ID
33715
Beschrijving
Study ID: 102936 Clinical Study ID: HZA102936 Study Title:A randomised, placebo-controlled, four-way crossover repeat dose study to evaluate the effect of the inhaled fluticasone furoate (FF)/GW642444M combination on electrocardiographic parameters, with moxifloxacin as a positive control, in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01209026 https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026 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 The study consists of a screening, 4 treatment periods and a follow up. Treatment periods 1-4 are each 7 days long. Treatment period 1 Days 1-6 (TP1D-D6) Treatment period 1 Day 7 (TP1D7) Treatment period 2 Days 1-6 (TP2D1-D6) Treatment period 2 Day 7 (TP2D7) Treatment period 3 Days 1-6 (TP3D1-D6) Treatment period 3 Day 7 (TP3D7) Treatment period 4 Days 1-6 (TP4D1-D6) Treatment period 4 Day 7 (TP4D7) This document contains the 12-Lead ECG Abnormalities form. It has to be filled in for screening if there is a clinical sigificance ECG. It also has to be filled in during study if such a significance occur.
Link
https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026
Trefwoorden
Versies (2)
- 20-12-18 20-12-18 -
- 20-12-18 20-12-18 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
20 december 2018
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026
12-Lead ECG Abnormalities
- StudyEvent: ODM
Beschrijving
12 Lead ECG abnormalities
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
Beschrijving
Rhythm
Alias
- UMLS CUI-1
- C0232201
Beschrijving
Sinus bradycardia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschrijving
Sinus bradycardia (heart rate 40-50 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Beschrijving
Sinus bradycardia (heart rate 30-39 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Beschrijving
Sinus bradycardia (heart rate <30 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Beschrijving
Sinus pause
Datatype
boolean
Alias
- UMLS CUI [1]
- C1955864
Beschrijving
Sinus tachycardia (heart rate> 100 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0039239
- UMLS CUI [1,2]
- C0018810
Beschrijving
Ectopic supraventricular beats
Datatype
boolean
Alias
- UMLS CUI [1]
- C0033036
Beschrijving
Ectopic supraventricular rhythm
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348376
Beschrijving
Wandering atrial pacemaker
Datatype
boolean
Alias
- UMLS CUI [1]
- C1321523
Beschrijving
Multifocal atrial tachycardia (wandering atrial pacemaker with heart rate > 100 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0221158
- UMLS CUI [1,2]
- C0018810
Beschrijving
Supra ventricular tachycardia (heart rate > 100 beat/min)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0039240
- UMLS CUI [1,2]
- C0018810
Beschrijving
Atrial flutter
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004239
Beschrijving
Atrial fibrillation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004238
Beschrijving
Junctional rhythm (heart rate <= 100 beat /min)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0232208
- UMLS CUI [1,2]
- C0018810
Beschrijving
Junctional rhythm
Datatype
boolean
Alias
- UMLS CUI [1]
- C0232208
Beschrijving
Junctional tachycardia (heart rate > 100 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0039235
- UMLS CUI [1,2]
- C0018810
Beschrijving
Ectopic ventricular beats
Datatype
boolean
Alias
- UMLS CUI [1]
- C0151636
Beschrijving
Ventricular couplets
Datatype
boolean
Alias
- UMLS CUI [1]
- C0429001
Beschrijving
Bigeminy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0262662
Beschrijving
Trigeminy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0428999
Beschrijving
Electrical alternans
Datatype
boolean
Alias
- UMLS CUI [1]
- C1142551
Beschrijving
R on T phenomenon
Datatype
boolean
Alias
- UMLS CUI [1]
- C0877658
Beschrijving
Ventricular fibrillation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0042510
Beschrijving
ldioventricular rhythm
Datatype
boolean
Alias
- UMLS CUI [1]
- C0700363
Beschrijving
Sustained ventricular tachycardia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0750197
Beschrijving
Non-sustained ventricular tachycardia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0750194
Beschrijving
Wide QRS Tachycardia (diagnosis unknown)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0344429
- UMLS CUI [1,2]
- C0439673
- UMLS CUI [1,3]
- C0011900
Beschrijving
Ventricular tachycardia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0042514
Beschrijving
Monomorphic ventricular tachycardia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0344431
Beschrijving
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0040479
Beschrijving
Polymorphic (sustained and non-sustained) ventricular tachycardia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0344432
Beschrijving
Artificial Pacemaker
Datatype
boolean
Alias
- UMLS CUI [1]
- C0030163
Beschrijving
Other abnormal rhythm
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0199556
- UMLS CUI [1,3]
- C0205161
Beschrijving
Comment abnormal rhythm
Datatype
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0199556
- UMLS CUI [1,3]
- C0205161
Beschrijving
P-Wave Morphology
Alias
- UMLS CUI-1
- C2216025
Beschrijving
Left atrial abnormality (P mitrale)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0344711
- UMLS CUI [1,2]
- C0232310
Beschrijving
Right atrial abnormality (P pulmonale)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0344696
- UMLS CUI [1,2]
- C0232308
Beschrijving
Right ventricular hypertrophy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0162770
Beschrijving
Intraatrial conduction delay
Datatype
boolean
Alias
- UMLS CUI [1]
- C2346510
Beschrijving
Increased voltage consistent with left ventricular hypertrophy
