TDMS Study 05145-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Mason TRICAPRYLIN DATE: 09/17/94
EXPERIMENT: 05145 TEST: 01 TIME: 20:57:29
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-55123 ROUTE: GAVAGE NTP C#: 62215
PATHOLOGIST: K. MURTHY S. EUSTIS CAS: 538-23-8
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Mason TRICAPRYLIN DATE: 09/17/94
EXPERIMENT: 05145 TEST: 01 TIME: 20:57:29
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55123 ROUTE: GAVAGE NTP C#: 62215
PATHOLOGIST: K. MURTHY S. EUSTIS CAS: 538-23-8
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 TRICAPRYLIN DATE: 09/17/94
EXPERIMENT: 05145 TEST: 01 TIME: 20:57:29
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55123 ROUTE: GAVAGE NTP C#: 62215
PATHOLOGIST: K. MURTHY S. EUSTIS CAS: 538-23-8
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF TRICAPRYLIN
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Pancreas Adenoma
Stomach, Forestomach Squamous Cell Papilloma
====================================================================================================
DATE: 09/17/94 EXPERIMENT: 05145 TEST: 01 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 11/60 (18%) 41/176 (23%) |
|ADJUSTED (b) | 31.9% 42.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 8/31 (26%) 29/82 (35%) |
|FIRST INCIDENCE (DAYS) | 678 597 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.163 |
|INCIDENTAL TUMOR | P=0.105 |
|LOGISTIC REGRESSION | P=0.124 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.271 |
|==============================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/60 (3%) 1/176 (1%) |
|ADJUSTED (b) | 5.3% 1.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 1/31 (3%) 0/82 (0%) |
|FIRST INCIDENCE (DAYS) | 576 698 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.193N |
|INCIDENTAL TUMOR | P=0.201N |
|LOGISTIC REGRESSION | P=0.181N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.160N |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05145 TEST: 01 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 14/60 (23%) 42/176 (24%) |
|ADJUSTED (b) | 39.1% 43.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 10/31 (32%) 29/82 (35%) |
|FIRST INCIDENCE (DAYS) | 576 597 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.382 |
|INCIDENTAL TUMOR | P=0.295 |
|LOGISTIC REGRESSION | P=0.332 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.543 |
|==============================================================================|
| |
|Bone |
| Osteosarcoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 2/180 (1%) |
|ADJUSTED (b) | 0.0% 2.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 0/31 (0%) 1/84 (1%) |
|FIRST INCIDENCE (DAYS) | --- 569 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.470 |
|INCIDENTAL TUMOR | P=0.487 |
|LOGISTIC REGRESSION | P=0.487 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.562 |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05145 TEST: 01 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 7/60 (12%) 13/178 (7%) |
|ADJUSTED (b) | 20.0% 14.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 5/31 (16%) 8/83 (10%) |
|FIRST INCIDENCE (DAYS) | 541 608 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.297N |
|INCIDENTAL TUMOR | P=0.288N |
|LOGISTIC REGRESSION | P=0.300N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.212N |
|==============================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 8/60 (13%) 14/178 (8%) |
|ADJUSTED (b) | 23.1% 14.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 6/31 (19%) 8/83 (10%) |
|FIRST INCIDENCE (DAYS) | 541 608 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.232N |
|INCIDENTAL TUMOR | P=0.229N |
|LOGISTIC REGRESSION | P=0.233N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.157N |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05145 TEST: 01 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/59 (5%) 6/173 (3%) |
|ADJUSTED (b) | 10.0% 6.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 3/30 (10%) 4/84 (5%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 632 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.465N |
|INCIDENTAL TUMOR | P=0.488N |
|LOGISTIC REGRESSION | P=0.489N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.412N |
|==============================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/59 (3%) 0/173 (0%) |
|ADJUSTED (b) | 5.1% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 0/30 (0%) 0/84 (0%) |
|FIRST INCIDENCE (DAYS) | 625 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.070N |
|INCIDENTAL TUMOR | P=0.087N |
|LOGISTIC REGRESSION | P=0.059N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.064N |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05145 TEST: 01 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 5/59 (8%) 6/173 (3%) |
|ADJUSTED (b) | 14.6% 6.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 3/30 (10%) 4/84 (5%) |
|FIRST INCIDENCE (DAYS) | 625 632 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.141N |
|INCIDENTAL TUMOR | P=0.163N |
|LOGISTIC REGRESSION | P=0.150N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.116N |
|==============================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/60 (2%) 7/178 (4%) |
|ADJUSTED (b) | 3.2% 8.2% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 1/31 (3%) 6/84 (7%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 715 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.300 |
|INCIDENTAL TUMOR | P=0.283 |
|LOGISTIC REGRESSION | P=0.299 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.358 |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05145 TEST: 01 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 4/178 (2%) |
