ID
42674
Description
This form contains a form to document the telemetry and the summary telemetry abnormalities. To be assessed at visits V1-V3. 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
Lien
https://clinicaltrials.gov/ct2/show/NCT00875784
Mots-clés
Versions (4)
- 18/11/2018 18/11/2018 -
- 18/11/2018 18/11/2018 -
- 21/11/2018 21/11/2018 -
- 17/09/2021 17/09/2021 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
17 septembre 2021
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX NCT00875784
Telemetry and Summary Telemetry Abnormalities
- StudyEvent: ODM
Description
Dosing Date and Time
Alias
- UMLS CUI-1
- C0178602
- UMLS CUI-2
- C1264639
Description
Telemetry
Alias
- UMLS CUI-1
- C0039451
Description
Start Date and Time of Telemetry
Type de données
datetime
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0039451
- UMLS CUI [2,1]
- C0808070
- UMLS CUI [2,2]
- C0039451
Description
Stop Date and Time of Telemetry
Type de données
datetime
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0039451
- UMLS CUI [2,1]
- C1522314
- UMLS CUI [2,2]
- C0039451
Description
Result of Telemetry
Type de données
text
Alias
- UMLS CUI [1,1]
- C0039451
- UMLS CUI [1,2]
- C1274040
Description
Summary Telemetry Abnormalities
Alias
- UMLS CUI-1
- C0039451
- UMLS CUI-2
- C0522055
Description
If no, record any clinically significant abnormalities below
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0039451
- UMLS CUI [1,2]
- C0438154
Description
Sinus bradycardia (50-59 beats/min)
Type de données
boolean
Alias
- UMLS CUI [1]
- C0085610
Description
Sinus bradycardia (40-49 beats/min)
Type de données
boolean
Alias
- UMLS CUI [1]
- C0085610
Description
Sinus bradycardia (30-39 beats/min)
Type de données
boolean
Alias
- UMLS CUI [1]
- C0085610
Description
Sinus bradycardia (<30 beats/min)
Type de données
boolean
Alias
- UMLS CUI [1]
- C0085610
Description
Sinus pause
Type de données
boolean
Alias
- UMLS CUI [1]
- C1955864
Description
Sinus tachycardia (>100 beats/min)
Type de données
boolean
Alias
- UMLS CUI [1]
- C0039239
Description
Ectopic supraventricular beats
Type de données
boolean
Alias
- UMLS CUI [1]
- C0033036
Description
Ectopic supraventricular rhythm
Type de données
boolean
Alias
- UMLS CUI [1]
- C2348376
Description
Wandering atrial pacemaker
Type de données
boolean
Alias
- UMLS CUI [1]
- C1321523
Description
Multifocal atrial tachycardia
Type de données
boolean
Alias
- UMLS CUI [1]
- C0221158
Description
Non-sustained supra ventricular tachycardia
Type de données
boolean
Alias
- UMLS CUI [1]
- C4054337
Description
Sustained supraventricular tachycardia
Type de données
boolean
Alias
- UMLS CUI [1]
- C4053964
Description
Atrial flutter
Type de données
boolean
Alias
- UMLS CUI [1]
- C0004239
Description
Atrial fibrillation
Type de données
boolean
Alias
- UMLS CUI [1]
- C0004238
Description
Junctional rhythm
Type de données
boolean
Alias
- UMLS CUI [1]
- C0232208
Description
Junctional tachycardia
Type de données
boolean
Alias
- UMLS CUI [1]
- C0039235
Description
Ventricular premature depolarisation
Type de données
boolean
Alias
- UMLS CUI [1]
- C0151636
Description
Ventricular couplets
Type de données
boolean
Alias
- UMLS CUI [1]
- C0429001
Description
Bigeminy
Type de données
boolean
Alias
- UMLS CUI [1]
- C0262662
Description
Trigeminy
Type de données
boolean
Alias
- UMLS CUI [1]
- C0428999
Description
Electrical alternans
Type de données
boolean
Alias
- UMLS CUI [1]
- C1142551
Description
R on T phenomenon
Type de données
boolean
Alias
- UMLS CUI [1]
- C0877658
Description
Ventricular fibrillation
Type de données
boolean
Alias
- UMLS CUI [1]
- C0042510
Description
Idioventricular rhythm
Type de données
boolean
Alias
- UMLS CUI [1]
- C0700363
Description
Non-sustained ventricular tachycardia
Type de données
boolean
Alias
- UMLS CUI [1]
- C0750194
Description
Sustained ventricular tachycardia
Type de données
boolean
Alias
- UMLS CUI [1]
- C0750197
Description
Wide QRS tachycardia
Type de données
boolean
Alias
- UMLS CUI [1]
- C0344429
Description
Monomorphic non-sustained ventricular tachycardia
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0344431
- UMLS CUI [1,2]
- C0750194
Description
Monomorphic sustained ventricular tachycardia
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0344431
- UMLS CUI [1,2]
- C0750197
Description
Polymorphic non-sustained ventricular tachycardia
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0344432
- UMLS CUI [1,2]
- C0750194
Description
Polymorphic sustained ventricular tachycardia
