ID
41051
Description
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
Keywords
Versions (1)
- 6/16/20 6/16/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
June 16, 2020
DOI
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License
Creative Commons BY-NC 4.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629
Summary Telemetry Abnormalities
- StudyEvent: ODM
Description
TELEMETRY
Alias
- UMLS CUI-1
- C0039451
Description
Hr:Min (00:00-23:59)
Data type
datetime
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0242485
- UMLS CUI [1,3]
- C0332307
Description
Hr:Min (00:00-23:59)
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0039451
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [1,3]
- C1522314
Description
RECORD CLINICALLY SIGNIFICANT ABNORMALITIES BELOW
Alias
- UMLS CUI-1
- C0039451
- UMLS CUI-2
- C1704258
Description
No Telemetry Abnormalities
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0039451
- UMLS CUI [1,2]
- C0438154
Description
Sinus bradycardia (50-59 beats/min)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Description
Sinus bradycardia (40-49 beats/min)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Description
Sinus bradycardia (30-39 beats/min)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Description
Sinus bradycardia (<30 beats/min)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Description
Sinus pause
Data type
boolean
Alias
- UMLS CUI [1]
- C1955864
Description
Sinus tachycardia
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0039239
- UMLS CUI [1,2]
- C0018810
Description
Ectopic supraventricular beats
Data type
boolean
Alias
- UMLS CUI [1]
- C0033036
Description
Ectopic supraventricular rhythm
Data type
boolean
Alias
- UMLS CUI [1]
- C2348376
Description
Wandering atrial pacemaker
Data type
boolean
Alias
- UMLS CUI [1]
- C1321523
Description
Multifocal atrial tachycardia
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0221158
- UMLS CUI [1,2]
- C0018810
Description
Non-sustained supraventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0039240
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [1,3]
- C0205374
Description
Sustained supraventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0039240
- UMLS CUI [1,2]
- C0443318
- UMLS CUI [1,3]
- C0018810
Description
Atrial flutter
Data type
boolean
Alias
- UMLS CUI [1]
- C0004239
Description
Atrial fibrillation
Data type
boolean
Alias
- UMLS CUI [1]
- C0004238
Description
Junctional rhythm (<= 100 beats/min, defined by narrow QRS complex)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0232208
- UMLS CUI [1,2]
- C0018810
Description
Junctional tachycardia
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0039235
- UMLS CUI [1,2]
- C0018810
Description
Ventricular premature depolarisation
Data type
boolean
Alias
- UMLS CUI [1]
- C0151636
Description
Ventricular couplets
Data type
boolean
Alias
- UMLS CUI [1]
- C0429001
Description
Bigeminy
Data type
boolean
Alias
- UMLS CUI [1]
- C0262662
Description
Trigeminy
Data type
boolean
Alias
- UMLS CUI [1]
- C0428999
Description
Electrical alternans
Data type
boolean
Alias
- UMLS CUI [1]
- C1142551
Description
R on T phenomenon
Data type
boolean
Alias
- UMLS CUI [1]
- C0877658
Description
Ventricular fibrillation
Data type
boolean
Alias
- UMLS CUI [1]
- C0042510
Description
ldioventricular rhythm
Data type
boolean
Alias
- UMLS CUI [1]
- C0700363
Description
Non-sustained ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0750194
Description
Sustained ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0750197
Description
Wide QRS tachycardia
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0344429
- UMLS CUI [1,2]
- C0439673
- UMLS CUI [1,3]
- C0011900
Description
Monomorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0344431
- UMLS CUI [1,2]
- C0750194
Description
Monomorphic sustained ventricular tachycardia (> 100 beats/min, >30 beats)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0344431
- UMLS CUI [1,2]
- C0750197
Description
Polymorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0344432
- UMLS CUI [1,2]
- C0750194
Description
Polymorphic sustained ventricular tachycardia (>100 beats/min, >30 beats)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0344432
- UMLS CUI [1,2]
- C0750197
Description
Torsades de Pointes
Data type
boolean
Alias
- UMLS CUI [1]
- C0040479
Description
Artificial Pacemaker
Data type
boolean
Alias
- UMLS CUI [1]
- C0030163
Description
First degree AV block
Data type
boolean
Alias
- UMLS CUI [1]
- C0085614
Description
Short PR interval
Data type
boolean
Alias
- UMLS CUI [1]
- C0520878
Description
Second degree AV block (Mobitz type 1)
Data type
boolean
Alias
- UMLS CUI [1]
- C0264907
Description
Second degree AV block (Mobitz type 2)
Data type
boolean
Alias
- UMLS CUI [1]
- C0155700
Description
2: 1 AV block
Data type
boolean
Alias
- UMLS CUI [1]
- C2346542
Description
Third degree AV block
Data type
boolean
Alias
- UMLS CUI [1]
- C0151517
Description
Left axis deviation
Data type
boolean
Alias
- UMLS CUI [1]
- C0232297
Description
Right axis deviation
Data type
boolean
Alias
- UMLS CUI [1]
- C0232296
Description
Incomplete right bundle branch block
Data type
boolean
Alias
- UMLS CUI [1]
- C0262525
Description
Incomplete left bundle branch block
Data type
boolean
Alias
- UMLS CUI [1]
- C0281878
Description
Right bundle branch block
Data type
boolean
Alias
- UMLS CUI [1]
- C0085615
Description
Left anterior hemiblock
Data type
boolean
Alias
- UMLS CUI [1]
- C0264912
Description
