On-Study Crohn's Disease Background Medication, Non-study Drugs

Illustrates Domains

CM 

Illustrates Variables

CMTRT
CMROUTE
CMADJ
CMDOSFRQ
CMINDC
CMENRF


Content

cm.xpt
Row 1:

Shows the specific Crohn's medication used by the subject during the study. A record was included for each specific dose level used during the study. The reason for change was represented in the CMADJ variable when applicable.

Row 2:

Shows the specific Crohn's medication used by the subject during the study. The steroid was tapered for improving symptoms. The sponsor was not interested in zero doses, so these were not reflected in the data.

Row 3:

Shows the medication restart based on worsening symptoms. The value of "AFTER" in the CMENRF variable indicates that the medication was entered as ongoing at the end of the study reference period.

cm.xpt

RowSTUDYIDDOMAINUSUBJIDCMSEQCMTRTCMCATCMSCATCMDOSECMDOSUCMDOSFRQCMROUTECMADJCMINDCCMSTDTCCMENDTCCMENRF
1CR002CMCR002-00114BUDESONIDEON-STUDY BACKGROUND CROHN'S DISEASE MEDICATIONCORTICOSTEROIDS6mgQDORAL
CROHN'S DISEASE2010-10-092010-11-24
2CR002CMCR002-00115BUDESONIDEON-STUDY BACKGROUND CROHN'S DISEASE MEDICATION

CORTICOSTEROIDS

3mgQDORALIMPROVING SYMPTOMSCROHN'S DISEASE2010-11-242011-02-14
3CR002CMCR002-00116BUDESONIDEON-STUDY BACKGROUND CROHN'S DISEASE MEDICATIONCORTICOSTEROIDS6mgQDORALWORSENING SYMPTOMSCROHN'S DISEASE

2011-08-16


AFTER