TDMS Study 05002-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst GAMMA-BUTYROLACTONE DATE: 09/02/94
EXPERIMENT: 05002 TEST: 06 TIME: 19:57:36
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1CP9565101 ROUTE: GAVAGE NTP C#: 55878
PATHOLOGIST: J. HEATH CAS: 96-48-0
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst GAMMA-BUTYROLACTONE DATE: 09/02/94
EXPERIMENT: 05002 TEST: 06 TIME: 19:57:36
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1CP9565101 ROUTE: GAVAGE NTP C#: 55878
PATHOLOGIST: J. HEATH CAS: 96-48-0
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 Gland
Bone Marrow
Brain
Clitoral Gland
Epididymis
Gallbladder
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 GAMMA-BUTYROLACTONE DATE: 09/02/94
EXPERIMENT: 05002 TEST: 06 TIME: 19:57:36
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1CP9565101 ROUTE: GAVAGE NTP C#: 55878
PATHOLOGIST: J. HEATH CAS: 96-48-0
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF GAMMA-BUTYROLACTONE
====================================================================================================
MALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
Harderian Gland Adenoma
Carcinoma or Adenoma
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Stomach, Forestomach Squamous Cell Papilloma
All Organs Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
FEMALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
Liver Hepatocellular Adenoma
====================================================================================================
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 06 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 262. 525. | VEHICLE 262. 525. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/48 (6%) 3/50 (6%) 1/50 (2%) | 1/50 (2%) 0/1 (0%) 0/50 (0%) |
|ADJUSTED (b) | 8.8% 10.0% 8.3% | 2.6% 0.0% 0.0% |
|TERMINAL (d) | 3/34 (9%) 3/30 (10%) 1/12 (8%) | 1/38 (3%) 0/1 (0%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) | 730 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.602 P=0.605 P=0.705N | P=0.308N P=0.999N P=0.500N |
|INCIDENTAL TUMOR | P=0.602 P=0.605 P=0.705N | P=0.308N P=0.999N P=0.500N |
|LOGISTIC REGRESSION | P=0.602 P=0.605 P=0.705N | P=0.308N P=0.999N P=0.500N |
|COCHRAN-ARMITAGE | P=0.224N | P=0.307N |
|FISHER EXACT | P=0.641N P=0.293N | P=0.980N P=0.500N |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 5/50 (10%) 1/50 (2%) | 0/50 (0%) 0/0 (0%) 1/49 (2%) |
|ADJUSTED (b) | 2.3% 16.7% 5.3% | 0.0% 0.0% 2.7% |
|TERMINAL (d) | 0/34 (0%) 5/30 (17%) 0/12 (0%) | 0/38 (0%) 0/0 1/37 (3%) |
|FIRST INCIDENCE (DAYS) | 582 729 (T) 640 | --- --- 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.242 P=0.076 P=0.612 | P=0.304 (e) P=0.495 |
|INCIDENTAL TUMOR | P=0.376 P=0.069 P=0.673N | P=0.304 (e) P=0.495 |
|LOGISTIC REGRESSION | P=0.352 P=0.073 P=0.760 | P=0.304 (e) P=0.495 |
|COCHRAN-ARMITAGE | P=0.576N | P=0.304 |
|FISHER EXACT | P=0.112 P=0.742N | (e) P=0.495 |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 06 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 262. 525. | VEHICLE 262. 525. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 6/50 (12%) 1/50 (2%) | 0/50 (0%) 0/0 (0%) 2/49 (4%) |
