TDMS Study 05099-07 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst SALICYLAZOSULFAPYRIDINE DATE: 04/03/96
EXPERIMENT: 05099 TEST: 07 TIME: 19:25:38
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
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst SALICYLAZOSULFAPYRIDINE DATE: 04/03/96
EXPERIMENT: 05099 TEST: 07 TIME: 19:25:38
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 Gland
Clitoral/Preputial Gland
Epididymis
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Nose
Ovary
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: 04/03/96
EXPERIMENT: 05099 TEST: 07 TIME: 19:25:38
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
Clitoral/Preputial Gland Adenoma
Carcinoma or Adenoma
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Mammary Gland Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pancreas Carcinoma or Adenoma
Skin Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign,
malignant or NOS), or Trichoepithelioma
Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal
Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma
Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma
Testes Adenoma
Thyroid Gland: C-Cell Carcinoma or Adenoma
Urinary Bladder Papilloma
Zymbal's Gland Carcinoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst SALICYLAZOSULFAPYRIDINE DATE: 04/03/96
EXPERIMENT: 05099 TEST: 07 TIME: 19:25:38
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
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Kidney: Pelvis and Transitional Epithelium
Papilloma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Skin Squamous Cell Papilloma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/130 (0%) 0/60 (0%) 1/60 (2%) 2/130 (2%) | 1/60 (2%) 0/60 (0%) 1/60 (2%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 2.4% 3.8% | 2.9% 0.0% 3.2% 3.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/66 (0%) 0/33 (0%) 0/31 (0%) 2/53 (4%) | 1/35 (3%) 0/34 (0%) 1/31 (3%) 1/26 (4%) |
|FIRST INCIDENCE (DAYS) | --- --- 578 729 (T) | 737 (T) --- 737 (T) 737 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.087 (e) P=0.348 P=0.192 | P=0.462 P=0.506N P=0.735 P=0.694 |
|INCIDENTAL TUMOR | P=0.107 (e) P=0.433 P=0.192 | P=0.462 P=0.506N P=0.735 P=0.694 |
|LOGISTIC REGRESSION | P=0.102 (e) P=0.337 P=0.192 | P=0.462 P=0.506N P=0.735 P=0.694 |
|COCHRAN-ARMITAGE | P=0.118 | P=0.539 |
|FISHER EXACT | (e) P=0.316 P=0.249 | P=0.500N P=0.752N P=0.752N |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 24/130 (18%) 7/59 (12%) 6/60 (10%) 13/129 (10%)| 1/60 (2%) 0/60 (0%) 3/60 (5%) 0/60 (0%) |
|ADJUSTED (b) | 32.4% 21.2% 18.7% 21.1% | 2.6% 0.0% 9.7% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 1/20 (5%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 17/66 (26%) 7/33 (21%) 5/31 (16%) 8/53 (15%) | 0/35 (0%) 0/34 (0%) 3/31 (10%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 591 729 (T) 704 456 (I) | 691 --- 737 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.123N P=0.118N P=0.097N P=0.130N | P=0.581N P=0.505N P=0.283 P=0.539N |
|INCIDENTAL TUMOR | P=0.057N P=0.118N P=0.100N P=0.050N* | P=0.575N P=0.557N P=0.321 P=0.557N |
|LOGISTIC REGRESSION | P=0.074N P=0.123N P=0.091N P=0.073N | P=0.568N P=0.508N P=0.318 P=0.535N |
|COCHRAN-ARMITAGE | P=0.037N* | P=0.499N |
|FISHER EXACT | P=0.179N P=0.099N P=0.039N* | P=0.500N P=0.309 P=0.500N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/130 (1%) 0/59 (0%) 1/60 (2%) 2/129 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 1.5% 0.0% 3.2% 3.5% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/66 (2%) 0/33 (0%) 1/31 (3%) 1/53 (2%) | 0/35 (0%) 0/34 (0%) 0/31 (0%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- 729 (T) 704 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.246 P=0.638N P=0.584 P=0.431 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.285 P=0.638N P=0.584 P=0.486 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.260 P=0.638N P=0.584 P=0.447 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.313 | (e) |
|FISHER EXACT | P=0.688N P=0.533 P=0.497 | (e) (e) (e) |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 26/130 (20%) 7/59 (12%) 7/60 (12%) 15/129 (12%)| 1/60 (2%) 0/60 (0%) 3/60 (5%) 0/60 (0%) |
|ADJUSTED (b) | 34.7% 21.2% 21.8% 24.1% | 2.6% 0.0% 9.7% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 1/20 (5%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 18/66 (27%) 7/33 (21%) 6/31 (19%) 9/53 (17%) | 0/35 (0%) 0/34 (0%) 3/31 (10%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 591 729 (T) 704 456 (I) | 691 --- 737 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.166N P=0.078N P=0.110N P=0.158N | P=0.581N P=0.505N P=0.283 P=0.539N |
|INCIDENTAL TUMOR | P=0.073N P=0.075N P=0.114N P=0.054N | P=0.575N P=0.557N P=0.321 P=0.557N |
|LOGISTIC REGRESSION | P=0.101N P=0.078N P=0.102N P=0.088N | P=0.568N P=0.508N P=0.318 P=0.535N |
|COCHRAN-ARMITAGE | P=0.050N* | P=0.499N |
|FISHER EXACT | P=0.122N P=0.113N P=0.046N* | P=0.500N P=0.309 P=0.500N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Bone |
| Osteosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/130 (0%) 0/60 (0%) 0/60 (0%) 2/130 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 1.8% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/66 (0%) 0/33 (0%) 0/31 (0%) 0/53 (0%) | 0/35 (0%) 0/34 (0%) 0/31 (0%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 361 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.075 (e) (e) P=0.227 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.130 (e) (e) P=0.366 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.113 (e) (e) P=0.271 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.083 | (e) |
|FISHER EXACT | (e) (e) P=0.249 | (e) (e) (e) |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/130 (1%) 1/60 (2%) 3/60 (5%) 5/130 (4%) | 2/60 (3%) 3/60 (5%) 2/60 (3%) 2/60 (3%) |
|ADJUSTED (b) | 1.3% 3.0% 8.2% 9.4% | 5.7% 7.6% 6.5% 7.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 1/10 (10%) 0/20 (0%) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/66 (0%) 1/33 (3%) 2/31 (6%) 5/53 (9%) | 2/35 (6%) 2/34 (6%) 2/31 (6%) 2/26 (8%) |
|FIRST INCIDENCE (DAYS) | 684 729 (T) 456 (I) 729 (T) | 737 (T) 458 (I) 737 (T) 737 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.039 * P=0.591 P=0.096 P=0.065 | P=0.543 P=0.489 P=0.651 P=0.584 |
|INCIDENTAL TUMOR | P=0.046 * P=0.599 P=0.087 P=0.079 | P=0.543 P=0.489 P=0.651 P=0.584 |
|LOGISTIC REGRESSION | P=0.053 P=0.591 P=0.093 P=0.074 | P=0.584 P=0.485 P=0.652 P=0.584 |
|COCHRAN-ARMITAGE | P=0.076 | P=0.523N |
|FISHER EXACT | P=0.533 P=0.094 P=0.107 | P=0.500 P=0.691N P=0.691N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/130 (2%) 1/60 (2%) 3/60 (5%) 2/130 (2%) | 1/60 (2%) 2/60 (3%) 1/60 (2%) 0/60 (0%) |
