TDMS Study 05067-09 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst THEOPHYLLINE DATE: 07/11/96
EXPERIMENT: 05067 TEST: 09 TIME: 17:25:22
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-05297 ROUTE: GAVAGE NTP C#: 61609D
PATHOLOGIST: DANIEL FARNELL FARNELL, DANIEL R. 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: 07/11/96
EXPERIMENT: 05067 TEST: 09 TIME: 17:25:22
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-05297 ROUTE: GAVAGE NTP C#: 61609D
PATHOLOGIST: DANIEL FARNELL FARNELL, DANIEL R. CAS: 58-55-9
RATS(FISCHER344)
----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
----------------
Adrenal Cortex
Adrenal Medulla
Bone Marrow
Brain
Clitoral Gland
Clitoral/Preputial Gland
Epididymis
Heart
Islets, Pancreatic
Kidney
Larynx
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: 07/11/96
EXPERIMENT: 05067 TEST: 09 TIME: 17:25:22
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-05297 ROUTE: GAVAGE NTP C#: 61609D
PATHOLOGIST: DANIEL FARNELL FARNELL, DANIEL R. CAS: 58-55-9
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF THEOPHYLLINE
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Pancreas Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Skin Fibroma
Testes Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
All Organs Benign Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 07/11/96 EXPERIMENT: 05067 TEST: 09 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 7.5 25 MG/KG 75 MG/KG | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 5/49 (10%) 7/50 (14%) 10/50 (20%) | 2/50 (4%) 0/49 (0%) 0/50 (0%) 1/49 (2%) |
|ADJUSTED (b) | 25.7% 15.1% 24.1% 36.1% | 5.1% 0.0% 0.0% 3.0% |
|TERMINAL (d) | 5/23 (22%) 4/32 (13%) 7/29 (24%) 7/24 (29%) | 0/32 (0%) 0/30 (0%) 0/33 (0%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | 598 723 729 (T) 457 | 576 --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.070 P=0.206N P=0.467N P=0.283 | P=0.635N P=0.238N P=0.237N P=0.485N |
|INCIDENTAL TUMOR | P=0.058 P=0.304N P=0.510N P=0.201 | P=0.653N P=0.150N P=0.208N P=0.454N |
|LOGISTIC REGRESSION | P=0.043 * P=0.320N P=0.616N P=0.163 | P=0.650N P=0.233N P=0.260N P=0.504N |
|COCHRAN-ARMITAGE | P=0.143 | P=0.654N |
|FISHER EXACT | P=0.394N P=0.613N P=0.298 | P=0.253N P=0.247N P=0.508N |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/49 (4%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) |
|ADJUSTED (b) | 4.3% 5.2% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/23 (4%) 1/32 (3%) 0/29 (0%) 0/24 (0%) | 0/32 (0%) 0/30 (0%) 0/33 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 500 --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.236N P=0.571 P=0.454N P=0.492N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.151N P=0.518 P=0.454N P=0.492N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.198N P=0.495 P=0.454N P=0.492N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.208N | (e) |
|FISHER EXACT | P=0.492 P=0.500N P=0.500N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 07/11/96 EXPERIMENT: 05067 TEST: 09 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 7.5 25 MG/KG 75 MG/KG | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 7/49 (14%) 7/50 (14%) 10/50 (20%) | 3/50 (6%) 0/49 (0%) 0/50 (0%) 1/49 (2%) |
|ADJUSTED (b) | 29.8% 19.8% 24.1% 36.1% | 8.1% 0.0% 0.0% 3.0% |
|TERMINAL (d) | 6/23 (26%) 5/32 (16%) 7/29 (24%) 7/24 (29%) | 1/32 (3%) 0/30 (0%) 0/33 (0%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | 598 500 729 (T) 457 | 576 --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.159 P=0.292N P=0.342N P=0.384 | P=0.433N P=0.127N P=0.121N P=0.294N |
|INCIDENTAL TUMOR | P=0.169 P=0.420N P=0.381N P=0.293 | P=0.447N P=0.079N P=0.106N P=0.269N |
|LOGISTIC REGRESSION | P=0.115 P=0.480N P=0.496N P=0.234 | P=0.452N P=0.122N P=0.126N P=0.313N |
|COCHRAN-ARMITAGE | P=0.278 | P=0.452N |
|FISHER EXACT | P=0.517N P=0.500N P=0.398 | P=0.125N P=0.121N P=0.316N |
|=================================================================================================================================|
| |
|Brain |
| Oligodendroglioma, Glioma, or Astrocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/49 (4%) 0/50 (0%) 0/49 (0%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 5.0% 0.0% 0.0% | 2.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 1/33 (3%) 0/29 (0%) 0/24 (0%) | 0/32 (0%) 0/30 (0%) 0/33 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | --- 372 --- --- | 498 --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.386N P=0.277 (e) (e) | P=0.482N P=0.508N P=0.496N P=0.513N |
|INCIDENTAL TUMOR | P=0.276N P=0.219 (e) (e) | P=0.626N P=0.669N P=0.567N P=0.748N |
|LOGISTIC REGRESSION | P=0.261N P=0.273 (e) (e) | P=0.468N P=0.409N P=0.680N P=0.392N |
|COCHRAN-ARMITAGE | P=0.371N | P=0.474N |
|FISHER EXACT | P=0.242 (e) (e) | P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 07/11/96 EXPERIMENT: 05067 TEST: 09 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 7.5 25 MG/KG 75 MG/KG | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/49 (4%) 4/50 (8%) 3/50 (6%) | 4/49 (8%) 3/50 (6%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 5.6% 11.6% 12.5% | 11.7% 8.6% 2.6% 3.0% |
