Browse EPPT > NWU2016-08-02
A phase I single-arm, multicenter pilot study aimed at validating γ-OHPdG as a biomarker and testing the effects of Polyphenon E® on its levels in patients with cirrhosis
The following datasets contain the data available for EPPT NWU2016-08-02. The description and documentation for each file is listed below. SAS7bdat and CSV versions of the actual data will be available to CDAS projects approved to use this study's data.
Analysis Datasets
Files | Description |
---|---|
Data Dictionary
(PDF - 1014.7 KB) |
1. The Enhanced Person dataset contains enhanced Person |
Data Dictionary
(PDF - 129.7 KB) |
2. The Adverse Events dataset contains adverse Events |
Raw Datasets
These 40 datasets contain the raw form data received, excluding PII.
Files | Description |
---|---|
Data Dictionary
(PDF - 125.3 KB) |
1. The Adverse Events dataset contains adverse Events That Occurred |
Data Dictionary
(PDF - 116.6 KB) |
2. The AFP/-L3 dataset contains blood Lab Tests |
Data Dictionary
(PDF - 104.9 KB) |
3. The Agent Interruption dataset contains agen Interruptions That Occurred |
Data Dictionary
(PDF - 103.6 KB) |
4. The Agent Return And Compliance dataset contains agent Return Information |
Data Dictionary
(PDF - 124.7 KB) |
5. The Baseline Alcohol dataset contains alcohol Use Details At Baseline |
Data Dictionary
(PDF - 103.1 KB) |
6. The Baseline Symptoms dataset contains adverse Symptoms At Baseline |
Data Dictionary
(PDF - 147.7 KB) |
7. The Baseline Tobacco dataset contains tobacco Use Details At Baseline |
Data Dictionary
(PDF - 108.1 KB) |
8. The Batch Shipment Specimen Inventory dataset contains batch Shipment Specimen Inventory Information |
Data Dictionary
(PDF - 104.6 KB) |
9. The Blood and Urinary g-OHPdG dataset contains blood And Urinary g-OHPdG Results |
Data Dictionary
(PDF - 132.2 KB) |
10. The Blood Comprehensive Metabolic Panel dataset contains comprehensive Metabolic Panel Blood Chemistry Lab Tests |
Data Dictionary
(PDF - 108.8 KB) |
11. The Child Pugh Score dataset contains child Pugh Score Results |
Data Dictionary
(PDF - 106.9 KB) |
12. The Compliance Urine dataset contains compliance Urine Results |
Data Dictionary
(PDF - 118.6 KB) |
13. The Concomitant Medications dataset contains concomitant Medications Taken |
Data Dictionary
(PDF - 101.0 KB) |
14. The Eligibility dataset contains eligibility Information |
Data Dictionary
(PDF - 103.2 KB) |
15. The Enrollment dataset contains enrollment Information |
Data Dictionary
(PDF - 108.5 KB) |
16. The FIB-4 Score dataset contains FIB-4 Score Results |
Data Dictionary
(PDF - 100.8 KB) |
17. The Fibroscan Results dataset contains fibroscan Results |
Data Dictionary
(PDF - 107.5 KB) |
18. The Follow Up Alcohol dataset contains follow Up Alcohol Use Details |
Data Dictionary
(PDF - 136.9 KB) |
19. The Follow Up Tobacco dataset contains tobacco Use Details |
Data Dictionary
(PDF - 105.6 KB) |
20. The HCC Imaging dataset contains HCC Imaging |
Data Dictionary
(PDF - 123.8 KB) |
21. The Hematology dataset contains hematology |
Data Dictionary
(PDF - 106.1 KB) |
22. The Immunohistochemistry dataset contains immunohistochemistry |
Data Dictionary
(PDF - 118.6 KB) |
23. The Informed Consent Form dataset contains informed Consent Details |
Data Dictionary
(PDF - 104.3 KB) |
24. The Liver dataset contains participant Liver |
Data Dictionary
(PDF - 117.9 KB) |
25. The Liver Biopsy dataset contains liver Biopsy Results |
Data Dictionary
(PDF - 97.4 KB) |
26. The Liver Biopsy Date dataset contains liver Biopsy Date |
Data Dictionary
(PDF - 149.1 KB) |
27. The Liver Function Tests and Coagulation dataset contains liver Function Tests and Coagulation Results |
Data Dictionary
(PDF - 115.1 KB) |
28. The Medical/Surgical History dataset contains medical/Surgical History |
Data Dictionary
(PDF - 114.4 KB) |
29. The Off Study dataset contains off Study |
Data Dictionary
(PDF - 118.1 KB) |
30. The Physical Exam dataset contains physical Exam Details |
Data Dictionary
(PDF - 108.9 KB) |
31. The Polyphenon E/EGCG dataset contains polyphenon E/EGCG Results |
Data Dictionary
(PDF - 107.6 KB) |
32. The Polyphenon E/EGCG Pharmacokinetic Data dataset contains polyphenon E/EGCG Pharmacokinetic Data Information |
Data Dictionary
(PDF - 120.5 KB) |
33. The Pre-Enrollment dataset contains pre-Enrollment Information |
Data Dictionary
(PDF - 100.0 KB) |
34. The Pregnancy Test dataset contains pregnancy Test Results |
Data Dictionary
(PDF - 124.9 KB) |
35. The Research Blood Specimen Collection dataset contains research Blood Specimen Collection Results |
Data Dictionary
(PDF - 103.1 KB) |
36. The Research Urine Specimen Collection dataset contains research Urine Specimen Collection Results |
Data Dictionary
(PDF - 105.0 KB) |
37. The Stability dataset contains participant Stability |
Data Dictionary
(PDF - 99.4 KB) |
38. The Treatment Assignment Codes/Descriptions dataset contains treatment Assignment Details |
Data Dictionary
(PDF - 111.4 KB) |
39. The Unblinding dataset contains study Unblinding Details |
Data Dictionary
(PDF - 111.4 KB) |
40. The Vitals dataset contains participant Vitals |