Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
Item
Did the subject withdraw from study as a result of this AE?
text
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Did the subject withdraw from study as a result of this AE?
Item
Primary reason for withdrawal
text
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Primary reason for withdrawal
CL Item
Adverse event (record details on the Non-Serious Adverse Event or Serious Adverse Events forms as appropriate) (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Lack of efficacy (5)
CL Item
Sponsor terminated study (6)
CL Item
Non-compliance (17)
Other primary reason for withdrawal
Item
Other, specify
text
Item
Did the subject become pregnant during the study?
text
C0032961 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Code List
Did the subject become pregnant during the study?
CL Item
Not applicable (Not of childbearing potential or male) (Not applicable)
Overall compliance
Item
Did the subject generally take their morning dose of medication within 2 hours of a meal?
boolean
Investigator Signature
Item
Investigator’s Signature
text
C2346576 (UMLS CUI [1])
InvestigatorName
Item
Investigator’s name (print)
text
C0035173 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C1547383 (UMLS CUI [1,3])
Investigator Signature Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])