Was the treatment mask broken during the study?
Item
Was the treatment mask broken during the study?
boolean
C3897431 (UMLS CUI [1])
Date mask broken
Item
Date mask broken
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Reason mask broken
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Reason mask broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other, specify (2)
If other reason for mask broken, specify
Item
If other reason for mask broken, specify
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Was the investigational product stopped permanently before the scheduled end of the treatment period?
Item
Was the investigational product stopped permanently before the scheduled end of the treatment period?
boolean
C0304229 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0205539 (UMLS CUI [2,3])
C0444930 (UMLS CUI [2,4])
C0332152 (UMLS CUI [2,5])
Item
Select primary reason the investigational product was stopped
text
C0392360 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])
Code List
Select primary reason the investigational product was stopped
CL Item
Other, specify (OT)
CL Item
Adverse Event, specify (1)
CL Item
Lack of efficacy (2)
CL Item
Protocol Deviation (3)
CL Item
Study closed/terminated (4)
CL Item
Lost to Follow-up (5)
CL Item
Investigator discretion, specify (6)
CL Item
Decision by subject or proxy (7)
Item
If reason is Adverse Event, specify
text
C1519255 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Code List
If reason is Adverse Event, specify
CL Item
Exclusionary blood pressure (006)
CL Item
Subject met GSK defined liver chemistry stopping criteria (055)
CL Item
No subreasons (-99)
If Investigator discretion, specify
Item
If Investigator discretion, specify
text
C0008961 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
If decision by subject or proxy, specify
text
C0679006 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0600420 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Code List
If decision by subject or proxy, specify
CL Item
Burden of procedures (39)
CL Item
Other, specify (OT)
CL Item
No subreasons (-99)
If other decision by subject or proxy, specify
Item
If other decision by subject or proxy, specify
text
C0679006 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0600420 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Did the subject become pregnant during the study?
Item
Did the subject become pregnant during the study?
boolean
C3828490 (UMLS CUI [1])
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1])
Item
Was the subject withdrawn from the study?
text
C0422727 (UMLS CUI [1])
Code List
Was the subject withdrawn from the study?
CL Item
Yes, complete primary reason for withdrawal (Y)
Item
Primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Primary reason for withdrawal
CL Item
Adverse Event, specify (1)
CL Item
Lack of efficacy (2)
CL Item
Protocol Deviation (3)
CL Item
Study closed/terminated (5)
CL Item
Lost to Follow-up (6)
CL Item
Investigator discretion, specify (7)
CL Item
Withdrew consent, specify (8)
Item
If reason for withdrawal is Adverse Event, specify
text
C0877248 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
Code List
If reason for withdrawal is Adverse Event, specify
CL Item
Exclusionary blood pressure (006)
CL Item
Liver function test abnormality (017)
CL Item
No subreasons (-99)
Investigator discretion, specify
Item
Investigator discretion, specify
text
C2348235 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0022423 (UMLS CUI [1,3])
Item
Withdrew consent, specify
text
C1707492 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Code List
Withdrew consent, specify
CL Item
Burden of procedures (38)
CL Item
Other, specify (OT)
CL Item
No subreasons (-99)