|ADJUSTED (b) | 2.9% 1.8% 7.4% 2.8% | 2.4% 5.9% 3.2% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/66 (2%) 0/33 (0%) 0/31 (0%) 1/53 (2%) | 0/35 (0%) 2/34 (6%) 1/31 (3%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 708 424 502 383 | 663 737 (T) 737 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.493 P=0.724 P=0.189 P=0.627 | P=0.312N P=0.485 P=0.755 P=0.554N |
|INCIDENTAL TUMOR | P=0.570N P=0.721 P=0.227 P=0.682 | P=0.299N P=0.460 P=0.715N P=0.557N |
|LOGISTIC REGRESSION | P=0.567 P=0.714 P=0.191 P=0.680 | P=0.290N P=0.483 P=0.755N P=0.521N |
|COCHRAN-ARMITAGE | P=0.563 | P=0.248N |
|FISHER EXACT | P=0.682 P=0.182 P=0.689N | P=0.500 P=0.752N P=0.500N |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/130 (2%) 2/60 (3%) 6/60 (10%) 7/130 (5%) | 3/60 (5%) 5/60 (8%) 3/60 (5%) 2/60 (3%) |
|ADJUSTED (b) | 4.1% 4.8% 14.9% 12.1% | 8.0% 13.4% 9.7% 7.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 1/10 (10%) 0/20 (0%) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/66 (2%) 1/33 (3%) 2/31 (6%) 6/53 (11%) | 2/35 (6%) 4/34 (12%) 3/31 (10%) 2/26 (8%) |
|FIRST INCIDENCE (DAYS) | 684 424 456 (I) 383 | 663 458 (I) 737 (T) 737 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.072 P=0.551 P=0.030 * P=0.099 | P=0.433N P=0.341 P=0.621 P=0.631N |
|INCIDENTAL TUMOR | P=0.109 P=0.554 P=0.033 * P=0.131 | P=0.427N P=0.327 P=0.659 P=0.632N |
|LOGISTIC REGRESSION | P=0.109 P=0.541 P=0.027 * P=0.131 | P=0.387N P=0.334 P=0.645N P=0.613N |
|COCHRAN-ARMITAGE | P=0.132 | P=0.298N |
|FISHER EXACT | P=0.505 P=0.029 * P=0.167 | P=0.359 P=0.660N P=0.500N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Heart |
| Schwannoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/130 (1%) 0/60 (0%) 0/60 (0%) 3/130 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 1.5% 0.0% 0.0% 5.5% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/66 (2%) 0/33 (0%) 0/31 (0%) 2/53 (4%) | 0/35 (0%) 0/34 (0%) 0/31 (0%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- --- 718 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.095 P=0.638N P=0.651N P=0.235 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.120 P=0.638N P=0.651N P=0.277 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.100 P=0.638N P=0.651N P=0.242 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.140 | (e) |
|FISHER EXACT | P=0.684N P=0.684N P=0.311 | (e) (e) (e) |
|=================================================================================================================================|
| |
|Heart |
| Schwannoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/130 (0%) 1/60 (2%) 1/60 (2%) 0/130 (0%) | 3/60 (5%) 0/60 (0%) 0/60 (0%) 3/60 (5%) |
|ADJUSTED (b) | 0.0% 3.0% 3.2% 0.0% | 8.6% 0.0% 0.0% 11.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/66 (0%) 1/33 (3%) 1/31 (3%) 0/53 (0%) | 3/35 (9%) 0/34 (0%) 0/31 (0%) 2/26 (8%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) 729 (T) --- | 737 (T) --- --- 733 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.610N P=0.362 P=0.349 (e) | P=0.336 P=0.126N P=0.143N P=0.523 |
|INCIDENTAL TUMOR | P=0.610N P=0.362 P=0.349 (e) | P=0.344 P=0.126N P=0.143N P=0.520 |
|LOGISTIC REGRESSION | P=0.610N P=0.362 P=0.349 (e) | P=0.347 P=0.126N P=0.143N P=0.539 |
|COCHRAN-ARMITAGE | P=0.552N | P=0.443 |
|FISHER EXACT | P=0.316 P=0.316 (e) | P=0.122N P=0.122N P=0.660N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Intestine Large: Colon/Rectum |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/130 (2%) 0/60 (0%) 0/60 (0%) 0/130 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 1.9% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 1/20 (5%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/66 (0%) 0/33 (0%) 0/31 (0%) 0/53 (0%) | 0/35 (0%) 0/34 (0%) 0/31 (0%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 456 (I) --- --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.137N P=0.411N P=0.411N P=0.252N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.124N P=0.415N P=0.346N P=0.240N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.118N P=0.455N P=0.484N P=0.214N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.131N | (e) |
|FISHER EXACT | P=0.467N P=0.467N P=0.249N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/130 (3%) 3/60 (5%) 6/60 (10%) 6/129 (5%) | 1/60 (2%) 0/60 (0%) 1/60 (2%) 1/60 (2%) |
|ADJUSTED (b) | 4.9% 9.1% 17.1% 9.4% | 2.9% 0.0% 3.2% 3.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 1/20 (5%) 0/10 (0%) 0/10 (0%) 1/20 (5%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/66 (2%) 3/33 (9%) 4/31 (13%) 3/53 (6%) | 1/35 (3%) 0/34 (0%) 1/31 (3%) 1/26 (4%) |
|FIRST INCIDENCE (DAYS) | 456 (I) 729 (T) 502 456 (I) | 737 (T) --- 737 (T) 737 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.218 P=0.438 P=0.057 P=0.286 | P=0.462 P=0.506N P=0.735 P=0.694 |
|INCIDENTAL TUMOR | P=0.306 P=0.446 P=0.053 P=0.393 | P=0.462 P=0.506N P=0.735 P=0.694 |
|LOGISTIC REGRESSION | P=0.282 P=0.424 P=0.055 P=0.339 | P=0.462 P=0.506N P=0.735 P=0.694 |
|COCHRAN-ARMITAGE | P=0.334 | P=0.539 |
|FISHER EXACT | P=0.388 P=0.055 P=0.370 | P=0.500N P=0.752N P=0.752N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/130 (2%) 1/60 (2%) 0/60 (0%) 0/129 (0%) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 3.0% 3.0% 0.0% 0.0% | 0.0% 2.9% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/66 (3%) 1/33 (3%) 0/31 (0%) 0/53 (0%) | 0/35 (0%) 1/34 (3%) 0/31 (0%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) --- --- | --- 737 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.141N P=0.732 P=0.416N P=0.288N | P=0.614N P=0.494 (e) (e) |
|INCIDENTAL TUMOR | P=0.141N P=0.732 P=0.416N P=0.288N | P=0.614N P=0.494 (e) (e) |
|LOGISTIC REGRESSION | P=0.141N P=0.732 P=0.416N P=0.288N | P=0.614N P=0.494 (e) (e) |
|COCHRAN-ARMITAGE | P=0.115N | P=0.568N |
|FISHER EXACT | P=0.682 P=0.467N P=0.251N | P=0.500 (e) (e) |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/130 (5%) 4/60 (7%) 6/60 (10%) 6/129 (5%) | 1/60 (2%) 1/60 (2%) 1/60 (2%) 1/60 (2%) |
|ADJUSTED (b) | 7.8% 12.1% 17.1% 9.4% | 2.9% 2.9% 3.2% 3.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 1/20 (5%) 0/10 (0%) 0/10 (0%) 1/20 (5%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 3/66 (5%) 4/33 (12%) 4/31 (13%) 3/53 (6%) | 1/35 (3%) 1/34 (3%) 1/31 (3%) 1/26 (4%) |
|FIRST INCIDENCE (DAYS) | 456 (I) 729 (T) 502 456 (I) | 737 (T) 737 (T) 737 (T) 737 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.423 P=0.447 P=0.147 P=0.502 | P=0.550 P=0.755 P=0.735 P=0.694 |
|INCIDENTAL TUMOR | P=0.522 P=0.454 P=0.142 P=0.610 | P=0.550 P=0.755 P=0.735 P=0.694 |
|LOGISTIC REGRESSION | P=0.507 P=0.431 P=0.144 P=0.570 | P=0.550 P=0.755 P=0.735 P=0.694 |
|COCHRAN-ARMITAGE | P=0.530N | P=0.634 |
|FISHER EXACT | P=0.392 P=0.137 P=0.610 | P=0.752N P=0.752N P=0.752N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney: Pelvis and Transitional Epithelium |
| Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/130 (0%) 0/60 (0%) 0/60 (0%) 0/130 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 2/60 (3%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 7.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/66 (0%) 0/33 (0%) 0/31 (0%) 0/53 (0%) | 0/35 (0%) 0/34 (0%) 0/31 (0%) 2/26 (8%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- --- 737 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.028 * (e) (e) P=0.175 |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.028 * (e) (e) P=0.175 |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.028 * (e) (e) P=0.175 |
|COCHRAN-ARMITAGE | (e) | P=0.046 * |
|FISHER EXACT | (e) (e) (e) | (e) (e) P=0.248 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/130 (3%) 1/60 (2%) 0/60 (0%) 0/130 (0%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 0/60 (0%) |
|ADJUSTED (b) | 5.9% 1.8% 0.0% 0.0% | 0.0% 0.0% 3.2% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 1/10 (10%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 3/66 (5%) 0/33 (0%) 0/31 (0%) 0/53 (0%) | 0/35 (0%) 0/34 (0%) 1/31 (3%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 726 456 (I) --- --- | --- --- 737 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.037N* P=0.437N P=0.202N P=0.098N | P=0.661 (e) P=0.476 (e) |
|INCIDENTAL TUMOR | P=0.031N* P=0.437N P=0.212N P=0.076N | P=0.661 (e) P=0.476 (e) |
|LOGISTIC REGRESSION | P=0.031N* P=0.455N P=0.204N P=0.094N | P=0.661 (e) P=0.476 (e) |
|COCHRAN-ARMITAGE | P=0.028N* | P=0.696 |
|FISHER EXACT | P=0.495N P=0.216N P=0.061N | (e) P=0.500 (e) |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/130 (3%) 2/60 (3%) 1/60 (2%) 0/130 (0%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 0/60 (0%) |
|ADJUSTED (b) | 5.9% 4.8% 3.2% 0.0% | 0.0% 0.0% 3.2% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 1/10 (10%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 3/66 (5%) 1/33 (3%) 1/31 (3%) 0/53 (0%) | 0/35 (0%) 0/34 (0%) 1/31 (3%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 726 456 (I) 729 (T) --- | --- --- 737 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.055N P=0.669N P=0.465N P=0.098N | P=0.661 (e) P=0.476 (e) |
|INCIDENTAL TUMOR | P=0.047N* P=0.669N P=0.480N P=0.076N | P=0.661 (e) P=0.476 (e) |
|LOGISTIC REGRESSION | P=0.045N* P=0.654 P=0.475N P=0.094N | P=0.661 (e) P=0.476 (e) |
|COCHRAN-ARMITAGE | P=0.038N* | P=0.696 |
|FISHER EXACT | P=0.617 P=0.495N P=0.061N | (e) P=0.500 (e) |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/130 (3%) 2/60 (3%) 1/60 (2%) 0/130 (0%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 0/60 (0%) |
|ADJUSTED (b) | 5.9% 4.8% 3.2% 0.0% | 0.0% 0.0% 3.2% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 1/10 (10%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 3/66 (5%) 1/33 (3%) 1/31 (3%) 0/53 (0%) | 0/35 (0%) 0/34 (0%) 1/31 (3%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 726 456 (I) 729 (T) --- | --- --- 737 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.055N P=0.669N P=0.465N P=0.098N | P=0.661 (e) P=0.476 (e) |
|INCIDENTAL TUMOR | P=0.047N* P=0.669N P=0.480N P=0.076N | P=0.661 (e) P=0.476 (e) |
|LOGISTIC REGRESSION | P=0.045N* P=0.654 P=0.475N P=0.094N | P=0.661 (e) P=0.476 (e) |
|COCHRAN-ARMITAGE | P=0.038N* | P=0.696 |
|FISHER EXACT | P=0.617 P=0.495N P=0.061N | (e) P=0.500 (e) |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/130 (2%) 0/60 (0%) 0/60 (0%) 0/130 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 4.5% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 3/66 (5%) 0/33 (0%) 0/31 (0%) 0/53 (0%) | 0/35 (0%) 0/34 (0%) 0/31 (0%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.077N P=0.268N P=0.283N P=0.164N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.077N P=0.268N P=0.283N P=0.164N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.077N P=0.268N P=0.283N P=0.164N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.061N | (e) |
|FISHER EXACT | P=0.318N P=0.318N P=0.124N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/130 (1%) 0/60 (0%) 0/60 (0%) 2/130 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.8% 0.0% 0.0% 3.8% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 1/20 (5%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/66 (0%) 0/33 (0%) 0/31 (0%) 2/53 (4%) | 0/35 (0%) 0/34 (0%) 0/31 (0%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 456 (I) --- --- 729 (T) | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.262 P=0.638N P=0.638N P=0.449 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.262 P=0.638N P=0.638N P=0.449 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.296 P=0.684N P=0.713N P=0.486 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.307 | (e) |
|FISHER EXACT | P=0.684N P=0.684N P=0.500 | (e) (e) (e) |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/130 (3%) 0/60 (0%) 0/60 (0%) 2/130 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 5.4% 0.0% 0.0% 3.8% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 1/20 (5%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 3/66 (5%) 0/33 (0%) 0/31 (0%) 2/53 (4%) | 0/35 (0%) 0/34 (0%) 0/31 (0%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 456 (I) --- --- 729 (T) | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.381N P=0.187N P=0.197N P=0.425N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.381N P=0.187N P=0.197N P=0.425N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.342N P=0.197N P=0.198N P=0.379N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.310N | (e) |
|FISHER EXACT | P=0.216N P=0.216N P=0.342N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Mammary Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/130 (0%) 0/60 (0%) 0/60 (0%) 0/130 (0%) | 0/60 (0%) 1/60 (2%) 2/60 (3%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 2.9% 5.4% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/66 (0%) 0/33 (0%) 0/31 (0%) 0/53 (0%) | 0/35 (0%) 1/34 (3%) 1/31 (3%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | --- 737 (T) 687 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.635 P=0.494 P=0.239 (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.644 P=0.494 P=0.285 (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.647 P=0.494 P=0.246 (e) |
|COCHRAN-ARMITAGE | (e) | P=0.615N |
|FISHER EXACT | (e) (e) (e) | P=0.500 P=0.248 (e) |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/130 (0%) 0/60 (0%) 1/60 (2%) 0/130 (0%) | 2/60 (3%) 0/60 (0%) 3/60 (5%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 3.0% 0.0% | 5.6% 0.0% 7.9% 2.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/66 (0%) 0/33 (0%) 0/31 (0%) 0/53 (0%) | 1/35 (3%) 0/34 (0%) 1/31 (3%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 704 --- | 709 --- 544 568 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.669 (e) P=0.342 (e) | P=0.574 P=0.243N P=0.481 P=0.596N |
|INCIDENTAL TUMOR | P=0.700N (e) P=0.305 (e) | P=0.498N P=0.275N P=0.577 P=0.600N |
|LOGISTIC REGRESSION | P=0.677 (e) P=0.348 (e) | P=0.587N P=0.248N P=0.512 P=0.544N |
|COCHRAN-ARMITAGE | P=0.692 | P=0.555N |
