TDMS Study 05067-10 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst THEOPHYLLINE DATE: 07/03/96
EXPERIMENT: 05067 TEST: 10 TIME: 12:40:28
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-05297 ROUTE: GAVAGE NTP C#: 61609D
PATHOLOGIST: ROGER THOMPSON CAS: 58-55-9
------------------------------------------------------------------------------------------------------------------------------------
CORE STUDY
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst THEOPHYLLINE DATE: 07/03/96
EXPERIMENT: 05067 TEST: 10 TIME: 12:40:28
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-05297 ROUTE: GAVAGE NTP C#: 61609D
PATHOLOGIST: ROGER THOMPSON CAS: 58-55-9
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
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 THEOPHYLLINE DATE: 07/03/96
EXPERIMENT: 05067 TEST: 10 TIME: 12:40:28
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-05297 ROUTE: GAVAGE NTP C#: 61609D
PATHOLOGIST: ROGER THOMPSON CAS: 58-55-9
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF THEOPHYLLINE
====================================================================================================
MALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
All Organs Hemangiosarcoma
Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated
Cell Type
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
FEMALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
All Organs Histiocytic Sarcoma
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 07/03/96 EXPERIMENT: 05067 TEST: 10 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 15 MG/KG 50 MG/KG 150 | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 1/50 (2%) 1/49 (2%) | 1/49 (2%) 0/50 (0%) 0/50 (0%) 1/49 (2%) |
|ADJUSTED (b) | 11.1% 5.7% 2.3% 3.8% | 2.8% 0.0% 0.0% 3.0% |
|TERMINAL (d) | 4/36 (11%) 2/35 (6%) 1/44 (2%) 1/26 (4%) | 1/36 (3%) 0/37 (0%) 0/34 (0%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | 725 (T) 725 (T) 725 (T) 725 (T) | 725 (T) --- --- 725 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.255N P=0.349N P=0.124N P=0.288N | P=0.514 P=0.495N P=0.511N P=0.742 |
|INCIDENTAL TUMOR | P=0.255N P=0.349N P=0.124N P=0.288N | P=0.514 P=0.495N P=0.511N P=0.742 |
|LOGISTIC REGRESSION | P=0.255N P=0.349N P=0.124N P=0.288N | P=0.514 P=0.495N P=0.511N P=0.742 |
|COCHRAN-ARMITAGE | P=0.182N | P=0.534 |
|FISHER EXACT | P=0.339N P=0.181N P=0.187N | P=0.495N P=0.495N P=0.753N |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/50 (2%) 0/49 (0%) 0/49 (0%) | 1/50 (2%) 2/48 (4%) 2/50 (4%) 1/49 (2%) |
|ADJUSTED (b) | 0.0% 2.9% 0.0% 0.0% | 2.7% 5.4% 5.9% 3.0% |
|TERMINAL (d) | 0/35 (0%) 1/35 (3%) 0/44 (0%) 0/26 (0%) | 1/37 (3%) 2/37 (5%) 2/34 (6%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | --- 725 (T) --- --- | 725 (T) 725 (T) 725 (T) 725 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.631N P=0.500 (e) (e) | P=0.567N P=0.500 P=0.470 P=0.736 |
|INCIDENTAL TUMOR | P=0.631N P=0.500 (e) (e) | P=0.567N P=0.500 P=0.470 P=0.736 |
|LOGISTIC REGRESSION | P=0.631N P=0.500 (e) (e) | P=0.567N P=0.500 P=0.470 P=0.736 |
|COCHRAN-ARMITAGE | P=0.578N | P=0.523N |
|FISHER EXACT | P=0.505 (e) (e) | P=0.485 P=0.500 P=0.747 |
|=================================================================================================================================|
