TDMS Study 88066-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: A. D. Little POLYVINYL ALCOHOL DATE: 08/14/96
EXPERIMENT: 88066 TEST: 01 TIME: 19:38:41
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-15330 ROUTE: VAGINAL NTP C#: 88066
PATHOLOGIST: GOAD, MARY CAS: 9002-89-5
------------------------------------------------------------------------------------------------------------------------------------
VEHICLE CONTROL VS 25%
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 002 VEHICLE CONTROL
INCLUDE 003 25%
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: A. D. Little POLYVINYL ALCOHOL DATE: 08/14/96
EXPERIMENT: 88066 TEST: 01 TIME: 19:38:41
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-15330 ROUTE: VAGINAL NTP C#: 88066
PATHOLOGIST: GOAD, MARY CAS: 9002-89-5
MICE(B6C3F1)
----------------------------
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 NUMBER OF ANIMALS NECROPSIED.
----------------
Adrenal Cortex
Adrenal Medulla
Bone Marrow
Brain
Clitoral Gland
Gallbladder
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Nose
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Salivary Glands
Spleen
Thymus
Thyroid Gland
Urinary Bladder
DATE: 08/15/96 EXPERIMENT: 88066 TEST: 01 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | VEHICLE 25% |
| | CONTROL |
|==============================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/94 (2%) 0/92 (0%) |
|ADJUSTED (b) | 4.0% 0.0% |
|TERMINAL (d) | 2/50 (4%) 0/55 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.218N |
|INCIDENTAL TUMOR | P=0.218N |
|LOGISTIC REGRESSION | P=0.218N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.254N |
|==============================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 9/100 (9%) 4/100 (4%) |
|ADJUSTED (b) | 15.0% 6.3% |
|TERMINAL (d) | 5/51 (10%) 3/61 (5%) |
|FIRST INCIDENCE (DAYS) | 668 690 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.081N |
|INCIDENTAL TUMOR | P=0.121N |
|LOGISTIC REGRESSION | P=0.107N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.125N |
|==============================================================================|
DATE: 08/15/96 EXPERIMENT: 88066 TEST: 01 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | VEHICLE 25% |
| | CONTROL |
|==============================================================================|
| |
|Harderian Gland |
| Carcinoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 2/100 (2%) 1/100 (1%) |
|ADJUSTED (b) | 2.5% 1.2% |
|TERMINAL (d) | 0/51 (0%) 0/61 (0%) |
|FIRST INCIDENCE (DAYS) | 620 646 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.482N |
|INCIDENTAL TUMOR | P=0.632N |
|LOGISTIC REGRESSION | P=0.496N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.500N |
|==============================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 11/100 (11%) 5/100 (5%) |
|ADJUSTED (b) | 17.1% 7.4% |
|TERMINAL (d) | 5/51 (10%) 3/61 (5%) |
|FIRST INCIDENCE (DAYS) | 620 646 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.063N |
|INCIDENTAL TUMOR | P=0.120N |
|LOGISTIC REGRESSION | P=0.091N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.096N |
|==============================================================================|
DATE: 08/15/96 EXPERIMENT: 88066 TEST: 01 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | VEHICLE 25% |
| | CONTROL |
|==============================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/94 (3%) 1/97 (1%) |
|ADJUSTED (b) | 5.0% 1.6% |
|TERMINAL (d) | 2/51 (4%) 1/61 (2%) |
|FIRST INCIDENCE (DAYS) | 588 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.260N |
|INCIDENTAL TUMOR | P=0.291N |
|LOGISTIC REGRESSION | P=0.296N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.299N |
|==============================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 56/99 (57%) 55/100 (55%) |
|ADJUSTED (b) | 80.5% 69.2% |
|TERMINAL (d) | 38/51 (75%) 37/61 (61%) |
|FIRST INCIDENCE (DAYS) | 611 514 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.147N |
|INCIDENTAL TUMOR | P=0.366N |
|LOGISTIC REGRESSION | P=0.373N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.468N |
|==============================================================================|