|TERMINAL (d) | 0/23 (0%) 1/32 (3%) 2/29 (7%) 3/24 (13%) | 3/32 (9%) 1/30 (3%) 0/33 (0%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | --- 666 498 729 (T) | 667 614 670 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.137 P=0.299 P=0.081 P=0.126 | P=0.127N P=0.532N P=0.179N P=0.175N |
|INCIDENTAL TUMOR | P=0.150 P=0.196 P=0.055 P=0.126 | P=0.128N P=0.449N P=0.159N P=0.174N |
|LOGISTIC REGRESSION | P=0.139 P=0.240 P=0.065 P=0.126 | P=0.131N P=0.507N P=0.167N P=0.172N |
|COCHRAN-ARMITAGE | P=0.200 | P=0.132N |
|FISHER EXACT | P=0.242 P=0.059 P=0.121 | P=0.489N P=0.175N P=0.175N |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/49 (4%) 0/50 (0%) 4/50 (8%) | 0/49 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 8.9% 6.3% 0.0% 13.7% | 0.0% 5.4% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 2/32 (6%) 0/29 (0%) 2/24 (8%) | 0/32 (0%) 0/30 (0%) 0/33 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 572 729 (T) --- 498 | --- 595 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.207 P=0.402N P=0.125N P=0.423 | P=0.362N P=0.237 (e) (e) |
|INCIDENTAL TUMOR | P=0.224 P=0.596N P=0.241N P=0.357 | P=0.370N P=0.342 (e) (e) |
|LOGISTIC REGRESSION | P=0.278 P=0.508N P=0.111N P=0.508 | P=0.365N P=0.249 (e) (e) |
|COCHRAN-ARMITAGE | P=0.291 | P=0.367N |
|FISHER EXACT | P=0.510N P=0.121N P=0.500 | P=0.253 (e) (e) |
|=================================================================================================================================|
DATE: 07/11/96 EXPERIMENT: 05067 TEST: 09 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 7.5 25 MG/KG 75 MG/KG | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/49 (8%) 4/50 (8%) 7/50 (14%) | 4/49 (8%) 5/50 (10%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 8.9% 11.7% 11.6% 25.4% | 11.7% 13.6% 2.6% 3.0% |
|TERMINAL (d) | 0/23 (0%) 3/32 (9%) 2/29 (7%) 5/24 (21%) | 3/32 (9%) 1/30 (3%) 0/33 (0%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | 572 666 498 498 | 667 595 670 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.056 P=0.622 P=0.533 P=0.131 | P=0.075N P=0.470 P=0.179N P=0.175N |
|INCIDENTAL TUMOR | P=0.064 P=0.391 P=0.348 P=0.096 | P=0.073N P=0.610 P=0.159N P=0.174N |
|LOGISTIC REGRESSION | P=0.076 P=0.494 P=0.516 P=0.118 | P=0.076N P=0.500 P=0.167N P=0.172N |
|COCHRAN-ARMITAGE | P=0.111 | P=0.077N |
|FISHER EXACT | P=0.489 P=0.500 P=0.159 | P=0.513 P=0.175N P=0.175N |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 11.9% 3.0% 0.0% 0.0% | 0.0% 2.9% 0.0% 0.0% |
|TERMINAL (d) | 1/23 (4%) 1/33 (3%) 0/29 (0%) 0/24 (0%) | 0/32 (0%) 0/30 (0%) 0/33 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 726 729 (T) --- --- | --- 670 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.109N P=0.203N P=0.095N P=0.126N | P=0.571N P=0.484 (e) (e) |
|INCIDENTAL TUMOR | P=0.157N P=0.357N P=0.209N P=0.255N | P=0.591N P=0.473 (e) (e) |
|LOGISTIC REGRESSION | P=0.114N P=0.211N P=0.102N P=0.132N | P=0.573N P=0.497 (e) (e) |
|COCHRAN-ARMITAGE | P=0.097N | P=0.575N |
|FISHER EXACT | P=0.309N P=0.121N P=0.121N | P=0.495 (e) (e) |
|=================================================================================================================================|
DATE: 07/11/96 EXPERIMENT: 05067 TEST: 09 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 7.5 25 MG/KG 75 MG/KG | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 2/49 (4%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 11.9% 3.0% 0.0% 0.0% | 0.0% 6.1% 0.0% 3.0% |
|TERMINAL (d) | 1/23 (4%) 1/33 (3%) 0/29 (0%) 0/24 (0%) | 0/32 (0%) 1/30 (3%) 0/33 (0%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | 726 729 (T) --- --- | --- 670 --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.109N P=0.203N P=0.095N P=0.126N | P=0.634 P=0.224 (e) P=0.506 |
|INCIDENTAL TUMOR | P=0.157N P=0.357N P=0.209N P=0.255N | P=0.625 P=0.218 (e) P=0.506 |
|LOGISTIC REGRESSION | P=0.114N P=0.211N P=0.102N P=0.132N | P=0.627 P=0.230 (e) P=0.506 |
|COCHRAN-ARMITAGE | P=0.097N | P=0.624 |
|FISHER EXACT | P=0.309N P=0.121N P=0.121N | P=0.242 (e) P=0.500 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 6.4% 6.1% 0.0% 3.2% | 0.0% 0.0% 3.0% 0.0% |
|TERMINAL (d) | 1/23 (4%) 2/33 (6%) 0/29 (0%) 0/24 (0%) | 0/32 (0%) 0/30 (0%) 1/33 (3%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 546 729 (T) --- 595 | --- --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.447N P=0.594N P=0.221N P=0.567N | P=0.777N (e) P=0.506 (e) |
|INCIDENTAL TUMOR | P=0.338N P=0.644N P=0.196N P=0.439N | P=0.777N (e) P=0.506 (e) |
|LOGISTIC REGRESSION | P=0.396N P=0.693N P=0.220N P=0.468N | P=0.777N (e) P=0.506 (e) |
|COCHRAN-ARMITAGE | P=0.382N | P=0.786N |
|FISHER EXACT | P=0.691N P=0.247N P=0.500N | (e) P=0.500 (e) |
|=================================================================================================================================|
DATE: 07/11/96 EXPERIMENT: 05067 TEST: 09 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 7.5 25 MG/KG 75 MG/KG | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 6.6% 0.0% 3.4% 8.3% | 0.0% 3.3% 0.0% 3.0% |
