ID
32958
Beskrivning
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
Länk
https://clinicaltrials.gov/ct2/show/NCT00875784
Nyckelord
Versioner (4)
- 2018-11-18 2018-11-18 -
- 2018-11-18 2018-11-18 -
- 2018-11-21 2018-11-21 -
- 2021-09-17 2021-09-17 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
21 november 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX NCT00875784
Telemetry and Summary Telemetry Abnormalities
- StudyEvent: ODM
Beskrivning
Dosing Date and Time
Alias
- UMLS CUI-1
- C0178602
- UMLS CUI-2
- C1264639
Beskrivning
Telemetry
Alias
- UMLS CUI-1
- C0039451
Beskrivning
Start Date and Time of Telemetry
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0039451
- UMLS CUI [2,1]
- C0808070
- UMLS CUI [2,2]
- C0039451
Beskrivning
Stop Date and Time of Telemetry
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0039451
- UMLS CUI [2,1]
- C1522314
- UMLS CUI [2,2]
- C0039451
Beskrivning
Result of Telemetry
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0039451
- UMLS CUI [1,2]
- C1274040
Beskrivning
Summary Telemetry Abnormalities
Alias
- UMLS CUI-1
- C0039451
- UMLS CUI-2
- C0522055
Beskrivning
If no, record any clinically significant abnormalities below
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0039451
- UMLS CUI [1,2]
- C0438154
Beskrivning
Sinus bradycardia (50-59 beats/min)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0085610
Beskrivning
Sinus bradycardia (40-49 beats/min)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0085610
Beskrivning
Sinus bradycardia (30-39 beats/min)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0085610
Beskrivning
Sinus bradycardia (<30 beats/min)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0085610
Beskrivning
Sinus pause
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1955864
Beskrivning
Sinus tachycardia (>100 beats/min)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0039239
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]
- C0221158
Beskrivning
Non-sustained supra ventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C4054337
Beskrivning
Sustained supraventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C4053964
Beskrivning
Atrial flutter
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0004239
Beskrivning
Atrial fibrillation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0004238
Beskrivning
Junctional rhythm
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0232208
Beskrivning
Junctional tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0039235
Beskrivning
Ventricular premature depolarisation
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
Idioventricular rhythm
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0700363
Beskrivning
Non-sustained ventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0750194
Beskrivning
Sustained ventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0750197
Beskrivning
Wide QRS tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0344429
Beskrivning
Monomorphic non-sustained ventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0344431
- UMLS CUI [1,2]
- C0750194
Beskrivning
Monomorphic sustained ventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0344431
- UMLS CUI [1,2]
- C0750197
Beskrivning
Polymorphic non-sustained ventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0344432
- UMLS CUI [1,2]
- C0750194
Beskrivning
Polymorphic sustained ventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0344432
- UMLS CUI [1,2]
- C0750197
Beskrivning
Torsade de Pointes (TdP)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0040479
Beskrivning
Pacemaker
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0030163
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 I)
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
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1963785
Beskrivning
QTc prolongation >=500 msec
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1969409
Beskrivning
AV dissociation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0004331
Beskrivning
Myocardial infarction, old
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0155668
Beskrivning
Myocardial infarction, non Q-wave
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0542269
Beskrivning
Non-specific ST-T changes
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1112720
Beskrivning
J point devation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2346597
Beskrivning
ST elevation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0520886
Beskrivning
ST depression
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0520887
Beskrivning
ST segment abnormality
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2348120
Beskrivning
U waves
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0232333
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 biphasic
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2348639
Beskrivning
T waves flat
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2215959
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 abnomality
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0438167
Beskrivning
Other abnormal rhythm
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0232187
- UMLS CUI [1,2]
- C0522055
Beskrivning
Other morphology
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0332437
- UMLS CUI [1,2]
- C0522055
Beskrivning
Other conduction
Datatyp
text
Alias
- UMLS CUI [1]
- C0232219
Beskrivning
Other myocardial infarction
Datatyp
text
Alias
- UMLS CUI [1]
- C0027051
Beskrivning
Other depolarisation/repolarisation
Datatyp
text
Alias
- UMLS CUI [1]
- C0948857
Beskrivning
Other abnormality/Cardiologist comments
Datatyp
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])