Date of darapladib/placebo dose two days
Item
1. Date of darapladib/placebo dose on day two days prior to PK and/or PD
date
C0304229 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of darapladib/placebo dose two days
Item
1. Time of darapladib/placebo dose on two days prior to PK and/or PD Hr:Min (00:00-23:59)
time
C0013227 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Date of darapladib/placebo dose one day
Item
2. Date of darapladib/placebo dose one day prior to PK and/or PD
date
C0304229 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of darapladib/placebo dose one day
Item
2. Time of darapladib/placebo dose one day prior to PK and/or PD Hr:Min (00:00-23:59)
time
C0013227 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
1. Was the investigational product stopped permanently before study reached GSK target number of primary clinical endpoints?
text
C0304229 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
Code List
1. Was the investigational product stopped permanently before study reached GSK target number of primary clinical endpoints?
CL Item
Yes, complete primary reason (Y)
Item
2. 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
2. Select primary reason the investigational product was stopped
CL Item
Adverse event (1)
C0877248 (UMLS CUI-1)
(Comment:en)
CL Item
Study closed/terminated (5)
C2348570 (UMLS CUI-1)
(Comment:en)
CL Item
Lost to follow-up (6)
C1302313 (UMLS CUI-1)
(Comment:en)
CL Item
Protocol deviation (3)
C1705236 (UMLS CUI-1)
(Comment:en)
CL Item
Decision by subject or proxy (8)
C0679006 (UMLS CUI-1)
(Comment:en)
CL Item
Sponsor terminated study treatment, specify (9)
C1710224 (UMLS CUI-1)
(Comment:en)
CL Item
Investigator site closed (10)
C0035173 (UMLS CUI-1)
(Comment:en)
Adverse event No subreasons
Item
Adverse event: No subreasons
boolean
C2699517 (UMLS CUI [1])
Adverse event MACE
Item
Adverse event: MACE
boolean
C1516728 (UMLS CUI [1,1])
C2826934 (UMLS CUI [1,2])
Protocol deviation specification
Item
If Protocol deviation, specify
text
C1705236 (UMLS CUI [1])
Decision by subject or proxy specification
Item
If Decision by subject or proxy, specify
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Sponsor terminated study treatment specification
Item
If Sponsor terminated study treatment, specify
text
C1710224 (UMLS CUI [1])
Investigator site closed specification
Item
If Investigator site closed, specify
text
C2348235 (UMLS CUI [1])
Item
1. Type of regular post-IP follow-up
integer
C0589121 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
Code List
1. Type of regular post-IP follow-up
CL Item
Post-IP Phone Follow-up With Subject (1)
CL Item
Post-IP Follow-up through designated third party such as friend, family member, physician or medical records (2)
CL Item
No longer ongoing in study (e.g. Withdraw of consent, Lost to Follow-up, Death) (3)
Item
Contact Frequency
text
C3476109 (UMLS CUI [1])
Code List
Contact Frequency
CL Item
Every 3 months (preferred frequency per protocol) ([1])
CL Item
Every 6 months (only if regular follow-up refused) ([2])
CL Item
Every 12 months (only if regular follow-up refused) ([3])
CL Item
Every 18 months (only if regular follow-up refused) ([4])
CL Item
End of study only (only if regular follow-up refused) ([5])
Contact frequency other
Item
Other contact frequency, specify
text
C0337611 (UMLS CUI [1])
Item
2. Did subject sign the Authorization for Release of Health Information or other site medical release form for follow-up on medical information?
text
C0680281 (UMLS CUI [1,1])
C0018724 (UMLS CUI [1,2])
Code List
2. Did subject sign the Authorization for Release of Health Information or other site medical release form for follow-up on medical information?
CL Item
Not applicable (e.g. additional consent for release of medical information not required) (X)