|TERMINAL (d) | 1/23 (4%) 0/33 (0%) 1/29 (3%) 2/24 (8%) | 0/32 (0%) 1/30 (3%) 0/33 (0%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | 614 --- 729 (T) 729 (T) | --- 729 (T) --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.340 P=0.198N P=0.458N P=0.676 | P=0.477 P=0.487 (e) P=0.506 |
|INCIDENTAL TUMOR | P=0.349 P=0.236N P=0.459N P=0.675 | P=0.477 P=0.487 (e) P=0.506 |
|LOGISTIC REGRESSION | P=0.322 P=0.238N P=0.509N P=0.628 | P=0.477 P=0.487 (e) P=0.506 |
|COCHRAN-ARMITAGE | P=0.404 | P=0.464 |
|FISHER EXACT | P=0.247N P=0.500N P=0.691N | P=0.500 (e) P=0.500 |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 10.9% 0.0% 3.4% 8.3% | 0.0% 3.3% 0.0% 3.0% |
|TERMINAL (d) | 2/23 (9%) 0/33 (0%) 1/29 (3%) 2/24 (8%) | 0/32 (0%) 1/30 (3%) 0/33 (0%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | 614 --- 729 (T) 729 (T) | --- 729 (T) --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.501 P=0.082N P=0.254N P=0.515N | P=0.477 P=0.487 (e) P=0.506 |
|INCIDENTAL TUMOR | P=0.509 P=0.099N P=0.255N P=0.517N | P=0.477 P=0.487 (e) P=0.506 |
|LOGISTIC REGRESSION | P=0.473 P=0.116N P=0.312N P=0.585N | P=0.477 P=0.487 (e) P=0.506 |
|COCHRAN-ARMITAGE | P=0.563 | P=0.464 |
|FISHER EXACT | P=0.121N P=0.309N P=0.500N | P=0.500 (e) P=0.500 |
|=================================================================================================================================|
DATE: 07/11/96 EXPERIMENT: 05067 TEST: 09 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 7.5 25 MG/KG 75 MG/KG | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | 22/50 (44%) 19/50 (38%) 12/50 (24%) 12/50 (24%) |
|ADJUSTED (b) | 10.2% 6.1% 3.4% 4.2% | 54.4% 53.6% 32.2% 31.6% |
|TERMINAL (d) | 0/23 (0%) 2/33 (6%) 1/29 (3%) 1/24 (4%) | 14/32 (44%) 14/30 (47%) 9/33 (27%) 8/33 (24%) |
|FIRST INCIDENCE (DAYS) | 670 729 (T) 729 (T) 729 (T) | 498 614 498 393 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.314N P=0.382N P=0.271N P=0.334N | P=0.022N* P=0.452N P=0.033N* P=0.036N* |
|INCIDENTAL TUMOR | P=0.420N P=0.622N P=0.527N P=0.610N | P=0.030N* P=0.407N P=0.029N* P=0.055N |
|LOGISTIC REGRESSION | P=0.341N P=0.466N P=0.313N P=0.372N | P=0.023N* P=0.391N P=0.025N* P=0.030N* |
|COCHRAN-ARMITAGE | P=0.263N | P=0.025N* |
|FISHER EXACT | P=0.500N P=0.309N P=0.309N | P=0.342N P=0.028N* P=0.028N* |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | 23/50 (46%) 20/50 (40%) 12/50 (24%) 12/50 (24%) |
|ADJUSTED (b) | 10.2% 6.1% 3.4% 4.2% | 57.0% 55.0% 32.2% 31.6% |
|TERMINAL (d) | 0/23 (0%) 2/33 (6%) 1/29 (3%) 1/24 (4%) | 15/32 (47%) 14/30 (47%) 9/33 (27%) 8/33 (24%) |
|FIRST INCIDENCE (DAYS) | 670 729 (T) 729 (T) 729 (T) | 498 614 498 393 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.314N P=0.382N P=0.271N P=0.334N | P=0.013N* P=0.456N P=0.021N* P=0.024N* |
|INCIDENTAL TUMOR | P=0.420N P=0.622N P=0.527N P=0.610N | P=0.017N* P=0.415N P=0.018N* P=0.035N* |
|LOGISTIC REGRESSION | P=0.341N P=0.466N P=0.313N P=0.372N | P=0.013N* P=0.394N P=0.015N* P=0.019N* |
|COCHRAN-ARMITAGE | P=0.263N | P=0.015N* |
|FISHER EXACT | P=0.500N P=0.309N P=0.309N | P=0.343N P=0.018N* P=0.018N* |
|=================================================================================================================================|
DATE: 07/11/96 EXPERIMENT: 05067 TEST: 09 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 7.5 25 MG/KG 75 MG/KG | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Papilloma Squamous or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 5.8% 0.0% 3.4% 0.0% | 0.0% 0.0% 0.0% 3.0% |
|TERMINAL (d) | 0/23 (0%) 0/33 (0%) 1/29 (3%) 0/24 (0%) | 0/32 (0%) 0/30 (0%) 0/33 (0%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | 617 --- 729 (T) --- | --- --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.312N P=0.214N P=0.479N P=0.284N | P=0.223 (e) (e) P=0.506 |
|INCIDENTAL TUMOR | P=0.358N P=0.360N P=0.582N P=0.403N | P=0.223 (e) (e) P=0.506 |
|LOGISTIC REGRESSION | P=0.284N P=0.234N P=0.503N P=0.231N | P=0.223 (e) (e) P=0.506 |
|COCHRAN-ARMITAGE | P=0.271N | P=0.214 |
|FISHER EXACT | P=0.247N P=0.500N P=0.247N | (e) (e) P=0.500 |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 5.8% 0.0% 3.4% 0.0% | 2.0% 0.0% 2.9% 3.0% |
|TERMINAL (d) | 0/23 (0%) 0/33 (0%) 1/29 (3%) 0/24 (0%) | 0/32 (0%) 0/30 (0%) 0/33 (0%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | 617 --- 729 (T) --- | 399 --- 723 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.312N P=0.214N P=0.479N P=0.284N | P=0.548 P=0.508N P=0.754N P=0.755 |
|INCIDENTAL TUMOR | P=0.358N P=0.360N P=0.582N P=0.403N | P=0.466 P=0.669N P=0.724 P=0.638 |
|LOGISTIC REGRESSION | P=0.284N P=0.234N P=0.503N P=0.231N | P=0.552 P=0.333N P=0.685 P=0.716N |
|COCHRAN-ARMITAGE | P=0.271N | P=0.545 |
|FISHER EXACT | P=0.247N P=0.500N P=0.247N | P=0.500N P=0.753N P=0.753N |
|=================================================================================================================================|
DATE: 07/11/96 EXPERIMENT: 05067 TEST: 09 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 7.5 25 MG/KG 75 MG/KG | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Pancreas |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 7/50 (14%) 4/50 (8%) 4/50 (8%) | 1/50 (2%) 1/48 (2%) 0/49 (0%) 2/50 (4%) |