|ADJUSTED (b) | 4.9% 20.0% 5.3% | 0.0% 0.0% 4.7% |
|TERMINAL (d) | 0/34 (0%) 6/30 (20%) 0/12 (0%) | 0/38 (0%) 0/0 1/37 (3%) |
|FIRST INCIDENCE (DAYS) | 582 729 (T) 640 | --- --- 592 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.335 P=0.095 P=0.716 | P=0.124 (e) P=0.239 |
|INCIDENTAL TUMOR | P=0.563 P=0.083 P=0.327N | P=0.082 (e) P=0.152 |
|LOGISTIC REGRESSION | P=0.472 P=0.092 P=0.592N | P=0.082 (e) P=0.152 |
|COCHRAN-ARMITAGE | P=0.396N | P=0.139 |
|FISHER EXACT | P=0.148 P=0.485N | (e) P=0.242 |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 1/50 (2%) 0/50 (0%) | 1/50 (2%) 2/50 (4%) 3/50 (6%) |
|ADJUSTED (b) | 21.9% 3.3% 0.0% | 2.5% 5.9% 7.6% |
|TERMINAL (d) | 7/35 (20%) 1/30 (3%) 0/12 (0%) | 0/38 (0%) 2/34 (6%) 2/38 (5%) |
|FIRST INCIDENCE (DAYS) | 582 729 (T) --- | 673 730 (T) 693 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.009N** P=0.031N* P=0.081N | P=0.233 P=0.459 P=0.315 |
|INCIDENTAL TUMOR | P=0.007N** P=0.034N* P=0.055N | P=0.329 P=0.355 P=0.430 |
|LOGISTIC REGRESSION | P=0.006N** P=0.033N* P=0.043N* | P=0.286 P=0.475 P=0.370 |
|COCHRAN-ARMITAGE | P<0.001N** | P=0.222 |
|FISHER EXACT | P=0.015N* P=0.003N** | P=0.500 P=0.309 |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 06 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 262. 525. | VEHICLE 262. 525. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 1/50 (2%) 0/50 (0%) | 2/50 (4%) 2/50 (4%) 4/50 (8%) |
|ADJUSTED (b) | 21.9% 3.3% 0.0% | 4.8% 5.9% 10.1% |
|TERMINAL (d) | 7/35 (20%) 1/30 (3%) 0/12 (0%) | 0/38 (0%) 2/34 (6%) 3/38 (8%) |
|FIRST INCIDENCE (DAYS) | 582 729 (T) --- | 630 730 (T) 693 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.009N** P=0.031N* P=0.081N | P=0.268 P=0.653 P=0.353 |
|INCIDENTAL TUMOR | P=0.007N** P=0.034N* P=0.055N | P=0.316 P=0.609 P=0.378 |
|LOGISTIC REGRESSION | P=0.006N** P=0.033N* P=0.043N* | P=0.255 P=0.692N P=0.336 |
|COCHRAN-ARMITAGE | P<0.001N** | P=0.252 |
|FISHER EXACT | P=0.015N* P=0.003N** | P=0.691N P=0.339 |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/49 (0%) 0/48 (0%) | 1/50 (2%) 0/49 (0%) 2/47 (4%) |
|ADJUSTED (b) | 2.9% 0.0% 0.0% | 2.6% 0.0% 4.9% |
|TERMINAL (d) | 1/35 (3%) 0/30 (0%) 0/12 (0%) | 1/38 (3%) 0/34 (0%) 1/36 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- --- | 730 (T) --- 641 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.391N P=0.531N P=0.713N | P=0.365 P=0.522N P=0.501 |
|INCIDENTAL TUMOR | P=0.391N P=0.531N P=0.713N | P=0.292 P=0.522N P=0.397 |
|LOGISTIC REGRESSION | P=0.391N P=0.531N P=0.713N | P=0.344 P=0.522N P=0.475 |
|COCHRAN-ARMITAGE | P=0.276N | P=0.344 |
|FISHER EXACT | P=0.505N P=0.510N | P=0.505N P=0.477 |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 06 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 262. 525. | VEHICLE 262. 525. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/49 (0%) 0/48 (0%) | 1/50 (2%) 1/49 (2%) 2/47 (4%) |
|ADJUSTED (b) | 2.9% 0.0% 0.0% | 2.6% 2.9% 4.9% |
|TERMINAL (d) | 1/35 (3%) 0/30 (0%) 0/12 (0%) | 1/38 (3%) 1/34 (3%) 1/36 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- --- | 730 (T) 730 (T) 641 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.391N P=0.531N P=0.713N | P=0.378 P=0.737 P=0.501 |
