ID
31775
Description
This study contains a form to document clinically significant ECG-abnormalities. To be filled when such an abnormality is found at screening or any follo-up examination. Study ID: 106396 Clinical Study ID: TRX106396 Study Title: An open-label, randomized, single-dose, 2-period crossover study to evaluate sumatriptan pharmacokinetics for a TREXIMA™(sumatriptan 85mg and naproxen sodium 500mg)*, Tablet compared with an IMITREX® (sumatriptan) 100mg Tablet Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders Sponstor: GlaxoSmithKline
Keywords
Versions (3)
- 9/27/18 9/27/18 -
- 9/27/18 9/27/18 -
- 9/27/18 9/27/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
September 27, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet ID 106396
12-Lead ECG-Abnormalities
- StudyEvent: ODM
Description
Date and Time of ECG
Alias
- UMLS CUI-1
- C2826846
Description
A. Rhythm
Alias
- UMLS CUI-1
- C0232187
Description
Sinus bradycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0085610
Description
Sinus bradycardia (heart rate 40-50 beats/min)
Data type
boolean
Alias
- UMLS CUI [1]
- C0085610
Description
Sinus bradycardia (heart rate 30-39 beats/min)
Data type
boolean
Alias
- UMLS CUI [1]
- C0085610
Description
Sinus bradycardia (<30 beats/min)
Data type
boolean
Alias
- UMLS CUI [1]
- C0085610
Description
Sinus pause
Data type
boolean
Alias
- UMLS CUI [1]
- C1955864
Description
Sinus tachycardia (>100 beats/min)
Data type
boolean
Alias
- UMLS CUI [1]
- C0039239
Description
Ectopic supraventricular beats
Data type
boolean
Alias
- UMLS CUI [1]
- C0033036
Description
Ectopic supraventricular rhythm
Data type
boolean
Alias
- UMLS CUI [1]
- C2348376
Description
Wandering atrial pacemaker
Data type
boolean
Alias
- UMLS CUI [1]
- C1321523
Description
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min)
Data type
boolean
Alias
- UMLS CUI [1]
- C0221158
Description
Supraventricular tachycardia (heart rate >100 beats/min)
Data type
boolean
Alias
- UMLS CUI [1]
- C0039240
Description
Atrial flutter
Data type
boolean
Alias
- UMLS CUI [1]
- C0004239
Description
Atrial Fibrillation
Data type
boolean
Alias
- UMLS CUI [1]
- C0004238
Description
Junctional rhythm (heart rate ≤100 beats/min)
Data type
boolean
Alias
- UMLS CUI [1]
- C0232208
Description
Junctional rhythm
Data type
boolean
Alias
- UMLS CUI [1]
- C0232208
Description
Sinus tachycardia (heart rate >100 beats/min)
Data type
boolean
Alias
- UMLS CUI [1]
- C0039239
Description
Junctional tachycardia (heart rate > 100 beats/min)
Data type
boolean
Alias
- UMLS CUI [1]
- C0039235
Description
Ectopic ventricular beats
Data type
boolean
Alias
- UMLS CUI [1]
- C0151636
Description
Ventricular couplets
Data type
boolean
Alias
- UMLS CUI [1]
- C0429001
Description
Bigeminy
Data type
boolean
Alias
- UMLS CUI [1]
- C0262662
Description
Trigeminy
Data type
boolean
Alias
- UMLS CUI [1]
- C0428999
Description
Electrical alternans
Data type
boolean
Alias
- UMLS CUI [1]
- C1142551
Description
R on T phenomenon
Data type
boolean
Alias
- UMLS CUI [1]
- C0877658
Description
Ventricular fibrillation
Data type
boolean
Alias
- UMLS CUI [1]
- C0042510
Description
Idioventricular rhythm (heart rate < 100 beats/min)
Data type
boolean
Alias
- UMLS CUI [1]
- C0700363
Description
Sustained ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0750197
Description
Non-sustained ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0750194
Description
Wide QRS tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0344429
Description
Ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0042514
Description
Monomorphic ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0344431
Description
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT)
Data type
boolean
Alias
- UMLS CUI [1]
- C0040479
Description
Polymorphic (sustained and non-sustained) ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0344432
Description
Artificial pacemaker
Data type
boolean
Alias
- UMLS CUI [1]
- C0030163
Description
Other abnormal rhythm
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1533266
- UMLS CUI [1,2]
- C0205394
Description
Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
B. P-Wave and QRS Morphology
Alias
- UMLS CUI-1
- C2216025
- UMLS CUI-3
- C0429098
Description
Left atrial abnormality (P mitrale)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0344711
- UMLS CUI [1,2]
- C0232310
Description
Right atrial abnormality (P pulmonale)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0344696
- UMLS CUI [1,2]
- C0232308
Description
Right ventricular hypertrophy
Data type
boolean
Alias
- UMLS CUI [1]
- C0162770
Description
Intraatrial conduction delay
Data type
boolean
Alias
- UMLS CUI [1]
- C2346510
Description
Increased voltage consistent with left ventricular hypertrophy
Data type
boolean
Alias
- UMLS CUI [1]
- C1112650
Description
Other morphology
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0332437
Description
Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
C. Conduction
Alias
- UMLS CUI-1
- C0232217
Description