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1112650
- UMLS CUI [1,2]
- C0149721
Beschrijving
Other morphology
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0332437
Beschrijving
Comment other morphology
Datatype
text
Alias
- UMLS CUI [1,1]
- C0332437
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beschrijving
Conduction
Alias
- UMLS CUI-1
- C0264886
Beschrijving
First degree AV block (PR interval> 200msec)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085614
Beschrijving
Short PR interval
Datatype
boolean
Alias
- UMLS CUI [1]
- C0520878
Beschrijving
Second degree AV block (Mobitz type 1)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0264907
Beschrijving
Second degree AV block (Mobitz type 2)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0155700
Beschrijving
2: 1 AV block
Datatype
boolean
Alias
- UMLS CUI [1]
- C2346542
Beschrijving
Third degree AV block
Datatype
boolean
Alias
- UMLS CUI [1]
- C0151517
Beschrijving
Left axis deviation (QRS axis more negative than -30 degrees)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0232297
Beschrijving
Right axis deviation (QRS axis more positive than +110 degrees)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0232296
Beschrijving
Incomplete right bundle branch block
Datatype
boolean
Alias
- UMLS CUI [1]
- C0262525
Beschrijving
Incomplete left bundle branch block
Datatype
boolean
Alias
- UMLS CUI [1]
- C0281878
Beschrijving
Right bundle branch block
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085615
Beschrijving
Left anterior hemiblock (synonymous to left anterior fascicular block)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0264912
Beschrijving
Left posterior hemiblock (synonymous to left posterior fascicular block)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0264913
Beschrijving
Left bundle branch block
Datatype
boolean
Alias
- UMLS CUI [1]
- C0023211
Beschrijving
Bifascicular block
Datatype
boolean
Alias
- UMLS CUI [1]
- C0264914
Beschrijving
Non-specific intraventricular conduction delay (QRS >= 120 msec)
Datatype
boolean
Alias
- UMLS CUI [1]
- C3697597
Beschrijving
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1963785
- UMLS CUI [1,2]
- C0043202
- UMLS CUI [1,3]
- C0024054
Beschrijving
Prolonged QT interval
Datatype
boolean
Alias
- UMLS CUI [1]
- C0151878
Beschrijving
QT/QTc prolongation >=500msec
Datatype
boolean
Alias
- UMLS CUI [1]
- C0855333
Beschrijving
AV dissociation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004331
Beschrijving
Other conduction
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
Beschrijving
Comment other conduction
Datatype
text
Alias
- UMLS CUI [1,1]
- C0340494
- UMLS CUI [1,2]
- C0947611
Beschrijving
Myocardial Infarction
Alias
- UMLS CUI-1
- C0027051
Beschrijving
Myocardial infarction, old
Datatype
boolean
Alias
- UMLS CUI [1]
- C0155668
Beschrijving
Myocardial infarction, anterior
Datatype
boolean
Alias
- UMLS CUI [1]
- C0340293
Beschrijving
Myocardial infarction, lateral
Datatype
boolean
Alias
- UMLS CUI [1]
- C0340312
Beschrijving
Myocardial infarction, posterior
Datatype
boolean
Alias
- UMLS CUI [1]
- C0340319
Beschrijving
Myocardial infarction, inferior
Datatype
boolean
Alias
- UMLS CUI [1]
- C0340305
Beschrijving
Myocardial infarction, septal
Datatype
boolean
Alias
- UMLS CUI [1]
- C0746727
Beschrijving
Myocardial infarction, Non Q-wave
Datatype
boolean
Alias
- UMLS CUI [1]
- C0542269
Beschrijving
Other myocardial infarction
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0027051
Beschrijving
Comment other myocardial infarction
Datatype
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beschrijving
Depolarisation/Repolarisation (QRS-T)
Alias
- UMLS CUI-1
- C0948857
- UMLS CUI-2
- C1331539
Beschrijving
Non-specific ST-T changes
Datatype
boolean
Alias
- UMLS CUI [1]
- C1112720
Beschrijving
J point elevation
Datatype
boolean
Alias
- UMLS CUI [1]
- C2346597
Beschrijving
ST elevation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0520886
Beschrijving
ST-elevation - pericarditis
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348119
Beschrijving
ST depression
Datatype
boolean
Alias
- UMLS CUI [1]
- C0520887
Beschrijving
U waves abnormal
Datatype
boolean
Alias
- UMLS CUI [1]
- C0438169
Beschrijving
T wave inversion
Datatype
boolean
Alias
- UMLS CUI [1]
- C0520888
Beschrijving
T wave peaked
Datatype
boolean
Alias
- UMLS CUI [1]
- C0239242
Beschrijving
T waves flat
Datatype
boolean
Alias
- UMLS CUI [1]
- C2215959
Beschrijving
T waves biphasic
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348639
Beschrijving
Notched T-waves
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347367
Beschrijving
Low QRS voltage
Datatype
boolean
Alias
- UMLS CUI [1]
- C2349945
Beschrijving
T-wave flattening/inversion
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0520888
- UMLS CUI [1,2]
- C0429059
Beschrijving
Other depolarisation/repolarisation
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0948857
- UMLS CUI [1,2]
- C0205394
Beschrijving
Comment other depolarisation/repolarisation
Datatype
text
Alias
- UMLS CUI [1,1]
- C0948857
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beschrijving
Other abnormalities
Alias
- UMLS CUI-1
- C0522055
- UMLS CUI-2
- C0205394
Similar models
12-Lead ECG Abnormalities
- StudyEvent: ODM
C1704258 (UMLS CUI-2)
C0040223 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
C0199556 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0199556 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0232310 (UMLS CUI [1,2])
C0232308 (UMLS CUI [1,2])
C0149721 (UMLS CUI [1,2])
C0332437 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0043202 (UMLS CUI [1,2])
C0024054 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C1331539 (UMLS CUI-2)
C0429059 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])