|INCIDENTAL TUMOR | P=0.391N P=0.531N P=0.713N | P=0.315 P=0.737 P=0.397 |
|LOGISTIC REGRESSION | P=0.391N P=0.531N P=0.713N | P=0.363 P=0.737 P=0.475 |
|COCHRAN-ARMITAGE | P=0.276N | P=0.359 |
|FISHER EXACT | P=0.505N P=0.510N | P=0.747 P=0.477 |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 5.0% 3.3% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/35 (3%) 1/30 (3%) 0/12 (0%) | 0/38 (0%) 0/34 (0%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | 540 729 (T) --- | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.282N P=0.561N P=0.416N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.206N P=0.482N P=0.285N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.199N P=0.525N P=0.282N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.142N | (e) |
|FISHER EXACT | P=0.500N P=0.247N | (e) (e) |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 06 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 262. 525. | VEHICLE 262. 525. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 6/50 (12%) 1/50 (2%) | 5/50 (10%) 0/50 (0%) 3/50 (6%) |
|ADJUSTED (b) | 21.9% 17.3% 8.3% | 13.2% 0.0% 7.2% |
|TERMINAL (d) | 7/35 (20%) 3/30 (10%) 1/12 (8%) | 5/38 (13%) 0/34 (0%) 2/38 (5%) |
|FIRST INCIDENCE (DAYS) | 582 344 729 (T) | 730 (T) --- 592 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.185N P=0.508N P=0.232N | P=0.256N P=0.043N* P=0.356N |
|INCIDENTAL TUMOR | P=0.052N P=0.460N P=0.178N | P=0.282N P=0.043N* P=0.410N |
|LOGISTIC REGRESSION | P=0.068N P=0.465N P=0.144N | P=0.250N P=0.043N* P=0.351N |
|COCHRAN-ARMITAGE | P=0.015N* | P=0.253N |
|FISHER EXACT | P=0.387N P=0.015N* | P=0.028N* P=0.357N |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 2/50 (4%) 8/50 (16%) | 4/50 (8%) 2/50 (4%) 1/50 (2%) |
|ADJUSTED (b) | 37.3% 5.6% 33.8% | 9.9% 5.4% 2.6% |
|TERMINAL (d) | 9/35 (26%) 0/30 (0%) 1/12 (8%) | 3/38 (8%) 1/34 (3%) 1/38 (3%) |
|FIRST INCIDENCE (DAYS) | 385 584 514 | 592 624 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.357N P=0.002N** P=0.484 | P=0.121N P=0.384N P=0.180N |
|INCIDENTAL TUMOR | P=0.019N* P<0.001N** P=0.074N | P=0.154N P=0.328N P=0.228N |
|LOGISTIC REGRESSION | P=0.019N* P<0.001N** P=0.180N | P=0.118N P=0.324N P=0.180N |
|COCHRAN-ARMITAGE | P=0.024N* | P=0.118N |
|FISHER EXACT | P<0.001N** P=0.050N | P=0.339N P=0.181N |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 06 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 262. 525. | VEHICLE 262. 525. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 24/50 (48%) 8/50 (16%) 9/50 (18%) | 8/50 (16%) 2/50 (4%) 4/50 (8%) |
|ADJUSTED (b) | 55.3% 21.9% 39.8% | 20.2% 5.4% 9.8% |
|TERMINAL (d) | 16/35 (46%) 3/30 (10%) 2/12 (17%) | 7/38 (18%) 1/34 (3%) 3/38 (8%) |
|FIRST INCIDENCE (DAYS) | 385 344 514 | 592 624 592 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.168N P=0.008N** P=0.447N | P=0.118N P=0.069N P=0.179N |
|INCIDENTAL TUMOR | P=0.001N** P=0.002N** P=0.017N* | P=0.156N P=0.054N P=0.244N |
|LOGISTIC REGRESSION | P=0.002N** P=0.001N** P=0.033N* | P=0.115N P=0.055N P=0.177N |
|COCHRAN-ARMITAGE | P<0.001N** | P=0.115N |
