TDMS Study 05099-07 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst SALICYLAZOSULFAPYRIDINE DATE: 04/10/95
EXPERIMENT: 05099 TEST: 07 TIME: 09:00:10
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-85233 ROUTE: GAVAGE NTP C#: 61552B
PATHOLOGIST: DR J. HEATH CAS: 599-79-1
------------------------------------------------------------------------------------------------------------------------------------
STOP COMPARISON 2 YEAR CORE
REASONS FOR REMOVAL: 25018 Dosing Accident
25019 Moribund Sacrifice
25020 Natural Death
25021 Terminal Sacrifice
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 0 MG/KG
INCLUDE 009 337.5 STOP
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst SALICYLAZOSULFAPYRIDINE DATE: 04/10/95
EXPERIMENT: 05099 TEST: 07 TIME: 09:00:10
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
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
Clitoral/Preputial Gland
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: 04/10/95
EXPERIMENT: 05099 TEST: 07 TIME: 09:00:10
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
Pancreas Adenoma
Carcinoma or Adenoma
Testes Adenoma
All Organs Benign Tumors
====================================================================================================
DATE: 04/10/95 EXPERIMENT: 05099 TEST: 07 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 337.5 |
| | STOP |
|==============================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 6.7% |
|TERMINAL (d) | 0/35 (0%) 2/30 (7%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.205 |
|INCIDENTAL TUMOR | P=0.205 |
|LOGISTIC REGRESSION | P=0.205 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.247 |
|==============================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 15/50 (30%) 4/50 (8%) |
|ADJUSTED (b) | 38.2% 13.3% |
|TERMINAL (d) | 11/35 (31%) 4/30 (13%) |
|FIRST INCIDENCE (DAYS) | 653 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.016N* |
|INCIDENTAL TUMOR | P=0.016N* |
|LOGISTIC REGRESSION | P=0.015N* |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.005N** |
|==============================================================================|
DATE: 04/10/95 EXPERIMENT: 05099 TEST: 07 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 337.5 |
| | STOP |
|==============================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 6.5% |
|TERMINAL (d) | 0/35 (0%) 1/30 (3%) |
|FIRST INCIDENCE (DAYS) | --- 704 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.199 |
|INCIDENTAL TUMOR | P=0.188 |
|LOGISTIC REGRESSION | P=0.199 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.247 |
|==============================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 16/50 (32%) 6/50 (12%) |
|ADJUSTED (b) | 39.8% 19.4% |
|TERMINAL (d) | 11/35 (31%) 5/30 (17%) |
|FIRST INCIDENCE (DAYS) | 653 704 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.048N* |
|INCIDENTAL TUMOR | P=0.042N* |
|LOGISTIC REGRESSION | P=0.039N* |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.014N* |
|==============================================================================|
DATE: 04/10/95 EXPERIMENT: 05099 TEST: 07 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 337.5 |
| | STOP |
|==============================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 5/50 (10%) |
|ADJUSTED (b) | 2.5% 16.7% |
|TERMINAL (d) | 0/35 (0%) 5/30 (17%) |
|FIRST INCIDENCE (DAYS) | 684 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.072 |
|INCIDENTAL TUMOR | P=0.067 |
|LOGISTIC REGRESSION | P=0.064 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.102 |
|==============================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) |
|ADJUSTED (b) | 5.3% 5.5% |
|TERMINAL (d) | 1/35 (3%) 1/30 (3%) |
|FIRST INCIDENCE (DAYS) | 708 383 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.633 |
|INCIDENTAL TUMOR | P=0.672 |
|LOGISTIC REGRESSION | P=0.681N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.691N |
|==============================================================================|
DATE: 04/10/95 EXPERIMENT: 05099 TEST: 07 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 337.5 |
| | STOP |
|==============================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 7/50 (14%) |
|ADJUSTED (b) | 7.7% 21.8% |
|TERMINAL (d) | 1/35 (3%) 6/30 (20%) |
|FIRST INCIDENCE (DAYS) | 684 383 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.106 |
|INCIDENTAL TUMOR | P=0.111 |
|LOGISTIC REGRESSION | P=0.122 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.159 |
|==============================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/49 (0%) |
|ADJUSTED (b) | 5.3% 0.0% |
|TERMINAL (d) | 1/35 (3%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | 684 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.279N |
|INCIDENTAL TUMOR | P=0.295N |
|LOGISTIC REGRESSION | P=0.269N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.253N |