|ADJUSTED (b) | 0.0% 4.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 0/31 (0%) 3/84 (4%) |
|FIRST INCIDENCE (DAYS) | --- 718 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.260 |
|INCIDENTAL TUMOR | P=0.240 |
|LOGISTIC REGRESSION | P=0.254 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.310 |
|==============================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 5/178 (3%) |
|ADJUSTED (b) | 0.0% 5.2% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 0/31 (0%) 3/84 (4%) |
|FIRST INCIDENCE (DAYS) | --- 426 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.199 |
|INCIDENTAL TUMOR | P=0.215 |
|LOGISTIC REGRESSION | P=0.198 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.231 |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05145 TEST: 01 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 1/60 (2%) 2/180 (1%) |
|ADJUSTED (b) | 2.9% 2.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 0/31 (0%) 1/84 (1%) |
|FIRST INCIDENCE (DAYS) | 704 601 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.663N |
|INCIDENTAL TUMOR | P=0.671N |
|LOGISTIC REGRESSION | P=0.656N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.580N |
|==============================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 5/60 (8%) 7/180 (4%) |
|ADJUSTED (b) | 16.1% 8.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 5/31 (16%) 6/84 (7%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 670 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.199N |
|INCIDENTAL TUMOR | P=0.207N |
|LOGISTIC REGRESSION | P=0.202N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.152N |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05145 TEST: 01 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 6/60 (10%) 8/180 (4%) |
|ADJUSTED (b) | 18.6% 9.2% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 5/31 (16%) 7/84 (8%) |
|FIRST INCIDENCE (DAYS) | 704 670 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.142N |
|INCIDENTAL TUMOR | P=0.156N |
|LOGISTIC REGRESSION | P=0.146N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.105N |
|==============================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 6/60 (10%) 9/180 (5%) |
|ADJUSTED (b) | 18.6% 10.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 5/31 (16%) 7/84 (8%) |
|FIRST INCIDENCE (DAYS) | 704 601 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.195N |
|INCIDENTAL TUMOR | P=0.205N |
|LOGISTIC REGRESSION | P=0.203N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.141N |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05145 TEST: 01 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) |
| Papilloma Squamous or Papilloma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 2/60 (3%) 0/180 (0%) |
|ADJUSTED (b) | 6.5% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 2/31 (6%) 0/84 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.062N |
|INCIDENTAL TUMOR | P=0.062N |
|LOGISTIC REGRESSION | P=0.062N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.062N |
|==============================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 2/60 (3%) 1/180 (1%) |
|ADJUSTED (b) | 6.5% 1.2% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 2/31 (6%) 1/84 (1%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.182N |
|INCIDENTAL TUMOR | P=0.182N |
|LOGISTIC REGRESSION | P=0.182N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.155N |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05145 TEST: 01 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Pancreas |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/59 (3%) 38/175 (22%) |
|ADJUSTED (b) | 6.7% 41.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/27 (4%) |
|TERMINAL (d) | 2/30 (7%) 33/84 (39%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 464 (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 ** |
|==============================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 8/60 (13%) 17/174 (10%) |
|ADJUSTED (b) | 21.7% 18.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 4/31 (13%) 13/82 (16%) |
|FIRST INCIDENCE (DAYS) | 593 518 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.389N |
|INCIDENTAL TUMOR | P=0.375N |
|LOGISTIC REGRESSION | P=0.404N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.291N |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05145 TEST: 01 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 2/60 (3%) 4/180 (2%) |
|ADJUSTED (b) | 6.5% 4.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 2/31 (6%) 3/84 (4%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 687 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.547N |
|INCIDENTAL TUMOR | P=0.563N |
|LOGISTIC REGRESSION | P=0.553N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.467N |
|==============================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 4/60 (7%) 5/180 (3%) |
|ADJUSTED (b) | 12.2% 5.2% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 3/31 (10%) 2/84 (2%) |
|FIRST INCIDENCE (DAYS) | 691 628 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.218N |
|INCIDENTAL TUMOR | P=0.241N |
|LOGISTIC REGRESSION | P=0.214N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.162N |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05145 TEST: 01 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Skin |
| Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, |
| Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 7/60 (12%) 9/180 (5%) |
|ADJUSTED (b) | 21.6% 9.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 6/31 (19%) 5/84 (6%) |
