TDMS Study 88066-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: A. D. Little POLYVINYL ALCOHOL DATE: 08/30/94
EXPERIMENT: 88066 TEST: 01 TIME: 07:01:06
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: 08/30/94 EXPERIMENT: 88066 TEST: 01 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | UNTREATD VEHICLE |
| | CONTROL CONTROL |
|==============================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 4/100 (4%) 8/100 (8%) |
|ADJUSTED (b) | 7.1% 13.8% |
|TERMINAL (d) | 2/47 (4%) 5/51 (10%) |
|FIRST INCIDENCE (DAYS) | 640 668 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.225 |
|INCIDENTAL TUMOR | P=0.229 |
|LOGISTIC REGRESSION | P=0.220 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.186 |
|==============================================================================|
| |
|Harderian Gland |
| Carcinoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 1/100 (1%) 3/100 (3%) |
|ADJUSTED (b) | 1.4% 3.9% |
|TERMINAL (d) | 0/47 (0%) 0/51 (0%) |
|FIRST INCIDENCE (DAYS) | 646 620 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.330 |
|INCIDENTAL TUMOR | P=0.413 |
|LOGISTIC REGRESSION | P=0.296 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.311 |
|==============================================================================|
DATE: 08/30/94 EXPERIMENT: 88066 TEST: 01 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | UNTREATD VEHICLE |
| | CONTROL CONTROL |
|==============================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 5/100 (5%) 11/100 (11%) |
|ADJUSTED (b) | 8.3% 17.1% |
|TERMINAL (d) | 2/47 (4%) 5/51 (10%) |
|FIRST INCIDENCE (DAYS) | 640 620 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.130 |
|INCIDENTAL TUMOR | P=0.152 |
|LOGISTIC REGRESSION | P=0.115 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.096 |
|==============================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/97 (0%) 3/94 (3%) |
|ADJUSTED (b) | 0.0% 5.0% |
|TERMINAL (d) | 0/47 (0%) 2/51 (4%) |
|FIRST INCIDENCE (DAYS) | --- 588 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.139 |
|INCIDENTAL TUMOR | P=0.163 |
|LOGISTIC REGRESSION | P=0.122 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.117 |
|==============================================================================|
DATE: 08/30/94 EXPERIMENT: 88066 TEST: 01 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | UNTREATD VEHICLE |
| | CONTROL CONTROL |
|==============================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 56/99 (57%) 58/100 (58%) |
|ADJUSTED (b) | 80.5% 80.9% |
|TERMINAL (d) | 34/47 (72%) 38/51 (75%) |
|FIRST INCIDENCE (DAYS) | 365 588 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.431N |
|INCIDENTAL TUMOR | P=0.346N |
|LOGISTIC REGRESSION | P=0.399N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.476 |
|==============================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 14/99 (14%) 18/100 (18%) |
|ADJUSTED (b) | 24.4% 26.9% |
|TERMINAL (d) | 8/47 (17%) 8/51 (16%) |
|FIRST INCIDENCE (DAYS) | 538 548 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.373 |
|INCIDENTAL TUMOR | P=0.398 |
|LOGISTIC REGRESSION | P=0.347 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.292 |
|==============================================================================|
DATE: 08/30/94 EXPERIMENT: 88066 TEST: 01 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | UNTREATD VEHICLE |
| | CONTROL CONTROL |
|==============================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 61/99 (62%) 65/100 (65%) |
|ADJUSTED (b) | 84.2% 83.8% |
|TERMINAL (d) | 36/47 (77%) 39/51 (76%) |
|FIRST INCIDENCE (DAYS) | 365 548 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.509N |
|INCIDENTAL TUMOR | P=0.373N |
|LOGISTIC REGRESSION | P=0.501N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.364 |
|==============================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 61/99 (62%) 65/100 (65%) |
|ADJUSTED (b) | 84.2% 83.8% |
|TERMINAL (d) | 36/47 (77%) 39/51 (76%) |
|FIRST INCIDENCE (DAYS) | 365 548 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.509N |
|INCIDENTAL TUMOR | P=0.373N |
|LOGISTIC REGRESSION | P=0.501N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.364 |
|==============================================================================|
