TDMS Study 05099-99 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: SOUTHERN RESEARCH INST SALICYLAZOSULFAPYRIDINE DATE: 05/05/95
EXPERIMENT: 05099 TEST: 99 TIME: 09:58:26
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85233 ROUTE: GAVAGE NTP C#: 61552B
PATHOLOGIST: R.B. THOMPSON CAS: 599-79-1
05099/08 -VS- 05099/10 COMPARISON
MICE(B6C3F1)
----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
----------------
Adrenal Cortex
Adrenal Medulla
Bone Marrow
Brain
Epididymis
Gallbladder
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Nose
Pancreas
Parathyroid Gland
Pituitary Gland
Preputial Gland
Prostate
Salivary Glands
Spleen
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: SOUTHERN RESEARCH INST SALICYLAZOSULFAPYRIDINE DATE: 05/05/95
EXPERIMENT: 05099 TEST: 99 TIME: 09:58:26
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85233 ROUTE: GAVAGE NTP C#: 61552B
PATHOLOGIST: R.B. THOMPSON CAS: 599-79-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF SALICYLAZOSULFAPYRIDINE
====================================================================================================
MALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
All Organs Hemangiosarcoma or Hemangioma
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
====================================================================================================
DATE: 05/05/95 EXPERIMENT: 05099 TEST: 99 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 104 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG RTD |
| | 0 MG/KG |
|==============================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 2/50 (4%) 2/52 (4%) |
|ADJUSTED (b) | 5.0% 4.5% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/42 (0%) |
|TERMINAL (d) | 2/40 (5%) 0/0 |
|FIRST INCIDENCE (DAYS) | 728 (T) 660 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.518 |
|INCIDENTAL TUMOR | P=0.581 |
|LOGISTIC REGRESSION | P=0.480N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.676N |
|==============================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 3/50 (6%) 3/52 (6%) |
|ADJUSTED (b) | 7.5% 6.7% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/42 (0%) |
|TERMINAL (d) | 3/40 (8%) 0/0 |
|FIRST INCIDENCE (DAYS) | 728 (T) 660 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.258 |
|INCIDENTAL TUMOR | P=0.323 |
|LOGISTIC REGRESSION | P=0.462N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.642N |
|==============================================================================|
DATE: 05/05/95 EXPERIMENT: 05099 TEST: 99 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 104 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG RTD |
| | 0 MG/KG |
|==============================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/52 (0%) |
|ADJUSTED (b) | 5.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/42 (0%) |
|TERMINAL (d) | 2/40 (5%) 0/0 |
|FIRST INCIDENCE (DAYS) | 728 (T) --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) |
|INCIDENTAL TUMOR | (e) (e) |
|LOGISTIC REGRESSION | P=0.207N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.238N |
|==============================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 13/50 (26%) 13/52 (25%) |
|ADJUSTED (b) | 32.5% 28.7% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/42 (0%) |
|TERMINAL (d) | 13/40 (33%) 0/0 |
|FIRST INCIDENCE (DAYS) | 728 (T) 616 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.145 |
|INCIDENTAL TUMOR | P=0.196 |
|LOGISTIC REGRESSION | P=0.004N** |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.544N |
|==============================================================================|
DATE: 05/05/95 EXPERIMENT: 05099 TEST: 99 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 104 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG RTD |
| | 0 MG/KG |
|==============================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 13/50 (26%) 7/52 (13%) |
|ADJUSTED (b) | 29.2% 14.9% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/42 (0%) |
|TERMINAL (d) | 9/40 (23%) 0/0 |
|FIRST INCIDENCE (DAYS) | 420 495 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.454N |
|INCIDENTAL TUMOR | P=0.438N |
|LOGISTIC REGRESSION | P=0.002N** |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.089N |
|==============================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 24/50 (48%) 18/52 (35%) |
|ADJUSTED (b) | 54.3% 37.1% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/42 (0%) |
|TERMINAL (d) | 20/40 (50%) 0/0 |
|FIRST INCIDENCE (DAYS) | 420 495 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.434 |
|INCIDENTAL TUMOR | P=0.488 |
|LOGISTIC REGRESSION | P<0.001N** |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.121N |
|==============================================================================|
DATE: 05/05/95 EXPERIMENT: 05099 TEST: 99 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 104 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG RTD |
| | 0 MG/KG |
|==============================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 24/50 (48%) 18/52 (35%) |
|ADJUSTED (b) | 54.3% 37.1% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/42 (0%) |
|TERMINAL (d) | 20/40 (50%) 0/0 |
|FIRST INCIDENCE (DAYS) | 420 495 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.434 |
|INCIDENTAL TUMOR | P=0.488 |
|LOGISTIC REGRESSION | P<0.001N** |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.121N |
|==============================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 11/50 (22%) 11/52 (21%) |
|ADJUSTED (b) | 27.5% 24.9% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/42 (0%) |
|TERMINAL (d) | 11/40 (28%) 0/0 |
|FIRST INCIDENCE (DAYS) | 728 (T) 717 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.263 |
|INCIDENTAL TUMOR | P=0.323 |
|LOGISTIC REGRESSION | P=0.004N** |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.554N |
|==============================================================================|
DATE: 05/05/95 EXPERIMENT: 05099 TEST: 99 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 104 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG RTD |
| | 0 MG/KG |
|==============================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 2/52 (4%) |
