Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item
Session Number
integer
C1883017 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Date of subject completion or discontinuation from the study
Item
Date of subject completion or discontinuation from the study
date
C2348577 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0457454 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0011008 (UMLS CUI [2,3])
Time of subject completion or discontinuation from the study
Item
Time of subject completion or discontinuation from the study
time
C2348577 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0457454 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
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) (X)
Item
Did the subject experience an incident or near incident with GlaxoSmithKline medical devices provided for use during the study?
text
C0025080 (UMLS CUI [1,1])
C1551358 (UMLS CUI [1,2])
Code List
Did the subject experience an incident or near incident with GlaxoSmithKline medical devices provided for use during the study?
Item
Did the subject discontinue the study prematurely?
text
C0457454 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Code List
Did the subject discontinue the study prematurely?
Item
If you tick yes in "Discontinuation of study", tick the primary reason for discontinuation.
text
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Code List
If you tick yes in "Discontinuation of study", tick the primary reason for discontinuation.
CL Item
Adverse event (A)
CL Item
Consent withdrawn (C)
CL Item
Lost to follow up (L)
CL Item
Protocol violation (P)
Other reason
Item
If other reason, please specify
text
C3840932 (UMLS CUI [1])
Date of comment
Item
Date of comment
date
C0947611 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
CRF page number
Item
CRF page number if applicable
integer
C1704732 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Confirmation
Item
Confirmation
boolean
C0750484 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Investigator’s signature
Item
Investigator’s signature
text
C2346576 (UMLS CUI [1])
Investigator’s name - print
Item
Investigator’s name - print
text
C2826892 (UMLS CUI [1])