TDMS Study 05144-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Mason SAFFLOWER OIL DATE: 09/17/94
EXPERIMENT: 05144 TEST: 01 TIME: 19:56:57
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-55123 ROUTE: GAVAGE NTP C#: 62204
PATHOLOGIST: K. MURTHY S. EUSTIS CAS: 8001-23-8
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Mason SAFFLOWER OIL DATE: 09/17/94
EXPERIMENT: 05144 TEST: 01 TIME: 19:56:57
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55123 ROUTE: GAVAGE NTP C#: 62204
PATHOLOGIST: K. MURTHY S. EUSTIS CAS: 8001-23-8
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 SAFFLOWER OIL DATE: 09/17/94
EXPERIMENT: 05144 TEST: 01 TIME: 19:56:57
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55123 ROUTE: GAVAGE NTP C#: 62204
PATHOLOGIST: K. MURTHY S. EUSTIS CAS: 8001-23-8
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF SAFFLOWER OIL
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear,
or Undifferentiated
Malignant Tumors
Mammary Gland Fibroadenoma
Pancreas Adenoma
Carcinoma or Adenoma
Testes Adenoma
====================================================================================================
DATE: 09/17/94 EXPERIMENT: 05144 TEST: 01 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 2/177 (1%) |
|ADJUSTED (b) | 0.0% 1.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/29 (0%) |
|TERMINAL (d) | 0/30 (0%) 1/109 (1%) |
|FIRST INCIDENCE (DAYS) | --- 722 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.551 |
|INCIDENTAL TUMOR | P=0.381 |
|LOGISTIC REGRESSION | P=0.525 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.557 |
|==============================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 15/59 (25%) 31/175 (18%) |
|ADJUSTED (b) | 39.2% 26.5% |
|INTERIM SACRIFICE 1 (c)| 4/10 (40%) 2/29 (7%) |
|TERMINAL (d) | 9/29 (31%) 24/107 (22%) |
|FIRST INCIDENCE (DAYS) | 462 (I) 462 (I) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.046N* |
|INCIDENTAL TUMOR | P=0.105N |
|LOGISTIC REGRESSION | P=0.130N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.136N |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05144 TEST: 01 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/59 (3%) 1/175 (1%) |
|ADJUSTED (b) | 6.9% 0.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/29 (0%) |
|TERMINAL (d) | 2/29 (7%) 0/107 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 672 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.123N |
|INCIDENTAL TUMOR | P=0.218N |
|LOGISTIC REGRESSION | P=0.150N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.157N |
|==============================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 17/59 (29%) 32/175 (18%) |
|ADJUSTED (b) | 45.3% 27.1% |
|INTERIM SACRIFICE 1 (c)| 4/10 (40%) 2/29 (7%) |
|TERMINAL (d) | 11/29 (38%) 24/107 (22%) |
|FIRST INCIDENCE (DAYS) | 462 (I) 462 (I) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.016N* |
|INCIDENTAL TUMOR | P=0.051N |
|LOGISTIC REGRESSION | P=0.058N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.065N |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05144 TEST: 01 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Brain |
| Oligodendroglioma, Glioma, or Astrocytoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 3/180 (2%) |
|ADJUSTED (b) | 0.0% 1.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/29 (0%) |
|TERMINAL (d) | 0/30 (0%) 0/109 (0%) |
|FIRST INCIDENCE (DAYS) | --- 329 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.364 |
|INCIDENTAL TUMOR | P=0.707 |
|LOGISTIC REGRESSION | P=0.475 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.420 |
|==============================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 8/60 (13%) 14/177 (8%) |
|ADJUSTED (b) | 24.7% 11.8% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 2/29 (7%) |
|TERMINAL (d) | 7/30 (23%) 10/107 (9%) |
|FIRST INCIDENCE (DAYS) | 462 (I) 461 (I) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.089N |
|INCIDENTAL TUMOR | P=0.111N |
|LOGISTIC REGRESSION | P=0.159N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.160N |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05144 TEST: 01 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 7/59 (12%) 11/177 (6%) |
|ADJUSTED (b) | 18.1% 10.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/29 (0%) |
|TERMINAL (d) | 3/30 (10%) 11/109 (10%) |
|FIRST INCIDENCE (DAYS) | 476 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.072N |
|INCIDENTAL TUMOR | P=0.092N |
|LOGISTIC REGRESSION | P=0.118N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.130N |
|==============================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/60 (3%) 3/180 (2%) |
|ADJUSTED (b) | 6.7% 2.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/29 (0%) |
|TERMINAL (d) | 2/30 (7%) 2/109 (2%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 624 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.341N |
|INCIDENTAL TUMOR | P=0.342N |
|LOGISTIC REGRESSION | P=0.384N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.367N |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05144 TEST: 01 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/60 (5%) 4/180 (2%) |
|ADJUSTED (b) | 10.0% 3.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/29 (0%) |
|TERMINAL (d) | 3/30 (10%) 3/109 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 624 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.190N |
|INCIDENTAL TUMOR | P=0.192N |
|LOGISTIC REGRESSION | P=0.233N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.241N |
|==============================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/60 (5%) 4/180 (2%) |
|ADJUSTED (b) | 10.0% 3.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/29 (0%) |
|TERMINAL (d) | 3/30 (10%) 3/109 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 624 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.190N |
