Illustrates Domains
CM
Illustrates Variables
CMTRT
CMROUTE
CMADJ
CMDOSFRQ
CMINDC
CMENRF
Content
CM
CMTRT
CMROUTE
CMADJ
CMDOSFRQ
CMINDC
CMENRF
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. |
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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
Row | STUDYID | DOMAIN | USUBJID | CMSEQ | CMTRT | CMCAT | CMSCAT | CMDOSE | CMDOSU | CMDOSFRQ | CMROUTE | CMADJ | CMINDC | CMSTDTC | CMENDTC | CMENRF |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | CR002 | CM | CR002-001 | 14 | BUDESONIDE | ON-STUDY BACKGROUND CROHN'S DISEASE MEDICATION | CORTICOSTEROIDS | 6 | mg | QD | ORAL | CROHN'S DISEASE | 2010-10-09 | 2010-11-24 | ||
2 | CR002 | CM | CR002-001 | 15 | BUDESONIDE | ON-STUDY BACKGROUND CROHN'S DISEASE MEDICATION | CORTICOSTEROIDS | 3 | mg | QD | ORAL | IMPROVING SYMPTOMS | CROHN'S DISEASE | 2010-11-24 | 2011-02-14 | |
3 | CR002 | CM | CR002-001 | 16 | BUDESONIDE | ON-STUDY BACKGROUND CROHN'S DISEASE MEDICATION | CORTICOSTEROIDS | 6 | mg | QD | ORAL | WORSENING SYMPTOMS | CROHN'S DISEASE | 2011-08-16 | AFTER |