TDMS Study 05143-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Mason CORN OIL / CORN OIL DATE: 09/17/94
EXPERIMENT: 05143 TEST: 01 TIME: 18:53:54
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-55123 ROUTE: GAVAGE NTP C#: 00577
PATHOLOGIST: K. MURTHY S. EUSTIS CAS: 8001-30-7
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Mason CORN OIL / CORN OIL DATE: 09/17/94
EXPERIMENT: 05143 TEST: 01 TIME: 18:53:54
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55123 ROUTE: GAVAGE NTP C#: 00577
PATHOLOGIST: K. MURTHY S. EUSTIS CAS: 8001-30-7
RATS(FISCHER344)
----------------------------
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
Epididymis
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Nose
Pancreas
Parathyroid Gland
Pituitary Gland
Preputial Gland
Prostate
Salivary Glands
Spleen
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Mason CORN OIL / CORN OIL DATE: 09/17/94
EXPERIMENT: 05143 TEST: 01 TIME: 18:53:54
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55123 ROUTE: GAVAGE NTP C#: 00577
PATHOLOGIST: K. MURTHY S. EUSTIS CAS: 8001-30-7
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF CORN OIL / CORN OIL
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear,
or Undifferentiated
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
Clitoral/Preputial Gland Adenoma
Pancreas Adenoma
Carcinoma or Adenoma
Skin Squamous Cell Carcinoma
Testes Adenoma
====================================================================================================
DATE: 09/17/94 EXPERIMENT: 05143 TEST: 01 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 10 10.0 |
| | ML/KG ML/KG |
|==============================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 35/98 (36%) 30/150 (20%) |
|ADJUSTED (b) | 48.4% 25.1% |
|TERMINAL (d) | 21/56 (38%) 23/111 (21%) |
|FIRST INCIDENCE (DAYS) | 600 586 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001N** |
|INCIDENTAL TUMOR | P=0.006N** |
|LOGISTIC REGRESSION | P=0.003N** |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.005N** |
|==============================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 4/98 (4%) 4/150 (3%) |
|ADJUSTED (b) | 6.2% 3.2% |
|TERMINAL (d) | 2/56 (4%) 2/111 (2%) |
|FIRST INCIDENCE (DAYS) | 635 576 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.328N |
|INCIDENTAL TUMOR | P=0.390N |
|LOGISTIC REGRESSION | P=0.417N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.394N |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05143 TEST: 01 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 10 10.0 |
| | ML/KG ML/KG |
|==============================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 38/98 (39%) 35/150 (23%) |
|ADJUSTED (b) | 51.2% 28.3% |
|TERMINAL (d) | 22/56 (39%) 25/111 (23%) |
|FIRST INCIDENCE (DAYS) | 600 520 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001N** |
|INCIDENTAL TUMOR | P=0.008N** |
|LOGISTIC REGRESSION | P=0.005N** |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.007N** |
|==============================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 14/100 (14%) 10/148 (7%) |
|ADJUSTED (b) | 19.6% 8.7% |
|TERMINAL (d) | 7/58 (12%) 8/110 (7%) |
|FIRST INCIDENCE (DAYS) | 591 576 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.017N* |
|INCIDENTAL TUMOR | P=0.058N |
|LOGISTIC REGRESSION | P=0.044N* |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.048N* |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05143 TEST: 01 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 10 10.0 |
| | ML/KG ML/KG |
|==============================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 14/99 (14%) 14/147 (10%) |
|ADJUSTED (b) | 20.0% 12.2% |
|TERMINAL (d) | 7/58 (12%) 11/110 (10%) |
|FIRST INCIDENCE (DAYS) | 591 599 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.077N |
|INCIDENTAL TUMOR | P=0.215N |
|LOGISTIC REGRESSION | P=0.159N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.180N |
|==============================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 4/100 (4%) 3/150 (2%) |
|ADJUSTED (b) | 5.7% 2.6% |
|TERMINAL (d) | 1/58 (2%) 2/111 (2%) |
|FIRST INCIDENCE (DAYS) | 610 695 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.220N |
|INCIDENTAL TUMOR | P=0.403N |
|LOGISTIC REGRESSION | P=0.288N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.287N |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05143 TEST: 01 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 10 10.0 |
| | ML/KG ML/KG |
|==============================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/98 (2%) 4/148 (3%) |
|ADJUSTED (b) | 3.3% 3.6% |
|TERMINAL (d) | 1/56 (2%) 3/110 (3%) |
|FIRST INCIDENCE (DAYS) | 710 706 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.650 |
|INCIDENTAL TUMOR | P=0.483 |
