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A Randomized Phase II Trial of Low Dose Aspirin Versus Placebo in High-Risk Individuals With CT-Detected Subsolid Lung Nodules

The following datasets contain the data available for EPPT MDA2013-01-01. 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 - 785.3 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 - 168.2 KB)
2. The Adverse Events dataset includes updated variable names, formats, and labels.

Raw Datasets

These 51 datasets contain the raw form data received, excluding PII.

+ Show these datasets

Data Dictionary
(PDF - 172.8 KB)
1. The adverseevents dataset contains adverse event information
Data Dictionary
(PDF - 161.8 KB)
2. The aeandconmedeval dataset contains concomitant medication and adverse event information
Data Dictionary
(PDF - 163.3 KB)
3. The agentinterrupt dataset contains agent interruption reasons and details
Data Dictionary
(PDF - 166.7 KB)
4. The agentmodification dataset contains agent modification reasons and details
Data Dictionary
(PDF - 166.7 KB)
5. The basemedsurghist dataset contains medical and surgical histories of body systems
Data Dictionary
(PDF - 161.7 KB)
6. The basesymptoms dataset contains symptoms experienced at baseline
Data Dictionary
(PDF - 173.3 KB)
7. The bioptissuehist dataset contains tissue biopsy information
Data Dictionary
(PDF - 165.0 KB)
8. The bloodchemistry dataset contains blood chemistry test resuslts
Data Dictionary
(PDF - 164.3 KB)
9. The bloodspecimen dataset contains blood specimen results
Data Dictionary
(PDF - 159.7 KB)
10. The comments dataset contains general comments
Data Dictionary
(PDF - 173.9 KB)
11. The compliance dataset contains general study compliance information
Data Dictionary
(PDF - 161.6 KB)
12. The compliancedruglabels dataset contains agent compliance information
Data Dictionary
(PDF - 172.1 KB)
13. The compliancephoneinterview dataset contains phone interview compliance information
Data Dictionary
(PDF - 164.5 KB)
14. The conmeds dataset contains concomitant medication information
Data Dictionary
(PDF - 172.5 KB)
15. The ctscannewlesions dataset contains CT scan new lesions information
Data Dictionary
(PDF - 166.8 KB)
16. The ctscannontargetlesions dataset contains CT scan non-target lesions information
Data Dictionary
(PDF - 166.8 KB)
17. The ctscannontargetlesionsv12 dataset contains CT scan non-target lesions information
Data Dictionary
(PDF - 167.0 KB)
18. The ctscannontargetmth3_6_12 dataset contains CT scan non-target lesions information for month 3, 6, and 12
Data Dictionary
(PDF - 166.8 KB)
19. The ctscannontargetv12mth3_6_12 dataset contains CT scan non-target lesions information for month 3, 6, and 12
Data Dictionary
(PDF - 168.3 KB)
20. The ctscantargetlesions dataset contains CT scan target lesions information
Data Dictionary
(PDF - 169.0 KB)
21. The ctscantargetlesionsv14 dataset contains CT scan target lesions information
Data Dictionary
(PDF - 168.5 KB)
22. The ctscantargetmth3_6_12 dataset contains CT scan target lesions information for month 3, 6, and 12
Data Dictionary
(PDF - 170.1 KB)
23. The ctscantargetv14mth3_6_12 dataset contains CT scan target lesions information for month 3, 6, and 12
Data Dictionary
(PDF - 161.7 KB)
24. The demographics dataset contains participant demographics information
Data Dictionary
(PDF - 162.0 KB)
25. The eligibilityverification dataset contains participant eligibility verification information
Data Dictionary
(PDF - 161.1 KB)
26. The exclusioncriteriaprev12 dataset contains exclusion criteria information
Data Dictionary
(PDF - 160.1 KB)
27. The exclusioncriteriav12 dataset contains exclusion criteria information
Data Dictionary
(PDF - 161.9 KB)
28. The finalctscansummaryv12_06212016 dataset contains final CT scan summary information
Data Dictionary
(PDF - 165.0 KB)
29. The hematology1 dataset contains contains hematology test results
Data Dictionary
(PDF - 164.9 KB)
30. The hematology2 dataset contains contains hematology test results
Data Dictionary
(PDF - 160.0 KB)
31. The inclusioncriteriaprev8 dataset contains inclusion criteria information
Data Dictionary
(PDF - 160.1 KB)
32. The inclusioncriteriav12 dataset contains inclusion criteria information
Data Dictionary
(PDF - 160.1 KB)
33. The inclusioncriteriav13 dataset contains inclusion criteria information
Data Dictionary
(PDF - 159.6 KB)
34. The inclusioncriteriav8 dataset contains inclusion criteria information
Data Dictionary
(PDF - 162.3 KB)
35. The interventionadmin dataset contains intervention and admin information
Data Dictionary
(PDF - 163.4 KB)
36. The mirna dataset contains miRNA information and results
Data Dictionary
(PDF - 165.5 KB)
37. The offstudy dataset contains information about when and why a participant exited the study
Data Dictionary
(PDF - 163.7 KB)
38. The otherlabtests dataset contains information about other lab tests that were performed
Data Dictionary
(PDF - 178.8 KB)
39. The physicalexam dataset contains anthropometry and physical examination information of different body systems
Data Dictionary
(PDF - 164.0 KB)
40. The pregnancyspecimendata dataset contains pregnancy test information and results
Data Dictionary
(PDF - 168.9 KB)
41. The randomization dataset contains general information pertinent to the participants randomization
Data Dictionary
(PDF - 174.4 KB)
42. The registration dataset contains participant registration information
Data Dictionary
(PDF - 164.0 KB)
43. The researchblood dataset contains blood test sample information
Data Dictionary
(PDF - 164.1 KB)
44. The researchbloodmonth6 dataset contains blood test sample information
Data Dictionary
(PDF - 164.0 KB)
45. The researchurine dataset contains urine test sample information
Data Dictionary
(PDF - 164.2 KB)
46. The researchurinemonth6 dataset contains urine test sample information
Data Dictionary
(PDF - 162.3 KB)
47. The telephonecontact dataset contains telephone contact information
Data Dictionary
(PDF - 183.1 KB)
48. The tobaccoassessment dataset contains results of the tobacco assessment
Data Dictionary
(PDF - 165.8 KB)
49. The unblind dataset contains study unblinding information
Data Dictionary
(PDF - 163.3 KB)
50. The urinespecimen dataset contains urine specimen results
Data Dictionary
(PDF - 159.8 KB)
51. The verification dataset contains participant verification information