|FISHER EXACT | P<0.001N** P=0.001N** | P=0.046N* P=0.178N |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 24/50 (48%) 8/50 (16%) 9/50 (18%) | 8/50 (16%) 2/50 (4%) 4/50 (8%) |
|ADJUSTED (b) | 55.3% 21.9% 39.8% | 20.2% 5.4% 9.8% |
|TERMINAL (d) | 16/35 (46%) 3/30 (10%) 2/12 (17%) | 7/38 (18%) 1/34 (3%) 3/38 (8%) |
|FIRST INCIDENCE (DAYS) | 385 344 514 | 592 624 592 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.168N P=0.008N** P=0.447N | P=0.118N P=0.069N P=0.179N |
|INCIDENTAL TUMOR | P=0.001N** P=0.002N** P=0.017N* | P=0.156N P=0.054N P=0.244N |
|LOGISTIC REGRESSION | P=0.002N** P=0.001N** P=0.033N* | P=0.115N P=0.055N P=0.177N |
|COCHRAN-ARMITAGE | P<0.001N** | P=0.115N |
|FISHER EXACT | P<0.001N** P=0.001N** | P=0.046N* P=0.178N |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 06 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 262. 525. | VEHICLE 262. 525. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 9/50 (18%) 6/50 (12%) | 5/50 (10%) 3/50 (6%) 3/50 (6%) |
|ADJUSTED (b) | 27.7% 27.4% 28.2% | 13.2% 8.8% 7.9% |
|TERMINAL (d) | 9/35 (26%) 7/30 (23%) 1/12 (8%) | 5/38 (13%) 3/34 (9%) 3/38 (8%) |
|FIRST INCIDENCE (DAYS) | 703 187 568 | 730 (T) 730 (T) 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.255 P=0.555 P=0.284 | P=0.284N P=0.418N P=0.355N |
|INCIDENTAL TUMOR | P=0.441N P=0.596N P=0.552N | P=0.284N P=0.418N P=0.355N |
|LOGISTIC REGRESSION | P=0.535N P=0.562 P=0.581 | P=0.284N P=0.418N P=0.355N |
|COCHRAN-ARMITAGE | P=0.174N | P=0.283N |
|FISHER EXACT | P=0.500N P=0.207N | P=0.357N P=0.357N |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% | 4.7% 2.5% 2.6% |
|TERMINAL (d) | 0/35 (0%) 0/30 (0%) 0/12 (0%) | 1/38 (3%) 0/34 (0%) 1/38 (3%) |
|FIRST INCIDENCE (DAYS) | --- --- --- | 586 624 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.374N P=0.526N P=0.500N |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.474N P=0.446N P=0.590N |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.371N P=0.399N P=0.496N |
|COCHRAN-ARMITAGE | (e) | P=0.379N |
|FISHER EXACT | (e) (e) | P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 06 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 262. 525. | VEHICLE 262. 525. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 9/50 (18%) 6/50 (12%) | 7/50 (14%) 4/50 (8%) 4/50 (8%) |
|ADJUSTED (b) | 27.7% 27.4% 28.2% | 17.5% 11.1% 10.5% |
|TERMINAL (d) | 9/35 (26%) 7/30 (23%) 1/12 (8%) | 6/38 (16%) 3/34 (9%) 4/38 (11%) |
|FIRST INCIDENCE (DAYS) | 703 187 568 | 586 624 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.255 P=0.555 P=0.284 | P=0.204N P=0.324N P=0.261N |
|INCIDENTAL TUMOR | P=0.441N P=0.596N P=0.552N | P=0.241N P=0.284N P=0.302N |
|LOGISTIC REGRESSION | P=0.535N P=0.562 P=0.581 | P=0.198N P=0.293N P=0.252N |
|COCHRAN-ARMITAGE | P=0.174N | P=0.203N |
|FISHER EXACT | P=0.500N P=0.207N | P=0.262N P=0.262N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% | 5.3% 2.2% 2.6% |
|TERMINAL (d) | 0/35 (0%) 0/30 (0%) 0/12 (0%) | 2/38 (5%) 0/34 (0%) 1/38 (3%) |
|FIRST INCIDENCE (DAYS) | --- --- --- | 730 (T) 560 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.384N P=0.535N P=0.500N |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.425N P=0.493N P=0.500N |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.378N P=0.461N P=0.500N |
