ID
41685
Description
The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia The 12-Lead ECG Abnormalities Form has to be filled in whenever an abnormal ECG curve is recorded durig the study. ECG curves are recorded during the Screening, P1 D1, P2 D1, Follow-Up and Repeat Visits.
Mots-clés
Versions (1)
- 17/12/2020 17/12/2020 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
17 décembre 2020
DOI
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Licence
Creative Commons BY-NC 4.0
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GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122
12-Lead ECG Abnormalities
- StudyEvent: ODM
Description
ECG Abnormalities
Alias
- UMLS CUI-1
- C0522055
Description
12-Lead ECG Rhythm
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0199556
Description
sinus bradycardia
Type de données
boolean
Alias
- UMLS CUI [1]
- C0085610
Description
sinus bradycardia (heart rate 40-50 beats/min)
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Description
Sinus bradycardia (heart rate 30-39 beats/min)
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Description
Sinus bradycardia (heart rate < 30 beats/min)
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Description
Sinus pause
Type de données
boolean
Alias
- UMLS CUI [1]
- C1955864
Description
Sinus tachycardia
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0039239
- UMLS CUI [1,2]
- C0018810
Description
Ectopic supraventricular beats
Type de données
boolean
Alias
- UMLS CUI [1]
- C0033036
Description
Ectopic supraventricular rhythm
Type de données
boolean
Alias
- UMLS CUI [1]
- C2348376
Description
Wandering atrial pacemaker
Type de données
boolean
Alias
- UMLS CUI [1]
- C1321523
Description
Multifocal atrial tachycardia (wandering atrial pacemaker with heart rate > 100 beats/min)
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0221158
- UMLS CUI [1,2]
- C1321523
- UMLS CUI [1,3]
- C0018810
Description
Supraventricular tachycardia
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0039240
- UMLS CUI [1,2]
- C0018810
Description
Atrial flutter
Type de données
boolean
Alias
- UMLS CUI [1]
- C0004239
Description
Atrial fibrillation
Type de données
boolean
Alias
- UMLS CUI [1]
- C0004238
Description
Junctional rhythm (heart rate <= 100 beats/min)
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0232208
- UMLS CUI [1,2]
- C0018810
Description
Junctional rhythm
Type de données
boolean
Alias
- UMLS CUI [1]
- C0232208
Description
Junctional tachycardia
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0039235
- UMLS CUI [1,2]
- C0018810
Description
Ectopic ventricular beats
Type de données
boolean
Alias
- UMLS CUI [1]
- C0151636
Description
Ventricular couplets
Type de données
boolean
Alias
- UMLS CUI [1]
- C0429001
Description
Bigeminy
Type de données
boolean
Alias
- UMLS CUI [1]
- C0262662
Description
Trigeminy
Type de données
boolean
Alias
- UMLS CUI [1]
- C0428999
Description
Electrical alternans
Type de données
boolean
Alias
- UMLS CUI [1]
- C1142551
Description
R on T phenomenon
Type de données
boolean
Alias
- UMLS CUI [1]
- C0877658
Description
Ventricular fibrillation
Type de données
boolean
Alias
- UMLS CUI [1]
- C0042510
Description
ldioventricular rhythm
Type de données
boolean
Alias
- UMLS CUI [1]
- C0700363
Description
Sustained ventricular tachycardia
Type de données
boolean
Alias
- UMLS CUI [1]
- C0750197
Description
Non-sustained ventricular tachycardia
Type de données
boolean
Alias
- UMLS CUI [1]
- C0750194
Description
ventricular tachycardia
Type de données
boolean
Alias
- UMLS CUI [1]
- C0042514
Description
Monomorphic ventricular tachycardia
Type de données
boolean
Alias
- UMLS CUI [1]
- C0344431
Description
Torsades de Pointes
Type de données
boolean
Alias
- UMLS CUI [1]
- C0040479
Description
Polymorphic (sustained and non-sustained) ventricular tachycardia
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0344432
- UMLS CUI [1,2]
- C0750197
- UMLS CUI [2,1]
- C0344432
- UMLS CUI [2,2]
- C0750194
Description
Artificial Pacemaker
Type de données
boolean
Alias
- UMLS CUI [1]
- C0030163
Description
Other abnormal rhythm
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0199556
- UMLS CUI [1,3]
- C0205161
Description
12 lead ecg, other abnormal rythm, specification
Type de données
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0199556
- UMLS CUI [1,4]
- C2348235
Description
P-Wave Morphology
Alias
- UMLS CUI-1
- C2216025
- UMLS CUI-2
- C0430456
Description
Left atrial abnormality (P mitrale)
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0344711
- UMLS CUI [1,2]
- C0232310
Description
Right atrial abnormality (P pulmonale)
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0344696
- UMLS CUI [1,2]
- C0232308
Description
Right ventricular hypertrophy
Type de données
boolean
Alias
- UMLS CUI [1]
- C0162770
Description
Intraatrial conduction delay
Type de données
boolean
Alias
- UMLS CUI [1]
- C2346510
Description
Increased voltage consistent with left ventricular hypertrophy
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1112650
- UMLS CUI [1,2]
- C0332290
- UMLS CUI [1,3]
- C0149721
Description
Other P-wave morphology
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2216025
Description
12 lead ECG, other abnormality in P-wave morphology, specification
Type de données
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [1,4]
- C2216025
- UMLS CUI [1,5]
- C2348235
Description
Conduction
Alias
- UMLS CUI-1
- C0264886
Description
First degree AV block
Type de données
boolean