DATE: 08/15/96 EXPERIMENT: 88066 TEST: 01 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | VEHICLE 25% |
| | CONTROL |
|==============================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 18/99 (18%) 20/100 (20%) |
|ADJUSTED (b) | 27.5% 28.0% |
|TERMINAL (d) | 9/51 (18%) 13/61 (21%) |
|FIRST INCIDENCE (DAYS) | 548 507 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.533N |
|INCIDENTAL TUMOR | P=0.416 |
|LOGISTIC REGRESSION | P=0.452 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.442 |
|==============================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 61/99 (62%) 62/100 (62%) |
|ADJUSTED (b) | 82.9% 73.4% |
|TERMINAL (d) | 39/51 (76%) 39/61 (64%) |
|FIRST INCIDENCE (DAYS) | 548 507 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.213N |
|INCIDENTAL TUMOR | P=0.540N |
|LOGISTIC REGRESSION | P=0.535N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.536 |
|==============================================================================|
DATE: 08/15/96 EXPERIMENT: 88066 TEST: 01 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | VEHICLE 25% |
| | CONTROL |
|==============================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 61/99 (62%) 62/100 (62%) |
|ADJUSTED (b) | 82.9% 73.4% |
|TERMINAL (d) | 39/51 (76%) 39/61 (64%) |
|FIRST INCIDENCE (DAYS) | 548 507 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.213N |
|INCIDENTAL TUMOR | P=0.540N |
|LOGISTIC REGRESSION | P=0.535N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.536 |
|==============================================================================|
| |
|Liver |
| Hepatocholangiocarcinoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/99 (0%) 2/100 (2%) |
|ADJUSTED (b) | 0.0% 2.2% |
|TERMINAL (d) | 0/51 (0%) 0/61 (0%) |
|FIRST INCIDENCE (DAYS) | --- 553 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.249 |
|INCIDENTAL TUMOR | P=0.157 |
|LOGISTIC REGRESSION | P=0.252 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.251 |
|==============================================================================|
DATE: 08/15/96 EXPERIMENT: 88066 TEST: 01 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | VEHICLE 25% |
| | CONTROL |
|==============================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 7/98 (7%) 8/100 (8%) |
|ADJUSTED (b) | 11.8% 11.7% |
|TERMINAL (d) | 3/51 (6%) 6/61 (10%) |
|FIRST INCIDENCE (DAYS) | 611 313 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.603 |
|INCIDENTAL TUMOR | P=0.552 |
|LOGISTIC REGRESSION | P=0.516 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.516 |
|==============================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/98 (3%) 5/100 (5%) |
|ADJUSTED (b) | 5.0% 7.8% |
|TERMINAL (d) | 2/51 (4%) 4/61 (7%) |
|FIRST INCIDENCE (DAYS) | 548 675 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.437 |
|INCIDENTAL TUMOR | P=0.392 |
|LOGISTIC REGRESSION | P=0.377 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.372 |
|==============================================================================|
DATE: 08/15/96 EXPERIMENT: 88066 TEST: 01 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | VEHICLE 25% |
| | CONTROL |
|==============================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 10/98 (10%) 13/100 (13%) |
|ADJUSTED (b) | 16.4% 19.3% |
|TERMINAL (d) | 5/51 (10%) 10/61 (16%) |
|FIRST INCIDENCE (DAYS) | 548 313 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.461 |
|INCIDENTAL TUMOR | P=0.390 |
|LOGISTIC REGRESSION | P=0.349 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.348 |
|==============================================================================|
| |
|Ovary |
| Cystadenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 5/97 (5%) 3/97 (3%) |
|ADJUSTED (b) | 9.4% 4.8% |
|TERMINAL (d) | 4/51 (8%) 2/59 (3%) |
|FIRST INCIDENCE (DAYS) | 711 690 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.290N |
|INCIDENTAL TUMOR | P=0.331N |
|LOGISTIC REGRESSION | P=0.320N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.360N |
|==============================================================================|
DATE: 08/15/96 EXPERIMENT: 88066 TEST: 01 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | VEHICLE 25% |
