ID
41045
Beskrivning
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
Länk
https://clinicaltrials.gov/ct2/show/NCT00875784
Nyckelord
Versioner (2)
- 2020-06-16 2020-06-16 -
- 2021-09-17 2021-09-17 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
16 juni 2020
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 4.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629
ECG Abnormalities
- StudyEvent: ODM
Beskrivning
12-Lead ECG Abnormalities
Alias
- UMLS CUI-1
- C0522055
Beskrivning
A. Rhythm
Alias
- UMLS CUI-1
- C0232187
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
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
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0221158
- UMLS CUI [1,2]
- C0018810
Beskrivning
Supraventricular tachycardia
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 beats/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
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
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
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0040479
Beskrivning
Polymorphic ventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0344432
- UMLS CUI [1,2]
- C0750197
- UMLS CUI [2,1]
- C0344432
- UMLS CUI [2,2]
- C0750194
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
12 lead ECG, Abnormality, Electrocardiogram: Rhythm, Comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0199556
- UMLS CUI [1,4]
- C0947611
Beskrivning
B. P-Wave Morphology
Alias
- UMLS CUI-1
- C2216025
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]
- C0332290
- UMLS CUI [1,3]
- C0149721
Beskrivning
Other morphology
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0332437
Beskrivning
12 lead ECG, Abnormality, electrocardiogram: P wave shifting morphology, Comment; 12 lead ECG, Abnormality, Electrocardiogram QRS complex, Comment
Datatyp
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
Beskrivning
C. Conduction
Alias
- UMLS CUI-1
- C0264886
Beskrivning
First degree AV block
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
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0232297
Beskrivning
Right axis deviation
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
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0264912
Beskrivning
Left posterior hemiblock
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
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3697597
Beskrivning
Accessory pathway in Wolff-Parkinson White/Lown-Ganong-Levine Syndrome
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1963785
- UMLS CUI [1,2]
- C0043202
- UMLS CUI [2,1]
- C1963785
- UMLS CUI [2,2]
- C0024054
Beskrivning
Prolonged QT interval
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0151878
Beskrivning
QT/QTc prolongation by QTc time
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0855333
- UMLS CUI [2]
- C0489625
Beskrivning
AV dissociation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0004331
Beskrivning
Other conduction abnormality
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0340494
Beskrivning
12 lead ECG, Abnormality, Cardiac Conduction, Comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0232217
- UMLS CUI [1,4]
- C0947611
Beskrivning
D. 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
12 lead ECG, Abnormality, Myocardial Infarction, Comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0027051
- UMLS CUI [1,4]
- C0947611
Beskrivning
E. 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
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]
- C0520888
- UMLS CUI [2]
- C0429059
Beskrivning
Other depolarisation/repolarisation
Datatyp
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
Beskrivning
12 lead ECG, Abnormality, Ventricular Depolarization [PE], Comment; 12 lead ECG, Abnormality, Electrocardiogram repolarisation abnormality, Comment
Datatyp
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
Beskrivning
Other abnormalities
Alias
- UMLS CUI-1
- C0522055
- UMLS CUI-2
- C0205394
Beskrivning
12 lead ECG, Abnormality, Other
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
Beskrivning
12 lead ECG, Abnormality, Other, Comment
Datatyp
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])