|LOGISTIC REGRESSION | P=0.584 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.548 |
|==============================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/98 (1%) 2/148 (1%) |
|ADJUSTED (b) | 1.3% 1.8% |
|TERMINAL (d) | 0/56 (0%) 2/110 (2%) |
|FIRST INCIDENCE (DAYS) | 685 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.704 |
|INCIDENTAL TUMOR | P=0.607 |
|LOGISTIC REGRESSION | P=0.658 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.651 |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05143 TEST: 01 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 10 10.0 |
| | ML/KG ML/KG |
|==============================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/98 (3%) 6/148 (4%) |
|ADJUSTED (b) | 4.6% 5.4% |
|TERMINAL (d) | 1/56 (2%) 5/110 (5%) |
|FIRST INCIDENCE (DAYS) | 685 706 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.608 |
|INCIDENTAL TUMOR | P=0.409 |
|LOGISTIC REGRESSION | P=0.521 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.486 |
|==============================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 6/100 (6%) 5/150 (3%) |
|ADJUSTED (b) | 8.7% 4.3% |
|TERMINAL (d) | 3/58 (5%) 4/111 (4%) |
|FIRST INCIDENCE (DAYS) | 216 622 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.162N |
|INCIDENTAL TUMOR | P=0.363N |
|LOGISTIC REGRESSION | P=0.278N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.242N |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05143 TEST: 01 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 10 10.0 |
| | ML/KG ML/KG |
|==============================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) |
| Papilloma Squamous or Papilloma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 0/100 (0%) 2/150 (1%) |
|ADJUSTED (b) | 0.0% 1.8% |
|TERMINAL (d) | 0/58 (0%) 2/111 (2%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.390 |
|INCIDENTAL TUMOR | P=0.390 |
|LOGISTIC REGRESSION | P=0.390 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.359 |
|==============================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 0/100 (0%) 2/150 (1%) |
|ADJUSTED (b) | 0.0% 1.8% |
|TERMINAL (d) | 0/58 (0%) 2/111 (2%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.390 |
|INCIDENTAL TUMOR | P=0.390 |
|LOGISTIC REGRESSION | P=0.390 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.359 |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05143 TEST: 01 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 10 10.0 |
| | ML/KG ML/KG |
|==============================================================================|
| |
|Pancreas |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/100 (2%) 41/147 (28%) |
|ADJUSTED (b) | 3.4% 35.3% |
|TERMINAL (d) | 2/58 (3%) 36/110 (33%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 569 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** |
|LOGISTIC REGRESSION | P<0.001 ** |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P<0.001 ** |
|==============================================================================|
| |
|Pancreas |
| Carcinoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/100 (2%) 42/147 (29%) |
|ADJUSTED (b) | 3.4% 36.2% |
|TERMINAL (d) | 2/58 (3%) 37/110 (34%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 569 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** |
|LOGISTIC REGRESSION | P<0.001 ** |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P<0.001 ** |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05143 TEST: 01 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 10 10.0 |
| | ML/KG ML/KG |
|==============================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 11/99 (11%) 23/149 (15%) |
|ADJUSTED (b) | 17.8% 18.8% |
|TERMINAL (d) | 9/58 (16%) 15/110 (14%) |
|FIRST INCIDENCE (DAYS) | 620 409 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.409 |
|INCIDENTAL TUMOR | P=0.282 |
|LOGISTIC REGRESSION | P=0.220 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.219 |
|==============================================================================|
| |
|Prostate |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/99 (0%) 2/148 (1%) |
|ADJUSTED (b) | 0.0% 1.8% |
|TERMINAL (d) | 0/57 (0%) 2/110 (2%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.392 |
|INCIDENTAL TUMOR | P=0.392 |
|LOGISTIC REGRESSION | P=0.392 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.358 |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05143 TEST: 01 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 10 10.0 |
| | ML/KG ML/KG |
|==============================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 1/100 (1%) 2/150 (1%) |
|ADJUSTED (b) | 1.7% 1.8% |
|TERMINAL (d) | 1/58 (2%) 2/111 (2%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.718 |
|INCIDENTAL TUMOR | P=0.718 |
|LOGISTIC REGRESSION | P=0.718 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.649 |