DATE: 07/03/96 EXPERIMENT: 05067 TEST: 10 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 15 MG/KG 50 MG/KG 150 | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|ADJUSTED (b) | 4.9% 2.1% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/36 (3%) 0/35 (0%) 0/44 (0%) 0/26 (0%) | 0/37 (0%) 0/37 (0%) 0/34 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 635 511 --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.216N P=0.520N P=0.213N P=0.327N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.182N P=0.364N P=0.270N P=0.380N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.097N P=0.412N P=0.266N P=0.297N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.172N | (e) |
|FISHER EXACT | P=0.500N P=0.247N P=0.253N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 2/50 (4%) 2/50 (4%) | 6/50 (12%) 5/50 (10%) 4/50 (8%) 2/50 (4%) |
|ADJUSTED (b) | 2.4% 8.6% 4.5% 6.7% | 15.3% 12.7% 10.5% 6.1% |
|TERMINAL (d) | 0/36 (0%) 3/35 (9%) 2/44 (5%) 1/26 (4%) | 4/37 (11%) 4/37 (11%) 2/34 (6%) 2/33 (6%) |
|FIRST INCIDENCE (DAYS) | 700 725 (T) 725 (T) 407 | 654 603 688 725 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.440 P=0.288 P=0.554 P=0.369 | P=0.135N P=0.497N P=0.382N P=0.164N |
|INCIDENTAL TUMOR | P=0.464 P=0.228 P=0.452 P=0.390 | P=0.091N P=0.471N P=0.126N P=0.088N |
|LOGISTIC REGRESSION | P=0.513 P=0.275 P=0.519 P=0.522 | P=0.117N P=0.496N P=0.093N P=0.147N |
|COCHRAN-ARMITAGE | P=0.586 | P=0.105N |
|FISHER EXACT | P=0.309 P=0.500 P=0.500 | P=0.500N P=0.370N P=0.134N |
|=================================================================================================================================|
DATE: 07/03/96 EXPERIMENT: 05067 TEST: 10 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 15 MG/KG 50 MG/KG 150 | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 5.1% 0.0% |
|TERMINAL (d) | 0/36 (0%) 0/35 (0%) 0/44 (0%) 0/26 (0%) | 0/37 (0%) 0/37 (0%) 1/34 (3%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- 661 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.710N (e) P=0.249 (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.646N (e) P=0.365 (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.699N (e) P=0.229 (e) |
|COCHRAN-ARMITAGE | (e) | P=0.697N |
|FISHER EXACT | (e) (e) (e) | (e) P=0.247 (e) |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 2/50 (4%) 2/50 (4%) | 6/50 (12%) 5/50 (10%) 6/50 (12%) 2/50 (4%) |
|ADJUSTED (b) | 2.4% 8.6% 4.5% 6.7% | 15.3% 12.7% 15.3% 6.1% |
|TERMINAL (d) | 0/36 (0%) 3/35 (9%) 2/44 (5%) 1/26 (4%) | 4/37 (11%) 4/37 (11%) 3/34 (9%) 2/33 (6%) |
|FIRST INCIDENCE (DAYS) | 700 725 (T) 725 (T) 407 | 654 603 661 725 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.440 P=0.288 P=0.554 P=0.369 | P=0.143N P=0.497N P=0.614 P=0.164N |
|INCIDENTAL TUMOR | P=0.464 P=0.228 P=0.452 P=0.390 | P=0.087N P=0.471N P=0.281N P=0.088N |
|LOGISTIC REGRESSION | P=0.513 P=0.275 P=0.519 P=0.522 | P=0.124N P=0.496N P=0.264N P=0.147N |
|COCHRAN-ARMITAGE | P=0.586 | P=0.111N |
|FISHER EXACT | P=0.309 P=0.500 P=0.500 | P=0.500N P=0.620N P=0.134N |
|=================================================================================================================================|
DATE: 07/03/96 EXPERIMENT: 05067 TEST: 10 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 15 MG/KG 50 MG/KG 150 | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 4.9% 8.3% 2.3% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/36 (3%) 2/35 (6%) 1/44 (2%) 0/26 (0%) | 0/37 (0%) 0/37 (0%) 0/34 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 635 711 725 (T) --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.146N P=0.477 P=0.449N P=0.327N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.193N P=0.450 P=0.512N P=0.335N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.151N P=0.479 P=0.525N P=0.292N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.104N | (e) |