|==============================================================================|
DATE: 04/10/95 EXPERIMENT: 05099 TEST: 07 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 337.5 |
| | STOP |
|==============================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 0/49 (0%) |
|ADJUSTED (b) | 8.1% 0.0% |
|TERMINAL (d) | 2/35 (6%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | 684 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.154N |
|INCIDENTAL TUMOR | P=0.163N |
|LOGISTIC REGRESSION | P=0.150N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.125N |
|==============================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 5.6% 0.0% |
|TERMINAL (d) | 1/35 (3%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | 726 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.277N |
|INCIDENTAL TUMOR | P=0.295N |
|LOGISTIC REGRESSION | P=0.283N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.247N |
|==============================================================================|
DATE: 04/10/95 EXPERIMENT: 05099 TEST: 07 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 337.5 |
| | STOP |
|==============================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 5.7% 0.0% |
|TERMINAL (d) | 2/35 (6%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.273N |
|INCIDENTAL TUMOR | P=0.273N |
|LOGISTIC REGRESSION | P=0.273N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.247N |
|==============================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 6.7% |
|TERMINAL (d) | 0/35 (0%) 2/30 (7%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.205 |
|INCIDENTAL TUMOR | P=0.205 |
|LOGISTIC REGRESSION | P=0.205 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.247 |
|==============================================================================|
DATE: 04/10/95 EXPERIMENT: 05099 TEST: 07 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 337.5 |
| | STOP |
|==============================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) |
|ADJUSTED (b) | 5.7% 6.7% |
|TERMINAL (d) | 2/35 (6%) 2/30 (7%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.639 |
|INCIDENTAL TUMOR | P=0.639 |
|LOGISTIC REGRESSION | P=0.639 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.691N |
|==============================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) |
|ADJUSTED (b) | 8.6% 12.1% |
|TERMINAL (d) | 3/35 (9%) 2/30 (7%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 644 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.414 |
|INCIDENTAL TUMOR | P=0.437 |
|LOGISTIC REGRESSION | P=0.412 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.500 |
|==============================================================================|
DATE: 04/10/95 EXPERIMENT: 05099 TEST: 07 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 337.5 |
| | STOP |
|==============================================================================|
| |
|Pancreas |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 12/50 (24%) 4/48 (8%) |
|ADJUSTED (b) | 31.4% 12.8% |
|TERMINAL (d) | 9/35 (26%) 3/30 (10%) |
|FIRST INCIDENCE (DAYS) | 684 696 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.064N |
|INCIDENTAL TUMOR | P=0.065N |
|LOGISTIC REGRESSION | P=0.062N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.033N* |
|==============================================================================|
| |
|Pancreas |
| Carcinoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 13/50 (26%) 4/48 (8%) |
|ADJUSTED (b) | 34.1% 12.8% |
|TERMINAL (d) | 10/35 (29%) 3/30 (10%) |
|FIRST INCIDENCE (DAYS) | 684 696 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.041N* |
|INCIDENTAL TUMOR | P=0.041N* |
|LOGISTIC REGRESSION | P=0.040N* |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.019N* |
|==============================================================================|
DATE: 04/10/95 EXPERIMENT: 05099 TEST: 07 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 337.5 |
| | STOP |
|==============================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 14/50 (28%) 18/49 (37%) |
|ADJUSTED (b) | 34.3% 46.4% |
|TERMINAL (d) | 9/35 (26%) 10/30 (33%) |
|FIRST INCIDENCE (DAYS) | 473 423 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.140 |
|INCIDENTAL TUMOR | P=0.160 |
|LOGISTIC REGRESSION | P=0.177 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.238 |
|==============================================================================|
| |
|Skin |
| Basal Cell Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 5.4% 0.0% |
|TERMINAL (d) | 1/35 (3%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | 717 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.284N |
|INCIDENTAL TUMOR | P=0.295N |
|LOGISTIC REGRESSION | P=0.280N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.247N |
|==============================================================================|
DATE: 04/10/95 EXPERIMENT: 05099 TEST: 07 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 337.5 |
