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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.

+ Show these datasets

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