| | CONTROL |
|==============================================================================|
| |
|Ovary |
| Granulosa Cell Tumor Benign |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/97 (2%) 0/97 (0%) |
|ADJUSTED (b) | 3.9% 0.0% |
|TERMINAL (d) | 2/51 (4%) 0/59 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.207N |
|INCIDENTAL TUMOR | P=0.207N |
|LOGISTIC REGRESSION | P=0.207N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.249N |
|==============================================================================|
| |
|Ovary |
| Luteoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/97 (0%) 2/97 (2%) |
|ADJUSTED (b) | 0.0% 3.0% |
|TERMINAL (d) | 0/51 (0%) 1/59 (2%) |
|FIRST INCIDENCE (DAYS) | --- 658 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.262 |
|INCIDENTAL TUMOR | P=0.229 |
|LOGISTIC REGRESSION | P=0.240 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.249 |
|==============================================================================|
DATE: 08/15/96 EXPERIMENT: 88066 TEST: 01 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | VEHICLE 25% |
| | CONTROL |
|==============================================================================|
| |
|Ovary |
| Yolk Sac Carcinoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/97 (0%) 2/97 (2%) |
|ADJUSTED (b) | 0.0% 2.7% |
|TERMINAL (d) | 0/51 (0%) 1/59 (2%) |
|FIRST INCIDENCE (DAYS) | --- 372 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.256 |
|INCIDENTAL TUMOR | P=0.313 |
|LOGISTIC REGRESSION | P=0.259 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.249 |
|==============================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 9/86 (10%) 10/84 (12%) |
|ADJUSTED (b) | 14.9% 16.5% |
|TERMINAL (d) | 4/47 (9%) 6/50 (12%) |
|FIRST INCIDENCE (DAYS) | 620 634 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.559 |
|INCIDENTAL TUMOR | P=0.445 |
|LOGISTIC REGRESSION | P=0.478 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.478 |
|==============================================================================|
DATE: 08/15/96 EXPERIMENT: 88066 TEST: 01 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | VEHICLE 25% |
| | CONTROL |
|==============================================================================|
| |
|Skeletal Muscle |
| Rhabdomyosarcoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 2/100 (2%) 2/100 (2%) |
|ADJUSTED (b) | 2.7% 3.3% |
|TERMINAL (d) | 0/51 (0%) 2/61 (3%) |
|FIRST INCIDENCE (DAYS) | 548 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.649N |
|INCIDENTAL TUMOR | P=0.662 |
|LOGISTIC REGRESSION | P=0.693N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.689N |
|==============================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 2/100 (2%) 1/100 (1%) |
|ADJUSTED (b) | 3.1% 1.6% |
|TERMINAL (d) | 0/51 (0%) 1/61 (2%) |
|FIRST INCIDENCE (DAYS) | 675 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.455N |
|INCIDENTAL TUMOR | P=0.543N |
|LOGISTIC REGRESSION | P=0.493N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.500N |
|==============================================================================|
DATE: 08/15/96 EXPERIMENT: 88066 TEST: 01 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | VEHICLE 25% |
| | CONTROL |
|==============================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 9/96 (9%) 11/100 (11%) |
|ADJUSTED (b) | 15.8% 16.7% |
|TERMINAL (d) | 6/51 (12%) 8/61 (13%) |
|FIRST INCIDENCE (DAYS) | 634 637 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.549 |
|INCIDENTAL TUMOR | P=0.445 |
|LOGISTIC REGRESSION | P=0.472 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.445 |
|==============================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 10/96 (10%) 11/100 (11%) |
|ADJUSTED (b) | 17.6% 16.7% |
|TERMINAL (d) | 7/51 (14%) 8/61 (13%) |
|FIRST INCIDENCE (DAYS) | 634 637 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.535N |
|INCIDENTAL TUMOR | P=0.547 |
|LOGISTIC REGRESSION | P=0.571 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.540 |
|==============================================================================|
DATE: 08/15/96 EXPERIMENT: 88066 TEST: 01 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | VEHICLE 25% |