DATE: 08/30/94 EXPERIMENT: 88066 TEST: 01 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | UNTREATD VEHICLE |
| | CONTROL CONTROL |
|==============================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 6/100 (6%) 8/98 (8%) |
|ADJUSTED (b) | 11.0% 13.6% |
|TERMINAL (d) | 4/47 (9%) 4/51 (8%) |
|FIRST INCIDENCE (DAYS) | 646 611 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.452 |
|INCIDENTAL TUMOR | P=0.442 |
|LOGISTIC REGRESSION | P=0.435 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.376 |
|==============================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/100 (3%) 2/98 (2%) |
|ADJUSTED (b) | 4.7% 3.0% |
|TERMINAL (d) | 0/47 (0%) 1/51 (2%) |
|FIRST INCIDENCE (DAYS) | 473 548 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.463N |
|INCIDENTAL TUMOR | P=0.559N |
|LOGISTIC REGRESSION | P=0.537N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.510N |
|==============================================================================|
DATE: 08/30/94 EXPERIMENT: 88066 TEST: 01 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | UNTREATD VEHICLE |
| | CONTROL CONTROL |
|==============================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 9/100 (9%) 10/98 (10%) |
|ADJUSTED (b) | 15.2% 16.4% |
|TERMINAL (d) | 4/47 (9%) 5/51 (10%) |
|FIRST INCIDENCE (DAYS) | 473 548 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.571 |
|INCIDENTAL TUMOR | P=0.515 |
|LOGISTIC REGRESSION | P=0.525 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.481 |
|==============================================================================|
| |
|Ovary |
| Cystadenocarcinoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/95 (2%) 0/97 (0%) |
|ADJUSTED (b) | 2.5% 0.0% |
|TERMINAL (d) | 0/45 (0%) 0/51 (0%) |
|FIRST INCIDENCE (DAYS) | 592 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.224N |
|INCIDENTAL TUMOR | P=0.111N |
|LOGISTIC REGRESSION | P=0.253N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.244N |
|==============================================================================|
DATE: 08/30/94 EXPERIMENT: 88066 TEST: 01 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | UNTREATD VEHICLE |
| | CONTROL CONTROL |
|==============================================================================|
| |
|Ovary |
| Cystadenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 5/95 (5%) 6/97 (6%) |
|ADJUSTED (b) | 10.0% 11.4% |
|TERMINAL (d) | 3/45 (7%) 5/51 (10%) |
|FIRST INCIDENCE (DAYS) | 696 711 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.574 |
|INCIDENTAL TUMOR | P=0.554 |
|LOGISTIC REGRESSION | P=0.571 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.514 |
|==============================================================================|
| |
|Ovary |
| Granulosa Cell Tumor Benign |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/95 (2%) 2/97 (2%) |
|ADJUSTED (b) | 4.1% 3.8% |
|TERMINAL (d) | 1/45 (2%) 1/51 (2%) |
|FIRST INCIDENCE (DAYS) | 711 722 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.653N |
|INCIDENTAL TUMOR | P=0.678N |
|LOGISTIC REGRESSION | P=0.657N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.682N |
|==============================================================================|
DATE: 08/30/94 EXPERIMENT: 88066 TEST: 01 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | UNTREATD VEHICLE |
| | CONTROL CONTROL |
|==============================================================================|
| |
|Pancreas |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/97 (2%) 0/95 (0%) |
|ADJUSTED (b) | 4.3% 0.0% |
|TERMINAL (d) | 2/47 (4%) 0/51 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.221N |
|INCIDENTAL TUMOR | P=0.221N |
|LOGISTIC REGRESSION | P=0.221N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.254N |
|==============================================================================|
| |
|Pancreas |
| Carcinoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/97 (2%) 1/95 (1%) |
|ADJUSTED (b) | 4.3% 1.4% |
|TERMINAL (d) | 2/47 (4%) 0/51 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 661 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.471N |
|INCIDENTAL TUMOR | P=0.490N |
|LOGISTIC REGRESSION | P=0.483N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.508N |