|FISHER EXACT | P=0.500 P=0.500N P=0.247N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 21/50 (42%) 18/50 (36%) 12/50 (24%) 2/50 (4%) | 20/50 (40%) 11/50 (22%) 12/50 (24%) 3/50 (6%) |
|ADJUSTED (b) | 52.1% 48.1% 26.6% 7.7% | 48.3% 29.7% 34.0% 9.1% |
|TERMINAL (d) | 17/36 (47%) 16/35 (46%) 11/44 (25%) 2/26 (8%) | 16/37 (43%) 11/37 (30%) 11/34 (32%) 3/33 (9%) |
|FIRST INCIDENCE (DAYS) | 605 521 668 725 (T) | 624 725 (T) 669 725 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001N** P=0.396N P=0.011N* P<0.001N** | P<0.001N** P=0.042N* P=0.098N P<0.001N** |
|INCIDENTAL TUMOR | P<0.001N** P=0.363N P=0.026N* P<0.001N** | P<0.001N** P=0.044N* P=0.158N P<0.001N** |
|LOGISTIC REGRESSION | P<0.001N** P=0.447N P=0.030N* P<0.001N** | P<0.001N** P=0.035N* P=0.049N* P<0.001N** |
|COCHRAN-ARMITAGE | P<0.001N** | P<0.001N** |
|FISHER EXACT | P=0.341N P=0.044N* P<0.001N** | P=0.041N* P=0.066N P<0.001N** |
|=================================================================================================================================|
DATE: 07/03/96 EXPERIMENT: 05067 TEST: 10 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 15 MG/KG 50 MG/KG 150 | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 19/50 (38%) 14/50 (28%) 12/50 (24%) 2/50 (4%) | 11/50 (22%) 5/50 (10%) 6/50 (12%) 5/50 (10%) |
|ADJUSTED (b) | 42.0% 32.2% 26.0% 7.2% | 26.0% 11.8% 15.3% 14.6% |
|TERMINAL (d) | 11/36 (31%) 7/35 (20%) 10/44 (23%) 1/26 (4%) | 7/37 (19%) 2/37 (5%) 3/34 (9%) 4/33 (12%) |
|FIRST INCIDENCE (DAYS) | 485 464 556 636 | 501 591 667 704 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.001N** P=0.279N P=0.050N P=0.002N** | P=0.217N P=0.095N P=0.164N P=0.129N |
|INCIDENTAL TUMOR | P=0.001N** P=0.164N P=0.170N P=0.001N** | P=0.150N P=0.088N P=0.084N P=0.083N |
|LOGISTIC REGRESSION | P=0.002N** P=0.129N P=0.137N P=0.001N** | P=0.156N P=0.090N P=0.171N P=0.092N |
|COCHRAN-ARMITAGE | P<0.001N** | P=0.164N |
|FISHER EXACT | P=0.198N P=0.097N P<0.001N** | P=0.086N P=0.143N P=0.086N |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 34/50 (68%) 27/50 (54%) 22/50 (44%) 4/50 (8%) | 29/50 (58%) 14/50 (28%) 18/50 (36%) 8/50 (16%) |
|ADJUSTED (b) | 72.1% 62.2% 46.7% 14.6% | 64.1% 34.5% 46.7% 23.4% |
|TERMINAL (d) | 23/36 (64%) 19/35 (54%) 19/44 (43%) 3/26 (12%) | 21/37 (57%) 11/37 (30%) 14/34 (41%) 7/33 (21%) |
|FIRST INCIDENCE (DAYS) | 485 464 556 636 | 501 591 667 704 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001N** P=0.221N P=0.004N** P<0.001N** | P=0.002N** P=0.005N** P=0.050N* P<0.001N** |
|INCIDENTAL TUMOR | P<0.001N** P=0.123N P=0.021N* P<0.001N** | P<0.001N** P=0.003N** P=0.040N* P<0.001N** |
|LOGISTIC REGRESSION | P<0.001N** P=0.113N P=0.016N* P<0.001N** | P<0.001N** P=0.002N** P=0.020N* P<0.001N** |
|COCHRAN-ARMITAGE | P<0.001N** | P<0.001N** |
|FISHER EXACT | P=0.109N P=0.013N* P<0.001N** | P=0.002N** P=0.022N* P<0.001N** |
|=================================================================================================================================|
