Information:
Fel:
ID
29274
Beskrivning
Study ID: 102932 Clinical Study ID: HZA102932 Study Title:An open-label, randomised, 3-way crossover single dose study to demonstrate dose proportionality of fluticasone furoate (FF) and equivalence of vilanterol (VI) when administered as FF/VI inhalation powder from the novel dry powder inhaler in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01213849 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma Documentation part: 12-lead ECG Abnormalities
Nyckelord
Versioner (1)
- 2018-03-15 2018-03-15 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
15 mars 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Dose proportionality of fluticasone furoate and equivalence of vilanterol in healthy adults GSK102932
Similar models
12-lead ECG Abnormalities
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
12-lead ECG Abnormalities
C0522055 (UMLS CUI-1)
C0430456 (UMLS CUI-2)
C0430456 (UMLS CUI-2)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
Time of ECG
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
Rhythm Abnormalities
Item
Other abnormal rhythm, enter comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
Item
Record clinically significant abnormalities: P Wave Morphology
integer
C2216025 (UMLS CUI [1,1])
C0429098 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,3])
C0429098 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,3])
Code List
Record clinically significant abnormalities: P Wave Morphology
CL Item
Left atrial abnormality (P mltrale) (1)
CL Item
Right atrial abnormality (P pulmonale) (2)
CL Item
Right ventricular hypertrophy (3)
CL Item
Intraatrial conduction delay (4)
CL Item
Increased voltage consistent with left ventricular hypertrophy (5)
CL Item
Other morphology, enter comment (6)
P Wave Morphology Abnormalities
Item
Other morphology, enter comment
text
C2216025 (UMLS CUI [1,1])
C0429098 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,3])
C0429098 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,3])
Conduction Abnormalities
Item
Other conduction, enter comment
text
C0232219 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
Item
Record clinically significant abnormalities: Myocardial Infarction
integer
C3854475 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
Code List
Record clinically significant abnormalities: Myocardial Infarction
CL Item
Myocardial infarction, old (1)
CL Item
Myocardial infarction, anterior (2)
CL Item
Myocardial infarction, lateral (3)
CL Item
Myocardial infarction, posterior (4)
CL Item
Myocardial infarction, inferior (5)
CL Item
Myocardial infarction, septal (6)
CL Item
Myocardial infarction, non Q-wave (7)
CL Item
Other myocardial infarction, enter comment (8)
Myocardial Infarction ECG
Item
Other myocardial infarction, enter comment
text
C3854475 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
Depolarisation/Repolarisation Abnormalities
Item
Other depolarisation/repolarisation, enter comment
text
C0948857 (UMLS CUI [1])
12-lead ECG Abnormalities
Item
Other abnormalities
text
C0522055 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
Item
Record clinically significant abnormalities: Rhythm
integer
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
CL Item
Sinus bradycardia (heart rate 40-50 beats/min) (1)
CL Item
Sinus bradycardia (heart rate 30-39 beats/min) (2)
CL Item
Sinus bradycardia (heart rate < 30 beats/min) (3)
CL Item
Sinus pause (4)
CL Item
Sinus tachycardia (heart rate >100 beats/min) (5)
CL Item
Ectopic supraventricular beats (6)
CL Item
Ectopic supraventricular rhythm (7)
CL Item
Wandering atrial pacemaker (8)
CL Item
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min) (9)
CL Item
Supraventricular tachycardia (heart rate >100 beats/min) (10)
CL Item
Atrial flutter (11)
CL Item
Atrial fibrillation (12)
CL Item
unctional rhythm (heart rate ≤100 beats/min) (13)
CL Item
Junctional rhythm (14)
CL Item
Junctional tachycardia (heart rate > 100 beats/min) (15)
CL Item
Ectopic ventricular beats (16)
CL Item
Ventricular couplets (17)
CL Item
Bigeminy (18)
CL Item
Trigeminy (19)
CL Item
Electrical alternans (20)
CL Item
R on T phenomenon (21)
CL Item
Ventricular fibrillation (22)
CL Item
Idioventricular rhythm (heart rate < 100 beats/min) (23)
CL Item
Sustained ventricular tachycardia (24)
CL Item
Non-sustained ventricular tachycardia (25)
CL Item
Ventricular tachycardia (26)
CL Item
Monomorphic ventricular tachycardia (27)
CL Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (28)
CL Item
Polymorphic (sustained and non-sustained) ventricular tachycardia (29)
CL Item
Artificial pacemaker (30)
CL Item
Other abnormal rhythm (31)
Item
Record clinically significant abnormalities: Conduction
integer
C0232219 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
CL Item
First degree AV block (PR interval > 200 msec) (1)
CL Item
Second degree AV block (Mobitz type 1) (2)
CL Item
Second degree AV block (Mobitz type 2) (3)
CL Item
2:1 AV block (4)
CL Item
Third degree AV block (5)
CL Item
Left axis deviation (QRS axis more negative than -30°) (6)
CL Item
Right axis deviation (QRS axis more positive than +110°) (7)
CL Item
Incomplete right bundle branch block (8)
CL Item
Incomplete left bundle branch block (9)
CL Item
Right bundle branch block (10)
CL Item
Left anterior hemiblock (synonymous to left anterior fascicular block) (11)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block) (12)
CL Item
Left bundle branch block (13)
CL Item
Bifascicular block (14)
CL Item
Non-specific intraventricular conduction delay (QRS ≥ 120 msec) (15)
CL Item
QT/QTc prolongation ≥ 500 msec (17)
CL Item
AV dissociation (18)
CL Item
Other conduction (19)
Item
Record clinically significant abnormalities: Depolarisation/Repolarisation (QRS-T)
integer
C0948857 (UMLS CUI [1])
Code List
Record clinically significant abnormalities: Depolarisation/Repolarisation (QRS-T)
CL Item
Non-specific ST-T changes (1)
CL Item
J point elevation (2)
CL Item
ST elevation (3)
CL Item
ST elevation-pericarditis (4)
CL Item
ST depression (5)
CL Item
U waves abnormal (6)
CL Item
T wave inversion (7)
CL Item
T wave peaked (8)
CL Item
T waves flat (9)
CL Item
T waves biphasic (10)
CL Item
Notched T-waves (11)
CL Item
Low QRS voltage (12)
CL Item
T-wave flattening/inversion (13)
CL Item
Other depolarisation/repolarisation (14)