TDMS Study 05099-98 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: SOUTHERN RESEARCH INST SALICYLAZOSULFAPYRIDINE DATE: 05/10/95
EXPERIMENT: 05099 TEST: 98 TIME: 15:32:13
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85233 ROUTE: GAVAGE NTP C#: 61552B
PATHOLOGIST: DR J. HEATH CAS: 599-79-1
05099/07 -VS- 05099/09 COMPARISON
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: SOUTHERN RESEARCH INST SALICYLAZOSULFAPYRIDINE DATE: 05/10/95
EXPERIMENT: 05099 TEST: 98 TIME: 15:32:13
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85233 ROUTE: GAVAGE NTP C#: 61552B
PATHOLOGIST: DR J. HEATH CAS: 599-79-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF SALICYLAZOSULFAPYRIDINE
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
All Organs Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
Pancreas Adenoma
Carcinoma or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Skin Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,
Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma
Testes Adenoma
Thyroid Gland: C-Cell Carcinoma or Adenoma
Thyroid Gland: Follicular Cell
Carcinoma or Adenoma
====================================================================================================
DATE: 05/11/95 EXPERIMENT: 05099 TEST: 98 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 0 MG/KG |
| | AD LIB RTD |
|==============================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 15/50 (30%) 8/50 (16%) |
|ADJUSTED (b) | 38.2% 22.8% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 11/35 (31%) 0/0 |
|FIRST INCIDENCE (DAYS) | 653 700 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.371N |
|INCIDENTAL TUMOR | P=0.152N |
|LOGISTIC REGRESSION | P<0.001N** |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.077N |
|==============================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 6.1% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 0/35 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) |
|INCIDENTAL TUMOR | (e) (e) |
|LOGISTIC REGRESSION | (e) (e) |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.247 |
|==============================================================================|
DATE: 05/11/95 EXPERIMENT: 05099 TEST: 98 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 0 MG/KG |
| | AD LIB RTD |
|==============================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 16/50 (32%) 9/50 (18%) |
|ADJUSTED (b) | 39.8% 25.7% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 11/35 (31%) 0/0 |
|FIRST INCIDENCE (DAYS) | 653 700 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.255N |
|INCIDENTAL TUMOR | P=0.058N |
|LOGISTIC REGRESSION | P<0.001N** |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.083N |
|==============================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) |
|ADJUSTED (b) | 2.5% 9.1% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 0/35 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 684 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.510N |
|INCIDENTAL TUMOR | P=0.429N |
|LOGISTIC REGRESSION | P=0.503N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.309 |
|==============================================================================|
DATE: 05/11/95 EXPERIMENT: 05099 TEST: 98 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 0 MG/KG |
| | AD LIB RTD |
|==============================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 5.3% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 1/35 (3%) 0/0 |
|FIRST INCIDENCE (DAYS) | 708 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.527N |
|INCIDENTAL TUMOR | P=0.429N |
|LOGISTIC REGRESSION | P=0.236N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.247N |
|==============================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) |
|ADJUSTED (b) | 7.7% 9.1% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 1/35 (3%) 0/0 |
|FIRST INCIDENCE (DAYS) | 684 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.261N |
|INCIDENTAL TUMOR | P=0.158N |
|LOGISTIC REGRESSION | P=0.118N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.661N |
|==============================================================================|
DATE: 05/11/95 EXPERIMENT: 05099 TEST: 98 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 0 MG/KG |
| | AD LIB RTD |
|==============================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) |
|ADJUSTED (b) | 5.3% 3.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 1/35 (3%) 0/0 |
|FIRST INCIDENCE (DAYS) | 684 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.510N |
|INCIDENTAL TUMOR | P=0.429N |
|LOGISTIC REGRESSION | P=0.235N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.500N |
|==============================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) |
|ADJUSTED (b) | 8.1% 3.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 2/35 (6%) 0/0 |
|FIRST INCIDENCE (DAYS) | 684 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.510N |
|INCIDENTAL TUMOR | P=0.429N |
|LOGISTIC REGRESSION | P=0.118N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.309N |
|==============================================================================|
DATE: 05/11/95 EXPERIMENT: 05099 TEST: 98 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 0 MG/KG |
| | AD LIB RTD |
|==============================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) |
|ADJUSTED (b) | 5.6% 2.8% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 1/35 (3%) 0/0 |
|FIRST INCIDENCE (DAYS) | 726 700 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.742 |
|INCIDENTAL TUMOR | P=0.684N |
|LOGISTIC REGRESSION | P=0.499N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.500N |
|==============================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) |
|ADJUSTED (b) | 5.7% 6.1% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 2/35 (6%) 0/0 |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) |
|INCIDENTAL TUMOR | (e) (e) |
|LOGISTIC REGRESSION | P=0.235N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.691N |
|==============================================================================|
DATE: 05/11/95 EXPERIMENT: 05099 TEST: 98 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 0 MG/KG |
| | AD LIB RTD |
|==============================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) |
|ADJUSTED (b) | 8.6% 6.1% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 3/35 (9%) 0/0 |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) |