|COCHRAN-ARMITAGE | (e) | P=0.379N |
|FISHER EXACT | (e) (e) | P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 06 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 262. 525. | VEHICLE 262. 525. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Mesentery |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% | 0.0% 5.9% 2.4% |
|TERMINAL (d) | 0/35 (0%) 0/30 (0%) 0/12 (0%) | 0/38 (0%) 2/34 (6%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- | --- 730 (T) 693 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.370 P=0.214 P=0.510 |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.447 P=0.214 P=0.638 |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.369 P=0.214 P=0.500 |
|COCHRAN-ARMITAGE | (e) | P=0.361 |
|FISHER EXACT | (e) (e) | P=0.247 P=0.500 |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 1/48 (2%) 1/49 (2%) 4/46 (9%) |
|ADJUSTED (b) | | 2.8% 3.0% 10.9% |
|TERMINAL (d) | | 1/36 (3%) 1/33 (3%) 3/34 (9%) |
|FIRST INCIDENCE (DAYS) | | 730 (T) 730 (T) 655 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.098 P=0.742 P=0.172 |
|INCIDENTAL TUMOR | | P=0.127 P=0.742 P=0.206 |
|LOGISTIC REGRESSION | | P=0.097 P=0.742 P=0.169 |
|COCHRAN-ARMITAGE | | P=0.092 |
|FISHER EXACT | | P=0.747N P=0.168 |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 06 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 262. 525. | VEHICLE 262. 525. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/43 (0%) 0/48 (0%) 0/43 (0%) | 3/48 (6%) 5/48 (10%) 7/43 (16%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% | 8.0% 15.2% 20.6% |
|TERMINAL (d) | 0/31 (0%) 0/29 (0%) 0/12 (0%) | 2/36 (6%) 5/33 (15%) 7/34 (21%) |
|FIRST INCIDENCE (DAYS) | --- --- --- | 697 730 (T) 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.105 P=0.306 P=0.139 |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.114 P=0.249 P=0.149 |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.105 P=0.306 P=0.137 |
|COCHRAN-ARMITAGE | (e) | P=0.086 |
|FISHER EXACT | (e) (e) | P=0.357 P=0.117 |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibrosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 6/50 (12%) 6/50 (12%) | 1/50 (2%) 3/50 (6%) 0/50 (0%) |
|ADJUSTED (b) | 23.2% 18.4% 28.9% | 2.6% 7.6% 0.0% |
|TERMINAL (d) | 6/35 (17%) 4/30 (13%) 1/12 (8%) | 0/38 (0%) 1/34 (3%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | 578 605 545 | 697 477 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.274 P=0.419N P=0.266 | P=0.371N P=0.274 P=0.495N |
|INCIDENTAL TUMOR | P=0.366N P=0.474N P=0.426N | P=0.251N P=0.401 P=0.362N |
|LOGISTIC REGRESSION | P=0.545 P=0.397N P=0.575 | P=0.348N P=0.431 P=0.500N |
|COCHRAN-ARMITAGE | P=0.236N | P=0.378N |
|FISHER EXACT | P=0.288N P=0.288N | P=0.309 P=0.500N |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 06 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 262. 525. | VEHICLE 262. 525. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, Sarcoma, |
| Neurofibroma, or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 7/50 (14%) 6/50 (12%) | 1/50 (2%) 3/50 (6%) 1/50 (2%) |
