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Phase I Trial of Berberine in Subjects with Ulcerative Colitis

The following datasets contain the data available for EPPT NWU2014-03-01. 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

Data Dictionary
(PDF - 716.4 KB)
1. The Enhanced Person dataset contains all information relevant for most analyses. Each record represents one person and contains updated variable names, formats, and labels. All information coming from non-person-based datasets has been converted into a person-based format.
Data Dictionary
(PDF - 175.7 KB)
2. The Adverse Events dataset contains adverse events that occurred during the study.

Raw Datasets

These 28 datasets contain the the raw form data received, excluding PII.

+ Show these datasets

Data Dictionary
(PDF - 180.0 KB)
1. The Adverse Events dataset contains adverse event information, including onset date, grade of severity, attribution to the study agent, and outcome. This version of the dataset includes updated variable names, formats, and labels.
Data Dictionary
(PDF - 175.0 KB)
2. The Agent Interruption dataset contains agent interruptions during the study due to adverse events, participant error, etc.
Data Dictionary
(PDF - 172.5 KB)
3. The Agent Returned dataset contains amount of study agent returned, used, missing, etc.
Data Dictionary
(PDF - 172.0 KB)
4. The Baseline Symptoms dataset contains adverse symptoms already occurring at baseline visit.
Data Dictionary
(PDF - 166.8 KB)
5. The Berberine Concentration dataset contains berberine concentration pre and post-treatment.
Data Dictionary
(PDF - 225.0 KB)
6. The Blood Chemistry dataset contains results of blood chemistry tests and whether or not they were abnormal/out of range.
Data Dictionary
(PDF - 177.9 KB)
7. The Concomitant Medications dataset contains concomitant medications taken throughout the study.
Data Dictionary
(PDF - 171.3 KB)
8. The Consent Answers dataset contains answers given to each consent question.
Data Dictionary
(PDF - 168.9 KB)
9. The Consent Date dataset contains date of consent.
Data Dictionary
(PDF - 172.0 KB)
10. The Contact dataset contains participant contact date and indicators for adverse events, concomitant medications, and compliance since last contact.
Data Dictionary
(PDF - 175.6 KB)
11. The Cytokines dataset contains TNFα, IL-2, IL-4, IL-6, IL-8 and IL-10 pre and post-treatment.
Data Dictionary
(PDF - 182.0 KB)
12. The Demographics dataset contains demographic information and screen results.
Data Dictionary
(PDF - 170.0 KB)
13. The Eligibility dataset contains eligibility for participation in the study.
Data Dictionary
(PDF - 171.5 KB)
14. The Enrollment dataset contains registration, randomization, and agent start date.
Data Dictionary
(PDF - 216.8 KB)
15. The Hematology dataset contains results of hematology tests and whether or not they were abnormal/out of range.
Data Dictionary
(PDF - 183.1 KB)
16. The Medical History dataset contains any history of abnormal body systems.
Data Dictionary
(PDF - 187.6 KB)
17. The Pathology dataset contains immunohistochemistry and Geboes values pre and post-treatment.
Data Dictionary
(PDF - 189.4 KB)
18. The Physical Examination dataset contains body system abnormality and comments.
Data Dictionary
(PDF - 170.2 KB)
19. The Pregnancy Test dataset contains pregnancy test results.
Data Dictionary
(PDF - 173.1 KB)
20. The Reason Off Study dataset contains reason why the participant went off of the study.
Data Dictionary
(PDF - 229.1 KB)
21. The Specimens Post-Treatment dataset contains information about blood and tissue samples taken before treatment.
Data Dictionary
(PDF - 228.3 KB)
22. The Specimens Pre-Treatment dataset contains information about blood and tissue samples taken after treatment.
Data Dictionary
(PDF - 168.3 KB)
23. The System Registry dataset contains identifying variables.
Data Dictionary
(PDF - 169.6 KB)
24. The TAC dataset contains treatment assignment information.
Data Dictionary
(PDF - 185.4 KB)
25. The Time Points dataset contains dates of start and end of time points.
Data Dictionary
(PDF - 173.7 KB)
26. The UCDAI dataset contains Ulcerative Colitis Disease Activity Index (UCDAI).
Data Dictionary
(PDF - 164.1 KB)
27. The Unblinding dataset contains unblinding information.
Data Dictionary
(PDF - 176.2 KB)
28. The Vitals dataset contains weight, blood pressure, heart rate, and other information about vitals.