Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
concomitant medications
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1])
non-serious adverse events
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
serious adverse events
Item
Did the subject experience any serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1])
abnormal ECG
Item
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
boolean
C0522055 (UMLS CUI [1])
repeat haematology or clinical chemistry samples taken
Item
Were any repeat haematology or clinical chemistry samples taken?
boolean
C0008000 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
urinalysis samples
Item
Were any repeat urinalysis samples taken?
boolean
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
ECG
Item
Were any repeat ECGs performed?
boolean
C0013798 (UMLS CUI [1])
vital signs
Item
Were any repeat vital signs recorded?
boolean
C0518766 (UMLS CUI [1])
Pulmonary Function Tests
Item
Were any repeat Pulmonary Function Tests performed?
boolean
C0024119 (UMLS CUI [1])
PK blood samples taken
Item
Were any repeat PK blood samples taken?
boolean
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
IP device malfunctions
Item
Any IP device malfunctions?
boolean
C0699733 (UMLS CUI [1])
liver chemistry
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])