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ID
41051
Beschrijving
This form documents the recorded abnormalities on telemetry. To be filled in when telemetry is evaluated. 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 (1)
- 16-06-20 16-06-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
16 juni 2020
DOI
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Licentie
Creative Commons BY-NC 4.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629
Summary Telemetry Abnormalities
- StudyEvent: ODM
Similar models
Summary Telemetry Abnormalities
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
Telemetry Start Date Time
Item
1. Start Date and Time of Telemetry
datetime
C1623258 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0242485 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Telemetry Stop Date Time
Item
2. Stop Date and Time of Telemetry
datetime
C0039451 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item Group
RECORD CLINICALLY SIGNIFICANT ABNORMALITIES BELOW
C0039451 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C1704258 (UMLS CUI-2)
No 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 [1,1])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
Sinus bradycardia (40-49 beats/min)
Item
Sinus bradycardia (40-49 beats/min)
boolean
C0085610 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
Sinus bradycardia (30-39 beats/min)
Item
Sinus bradycardia (30-39 beats/min)
boolean
C0085610 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
Sinus bradycardia (<30 beats/min)
Item
Sinus bradycardia (<30 beats/min)
boolean
C0085610 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
Sinus pause
Item
Sinus pause
boolean
C1955864 (UMLS CUI [1])
Sinus tachycardia
Item
Sinus tachycardia (heart rate > 100 beats/min)
boolean
C0039239 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
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 with heart rate > 100 beats/min)
boolean
C0221158 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
Non-sustained supraventricular tachycardia
Item
Non-sustained supraventricular tachycardia (>100 beats/min, 3-30 beats)
boolean
C0039240 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0205374 (UMLS CUI [1,3])
C0018810 (UMLS CUI [1,2])
C0205374 (UMLS CUI [1,3])
Sustained supraventricular tachycardia
Item
Sustained supraventricular tachycardia, (>100 beats/min, >30 beats)
boolean
C0039240 (UMLS CUI [1,1])
C0443318 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,3])
C0443318 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,3])
Atrial flutter
Item
Atrial flutter
boolean
C0004239 (UMLS CUI [1])
Atrial fibrillation
Item
Atrial fibrillation
boolean
C0004238 (UMLS CUI [1])
Junctional rhythm (<= 100 beats/min, defined by narrow QRS complex)
Item
Junctional rhythm (<= 100 beats/min, defined by narrow QRS complex)
boolean
C0232208 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
Junctional tachycardia
Item
Junctional tachycardia (heart rate > 100 beats/min)
boolean
C0039235 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
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])
ldioventricular rhythm
Item
ldioventricular 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 [1,1])
C0439673 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
C0439673 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Monomorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats)
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 (> 100 beats/min, >30 beats)
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 (>100 beats/min, 3-30 beats)
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 (>100 beats/min, >30 beats)
Item
Polymorphic sustained ventricular tachycardia (>100 beats/min, >30 beats)
boolean
C0344432 (UMLS CUI [1,1])
C0750197 (UMLS CUI [1,2])
C0750197 (UMLS CUI [1,2])
Torsades de Pointes
Item
Torsades de Pointes (TdP)
boolean
C0040479 (UMLS CUI [1])
Artificial 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 1)
Item
Second degree AV block (Mobitz type 1)
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 in Wolff-Parkinson White/Lown-Ganong-Levine Syndrome
Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
boolean
C1963785 (UMLS CUI [1,1])
C0043202 (UMLS CUI [1,2])
C1963785 (UMLS CUI [2,1])
C0024054 (UMLS CUI [2,2])
C0043202 (UMLS CUI [1,2])
C1963785 (UMLS CUI [2,1])
C0024054 (UMLS CUI [2,2])
QT/QTc prolongation by QTc time
Item
QT/QTc prolongation >=500msec
boolean
C0855333 (UMLS CUI [1])
C0489625 (UMLS CUI [2])
C0489625 (UMLS CUI [2])
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 elevation
Item
J point elevation
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 abnormality
Item
T wave abnormality
boolean
C0438167 (UMLS CUI [1])
Other abnormal rhythm
Item
Other abnormal rhythm
boolean
C0205394 (UMLS CUI [1,1])
C0199556 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0199556 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
12 lead ECG, Abnormality, Electrocardiogram: Rhythm, Comment
Item
Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
Other morphology
Item
Other morphology
boolean
C0205394 (UMLS CUI [1,1])
C0332437 (UMLS CUI [1,2])
C0332437 (UMLS CUI [1,2])
12 lead ECG, Abnormality, electrocardiogram: P wave shifting morphology, Comment; 12 lead ECG, Abnormality, Electrocardiogram QRS complex, Comment
Item
Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2216025 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0430456 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0429098 (UMLS CUI [2,3])
C0947611 (UMLS CUI [2,4])
C1704258 (UMLS CUI [1,2])
C2216025 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0430456 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0429098 (UMLS CUI [2,3])
C0947611 (UMLS CUI [2,4])
Other conduction
Item
Other conduction
boolean
C0340494 (UMLS CUI [1])
12 lead ECG, Abnormality, Cardiac Conduction, Comment
Item
Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
Other myocardial infarction
Item
Other myocardial infarction
boolean
C0205394 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,2])
12 lead ECG, Abnormality, Myocardial Infarction, Comment
Item
Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C1704258 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
Other depolarisation/repolarisation
Item
Other depolarisation/repolarisation
boolean
C0205394 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C2746082 (UMLS CUI [1,3])
C0948857 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0205161 (UMLS CUI [1,2])
C2746082 (UMLS CUI [1,3])
C0948857 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
12 lead ECG, Abnormality, Ventricular Depolarization [PE], Comment; 12 lead ECG, Abnormality, Electrocardiogram repolarisation abnormality, Comment
Item
Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1331539 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0430456 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0948857 (UMLS CUI [2,3])
C0947611 (UMLS CUI [2,4])
C1704258 (UMLS CUI [1,2])
C1331539 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0430456 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0948857 (UMLS CUI [2,3])
C0947611 (UMLS CUI [2,4])
12 lead ECG, Abnormality, Other | Cardiologists, comment
Item
Other abnormalities/Cardiologist Comments
boolean
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0175906 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0175906 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])
12 lead ECG, Abnormality, Other, Comment | Cardiologists, Comment
Item
Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0175906 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0175906 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])
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