ID
41045
Beschrijving
This form documents the recorded abnormalities on ECG. To be filled in continously. Study ID: 103629 Clinical Study ID: TRX103629 Study Title: An open-label, randomized, 3-period crossover study to evaluate sumatriptan and naproxen pharmacokinetics for a combination tablet product containing sumatriptan/naproxen sodium followed by IMITREX™ (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System and a sumatriptan/naproxen sodium tablet followed by IMITREX (sumatriptan succinate) Injection 6mg administered using the STATdose system compared with an IMITREX tablet 100mg followed by an IMITREX tablet 100mg Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00875784 Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT00875784 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
Link
https://clinicaltrials.gov/ct2/show/NCT00875784
Trefwoorden
Versies (2)
- 16-06-20 16-06-20 -
- 17-09-21 17-09-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
16 juni 2020
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 4.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629
ECG Abnormalities
- StudyEvent: ODM
Beschrijving
12-Lead ECG Abnormalities
Alias
- UMLS CUI-1
- C0522055
Beschrijving
A. Rhythm
Alias
- UMLS CUI-1
- C0232187
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
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
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0221158
- UMLS CUI [1,2]
- C0018810
Beschrijving
Supraventricular tachycardia
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 beats/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
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
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
Datatype
boolean
Alias
- UMLS CUI [1]
- C0040479
Beschrijving
Polymorphic ventricular tachycardia
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0344432
- UMLS CUI [1,2]
- C0750197
- UMLS CUI [2,1]
- C0344432
- UMLS CUI [2,2]
- C0750194
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
12 lead ECG, Abnormality, Electrocardiogram: Rhythm, Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0199556
- UMLS CUI [1,4]
- C0947611
Beschrijving
B. 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]
- C0332290
- UMLS CUI [1,3]
- C0149721
Beschrijving
Other morphology
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0332437
Beschrijving
12 lead ECG, Abnormality, electrocardiogram: P wave shifting morphology, Comment; 12 lead ECG, Abnormality, Electrocardiogram QRS complex, Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C2216025
- UMLS CUI [1,4]
- C0947611
- UMLS CUI [2,1]
- C0430456
- UMLS CUI [2,2]
- C1704258
- UMLS CUI [2,3]
- C0429098
- UMLS CUI [2,4]
- C0947611
Beschrijving
C. Conduction
Alias
- UMLS CUI-1
- C0264886
Beschrijving
First degree AV block
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
Datatype
boolean
Alias
- UMLS CUI [1]
- C0232297
Beschrijving
Right axis deviation
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
Datatype
boolean
Alias
- UMLS CUI [1]
- C0264912
Beschrijving
Left posterior hemiblock
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
Datatype
boolean
Alias
- UMLS CUI [1]
- C3697597
Beschrijving
Accessory pathway in Wolff-Parkinson White/Lown-Ganong-Levine Syndrome
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1963785
- UMLS CUI [1,2]
- C0043202
- UMLS CUI [2,1]
- C1963785
- UMLS CUI [2,2]
- C0024054
Beschrijving
Prolonged QT interval
Datatype
boolean
Alias
- UMLS CUI [1]
- C0151878
Beschrijving
QT/QTc prolongation by QTc time
Datatype
boolean
Alias
- UMLS CUI [1]
- C0855333
- UMLS CUI [2]
- C0489625
Beschrijving
AV dissociation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004331
Beschrijving
Other conduction abnormality
Datatype
boolean
Alias
- UMLS CUI [1]
- C0340494
Beschrijving
12 lead ECG, Abnormality, Cardiac Conduction, Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0232217
- UMLS CUI [1,4]
- C0947611
Beschrijving
D. 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
12 lead ECG, Abnormality, Myocardial Infarction, Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0027051
- UMLS CUI [1,4]
- C0947611
Beschrijving
E. 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]
- C0520888
- UMLS CUI [2]
- C0429059
Beschrijving
Other depolarisation/repolarisation
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [1,3]
- C2746082
- UMLS CUI [2,1]
- C0948857
- UMLS CUI [2,2]
- C0205394
Beschrijving
12 lead ECG, Abnormality, Ventricular Depolarization [PE], Comment; 12 lead ECG, Abnormality, Electrocardiogram repolarisation abnormality, Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C1331539
- UMLS CUI [1,4]
- C0947611
- UMLS CUI [2,1]
- C0430456
- UMLS CUI [2,2]
- C1704258
- UMLS CUI [2,3]
- C0948857
- UMLS CUI [2,4]
- C0947611
Beschrijving
Other abnormalities
Alias
- UMLS CUI-1
- C0522055
- UMLS CUI-2
- C0205394
Beschrijving
12 lead ECG, Abnormality, Other
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
Beschrijving
12 lead ECG, Abnormality, Other, Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0947611
Similar models
ECG Abnormalities
- StudyEvent: ODM
C0242485 (UMLS CUI [1,2])
C1704733 (UMLS CUI [1,3])
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])
C0750197 (UMLS CUI [1,2])
C0344432 (UMLS CUI [2,1])
C0750194 (UMLS CUI [2,2])
C0199556 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0232310 (UMLS CUI [1,2])
C0232308 (UMLS CUI [1,2])
C0332290 (UMLS CUI [1,2])
C0149721 (UMLS CUI [1,3])
C0332437 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C2216025 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0430456 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0429098 (UMLS CUI [2,3])
C0947611 (UMLS CUI [2,4])
C0043202 (UMLS CUI [1,2])
C1963785 (UMLS CUI [2,1])
C0024054 (UMLS CUI [2,2])
C0489625 (UMLS CUI [2])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0027051 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C1331539 (UMLS CUI-2)
C0429059 (UMLS CUI [2])
C0205161 (UMLS CUI [1,2])
C2746082 (UMLS CUI [1,3])
C0948857 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C1704258 (UMLS CUI [1,2])
C1331539 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0430456 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0948857 (UMLS CUI [2,3])
C0947611 (UMLS CUI [2,4])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])