|INCIDENTAL TUMOR | P=0.192N |
|LOGISTIC REGRESSION | P=0.233N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.241N |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05144 TEST: 01 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 7/60 (12%) 5/180 (3%) |
|ADJUSTED (b) | 22.2% 4.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/29 (0%) |
|TERMINAL (d) | 6/30 (20%) 5/109 (5%) |
|FIRST INCIDENCE (DAYS) | 691 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.002N** |
|INCIDENTAL TUMOR | P=0.004N** |
|LOGISTIC REGRESSION | P=0.003N** |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.012N* |
|==============================================================================|
| |
|Pancreas |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/60 (2%) 51/178 (29%) |
|ADJUSTED (b) | 3.3% 44.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/29 (3%) |
|TERMINAL (d) | 1/30 (3%) 45/109 (41%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 461 (I) |
|-----------------------| |
|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: 05144 TEST: 01 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Pancreas |
| Carcinoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 2/178 (1%) |
|ADJUSTED (b) | 0.0% 1.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/29 (0%) |
|TERMINAL (d) | 0/30 (0%) 1/109 (1%) |
|FIRST INCIDENCE (DAYS) | --- 633 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.519 |
|INCIDENTAL TUMOR | P=0.515 |
|LOGISTIC REGRESSION | P=0.499 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.559 |
|==============================================================================|
| |
|Pancreas |
| Carcinoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/60 (2%) 52/178 (29%) |
|ADJUSTED (b) | 3.3% 44.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/29 (3%) |
|TERMINAL (d) | 1/30 (3%) 45/109 (41%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 461 (I) |
|-----------------------| |
|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: 05144 TEST: 01 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 8/60 (13%) 22/176 (13%) |
|ADJUSTED (b) | 21.5% 19.1% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/29 (0%) |
|TERMINAL (d) | 4/30 (13%) 17/107 (16%) |
|FIRST INCIDENCE (DAYS) | 461 (I) 485 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.369N |
|INCIDENTAL TUMOR | P=0.538N |
|LOGISTIC REGRESSION | P=0.510N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.512N |
|==============================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 5/180 (3%) |
|ADJUSTED (b) | 0.0% 4.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/29 (0%) |
|TERMINAL (d) | 0/30 (0%) 5/109 (5%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.261 |
|INCIDENTAL TUMOR | P=0.261 |
|LOGISTIC REGRESSION | P=0.261 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.234 |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05144 TEST: 01 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Skin |
| Squamous Cell Carcinoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 3/180 (2%) |
|ADJUSTED (b) | 0.0% 2.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/29 (0%) |
|TERMINAL (d) | 0/30 (0%) 2/109 (2%) |
|FIRST INCIDENCE (DAYS) | --- 547 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.400 |
|INCIDENTAL TUMOR | P=0.396 |
|LOGISTIC REGRESSION | P=0.369 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.420 |
|==============================================================================|
| |
|Skin |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 2/60 (3%) 10/180 (6%) |
|ADJUSTED (b) | 5.5% 8.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/29 (0%) |
|TERMINAL (d) | 1/30 (3%) 8/109 (7%) |
|FIRST INCIDENCE (DAYS) | 635 547 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.440 |
|INCIDENTAL TUMOR | P=0.436 |
|LOGISTIC REGRESSION | P=0.375 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.386 |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05144 TEST: 01 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 2/60 (3%) 7/180 (4%) |
|ADJUSTED (b) | 5.5% 6.2% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/29 (0%) |
|TERMINAL (d) | 1/30 (3%) 6/109 (6%) |
|FIRST INCIDENCE (DAYS) | 635 634 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.649 |
|INCIDENTAL TUMOR | P=0.649 |
|LOGISTIC REGRESSION | P=0.595 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.601 |
|==============================================================================|
| |
|Skin |
| Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, |
| Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 2/60 (3%) 16/180 (9%) |
|ADJUSTED (b) | 5.5% 13.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/29 (0%) |
|TERMINAL (d) | 1/30 (3%) 13/109 (12%) |
|FIRST INCIDENCE (DAYS) | 635 547 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.182 |
|INCIDENTAL TUMOR | P=0.175 |
|LOGISTIC REGRESSION | P=0.135 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.125 |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05144 TEST: 01 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibroma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 2/60 (3%) 7/180 (4%) |
|ADJUSTED (b) | 6.7% 5.2% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/29 (3%) |
|TERMINAL (d) | 2/30 (7%) 2/109 (2%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 398 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.612 |
|INCIDENTAL TUMOR | P=0.598 |
|LOGISTIC REGRESSION | P=0.586 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.601 |
|==============================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibrosarcoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 3/180 (2%) |
