Protocol Identifier
Item
Protocol Identifier: AVA100193
boolean
C2826693 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Visit Description
Item
Visit Description: Study Conclusion
boolean
C0545082 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
Did the subject become pregnant during the study?
text
C0032961 (UMLS CUI [1])
Code List
Did the subject become pregnant during the study?
CL Item
Not applicable (not of childbearing potential or male) (3)
Item
Was the treatment blind broken during the study?
text
C2347038 (UMLS CUI [1])
Code List
Was the treatment blind broken during the study?
Date blind broken
Item
Date blind broken
date
C0011008 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
Item
Reason blind broken
text
C2347038 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other (specify) (2)
Other
Item
If Other, please specify
text
C2347038 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Non-Serious Adverse Event, Serious Adverse Event and/or Investigational Product
Item
Complete Non-Serious Adverse Event, Serious Adverse Event and/or Investigational Product pages, as appropriate.
boolean
C1518404 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
C0304229 (UMLS CUI [3])
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1])
Withdrawl
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
If yes, select the primary (!) reason for withdrawal
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
If yes, select the primary (!) reason for withdrawal
CL Item
Adverse event (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
Sponsor terminated study (5)
CL Item
Non-compliance (6)
Specification of Other
Item
If other, please specify
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Investigator´s signature
Item
Investigator´s signature
text
C2346576 (UMLS CUI [1])
Investigator´s name
Item
Investigator´s name (print)
text
C2361125 (UMLS CUI [1])