|FISHER EXACT | (e) P=0.316 (e) | P=0.248N P=0.500 P=0.500N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/130 (0%) 0/60 (0%) 1/60 (2%) 0/130 (0%) | 2/60 (3%) 1/60 (2%) 5/60 (8%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 3.0% 0.0% | 5.6% 2.9% 13.0% 2.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/66 (0%) 0/33 (0%) 0/31 (0%) 0/53 (0%) | 1/35 (3%) 1/34 (3%) 2/31 (6%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 704 --- | 709 737 (T) 544 568 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.669 (e) P=0.342 (e) | P=0.546 P=0.507N P=0.211 P=0.596N |
|INCIDENTAL TUMOR | P=0.700N (e) P=0.305 (e) | P=0.509N P=0.540N P=0.295 P=0.600N |
|LOGISTIC REGRESSION | P=0.677 (e) P=0.348 (e) | P=0.582N P=0.515N P=0.230 P=0.544N |
|COCHRAN-ARMITAGE | P=0.692 | P=0.522N |
|FISHER EXACT | (e) P=0.316 (e) | P=0.500N P=0.219 P=0.500N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/130 (3%) 4/60 (7%) 5/60 (8%) 7/130 (5%) | 22/60 (37%) 9/60 (15%) 20/60 (33%) 5/60 (8%) |
|ADJUSTED (b) | 6.1% 11.5% 15.4% 11.5% | 54.3% 25.7% 48.4% 15.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 4/66 (6%) 3/33 (9%) 4/31 (13%) 4/53 (8%) | 17/35 (49%) 8/34 (24%) 11/31 (35%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 691 696 644 | 507 724 619 603 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.158 P=0.259 P=0.115 P=0.171 | P=0.020N* P=0.008N** P=0.526N P=0.004N** |
|INCIDENTAL TUMOR | P=0.225 P=0.260 P=0.107 P=0.224 | P=0.006N** P=0.006N** P=0.362N P=0.001N** |
|LOGISTIC REGRESSION | P=0.189 P=0.246 P=0.105 P=0.197 | P=0.009N** P=0.007N** P=0.352N P=0.002N** |
|COCHRAN-ARMITAGE | P=0.287 | P=0.002N** |
|FISHER EXACT | P=0.220 P=0.114 P=0.270 | P=0.006N** P=0.424N P<0.001N** |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/130 (3%) 4/60 (7%) 5/60 (8%) 7/130 (5%) | 22/60 (37%) 10/60 (17%) 21/60 (35%) 5/60 (8%) |
|ADJUSTED (b) | 6.1% 11.5% 15.4% 11.5% | 54.3% 28.6% 49.6% 15.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 4/66 (6%) 3/33 (9%) 4/31 (13%) 4/53 (8%) | 17/35 (49%) 9/34 (26%) 11/31 (35%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 691 696 644 | 507 724 619 603 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.158 P=0.259 P=0.115 P=0.171 | P=0.020N* P=0.014N* P=0.550 P=0.004N** |
|INCIDENTAL TUMOR | P=0.225 P=0.260 P=0.107 P=0.224 | P=0.005N** P=0.011N* P=0.418N P=0.001N** |
|LOGISTIC REGRESSION | P=0.189 P=0.246 P=0.105 P=0.197 | P=0.009N** P=0.013N* P=0.397N P=0.002N** |
|COCHRAN-ARMITAGE | P=0.287 | P=0.002N** |
|FISHER EXACT | P=0.220 P=0.114 P=0.270 | P=0.011N* P=0.500N P<0.001N** |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/130 (3%) 4/60 (7%) 6/60 (10%) 7/130 (5%) | 24/60 (40%) 10/60 (17%) 23/60 (38%) 6/60 (10%) |
|ADJUSTED (b) | 6.1% 11.5% 18.0% 11.5% | 58.0% 28.6% 53.0% 18.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 4/66 (6%) 3/33 (9%) 4/31 (13%) 4/53 (8%) | 18/35 (51%) 9/34 (26%) 12/31 (39%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 691 696 644 | 507 724 544 568 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.155 P=0.259 P=0.053 P=0.171 | P=0.024N* P=0.005N** P=0.541 P=0.005N** |
|INCIDENTAL TUMOR | P=0.234 P=0.260 P=0.045 * P=0.224 | P=0.004N** P=0.004N** P=0.405N P<0.001N** |
|LOGISTIC REGRESSION | P=0.186 P=0.246 P=0.047 * P=0.197 | P=0.009N** P=0.005N** P=0.391N P=0.002N** |
|COCHRAN-ARMITAGE | P=0.285 | P=0.002N** |
|FISHER EXACT | P=0.220 P=0.055 P=0.270 | P=0.004N** P=0.500N P<0.001N** |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/130 (0%) 0/60 (0%) 2/60 (3%) 2/130 (2%) | 1/60 (2%) 1/60 (2%) 1/60 (2%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 4.8% 3.3% | 2.9% 2.9% 2.2% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/66 (0%) 0/33 (0%) 0/31 (0%) 0/53 (0%) | 1/35 (3%) 1/34 (3%) 0/31 (0%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 515 684 | 737 (T) 737 (T) 625 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.112 (e) P=0.095 P=0.199 | P=0.376N P=0.755 P=0.752 P=0.559N |
|INCIDENTAL TUMOR | P=0.197 (e) P=0.178 P=0.310 | P=0.365N P=0.755 P=0.747 P=0.559N |
|LOGISTIC REGRESSION | P=0.132 (e) P=0.085 P=0.214 | P=0.344N P=0.755 P=0.758N P=0.559N |
|COCHRAN-ARMITAGE | P=0.141 | P=0.312N |
|FISHER EXACT | (e) P=0.099 P=0.249 | P=0.752N P=0.752N P=0.500N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Pancreas |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 24/130 (18%) 6/60 (10%) 7/60 (12%) 14/128 (11%)| 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 32.3% 17.3% 20.7% 23.7% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 17/66 (26%) 5/33 (15%) 5/31 (16%) 9/53 (17%) | 0/35 (0%) 0/34 (0%) 0/31 (0%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 591 659 611 696 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.201N P=0.072N P=0.163N P=0.183N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.091N P=0.075N P=0.146N P=0.074N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.134N P=0.072N P=0.153N P=0.116N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.073N | (e) |
|FISHER EXACT | P=0.099N P=0.167N P=0.063N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Pancreas |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 25/130 (19%) 6/60 (10%) 7/60 (12%) 14/128 (11%)| 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 33.7% 17.3% 20.7% 23.7% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 18/66 (27%) 5/33 (15%) 5/31 (16%) 9/53 (17%) | 0/35 (0%) 0/34 (0%) 0/31 (0%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 591 659 611 696 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.162N P=0.057N P=0.134N P=0.147N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.069N P=0.059N P=0.119N P=0.055N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.104N P=0.056N P=0.125N P=0.088N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.054N | (e) |
|FISHER EXACT | P=0.079N P=0.138N P=0.045N* | (e) (e) (e) |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 38/128 (30%) 19/60 (32%) 18/59 (31%) 38/127 (30%)| 27/60 (45%) 20/59 (34%) 24/60 (40%) 13/60 (22%) |
|ADJUSTED (b) | 44.9% 46.2% 45.2% 49.1% | 58.4% 47.8% 57.6% 44.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 5/20 (25%) 3/10 (30%) 0/10 (0%) 2/19 (11%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 21/64 (33%) 12/33 (36%) 10/31 (32%) 17/52 (33%) | 16/35 (46%) 12/33 (36%) 14/31 (45%) 10/26 (38%) |
|FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 396 423 | 458 (I) 432 619 693 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.220 P=0.553N P=0.551N P=0.258 | P=0.107N P=0.216N P=0.458N P=0.078N |
|INCIDENTAL TUMOR | P=0.519 P=0.562 P=0.544N P=0.525 | P=0.027N* P=0.236N P=0.193N P=0.055N |
|LOGISTIC REGRESSION | P=0.410 P=0.524 P=0.562N P=0.438 | P=0.041N* P=0.303N P=0.237N P=0.055N |
|COCHRAN-ARMITAGE | P=0.519N | P=0.008N** |
