ID
33193
Beskrivning
Study ID: 107806 Clinical Study ID: RA3107806 Study Title: An open label study to determine the safety, tolerability, excretion balance and pharmacokinetics of Losmapimod, administered as a single dose of an oral solution to healthy adult male subjects Patient Level Data: Clinicaltrials.gov Identifier: NCT00599612 https://clinicaltrials.gov/ct2/show/NCT00599612 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: losmapimod Trade Name: losmapimod Study Indication: Pulmonary Disease, Chronic Obstructive The study consists of a screening, study visit and follow-up. The protocol identifier for all: RA3107806 This document contains the 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.
Länk
https://clinicaltrials.gov/ct2/show/NCT00599612
Nyckelord
Versioner (3)
- 2018-11-28 2018-11-28 -
- 2018-11-29 2018-11-29 -
- 2018-11-30 2018-11-30 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
30 november 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612
12- Lead ECG Abnormalities
- StudyEvent: ODM
Beskrivning
12 Lead ECG abnormalities
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
Beskrivning
Transcribe from the 12 Lead ECG result page. Complete additional ECG abnormalities pages if clinically significant abnormalities are present.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0237753
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1]
- C2826640
Beskrivning
Time of ECG
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0040223
Beskrivning
Rhythm
Alias
- UMLS CUI-1
- C0232201
Beskrivning
Sinus bradycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0085610
Beskrivning
Sinus bradycardia (heart rate 40-50 beats/min)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Beskrivning
Sinus bradycardia (heart rate 30-39 beats/min)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Beskrivning
Sinus bradycardia (heart rate <30 beats/min)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Beskrivning
Sinus pause
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1955864
Beskrivning
Sinus tachycardia (heart rate> 100 beats/min)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0039239
- UMLS CUI [1,2]
- C0018810
Beskrivning
Ectopic supraventricular beats
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0033036
Beskrivning
Ectopic supraventricular rhythm
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2348376
Beskrivning
Wandering atrial pacemaker
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1321523
Beskrivning
Multifocal atrial tachycardia (wandering atrial pacemaker with heart rate > I00 beats/min)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0221158
- UMLS CUI [1,2]
- C0018810
Beskrivning
Supra ventricular tachycardia (heart rate> I 00 beat/min)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0039240
- UMLS CUI [1,2]
- C0018810
Beskrivning
Atrial flutter
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0004239
Beskrivning
Atrial fibrillation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0004238
Beskrivning
Junctional rhythm (heart rate <= 100 beat /min)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0232208
- UMLS CUI [1,2]
- C0018810
Beskrivning
Junctional rhythm
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0232208
Beskrivning
Junctional tachycardia (heart rate> I 00 beats/min)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0039235
- UMLS CUI [1,2]
- C0018810
Beskrivning
Ectopic ventricular beats
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0151636
Beskrivning
Ventricular couplets
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0429001
Beskrivning
Bigeminy
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0262662
Beskrivning
Trigeminy
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0428999
Beskrivning
Electrical alternans
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1142551
Beskrivning
R on T phenomenon
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0877658
Beskrivning
Ventricular fibrillation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0042510
Beskrivning
ldioventricular rhythm
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0700363
Beskrivning
Sustained ventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0750197
Beskrivning
Non-sustained ventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0750194
Beskrivning
Wide QRS Tachycardia (diagnosis unknown)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0344429
- UMLS CUI [1,2]
- C0439673
- UMLS CUI [1,3]
- C0011900
Beskrivning
Ventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0042514
Beskrivning
Monomorphic ventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0344431
Beskrivning
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0040479
Beskrivning
Polymorphic (sustained and non-sustained) ventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0344432
Beskrivning
Artificial Pacemaker
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0030163
Beskrivning
Other abnormal rhythm
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0199556
- UMLS CUI [1,3]
- C0205161
Beskrivning
Comment abnormal rhythm
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0199556
- UMLS CUI [1,3]
- C0205161
Beskrivning
P-Wave and QRS Morphology
Alias
- UMLS CUI-1
- C2216025
- UMLS CUI-2
- C0429098
Beskrivning
Left atrial abnormality (P mitrale)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0344711
- UMLS CUI [1,2]
- C0232310
Beskrivning
Right atrial abnormality (P pulmonale)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0344696
- UMLS CUI [1,2]
- C0232308
Beskrivning
Right ventricular hypertrophy
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0162770
Beskrivning
Intraatrial conduction delay
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2346510
Beskrivning
Increased voltage consistent with left ventricular hypertrophy
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1112650
- UMLS CUI [1,2]
- C0149721
Beskrivning
Other morphology
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0332437