|INCIDENTAL TUMOR | (e) (e) |
|LOGISTIC REGRESSION | P=0.118N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.500N |
|==============================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Papilloma Squamous or Papilloma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 4.6% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 0/35 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 627 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.247 |
|INCIDENTAL TUMOR | P=0.313 |
|LOGISTIC REGRESSION | P=0.212 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.247 |
|==============================================================================|
DATE: 05/11/95 EXPERIMENT: 05099 TEST: 98 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 0 MG/KG |
| | AD LIB RTD |
|==============================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) |
|ADJUSTED (b) | 0.0% 6.8% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 0/35 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 627 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.130 |
|INCIDENTAL TUMOR | P=0.184 |
|LOGISTIC REGRESSION | P=0.099 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.121 |
|==============================================================================|
| |
|Pancreas |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 12/50 (24%) 5/50 (10%) |
|ADJUSTED (b) | 31.4% 13.9% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 9/35 (26%) 0/0 |
|FIRST INCIDENCE (DAYS) | 684 667 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.527N |
|INCIDENTAL TUMOR | P=0.322N |
|LOGISTIC REGRESSION | P=0.004N** |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.054N |
|==============================================================================|
DATE: 05/11/95 EXPERIMENT: 05099 TEST: 98 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 0 MG/KG |
| | AD LIB RTD |
|==============================================================================|
| |
|Pancreas |
| Carcinoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 13/50 (26%) 5/50 (10%) |
|ADJUSTED (b) | 34.1% 13.9% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 10/35 (29%) 0/0 |
|FIRST INCIDENCE (DAYS) | 684 667 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.527N |
|INCIDENTAL TUMOR | P=0.322N |
|LOGISTIC REGRESSION | P=0.002N** |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.033N* |
|==============================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 14/50 (28%) 13/50 (26%) |
|ADJUSTED (b) | 34.3% 31.9% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 9/35 (26%) 0/0 |
|FIRST INCIDENCE (DAYS) | 473 520 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.491 |
|INCIDENTAL TUMOR | P=0.614N |
|LOGISTIC REGRESSION | P=0.045N* |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.500N |
|==============================================================================|
DATE: 05/11/95 EXPERIMENT: 05099 TEST: 98 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 0 MG/KG |
| | AD LIB RTD |
|==============================================================================|
| |
|Skin |
| Basal Cell Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) |
|ADJUSTED (b) | 5.4% 3.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 1/35 (3%) 0/0 |
|FIRST INCIDENCE (DAYS) | 717 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.522N |
|INCIDENTAL TUMOR | P=0.429N |
|LOGISTIC REGRESSION | P=0.239N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.500N |
|==============================================================================|
| |
|Skin |
| Fibroma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) |
|ADJUSTED (b) | 5.7% 5.1% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 2/35 (6%) 0/0 |
|FIRST INCIDENCE (DAYS) | 729 (T) 597 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.513 |
|INCIDENTAL TUMOR | P=0.557 |
|LOGISTIC REGRESSION | P=0.504N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.691N |
|==============================================================================|
DATE: 05/11/95 EXPERIMENT: 05099 TEST: 98 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 0 MG/KG |
| | AD LIB RTD |
|==============================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) |
|ADJUSTED (b) | 8.6% 3.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 3/35 (9%) 0/0 |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) |
|INCIDENTAL TUMOR | (e) (e) |
|LOGISTIC REGRESSION | P=0.118N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.309N |
|==============================================================================|
| |
|Skin |
| Trichoepithelioma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 6.1% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 0/35 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) |
|INCIDENTAL TUMOR | (e) (e) |
|LOGISTIC REGRESSION | (e) (e) |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.247 |
|==============================================================================|
DATE: 05/11/95 EXPERIMENT: 05099 TEST: 98 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 0 MG/KG |
| | AD LIB RTD |
|==============================================================================|
| |
|Skin |
| Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) |
|ADJUSTED (b) | 5.4% 9.1% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 1/35 (3%) 0/0 |
|FIRST INCIDENCE (DAYS) | 717 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.522N |
|INCIDENTAL TUMOR | P=0.429N |
|LOGISTIC REGRESSION | P=0.239N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.500 |
|==============================================================================|
| |
|Skin |
| Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, |
| Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 6/50 (12%) 4/50 (8%) |
|ADJUSTED (b) | 16.5% 12.1% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 5/35 (14%) 0/0 |
|FIRST INCIDENCE (DAYS) | 717 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.522N |
|INCIDENTAL TUMOR | P=0.429N |
|LOGISTIC REGRESSION | P=0.019N* |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.370N |
|==============================================================================|
DATE: 05/11/95 EXPERIMENT: 05099 TEST: 98 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 0 MG/KG |
| | AD LIB RTD |
|==============================================================================|
