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ID
32958
Descrição
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
Palavras-chave
Versões (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 -
Titular dos direitos
GlaxoSmithKline
Transferido a
21 de novembro de 2018
DOI
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Licença
Creative Commons BY-NC 3.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX NCT00875784
Telemetry and Summary Telemetry Abnormalities
- StudyEvent: ODM
Similar models
Telemetry and Summary Telemetry Abnormalities
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Date of Visit/Assessment
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
CL Item
V1 (V1)
CL Item
V2 (V2)
CL Item
V3 (V3)
CL Item
logs/repeats (logs/repeats)
Dosing date/time
Item
Dosing date/time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
Start Date and Time of Telemetry
Item
Start Date and Time of Telemetry Hr:Min (00:00-23:59)
datetime
C1301880 (UMLS CUI [1,1])
C0039451 (UMLS CUI [1,2])
C0808070 (UMLS CUI [2,1])
C0039451 (UMLS CUI [2,2])
C0039451 (UMLS CUI [1,2])
C0808070 (UMLS CUI [2,1])
C0039451 (UMLS CUI [2,2])
Stop Date and Time of Telemetry
Item
Stop Date and Time of Telemetry Hr:Min (00:00-23:59)
datetime
C0806020 (UMLS CUI [1,1])
C0039451 (UMLS CUI [1,2])
C1522314 (UMLS CUI [2,1])
C0039451 (UMLS CUI [2,2])
C0039451 (UMLS CUI [1,2])
C1522314 (UMLS CUI [2,1])
C0039451 (UMLS CUI [2,2])
Item
Result of Telemetry
text
C0039451 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
CL Item
Normal (Normal)
CL Item
Abnormal - Not clinically significant (Abnormal - Not clinically significant)
CL Item
Abnormal - Clinically significant (Abnormal - Clinically significant)
CL Item
No result (No result)
CL Item
Unable to evaluate (Unable to evaluate)
Item Group
Summary Telemetry Abnormalities
C0039451 (UMLS CUI-1)
C0522055 (UMLS CUI-2)
C0522055 (UMLS CUI-2)
Telemetry Abnormalities
Item
no abnormalities
boolean
C0039451 (UMLS CUI [1,1])
C0438154 (UMLS CUI [1,2])
C0438154 (UMLS CUI [1,2])
Sinus bradycardia (50-59 beats/min)
Item
Sinus bradycardia (50-59 beats/min)
boolean
C0085610 (UMLS CUI [1])
Sinus bradycardia (40-49 beats/min)
Item
Sinus bradycardia (40-49 beats/min)
boolean
C0085610 (UMLS CUI [1])
Sinus bradycardia (30-39 beats/min)
Item
Sinus bradycardia (30-39 beats/min)
boolean
C0085610 (UMLS CUI [1])
Sinus bradycardia (<30 beats/min)
Item
Sinus bradycardia (<30 beats/min)
boolean
C0085610 (UMLS CUI [1])
Sinus pause
Item
Sinus pause
boolean
C1955864 (UMLS CUI [1])
Sinus tachycardia (>100 beats/min)
Item
Sinus tachycardia (>100 beats/min)
boolean
C0039239 (UMLS CUI [1])
Ectopic supraventricular beats
Item
Ectopic supraventricular beats
boolean
C0033036 (UMLS CUI [1])
Ectopic supraventricular rhythm
Item
Ectopic supraventricular rhythm
boolean
C2348376 (UMLS CUI [1])
Wandering atrial pacemaker
Item
Wandering atrial pacemaker
boolean
C1321523 (UMLS CUI [1])
Multifocal atrial tachycardia
Item
Multifocal atrial tachycardia (wandering atrial pacemaker w/rate> 100 beats/min)
boolean
C0221158 (UMLS CUI [1])
Non-sustained supra ventricular tachycardia
Item
Non-sustained supraventricular tachycardia (> 100 beats/min, 3-30 beats)
boolean