|FISHER EXACT | P=0.455 P=0.520 P=0.538 | P=0.147N P=0.356N P=0.006N** |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/128 (0%) 0/60 (0%) 0/59 (0%) 0/127 (0%) | 0/60 (0%) 2/59 (3%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 6.1% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/19 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/64 (0%) 0/33 (0%) 0/31 (0%) 0/52 (0%) | 0/35 (0%) 2/33 (6%) 0/31 (0%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | --- 737 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.464N P=0.225 (e) (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.464N P=0.225 (e) (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.464N P=0.225 (e) (e) |
|COCHRAN-ARMITAGE | (e) | P=0.404N |
|FISHER EXACT | (e) (e) (e) | P=0.244 (e) (e) |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 38/128 (30%) 19/60 (32%) 18/59 (31%) 38/127 (30%)| 27/60 (45%) 22/59 (37%) 24/60 (40%) 13/60 (22%) |
|ADJUSTED (b) | 44.9% 46.2% 45.2% 49.1% | 58.4% 52.8% 57.6% 44.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 5/20 (25%) 3/10 (30%) 0/10 (0%) 2/19 (11%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 21/64 (33%) 12/33 (36%) 10/31 (32%) 17/52 (33%) | 16/35 (46%) 14/33 (42%) 14/31 (45%) 10/26 (38%) |
|FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 396 423 | 458 (I) 432 619 693 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.220 P=0.553N P=0.551N P=0.258 | P=0.089N P=0.330N P=0.458N P=0.078N |
|INCIDENTAL TUMOR | P=0.519 P=0.562 P=0.544N P=0.525 | P=0.020N* P=0.391N P=0.193N P=0.055N |
|LOGISTIC REGRESSION | P=0.410 P=0.524 P=0.562N P=0.438 | P=0.031N* P=0.466N P=0.237N P=0.055N |
|COCHRAN-ARMITAGE | P=0.519N | P=0.006N** |
|FISHER EXACT | P=0.455 P=0.520 P=0.538 | P=0.252N P=0.356N P=0.006N** |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/130 (2%) 3/60 (5%) 0/60 (0%) 0/130 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 2.9% 8.7% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/66 (2%) 2/33 (6%) 0/31 (0%) 0/53 (0%) | 0/35 (0%) 0/34 (0%) 0/31 (0%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 717 709 --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.116N P=0.210 P=0.424N P=0.290N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.083N P=0.211 P=0.443N P=0.227N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.104N P=0.200 P=0.422N P=0.274N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.083N | (e) |
|FISHER EXACT | P=0.182 P=0.467N P=0.249N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma, Basosquamous Tumor Benign, or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/130 (2%) 3/60 (5%) 1/60 (2%) 0/130 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 4.4% 8.7% 2.6% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/66 (3%) 2/33 (6%) 0/31 (0%) 0/53 (0%) | 0/35 (0%) 0/34 (0%) 0/31 (0%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 717 709 639 --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.089N P=0.328 P=0.601N P=0.165N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.057N P=0.330 P=0.573N P=0.129N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.076N P=0.316 P=0.598N P=0.154N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.060N | (e) |
|FISHER EXACT | P=0.283 P=0.624N P=0.124N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign, |
| malignant or NOS), or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/130 (2%) 4/60 (7%) 1/60 (2%) 0/130 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 4.4% 11.2% 2.6% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/66 (3%) 2/33 (6%) 0/31 (0%) 0/53 (0%) | 0/35 (0%) 0/34 (0%) 0/31 (0%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 717 691 639 --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.079N P=0.169 P=0.601N P=0.165N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.044N* P=0.168 P=0.573N P=0.129N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.065N P=0.158 P=0.598N P=0.154N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.051N | (e) |
|FISHER EXACT | P=0.143 P=0.624N P=0.124N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal |
| Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 9/130 (7%) 9/60 (15%) 6/60 (10%) 7/130 (5%) | 3/60 (5%) 0/60 (0%) 1/60 (2%) 1/60 (2%) |
|ADJUSTED (b) | 13.1% 24.9% 16.9% 12.0% | 8.6% 0.0% 2.9% 2.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 7/66 (11%) 6/33 (18%) 3/31 (10%) 4/53 (8%) | 3/35 (9%) 0/34 (0%) 0/31 (0%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 709 691 639 687 | 737 (T) --- 733 458 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.397N P=0.093 P=0.337 P=0.572N | P=0.363N P=0.126N P=0.342N P=0.388N |
|INCIDENTAL TUMOR | P=0.231N P=0.089 P=0.320 P=0.438N | P=0.351N P=0.126N P=0.288N P=0.388N |
|LOGISTIC REGRESSION | P=0.330N P=0.039 * P=0.326 P=0.524N | P=0.325N P=0.126N P=0.311N P=0.344N |
|COCHRAN-ARMITAGE | P=0.215N | P=0.297N |
|FISHER EXACT | P=0.070 P=0.321 P=0.399N | P=0.122N P=0.309N P=0.309N |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 5/130 (4%) 5/60 (8%) 1/60 (2%) 9/130 (7%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 6.9% 13.2% 2.5% 16.1% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 3/66 (5%) 2/33 (6%) 0/31 (0%) 7/53 (13%) | 0/35 (0%) 0/34 (0%) 0/31 (0%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 620 654 611 696 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.131 P=0.212 P=0.361N P=0.110 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.234 P=0.184 P=0.309N P=0.165 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.167 P=0.192 P=0.353N P=0.135 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.242 | (e) |
|FISHER EXACT | P=0.173 P=0.383N P=0.205 | (e) (e) (e) |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 5/130 (4%) 5/60 (8%) 1/60 (2%) 11/130 (8%) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 6.9% 13.2% 2.5% 18.6% | 0.0% 2.9% 0.0% 3.2% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 3/66 (5%) 2/33 (6%) 0/31 (0%) 7/53 (13%) | 0/35 (0%) 1/34 (3%) 0/31 (0%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 620 654 611 645 | --- 737 (T) --- 696 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.048 * P=0.212 P=0.361N P=0.046 * | P=0.354 P=0.494 (e) P=0.465 |
|INCIDENTAL TUMOR | P=0.114 P=0.184 P=0.309N P=0.087 | P=0.358 P=0.494 (e) P=0.443 |
|LOGISTIC REGRESSION | P=0.065 P=0.192 P=0.353N P=0.058 | P=0.359 P=0.494 (e) P=0.462 |
|COCHRAN-ARMITAGE | P=0.110 | P=0.405 |
|FISHER EXACT | P=0.173 P=0.383N P=0.098 | P=0.500 (e) P=0.500 |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/130 (0%) 0/60 (0%) 0/60 (0%) 2/130 (2%) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 2.9% | 0.0% 2.9% 0.0% 3.2% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/66 (0%) 0/33 (0%) 0/31 (0%) 0/53 (0%) | 0/35 (0%) 1/34 (3%) 0/31 (0%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 645 | --- 737 (T) --- 696 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.068 (e) (e) P=0.212 | P=0.354 P=0.494 (e) P=0.465 |
|INCIDENTAL TUMOR | P=0.123 (e) (e) P=0.310 | P=0.358 P=0.494 (e) P=0.443 |
|LOGISTIC REGRESSION | P=0.073 (e) (e) P=0.222 | P=0.359 P=0.494 (e) P=0.462 |