|==============================================================================|
DATE: 08/30/94 EXPERIMENT: 88066 TEST: 01 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | UNTREATD VEHICLE |
| | CONTROL CONTROL |
|==============================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 14/88 (16%) 10/86 (12%) |
|ADJUSTED (b) | 28.4% 16.8% |
|TERMINAL (d) | 10/43 (23%) 5/47 (11%) |
|FIRST INCIDENCE (DAYS) | 657 620 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.199N |
|INCIDENTAL TUMOR | P=0.211N |
|LOGISTIC REGRESSION | P=0.213N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.275N |
|==============================================================================|
| |
|Skeletal Muscle |
| Rhabdomyosarcoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 4/100 (4%) 3/100 (3%) |
|ADJUSTED (b) | 7.8% 4.1% |
|TERMINAL (d) | 2/47 (4%) 0/51 (0%) |
|FIRST INCIDENCE (DAYS) | 709 548 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.457N |
|INCIDENTAL TUMOR | P=0.452N |
|LOGISTIC REGRESSION | P=0.476N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.500N |
|==============================================================================|
DATE: 08/30/94 EXPERIMENT: 88066 TEST: 01 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | UNTREATD VEHICLE |
| | CONTROL CONTROL |
|==============================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 3/100 (3%) 0/100 (0%) |
|ADJUSTED (b) | 4.7% 0.0% |
|TERMINAL (d) | 1/47 (2%) 0/51 (0%) |
|FIRST INCIDENCE (DAYS) | 410 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.113N |
|INCIDENTAL TUMOR | P=0.188N |
|LOGISTIC REGRESSION | P=0.139N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.123N |
|==============================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 2/100 (2%) 0/100 (0%) |
|ADJUSTED (b) | 3.6% 0.0% |
|TERMINAL (d) | 1/47 (2%) 0/51 (0%) |
|FIRST INCIDENCE (DAYS) | 666 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.223N |
|INCIDENTAL TUMOR | P=0.235N |
|LOGISTIC REGRESSION | P=0.225N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.249N |
|==============================================================================|
DATE: 08/30/94 EXPERIMENT: 88066 TEST: 01 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | UNTREATD VEHICLE |
| | CONTROL CONTROL |
|==============================================================================|
| |
|Stomach, Glandular |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 0/100 (0%) 2/100 (2%) |
|ADJUSTED (b) | 0.0% 3.8% |
|TERMINAL (d) | 0/47 (0%) 1/51 (2%) |
|FIRST INCIDENCE (DAYS) | --- 728 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.260 |
|INCIDENTAL TUMOR | P=0.244 |
|LOGISTIC REGRESSION | P=0.256 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.249 |
|==============================================================================|
| |
|Thymus |
| Thymoma Benign |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/98 (2%) 1/93 (1%) |
|ADJUSTED (b) | 3.3% 1.8% |
|TERMINAL (d) | 1/47 (2%) 0/51 (0%) |
|FIRST INCIDENCE (DAYS) | 529 717 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.468N |
|INCIDENTAL TUMOR | P=0.633N |
|LOGISTIC REGRESSION | P=0.522N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.520N |
|==============================================================================|
DATE: 08/30/94 EXPERIMENT: 88066 TEST: 01 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | UNTREATD VEHICLE |
| | CONTROL CONTROL |
|==============================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 19/100 (19%) 21/96 (22%) |
|ADJUSTED (b) | 38.4% 36.5% |
|TERMINAL (d) | 17/47 (36%) 16/51 (31%) |
|FIRST INCIDENCE (DAYS) | 686 634 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.543 |
|INCIDENTAL TUMOR | P=0.529 |
|LOGISTIC REGRESSION | P=0.518 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.374 |
|==============================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/100 (1%) 2/96 (2%) |
|ADJUSTED (b) | 2.1% 3.9% |
|TERMINAL (d) | 1/47 (2%) 2/51 (4%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.528 |
|INCIDENTAL TUMOR | P=0.528 |
|LOGISTIC REGRESSION | P=0.528 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.485 |
|==============================================================================|
