Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item
Were any concomitant medications taken by the subject during the study?
text
C2347852 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
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 [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
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 [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Code List
Did the subject experience any serious adverse events during the study?
Item
Did the subject experience any CF exacerbations during the study?
text
C0010674 (UMLS CUI [1,1])
C4086268 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
Code List
Did the subject experience any CF exacerbations during the study?
Item
Were any repeat haematology or clinical chemistry samples taken?
text
C0525044 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0018941 (UMLS CUI [2,1])
C0205341 (UMLS CUI [2,2])
Code List
Were any repeat haematology or clinical chemistry samples taken?
Item
Were any repeat urinalysis samples taken?
text
C0200345 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,3])
Code List
Were any repeat urinalysis samples taken?
Item
Were any repeat ECGs performed?
text
C1623258 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Code List
Were any repeat ECGs performed?
Item
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
text
C1832603 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
Code List
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
Item
Were any repeat vital signs recorded?
text
C0518766 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Code List
Were any repeat vital signs recorded?
Item
Were any repeat PD samples taken?
text
C0205341 (UMLS CUI [1,1])
C0851347 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
Code List
Were any repeat PD samples taken?
Item
Were any repeat Pulmonary Function Tests performed?
text
C0205341 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Code List
Were any repeat Pulmonary Function Tests performed?
Item
Were any repeat PK blood samples taken?
text
C0205341 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0005767 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,4])
Code List
Were any repeat PK blood samples taken?
Item
Were any repeat sputum samples induced?
text
C0205341 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0038056 (UMLS CUI [1,3])
Code List
Were any repeat sputum samples induced?
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
text
C0023884 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,4])
C0243161 (UMLS CUI [1,5])
Code List
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?