after week 24 (Core study phase)
Item
after week 24 (Core study phase)
boolean
C2983670 (UMLS CUI [1])
after week 48 (Follow up phase)
Item
after week 48 (Follow up phase)
boolean
C2983670 (UMLS CUI [1])
during the Screening phase (Screening failure)
Item
during the Screening phase (Screening failure)
boolean
C1710477 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
If screening failure, please specify:
Item
If screening failure, please specify:
text
C1710477 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
during the Core study phase
Item
during the Core study phase
boolean
during Follow up phase
Item
during Follow up phase
text
C1522577 (UMLS CUI [1])
Item
Reason for discontinuation of the Core study phase / Follow up phase:
text
C0392360 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Code List
Reason for discontinuation of the Core study phase / Follow up phase:
CL Item
Patient withdraws informed consent (1)
CL Item
Lack of efficacy (2)
CL Item
Other medical, cognitive, or other conditions, in the Investigator’s opinion, com- promise the patient’s ability to understand the nature, signi cance, implications and risks of the study, to comply with the protocol or to complete the study (3)
CL Item
Adverse Event (4)
CL Item
Serious Adverse Event (5)
CL Item
Lost to Follow up (6)
If "other reason", please specify:
Item
If "other reason", please specify:
text
C3840932 (UMLS CUI [1])
Investigator Signature Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Signature Investigator
Item
Signature Investigator
text
C2346576 (UMLS CUI [1])