|COCHRAN-ARMITAGE | P=0.083 | P=0.405 |
|FISHER EXACT | (e) (e) P=0.249 | P=0.500 (e) P=0.500 |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 21
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 5/130 (4%) 3/60 (5%) 3/60 (5%) 5/130 (4%) | 1/60 (2%) 0/60 (0%) 1/60 (2%) 1/60 (2%) |
|ADJUSTED (b) | 7.4% 8.8% 8.0% 8.8% | 2.9% 0.0% 2.9% 2.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 4/66 (6%) 2/33 (6%) 0/31 (0%) 3/53 (6%) | 1/35 (3%) 0/34 (0%) 0/31 (0%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 709 726 639 687 | 737 (T) --- 733 458 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.443 P=0.550 P=0.513 P=0.491 | P=0.493 P=0.506N P=0.744 P=0.728 |
|INCIDENTAL TUMOR | P=0.522N P=0.551 P=0.504 P=0.592 | P=0.507 P=0.506N P=0.715N P=0.728 |
|LOGISTIC REGRESSION | P=0.492 P=0.537 P=0.513 P=0.530 | P=0.538 P=0.506N P=0.763 P=0.750N |
|COCHRAN-ARMITAGE | P=0.532N | P=0.539 |
|FISHER EXACT | P=0.490 P=0.490 P=0.625N | P=0.500N P=0.752N P=0.752N |
|=================================================================================================================================|
| |
|Skin |
| Neurofibrosarcoma, Neurofibroma, or Schwannoma (benign, malignant or NOS) |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/130 (1%) 0/60 (0%) 1/60 (2%) 3/130 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 1.1% 0.0% 3.2% 3.9% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/66 (0%) 0/33 (0%) 1/31 (3%) 1/53 (2%) | 0/35 (0%) 0/34 (0%) 0/31 (0%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 542 --- 729 (T) 423 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.126 P=0.647N P=0.583 P=0.275 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.126 P=0.662N P=0.647 P=0.280 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.160 P=0.667N P=0.583 P=0.317 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.157 | (e) |
|FISHER EXACT | P=0.684N P=0.533 P=0.311 | (e) (e) (e) |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 22
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Schwannoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/130 (1%) 0/60 (0%) 1/60 (2%) 2/130 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 1.1% 0.0% 3.2% 3.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/66 (0%) 0/33 (0%) 1/31 (3%) 1/53 (2%) | 0/35 (0%) 0/34 (0%) 0/31 (0%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 542 --- 729 (T) 542 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.268 P=0.647N P=0.583 P=0.462 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.275 P=0.662N P=0.647 P=0.474 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.303 P=0.667N P=0.583 P=0.497 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.314 | (e) |
|FISHER EXACT | P=0.684N P=0.533 P=0.500 | (e) (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/130 (2%) 2/60 (3%) 3/60 (5%) 2/130 (2%) | 3/60 (5%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 4.5% 6.1% 9.7% 3.4% | 8.6% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 3/66 (5%) 2/33 (6%) 3/31 (10%) 1/53 (2%) | 3/35 (9%) 0/34 (0%) 0/31 (0%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) 696 | 737 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.513N P=0.564 P=0.300 P=0.593N | P=0.063N P=0.126N P=0.143N P=0.178N |
|INCIDENTAL TUMOR | P=0.486N P=0.564 P=0.300 P=0.551N | P=0.063N P=0.126N P=0.143N P=0.178N |
|LOGISTIC REGRESSION | P=0.494N P=0.564 P=0.300 P=0.572N | P=0.063N P=0.126N P=0.143N P=0.178N |
|COCHRAN-ARMITAGE | P=0.394N | P=0.048N* |
|FISHER EXACT | P=0.505 P=0.283 P=0.500N | P=0.122N P=0.122N P=0.122N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 23
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 7/130 (5%) 5/60 (8%) 6/60 (10%) 7/130 (5%) | 3/60 (5%) 0/60 (0%) 1/60 (2%) 1/60 (2%) |
|ADJUSTED (b) | 10.4% 14.7% 16.9% 12.0% | 8.6% 0.0% 2.9% 2.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 6/66 (9%) 4/33 (12%) 3/31 (10%) 4/53 (8%) | 3/35 (9%) 0/34 (0%) 0/31 (0%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 709 726 639 687 | 737 (T) --- 733 458 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.412 P=0.374 P=0.202 P=0.448 | P=0.363N P=0.126N P=0.342N P=0.388N |
|INCIDENTAL TUMOR | P=0.542N P=0.375 P=0.193 P=0.560 | P=0.351N P=0.126N P=0.288N P=0.388N |
|LOGISTIC REGRESSION | P=0.468 P=0.356 P=0.191 P=0.492 | P=0.325N P=0.126N P=0.311N P=0.344N |
|COCHRAN-ARMITAGE | P=0.497N | P=0.297N |
|FISHER EXACT | P=0.315 P=0.192 P=0.608N | P=0.122N P=0.309N P=0.309N |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 7/130 (5%) 5/60 (8%) 6/60 (10%) 7/130 (5%) | 3/60 (5%) 0/60 (0%) 1/60 (2%) 1/60 (2%) |
|ADJUSTED (b) | 10.4% 14.7% 16.9% 12.0% | 8.6% 0.0% 2.9% 2.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 6/66 (9%) 4/33 (12%) 3/31 (10%) 4/53 (8%) | 3/35 (9%) 0/34 (0%) 0/31 (0%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 709 726 639 687 | 737 (T) --- 733 458 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.412 P=0.374 P=0.202 P=0.448 | P=0.363N P=0.126N P=0.342N P=0.388N |
|INCIDENTAL TUMOR | P=0.542N P=0.375 P=0.193 P=0.560 | P=0.351N P=0.126N P=0.288N P=0.388N |
|LOGISTIC REGRESSION | P=0.468 P=0.356 P=0.191 P=0.492 | P=0.325N P=0.126N P=0.311N P=0.344N |
|COCHRAN-ARMITAGE | P=0.497N | P=0.297N |
|FISHER EXACT | P=0.315 P=0.192 P=0.608N | P=0.122N P=0.309N P=0.309N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 24
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) |107/130 (82%) 48/59 (81%) 56/60 (93%) 101/130 (78%)| |
|ADJUSTED (b) | 98.1% 94.0% 100.0% 99.0% | |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 17/20 (85%) 7/10 (70%) 10/10 (100%) 19/20 (95%) | |
|TERMINAL (d) | 64/66 (97%) 30/33 (91%) 31/31 (100%) 52/53 (98%) | |
|FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 414 423 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.051 P=0.182N P=0.157 P=0.112 | |
|INCIDENTAL TUMOR | P=0.439 P=0.177N P=0.179 P=0.575N | |
|LOGISTIC REGRESSION | P=0.467 P=0.267N P=0.101 P=0.536N | |
|COCHRAN-ARMITAGE | P=0.203N | |
|FISHER EXACT | P=0.512N P=0.031 * P=0.219N | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/130 (7%) 9/60 (15%) 5/60 (8%) 10/130 (8%) | 3/60 (5%) 5/60 (8%) 2/60 (3%) 5/60 (8%) |
|ADJUSTED (b) | 13.2% 25.4% 14.6% 16.8% | 7.8% 12.9% 5.6% 17.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 8/66 (12%) 7/33 (21%) 3/31 (10%) 6/53 (11%) | 1/35 (3%) 2/34 (6%) 1/31 (3%) 4/26 (15%) |
|FIRST INCIDENCE (DAYS) | 646 680 680 648 | 684 544 695 495 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.403 P=0.089 P=0.491 P=0.324 | P=0.240 P=0.345 P=0.506N P=0.230 |
|INCIDENTAL TUMOR | P=0.543 P=0.090 P=0.460 P=0.428 | P=0.402 P=0.361 P=0.371N P=0.323 |
|LOGISTIC REGRESSION | P=0.472 P=0.078 P=0.481 P=0.377 | P=0.293 P=0.218 P=0.482N P=0.257 |
|COCHRAN-ARMITAGE | P=0.466N | P=0.376 |
|FISHER EXACT | P=0.070 P=0.468 P=0.500 | P=0.359 P=0.500N P=0.359 |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 25