|FIRST INCIDENCE (DAYS) | 691 628 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.108N |
|INCIDENTAL TUMOR | P=0.124N |
|LOGISTIC REGRESSION | P=0.108N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.072N |
|==============================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibroma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 3/60 (5%) 7/180 (4%) |
|ADJUSTED (b) | 8.1% 7.2% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/27 (0%) |
|TERMINAL (d) | 2/31 (6%) 4/84 (5%) |
|FIRST INCIDENCE (DAYS) | 463 (I) 446 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.555N |
|INCIDENTAL TUMOR | P=0.484N |
|LOGISTIC REGRESSION | P=0.532N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.476N |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05145 TEST: 01 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibroma or Fibroma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 3/60 (5%) 8/180 (4%) |
|ADJUSTED (b) | 8.1% 8.3% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/27 (0%) |
|TERMINAL (d) | 2/31 (6%) 5/84 (6%) |
|FIRST INCIDENCE (DAYS) | 463 (I) 446 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.625N |
|INCIDENTAL TUMOR | P=0.562N |
|LOGISTIC REGRESSION | P=0.609N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.548N |
|==============================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, Sarcoma, |
| Neurofibroma, or Fibroma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 3/60 (5%) 12/180 (7%) |
|ADJUSTED (b) | 8.1% 11.6% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/27 (0%) |
|TERMINAL (d) | 2/31 (6%) 5/84 (6%) |
|FIRST INCIDENCE (DAYS) | 463 (I) 386 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.372 |
|INCIDENTAL TUMOR | P=0.461 |
|LOGISTIC REGRESSION | P=0.416 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.457 |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05145 TEST: 01 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, or Sarcoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 4/180 (2%) |
|ADJUSTED (b) | 0.0% 3.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 0/31 (0%) 0/84 (0%) |
|FIRST INCIDENCE (DAYS) | --- 386 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.253 |
|INCIDENTAL TUMOR | P=0.296 |
|LOGISTIC REGRESSION | P=0.297 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.314 |
|==============================================================================|
| |
|Skin: Subcutaneous Tissue |
| Sarcoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 3/180 (2%) |
|ADJUSTED (b) | 0.0% 2.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 0/31 (0%) 0/84 (0%) |
|FIRST INCIDENCE (DAYS) | --- 386 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.337 |
|INCIDENTAL TUMOR | P=0.431 |
|LOGISTIC REGRESSION | P=0.416 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.420 |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05145 TEST: 01 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 13/180 (7%) |
|ADJUSTED (b) | 0.0% 14.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 0/31 (0%) 11/84 (13%) |
|FIRST INCIDENCE (DAYS) | --- 623 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.025 * |
|INCIDENTAL TUMOR | P=0.026 * |
|LOGISTIC REGRESSION | P=0.023 * |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.021 * |
|==============================================================================|
| |
|Testes |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 57/59 (97%) 161/179 (90%) |
|ADJUSTED (b) | 100.0% 99.4% |
|INTERIM SACRIFICE 1 (c)| 9/10 (90%) 25/27 (93%) |
|TERMINAL (d) | 30/30 (100%) 83/84 (99%) |
|FIRST INCIDENCE (DAYS) | 390 322 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.400 |
|INCIDENTAL TUMOR | P=0.525N |
|LOGISTIC REGRESSION | P=0.475N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.085N |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05145 TEST: 01 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 6/57 (11%) 18/169 (11%) |
|ADJUSTED (b) | 19.8% 19.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/27 (4%) |
|TERMINAL (d) | 5/29 (17%) 13/83 (16%) |
|FIRST INCIDENCE (DAYS) | 707 463 (I) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.537 |
|INCIDENTAL TUMOR | P=0.483 |
|LOGISTIC REGRESSION | P=0.498 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.600 |
|==============================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 6/57 (11%) 19/169 (11%) |
|ADJUSTED (b) | 19.8% 20.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/27 (4%) |
|TERMINAL (d) | 5/29 (17%) 14/83 (17%) |
|FIRST INCIDENCE (DAYS) | 707 463 (I) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.486 |
|INCIDENTAL TUMOR | P=0.434 |
|LOGISTIC REGRESSION | P=0.445 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.550 |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05145 TEST: 01 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/57 (0%) 3/169 (2%) |
|ADJUSTED (b) | 0.0% 3.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 0/29 (0%) 2/83 (2%) |
|FIRST INCIDENCE (DAYS) | --- 698 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.350 |
|INCIDENTAL TUMOR | P=0.317 |
|LOGISTIC REGRESSION | P=0.341 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.416 |
|==============================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/57 (0%) 4/169 (2%) |
|ADJUSTED (b) | 0.0% 4.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 0/29 (0%) 3/83 (4%) |
|FIRST INCIDENCE (DAYS) | --- 698 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.264 |
|INCIDENTAL TUMOR | P=0.239 |