DATE: 07/03/96 EXPERIMENT: 05067 TEST: 10 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 15 MG/KG 50 MG/KG 150 | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 34/50 (68%) 27/50 (54%) 22/50 (44%) 4/50 (8%) | 29/50 (58%) 14/50 (28%) 18/50 (36%) 8/50 (16%) |
|ADJUSTED (b) | 72.1% 62.2% 46.7% 14.6% | 64.1% 34.5% 46.7% 23.4% |
|TERMINAL (d) | 23/36 (64%) 19/35 (54%) 19/44 (43%) 3/26 (12%) | 21/37 (57%) 11/37 (30%) 14/34 (41%) 7/33 (21%) |
|FIRST INCIDENCE (DAYS) | 485 464 556 636 | 501 591 667 704 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001N** P=0.221N P=0.004N** P<0.001N** | P=0.002N** P=0.005N** P=0.050N* P<0.001N** |
|INCIDENTAL TUMOR | P<0.001N** P=0.123N P=0.021N* P<0.001N** | P<0.001N** P=0.003N** P=0.040N* P<0.001N** |
|LOGISTIC REGRESSION | P<0.001N** P=0.113N P=0.016N* P<0.001N** | P<0.001N** P=0.002N** P=0.020N* P<0.001N** |
|COCHRAN-ARMITAGE | P<0.001N** | P<0.001N** |
|FISHER EXACT | P=0.109N P=0.013N* P<0.001N** | P=0.002N** P=0.022N* P<0.001N** |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 8/50 (16%) 10/50 (20%) 4/50 (8%) | 3/50 (6%) 4/50 (8%) 4/50 (8%) 3/50 (6%) |
|ADJUSTED (b) | 22.2% 22.0% 22.7% 14.6% | 7.6% 9.7% 10.8% 9.1% |
|TERMINAL (d) | 8/36 (22%) 7/35 (20%) 10/44 (23%) 3/26 (12%) | 2/37 (5%) 2/37 (5%) 3/34 (9%) 3/33 (9%) |
|FIRST INCIDENCE (DAYS) | 725 (T) 633 725 (T) 636 | 642 611 655 725 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.300N P=0.580 P=0.585 P=0.372N | P=0.567N P=0.502 P=0.485 P=0.614 |
|INCIDENTAL TUMOR | P=0.317N P=0.605 P=0.585 P=0.378N | P=0.556 P=0.472 P=0.482 P=0.556 |
|LOGISTIC REGRESSION | P=0.366N P=0.534 P=0.585 P=0.441N | P=0.533N P=0.494 P=0.505 P=0.645 |
|COCHRAN-ARMITAGE | P=0.123N | P=0.514N |
|FISHER EXACT | P=0.607N P=0.398 P=0.178N | P=0.500 P=0.500 P=0.661N |
|=================================================================================================================================|
DATE: 07/03/96 EXPERIMENT: 05067 TEST: 10 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 15 MG/KG 50 MG/KG 150 | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 1/50 (2%) 5/50 (10%) 1/50 (2%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 15.9% 2.9% 11.0% 3.8% | 2.7% 2.0% 0.0% 0.0% |
|TERMINAL (d) | 5/36 (14%) 1/35 (3%) 4/44 (9%) 1/26 (4%) | 1/37 (3%) 0/37 (0%) 0/34 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 700 725 (T) 620 725 (T) | 725 (T) 584 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.221N P=0.066N P=0.383N P=0.131N | P=0.321N P=0.753N P=0.517N P=0.523N |
|INCIDENTAL TUMOR | P=0.261N P=0.082N P=0.468N P=0.172N | P=0.388N P=0.747 P=0.517N P=0.523N |
|LOGISTIC REGRESSION | P=0.246N P=0.071N P=0.477N P=0.148N | P=0.249N P=0.755 P=0.517N P=0.523N |
|COCHRAN-ARMITAGE | P=0.126N | P=0.303N |
|FISHER EXACT | P=0.056N P=0.500N P=0.056N | P=0.753N P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 9/50 (18%) 15/50 (30%) 5/50 (10%) | 4/50 (8%) 5/50 (10%) 4/50 (8%) 3/50 (6%) |
|ADJUSTED (b) | 34.9% 24.8% 33.2% 18.3% | 10.2% 11.6% 10.8% 9.1% |
|TERMINAL (d) | 12/36 (33%) 8/35 (23%) 14/44 (32%) 4/26 (15%) | 3/37 (8%) 2/37 (5%) 3/34 (9%) 3/33 (9%) |
|FIRST INCIDENCE (DAYS) | 700 633 620 636 | 642 584 655 725 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.172N P=0.262N P=0.532N P=0.139N | P=0.408N P=0.506 P=0.623 P=0.557N |
|INCIDENTAL TUMOR | P=0.205N P=0.270N P=0.585 P=0.173N | P=0.498N P=0.467 P=0.626 P=0.613N |
|LOGISTIC REGRESSION | P=0.231N P=0.306N P=0.512 P=0.189N | P=0.355N P=0.489 P=0.634N P=0.522N |
