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 investigational Product Device Malfunctions?
text
C0304229 (UMLS CUI [1,1])
C0086138 (UMLS CUI [1,2])
Code List
Did the subject experience any investigational Product Device Malfunctions?
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 haematology or clinical chemistry samples taken?
text
C3854240 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C3854240 (UMLS CUI [2,1])
C0018941 (UMLS CUI [2,2])
Code List
Were any unscheduled haematology or clinical chemistry samples taken?
Item
Were any unscheduled urinalysis samples taken?
text
C3854240 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
Code List
Were any unscheduled urinalysis samples taken?
Item
Were any unscheduled ECGs performed?
text
C3854240 (UMLS CUI [1,1])
C0013798 (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
C3854240 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Code List
Were any unscheduled vital signs recorded?
Item
Were any chest x-rays taken for suspected Pneumonia?
text
C0039985 (UMLS CUI [1,1])
C0032285 (UMLS CUI [1,2])
C0750491 (UMLS CUI [1,3])
Code List
Were any chest x-rays taken for suspected Pneumonia?
Item
Were any unscheduled FEV1 performed?
text
C3854240 (UMLS CUI [1,1])
C0748133 (UMLS CUI [1,2])
Code List
Were any unscheduled FEV1 performed?
Item
Were any unscheduled PK blood samples taken?
text
C3854240 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C3854240 (UMLS CUI [2,1])
C0178913 (UMLS CUI [2,2])
Code List
Were any unscheduled PK blood samples taken?
Item
Have liver chemistry results reached or exceeded protocol- defined investigational product stopping criteria?
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
Code List
Have liver chemistry results reached or exceeded protocol- defined investigational product stopping criteria?