|LOGISTIC REGRESSION | P=0.254 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.310 |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05145 TEST: 01 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|Tongue |
| Squamous Cell Papilloma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 2/60 (3%) 0/180 (0%) |
|ADJUSTED (b) | 6.5% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 2/31 (6%) 0/84 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.062N |
|INCIDENTAL TUMOR | P=0.062N |
|LOGISTIC REGRESSION | P=0.062N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.062N |
|==============================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, |
| or Undifferentiated |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 23/60 (38%) 61/180 (34%) |
|ADJUSTED (b) | 54.9% 55.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 2/27 (7%) |
|TERMINAL (d) | 13/31 (42%) 37/84 (44%) |
|FIRST INCIDENCE (DAYS) | 593 446 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.546N |
|INCIDENTAL TUMOR | P=0.558N |
|LOGISTIC REGRESSION | P=0.518 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.318N |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05145 TEST: 01 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|All Organs |
| Malignant Lymphoma And Histiocytic Sarcoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 2/180 (1%) |
|ADJUSTED (b) | 0.0% 2.2% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 0/31 (0%) 1/84 (1%) |
|FIRST INCIDENCE (DAYS) | --- 686 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.470 |
|INCIDENTAL TUMOR | P=0.443 |
|LOGISTIC REGRESSION | P=0.469 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.562 |
|==============================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 2/180 (1%) |
|ADJUSTED (b) | 0.0% 2.2% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 0/31 (0%) 1/84 (1%) |
|FIRST INCIDENCE (DAYS) | --- 686 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.470 |
|INCIDENTAL TUMOR | P=0.443 |
|LOGISTIC REGRESSION | P=0.469 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.562 |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05145 TEST: 01 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|All Organs |
| Mesothelioma Benign, Malignant, NOS |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 5/60 (8%) 7/180 (4%) |
|ADJUSTED (b) | 11.9% 7.6% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/27 (0%) |
|TERMINAL (d) | 2/31 (6%) 4/84 (5%) |
|FIRST INCIDENCE (DAYS) | 390 593 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.211N |
|INCIDENTAL TUMOR | P=0.182N |
|LOGISTIC REGRESSION | P=0.176N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.152N |
|==============================================================================|
| |
|All Organs |
| Osteosarcoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 2/180 (1%) |
|ADJUSTED (b) | 0.0% 2.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 0/31 (0%) 1/84 (1%) |
|FIRST INCIDENCE (DAYS) | --- 569 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.470 |
|INCIDENTAL TUMOR | P=0.487 |
|LOGISTIC REGRESSION | P=0.487 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.562 |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05145 TEST: 01 PAGE 21
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|All Organs |
| Osteosarcoma or Osteoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 2/180 (1%) |
|ADJUSTED (b) | 0.0% 2.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/27 (0%) |
|TERMINAL (d) | 0/31 (0%) 1/84 (1%) |
|FIRST INCIDENCE (DAYS) | --- 569 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.470 |
|INCIDENTAL TUMOR | P=0.487 |
|LOGISTIC REGRESSION | P=0.487 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.562 |
|==============================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 57/60 (95%) 162/180 (90%) |
|ADJUSTED (b) | 98.3% 100.0% |
|INTERIM SACRIFICE 1 (c)| 9/10 (90%) 25/27 (93%) |
|TERMINAL (d) | 30/31 (97%) 84/84 (100%) |
|FIRST INCIDENCE (DAYS) | 390 322 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.305 |
|INCIDENTAL TUMOR | P=0.482 |
|LOGISTIC REGRESSION | P=0.482 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.180N |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05145 TEST: 01 PAGE 22
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 ML/KG 10.0 |
| | ML/KG |
|==============================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 34/60 (57%) 85/180 (47%) |
|ADJUSTED (b) | 71.7% 66.9% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 2/27 (7%) |
|TERMINAL (d) | 18/31 (58%) 44/84 (52%) |
|FIRST INCIDENCE (DAYS) | 390 324 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.400N |
|INCIDENTAL TUMOR | P=0.252N |
|LOGISTIC REGRESSION | P=0.347N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.132N |
|==============================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 58/60 (97%) 165/180 (92%) |
|ADJUSTED (b) | 100.0% 100.0% |
|INTERIM SACRIFICE 1 (c)| 9/10 (90%) 25/27 (93%) |
|TERMINAL (d) | 31/31 (100%) 84/84 (100%) |
|FIRST INCIDENCE (DAYS) | 390 322 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.300 |
|INCIDENTAL TUMOR | P=0.583 |
|LOGISTIC REGRESSION | P=0.540 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.154N |
|==============================================================================|
DATE: 09/17/94 EXPERIMENT: 05145 TEST: 01 PAGE 23
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- TRICAPRYLIN
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.
(c) Observed incidence at interim kill.
Male interim sacrifices(days): 463
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).