|ADJUSTED (b) | 38.6% 20.5% 13.8% 15.4% | 3.1% 3.4% 0.0% 6.1% |
|TERMINAL (d) | 8/23 (35%) 6/33 (18%) 4/29 (14%) 3/24 (13%) | 1/32 (3%) 1/29 (3%) 0/32 (0%) 2/33 (6%) |
|FIRST INCIDENCE (DAYS) | 649 719 729 (T) 642 | 729 (T) 729 (T) --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.115N P=0.096N P=0.029N* P=0.073N | P=0.356 P=0.740 P=0.500N P=0.511 |
|INCIDENTAL TUMOR | P=0.145N P=0.163N P=0.046N* P=0.110N | P=0.356 P=0.740 P=0.500N P=0.511 |
|LOGISTIC REGRESSION | P=0.156N P=0.163N P=0.061N P=0.130N | P=0.356 P=0.740 P=0.500N P=0.511 |
|COCHRAN-ARMITAGE | P=0.078N | P=0.339 |
|FISHER EXACT | P=0.298N P=0.074N P=0.074N | P=0.742 P=0.505N P=0.500 |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 19/50 (38%) 18/49 (37%) 16/50 (32%) 10/48 (21%) | 22/47 (47%) 18/50 (36%) 17/49 (35%) 14/49 (29%) |
|ADJUSTED (b) | 55.2% 42.1% 42.7% 39.2% | 56.7% 49.2% 43.1% 38.2% |
|TERMINAL (d) | 9/23 (39%) 9/33 (27%) 9/29 (31%) 9/24 (38%) | 15/31 (48%) 12/30 (40%) 11/32 (34%) 11/33 (33%) |
|FIRST INCIDENCE (DAYS) | 598 497 498 497 | 498 595 498 586 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.102N P=0.212N P=0.236N P=0.063N | P=0.064N P=0.335N P=0.200N P=0.060N |
|INCIDENTAL TUMOR | P=0.096N P=0.504 P=0.390N P=0.121N | P=0.081N P=0.191N P=0.128N P=0.048N* |
|LOGISTIC REGRESSION | P=0.070N P=0.514N P=0.364N P=0.121N | P=0.074N P=0.237N P=0.158N P=0.059N |
|COCHRAN-ARMITAGE | P=0.030N* | P=0.073N |
|FISHER EXACT | P=0.531N P=0.338N P=0.050N* | P=0.191N P=0.159N P=0.051N |
|=================================================================================================================================|
DATE: 07/11/96 EXPERIMENT: 05067 TEST: 09 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 7.5 25 MG/KG 75 MG/KG | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma, Basosquamous Tumor Benign, or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 6.1% 0.0% 0.0% | 0.0% 0.0% 3.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 2/33 (6%) 0/29 (0%) 0/24 (0%) | 0/32 (0%) 0/30 (0%) 1/33 (3%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) --- --- | --- --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.391N P=0.321 (e) (e) | P=0.777N (e) P=0.506 (e) |
|INCIDENTAL TUMOR | P=0.391N P=0.321 (e) (e) | P=0.777N (e) P=0.506 (e) |
|LOGISTIC REGRESSION | P=0.391N P=0.321 (e) (e) | P=0.777N (e) P=0.506 (e) |
|COCHRAN-ARMITAGE | P=0.369N | P=0.786N |
|FISHER EXACT | P=0.247 (e) (e) | (e) P=0.500 (e) |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign, |
| malignant or NOS), or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 6.1% 0.0% 0.0% | 0.0% 0.0% 3.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 2/33 (6%) 0/29 (0%) 0/24 (0%) | 0/32 (0%) 0/30 (0%) 1/33 (3%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) --- --- | --- --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.391N P=0.321 (e) (e) | P=0.777N (e) P=0.506 (e) |
|INCIDENTAL TUMOR | P=0.391N P=0.321 (e) (e) | P=0.777N (e) P=0.506 (e) |
|LOGISTIC REGRESSION | P=0.391N P=0.321 (e) (e) | P=0.777N (e) P=0.506 (e) |
|COCHRAN-ARMITAGE | P=0.369N | P=0.786N |
|FISHER EXACT | P=0.247 (e) (e) | (e) P=0.500 (e) |
|=================================================================================================================================|
DATE: 07/11/96 EXPERIMENT: 05067 TEST: 09 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 7.5 25 MG/KG 75 MG/KG | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal |
| Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 7.8% 9.1% 3.4% 0.0% | 0.0% 0.0% 6.1% 0.0% |
|TERMINAL (d) | 1/23 (4%) 3/33 (9%) 1/29 (3%) 0/24 (0%) | 0/32 (0%) 0/30 (0%) 2/33 (6%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 700 729 (T) 729 (T) --- | --- --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.119N P=0.654 P=0.438N P=0.243N | P=0.685N (e) P=0.245 (e) |
|INCIDENTAL TUMOR | P=0.138N P=0.571 P=0.543N P=0.347N | P=0.685N (e) P=0.245 (e) |
|LOGISTIC REGRESSION | P=0.134N P=0.598 P=0.491N P=0.275N | P=0.685N (e) P=0.245 (e) |
|COCHRAN-ARMITAGE | P=0.104N | P=0.697N |
|FISHER EXACT | P=0.500 P=0.500N P=0.247N | (e) P=0.247 (e) |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 1/50 (2%) 6/50 (12%) 5/50 (10%) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 19.5% 3.0% 17.7% 18.1% | 5.5% 2.4% 0.0% 2.6% |
|TERMINAL (d) | 1/23 (4%) 1/33 (3%) 3/29 (10%) 3/24 (13%) | 1/32 (3%) 0/30 (0%) 0/33 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 614 729 (T) 558 595 | 667 600 --- 671 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.293 P=0.033N* P=0.550N P=0.565N | P=0.484N P=0.520N P=0.242N P=0.496N |
|INCIDENTAL TUMOR | P=0.173 P=0.119N P=0.355 P=0.440 | P=0.510N P=0.416N P=0.236N P=0.528N |
|LOGISTIC REGRESSION | P=0.312 P=0.052N P=0.605 P=0.615N | P=0.499N P=0.497N P=0.234N P=0.503N |
|COCHRAN-ARMITAGE | P=0.420 | P=0.500N |
|FISHER EXACT | P=0.056N P=0.620N P=0.500N | P=0.500N P=0.247N P=0.500N |
|=================================================================================================================================|