| | STOP |
|==============================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal |
| Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoep|thelioma
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 6/50 (12%) 4/50 (8%) |
|ADJUSTED (b) | 16.5% 13.3% |
|TERMINAL (d) | 5/35 (14%) 4/30 (13%) |
|FIRST INCIDENCE (DAYS) | 717 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.474N |
|INCIDENTAL TUMOR | P=0.481N |
|LOGISTIC REGRESSION | P=0.502N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.370N |
|==============================================================================|
| |
|Skin |
| Fibroma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 2/50 (4%) 6/50 (12%) |
|ADJUSTED (b) | 5.7% 19.3% |
|TERMINAL (d) | 2/35 (6%) 5/30 (17%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 696 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.089 |
|INCIDENTAL TUMOR | P=0.085 |
|LOGISTIC REGRESSION | P=0.077 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.134 |
|==============================================================================|
DATE: 04/10/95 EXPERIMENT: 05099 TEST: 07 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 337.5 |
| | STOP |
|==============================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) |
|ADJUSTED (b) | 8.6% 10.0% |
|TERMINAL (d) | 3/35 (9%) 3/30 (10%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.591 |
|INCIDENTAL TUMOR | P=0.591 |
|LOGISTIC REGRESSION | P=0.591 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.661N |
|==============================================================================|
| |
|Skin |
| Neurofibrosarcoma, Neurofibroma, or Schwannoma (benign, malignant or NOS)|
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) |
|ADJUSTED (b) | 0.0% 7.9% |
|TERMINAL (d) | 0/35 (0%) 1/30 (3%) |
|FIRST INCIDENCE (DAYS) | --- 423 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.103 |
|INCIDENTAL TUMOR | P=0.154 |
|LOGISTIC REGRESSION | P=0.156 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.121 |
|==============================================================================|
DATE: 04/10/95 EXPERIMENT: 05099 TEST: 07 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 337.5 |
| | STOP |
|==============================================================================|
| |
|Skin |
| Schwannoma Malignant |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 5.8% |
|TERMINAL (d) | 0/35 (0%) 1/30 (3%) |
|FIRST INCIDENCE (DAYS) | --- 542 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.210 |
|INCIDENTAL TUMOR | P=0.265 |
|LOGISTIC REGRESSION | P=0.244 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.247 |
|==============================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacan|homa
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 4/50 (8%) 4/50 (8%) |
|ADJUSTED (b) | 11.4% 13.3% |
|TERMINAL (d) | 4/35 (11%) 4/30 (13%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.557 |
|INCIDENTAL TUMOR | P=0.557 |
|LOGISTIC REGRESSION | P=0.557 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.643N |
|==============================================================================|
DATE: 04/10/95 EXPERIMENT: 05099 TEST: 07 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 337.5 |
| | STOP |
|==============================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 4/50 (8%) 4/50 (8%) |
|ADJUSTED (b) | 11.4% 13.3% |
|TERMINAL (d) | 4/35 (11%) 4/30 (13%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.557 |
|INCIDENTAL TUMOR | P=0.557 |
|LOGISTIC REGRESSION | P=0.557 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.643N |
|==============================================================================|
| |
|Testes |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 45/50 (90%) 37/50 (74%) |
|ADJUSTED (b) | 97.8% 97.3% |
|TERMINAL (d) | 34/35 (97%) 29/30 (97%) |
|FIRST INCIDENCE (DAYS) | 477 423 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.466N |
|INCIDENTAL TUMOR | P=0.238N |
|LOGISTIC REGRESSION | P=0.308N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.033N* |
|==============================================================================|
DATE: 04/10/95 EXPERIMENT: 05099 TEST: 07 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 337.5 |
| | STOP |
|==============================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) |
|ADJUSTED (b) | 8.6% 12.3% |
|TERMINAL (d) | 3/35 (9%) 2/30 (7%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 648 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.409 |
|INCIDENTAL TUMOR | P=0.389 |
|LOGISTIC REGRESSION | P=0.410 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.500 |
|==============================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) |
|ADJUSTED (b) | 5.7% 6.7% |
|TERMINAL (d) | 2/35 (6%) 2/30 (7%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.639 |
|INCIDENTAL TUMOR | P=0.639 |