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/130 (2%) 2/60 (3%) 2/60 (3%) 3/130 (2%) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 3.0% 6.1% 6.5% 5.1% | 0.0% 2.9% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/66 (3%) 2/33 (6%) 2/31 (6%) 2/53 (4%) | 0/35 (0%) 1/34 (3%) 0/31 (0%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) 653 | --- 737 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.353 P=0.429 P=0.405 P=0.412 | P=0.614N P=0.494 (e) (e) |
|INCIDENTAL TUMOR | P=0.379 P=0.429 P=0.405 P=0.449 | P=0.614N P=0.494 (e) (e) |
|LOGISTIC REGRESSION | P=0.384 P=0.429 P=0.405 P=0.441 | P=0.614N P=0.494 (e) (e) |
|COCHRAN-ARMITAGE | P=0.467 | P=0.568N |
|FISHER EXACT | P=0.376 P=0.376 P=0.500 | P=0.500 (e) (e) |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/130 (8%) 11/60 (18%) 7/60 (12%) 13/130 (10%)| 3/60 (5%) 6/60 (10%) 2/60 (3%) 5/60 (8%) |
|ADJUSTED (b) | 16.2% 31.2% 20.7% 21.4% | 7.8% 15.6% 5.6% 17.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 10/66 (15%) 9/33 (27%) 5/31 (16%) 8/53 (15%) | 1/35 (3%) 3/34 (9%) 1/31 (3%) 4/26 (15%) |
|FIRST INCIDENCE (DAYS) | 646 680 680 648 | 684 544 695 495 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.306 P=0.058 P=0.341 P=0.231 | P=0.280 P=0.236 P=0.506N P=0.230 |
|INCIDENTAL TUMOR | P=0.438 P=0.058 P=0.313 P=0.327 | P=0.447 P=0.240 P=0.371N P=0.323 |
|LOGISTIC REGRESSION | P=0.379 P=0.049 * P=0.325 P=0.282 | P=0.338 P=0.137 P=0.482N P=0.257 |
|COCHRAN-ARMITAGE | P=0.524N | P=0.430 |
|FISHER EXACT | P=0.045 * P=0.324 P=0.415 | P=0.245 P=0.500N P=0.359 |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 26
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/130 (3%) 0/60 (0%) 3/60 (5%) 1/130 (1%) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 0/60 (0%) |
|ADJUSTED (b) | 6.1% 0.0% 8.5% 1.9% | 0.0% 0.0% 5.2% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 4/66 (6%) 0/33 (0%) 2/31 (6%) 1/53 (2%) | 0/35 (0%) 0/34 (0%) 1/31 (3%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- 502 729 (T) | --- --- 544 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.290N P=0.185N P=0.416 P=0.253N | P=0.543 (e) P=0.233 (e) |
|INCIDENTAL TUMOR | P=0.283N P=0.185N P=0.453 P=0.253N | P=0.626N (e) P=0.226 (e) |
|LOGISTIC REGRESSION | P=0.254N P=0.185N P=0.413 P=0.253N | P=0.598 (e) P=0.230 (e) |
|COCHRAN-ARMITAGE | P=0.215N | P=0.597 |
|FISHER EXACT | P=0.216N P=0.388 P=0.185N | (e) P=0.248 (e) |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/130 (1%) 0/60 (0%) 1/60 (2%) 2/130 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 1.5% 0.0% 2.9% 3.8% | 0.0% 0.0% 0.0% 3.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/66 (2%) 0/33 (0%) 0/31 (0%) 2/53 (4%) | 0/35 (0%) 0/34 (0%) 0/31 (0%) 1/26 (4%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- 702 729 (T) | --- --- --- 737 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.245 P=0.638N P=0.581 P=0.424 | P=0.161 (e) (e) P=0.441 |
|INCIDENTAL TUMOR | P=0.285 P=0.638N P=0.557 P=0.424 | P=0.161 (e) (e) P=0.441 |
|LOGISTIC REGRESSION | P=0.261 P=0.638N P=0.580 P=0.424 | P=0.161 (e) (e) P=0.441 |
|COCHRAN-ARMITAGE | P=0.314 | P=0.199 |
|FISHER EXACT | P=0.684N P=0.533 P=0.500 | (e) (e) P=0.500 |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 27
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/130 (4%) 0/60 (0%) 4/60 (7%) 3/130 (2%) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 1/60 (2%) |
|ADJUSTED (b) | 7.6% 0.0% 11.2% 5.7% | 0.0% 0.0% 5.2% 3.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 5/66 (8%) 0/33 (0%) 2/31 (6%) 3/53 (6%) | 0/35 (0%) 0/34 (0%) 1/31 (3%) 1/26 (4%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- 502 729 (T) | --- --- 544 737 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.552N P=0.129N P=0.324 P=0.482N | P=0.185 (e) P=0.233 P=0.441 |
|INCIDENTAL TUMOR | P=0.520N P=0.129N P=0.343 P=0.482N | P=0.334 (e) P=0.226 P=0.441 |
|LOGISTIC REGRESSION | P=0.499N P=0.129N P=0.320 P=0.482N | P=0.224 (e) P=0.230 P=0.441 |
|COCHRAN-ARMITAGE | P=0.424N | P=0.247 |
|FISHER EXACT | P=0.146N P=0.304 P=0.361N | (e) P=0.248 P=0.500 |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/130 (0%) 0/59 (0%) 2/60 (3%) 6/127 (5%) | 0/59 (0%) 0/60 (0%) 2/60 (3%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 6.5% 10.3% | 0.0% 0.0% 5.6% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/66 (0%) 0/33 (0%) 2/31 (6%) 3/53 (6%) | 0/34 (0%) 0/34 (0%) 1/31 (3%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 729 (T) 653 | --- --- 695 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.002 ** (e) P=0.095 P=0.010 * | P=0.554 (e) P=0.238 (e) |
|INCIDENTAL TUMOR | P=0.004 ** (e) P=0.095 P=0.021 * | P=0.564 (e) P=0.289 (e) |
|LOGISTIC REGRESSION | P=0.002 ** (e) P=0.095 P=0.012 * | P=0.562 (e) P=0.252 (e) |
|COCHRAN-ARMITAGE | P=0.004 ** | P=0.599 |
|FISHER EXACT | (e) P=0.099 P=0.014 * | (e) P=0.252 (e) |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 28
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 6/60 (10%) 8/60 (13%) 8/60 (13%) 5/60 (8%) |
|ADJUSTED (b) | | 16.2% 20.8% 23.9% 16.4% |
|INTERIM SACRIFICE 1 (c)| | |
|INTERIM SACRIFICE 2 (c)| | 0/10 (0%) 1/10 (10%) 1/10 (10%) 1/10 (10%) |
|TERMINAL (d) | | 5/35 (14%) 5/34 (15%) 7/31 (23%) 3/26 (12%) |
|FIRST INCIDENCE (DAYS) | | 635 458 (I) 458 (I) 458 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.529 P=0.370 P=0.310 P=0.568 |
|INCIDENTAL TUMOR | | P=0.547 P=0.308 P=0.309 P=0.567 |
|LOGISTIC REGRESSION | | P=0.506N P=0.349 P=0.418 P=0.616 |
|COCHRAN-ARMITAGE | | P=0.378N |
|FISHER EXACT | | P=0.389 P=0.389 P=0.500N |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 6/60 (10%) 8/60 (13%) 8/60 (13%) 6/60 (10%) |
|ADJUSTED (b) | | 16.2% 20.8% 23.9% 17.9% |
|INTERIM SACRIFICE 1 (c)| | |
|INTERIM SACRIFICE 2 (c)| | 0/10 (0%) 1/10 (10%) 1/10 (10%) 1/10 (10%) |
|TERMINAL (d) | | 5/35 (14%) 5/34 (15%) 7/31 (23%) 3/26 (12%) |
|FIRST INCIDENCE (DAYS) | | 635 458 (I) 458 (I) 375 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.403 P=0.370 P=0.310 P=0.442 |
|INCIDENTAL TUMOR | | P=0.475 P=0.308 P=0.309 P=0.546 |
|LOGISTIC REGRESSION | | P=0.502 P=0.349 P=0.418 P=0.529 |
|COCHRAN-ARMITAGE | | P=0.500N |
|FISHER EXACT | | P=0.389 P=0.389 P=0.619N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 29
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/130 (2%) 0/60 (0%) 0/60 (0%) 0/130 (0%) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 3.4% 0.0% 0.0% 0.0% | 0.0% 2.7% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/66 (0%) 0/33 (0%) 0/31 (0%) 0/53 (0%) | 0/35 (0%) 0/34 (0%) 0/31 (0%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 578 --- --- --- | --- 703 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.069N P=0.273N P=0.288N P=0.142N | P=0.601N P=0.500 (e) (e) |
|INCIDENTAL TUMOR | P=0.030N* P=0.395N P=0.166N P=0.069N | P=0.589N P=0.443 (e) (e) |
|LOGISTIC REGRESSION | P=0.060N P=0.291N P=0.293N P=0.122N | P=0.596N P=0.491 (e) (e) |