Left posterior hemiblock
Data type
boolean
Alias
- UMLS CUI [1]
- C0264913
Description
Left bundle branch block
Data type
boolean
Alias
- UMLS CUI [1]
- C0023211
Description
Bifascicular block
Data type
boolean
Alias
- UMLS CUI [1]
- C0264914
Description
Non-specific intraventricular conduction delay
Data type
boolean
Alias
- UMLS CUI [1]
- C3697597
Description
Accessory pathway in Wolff-Parkinson White/Lown-Ganong-Levine Syndrome
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1963785
- UMLS CUI [1,2]
- C0043202
- UMLS CUI [2,1]
- C1963785
- UMLS CUI [2,2]
- C0024054
Description
QT/QTc prolongation by QTc time
Data type
boolean
Alias
- UMLS CUI [1]
- C0855333
- UMLS CUI [2]
- C0489625
Description
AV dissociation
Data type
boolean
Alias
- UMLS CUI [1]
- C0004331
Description
Myocardial infarction, old
Data type
boolean
Alias
- UMLS CUI [1]
- C0155668
Description
Myocardial infarction, Non Q-wave
Data type
boolean
Alias
- UMLS CUI [1]
- C0542269
Description
Non-specific ST-T changes
Data type
boolean
Alias
- UMLS CUI [1]
- C1112720
Description
J point elevation
Data type
boolean
Alias
- UMLS CUI [1]
- C2346597
Description
ST elevation
Data type
boolean
Alias
- UMLS CUI [1]
- C0520886
Description
ST depression
Data type
boolean
Alias
- UMLS CUI [1]
- C0520887
Description
ST segment abnormality
Data type
boolean
Alias
- UMLS CUI [1]
- C2348120
Description
U waves
Data type
boolean
Alias
- UMLS CUI [1]
- C0232333
Description
T wave inversion
Data type
boolean
Alias
- UMLS CUI [1]
- C0520888
Description
T wave peaked
Data type
boolean
Alias
- UMLS CUI [1]
- C0239242
Description
T waves biphasic
Data type
boolean
Alias
- UMLS CUI [1]
- C2348639
Description
T waves flat
Data type
boolean
Alias
- UMLS CUI [1]
- C2215959
Description
Notched T-waves
Data type
boolean
Alias
- UMLS CUI [1]
- C2347367
Description
Low QRS voltage
Data type
boolean
Alias
- UMLS CUI [1]
- C2349945
Description
T wave abnormality
Data type
boolean
Alias
- UMLS CUI [1]
- C0438167
Description
If yes, enter comment
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0199556
- UMLS CUI [1,3]
- C0205161
Description
12 lead ECG, Abnormality, Electrocardiogram: Rhythm, Comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0199556
- UMLS CUI [1,4]
- C0947611
Description
If yes, enter comment
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0332437
Description
12 lead ECG, Abnormality, electrocardiogram: P wave shifting morphology, Comment; 12 lead ECG, Abnormality, Electrocardiogram QRS complex, Comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C2216025
- UMLS CUI [1,4]
- C0947611
- UMLS CUI [2,1]
- C0430456
- UMLS CUI [2,2]
- C1704258
- UMLS CUI [2,3]
- C0429098
- UMLS CUI [2,4]
- C0947611
Description
If yes, enter comment
Data type
boolean
Alias
- UMLS CUI [1]
- C0340494
Description
12 lead ECG, Abnormality, Cardiac Conduction, Comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0232217
- UMLS CUI [1,4]
- C0947611
Description
If yes, enter comment
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0027051
Description
12 lead ECG, Abnormality, Myocardial Infarction, Comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0027051
- UMLS CUI [1,4]
- C0947611
Description
If yes, enter comment
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [1,3]
- C2746082
- UMLS CUI [2,1]
- C0948857
- UMLS CUI [2,2]
- C0205394
Description
12 lead ECG, Abnormality, Ventricular Depolarization [PE], Comment; 12 lead ECG, Abnormality, Electrocardiogram repolarisation abnormality, Comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C1331539
- UMLS CUI [1,4]
- C0947611
- UMLS CUI [2,1]
- C0430456
- UMLS CUI [2,2]
- C1704258
- UMLS CUI [2,3]
- C0948857
- UMLS CUI [2,4]
- C0947611
Description
12 lead ECG, Abnormality, Other | Cardiologists, comment
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [2,1]
- C0175906
- UMLS CUI [2,2]
- C0947611
Description
12 lead ECG, Abnormality, Other, Comment | Cardiologists, Comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0947611
- UMLS CUI [2,1]
- C0175906
- UMLS CUI [2,2]
- C0947611
Similar models
Summary Telemetry Abnormalities
- StudyEvent: ODM
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C1522314 (UMLS CUI [1,3])
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C0438154 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
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C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
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C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0205374 (UMLS CUI [1,3])
C0443318 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,3])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
C0750194 (UMLS CUI [1,2])
C0750197 (UMLS CUI [1,2])
C0750194 (UMLS CUI [1,2])
C0750197 (UMLS CUI [1,2])
C0043202 (UMLS CUI [1,2])
C1963785 (UMLS CUI [2,1])
C0024054 (UMLS CUI [2,2])
C0489625 (UMLS CUI [2])
C0199556 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0332437 (UMLS CUI [1,2])
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])
C0232217 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0027051 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0205161 (UMLS CUI [1,2])
C2746082 (UMLS CUI [1,3])
C0948857 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
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])
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])
C0947611 (UMLS CUI [1,4])
C0175906 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])
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