|LOGISTIC REGRESSION | P=0.639 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.691N |
|==============================================================================|
DATE: 04/10/95 EXPERIMENT: 05099 TEST: 07 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 337.5 |
| | STOP |
|==============================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 5/50 (10%) 6/50 (12%) |
|ADJUSTED (b) | 14.3% 18.5% |
|TERMINAL (d) | 5/35 (14%) 4/30 (13%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 648 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.387 |
|INCIDENTAL TUMOR | P=0.370 |
|LOGISTIC REGRESSION | P=0.373 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.500 |
|==============================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) |
|ADJUSTED (b) | 11.4% 0.0% |
|TERMINAL (d) | 4/35 (11%) 0/30 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.083N |
|INCIDENTAL TUMOR | P=0.083N |
|LOGISTIC REGRESSION | P=0.083N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.059N |
|==============================================================================|
DATE: 04/10/95 EXPERIMENT: 05099 TEST: 07 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 337.5 |
| | STOP |
|==============================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) |
|ADJUSTED (b) | 2.9% 6.7% |
|TERMINAL (d) | 1/35 (3%) 2/30 (7%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.446 |
|INCIDENTAL TUMOR | P=0.446 |
|LOGISTIC REGRESSION | P=0.446 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.500 |
|==============================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 5/50 (10%) 2/50 (4%) |
|ADJUSTED (b) | 14.3% 6.7% |
|TERMINAL (d) | 5/35 (14%) 2/30 (7%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.280N |
|INCIDENTAL TUMOR | P=0.280N |
|LOGISTIC REGRESSION | P=0.280N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.218N |
|==============================================================================|
DATE: 04/10/95 EXPERIMENT: 05099 TEST: 07 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 337.5 |
| | STOP |
|==============================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 13/50 (26%) 10/50 (20%) |
|ADJUSTED (b) | 32.0% 30.9% |
|TERMINAL (d) | 8/35 (23%) 8/30 (27%) |
|FIRST INCIDENCE (DAYS) | 477 648 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.492N |
|INCIDENTAL TUMOR | P=0.473N |
|LOGISTIC REGRESSION | P=0.468N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.318N |
|==============================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) |
|ADJUSTED (b) | 2.9% 6.7% |
|TERMINAL (d) | 1/35 (3%) 2/30 (7%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.446 |
|INCIDENTAL TUMOR | P=0.446 |
|LOGISTIC REGRESSION | P=0.446 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.500 |
|==============================================================================|
DATE: 04/10/95 EXPERIMENT: 05099 TEST: 07 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 337.5 |
| | STOP |
|==============================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 49/50 (98%) 42/50 (84%) |
|ADJUSTED (b) | 100.0% 100.0% |
|TERMINAL (d) | 35/35 (100%) 30/30 (100%) |
|FIRST INCIDENCE (DAYS) | 473 423 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.552 |
|INCIDENTAL TUMOR | P=0.175N |
|LOGISTIC REGRESSION | P=0.329N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.015N* |
|==============================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 23/50 (46%) 21/50 (42%) |
|ADJUSTED (b) | 49.9% 55.7% |
|TERMINAL (d) | 12/35 (34%) 14/30 (47%) |
|FIRST INCIDENCE (DAYS) | 477 361 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.459 |
|INCIDENTAL TUMOR | P=0.560N |
|LOGISTIC REGRESSION | P=0.525N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.420N |
|==============================================================================|
DATE: 04/10/95 EXPERIMENT: 05099 TEST: 07 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG 337.5 |
| | STOP |
|==============================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 49/50 (98%) 46/50 (92%) |
|ADJUSTED (b) | 100.0% 100.0% |
|TERMINAL (d) | 35/35 (100%) 30/30 (100%) |
|FIRST INCIDENCE (DAYS) | 473 361 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.259 |
|INCIDENTAL TUMOR | P=0.814 |
|LOGISTIC REGRESSION | P=0.814 |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.181N |
|==============================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for
intercurrent mortality.
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death. The incidental tumor
test regards these lesions as non-fatal. Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fisher's exact tests compare directly the overall incidence rates.
For all tests, a negative trend is indicated by "N".
(e) Value of Statistic cannot be computed.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).