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Randomized Multicenter Phase II Study of Docosahexaenoic Acid (DHA) in Patients with a History of Breast Cancer, Premalignant Lesions, or Benign Breast Disease

The following datasets contain the data available for EPPT MDA10-16-01. 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 - 840.3 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 - 164.6 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.
Data Dictionary
(PDF - 162.0 KB)
3. The RNA dataset contains RNA Fragments Per Kilobase Million and raw count gene values at the start and end of the trial. This version of the datasets includes updated variable names, formats, and labels, as well as additional study identifiers.

Raw Datasets

These 44 datasets contain the the raw form data received, excluding PII.

+ Show these datasets

Data Dictionary
(PDF - 172.8 KB)
1. The adverseevents dataset contains adverse events that occurred during the study.
Data Dictionary
(PDF - 165.8 KB)
2. The aeandconmedeval dataset contains yes/no variables for whether participants had any adverse events or used any concomitant medications since the last study visit.
Data Dictionary
(PDF - 167.2 KB)
3. The agentinterruption dataset contains agent interruptions during the study due to adverse events, participant error, etc.
Data Dictionary
(PDF - 162.6 KB)
4. The analysis_20160921_comorbidities dataset contains comorbidity information for Dyslipidemia, Diabetes Mellitus, and Hypertension.
Data Dictionary
(PDF - 166.3 KB)
5. The baselinesymptoms dataset contains unusual symptoms participant experienced before starting the study.
Data Dictionary
(PDF - 171.5 KB)
6. The bloodrbcfattyacidlevelsvisit1 dataset contains blood sample storage information at visit 1.
Data Dictionary
(PDF - 169.9 KB)
7. The bloodrbcfattyacidlevelsvisit2 dataset contains blood sample storage information at visit 2.
Data Dictionary
(PDF - 187.8 KB)
8. The breastcancerhistory dataset contains breast cancer history, including the site of the cancer, the severity of the cancer, and the current status of the breast cancer.
Data Dictionary
(PDF - 168.7 KB)
9. The breasttissuehistologyvisit1 dataset contains tissue core biopsy 1 results from visit 2. Used to determine continued study eligibility.
Data Dictionary
(PDF - 168.6 KB)
10. The breasttissuehistologyvisit2 dataset contains tissue core biopsy 1 results from visit 2. Used to determine continued study eligibility.
Data Dictionary
(PDF - 170.6 KB)
11. The clinicallabdatabloodchemistry dataset contains results of blood tests and whether or not they were abnormal/out of range.
Data Dictionary
(PDF - 169.4 KB)
12. The clinicallabdatahematology dataset contains results of hematology tests and whether or not they were abnormal/out of range.
Data Dictionary
(PDF - 169.6 KB)
13. The clinicallabdataotherlabtests dataset contains results of other lab tests and whether or not they were abnormal/out of range.
Data Dictionary
(PDF - 169.1 KB)
14. The cliniclabhematologydifferential dataset contains results of hematology tests and whether or not they were abnormal/out of range.
Data Dictionary
(PDF - 174.2 KB)
15. The cls_data_6116 dataset contains cLs data pre/post study, indicating adipose area, fibrous area, etc.
Data Dictionary
(PDF - 171.2 KB)
16. The compliance dataset contains study protocol compliance information.
Data Dictionary
(PDF - 173.7 KB)
17. The compliancepre2015 dataset contains study protocol compliance information (pre-2015).
Data Dictionary
(PDF - 173.7 KB)
18. The concomitantmedications dataset contains any concomitant medications taken throughout the study.
Data Dictionary
(PDF - 234.5 KB)
19. The dat_lipidswide_20160831 dataset contains lipid test results. Indicates value pre-study agent, post-study agent, and the difference between the two.
Data Dictionary
(PDF - 169.4 KB)
20. The dat_qpcrwide_20160809 dataset contains biomarker test results from Tissue Core Biopsies 3-6.
Data Dictionary
(PDF - 191.9 KB)
21. The dhafoodfrequencyquestionnaire dataset contains answers submitted for each question on the food frequency questionnaire.
Data Dictionary
(PDF - 165.5 KB)
22. The exclusioncriteria dataset contains whether or not the participant met any criteria that would exclude them from eligibility for the study.
Data Dictionary
(PDF - 167.9 KB)
23. The exclusioncriteriapre2015 dataset contains whether or not the participant met any criteria that would exclude them from eligibility for the study (pre-2015).
Data Dictionary
(PDF - 164.2 KB)
24. The fpkm_expr dataset contains RNA Fragments Per Kilobase Million gene values at the start and end of the trial.
Data Dictionary
(PDF - 166.2 KB)
25. The inclusioncriteria dataset contains whether or not the participant met all inclusion criteria that would allow eligibility for the study.
Data Dictionary
(PDF - 167.0 KB)
26. The inclusioncriteriapre2015 dataset contains whether or not the participant met all inclusion criteria that would allow eligibility for the study (pre-2015).
Data Dictionary
(PDF - 165.5 KB)
27. The interventionadministrationblind dataset contains study agent provide/start date.
Data Dictionary
(PDF - 166.5 KB)
28. The interventionadminpre2015 dataset contains study agent provide/start date (pre-2015).
Data Dictionary
(PDF - 169.2 KB)
29. The medicalsurgicalhistory dataset contains medical/surgical history for each body system and whether or not the participant has any allergies.
Data Dictionary
(PDF - 167.5 KB)
30. The medicalsurgicalhistothbodysystem dataset contains medical/surgical history for other body systems and whether or not the participant has any allergies.
Data Dictionary
(PDF - 170.0 KB)
31. The offstudy dataset contains the reason each participant went off of the study.
Data Dictionary
(PDF - 163.0 KB)
32. The patient_list_unblinded dataset contains unblinding information for the study.
Data Dictionary
(PDF - 185.9 KB)
33. The physicalexam dataset contains general anthropometry information, including height, weight, pulse, blood pressure, etc.
Data Dictionary
(PDF - 165.4 KB)
34. The previoustherapy dataset contains information on previous therapies, including radiation therapy, hormonal therapy, etc.
Data Dictionary
(PDF - 168.3 KB)
35. The previoustherapydetails dataset contains information on previous therapies, including radiation therapy, hormonal therapy, etc.
Data Dictionary
(PDF - 166.2 KB)
36. The randomization dataset contains study eligibility and randomization date.
Data Dictionary
(PDF - 164.1 KB)
37. The raw_counts dataset contains RNA raw count gene values at the start and end of the trial.
Data Dictionary
(PDF - 180.6 KB)
38. The registrationrace dataset contains general demographic information.
Data Dictionary
(PDF - 167.0 KB)
39. The screening dataset contains screening information, such as how participant heard about the study and their biggest influence for registering.
Data Dictionary
(PDF - 167.3 KB)
40. The telephonecontact dataset contains information on the last telephone contact with the participant as part of the study in order to determine if any possibly agent-related adverse events had resolved.
Data Dictionary
(PDF - 169.4 KB)
41. The tissuecorebiopsy2 dataset contains information on tissue core sample 2. These cores were used to determine CLS-B/CLS-B index/CLS-B/cm2.
Data Dictionary
(PDF - 172.4 KB)
42. The tissuecorebiopsy3thru6 dataset contains information on tissue core sample 3-6. These cores were used to determine primary study outcome results of TNFα /COX-2/IL1β /aromatase.
Data Dictionary
(PDF - 172.1 KB)
43. The tissuecorebiopsy7 dataset contains information on tissue core sample 7. These cores were stored for later use.
Data Dictionary
(PDF - 164.2 KB)
44. The verification dataset contains investigator verification information.