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0344432
- UMLS CUI [1,2]
- C0750197
Description
Torsade de Pointes (TdP)
Type de données
boolean
Alias
- UMLS CUI [1]
- C0040479
Description
Pacemaker
Type de données
boolean
Alias
- UMLS CUI [1]
- C0030163
Description
First degree AV block
Type de données
boolean
Alias
- UMLS CUI [1]
- C0085614
Description
Short PR Interval
Type de données
boolean
Alias
- UMLS CUI [1]
- C0520878
Description
Second degree AV block (Mobitz type I)
Type de données
boolean
Alias
- UMLS CUI [1]
- C0264907
Description
Second degree AV block (Mobitz type 2)
Type de données
boolean
Alias
- UMLS CUI [1]
- C0155700
Description
2:1 AV block
Type de données
boolean
Alias
- UMLS CUI [1]
- C2346542
Description
Third degree AV block
Type de données
boolean
Alias
- UMLS CUI [1]
- C0151517
Description
Left axis deviation
Type de données
boolean
Alias
- UMLS CUI [1]
- C0232297
Description
Right axis deviation
Type de données
boolean
Alias
- UMLS CUI [1]
- C0232296
Description
Incomplete right bundle branch block
Type de données
boolean
Alias
- UMLS CUI [1]
- C0262525
Description
Incomplete left bundle branch block
Type de données
boolean
Alias
- UMLS CUI [1]
- C0281878
Description
Right bundle branch block
Type de données
boolean
Alias
- UMLS CUI [1]
- C0085615
Description
Left anterior hemiblock
Type de données
boolean
Alias
- UMLS CUI [1]
- C0264912
Description
Left posterior hemiblock
Type de données
boolean
Alias
- UMLS CUI [1]
- C0264913
Description
Left bundle branch block
Type de données
boolean
Alias
- UMLS CUI [1]
- C0023211
Description
Bifascicular block
Type de données
boolean
Alias
- UMLS CUI [1]
- C0264914
Description
Non-specific intraventricular conduction delay
Type de données
boolean
Alias
- UMLS CUI [1]
- C3697597
Description
Accessory pathway
Type de données
boolean
Alias
- UMLS CUI [1]
- C1963785
Description
QTc prolongation >=500 msec
Type de données
boolean
Alias
- UMLS CUI [1]
- C1969409
Description
AV dissociation
Type de données
boolean
Alias
- UMLS CUI [1]
- C0004331
Description
Myocardial infarction, old
Type de données
boolean
Alias
- UMLS CUI [1]
- C0155668
Description
Myocardial infarction, non Q-wave
Type de données
boolean
Alias
- UMLS CUI [1]
- C0542269
Description
Non-specific ST-T changes
Type de données
boolean
Alias
- UMLS CUI [1]
- C1112720
Description
J point devation
Type de données
boolean
Alias
- UMLS CUI [1]
- C2346597
Description
ST elevation
Type de données
boolean
Alias
- UMLS CUI [1]
- C0520886
Description
ST depression
Type de données
boolean
Alias
- UMLS CUI [1]
- C0520887
Description
ST segment abnormality
Type de données
boolean
Alias
- UMLS CUI [1]
- C2348120
Description
U waves
Type de données
boolean
Alias
- UMLS CUI [1]
- C0232333
Description
T wave inversion
Type de données
boolean
Alias
- UMLS CUI [1]
- C0520888
Description
T wave peaked
Type de données
boolean
Alias
- UMLS CUI [1]
- C0239242
Description
T waves biphasic
Type de données
boolean
Alias
- UMLS CUI [1]
- C2348639
Description
T waves flat
Type de données
boolean
Alias
- UMLS CUI [1]
- C2215959
Description
Notched T-waves
Type de données
boolean
Alias
- UMLS CUI [1]
- C2347367
Description
Low QRS voltage
Type de données
boolean
Alias
- UMLS CUI [1]
- C2349945
Description
T wave abnomality
Type de données
boolean
Alias
- UMLS CUI [1]
- C0438167
Description
Other abnormal rhythm
Type de données
text
Alias
- UMLS CUI [1,1]
- C0232187
- UMLS CUI [1,2]
- C0522055
Description
Other morphology
Type de données
text
Alias
- UMLS CUI [1,1]
- C0332437
- UMLS CUI [1,2]
- C0522055
Description
Other conduction
Type de données
text
Alias
- UMLS CUI [1]
- C0232219
Description
Other myocardial infarction
Type de données
text
Alias
- UMLS CUI [1]
- C0027051
Description
Other depolarisation/repolarisation
Type de données
text
Alias
- UMLS CUI [1]
- C0948857
Description
Other abnormality/Cardiologist comments
Type de données
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0522055
- UMLS CUI [2]
- C0947611
Similar models
Telemetry and Summary Telemetry Abnormalities
- StudyEvent: ODM
C1264639 (UMLS CUI [1,2])
C0039451 (UMLS CUI [1,2])
C0808070 (UMLS CUI [2,1])
C0039451 (UMLS CUI [2,2])
C0039451 (UMLS CUI [1,2])
C1522314 (UMLS CUI [2,1])
C0039451 (UMLS CUI [2,2])
C1274040 (UMLS CUI [1,2])
C0522055 (UMLS CUI-2)
C0438154 (UMLS CUI [1,2])
C0750194 (UMLS CUI [1,2])
C0750197 (UMLS CUI [1,2])
C0750194 (UMLS CUI [1,2])
C0750197 (UMLS CUI [1,2])
C0522055 (UMLS CUI [1,2])
C0522055 (UMLS CUI [1,2])
C0522055 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])