DATE: 07/11/96 EXPERIMENT: 05067 TEST: 09 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 7.5 25 MG/KG 75 MG/KG | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 3/50 (6%) 6/50 (12%) 5/50 (10%) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 19.5% 8.4% 17.7% 18.1% | 5.5% 2.4% 3.0% 2.6% |
|TERMINAL (d) | 1/23 (4%) 2/33 (6%) 3/29 (10%) 3/24 (13%) | 1/32 (3%) 0/30 (0%) 1/33 (3%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 614 644 558 595 | 667 600 729 (T) 671 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.406 P=0.150N P=0.550N P=0.565N | P=0.471N P=0.520N P=0.499N P=0.496N |
|INCIDENTAL TUMOR | P=0.277 P=0.379N P=0.355 P=0.440 | P=0.493N P=0.416N P=0.493N P=0.528N |
|LOGISTIC REGRESSION | P=0.264 P=0.228N P=0.605 P=0.615N | P=0.489N P=0.497N P=0.492N P=0.503N |
|COCHRAN-ARMITAGE | P=0.548 | P=0.488N |
|FISHER EXACT | P=0.243N P=0.620N P=0.500N | P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 5.5% 0.0% 0.0% | 0.0% 0.0% 3.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 1/33 (3%) 0/29 (0%) 0/24 (0%) | 0/32 (0%) 0/30 (0%) 1/33 (3%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | --- 644 --- --- | --- --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.408N P=0.295 (e) (e) | P=0.777N (e) P=0.506 (e) |
|INCIDENTAL TUMOR | P=0.402N P=0.237 (e) (e) | P=0.777N (e) P=0.506 (e) |
|LOGISTIC REGRESSION | P=0.397N P=0.240 (e) (e) | P=0.777N (e) P=0.506 (e) |
|COCHRAN-ARMITAGE | P=0.369N | P=0.786N |
|FISHER EXACT | P=0.247 (e) (e) | (e) P=0.500 (e) |
|=================================================================================================================================|
DATE: 07/11/96 EXPERIMENT: 05067 TEST: 09 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 7.5 25 MG/KG 75 MG/KG | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 7.8% 3.0% 0.0% 0.0% | 0.0% 0.0% 3.0% 0.0% |
|TERMINAL (d) | 1/23 (4%) 1/33 (3%) 0/29 (0%) 0/24 (0%) | 0/32 (0%) 0/30 (0%) 1/33 (3%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 700 729 (T) --- --- | --- --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.186N P=0.385N P=0.207N P=0.243N | P=0.777N (e) P=0.506 (e) |
|INCIDENTAL TUMOR | P=0.222N P=0.494N P=0.301N P=0.347N | P=0.777N (e) P=0.506 (e) |
|LOGISTIC REGRESSION | P=0.199N P=0.439N P=0.235N P=0.275N | P=0.777N (e) P=0.506 (e) |
|COCHRAN-ARMITAGE | P=0.169N | P=0.786N |
|FISHER EXACT | P=0.500N P=0.247N P=0.247N | (e) P=0.500 (e) |
|=================================================================================================================================|
| |
|Skin |
| Melanoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 6.1% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 2/33 (6%) 0/29 (0%) 0/24 (0%) | 0/32 (0%) 0/30 (0%) 0/33 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.391N P=0.321 (e) (e) | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.391N P=0.321 (e) (e) | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.391N P=0.321 (e) (e) | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.369N | (e) |
|FISHER EXACT | P=0.247 (e) (e) | (e) (e) (e) |
|=================================================================================================================================|
DATE: 07/11/96 EXPERIMENT: 05067 TEST: 09 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 7.5 25 MG/KG 75 MG/KG | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 7.8% 3.0% 3.4% 0.0% | 0.0% 0.0% 3.0% 0.0% |
|TERMINAL (d) | 1/23 (4%) 1/33 (3%) 1/29 (3%) 0/24 (0%) | 0/32 (0%) 0/30 (0%) 1/33 (3%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 700 729 (T) 729 (T) --- | --- --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.216N P=0.385N P=0.438N P=0.243N | P=0.777N (e) P=0.506 (e) |
|INCIDENTAL TUMOR | P=0.252N P=0.494N P=0.543N P=0.347N | P=0.777N (e) P=0.506 (e) |
|LOGISTIC REGRESSION | P=0.235N P=0.439N P=0.491N P=0.275N | P=0.777N (e) P=0.506 (e) |
|COCHRAN-ARMITAGE | P=0.194N | P=0.786N |
|FISHER EXACT | P=0.500N P=0.500N P=0.247N | (e) P=0.500 (e) |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 7.8% 3.0% 3.4% 0.0% | 0.0% 0.0% 3.0% 0.0% |
|TERMINAL (d) | 1/23 (4%) 1/33 (3%) 1/29 (3%) 0/24 (0%) | 0/32 (0%) 0/30 (0%) 1/33 (3%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 700 729 (T) 729 (T) --- | --- --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.216N P=0.385N P=0.438N P=0.243N | P=0.777N (e) P=0.506 (e) |
|INCIDENTAL TUMOR | P=0.252N P=0.494N P=0.543N P=0.347N | P=0.777N (e) P=0.506 (e) |
|LOGISTIC REGRESSION | P=0.235N P=0.439N P=0.491N P=0.275N | P=0.777N (e) P=0.506 (e) |
|COCHRAN-ARMITAGE | P=0.194N | P=0.786N |
|FISHER EXACT | P=0.500N P=0.500N P=0.247N | (e) P=0.500 (e) |
|=================================================================================================================================|
