Study Site
Item
Site
text
C2825164 (UMLS CUI [1])
Clinical trial participant
Item
Subject
text
C1997894 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Subject No.
integer
C2348585 (UMLS CUI [1])
Oropharyngeal Candidiasis, Evidence
Item
Does the subject have clinical evidence of oropharyngeal candidiasis?
boolean
C0919659 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
Oropharyngeal Candidiasis, Taking of swab
Item
Was a culture swab taken?
boolean
C0919659 (UMLS CUI [1,1])
C0563454 (UMLS CUI [1,2])
Item
Result of culture swab
text
C0919659 (UMLS CUI [1,1])
C0563454 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Code List
Result of culture swab
CL Item
Not available (3)
Smoking Status, Changed status
Item
Has the smoking status changed since the last time it was assessed?
boolean
C1519386 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Item
If yes, Smoking Status
text
C1519386 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Code List
If yes, Smoking Status
CL Item
Subject started smoking (1)
CL Item
Subject stopped smoking (2)
Smoking Status, Changed status, Date in time
Item
Date a change was made
date
C1519386 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Date of Visit, Assessment Date
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Trial Screen Failure
Item
Was this subject a run-in failure?
boolean
C1710476 (UMLS CUI [1])
Item
Yes, complete run-in failure - reason
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Code List
Yes, complete run-in failure - reason
CL Item
Did not meet continuation criteria (1)
CL Item
Adverse Event (2)
CL Item
Study closed/terminated (3)
CL Item
Lost to Follow-up (4)
CL Item
Investigator discretion, specify (5)
CL Item
Withdrew consent, specify (6)
Trial Screen Failure, Date in time
Item
Run-in failure date
date
C1710476 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Randomization, Criteria
Item
Did the subject meet all of the Randomisation criteria?
boolean
C0034656 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Pneumonia; COPD Exacerbation
Item
Evidence of pneumonia and/or moderate or severe COPD exacerbation at Screening (Visit 1) or during the run-in period Note: Subjects who experience a pneumonia and/or moderate or severe exacerbations during the run-in period must not be randomized at the randomization visit (Visit 2), but may be re-screened at a later time provided the pneumonia and/or COPD exacerbation has resolved prior to the re-screening visit. At the Re-screening Visit, chest x- ray should confirm resolution of pneumonia. The Re- screening Visit must be conducted at least >=14 days following the resolution date of the exacerbation and/or pneumonia and at least 30 days following the last dose of oral corticosteroids (if applicable).
boolean
C0032285 (UMLS CUI [1])
C0740304 (UMLS CUI [2])
Laboratory Procedures, Abnormality
Item
Abnormal clinically significant laboratory findings in any liver chemistry, hematology, or chemistry tests at Screening (Visit 1) or upon repeat prior to the day of randomization.
boolean
C0022885 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
12 lead ECG, Abnormality
Item
Abnormal and clinically significant 12-lead ECG at Screening (Visit 1) or pre-dose (Visit 2). Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility. For this study, an abnormal and clinically significant finding that would preclude a subject from entering the trial is defined as a 12-lead tracing that is interpreted as, but not limited to, any of the following: - Sinus bradycardia <45bpm - Sinus tachycardia >=110bpm - Multifocal atrial tachycardia (wandering atrial pacemaker with rate >100bpm) - PR interval >240msec - Evidence of Mobitz II second degree or third degree atrioventricular (AV) block - Pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4mV (4mm with 10mm/mV setting)] or >25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads. Note: prior evidence (i.e., ECG obtained at least 12 months prior) of pathological QT waves that are unchanged are not exclusionary. - Evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes. - QTc(F) >=450msec or uncorrected QT >600msec or an ECG that is unsuitable for QT measurements (e.g., poor defined termination of the T wave) Note: QTc(F) >=450msec or uncorrected QT>600msec should be confirmed by three readings at least 5 minutes apart. -ST-T wave abnormalities (excluding non-specific ST-T wave abnormalities) - Right or left complete bundle branch block -Clinically significant conduction abnormalities (e.g., left bundle branch block, Wolff-Parkinson-White syndrome) - Clinically significant arrhythmias (e.g., atrial fibrillation with rapid ventricular response, ventricular tachycardia) The investigator will determine the medical significance of ECG abnormalities that are not exclusionary a priori and determine if the subject is precluded from entering the study.
boolean
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Non-Compliance
Item
Non-compliance: with IVRS diary completion (failure to complete at least 4 of the last 7 consecutive days for all data fields in the diary), run-in medication (failure to be at least 80% compliant), withholding of prohibited medications or keeping clinic visit appointments.
boolean
C0457432 (UMLS CUI [1])
Investigator Signature
Item
Is this casebook ready to sign?
boolean
C2346576 (UMLS CUI [1])
Laboratory Procedures, Sampling, Date in time
Item
Date sample taken
date
C0022885 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Laboratory Procedures, Sampling, Not done
Item
Not done
boolean
C0022885 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Randomization, Numbers
Item
Randomisation number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Randomization, Date in time
Item
Date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Liver, Laboratory Procedures, Stop, Criteria
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0023884 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
Withdrawal by Subject, Visit
Item
Did the subject withdraw at this visit?
boolean
C1710677 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Systolic Pressure
Item
Blood pressure (systolic)
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood Pressure (diastolic)
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])