Date/time of visit/assessment
Item
Date/time of visit/assessment
datetime
C1264639 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1264639 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item
Were any concomitant medications taken by the subject during the study?
text
C2347852 (UMLS CUI [1])
Code List
Were any concomitant medications taken by the subject during the study?
Item
Did the subject experience any non-serious adverse events during the study?
text
C1518404 (UMLS CUI [1])
Code List
Did the subject experience any non-serious adverse events during the study?
Item
Did the subject experience any serious adverse events during the study?
text
C1519255 (UMLS CUI [1])
Code List
Did the subject experience any serious adverse events during the study?
Item
Were any unscheduled ECGs performed?
text
C0013798 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
Code List
Were any unscheduled ECGs performed?
Item
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
text
C0522055 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Code List
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
Item
Were any unscheduled vital signs recorded?
text
C0518766 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
Code List
Were any unscheduled vital signs recorded?
Item
Were any unscheduled Spirometry tests performed?
text
C3854240 (UMLS CUI [1,1])
C0037981 (UMLS CUI [1,2])
Code List
Were any unscheduled Spirometry tests performed?
Item
Were any unscheduled PK blood samples taken?
text
C3854240 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,3])
Code List
Were any unscheduled PK blood samples taken?
Item
Were any unscheduled Holter performed?
text
C0013801 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
Code List
Were any unscheduled Holter performed?
Item
Were any abnormal, clinically significant Holter or Telemetry measurements recorded for this subject during the study?
text
C0013801 (UMLS CUI [1,1])
C0522055 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C0039451 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0205161 (UMLS CUI [2,3])
Code List
Were any abnormal, clinically significant Holter or Telemetry measurements recorded for this subject during the study?
Item
Was a unscheduled Immunogenicity performed?
text
C4054739 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
Code List
Was a unscheduled Immunogenicity performed?
Item
Was a unscheduled Biomarker Serum performed?
text
C3854240 (UMLS CUI [1,1])
C0005516 (UMLS CUI [1,2])
C0229671 (UMLS CUI [1,3])
Code List
Was a unscheduled Biomarker Serum performed?
Item
Was a unscheduled Biomarker WBA performed?
text
C3854240 (UMLS CUI [1,1])
C0005516 (UMLS CUI [1,2])
C0370231 (UMLS CUI [1,3])
Code List
Was a unscheduled Biomarker WBA performed?
Item
Did GSK Monitor identify any protocol deviations for this subject?
text
C1705236 (UMLS CUI [1])
Code List
Did GSK Monitor identify any protocol deviations for this subject?
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
text
C0023901 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C2746065 (UMLS CUI [1,5])
C0304229 (UMLS CUI [1,6])
Code List
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?