ID
41045
Beschreibung
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
Stichworte
Versionen (2)
- 16.06.20 16.06.20 -
- 17.09.21 17.09.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
16. Juni 2020
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY-NC 4.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629
ECG Abnormalities
- StudyEvent: ODM
Beschreibung
12-Lead ECG Abnormalities
Alias
- UMLS CUI-1
- C0522055
Beschreibung
A. Rhythm
Alias
- UMLS CUI-1
- C0232187
Beschreibung
Sinus bradycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschreibung
Sinus bradycardia (heart rate 40-50 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Beschreibung
Sinus bradycardia (heart rate 30-39 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Beschreibung
Sinus bradycardia (heart rate < 30 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Beschreibung
Sinus pause
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1955864
Beschreibung
Sinus tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0039239
- UMLS CUI [1,2]
- C0018810
Beschreibung
Ectopic supraventricular beats
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0033036
Beschreibung
Ectopic supraventricular rhythm
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348376
Beschreibung
Wandering atrial pacemaker
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1321523
Beschreibung
Multifocal atrial tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0221158
- UMLS CUI [1,2]
- C0018810
Beschreibung
Supraventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0039240
- UMLS CUI [1,2]
- C0018810
Beschreibung
Atrial flutter
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004239
Beschreibung
Atrial fibrillation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004238
Beschreibung
Junctional rhythm (heart rate <= 100 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0232208
- UMLS CUI [1,2]
- C0018810
Beschreibung
Junctional rhythm
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0232208
Beschreibung
Junctional tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0039235
- UMLS CUI [1,2]
- C0018810
Beschreibung
Ectopic ventricular beats
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0151636
Beschreibung
Ventricular couplets
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0429001
Beschreibung
Bigeminy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0262662
Beschreibung
Trigeminy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0428999
Beschreibung
Electrical alternans
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1142551
Beschreibung
R on T phenomenon
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0877658
Beschreibung
Ventricular fibrillation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0042510
Beschreibung
ldioventricular rhythm
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0700363
Beschreibung
Sustained ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0750197
Beschreibung
Non-sustained ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0750194
Beschreibung
Wide QRS tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0344429
- UMLS CUI [1,2]
- C0439673
- UMLS CUI [1,3]
- C0011900
Beschreibung
Ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0042514
Beschreibung
Monomorphic ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0344431
Beschreibung
Torsades de Pointes
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0040479
Beschreibung
Polymorphic ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0344432
- UMLS CUI [1,2]
- C0750197
- UMLS CUI [2,1]
- C0344432
- UMLS CUI [2,2]
- C0750194
Beschreibung
Artificial Pacemaker
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0030163
Beschreibung
Other abnormal rhythm
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0199556
- UMLS CUI [1,3]
- C0205161
Beschreibung
12 lead ECG, Abnormality, Electrocardiogram: Rhythm, Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0199556
- UMLS CUI [1,4]
- C0947611
Beschreibung
B. P-Wave Morphology
Alias
- UMLS CUI-1
- C2216025
Beschreibung
Left atrial abnormality (P mitrale)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0344711
- UMLS CUI [1,2]
- C0232310
Beschreibung
Right atrial abnormality (P pulmonale)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0344696
- UMLS CUI [1,2]
- C0232308
Beschreibung
Right ventricular hypertrophy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0162770
Beschreibung
Intraatrial conduction delay
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2346510
Beschreibung
Increased voltage consistent with left ventricular hypertrophy
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1112650
- UMLS CUI [1,2]
- C0332290
- UMLS CUI [1,3]
- C0149721
Beschreibung
Other morphology
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0332437
Beschreibung
12 lead ECG, Abnormality, electrocardiogram: P wave shifting morphology, Comment; 12 lead ECG, Abnormality, Electrocardiogram QRS complex, Comment
Datentyp
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
Beschreibung
C. Conduction
Alias
- UMLS CUI-1
- C0264886
Beschreibung
First degree AV block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085614
Beschreibung
Short PR interval
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0520878
Beschreibung
Second degree AV block (Mobitz type 1)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0264907
Beschreibung
Second degree AV block (Mobitz type 2)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0155700
Beschreibung
2: 1 AV block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2346542
Beschreibung
Third degree AV block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0151517
Beschreibung
Left axis deviation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0232297
Beschreibung
Right axis deviation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0232296
Beschreibung
Incomplete right bundle branch block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0262525
Beschreibung
Incomplete left bundle branch block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0281878
Beschreibung
Right bundle branch block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085615
Beschreibung
Left anterior hemiblock
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0264912
Beschreibung
Left posterior hemiblock
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0264913
Beschreibung
Left bundle branch block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0023211
Beschreibung
Bifascicular block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0264914
Beschreibung
Non-specific intraventricular conduction delay
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3697597
Beschreibung
Accessory pathway in Wolff-Parkinson White/Lown-Ganong-Levine Syndrome
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1963785
- UMLS CUI [1,2]
- C0043202
- UMLS CUI [2,1]
- C1963785
- UMLS CUI [2,2]
- C0024054
Beschreibung
Prolonged QT interval
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0151878
Beschreibung
QT/QTc prolongation by QTc time
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0855333
- UMLS CUI [2]
- C0489625
Beschreibung
AV dissociation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004331
Beschreibung
Other conduction abnormality
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0340494
Beschreibung
12 lead ECG, Abnormality, Cardiac Conduction, Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0232217
- UMLS CUI [1,4]
- C0947611
Beschreibung
D. Myocardial Infarction
Alias
- UMLS CUI-1
- C0027051
Beschreibung
Myocardial infarction, old
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0155668
Beschreibung
Myocardial infarction, anterior
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0340293
Beschreibung
Myocardial infarction, lateral
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0340312
Beschreibung
Myocardial infarction, posterior
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0340319
Beschreibung
Myocardial infarction, inferior
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0340305
Beschreibung
Myocardial infarction, septal
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0746727
Beschreibung
Myocardial infarction, Non Q-wave
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0542269
Beschreibung
Other myocardial infarction
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0027051
Beschreibung
12 lead ECG, Abnormality, Myocardial Infarction, Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0027051
- UMLS CUI [1,4]
- C0947611
Beschreibung
E. Depolarisation/Repolarisation (QRS-T)
Alias
- UMLS CUI-1
- C0948857
- UMLS CUI-2
- C1331539
Beschreibung
Non-specific ST-T changes
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1112720
Beschreibung
J point elevation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2346597
Beschreibung
ST elevation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0520886
Beschreibung
ST-elevation - pericarditis
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348119
Beschreibung
ST depression
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0520887
Beschreibung
U waves abnormal
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0438169
Beschreibung
T wave inversion
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0520888
Beschreibung
T wave peaked
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0239242
Beschreibung
T waves flat
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2215959
Beschreibung
T waves biphasic
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348639
Beschreibung
Notched T-waves
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2347367
Beschreibung
Low QRS voltage
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2349945
Beschreibung
T-wave flattening/inversion
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0520888
- UMLS CUI [2]
- C0429059
Beschreibung
Other depolarisation/repolarisation
Datentyp
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
Beschreibung
12 lead ECG, Abnormality, Ventricular Depolarization [PE], Comment; 12 lead ECG, Abnormality, Electrocardiogram repolarisation abnormality, Comment
Datentyp
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
Beschreibung
Other abnormalities
Alias
- UMLS CUI-1
- C0522055
- UMLS CUI-2
- C0205394
Beschreibung
12 lead ECG, Abnormality, Other
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
Beschreibung
12 lead ECG, Abnormality, Other, Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0947611
Ähnliche Modelle
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])