| |
|Testes |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 45/50 (90%) 44/50 (88%) |
|ADJUSTED (b) | 97.8% 95.6% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 34/35 (97%) 0/0 |
|FIRST INCIDENCE (DAYS) | 477 520 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.400 |
|INCIDENTAL TUMOR | P=0.536N |
|LOGISTIC REGRESSION | P<0.001N** |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.500N |
|==============================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 4/49 (8%) |
|ADJUSTED (b) | 8.6% 12.1% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 3/35 (9%) 0/0 |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) |
|INCIDENTAL TUMOR | (e) (e) |
|LOGISTIC REGRESSION | P=0.118N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.489 |
|==============================================================================|
DATE: 05/11/95 EXPERIMENT: 05099 TEST: 98 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 0 MG/KG |
| | AD LIB RTD |
|==============================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/49 (0%) |
|ADJUSTED (b) | 5.7% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 2/35 (6%) 0/0 |
|FIRST INCIDENCE (DAYS) | 729 (T) --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) |
|INCIDENTAL TUMOR | (e) (e) |
|LOGISTIC REGRESSION | P=0.235N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.253N |
|==============================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 5/50 (10%) 4/49 (8%) |
|ADJUSTED (b) | 14.3% 12.1% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 5/35 (14%) 0/0 |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) |
|INCIDENTAL TUMOR | (e) (e) |
|LOGISTIC REGRESSION | P=0.031N* |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.513N |
|==============================================================================|
DATE: 05/11/95 EXPERIMENT: 05099 TEST: 98 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 0 MG/KG |
| | AD LIB RTD |
|==============================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 0/49 (0%) |
|ADJUSTED (b) | 11.4% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 4/35 (11%) 0/0 |
|FIRST INCIDENCE (DAYS) | 729 (T) --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) |
|INCIDENTAL TUMOR | (e) (e) |
|LOGISTIC REGRESSION | P=0.060N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.061N |
|==============================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 5/50 (10%) 0/49 (0%) |
|ADJUSTED (b) | 14.3% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 5/35 (14%) 0/0 |
|FIRST INCIDENCE (DAYS) | 729 (T) --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) |
|INCIDENTAL TUMOR | (e) (e) |
|LOGISTIC REGRESSION | P=0.031N* |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.030N* |
|==============================================================================|
DATE: 05/11/95 EXPERIMENT: 05099 TEST: 98 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 0 MG/KG |
| | AD LIB RTD |
|==============================================================================|
| |
|Tongue |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 4.4% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 0/35 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 627 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.250 |
|INCIDENTAL TUMOR | P=0.313 |
|LOGISTIC REGRESSION | P=0.204 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.247 |
|==============================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, |
| or Undifferentiated |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 13/50 (26%) 10/50 (20%) |
|ADJUSTED (b) | 32.0% 23.7% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 8/35 (23%) 0/0 |
|FIRST INCIDENCE (DAYS) | 477 520 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.267 |
|INCIDENTAL TUMOR | P=0.441 |
|LOGISTIC REGRESSION | P=0.167N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.318N |
|==============================================================================|
DATE: 05/11/95 EXPERIMENT: 05099 TEST: 98 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 0 MG/KG |
| | AD LIB RTD |
|==============================================================================|
| |
|All Organs |
| Mesothelioma Benign, Malignant, NOS |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) |
|ADJUSTED (b) | 2.9% 8.5% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 1/35 (3%) 0/0 |
|FIRST INCIDENCE (DAYS) | 729 (T) 682 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.495 |
|INCIDENTAL TUMOR | P=0.571 |
|LOGISTIC REGRESSION | P=0.760N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.309 |
|==============================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 49/50 (98%) 48/50 (96%) |
|ADJUSTED (b) | 100.0% 100.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 35/35 (100%) 0/0 |
|FIRST INCIDENCE (DAYS) | 473 520 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.485 |
|INCIDENTAL TUMOR | P=0.157N |
|LOGISTIC REGRESSION | P<0.001N** |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.500N |
|==============================================================================|
DATE: 05/11/95 EXPERIMENT: 05099 TEST: 98 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 0 MG/KG |
| | AD LIB RTD |
|==============================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 23/50 (46%) 17/50 (34%) |
|ADJUSTED (b) | 49.9% 38.4% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 12/35 (34%) 0/0 |
|FIRST INCIDENCE (DAYS) | 477 520 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.556 |
|INCIDENTAL TUMOR | P=0.205N |
|LOGISTIC REGRESSION | P=0.001N** |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.154N |
|==============================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 49/50 (98%) 48/50 (96%) |
|ADJUSTED (b) | 100.0% 100.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) |
|TERMINAL (d) | 35/35 (100%) 0/0 |
|FIRST INCIDENCE (DAYS) | 473 520 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.485 |
|INCIDENTAL TUMOR | P=0.157N |
|LOGISTIC REGRESSION | P<0.001N** |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.500N |
|==============================================================================|
DATE: 05/11/95 EXPERIMENT: 05099 TEST: 98 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
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): 730
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).