|COCHRAN-ARMITAGE | P=0.045N* | P=0.352N |
|FISHER EXACT | P=0.235N P=0.412 P=0.033N* | P=0.500 P=0.643N P=0.500N |
|=================================================================================================================================|
DATE: 07/03/96 EXPERIMENT: 05067 TEST: 10 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 15 MG/KG 50 MG/KG 150 | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/44 (0%) | 9/49 (18%) 7/45 (16%) 7/50 (14%) 5/48 (10%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 24.1% 19.4% 20.6% 15.6% |
|TERMINAL (d) | 0/36 (0%) 0/35 (0%) 0/43 (0%) 0/25 (0%) | 8/36 (22%) 7/36 (19%) 7/34 (21%) 5/32 (16%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 643 725 (T) 725 (T) 725 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.261N P=0.391N P=0.432N P=0.257N |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.278N P=0.421N P=0.492N P=0.293N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.209N P=0.391N P=0.340N P=0.207N |
|COCHRAN-ARMITAGE | (e) | P=0.183N |
|FISHER EXACT | (e) (e) (e) | P=0.466N P=0.376N P=0.205N |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 4.9% 2.0% 0.0% | 5.2% 0.0% 2.6% 0.0% |
|TERMINAL (d) | 0/36 (0%) 0/35 (0%) 0/44 (0%) 0/26 (0%) | 1/37 (3%) 0/37 (0%) 0/34 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | --- 627 577 --- | 655 --- 704 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.480N P=0.217 P=0.504 (e) | P=0.279N P=0.237N P=0.488N P=0.247N |
|INCIDENTAL TUMOR | P=0.629N P=0.180 P=0.398 (e) | P=0.177N P=0.208N P=0.217N P=0.148N |
|LOGISTIC REGRESSION | P=0.305N P=0.258 P=0.305 (e) | P=0.271N P=0.239N P=0.509N P=0.240N |
|COCHRAN-ARMITAGE | P=0.378N | P=0.271N |
|FISHER EXACT | P=0.247 P=0.500 (e) | P=0.247N P=0.500N P=0.247N |
|=================================================================================================================================|
DATE: 07/03/96 EXPERIMENT: 05067 TEST: 10 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 15 MG/KG 50 MG/KG 150 | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 4.9% 2.0% 0.0% | 5.2% 0.0% 2.6% 0.0% |
|TERMINAL (d) | 0/36 (0%) 0/35 (0%) 0/44 (0%) 0/26 (0%) | 1/37 (3%) 0/37 (0%) 0/34 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | --- 627 577 --- | 655 --- 704 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.480N P=0.217 P=0.504 (e) | P=0.279N P=0.237N P=0.488N P=0.247N |
|INCIDENTAL TUMOR | P=0.629N P=0.180 P=0.398 (e) | P=0.177N P=0.208N P=0.217N P=0.148N |
|LOGISTIC REGRESSION | P=0.305N P=0.258 P=0.305 (e) | P=0.271N P=0.239N P=0.509N P=0.240N |
|COCHRAN-ARMITAGE | P=0.378N | P=0.271N |
|FISHER EXACT | P=0.247 P=0.500 (e) | P=0.247N P=0.500N P=0.247N |
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/49 (2%) 0/50 (0%) 0/49 (0%) | 0/50 (0%) 2/50 (4%) 0/49 (0%) 0/48 (0%) |
|ADJUSTED (b) | 4.9% 2.9% 0.0% 0.0% | 0.0% 4.7% 0.0% 0.0% |
|TERMINAL (d) | 1/36 (3%) 1/35 (3%) 0/44 (0%) 0/26 (0%) | 0/37 (0%) 1/37 (3%) 0/34 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 635 725 (T) --- --- | --- 591 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.207N P=0.523N P=0.213N P=0.327N | P=0.389N P=0.244 (e) (e) |
|INCIDENTAL TUMOR | P=0.226N P=0.468N P=0.270N P=0.335N | P=0.487N P=0.227 (e) (e) |
|LOGISTIC REGRESSION | P=0.194N P=0.509N P=0.266N P=0.294N | P=0.328N P=0.228 (e) (e) |
|COCHRAN-ARMITAGE | P=0.171N | P=0.377N |
|FISHER EXACT | P=0.508N P=0.247N P=0.253N | P=0.247 (e) (e) |