DATE: 07/11/96 EXPERIMENT: 05067 TEST: 09 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 7.5 25 MG/KG 75 MG/KG | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 2/50 (4%) 1/50 (2%) 0/49 (0%) | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 6.1% 3.4% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 2/33 (6%) 1/29 (3%) 0/24 (0%) | 0/32 (0%) 0/29 (0%) 0/33 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) 729 (T) --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.406N P=0.321 P=0.546 (e) | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.406N P=0.321 P=0.546 (e) | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.406N P=0.321 P=0.546 (e) | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.380N | (e) |
|FISHER EXACT | P=0.253 P=0.505 (e) | (e) (e) (e) |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 46/50 (92%) 42/50 (84%) 42/50 (84%) 44/50 (88%) | |
|ADJUSTED (b) | 100.0% 97.6% 97.6% 97.8% | |
|TERMINAL (d) | 23/23 (100%) 32/33 (97%) 28/29 (97%) 23/24 (96%) | |
|FIRST INCIDENCE (DAYS) | 529 372 425 387 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.101 P=0.006N** P=0.087N P=0.478 | |
|INCIDENTAL TUMOR | P=0.146 P=0.069N P=0.192N P=0.486 | |
|LOGISTIC REGRESSION | P=0.046 * P=0.174N P=0.348N P=0.271 | |
|COCHRAN-ARMITAGE | P=0.539N | |
|FISHER EXACT | P=0.178N P=0.178N P=0.370N | |
|=================================================================================================================================|
DATE: 07/11/96 EXPERIMENT: 05067 TEST: 09 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 7.5 25 MG/KG 75 MG/KG | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Thymus |
| Thymoma: Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/47 (0%) 2/47 (4%) 0/50 (0%) | 0/49 (0%) 0/49 (0%) 0/48 (0%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 6.5% 0.0% | 0.0% 0.0% 0.0% 2.4% |
|TERMINAL (d) | 0/22 (0%) 0/32 (0%) 1/27 (4%) 0/24 (0%) | 0/32 (0%) 0/29 (0%) 0/32 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 639 --- | --- --- --- 642 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.735N (e) P=0.259 (e) | P=0.222 (e) (e) P=0.505 |
|INCIDENTAL TUMOR | P=0.727N (e) P=0.236 (e) | P=0.226 (e) (e) P=0.682 |
|LOGISTIC REGRESSION | P=0.722N (e) P=0.223 (e) | P=0.221 (e) (e) P=0.515 |
|COCHRAN-ARMITAGE | P=0.687N | P=0.218 |
|FISHER EXACT | (e) P=0.237 (e) | (e) (e) P=0.505 |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 1/50 (2%) 3/50 (6%) 1/50 (2%) | 3/50 (6%) 8/50 (16%) 5/50 (10%) 6/50 (12%) |
|ADJUSTED (b) | 15.4% 3.0% 8.1% 3.3% | 8.9% 26.7% 15.2% 17.3% |
|TERMINAL (d) | 2/23 (9%) 1/33 (3%) 1/29 (3%) 0/24 (0%) | 2/32 (6%) 8/30 (27%) 5/33 (15%) 5/33 (15%) |
|FIRST INCIDENCE (DAYS) | 546 729 (T) 526 642 | 678 729 (T) 729 (T) 648 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.243N P=0.068N P=0.344N P=0.147N | P=0.486 P=0.079 P=0.369 P=0.258 |
|INCIDENTAL TUMOR | P=0.150N P=0.120N P=0.355N P=0.130N | P=0.477 P=0.077 P=0.371 P=0.240 |
|LOGISTIC REGRESSION | P=0.150N P=0.104N P=0.322N P=0.107N | P=0.474 P=0.073 P=0.368 P=0.243 |
|COCHRAN-ARMITAGE | P=0.169N | P=0.442 |
|FISHER EXACT | P=0.102N P=0.357N P=0.102N | P=0.100 P=0.357 P=0.243 |
|=================================================================================================================================|
DATE: 07/11/96 EXPERIMENT: 05067 TEST: 09 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 7.5 25 MG/KG 75 MG/KG | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 4.3% 5.7% 0.0% 0.0% | 0.0% 0.0% 2.9% 0.0% |
|TERMINAL (d) | 1/23 (4%) 1/33 (3%) 0/29 (0%) 0/24 (0%) | 0/32 (0%) 0/30 (0%) 0/33 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 706 --- --- | --- --- 723 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.229N P=0.619 P=0.454N P=0.492N | P=0.778N (e) P=0.512 (e) |
|INCIDENTAL TUMOR | P=0.273N P=0.506 P=0.454N P=0.492N | P=0.800N (e) P=0.500 (e) |
|LOGISTIC REGRESSION | P=0.245N P=0.568 P=0.454N P=0.492N | P=0.781N (e) P=0.505 (e) |
|COCHRAN-ARMITAGE | P=0.209N | P=0.786N |
|FISHER EXACT | P=0.500 P=0.500N P=0.500N | (e) P=0.500 (e) |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 3/50 (6%) 3/50 (6%) 1/50 (2%) | 3/50 (6%) 8/50 (16%) 6/50 (12%) 6/50 (12%) |
|ADJUSTED (b) | 19.5% 8.6% 8.1% 3.3% | 8.9% 26.7% 17.6% 17.3% |
|TERMINAL (d) | 3/23 (13%) 2/33 (6%) 1/29 (3%) 0/24 (0%) | 2/32 (6%) 8/30 (27%) 5/33 (15%) 5/33 (15%) |
|FIRST INCIDENCE (DAYS) | 546 706 526 642 | 678 729 (T) 723 648 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.110N P=0.142N P=0.224N P=0.086N | P=0.494 P=0.079 P=0.258 P=0.258 |
|INCIDENTAL TUMOR | P=0.072N P=0.263N P=0.229N P=0.074N | P=0.480 P=0.077 P=0.254 P=0.240 |
|LOGISTIC REGRESSION | P=0.071N P=0.237N P=0.224N P=0.069N | P=0.482 P=0.073 P=0.251 P=0.243 |
|COCHRAN-ARMITAGE | P=0.068N | P=0.449 |
|FISHER EXACT | P=0.243N P=0.243N P=0.056N | P=0.100 P=0.243 P=0.243 |
|=================================================================================================================================|
DATE: 07/11/96 EXPERIMENT: 05067 TEST: 09 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 7.5 25 MG/KG 75 MG/KG | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 6.9% 4.2% | 3.1% 0.0% 0.0% 3.0% |
|TERMINAL (d) | 0/23 (0%) 0/33 (0%) 2/29 (7%) 1/24 (4%) | 1/32 (3%) 0/30 (0%) 0/33 (0%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | --- --- 729 (T) 729 (T) | 729 (T) --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.310 (e) P=0.290 P=0.508 | P=0.549 P=0.513N P=0.494N P=0.755N |