|ADJUSTED (b) | 25.9% 21.6% 28.9% | 2.6% 7.6% 2.6% |
|TERMINAL (d) | 7/35 (20%) 5/30 (17%) 1/12 (8%) | 0/38 (0%) 1/34 (3%) 1/38 (3%) |
|FIRST INCIDENCE (DAYS) | 578 605 545 | 697 477 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.322 P=0.438N P=0.321 | P=0.597N P=0.274 P=0.757N |
|INCIDENTAL TUMOR | P=0.326N P=0.492N P=0.369N | P=0.500N P=0.401 P=0.686N |
|LOGISTIC REGRESSION | P=0.516N P=0.425N P=0.593N | P=0.605N P=0.431 P=0.761N |
|COCHRAN-ARMITAGE | P=0.166N | P=0.609N |
|FISHER EXACT | P=0.298N P=0.207N | P=0.309 P=0.753N |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 2/50 (4%) 1/50 (2%) | 2/50 (4%) 5/50 (10%) 4/50 (8%) |
|ADJUSTED (b) | 18.9% 6.7% 7.7% | 5.3% 14.7% 10.1% |
|TERMINAL (d) | 6/35 (17%) 2/30 (7%) 0/12 (0%) | 2/38 (5%) 5/34 (15%) 3/38 (8%) |
|FIRST INCIDENCE (DAYS) | 473 729 (T) 703 | 730 (T) 730 (T) 693 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.116N P=0.124N P=0.286N | P=0.289 P=0.172 P=0.342 |
|INCIDENTAL TUMOR | P=0.060N P=0.101N P=0.140N | P=0.327 P=0.172 P=0.389 |
|LOGISTIC REGRESSION | P=0.063N P=0.121N P=0.140N | P=0.300 P=0.172 P=0.349 |
|COCHRAN-ARMITAGE | P=0.014N* | P=0.283 |
|FISHER EXACT | P=0.080N P=0.030N* | P=0.218 P=0.339 |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 06 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 262. 525. | VEHICLE 262. 525. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 2/50 (4%) 2/48 (4%) | 0/49 (0%) 3/48 (6%) 1/50 (2%) |
|ADJUSTED (b) | 2.9% 6.7% 13.5% | 0.0% 8.5% 2.6% |
|TERMINAL (d) | 1/34 (3%) 2/30 (7%) 0/12 (0%) | 0/37 (0%) 2/32 (6%) 1/38 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 656 | --- 617 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.117 P=0.456 P=0.188 | P=0.394 P=0.104 P=0.505 |
|INCIDENTAL TUMOR | P=0.314 P=0.456 P=0.549 | P=0.338 P=0.121 P=0.505 |
|LOGISTIC REGRESSION | P=0.171 P=0.456 P=0.285 | P=0.388 P=0.114 P=0.505 |
|COCHRAN-ARMITAGE | P=0.383 | P=0.386 |
|FISHER EXACT | P=0.508 P=0.492 | P=0.117 P=0.505 |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 2/50 (4%) 2/48 (4%) | 0/49 (0%) 3/48 (6%) 1/50 (2%) |
|ADJUSTED (b) | 5.9% 6.7% 13.5% | 0.0% 8.5% 2.6% |
|TERMINAL (d) | 2/34 (6%) 2/30 (7%) 0/12 (0%) | 0/37 (0%) 2/32 (6%) 1/38 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 656 | --- 617 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.245 P=0.650 P=0.316 | P=0.394 P=0.104 P=0.505 |
|INCIDENTAL TUMOR | P=0.476 P=0.650 P=0.658 | P=0.338 P=0.121 P=0.505 |
|LOGISTIC REGRESSION | P=0.321 P=0.650 P=0.432 | P=0.388 P=0.114 P=0.505 |
|COCHRAN-ARMITAGE | P=0.593 | P=0.386 |
|FISHER EXACT | P=0.684N P=0.684 | P=0.117 P=0.505 |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 06 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 262. 525. | VEHICLE 262. 525. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | | 0.0% 5.0% 0.0% |
|TERMINAL (d) | | 0/38 (0%) 1/34 (3%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | | --- 551 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.662 P=0.221 (e) |
|INCIDENTAL TUMOR | | P=0.610 P=0.258 (e) |
|LOGISTIC REGRESSION | | P=0.666N P=0.300 (e) |