|=================================================================================================================================|
DATE: 07/03/96 EXPERIMENT: 05067 TEST: 10 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 15 MG/KG 50 MG/KG 150 | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/50 (8%) 1/50 (2%) 1/50 (2%) | 4/50 (8%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |
|ADJUSTED (b) | 2.8% 11.4% 2.3% 3.8% | 10.8% 5.4% 5.9% 5.3% |
|TERMINAL (d) | 1/36 (3%) 4/35 (11%) 1/44 (2%) 1/26 (4%) | 4/37 (11%) 2/37 (5%) 2/34 (6%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | 725 (T) 725 (T) 725 (T) 725 (T) | 725 (T) 725 (T) 725 (T) 627 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.445N P=0.170 P=0.716N P=0.688 | P=0.426N P=0.336N P=0.376N P=0.384N |
|INCIDENTAL TUMOR | P=0.445N P=0.170 P=0.716N P=0.688 | P=0.463N P=0.336N P=0.376N P=0.444N |
|LOGISTIC REGRESSION | P=0.445N P=0.170 P=0.716N P=0.688 | P=0.395N P=0.336N P=0.376N P=0.356N |
|COCHRAN-ARMITAGE | P=0.331N | P=0.375N |
|FISHER EXACT | P=0.181 P=0.753N P=0.753N | P=0.339N P=0.339N P=0.339N |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/50 (8%) 0/50 (0%) 1/50 (2%) | 4/50 (8%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |
|ADJUSTED (b) | 2.8% 11.4% 0.0% 3.8% | 10.8% 5.4% 5.9% 5.3% |
|TERMINAL (d) | 1/36 (3%) 4/35 (11%) 0/44 (0%) 1/26 (4%) | 4/37 (11%) 2/37 (5%) 2/34 (6%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | 725 (T) 725 (T) --- 725 (T) | 725 (T) 725 (T) 725 (T) 627 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.431N P=0.170 P=0.460N P=0.688 | P=0.426N P=0.336N P=0.376N P=0.384N |
|INCIDENTAL TUMOR | P=0.431N P=0.170 P=0.460N P=0.688 | P=0.463N P=0.336N P=0.376N P=0.444N |
|LOGISTIC REGRESSION | P=0.431N P=0.170 P=0.460N P=0.688 | P=0.395N P=0.336N P=0.376N P=0.356N |
|COCHRAN-ARMITAGE | P=0.329N | P=0.375N |
|FISHER EXACT | P=0.181 P=0.500N P=0.753N | P=0.339N P=0.339N P=0.339N |
|=================================================================================================================================|
DATE: 07/03/96 EXPERIMENT: 05067 TEST: 10 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 15 MG/KG 50 MG/KG 150 | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | 4/50 (8%) 2/50 (4%) 3/50 (6%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 2.9% 0.0% 7.2% | 10.8% 5.4% 8.8% 3.0% |
|TERMINAL (d) | 0/36 (0%) 1/35 (3%) 0/44 (0%) 1/26 (4%) | 4/37 (11%) 2/37 (5%) 3/34 (9%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | --- 725 (T) --- 636 | 725 (T) 725 (T) 725 (T) 725 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.086 P=0.494 (e) P=0.165 | P=0.229N P=0.336N P=0.547N P=0.214N |
|INCIDENTAL TUMOR | P=0.073 P=0.494 (e) P=0.154 | P=0.229N P=0.336N P=0.547N P=0.214N |
|LOGISTIC REGRESSION | P=0.091 P=0.494 (e) P=0.170 | P=0.229N P=0.336N P=0.547N P=0.214N |
|COCHRAN-ARMITAGE | P=0.151 | P=0.191N |
|FISHER EXACT | P=0.500 (e) P=0.247 | P=0.339N P=0.500N P=0.181N |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 2/50 (4%) | 4/50 (8%) 2/50 (4%) 3/50 (6%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 5.7% 0.0% 7.2% | 10.8% 5.4% 8.8% 3.0% |
|TERMINAL (d) | 0/36 (0%) 2/35 (6%) 0/44 (0%) 1/26 (4%) | 4/37 (11%) 2/37 (5%) 3/34 (9%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | --- 725 (T) --- 636 | 725 (T) 725 (T) 725 (T) 725 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.189 P=0.232 (e) P=0.165 | P=0.229N P=0.336N P=0.547N P=0.214N |