C4054337 (UMLS CUI [1])
Sustained supraventricular tachycardia
Item
Sustained supraventricular tachycardia(> 100 beats/min, >30 beats)
boolean
C4053964 (UMLS CUI [1])
Atrial flutter
Item
Atrial flutter
boolean
C0004239 (UMLS CUI [1])
Atrial fibrillation
Item
Atrial fibrillation
boolean
C0004238 (UMLS CUI [1])
Junctional rhythm
Item
Junctional rhythm (<=100 beats/min, defined by narrow QRS complex)
boolean
C0232208 (UMLS CUI [1])
Junctional tachycardia
Item
Junctional tachycardia (> I 00 beats/min)
boolean
C0039235 (UMLS CUI [1])
Ventricular premature depolarisation
Item
Ventricular premature depolarisation
boolean
C0151636 (UMLS CUI [1])
Ventricular couplets
Item
Ventricular couplets
boolean
C0429001 (UMLS CUI [1])
Bigeminy
Item
Bigeminy
boolean
C0262662 (UMLS CUI [1])
Trigeminy
Item
Trigeminy
boolean
C0428999 (UMLS CUI [1])
Electrical alternans
Item
Electrical alternans
boolean
C1142551 (UMLS CUI [1])
R on T phenomenon
Item
R on T phenomenon
boolean
C0877658 (UMLS CUI [1])
Ventricular fibrillation
Item
Ventricular fibrillation
boolean
C0042510 (UMLS CUI [1])
Idioventricular rhythm
Item
Idioventricular rhythm (<=100 beats/min, defined by wide QRS complex)
boolean
C0700363 (UMLS CUI [1])
Non-sustained ventricular tachycardia
Item
Non-sustained ventricular tachycardia (> 100 beats/min, 3-30 beats)
boolean
C0750194 (UMLS CUI [1])
Sustained ventricular tachycardia
Item
Sustained ventricular tachycardia (>100 beats/min, >30 beats)
boolean
C0750197 (UMLS CUI [1])
Wide QRS tachycardia
Item
Wide QRS tachycardia (diagnosis unknown)
boolean
C0344429 (UMLS CUI [1])
Monomorphic non-sustained ventricular tachycardia
Item
Monomorphic non-sustained ventricular tachycardia (> 100 beats/min, 3-30 beats)
boolean
C0344431 (UMLS CUI [1,1])
C0750194 (UMLS CUI [1,2])
C0750194 (UMLS CUI [1,2])
Monomorphic sustained ventricular tachycardia
Item
Monomorphic sustained ventricular tachycardia (> 100 beats/min,>30 beats)
boolean
C0344431 (UMLS CUI [1,1])
C0750197 (UMLS CUI [1,2])
C0750197 (UMLS CUI [1,2])
Polymorphic non-sustained ventricular tachycardia
Item
Polymorphic non-sustained ventricular tachycardia(> 100 beats/min, 3-30 beats)
boolean
C0344432 (UMLS CUI [1,1])
C0750194 (UMLS CUI [1,2])
C0750194 (UMLS CUI [1,2])
Polymorphic sustained ventricular tachycardia
Item
Polymorphic sustained ventricular tachycardia(> 1OO beats/min, >30 beats)
boolean
C0344432 (UMLS CUI [1,1])
C0750197 (UMLS CUI [1,2])
C0750197 (UMLS CUI [1,2])
Torsade de Pointes (TdP)
Item
Torsade de Pointes (TdP)
boolean
C0040479 (UMLS CUI [1])
Pacemaker
Item
Pacemaker
boolean
C0030163 (UMLS CUI [1])
First degree AV block
Item
First degree AV block (PR interval >200msec)
boolean
C0085614 (UMLS CUI [1])
Short PR Interval
Item
Short PR Interval
boolean
C0520878 (UMLS CUI [1])
Second degree AV block (Mobitz type I)
Item
Second degree AV block (Mobitz type I)
boolean
C0264907 (UMLS CUI [1])
Second degree AV block (Mobitz type 2)
Item
Second degree AV block (Mobitz type 2)
boolean
C0155700 (UMLS CUI [1])
2:1 AV block
Item
2:1 AV block
boolean
C2346542 (UMLS CUI [1])
Third degree AV block
Item
Third degree AV block
boolean
C0151517 (UMLS CUI [1])
Left axis deviation
Item
Left axis deviation (QRS axis more negative than -30 degrees)
