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9cUAB30 in Preventing Cancer in Healthy Volunteers

The following datasets contain the data available for EPPT UWI10-16-01R. 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 - 593.6 KB)
1. The Enhanced Person dataset contains all information relevant for most analyses. Each record represents one participant 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 - 182.4 KB)
2. 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.

Raw Datasets

These 17 datasets contain the the raw form data received, excluding PII.

+ Show these datasets

Data Dictionary
(PDF - 166.9 KB)
1. The ablab dataset details any abnormal lab test results.
Data Dictionary
(PDF - 166.0 KB)
2. The accrual dataset contains accrual information such as randomization date and study agent.
Data Dictionary
(PDF - 174.2 KB)
3. The aeout dataset contains adverse events that occurred during the study.
Data Dictionary
(PDF - 171.3 KB)
4. The aes2 dataset contains a summary of the adverse events that occurred.
Data Dictionary
(PDF - 172.2 KB)
5. The allvit dataset contains participant's vitals at the time of visit (all visits).
Data Dictionary
(PDF - 175.9 KB)
6. The baseline dataset contains baseline vitals and demographic information.
Data Dictionary
(PDF - 185.2 KB)
7. The biom dataset contains biomarkers data, including values for Cyclin-D1, Ki-67, etc.
Data Dictionary
(PDF - 166.5 KB)
8. The clrwide dataset contains renal clearance values.
Data Dictionary
(PDF - 167.2 KB)
9. The cmae dataset contains maximum attribution/severity for each patient by body system.
Data Dictionary
(PDF - 170.6 KB)
10. The genes2 dataset contains genetics information, including values for DNMT, CYP2B6, PDE7A1, and BRCA1.
Data Dictionary
(PDF - 169.7 KB)
11. The limlbs dataset contains lab test details and results.
Data Dictionary
(PDF - 166.4 KB)
12. The medhis dataset contains medical/surgical history.
Data Dictionary
(PDF - 165.6 KB)
13. The oreas dataset contains the reason the participant left the study.
Data Dictionary
(PDF - 168.4 KB)
14. The pk dataset contains pharmacokinetic information about 9cUAB30 found in the participant's plasma sampling.
Data Dictionary
(PDF - 168.0 KB)
15. The status dataset contains participant compliance and study agent interruption information.
Data Dictionary
(PDF - 171.0 KB)
16. The urine dataset contains urine collection information and 9cUAB30 levels found in the urine.
Data Dictionary
(PDF - 172.1 KB)
17. The vitals dataset contains participant's vitals at the time of visit.