|INCIDENTAL TUMOR | P=0.170 P=0.232 (e) P=0.154 | P=0.229N P=0.336N P=0.547N P=0.214N |
|LOGISTIC REGRESSION | P=0.187 P=0.232 (e) P=0.170 | P=0.229N P=0.336N P=0.547N P=0.214N |
|COCHRAN-ARMITAGE | P=0.287 | P=0.191N |
|FISHER EXACT | P=0.247 (e) P=0.247 | P=0.339N P=0.500N P=0.181N |
|=================================================================================================================================|
DATE: 07/03/96 EXPERIMENT: 05067 TEST: 10 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 15 MG/KG 50 MG/KG 150 | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | | 5.4% 0.0% 2.9% 2.9% |
|TERMINAL (d) | | 2/37 (5%) 0/37 (0%) 1/34 (3%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | | 725 (T) --- 725 (T) 705 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.650N P=0.238N P=0.530N P=0.533N |
|INCIDENTAL TUMOR | | P=0.597N P=0.238N P=0.530N P=0.419N |
|LOGISTIC REGRESSION | | P=0.633N P=0.238N P=0.530N P=0.512N |
|COCHRAN-ARMITAGE | | P=0.619N |
|FISHER EXACT | | P=0.247N P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 7.7% 13.0% 4.5% 0.0% | 0.0% 4.7% 0.0% 0.0% |
|TERMINAL (d) | 2/36 (6%) 3/35 (9%) 2/44 (5%) 0/26 (0%) | 0/37 (0%) 1/37 (3%) 0/34 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 635 511 725 (T) --- | --- 591 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.072N P=0.339 P=0.424N P=0.194N | P=0.389N P=0.244 (e) (e) |
|INCIDENTAL TUMOR | P=0.073N P=0.373 P=0.473N P=0.199N | P=0.463N P=0.227 (e) (e) |
|LOGISTIC REGRESSION | P=0.058N P=0.368 P=0.501N P=0.182N | P=0.318N P=0.228 (e) (e) |
|COCHRAN-ARMITAGE | P=0.041N* | P=0.369N |
|FISHER EXACT | P=0.357 P=0.500N P=0.121N | P=0.247 (e) (e) |
|=================================================================================================================================|
DATE: 07/03/96 EXPERIMENT: 05067 TEST: 10 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 15 MG/KG 50 MG/KG 150 | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | 1/50 (2%) 8/50 (16%) 4/50 (8%) 2/50 (4%) |
|ADJUSTED (b) | 2.0% 2.3% 2.3% 0.0% | 2.7% 18.2% 10.4% 5.8% |
|TERMINAL (d) | 0/36 (0%) 0/35 (0%) 1/44 (2%) 0/26 (0%) | 1/37 (3%) 3/37 (8%) 1/34 (3%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | 485 569 725 (T) --- | 725 (T) 603 696 705 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.411N P=0.746 P=0.736N P=0.598N | P=0.305N P=0.023 * P=0.179 P=0.467 |
|INCIDENTAL TUMOR | P=0.325N P=0.619N P=0.540 P=0.282N | P=0.269N P=0.016 * P=0.441 P=0.581 |
|LOGISTIC REGRESSION | P=0.171N P=0.650N P=0.628 P=0.344N | P=0.252N P=0.016 * P=0.189 P=0.488 |
|COCHRAN-ARMITAGE | P=0.323N | P=0.266N |
|FISHER EXACT | P=0.753N P=0.753N P=0.500N | P=0.015 * P=0.181 P=0.500 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated |
| Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 3/50 (6%) 5/50 (10%) 1/50 (2%) | 11/50 (22%) 8/50 (16%) 10/50 (20%) 8/50 (16%) |
|ADJUSTED (b) | 12.0% 7.9% 10.8% 2.8% | 26.6% 21.1% 24.3% 20.4% |
|TERMINAL (d) | 3/36 (8%) 2/35 (6%) 3/44 (7%) 0/26 (0%) | 8/37 (22%) 7/37 (19%) 5/34 (15%) 4/33 (12%) |
|FIRST INCIDENCE (DAYS) | 438 562 668 382 | 555 702 593 578 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.219N P=0.378N P=0.540N P=0.212N | P=0.445N P=0.307N P=0.526N P=0.385N |
|INCIDENTAL TUMOR | P=0.162N P=0.231N P=0.326 P=0.028N* | P=0.428N P=0.310N P=0.515N P=0.468N |
|LOGISTIC REGRESSION | P=0.056N P=0.245N P=0.470 P=0.041N* | P=0.368N P=0.302N P=0.541N P=0.306N |
