ID
32881
Beschreibung
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
Stichworte
Versionen (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 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
18. November 2018
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629
Telemetry and Summary Telemetry Abnormalities
- StudyEvent: ODM
Beschreibung
Telemetry
Alias
- UMLS CUI-1
- C0039451
Beschreibung
Start Date and Time of Telemetry
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0039451
- UMLS CUI [2,1]
- C0808070
- UMLS CUI [2,2]
- C0039451
Beschreibung
Stop Date and Time of Telemetry
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0039451
- UMLS CUI [2,1]
- C1522314
- UMLS CUI [2,2]
- C0039451
Beschreibung
Result of Telemetry
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0039451
- UMLS CUI [1,2]
- C1274040
Beschreibung
Summary Telemetry Abnormalities
Alias
- UMLS CUI-1
- C0039451
- UMLS CUI-2
- C0522055
Beschreibung
Telemetry Abnormalities
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0039451
- UMLS CUI [1,2]
- C0438154
Beschreibung
Sinus bradycardia (50-59 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschreibung
Sinus bradycardia (40-49 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschreibung
Sinus bradycardia (30-39 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschreibung
Sinus bradycardia (<30 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschreibung
Sinus pause
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1955864
Beschreibung
Sinus tachycardia (>100 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0039239
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]
- C0221158
Beschreibung
Non-sustained supra ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0039240
- UMLS CUI [1,2]
- C0750194
Beschreibung
Sustained supraventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0039240
- UMLS CUI [1,2]
- C0443318
Beschreibung
Atrial flutter
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004239
Beschreibung
Atrial fibrillation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004238
Beschreibung
Junctional rhythm
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0232208
Beschreibung
Junctional tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0039235
Beschreibung
Ventricular premature depolarisation
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
Idioventricular rhythm
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0700363
Beschreibung
Non-sustained ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0750194
Beschreibung
Sustained ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0750197
Beschreibung
Wide QRS tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0344429
Beschreibung
Monomorphic non-sustained ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0344431
- UMLS CUI [1,2]
- C0750194
Beschreibung
Monomorphic sustained ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0344431
- UMLS CUI [1,2]
- C0750197
Beschreibung
Polymorphic non-sustained ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0344432
- UMLS CUI [1,2]
- C0750194
Beschreibung
Polymorphic sustained ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0344432
- UMLS CUI [1,2]
- C0750197
Beschreibung
Torsade de Pointes (TdP)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0040479
Beschreibung
Pacemaker
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0030163
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 I)
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
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1963785
Beschreibung
QTc prolongation >=500 msec
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1969409
Beschreibung
AV dissociation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004331
Beschreibung
Myocardial infarction, old
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0155668
Beschreibung
Myocardial infarction, non Q-wave
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0542269
Beschreibung
Non-specific ST-T changes
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1112720
Beschreibung
J point devation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2346597
Beschreibung
ST elevation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0520886
Beschreibung
ST depression
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0520887
Beschreibung
ST segment abnormality
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348120
Beschreibung
U waves
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0232333
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 biphasic
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348639
Beschreibung
T waves flat
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2215959
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 abnomality
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0438167
Beschreibung
Other abnormal rhythm
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0232187
- UMLS CUI [1,2]
- C0522055
Beschreibung
Other morphology
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0332437
- UMLS CUI [1,2]
- C0522055
Beschreibung
Other conduction
Datentyp
text
Alias
- UMLS CUI [1]
- C0232219
Beschreibung
Other myocardial infarction
Datentyp
text
Alias
- UMLS CUI [1]
- C0027051
Beschreibung
Other depolarisation/repolarisation
Datentyp
text
Alias
- UMLS CUI [1]
- C0948857
Beschreibung
Other abnormality/Cardiologist comments
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1832603
- UMLS CUI [2]
- C0947611
Ähnliche Modelle
Telemetry and Summary Telemetry Abnormalities
- StudyEvent: ODM
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])
C0443318 (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])