|COCHRAN-ARMITAGE | P=0.061N | P=0.568N |
|FISHER EXACT | P=0.318N P=0.318N P=0.124N | P=0.500 (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 23/130 (18%) 18/60 (30%) 12/60 (20%) 13/130 (10%)| 15/60 (25%) 9/60 (15%) 9/60 (15%) 3/60 (5%) |
|ADJUSTED (b) | 29.4% 44.1% 29.2% 20.4% | 32.9% 23.4% 20.6% 8.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 1/10 (10%) 0/10 (0%) 1/10 (10%) 0/10 (0%) |
|TERMINAL (d) | 13/66 (20%) 11/33 (33%) 4/31 (13%) 8/53 (15%) | 7/35 (20%) 6/34 (18%) 2/31 (6%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 477 414 435 428 | 260 396 458 (I) 495 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.081N P=0.080 P=0.441 P=0.158N | P=0.014N* P=0.162N P=0.160N P=0.016N* |
|INCIDENTAL TUMOR | P=0.013N* P=0.047 * P=0.537 P=0.059N | P=0.001N** P=0.186N P=0.109N P=0.003N** |
|LOGISTIC REGRESSION | P=0.020N* P=0.044 * P=0.480 P=0.086N | P=0.003N** P=0.137N P=0.136N P=0.003N** |
|COCHRAN-ARMITAGE | P=0.017N* | P=0.002N** |
|FISHER EXACT | P=0.044 * P=0.423 P=0.053N | P=0.127N P=0.127N P=0.002N** |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 30
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/130 (2%) 1/60 (2%) 2/60 (3%) 5/130 (4%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 3.0% 3.0% 5.9% 8.5% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/66 (3%) 1/33 (3%) 1/31 (3%) 3/53 (6%) | 0/35 (0%) 0/34 (0%) 0/31 (0%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 695 585 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.084 P=0.732 P=0.407 P=0.150 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.124 P=0.732 P=0.385 P=0.192 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.103 P=0.732 P=0.396 P=0.175 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.146 | (e) |
|FISHER EXACT | P=0.682 P=0.376 P=0.223 | (e) (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/130 (0%) 0/60 (0%) 1/60 (2%) 2/130 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 1.8% 1.8% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/66 (0%) 0/33 (0%) 0/31 (0%) 0/53 (0%) | 0/35 (0%) 0/34 (0%) 0/31 (0%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 437 361 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.106 (e) P=0.351 P=0.227 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.163 (e) P=0.450 P=0.366 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.158 (e) P=0.277 P=0.271 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.118 | (e) |
|FISHER EXACT | (e) P=0.316 P=0.249 | (e) (e) (e) |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 31
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma or Osteoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/130 (0%) 0/60 (0%) 1/60 (2%) 2/130 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 1.8% 1.8% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/66 (0%) 0/33 (0%) 0/31 (0%) 0/53 (0%) | 0/35 (0%) 0/34 (0%) 0/31 (0%) 0/26 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 437 361 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.106 (e) P=0.351 P=0.227 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.163 (e) P=0.450 P=0.366 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.158 (e) P=0.277 P=0.271 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.118 | (e) |
|FISHER EXACT | (e) P=0.316 P=0.249 | (e) (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) |117/130 (90%) 54/60 (90%) 58/60 (97%) 109/130 (84%)| 42/60 (70%) 32/60 (53%) 45/60 (75%) 27/60 (45%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 87.4% 70.6% 93.7% 74.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 19/20 (95%) 10/10 (100%) 10/10 (100%) 20/20 (100%)| 1/10 (10%) 2/10 (20%) 1/10 (10%) 2/10 (20%) |
|TERMINAL (d) | 66/66 (100%) 33/33 (100%) 31/31 (100%) 53/53 (100%)| 29/35 (83%) 21/34 (62%) 28/31 (90%) 17/26 (65%) |
|FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 396 423 | 458 (I) 432 458 (I) 458 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.084 P=0.242N P=0.343 P=0.152 | P=0.379N P=0.103N P=0.219 P=0.201N |
|INCIDENTAL TUMOR | P=0.223N P=0.076N P=0.654N P=0.167N | P=0.088N P=0.059N P=0.500 P=0.060N |
|LOGISTIC REGRESSION | P=0.411N P=0.561N P=0.757 P=0.322N | P=0.120N P=0.100N P=0.502 P=0.058N |
|COCHRAN-ARMITAGE | P=0.065N | P=0.014N* |
|FISHER EXACT | P=0.593N P=0.093 P=0.099N | P=0.045N* P=0.342 P=0.005N** |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 32
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 84 MG/KG 168 337.5 | 0 MG/KG 84 MG/KG 168 337.5 |
| | FEED RTD MG/KG STOP | MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 41/130 (32%) 24/60 (40%) 24/60 (40%) 30/130 (23%)| 22/60 (37%) 21/60 (35%) 17/60 (28%) 12/60 (20%) |
|ADJUSTED (b) | 46.1% 54.8% 51.3% 40.6% | 46.8% 47.6% 39.2% 32.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 2/20 (10%) 0/10 (0%) 0/10 (0%) 0/20 (0%) | 1/10 (10%) 0/10 (0%) 1/10 (10%) 0/10 (0%) |
|TERMINAL (d) | 20/66 (30%) 14/33 (42%) 9/31 (29%) 15/53 (28%) | 11/35 (31%) 12/34 (35%) 7/31 (23%) 4/26 (15%) |
|FIRST INCIDENCE (DAYS) | 456 (I) 414 414 361 | 260 218 458 (I) 358 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.249N P=0.278 P=0.212 P=0.301N | P=0.131N P=0.546N P=0.286N P=0.187N |
|INCIDENTAL TUMOR | P=0.023N* P=0.169 P=0.293 P=0.065N | P=0.010N** P=0.578N P=0.154N P=0.052N |
|LOGISTIC REGRESSION | P=0.065N P=0.151 P=0.212 P=0.130N | P=0.028N* P=0.529N P=0.202N P=0.054N |
|COCHRAN-ARMITAGE | P=0.043N* | P=0.018N* |
|FISHER EXACT | P=0.164 P=0.164 P=0.082N | P=0.500N P=0.218N P=0.034N* |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) |117/130 (90%) 56/60 (93%) 59/60 (98%) 114/130 (88%)| 46/60 (77%) 43/60 (72%) 49/60 (82%) 33/60 (55%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 90.1% 84.0% 94.2% 79.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/10 (0%) | |
|INTERIM SACRIFICE 2 (c)| 19/20 (95%) 10/10 (100%) 10/10 (100%) 20/20 (100%)| 2/10 (20%) 2/10 (20%) 2/10 (20%) 2/10 (20%) |
|TERMINAL (d) | 66/66 (100%) 33/33 (100%) 31/31 (100%) 53/53 (100%)| 30/35 (86%) 26/34 (76%) 28/31 (90%) 18/26 (69%) |
|FIRST INCIDENCE (DAYS) | 456 (I) 414 396 361 | 260 218 458 (I) 358 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.029 * P=0.398N P=0.273 P=0.056 | P=0.435N P=0.470N P=0.237 P=0.378N |
|INCIDENTAL TUMOR | P=0.134 P=0.585N P=0.638 P=0.366 | P=0.014N* P=0.289N P=0.437 P=0.069N |
|LOGISTIC REGRESSION | P=0.119 P=0.697N P=0.472 P=0.309 | P=0.057N P=0.448N P=0.484 P=0.082N |
|COCHRAN-ARMITAGE | P=0.249N | P=0.007N** |
|FISHER EXACT | P=0.326 P=0.032 * P=0.347N | P=0.339N P=0.327 P=0.010N* |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05099 TEST: 07 PAGE 33
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SALICYLAZOSULFAPYRIDINE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 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): 183 456
Female interim sacrifices(days): 458
(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).