| | CONTROL |
|==============================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 1/100 (1%) 3/100 (3%) |
|ADJUSTED (b) | 2.0% 4.4% |
|TERMINAL (d) | 1/51 (2%) 2/61 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 620 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.362 |
|INCIDENTAL TUMOR | P=0.315 |
|LOGISTIC REGRESSION | P=0.315 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.311 |
|==============================================================================|
| |
|Uterus |
| Sarcoma Stromal |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 2/100 (2%) 0/100 (0%) |
|ADJUSTED (b) | 3.9% 0.0% |
|TERMINAL (d) | 2/51 (4%) 0/61 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.200N |
|INCIDENTAL TUMOR | P=0.200N |
|LOGISTIC REGRESSION | P=0.200N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.249N |
|==============================================================================|
DATE: 08/15/96 EXPERIMENT: 88066 TEST: 01 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | VEHICLE 25% |
| | CONTROL |
|==============================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 3/100 (3%) 3/100 (3%) |
|ADJUSTED (b) | 5.9% 4.4% |
|TERMINAL (d) | 3/51 (6%) 2/61 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 620 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.585N |
|INCIDENTAL TUMOR | P=0.626N |
|LOGISTIC REGRESSION | P=0.639N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.659N |
|==============================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 2/100 (2%) 1/100 (1%) |
|ADJUSTED (b) | 2.3% 1.6% |
|TERMINAL (d) | 0/51 (0%) 1/61 (2%) |
|FIRST INCIDENCE (DAYS) | 588 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.475N |
|INCIDENTAL TUMOR | P=0.580N |
|LOGISTIC REGRESSION | P=0.499N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.500N |
|==============================================================================|
DATE: 08/15/96 EXPERIMENT: 88066 TEST: 01 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | VEHICLE 25% |
| | CONTROL |
|==============================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferenti|ted
| Cell Type |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 14/100 (14%) 18/100 (18%) |
|ADJUSTED (b) | 23.0% 25.8% |
|TERMINAL (d) | 8/51 (16%) 12/61 (20%) |
|FIRST INCIDENCE (DAYS) | 627 624 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.447 |
|INCIDENTAL TUMOR | P=0.264 |
|LOGISTIC REGRESSION | P=0.316 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.282 |
|==============================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 72/100 (72%) 69/100 (69%) |
|ADJUSTED (b) | 92.1% 81.9% |
|TERMINAL (d) | 45/51 (88%) 46/61 (75%) |
|FIRST INCIDENCE (DAYS) | 588 313 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.070N |
|INCIDENTAL TUMOR | P=0.298N |
|LOGISTIC REGRESSION | P=0.292N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.378N |
|==============================================================================|
DATE: 08/15/96 EXPERIMENT: 88066 TEST: 01 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | VEHICLE 25% |
| | CONTROL |
|==============================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 42/100 (42%) 51/100 (51%) |
|ADJUSTED (b) | 55.9% 60.9% |
|TERMINAL (d) | 21/51 (41%) 30/61 (49%) |
|FIRST INCIDENCE (DAYS) | 548 324 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.397 |
|INCIDENTAL TUMOR | P=0.088 |
|LOGISTIC REGRESSION | P=0.089 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.128 |
|==============================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 82/100 (82%) 88/100 (88%) |
|ADJUSTED (b) | 96.4% 91.6% |
|TERMINAL (d) | 48/51 (94%) 53/61 (87%) |
|FIRST INCIDENCE (DAYS) | 548 313 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.314N |
|INCIDENTAL TUMOR | P=0.118 |
|LOGISTIC REGRESSION | P=0.141 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.161 |
|==============================================================================|
DATE: 08/15/96 EXPERIMENT: 88066 TEST: 01 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
(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).