Input data

• PRDRUG (SAS) - data (CRF page 3) represent NSAIDS/selenium/vitamin E that were taken within 12 months prior to visit 1 but stopped prior to visit 1
  • CMDRGCOL - drug collectionn code
  • CMDRGSYN - GSKDRUG synonym
  • DGSTDT/DGSPDT - drug start/stop date
  • DGTX - text for drug name (possibly corrected for purposes of coding)
  • DGVTX - Drug Verbatim Text
• DRUG (SAS) - data represents con meds taken sometime beyond visit 1
  • CMDRGCOL - drug collectionn code
  • CMDRGSYN - GSKDRUG synonym
  • DGSTDT/DGSPDT - drug start/stop date
  • DGPRTR - Drug Started Pre-Trial?
  • DGTX - text for drug name (possibly corrected for purposes of coding)
  • DGVTX - Drug Verbatim Text
• DRUGCODE.CSV file - drug coding (drug preferred terms and codes)
  • CMDRGCOL - drug collectionn code
  • CMATC1 - target organ system (ATC term)
  • PREF - prefered term

Method for finding all the relevant drugs.

1. Look through the DGTX for a drug name and note the corresponding CMDRGCOL value.
2. Select on the CMDRGCOL value to ensure that you get all the relevant entries regardless of spelling differences etc.
3. Provide a listing of all unique DGVTX values that map to the CMDRGCOL values of interest so that reviewers can ensure that the appropriate mapping has been done.
4. Method for handling multivitamins (which may or may not contain Vitamin E) is under construction.

Method for identifying if a drug was taken prio or during the study.

1. For concomitant medications report DRUG and PRDRUG are merged and variables DGPRTR, DGPSTR are defined for PRDRUG as DGPRTR="Yes", DGPSTR="No".
2. If dates of taking a medication are available the medication is assumed to be taken during the study if study drug period and period on the medication overlap, otherwise the medication is assumed to be taked prior to the study.
3. If dates of taking a medication are not available the medication is assumed to be taken during the study if DGPRTR="No" or DGPSTR="Yes" the medication is assumed to be taken prior to the study if DGPRTR="Yes" or DGPSTR="No"

Matt's E-mails on Concomitant Medications