Beskrivning
Comment other morphology
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0332437
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beskrivning
Conduction
Alias
- UMLS CUI-1
- C0264886
Beskrivning
First degree AV block (PR interval> 200msec)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0085614
Beskrivning
Short PR interval
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0520878
Beskrivning
Second degree AV block (Mobitz type 1)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0264907
Beskrivning
Second degree AV block (Mobitz type 2)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0155700
Beskrivning
2: 1 AV block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2346542
Beskrivning
Third degree AV block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0151517
Beskrivning
Left axis deviation (QRS axis more negative than -30 degrees)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0232297
Beskrivning
Right axis deviation (QRS axis more positive than+ 110 degrees)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0232296
Beskrivning
Incomplete right bundle branch block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0262525
Beskrivning
Incomplete left bundle branch block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0281878
Beskrivning
Right bundle branch block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0085615
Beskrivning
Left anterior hemiblock (synonymous to left anterior fascicular block)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0264912
Beskrivning
Left posterior hemiblock (synonymous to left posterior fascicular block)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0264913
Beskrivning
Left bundle branch block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0023211
Beskrivning
Bifascicular block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0264914
Beskrivning
Non-specific intraventricular conduction delay (QRS >= 120 msec)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3697597
Beskrivning
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1963785
- UMLS CUI [1,2]
- C0043202
- UMLS CUI [1,3]
- C0024054
Beskrivning
Prolonged QT interval
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0151878
Beskrivning
QT/QTc prolongation >=500msec
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0855333
Beskrivning
AV dissociation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0004331
Beskrivning
Other conduction
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
Beskrivning
Comment other conduction
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0340494
- UMLS CUI [1,2]
- C0947611
Beskrivning
Myocardial Infarction
Alias
- UMLS CUI-1
- C0027051
Beskrivning
Myocardial infarction, old
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0155668
Beskrivning
Myocardial infarction, anterior
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0340293
Beskrivning
Myocardial infarction, lateral
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0340312
Beskrivning
Myocardial infarction, posterior
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0340319
Beskrivning
Myocardial infarction, inferior
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0340305
Beskrivning
Myocardial infarction, septal
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0746727
Beskrivning
Myocardial infarction, Non Q-wave
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0542269
Beskrivning
Other myocardial infarction
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0027051
Beskrivning
Comment other myocardial infarction
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beskrivning
Depolarisation/Repolarisation (QRS-T)
Alias
- UMLS CUI-1
- C0948857
- UMLS CUI-2
- C1331539
Beskrivning
Non-specific ST-T changes
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1112720
Beskrivning
J point elevation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2346597
Beskrivning
ST elevation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0520886
Beskrivning
ST-elevation - pericarditis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2348119
Beskrivning
ST depression
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0520887
Beskrivning
ST segment abnormality, not specified
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2348120
- UMLS CUI [1,2]
- C0205370
Beskrivning
U waves abnormal
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0438169
Beskrivning
T wave inversion
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0520888
Beskrivning
T wave peaked
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0239242
Beskrivning
T waves flat
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2215959
Beskrivning
T waves biphasic
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2348639
Beskrivning
Notched T-waves
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2347367
Beskrivning
Low QRS voltage
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2349945
Beskrivning
T-wave flattening/inversion
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0520888
- UMLS CUI [1,2]
- C0429059
Beskrivning
T-wave abnormality, not specified
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0438167
- UMLS CUI [1,2]
- C0205370
Beskrivning
Other depolarisation/repolarisation
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0948857
- UMLS CUI [1,2]
- C0205394
Beskrivning
Comment other depolarisation/repolarisation
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0948857
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beskrivning
Other abnormalities
Alias
- UMLS CUI-1
- C0522055
- UMLS CUI-2
- C0205394
Similar models
12- Lead ECG Abnormalities
- StudyEvent: ODM
C0678257 (UMLS CUI [1,2])
C1704258 (UMLS CUI-2)
C0237753 (UMLS CUI [1,2])
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])
C0429098 (UMLS CUI-2)
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)
C0205370 (UMLS CUI [1,2])
C0429059 (UMLS CUI [1,2])
C0205370 (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])