|INCIDENTAL TUMOR | P=0.310 (e) P=0.290 P=0.508 | P=0.549 P=0.513N P=0.494N P=0.755N |
|LOGISTIC REGRESSION | P=0.310 (e) P=0.290 P=0.508 | P=0.549 P=0.513N P=0.494N P=0.755N |
|COCHRAN-ARMITAGE | P=0.350 | P=0.536 |
|FISHER EXACT | (e) P=0.247 P=0.500 | P=0.500N P=0.500N P=0.753N |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 2/50 (4%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 6.9% 8.3% | 3.1% 0.0% 0.0% 3.0% |
|TERMINAL (d) | 0/23 (0%) 0/33 (0%) 2/29 (7%) 2/24 (8%) | 1/32 (3%) 0/30 (0%) 0/33 (0%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | --- --- 729 (T) 729 (T) | 729 (T) --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.091 (e) P=0.290 P=0.247 | P=0.549 P=0.513N P=0.494N P=0.755N |
|INCIDENTAL TUMOR | P=0.091 (e) P=0.290 P=0.247 | P=0.549 P=0.513N P=0.494N P=0.755N |
|LOGISTIC REGRESSION | P=0.091 (e) P=0.290 P=0.247 | P=0.549 P=0.513N P=0.494N P=0.755N |
|COCHRAN-ARMITAGE | P=0.122 | P=0.536 |
|FISHER EXACT | (e) P=0.247 P=0.247 | P=0.500N P=0.500N P=0.753N |
|=================================================================================================================================|
DATE: 07/11/96 EXPERIMENT: 05067 TEST: 09 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 7.5 25 MG/KG 75 MG/KG | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 9/50 (18%) 7/50 (14%) 12/50 (24%) 7/50 (14%) |
|ADJUSTED (b) | | 25.2% 17.5% 32.2% 18.3% |
|TERMINAL (d) | | 6/32 (19%) 2/30 (7%) 9/33 (27%) 4/33 (12%) |
|FIRST INCIDENCE (DAYS) | | 667 404 497 614 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.370N P=0.449N P=0.340 P=0.379N |
|INCIDENTAL TUMOR | | P=0.481N P=0.493N P=0.303 P=0.352N |
|LOGISTIC REGRESSION | | P=0.405N P=0.388N P=0.328 P=0.398N |
|COCHRAN-ARMITAGE | | P=0.404N |
|FISHER EXACT | | P=0.393N P=0.312 P=0.393N |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 1/50 (2%) 1/50 (2%) 3/50 (6%) 0/50 (0%) |
|ADJUSTED (b) | | 2.2% 2.2% 7.5% 0.0% |
|TERMINAL (d) | | 0/32 (0%) 0/30 (0%) 1/33 (3%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | | 533 579 541 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.333N P=0.753N P=0.319 P=0.500N |
|INCIDENTAL TUMOR | | P=0.449N P=0.770N P=0.249 P=0.748N |
|LOGISTIC REGRESSION | | P=0.328N P=0.715N P=0.239 P=0.423N |
|COCHRAN-ARMITAGE | | P=0.339N |
|FISHER EXACT | | P=0.753N P=0.309 P=0.500N |
|=================================================================================================================================|
DATE: 07/11/96 EXPERIMENT: 05067 TEST: 09 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 7.5 25 MG/KG 75 MG/KG | 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) | | 10/50 (20%) 8/50 (16%) 14/50 (28%) 7/50 (14%) |
|ADJUSTED (b) | | 26.9% 19.3% 35.3% 18.3% |
|TERMINAL (d) | | 6/32 (19%) 2/30 (7%) 9/33 (27%) 4/33 (12%) |
|FIRST INCIDENCE (DAYS) | | 533 404 497 614 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.274N P=0.449N P=0.277 P=0.291N |
|INCIDENTAL TUMOR | | P=0.407N P=0.487N P=0.210 P=0.312N |
|LOGISTIC REGRESSION | | P=0.293N P=0.374N P=0.241 P=0.304N |
|COCHRAN-ARMITAGE | | P=0.295N |
|FISHER EXACT | | P=0.398N P=0.241 P=0.298N |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 5.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/33 (0%) 0/29 (0%) 0/24 (0%) | 0/32 (0%) 0/30 (0%) 0/33 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 558 --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.716 (e) P=0.226 (e) | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.728 (e) P=0.210 (e) | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.621N (e) P=0.280 (e) | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.697N | (e) |
|FISHER EXACT | (e) P=0.247 (e) | (e) (e) (e) |
|=================================================================================================================================|
DATE: 07/11/96 EXPERIMENT: 05067 TEST: 09 PAGE 21
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 7.5 25 MG/KG 75 MG/KG | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 5.0% 0.0% | 3.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/33 (0%) 0/29 (0%) 0/24 (0%) | 1/32 (3%) 0/30 (0%) 0/33 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 558 --- | 729 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.716 (e) P=0.226 (e) | P=0.466N P=0.513N P=0.494N P=0.494N |
|INCIDENTAL TUMOR | P=0.728 (e) P=0.210 (e) | P=0.466N P=0.513N P=0.494N P=0.494N |
|LOGISTIC REGRESSION | P=0.621N (e) P=0.280 (e) | P=0.466N P=0.513N P=0.494N P=0.494N |
|COCHRAN-ARMITAGE | P=0.697N | P=0.474N |
|FISHER EXACT | (e) P=0.247 (e) | P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 7.9% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/23 (4%) 0/33 (0%) 0/29 (0%) 0/24 (0%) | 0/32 (0%) 0/30 (0%) 0/33 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 719 --- --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.264N P=0.175N P=0.207N P=0.248N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.319N P=0.268N P=0.301N P=0.347N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.272N P=0.188N P=0.224N P=0.262N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.242N | (e) |