First degree AV block (PR interval > 200 msec)
Data type
boolean
Alias
- UMLS CUI [1]
- C0085614
Description
Short PR Interval
Data type
boolean
Alias
- UMLS CUI [1]
- C0520878
Description
Second degree AV block (Mobitz type 1)
Data type
boolean
Alias
- UMLS CUI [1]
- C0264907
Description
Second degree AV block (Mobitz type 2)
Data type
boolean
Alias
- UMLS CUI [1]
- C0155700
Description
2:1 AV block
Data type
boolean
Alias
- UMLS CUI [1]
- C2346542
Description
Third degree AV block
Data type
boolean
Alias
- UMLS CUI [1]
- C0151517
Description
Left axis deviation (QRS axis more negative than -30°)
Data type
boolean
Alias
- UMLS CUI [1]
- C0232297
Description
Left axis deviation (QRS axis more negative than - 30 degrees)
Data type
boolean
Alias
- UMLS CUI [1]
- C0232297
Description
Right axis deviation (QRS axis more positive than +110°)
Data type
boolean
Alias
- UMLS CUI [1]
- C0232296
Description
Incomplete right bundle branch block
Data type
boolean
Alias
- UMLS CUI [1]
- C0262525
Description
Incomplete left bundle branch block
Data type
boolean
Alias
- UMLS CUI [1]
- C0281878
Description
Right bundle branch block
Data type
boolean
Alias
- UMLS CUI [1]
- C0085615
Description
Left anterior hemiblock (synonymous to left anterior fascicular block)
Data type
boolean
Alias
- UMLS CUI [1]
- C0264912
Description
Left posterior hemiblock (synonymous to left posterior fascicular block)
Data type
boolean
Alias
- UMLS CUI [1]
- C0264913
Description
Left bundle branch block
Data type
boolean
Alias
- UMLS CUI [1]
- C0023211
Description
Bifascicular block
Data type
boolean
Alias
- UMLS CUI [1]
- C0264914
Description
Non-specific intraventricular conduction delay
Data type
boolean
Alias
- UMLS CUI [1]
- C3697597
Description
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0264897
- UMLS CUI [1,2]
- C0043202
Description
Prolonged QT interval
Data type
boolean
Alias
- UMLS CUI [1]
- C0151878
Description
QTc prolongation >=500 msec
Data type
boolean
Alias
- UMLS CUI [1]
- C1969409
Description
AV dissociation
Data type
boolean
Alias
- UMLS CUI [1]
- C0004331
Description
Other conduction
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
Description
Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
D. Myocardial Infarction
Alias
- UMLS CUI-1
- C0027051
Description
Myocardial infarction, old
Data type
boolean
Alias
- UMLS CUI [1]
- C0155668
Description
Myocardial infarction, anterior
Data type
boolean
Alias
- UMLS CUI [1]
- C0340293
Description
Myocardial infarction, lateral
Data type
boolean
Alias
- UMLS CUI [1]
- C0340312
Description
Myocardial infarction, posterior
Data type
boolean
Alias
- UMLS CUI [1]
- C0340319
Description
Myocardial infarction, inferior
Data type
boolean
Alias
- UMLS CUI [1]
- C0340305
Description
Myocardial infarction, septal
Data type
boolean
Alias
- UMLS CUI [1]
- C0746727
Description
Myocardial infarction, non Q-wave
Data type
boolean
Alias
- UMLS CUI [1]
- C0542269
Description
Other myocardial infarction
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
Description
Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
E. Depolarisation/Repolarisation (QRS-T)
Alias
- UMLS CUI-1
- C0948857
Description
Non-specific ST-T changes
Data type
boolean
Alias
- UMLS CUI [1]
- C1112720
Description
J point elevation
Data type
boolean
Alias
- UMLS CUI [1]
- C2346597
Description
ST elevation
Data type
boolean
Alias
- UMLS CUI [1]
- C0520886
Description
ST elevation-pericarditis
Data type
boolean
Alias
- UMLS CUI [1]
- C2348119
Description
ST depression
Data type
boolean
Alias
- UMLS CUI [1]
- C0520887
Description
ST segment abnormality, not specified
Data type
boolean
Alias
- UMLS CUI [1]
- C2348120
Description
U waves abnormal
Data type
boolean
Alias
- UMLS CUI [1]
- C0438169
Description
T wave inversion
Data type
boolean
Alias
- UMLS CUI [1]
- C0520888
Description
T wave peaked
Data type
boolean
Alias
- UMLS CUI [1]
- C0239242
Description
T waves flat
Data type
boolean
Alias
- UMLS CUI [1]
- C2215959
Description
T waves biphasic
Data type
boolean
Alias
- UMLS CUI [1]
- C2348639
Description
Notched T-waves
Data type
boolean
Alias
- UMLS CUI [1]
- C2347367
Description
Low QRS voltage
Data type
boolean
Alias
- UMLS CUI [1]
- C2349945
Description
T-wave flattening/inversion
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0520888
- UMLS CUI [1,2]
- C0429059
Description
T wave abnormality, not specified
Data type
boolean
Alias
- UMLS CUI [1]
- C0438167
Description
Other depolarisation/repolarisation
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0948857
- UMLS CUI [1,2]
- C0205394
Description
Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Other Abnormalities
Alias
- UMLS CUI-1
- C0522055
- UMLS CUI-2
- C0205394
Similar models
12-Lead ECG-Abnormalities
- StudyEvent: ODM
C0013798 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0429098 (UMLS CUI-3)
C0232310 (UMLS CUI [1,2])
C0232308 (UMLS CUI [1,2])
C0332437 (UMLS CUI [1,2])
C0043202 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0429059 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])