|COCHRAN-ARMITAGE | | P=0.668N |
|FISHER EXACT | | P=0.247 (e) |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 2/50 (4%) 2/50 (4%) 1/50 (2%) |
|ADJUSTED (b) | | 5.1% 5.3% 2.6% |
|TERMINAL (d) | | 1/38 (3%) 1/34 (3%) 1/38 (3%) |
|FIRST INCIDENCE (DAYS) | | 673 617 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.387N P=0.656 P=0.497N |
|INCIDENTAL TUMOR | | P=0.371N P=0.609 P=0.422N |
|LOGISTIC REGRESSION | | P=0.391N P=0.686N P=0.498N |
|COCHRAN-ARMITAGE | | P=0.390N |
|FISHER EXACT | | P=0.691N P=0.500N |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 06 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 262. 525. | VEHICLE 262. 525. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/50 (2%) | 2/50 (4%) 3/50 (6%) 1/50 (2%) |
|ADJUSTED (b) | 7.8% 3.3% 8.3% | 4.9% 8.8% 2.4% |
|TERMINAL (d) | 2/35 (6%) 1/30 (3%) 1/12 (8%) | 1/38 (3%) 3/34 (9%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | 540 729 (T) 729 (T) | 617 730 (T) 693 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.464N P=0.369N P=0.654N | P=0.394N P=0.455 P=0.486N |
|INCIDENTAL TUMOR | P=0.391N P=0.305N P=0.553N | P=0.382N P=0.486 P=0.512N |
|LOGISTIC REGRESSION | P=0.359N P=0.344N P=0.507N | P=0.398N P=0.474 P=0.495N |
|COCHRAN-ARMITAGE | P=0.202N | P=0.399N |
|FISHER EXACT | P=0.309N P=0.309N | P=0.500 P=0.500N |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/50 (2%) | 3/50 (6%) 3/50 (6%) 1/50 (2%) |
|ADJUSTED (b) | 7.8% 3.3% 8.3% | 7.5% 8.8% 2.4% |
|TERMINAL (d) | 2/35 (6%) 1/30 (3%) 1/12 (8%) | 2/38 (5%) 3/34 (9%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | 540 729 (T) 729 (T) | 617 730 (T) 693 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.464N P=0.369N P=0.654N | P=0.239N P=0.615 P=0.298N |
|INCIDENTAL TUMOR | P=0.391N P=0.305N P=0.553N | P=0.228N P=0.642 P=0.311N |
|LOGISTIC REGRESSION | P=0.359N P=0.344N P=0.507N | P=0.237N P=0.631 P=0.305N |
|COCHRAN-ARMITAGE | P=0.202N | P=0.238N |
|FISHER EXACT | P=0.309N P=0.309N | P=0.661N P=0.309N |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 06 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 262. 525. | VEHICLE 262. 525. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma And Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 1/50 (2%) | 11/50 (22%) 9/50 (18%) 9/50 (18%) |
|ADJUSTED (b) | 10.5% 9.5% 3.0% | 28.9% 23.1% 22.1% |
|TERMINAL (d) | 3/35 (9%) 2/30 (7%) 0/12 (0%) | 11/38 (29%) 6/34 (18%) 7/38 (18%) |
|FIRST INCIDENCE (DAYS) | 441 613 427 | 730 (T) 464 643 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.404N P=0.592N P=0.474N | P=0.348N P=0.502N P=0.393N |
|INCIDENTAL TUMOR | P=0.244N P=0.555N P=0.308N | P=0.342N P=0.365N P=0.405N |
|LOGISTIC REGRESSION | P=0.195N P=0.547N P=0.205N | P=0.348N P=0.353N P=0.375N |
|COCHRAN-ARMITAGE | P=0.133N | P=0.352N |
|FISHER EXACT | P=0.500N P=0.181N | P=0.402N P=0.402N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 1/50 (2%) | 11/50 (22%) 9/50 (18%) 9/50 (18%) |
|ADJUSTED (b) | 10.5% 9.5% 3.0% | 28.9% 23.1% 22.1% |
|TERMINAL (d) | 3/35 (9%) 2/30 (7%) 0/12 (0%) | 11/38 (29%) 6/34 (18%) 7/38 (18%) |
|FIRST INCIDENCE (DAYS) | 441 613 427 | 730 (T) 464 643 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.404N P=0.592N P=0.474N | P=0.348N P=0.502N P=0.393N |