|FISHER EXACT | P=0.247N P=0.247N P=0.247N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 07/11/96 EXPERIMENT: 05067 TEST: 09 PAGE 22
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 7.5 25 MG/KG 75 MG/KG | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 5/50 (10%) 6/50 (12%) 6/50 (12%) | 10/50 (20%) 8/50 (16%) 9/50 (18%) 12/50 (24%) |
|ADJUSTED (b) | 37.5% 14.0% 16.0% 21.8% | 24.2% 22.0% 23.6% 30.0% |
|TERMINAL (d) | 3/23 (13%) 3/33 (9%) 0/29 (0%) 3/24 (13%) | 3/32 (9%) 3/30 (10%) 5/33 (15%) 6/33 (18%) |
|FIRST INCIDENCE (DAYS) | 529 706 572 643 | 441 478 541 421 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.223N P=0.007N** P=0.040N* P=0.072N | P=0.303 P=0.450N P=0.482N P=0.430 |
|INCIDENTAL TUMOR | P=0.247N P=0.049N* P=0.090N P=0.094N | P=0.131 P=0.578 P=0.557N P=0.217 |
|LOGISTIC REGRESSION | P=0.356N P=0.013N* P=0.078N P=0.199N | P=0.248 P=0.379N P=0.527N P=0.417 |
|COCHRAN-ARMITAGE | P=0.096N | P=0.247 |
|FISHER EXACT | P=0.011N* P=0.024N* P=0.024N* | P=0.398N P=0.500N P=0.405 |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 4/50 (8%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 2.2% 5.1% 11.2% 11.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/33 (0%) 2/29 (7%) 2/24 (8%) | 0/32 (0%) 0/30 (0%) 0/33 (0%) 0/33 (0%) |
|FIRST INCIDENCE (DAYS) | 572 624 498 552 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.209 P=0.536 P=0.194 P=0.266 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.255 P=0.338 P=0.208 P=0.250 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.328 P=0.508 P=0.210 P=0.294 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.304 | (e) |
|FISHER EXACT | P=0.500 P=0.181 P=0.309 | (e) (e) (e) |
|=================================================================================================================================|
DATE: 07/11/96 EXPERIMENT: 05067 TEST: 09 PAGE 23
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 7.5 25 MG/KG 75 MG/KG | VEHICLE 7.5 25 MG/KG 75 MG/KG |
| | CONTROL MG/KG | CONTROL MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 49/50 (98%) 48/50 (96%) 46/50 (92%) | 37/50 (74%) 39/50 (78%) 32/50 (64%) 30/50 (60%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 84.0% 88.5% 75.6% 69.4% |
|TERMINAL (d) | 23/23 (100%) 33/33 (100%) 29/29 (100%) 24/24 (100%)| 25/32 (78%) 25/30 (83%) 23/33 (70%) 20/33 (61%) |
|FIRST INCIDENCE (DAYS) | 529 372 425 387 | 498 404 497 393 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.193 P=0.042N* P=0.217N P=0.510 | P=0.044N* P=0.297 P=0.199N P=0.128N |
|INCIDENTAL TUMOR | P=0.509 P=0.602 P=0.730 P=0.556 | P=0.047N* P=0.348 P=0.164N P=0.098N |
|LOGISTIC REGRESSION | P=0.544 P=0.420 P=0.730 P=0.647 | P=0.036N* P=0.309 P=0.153N P=0.112N |
|COCHRAN-ARMITAGE | P=0.073N | P=0.037N* |
|FISHER EXACT | P=0.753N P=0.500N P=0.181N | P=0.408 P=0.194N P=0.101N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 18/50 (36%) 14/50 (28%) 14/50 (28%) | 18/50 (36%) 11/50 (22%) 16/50 (32%) 14/50 (28%) |
|ADJUSTED (b) | 55.4% 42.7% 34.9% 43.3% | 40.2% 27.9% 37.0% 35.2% |
|TERMINAL (d) | 6/23 (26%) 10/33 (30%) 4/29 (14%) 7/24 (29%) | 7/32 (22%) 3/30 (10%) 7/33 (21%) 8/33 (24%) |
|FIRST INCIDENCE (DAYS) | 529 372 498 306 | 399 478 497 421 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.263N P=0.083N P=0.067N P=0.151N | P=0.400N P=0.154N P=0.399N P=0.274N |
|INCIDENTAL TUMOR | P=0.176N P=0.483N P=0.199N P=0.181N | P=0.441 P=0.183N P=0.500N P=0.534N |
|LOGISTIC REGRESSION | P=0.120N P=0.217N P=0.128N P=0.071N | P=0.512 P=0.071N P=0.482N P=0.392N |
|COCHRAN-ARMITAGE | P=0.067N | P=0.441N |
|FISHER EXACT | P=0.208N P=0.048N* P=0.048N* | P=0.093N P=0.417N P=0.260N |
|=================================================================================================================================|
DATE: 07/11/96 EXPERIMENT: 05067 TEST: 09 PAGE 24
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- THEOPHYLLINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 7.5 25 MG/KG 75 MG/KG | 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) | 49/50 (98%) 49/50 (98%) 48/50 (96%) 47/50 (94%) | 44/50 (88%) 41/50 (82%) 40/50 (80%) 36/50 (72%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 88.0% 89.1% 84.9% 78.1% |
|TERMINAL (d) | 23/23 (100%) 33/33 (100%) 29/29 (100%) 24/24 (100%)| 26/32 (81%) 25/30 (83%) 26/33 (79%) 23/33 (70%) |
|FIRST INCIDENCE (DAYS) | 529 372 425 306 | 399 404 497 393 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.147 P=0.042N* P=0.217N P=0.452 | P=0.077N P=0.519N P=0.265N P=0.117N |
|INCIDENTAL TUMOR | P=0.358 P=0.602 P=0.730 P=0.556 | P=0.105N P=0.464N P=0.221N P=0.147N |
|LOGISTIC REGRESSION | P=0.263 P=0.420 P=0.730 P=0.325 | P=0.100N P=0.339N P=0.219N P=0.130N |
|COCHRAN-ARMITAGE | P=0.181N | P=0.036N* |
|FISHER EXACT | P=0.753N P=0.500N P=0.309N | P=0.288N P=0.207N P=0.039N* |
|=================================================================================================================================|
(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).