DATE: 08/30/94 EXPERIMENT: 88066 TEST: 01 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | UNTREATD VEHICLE |
| | CONTROL CONTROL |
|==============================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 20/100 (20%) 23/96 (24%) |
|ADJUSTED (b) | 40.5% 40.1% |
|TERMINAL (d) | 18/47 (38%) 18/51 (35%) |
|FIRST INCIDENCE (DAYS) | 686 634 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.479 |
|INCIDENTAL TUMOR | P=0.464 |
|LOGISTIC REGRESSION | P=0.451 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.310 |
|==============================================================================|
| |
|Uterus |
| Sarcoma Stromal |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 7/100 (7%) 5/100 (5%) |
|ADJUSTED (b) | 10.4% 7.9% |
|TERMINAL (d) | 1/47 (2%) 2/51 (4%) |
|FIRST INCIDENCE (DAYS) | 538 588 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.337N |
|INCIDENTAL TUMOR | P=0.337N |
|LOGISTIC REGRESSION | P=0.376N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.384N |
|==============================================================================|
DATE: 08/30/94 EXPERIMENT: 88066 TEST: 01 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | UNTREATD VEHICLE |
| | CONTROL CONTROL |
|==============================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 3/100 (3%) 0/100 (0%) |
|ADJUSTED (b) | 6.4% 0.0% |
|TERMINAL (d) | 3/47 (6%) 0/51 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.108N |
|INCIDENTAL TUMOR | P=0.108N |
|LOGISTIC REGRESSION | P=0.106N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.123N |
|==============================================================================|
| |
|All Organs |
| Malignant Lymphoma And Histiocytic Sarcoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 13/100 (13%) 12/100 (12%) |
|ADJUSTED (b) | 23.1% 19.7% |
|TERMINAL (d) | 7/47 (15%) 7/51 (14%) |
|FIRST INCIDENCE (DAYS) | 652 627 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.423N |
|INCIDENTAL TUMOR | P=0.414N |
|LOGISTIC REGRESSION | P=0.424N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.500N |
|==============================================================================|
DATE: 08/30/94 EXPERIMENT: 88066 TEST: 01 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | UNTREATD VEHICLE |
| | CONTROL CONTROL |
|==============================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 10/100 (10%) 12/100 (12%) |
|ADJUSTED (b) | 17.3% 19.7% |
|TERMINAL (d) | 4/47 (9%) 7/51 (14%) |
|FIRST INCIDENCE (DAYS) | 652 627 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.483 |
|INCIDENTAL TUMOR | P=0.490 |
|LOGISTIC REGRESSION | P=0.477 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.411 |
|==============================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 69/100 (69%) 74/100 (74%) |
|ADJUSTED (b) | 93.0% 91.2% |
|TERMINAL (d) | 42/47 (89%) 44/51 (86%) |
|FIRST INCIDENCE (DAYS) | 365 588 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.522N |
|INCIDENTAL TUMOR | P=0.529N |
|LOGISTIC REGRESSION | P=0.533N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.266 |
|==============================================================================|
DATE: 08/30/94 EXPERIMENT: 88066 TEST: 01 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | UNTREATD VEHICLE |
| | CONTROL CONTROL |
|==============================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 43/100 (43%) 44/100 (44%) |
|ADJUSTED (b) | 56.8% 58.0% |
|TERMINAL (d) | 16/47 (34%) 22/51 (43%) |
|FIRST INCIDENCE (DAYS) | 410 548 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.441N |
|INCIDENTAL TUMOR | P=0.390N |
|LOGISTIC REGRESSION | P=0.422N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.500 |
|==============================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 81/100 (81%) 85/100 (85%) |
|ADJUSTED (b) | 96.4% 95.5% |
|TERMINAL (d) | 44/47 (94%) 47/51 (92%) |
|FIRST INCIDENCE (DAYS) | 365 548 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.438N |
|INCIDENTAL TUMOR | P=0.336N |
|LOGISTIC REGRESSION | P=0.432N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.286 |
|==============================================================================|
DATE: 08/30/94 EXPERIMENT: 88066 TEST: 01 PAGE 17
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).