|COCHRAN-ARMITAGE | P=0.111N | P=0.356N |
|FISHER EXACT | P=0.357N P=0.630N P=0.102N | P=0.306N P=0.500N P=0.306N |
|=================================================================================================================================|
DATE: 07/03/96 EXPERIMENT: 05067 TEST: 10 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 15 MG/KG 50 MG/KG 150 | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 29/50 (58%) 29/50 (58%) 22/50 (44%) 9/50 (18%) | 33/50 (66%) 27/50 (54%) 27/50 (54%) 18/50 (36%) |
|ADJUSTED (b) | 70.4% 76.0% 48.8% 31.5% | 76.6% 67.2% 70.6% 49.6% |
|TERMINAL (d) | 24/36 (67%) 26/35 (74%) 21/44 (48%) 7/26 (27%) | 27/37 (73%) 24/37 (65%) 23/34 (68%) 15/33 (45%) |
|FIRST INCIDENCE (DAYS) | 605 521 668 407 | 624 603 655 627 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001N** P=0.494 P=0.017N* P=0.004N** | P=0.013N* P=0.158N P=0.252N P=0.012N* |
|INCIDENTAL TUMOR | P<0.001N** P=0.517 P=0.042N* P=0.004N** | P=0.010N** P=0.150N P=0.156N P=0.007N** |
|LOGISTIC REGRESSION | P<0.001N** P=0.380 P=0.058N P=0.005N** | P=0.004N** P=0.123N P=0.079N P=0.003N** |
|COCHRAN-ARMITAGE | P<0.001N** | P=0.003N** |
|FISHER EXACT | P=0.580N P=0.115N P<0.001N** | P=0.154N P=0.154N P=0.002N** |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 32/50 (64%) 24/50 (48%) 25/50 (50%) 4/50 (8%) | 26/50 (52%) 24/50 (48%) 22/50 (44%) 17/50 (34%) |
|ADJUSTED (b) | 66.2% 50.5% 50.0% 13.4% | 56.0% 48.7% 48.3% 41.1% |
|TERMINAL (d) | 20/36 (56%) 12/35 (34%) 19/44 (43%) 2/26 (8%) | 17/37 (46%) 12/37 (32%) 11/34 (32%) 9/33 (27%) |
|FIRST INCIDENCE (DAYS) | 438 421 556 382 | 501 494 593 578 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001N** P=0.190N P=0.047N* P<0.001N** | P=0.126N P=0.424N P=0.342N P=0.140N |
|INCIDENTAL TUMOR | P<0.001N** P=0.046N* P=0.280N P<0.001N** | P=0.044N* P=0.425N P=0.175N P=0.053N |
|LOGISTIC REGRESSION | P<0.001N** P=0.029N* P=0.262N P<0.001N** | P=0.103N P=0.445N P=0.335N P=0.059N |
|COCHRAN-ARMITAGE | P<0.001N** | P=0.039N* |
|FISHER EXACT | P=0.079N P=0.113N P<0.001N** | P=0.421N P=0.274N P=0.053N |
|=================================================================================================================================|
DATE: 07/03/96 EXPERIMENT: 05067 TEST: 10 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 15 MG/KG 50 MG/KG 150 | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 44/50 (88%) 42/50 (84%) 38/50 (76%) 13/50 (26%) | 46/50 (92%) 39/50 (78%) 41/50 (82%) 28/50 (56%) |
|ADJUSTED (b) | 89.7% 87.4% 76.0% 42.6% | 92.0% 79.5% 87.1% 66.6% |
|TERMINAL (d) | 31/36 (86%) 29/35 (83%) 32/44 (73%) 9/26 (35%) | 33/37 (89%) 27/37 (73%) 28/34 (82%) 19/33 (58%) |
|FIRST INCIDENCE (DAYS) | 438 421 556 382 | 501 494 593 578 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001N** P=0.555N P=0.019N* P<0.001N** | P=0.014N* P=0.154N P=0.343N P=0.010N* |
|INCIDENTAL TUMOR | P<0.001N** P=0.362N P=0.164N P<0.001N** | P<0.001N** P=0.049N* P=0.097N P<0.001N** |
|LOGISTIC REGRESSION | P<0.001N** P=0.348N P=0.164N P<0.001N** | P<0.001N** P=0.046N* P=0.118N P<0.001N** |
|COCHRAN-ARMITAGE | P<0.001N** | P<0.001N** |
|FISHER EXACT | P=0.387N P=0.096N P<0.001N** | P=0.045N* P=0.117N P<0.001N** |
|=================================================================================================================================|
(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).