) | 135 162 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.174N |
|INCIDENTAL TUMOR | P=0.303N |
|LOGISTIC REGRESSION | P=0.072N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.178N |
|==============================================================================|
| |
|Lung |
| Thrombosis |
| |
|------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/98 (1%) 2/100 (2%) |
|ADJUSTED (b) | 1.0% 2.1% |
|TERMINAL (d) | 0/88 (0%) 1/94 (1%) |
|FIRST INCIDENCE (DAYS) | 135 162 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.515 |
|INCIDENTAL TUMOR | P=0.389 |
|LOGISTIC REGRESSION | P=0.518 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.508 |
|==============================================================================|
DATE: 12/18/97 EXPERIMENT: 89029 TEST: 11 PAGE 5
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN FEMALE RATS(SPRAGUE-DAWLEY) -- A MAGNETIC FIELDS + DMBA INITIATION PRO
TERMINAL SACRIFICE AT 27 WEEKS
|==============================================================================|
|DOSE | 10 DMBA 60 HZ/1G |
| | CONTROL 10 DMBA |
|==============================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
|------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 21/98 (21%) 10/100 (10%) |
|ADJUSTED (b) | 23.9% 10.6% |
|TERMINAL (d) | 21/88 (24%) 10/94 (11%) |
|FIRST INCIDENCE (DAYS) | 183 (T) 183 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.015N* |
|INCIDENTAL TUMOR | P=0.015N* |
|LOGISTIC REGRESSION | P=0.015N* |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.021N* |
|==============================================================================|
| |
|Lung: Alveolus |
| Infiltration Cellular Histiocyte |
| |
|------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 21/98 (21%) 15/100 (15%) |
|ADJUSTED (b) | 22.6% 15.8% |
|TERMINAL (d) | 17/88 (19%) 14/94 (15%) |
|FIRST INCIDENCE (DAYS) | 89 162 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.137N |
|INCIDENTAL TUMOR | P=0.189N |
|LOGISTIC REGRESSION | P=0.167N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.162N |
|==============================================================================|
DATE: 12/18/97 EXPERIMENT: 89029 TEST: 11 PAGE 6
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN FEMALE RATS(SPRAGUE-DAWLEY) -- A MAGNETIC FIELDS + DMBA INITIATION PRO
TERMINAL SACRIFICE AT 27 WEEKS
|==============================================================================|
|DOSE | 10 DMBA 60 HZ/1G |
| | CONTROL 10 DMBA |
|==============================================================================|
| |
|Mammary Gland |
| Galactocele |
| |
|------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/100 (0%) 3/100 (3%) |
|ADJUSTED (b) | 0.0% 3.2% |
|TERMINAL (d) | 0/88 (0%) 3/94 (3%) |
|FIRST INCIDENCE (DAYS) | --- 183 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.135 |
|INCIDENTAL TUMOR | P=0.135 |
|LOGISTIC REGRESSION | P=0.135 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.123 |
|==============================================================================|
| |
|Skin |
| Cyst Epithelial Inclusion |
| |
|------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/19 (32%) 1/10 (10%) |
|ADJUSTED (b) | 31.6% 10.0% |
|TERMINAL (d) | 6/19 (32%) 1/10 (10%) |
|FIRST INCIDENCE (DAYS) | 183 (T) 183 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.206N |
|INCIDENTAL TUMOR | P=0.206N |
|LOGISTIC REGRESSION | P=0.206N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.206N |
|==============================================================================|
DATE: 12/18/97 EXPERIMENT: 89029 TEST: 11 PAGE 7
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN FEMALE RATS(SPRAGUE-DAWLEY) -- A MAGNETIC FIELDS + DMBA INITIATION PRO
TERMINAL SACRIFICE AT 27 WEEKS
|==============================================================================|
|DOSE | 10 DMBA 60 HZ/1G |
| | CONTROL 10 DMBA |
|==============================================================================|
| |
|Skin |
| Hyperplasia Basal Cell |
| |
|------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/19 (32%) 0/10 (0%) |
|ADJUSTED (b) | 31.6% 0.0% |
|TERMINAL (d) | 6/19 (32%) 0/10 (0%) |
|FIRST INCIDENCE (DAYS) | 183 (T) --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.069N |
|INCIDENTAL TUMOR | P=0.069N |
|LOGISTIC REGRESSION | P=0.069N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.057N |
|==============================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for
intercurrent mortality.
(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. The incidental tumor
test regards these lesions as non-fatal. Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fisher's 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.
(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).