|INCIDENTAL TUMOR | P=0.244N P=0.555N P=0.308N | P=0.342N P=0.365N P=0.405N |
|LOGISTIC REGRESSION | P=0.195N P=0.547N P=0.205N | P=0.348N P=0.353N P=0.375N |
|COCHRAN-ARMITAGE | P=0.133N | P=0.352N |
|FISHER EXACT | P=0.500N P=0.181N | P=0.402N P=0.402N |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 06 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 262. 525. | VEHICLE 262. 525. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 25/50 (50%) 26/50 (52%) 12/50 (24%) | 17/50 (34%) 21/50 (42%) 25/50 (50%) |
|ADJUSTED (b) | 63.7% 73.9% 53.3% | 42.5% 59.8% 59.1% |
|TERMINAL (d) | 21/35 (60%) 21/30 (70%) 3/12 (25%) | 15/38 (39%) 20/34 (59%) 21/38 (55%) |
|FIRST INCIDENCE (DAYS) | 473 187 512 | 673 617 592 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.213 P=0.210 P=0.333 | P=0.067 P=0.134 P=0.086 |
|INCIDENTAL TUMOR | P=0.200N P=0.270 P=0.201N | P=0.074 P=0.098 P=0.090 |
|LOGISTIC REGRESSION | P=0.284N P=0.207 P=0.276N | P=0.073 P=0.127 P=0.085 |
|COCHRAN-ARMITAGE | P=0.006N** | P=0.064 |
|FISHER EXACT | P=0.500 P=0.006N** | P=0.268 P=0.078 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 29/50 (58%) 12/50 (24%) 16/50 (32%) | 24/50 (48%) 20/50 (40%) 16/50 (32%) |
|ADJUSTED (b) | 62.6% 34.8% 61.1% | 54.1% 46.4% 35.9% |
|TERMINAL (d) | 18/35 (51%) 8/30 (27%) 3/12 (25%) | 18/38 (47%) 12/34 (35%) 10/38 (26%) |
|FIRST INCIDENCE (DAYS) | 385 584 427 | 584 464 592 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.435 P=0.011N* P=0.245 | P=0.082N P=0.440N P=0.091N |
|INCIDENTAL TUMOR | P=0.017N* P=0.003N** P=0.028N* | P=0.083N P=0.183N P=0.136N |
|LOGISTIC REGRESSION | P=0.021N* P=0.001N** P=0.049N* | P=0.063N P=0.214N P=0.077N |
|COCHRAN-ARMITAGE | P=0.005N** | P=0.063N |
|FISHER EXACT | P<0.001N** P=0.008N** | P=0.273N P=0.076N |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 06 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 262. 525. | VEHICLE 262. 525. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 40/50 (80%) 31/50 (62%) 23/50 (46%) | 33/50 (66%) 31/50 (62%) 35/50 (70%) |
|ADJUSTED (b) | 85.0% 81.4% 78.3% | 73.1% 73.2% 75.9% |
|TERMINAL (d) | 28/35 (80%) 23/30 (77%) 6/12 (50%) | 26/38 (68%) 23/34 (68%) 27/38 (71%) |
|FIRST INCIDENCE (DAYS) | 385 187 427 | 584 464 592 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.107 P=0.338N P=0.095 | P=0.420 P=0.480 P=0.454 |
|INCIDENTAL TUMOR | P=0.028N* P=0.161N P=0.038N* | P=0.342 P=0.429N P=0.295 |
|LOGISTIC REGRESSION | P=0.117N P=0.159N P=0.039N* | P=0.380 P=0.473N P=0.422 |
|COCHRAN-ARMITAGE | P<0.001N** | P=0.376 |
|FISHER EXACT | P=0.038N* P<0.001N** | P=0.418N P=0.415 |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for
intercurrent mortality.
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death. The incidental tumor
test regards these lesions as non-fatal. Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fisher's exact tests compare directly the overall incidence rates.
For all tests, a negative trend is indicated by "N".
(e) Value of Statistic cannot be computed.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).