boolean
C0232297 (UMLS CUI [1])
Right axis deviation
Item
Right axis deviation (QRS axis more positive than + 110 degrees)
boolean
C0232296 (UMLS CUI [1])
Incomplete right bundle branch block
Item
Incomplete right bundle branch block
boolean
C0262525 (UMLS CUI [1])
Incomplete left bundle branch block
Item
Incomplete left bundle branch block
boolean
C0281878 (UMLS CUI [1])
Right bundle branch block
Item
Right bundle branch block
boolean
C0085615 (UMLS CUI [1])
Left anterior hemiblock
Item
Left anterior hemiblock
boolean
C0264912 (UMLS CUI [1])
Left posterior hemiblock
Item
Left posterior hemiblock
boolean
C0264913 (UMLS CUI [1])
Left bundle branch block
Item
Left bundle branch block
boolean
C0023211 (UMLS CUI [1])
Bifascicular block
Item
Bifascicular block
boolean
C0264914 (UMLS CUI [1])
Non-specific intraventricular conduction delay
Item
Non-specific intraventricular conduction delay (QRS >= 120 msec)
boolean
C3697597 (UMLS CUI [1])
Accessory pathway
Item
Accessory pathway (Wolff-Parkinson-White, Lown-Ganong-Levine)
boolean
C1963785 (UMLS CUI [1])
QTc prolongation >=500 msec
Item
QTc prolongation >=500 msec
boolean
C1969409 (UMLS CUI [1])
AV dissociation
Item
AV dissociation
boolean
C0004331 (UMLS CUI [1])
Myocardial infarction, old
Item
Myocardial infarction, old
boolean
C0155668 (UMLS CUI [1])
Myocardial infarction, non Q-wave
Item
Myocardial infarction, non Q-wave
boolean
C0542269 (UMLS CUI [1])
Non-specific ST-T changes
Item
Non-specific ST-T changes
boolean
C1112720 (UMLS CUI [1])
J point devation
Item
J point devation
boolean
C2346597 (UMLS CUI [1])
ST elevation
Item
ST elevation
boolean
C0520886 (UMLS CUI [1])
ST depression
Item
ST depression
boolean
C0520887 (UMLS CUI [1])
ST segment abnormality
Item
ST segment abnormality
boolean
C2348120 (UMLS CUI [1])
U waves
Item
U waves
boolean
C0232333 (UMLS CUI [1])
T wave inversion
Item
T wave inversion
boolean
C0520888 (UMLS CUI [1])
T wave peaked
Item
T wave peaked
boolean
C0239242 (UMLS CUI [1])
T waves biphasic
Item
T waves biphasic
boolean
C2348639 (UMLS CUI [1])
T waves flat
Item
T waves flat
boolean
C2215959 (UMLS CUI [1])
Notched T-waves
Item
Notched T-waves
boolean
C2347367 (UMLS CUI [1])
Low QRS voltage
Item
Low QRS voltage
boolean
C2349945 (UMLS CUI [1])
T wave abnomality
Item
T wave abnomality
boolean
C0438167 (UMLS CUI [1])
Other abnormal rhythm
Item
If Other abnormal rhythm, please specify
text
C0232187 (UMLS CUI [1,1])
C0522055 (UMLS CUI [1,2])
C0522055 (UMLS CUI [1,2])
Other morphology
Item
If Other morphology, please specify
text
C0332437 (UMLS CUI [1,1])
C0522055 (UMLS CUI [1,2])
C0522055 (UMLS CUI [1,2])
Other conduction
Item
If Other conduction, please specify
text
C0232219 (UMLS CUI [1])
Other myocardial infarction
Item
If Other myocardial infarction, please specify
text
C0027051 (UMLS CUI [1])
Other depolarisation/repolarisation
Item
If Other depolarisation/repolarisation, please specify
text
C0948857 (UMLS CUI [1])
Other abnormality/Cardiologist comments
Item
If Other abnormality/Cardiologist comments, please specify
text
C0205394 (UMLS CUI [1,1])
C1832603 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
C1832603 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])