|ADJUSTED (b) | 7.3% 4.5% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/42 (0%) |
|TERMINAL (d) | 2/40 (5%) 0/0 |
|FIRST INCIDENCE (DAYS) | 689 661 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.742N |
|INCIDENTAL TUMOR | P=0.677N |
|LOGISTIC REGRESSION | P=0.288N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.481N |
|==============================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 14/50 (28%) 13/52 (25%) |
|ADJUSTED (b) | 34.1% 28.8% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/42 (0%) |
|TERMINAL (d) | 13/40 (33%) 0/0 |
|FIRST INCIDENCE (DAYS) | 689 661 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.342 |
|INCIDENTAL TUMOR | P=0.450 |
|LOGISTIC REGRESSION | P=0.005N** |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.453N |
|==============================================================================|
DATE: 05/05/95 EXPERIMENT: 05099 TEST: 99 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 104 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG RTD |
| | 0 MG/KG |
|==============================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 3/50 (6%) 2/52 (4%) |
|ADJUSTED (b) | 7.5% 4.8% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/42 (0%) |
|TERMINAL (d) | 3/40 (8%) 0/0 |
|FIRST INCIDENCE (DAYS) | 728 (T) 728 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) |
|INCIDENTAL TUMOR | (e) (e) |
|LOGISTIC REGRESSION | P=0.096N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.481N |
|==============================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 3/50 (6%) 1/52 (2%) |
|ADJUSTED (b) | 7.5% 2.4% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/42 (0%) |
|TERMINAL (d) | 3/40 (8%) 0/0 |
|FIRST INCIDENCE (DAYS) | 728 (T) 728 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) |
|INCIDENTAL TUMOR | (e) (e) |
|LOGISTIC REGRESSION | P=0.096N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.294N |
|==============================================================================|
DATE: 05/05/95 EXPERIMENT: 05099 TEST: 99 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 104 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG RTD |
| | 0 MG/KG |
|==============================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 4/50 (8%) 1/52 (2%) |
|ADJUSTED (b) | 10.0% 2.4% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/42 (0%) |
|TERMINAL (d) | 4/40 (10%) 0/0 |
|FIRST INCIDENCE (DAYS) | 728 (T) 728 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) |
|INCIDENTAL TUMOR | (e) (e) |
|LOGISTIC REGRESSION | P=0.046N* |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.169N |
|==============================================================================|
| |
|All Organs |
| Malignant Lymphoma And Histiocytic Sarcoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 5/50 (10%) 6/52 (12%) |
|ADJUSTED (b) | 12.1% 13.4% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/42 (0%) |
|TERMINAL (d) | 4/40 (10%) 0/0 |
|FIRST INCIDENCE (DAYS) | 666 647 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.529 |
|INCIDENTAL TUMOR | P=0.656 |
|LOGISTIC REGRESSION | P=0.191N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.528 |
|==============================================================================|
DATE: 05/05/95 EXPERIMENT: 05099 TEST: 99 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 104 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG RTD |
| | 0 MG/KG |
|==============================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 5/50 (10%) 6/52 (12%) |
|ADJUSTED (b) | 12.1% 13.4% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/42 (0%) |
|TERMINAL (d) | 4/40 (10%) 0/0 |
|FIRST INCIDENCE (DAYS) | 666 647 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.529 |
|INCIDENTAL TUMOR | P=0.656 |
|LOGISTIC REGRESSION | P=0.191N |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.528 |
|==============================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 26/50 (52%) 26/52 (50%) |
|ADJUSTED (b) | 65.0% 56.4% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/42 (0%) |
|TERMINAL (d) | 26/40 (65%) 0/0 |
|FIRST INCIDENCE (DAYS) | 728 (T) 616 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.082 |
|INCIDENTAL TUMOR | P=0.109 |
|LOGISTIC REGRESSION | P<0.001N** |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.498N |
|==============================================================================|
DATE: 05/05/95 EXPERIMENT: 05099 TEST: 99 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 104 WEEKS
|==============================================================================|
|DOSE | 0 MG/KG RTD |
| | 0 MG/KG |
|==============================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 25/50 (50%) 19/52 (37%) |
|ADJUSTED (b) | 53.2% 37.8% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/42 (0%) |
|TERMINAL (d) | 18/40 (45%) 0/0 |
|FIRST INCIDENCE (DAYS) | 420 495 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.567 |
|INCIDENTAL TUMOR | P=0.516N |
|LOGISTIC REGRESSION | P<0.001N** |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.120N |
|==============================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # |
|----------- | |
|OVERALL (a) | 40/50 (80%) 37/52 (71%) |
|ADJUSTED (b) | 85.1% 72.5% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/42 (0%) |
|TERMINAL (d) | 33/40 (83%) 0/0 |
|FIRST INCIDENCE (DAYS) | 420 495 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.471 |
|INCIDENTAL TUMOR | P=0.738N |
|LOGISTIC REGRESSION | P<0.001N** |
|COCHRAN-ARMITAGE | |
|FISHER EXACT | P=0.210N |
|==============================================================================|
DATE: 05/05/95 EXPERIMENT: 05099 TEST: 99 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE MICE(B6C3F1) -- SALICYLAZOSULFAPYRIDINE
TERMINAL SACRIFICE AT 104 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): 729
Female interim sacrifices(days):
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death. The incidental tumor
test regards these lesions as non-fatal. Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fisher's exact tests compare directly the overall incidence rates.
For all tests, a negative trend is indicated by "N".
(e) Value of Statistic cannot be computed.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).