|ADJUSTED (b) | 0.0% 2.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/29 (0%) |
|TERMINAL (d) | 0/30 (0%) 3/109 (3%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.417 |
|INCIDENTAL TUMOR | P=0.417 |
|LOGISTIC REGRESSION | P=0.417 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.420 |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05144 TEST: 01 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, Sarcoma, |
| Neurofibroma, or Fibroma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 2/60 (3%) 10/180 (6%) |
|ADJUSTED (b) | 6.7% 7.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/29 (3%) |
|TERMINAL (d) | 2/30 (7%) 5/109 (5%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 398 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.422 |
|INCIDENTAL TUMOR | P=0.407 |
|LOGISTIC REGRESSION | P=0.367 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.386 |
|==============================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 1/60 (2%) 3/180 (2%) |
|ADJUSTED (b) | 3.3% 2.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/29 (0%) |
|TERMINAL (d) | 1/30 (3%) 2/109 (2%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 721 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.669N |
|INCIDENTAL TUMOR | P=0.688 |
|LOGISTIC REGRESSION | P=0.685N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.686N |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05144 TEST: 01 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Testes |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 57/60 (95%) 166/179 (93%) |
|ADJUSTED (b) | 100.0% 100.0% |
|INTERIM SACRIFICE 1 (c)| 7/10 (70%) 24/29 (83%) |
|TERMINAL (d) | 30/30 (100%) 108/108 (100%) |
|FIRST INCIDENCE (DAYS) | 457 461 (I) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.047N* |
|INCIDENTAL TUMOR | P=0.596N |
|LOGISTIC REGRESSION | P=0.634N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.395N |
|==============================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 5/58 (9%) 16/175 (9%) |
|ADJUSTED (b) | 13.2% 14.0% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 1/29 (3%) |
|TERMINAL (d) | 2/29 (7%) 13/109 (12%) |
|FIRST INCIDENCE (DAYS) | 461 (I) 462 (I) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.522N |
|INCIDENTAL TUMOR | P=0.465 |
|LOGISTIC REGRESSION | P=0.571 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.571 |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05144 TEST: 01 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/58 (3%) 3/175 (2%) |
|ADJUSTED (b) | 5.0% 2.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/29 (0%) |
|TERMINAL (d) | 0/29 (0%) 2/109 (2%) |
|FIRST INCIDENCE (DAYS) | 635 672 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.356N |
|INCIDENTAL TUMOR | P=0.559N |
|LOGISTIC REGRESSION | P=0.389N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.365N |
|==============================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 2/180 (1%) |
|ADJUSTED (b) | 0.0% 1.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/29 (0%) |
|TERMINAL (d) | 0/30 (0%) 1/109 (1%) |
|FIRST INCIDENCE (DAYS) | --- 708 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.545 |
|INCIDENTAL TUMOR | P=0.411 |
|LOGISTIC REGRESSION | P=0.515 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.562 |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05144 TEST: 01 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, |
| or Undifferentiated |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 35/60 (58%) 44/180 (24%) |
|ADJUSTED (b) | 74.9% 36.0% |
|INTERIM SACRIFICE 1 (c)| 2/10 (20%) 0/29 (0%) |
|TERMINAL (d) | 19/30 (63%) 33/109 (30%) |
|FIRST INCIDENCE (DAYS) | 457 491 |
|-----------------------| |
|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 |
| Mesothelioma Benign, Malignant, NOS |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 4/180 (2%) |
|ADJUSTED (b) | 0.0% 3.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/29 (0%) |
|TERMINAL (d) | 0/30 (0%) 4/109 (4%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.328 |
|INCIDENTAL TUMOR | P=0.328 |
|LOGISTIC REGRESSION | P=0.328 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.314 |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05144 TEST: 01 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 58/60 (97%) 171/180 (95%) |
|ADJUSTED (b) | 100.0% 99.4% |
|INTERIM SACRIFICE 1 (c)| 8/10 (80%) 26/29 (90%) |
|TERMINAL (d) | 30/30 (100%) 108/109 (99%) |
|FIRST INCIDENCE (DAYS) | 457 398 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.060N |
|INCIDENTAL TUMOR | P=0.601 |
|LOGISTIC REGRESSION | P=0.665 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.452N |
|==============================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 38/60 (63%) 68/180 (38%) |
|ADJUSTED (b) | 80.1% 50.2% |
|INTERIM SACRIFICE 1 (c)| 2/10 (20%) 0/29 (0%) |
|TERMINAL (d) | 21/30 (70%) 44/109 (40%) |
|FIRST INCIDENCE (DAYS) | 457 302 |
|-----------------------| |
|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: 05144 TEST: 01 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SAFFLOWER OIL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 59/60 (98%) 175/180 (97%) |
|ADJUSTED (b) | 100.0% 99.4% |
|INTERIM SACRIFICE 1 (c)| 9/10 (90%) 26/29 (90%) |
|TERMINAL (d) | 30/30 (100%) 108/109 (99%) |
|FIRST INCIDENCE (DAYS) | 457 302 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.075N |
|INCIDENTAL TUMOR | P=0.609N |
|LOGISTIC REGRESSION | P=0.634N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.533N |
|==============================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for
intercurrent mortality.
(c) Observed incidence at interim kill.
Male interim sacrifices(days): 461
Female interim sacrifices(days):
(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).