ID
32958
Beschrijving
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
Link
https://clinicaltrials.gov/ct2/show/NCT00875784
Trefwoorden
Versies (4)
- 18-11-18 18-11-18 -
- 18-11-18 18-11-18 -
- 21-11-18 21-11-18 -
- 17-09-21 17-09-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
21 november 2018
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX NCT00875784
Telemetry and Summary Telemetry Abnormalities
- StudyEvent: ODM
Beschrijving
Dosing Date and Time
Alias
- UMLS CUI-1
- C0178602
- UMLS CUI-2
- C1264639
Beschrijving
Telemetry
Alias
- UMLS CUI-1
- C0039451
Beschrijving
Start Date and Time of Telemetry
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0039451
- UMLS CUI [2,1]
- C0808070
- UMLS CUI [2,2]
- C0039451
Beschrijving
Stop Date and Time of Telemetry
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0039451
- UMLS CUI [2,1]
- C1522314
- UMLS CUI [2,2]
- C0039451
Beschrijving
Result of Telemetry
Datatype
text
Alias
- UMLS CUI [1,1]
- C0039451
- UMLS CUI [1,2]
- C1274040
Beschrijving
Summary Telemetry Abnormalities
Alias
- UMLS CUI-1
- C0039451
- UMLS CUI-2
- C0522055
Beschrijving
If no, record any clinically significant abnormalities below
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0039451
- UMLS CUI [1,2]
- C0438154
Beschrijving
Sinus bradycardia (50-59 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschrijving
Sinus bradycardia (40-49 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschrijving
Sinus bradycardia (30-39 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschrijving
Sinus bradycardia (<30 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschrijving
Sinus pause
Datatype
boolean
Alias
- UMLS CUI [1]
- C1955864
Beschrijving
Sinus tachycardia (>100 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0039239
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]
- C0221158
Beschrijving
Non-sustained supra ventricular tachycardia
Datatype
boolean
Alias
- UMLS CUI [1]
- C4054337
Beschrijving
Sustained supraventricular tachycardia
Datatype
boolean
Alias
- UMLS CUI [1]
- C4053964
Beschrijving
Atrial flutter
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004239
Beschrijving
Atrial fibrillation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004238
Beschrijving
Junctional rhythm
Datatype
boolean
Alias
- UMLS CUI [1]
- C0232208
Beschrijving
Junctional tachycardia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0039235
Beschrijving
Ventricular premature depolarisation
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
Idioventricular rhythm
Datatype
boolean
Alias
- UMLS CUI [1]
- C0700363
Beschrijving
Non-sustained ventricular tachycardia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0750194
Beschrijving
Sustained ventricular tachycardia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0750197
Beschrijving
Wide QRS tachycardia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0344429
Beschrijving
Monomorphic non-sustained ventricular tachycardia
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0344431
- UMLS CUI [1,2]
- C0750194
Beschrijving
Monomorphic sustained ventricular tachycardia
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0344431
- UMLS CUI [1,2]
- C0750197
Beschrijving
Polymorphic non-sustained ventricular tachycardia
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0344432
- UMLS CUI [1,2]
- C0750194
Beschrijving
Polymorphic sustained ventricular tachycardia
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0344432
- UMLS CUI [1,2]
- C0750197
Beschrijving
Torsade de Pointes (TdP)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0040479
Beschrijving
Pacemaker
Datatype
boolean
Alias
- UMLS CUI [1]
- C0030163
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 I)
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
Datatype
boolean
Alias
- UMLS CUI [1]
- C1963785
Beschrijving
QTc prolongation >=500 msec
Datatype
boolean
Alias
- UMLS CUI [1]
- C1969409
Beschrijving
AV dissociation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004331
Beschrijving
Myocardial infarction, old
Datatype
boolean
Alias
- UMLS CUI [1]
- C0155668
Beschrijving
Myocardial infarction, non Q-wave
Datatype
boolean
Alias
- UMLS CUI [1]
- C0542269
Beschrijving
Non-specific ST-T changes
Datatype
boolean
Alias
- UMLS CUI [1]
- C1112720
Beschrijving
J point devation
Datatype
boolean
Alias
- UMLS CUI [1]
- C2346597
Beschrijving
ST elevation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0520886
Beschrijving
ST depression
Datatype
boolean
Alias
- UMLS CUI [1]
- C0520887
Beschrijving
ST segment abnormality
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348120
Beschrijving
U waves
Datatype
boolean
Alias
- UMLS CUI [1]
- C0232333
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 biphasic
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348639
Beschrijving
T waves flat
Datatype
boolean
Alias
- UMLS CUI [1]
- C2215959
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 abnomality
Datatype
boolean
Alias
- UMLS CUI [1]
- C0438167
Beschrijving
Other abnormal rhythm
Datatype
text
Alias
- UMLS CUI [1,1]
- C0232187
- UMLS CUI [1,2]
- C0522055
Beschrijving
Other morphology
Datatype
text
Alias
- UMLS CUI [1,1]
- C0332437
- UMLS CUI [1,2]
- C0522055
Beschrijving
Other conduction
Datatype
text
Alias
- UMLS CUI [1]
- C0232219
Beschrijving
Other myocardial infarction
Datatype
text
Alias
- UMLS CUI [1]
- C0027051
Beschrijving
Other depolarisation/repolarisation
Datatype
text
Alias
- UMLS CUI [1]
- C0948857
Beschrijving
Other abnormality/Cardiologist comments
Datatype
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1832603
- 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])
C1832603 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])