|==============================================================================|
| |
|Skin |
| Squamous Cell Carcinoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 3/100 (3%) 0/150 (0%) |
|ADJUSTED (b) | 4.7% 0.0% |
|TERMINAL (d) | 2/58 (3%) 0/111 (0%) |
|FIRST INCIDENCE (DAYS) | 685 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.042N* |
|INCIDENTAL TUMOR | P=0.070N |
|LOGISTIC REGRESSION | P=0.056N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.063N |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05143 TEST: 01 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 10 10.0 |
| | ML/KG ML/KG |
|==============================================================================|
| |
|Skin |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 4/100 (4%) 7/150 (5%) |
|ADJUSTED (b) | 6.4% 6.3% |
|TERMINAL (d) | 3/58 (5%) 7/111 (6%) |
|FIRST INCIDENCE (DAYS) | 685 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.581N |
|INCIDENTAL TUMOR | P=0.623 |
|LOGISTIC REGRESSION | P=0.609 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.533 |
|==============================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 1/100 (1%) 7/150 (5%) |
|ADJUSTED (b) | 1.7% 6.3% |
|TERMINAL (d) | 1/58 (2%) 7/111 (6%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.172 |
|INCIDENTAL TUMOR | P=0.172 |
|LOGISTIC REGRESSION | P=0.172 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.103 |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05143 TEST: 01 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 10 10.0 |
| | ML/KG ML/KG |
|==============================================================================|
| |
|Skin |
| Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, |
| Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 6/100 (6%) 10/150 (7%) |
|ADJUSTED (b) | 9.8% 9.0% |
|TERMINAL (d) | 5/58 (9%) 10/111 (9%) |
|FIRST INCIDENCE (DAYS) | 685 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.507N |
|INCIDENTAL TUMOR | P=0.551N |
|LOGISTIC REGRESSION | P=0.573N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.527 |
|==============================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibroma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 4/100 (4%) 7/150 (5%) |
|ADJUSTED (b) | 5.8% 6.0% |
|TERMINAL (d) | 1/58 (2%) 5/111 (5%) |
|FIRST INCIDENCE (DAYS) | 658 619 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.615N |
|INCIDENTAL TUMOR | P=0.422 |
|LOGISTIC REGRESSION | P=0.534 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.533 |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05143 TEST: 01 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 10 10.0 |
| | ML/KG ML/KG |
|==============================================================================|
| |
|Testes |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 95/100 (95%) 141/149 (95%) |
|ADJUSTED (b) | 99.0% 100.0% |
|TERMINAL (d) | 57/58 (98%) 111/111 (100%) |
|FIRST INCIDENCE (DAYS) | 483 432 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.004N** |
|INCIDENTAL TUMOR | P=0.141N |
|LOGISTIC REGRESSION | P=0.388N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.571N |
|==============================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 7/99 (7%) 19/147 (13%) |
|ADJUSTED (b) | 11.0% 16.9% |
|TERMINAL (d) | 5/58 (9%) 18/111 (16%) |
|FIRST INCIDENCE (DAYS) | 620 653 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.249 |
|INCIDENTAL TUMOR | P=0.190 |
|LOGISTIC REGRESSION | P=0.149 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.104 |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05143 TEST: 01 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 10 10.0 |
| | ML/KG ML/KG |
|==============================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/99 (1%) 2/147 (1%) |
|ADJUSTED (b) | 1.1% 1.7% |
|TERMINAL (d) | 0/58 (0%) 1/111 (1%) |
|FIRST INCIDENCE (DAYS) | 635 669 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.669 |
|INCIDENTAL TUMOR | P=0.562 |
|LOGISTIC REGRESSION | P=0.621 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.645 |
|==============================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 8/99 (8%) 21/147 (14%) |
|ADJUSTED (b) | 12.0% 18.4% |
|TERMINAL (d) | 5/58 (9%) 19/111 (17%) |
|FIRST INCIDENCE (DAYS) | 620 653 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.244 |
|INCIDENTAL TUMOR | P=0.162 |
|LOGISTIC REGRESSION | P=0.130 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.099 |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05143 TEST: 01 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 10 10.0 |
| | ML/KG ML/KG |
|==============================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/99 (2%) 0/147 (0%) |
|ADJUSTED (b) | 3.4% 0.0% |
|TERMINAL (d) | 2/58 (3%) 0/111 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.112N |
|INCIDENTAL TUMOR | P=0.112N |
|LOGISTIC REGRESSION | P=0.112N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.161N |
|==============================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/99 (2%) 1/147 (1%) |
|ADJUSTED (b) | 3.4% 0.9% |
|TERMINAL (d) | 2/58 (3%) 1/111 (1%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.282N |
|INCIDENTAL TUMOR | P=0.282N |
|LOGISTIC REGRESSION | P=0.282N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.355N |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05143 TEST: 01 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 10 10.0 |
| | ML/KG ML/KG |
|==============================================================================|
| |
|Zymbal's Gland |
| Carcinoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 2/100 (2%) 1/150 (1%) |
|ADJUSTED (b) | 2.5% 0.8% |
|TERMINAL (d) | 0/58 (0%) 0/111 (0%) |
|FIRST INCIDENCE (DAYS) | 670 692 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.334N |
|INCIDENTAL TUMOR | P=0.623N |
|LOGISTIC REGRESSION | P=0.370N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.351N |
|==============================================================================|
| |
|All Organs |
| Hemangioma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 0/100 (0%) 2/150 (1%) |
|ADJUSTED (b) | 0.0% 1.8% |
|TERMINAL (d) | 0/58 (0%) 2/111 (2%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.390 |
|INCIDENTAL TUMOR | P=0.390 |
|LOGISTIC REGRESSION | P=0.390 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.359 |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05143 TEST: 01 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 10 10.0 |
| | ML/KG ML/KG |
|==============================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 0/100 (0%) 2/150 (1%) |
|ADJUSTED (b) | 0.0% 1.8% |
|TERMINAL (d) | 0/58 (0%) 2/111 (2%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.390 |
|INCIDENTAL TUMOR | P=0.390 |
|LOGISTIC REGRESSION | P=0.390 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.359 |
|==============================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, |
| or Undifferentiated |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 57/100 (57%) 34/150 (23%) |
|ADJUSTED (b) | 62.6% 26.6% |
|TERMINAL (d) | 25/58 (43%) 19/111 (17%) |
|FIRST INCIDENCE (DAYS) | 483 555 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001N** |
|INCIDENTAL TUMOR | P<0.001N** |
|LOGISTIC REGRESSION | P<0.001N** |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P<0.001N** |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05143 TEST: 01 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 10 10.0 |
| | ML/KG ML/KG |
|==============================================================================|
| |
|All Organs |
| Mesothelioma Benign, Malignant, NOS |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 3/100 (3%) 5/150 (3%) |
|ADJUSTED (b) | 4.6% 4.0% |
|TERMINAL (d) | 2/58 (3%) 2/111 (2%) |
|FIRST INCIDENCE (DAYS) | 635 562 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.627N |
|INCIDENTAL TUMOR | P=0.600 |
|LOGISTIC REGRESSION | P=0.559 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.595 |
|==============================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 98/100 (98%) 147/150 (98%) |
|ADJUSTED (b) | 100.0% 100.0% |
|TERMINAL (d) | 58/58 (100%) 111/111 (100%) |
|FIRST INCIDENCE (DAYS) | 216 409 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.007N** |
|INCIDENTAL TUMOR | P=0.268N |
|LOGISTIC REGRESSION | P=0.296N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.684N |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05143 TEST: 01 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 10 10.0 |
| | ML/KG ML/KG |
|==============================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 64/100 (64%) 53/150 (35%) |
|ADJUSTED (b) | 68.4% 38.8% |
|TERMINAL (d) | 29/58 (50%) 29/111 (26%) |
|FIRST INCIDENCE (DAYS) | 483 432 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001N** |
|INCIDENTAL TUMOR | P<0.001N** |
|LOGISTIC REGRESSION | P<0.001N** |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P<0.001N** |
|==============================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 98/100 (98%) 147/150 (98%) |
|ADJUSTED (b) | 100.0% 100.0% |
|TERMINAL (d) | 58/58 (100%) 111/111 (100%) |
|FIRST INCIDENCE (DAYS) | 216 409 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.007N** |
|INCIDENTAL TUMOR | P=0.268N |
|LOGISTIC REGRESSION | P=0.296N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.684N |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05143 TEST: 01 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- CORN OIL / CORN OIL
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).