Alias
- UMLS CUI [1]
- C0085614
Description
Second degree AV block (Mobitz type 1)
Type de données
boolean
Alias
- UMLS CUI [1]
- C0264907
Description
Second degree AV block (Mobitz type 2)
Type de données
boolean
Alias
- UMLS CUI [1]
- C0155700
Description
2: 1 AV block
Type de données
boolean
Alias
- UMLS CUI [1]
- C2346542
Description
Third degree AV block
Type de données
boolean
Alias
- UMLS CUI [1]
- C0151517
Description
Left axis deviation
Type de données
boolean
Alias
- UMLS CUI [1]
- C0232297
Description
Right axis deviation
Type de données
boolean
Alias
- UMLS CUI [1]
- C0232296
Description
Incomplete right bundle branch block
Type de données
boolean
Alias
- UMLS CUI [1]
- C0262525
Description
Incomplete left bundle branch block
Type de données
boolean
Alias
- UMLS CUI [1]
- C0281878
Description
Right bundle branch block
Type de données
boolean
Alias
- UMLS CUI [1]
- C0085615
Description
left anterior fascicular block
Type de données
boolean
Alias
- UMLS CUI [1]
- C0264912
Description
left posterior fascicular block
Type de données
boolean
Alias
- UMLS CUI [1]
- C0264913
Description
Left bundle branch block
Type de données
boolean
Alias
- UMLS CUI [1]
- C0023211
Description
Bifascicular block
Type de données
boolean
Alias
- UMLS CUI [1]
- C0264914
Description
Non-specific intraventricular conduction delay
Type de données
boolean
Alias
- UMLS CUI [1]
- C3697597
Description
Accessory pathway in Wolff-Parkinson White/Lown-Ganong-Levine Syndrome
Type de données
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
Type de données
boolean
Alias
- UMLS CUI [1]
- C0855333
- UMLS CUI [2]
- C0489625
Description
AV dissociation
Type de données
boolean
Alias
- UMLS CUI [1]
- C0004331
Description
Other conduction abnormality
Type de données
boolean
Alias
- UMLS CUI [1]
- C0340494
Description
12-lead ecg, other conduction abnormality, specification
Type de données
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [1,4]
- C0232217
- UMLS CUI [1,5]
- C0947611
Description
Myocardial Infarction
Alias
- UMLS CUI-1
- C0027051
Description
Myocardial infarction, old
Type de données
boolean
Alias
- UMLS CUI [1]
- C0155668
Description
Myocardial infarction, anterior
Type de données
boolean
Alias
- UMLS CUI [1]
- C0340293
Description
Myocardial infarction, lateral
Type de données
boolean
Alias
- UMLS CUI [1]
- C0340312
Description
Myocardial infarction, posterior
Type de données
boolean
Alias
- UMLS CUI [1]
- C0340319
Description
Myocardial infarction, inferior
Type de données
boolean
Alias
- UMLS CUI [1]
- C0340305
Description
Myocardial infarction, septal
Type de données
boolean
Alias
- UMLS CUI [1]
- C0746727
Description
Myocardial infarction, Non Q-wave
Type de données
boolean
Alias
- UMLS CUI [1]
- C0542269
Description
Other myocardial infarction
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0027051
Description
other myocardial infarction, specification
Type de données
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Depolarisation/Repolarisation (QRS-T)
Alias
- UMLS CUI-1
- C0948857
- UMLS CUI-2
- C1331539
Description
Non-specific ST-T changes
Type de données
boolean
Alias
- UMLS CUI [1]
- C1112720
Description
J point elevation
Type de données
boolean
Alias
- UMLS CUI [1]
- C2346597
Description
ST elevation
Type de données
boolean
Alias
- UMLS CUI [1]
- C0520886
Description
ST-elevation - pericarditis
Type de données
boolean
Alias
- UMLS CUI [1]
- C2348119
Description
ST depression
Type de données
boolean
Alias
- UMLS CUI [1]
- C0520887
Description
U waves abnormal
Type de données
boolean
Alias
- UMLS CUI [1]
- C0438169
Description
T wave inversion
Type de données
boolean
Alias
- UMLS CUI [1]
- C0520888
Description
T wave peaked
Type de données
boolean
Alias
- UMLS CUI [1]
- C0239242
Description
T waves flat
Type de données
boolean
Alias
- UMLS CUI [1]
- C2215959
Description
T waves biphasic
Type de données
boolean
Alias
- UMLS CUI [1]
- C2348639
Description
Notched T-waves
Type de données
boolean
Alias
- UMLS CUI [1]
- C2347367
Description
Low QRS voltage
Type de données
boolean
Alias
- UMLS CUI [1]
- C2349945
Description
T-wave flattening/inversion
Type de données
boolean
Alias
- UMLS CUI [1]
- C0520888
- UMLS CUI [2]
- C0429059
Description
Other depolarisation/repolarisation
Type de données
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
other depolarisation/repolarisation, specification
Type de données
text
Alias
- UMLS CUI [1,1]
- C1331539
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2,1]
- C0948857
- UMLS CUI [2,2]
- C2348235
Description
Other abnormalities
Alias
- UMLS CUI-1
- C0522055
- UMLS CUI-2
- C0205394
Description
12 lead ECG, Abnormality, Other
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
Description
other 12-lead ECG abnormalities, specification
Type de données
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Similar models
12-Lead ECG Abnormalities
- StudyEvent: ODM
C0011008 (UMLS CUI [1,2])
C0430456 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C1321523 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,3])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0750197 (UMLS CUI [1,2])
C0344432 (UMLS CUI [2,1])
C0750194 (UMLS CUI [2,2])
C0199556 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0430456 (UMLS CUI-2)
C0232310 (UMLS CUI [1,2])
C0232308 (UMLS CUI [1,2])
C0332290 (UMLS CUI [1,2])
C0149721 (UMLS CUI [1,3])
C2216025 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2216025 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C0043202 (UMLS CUI [1,2])
C1963785 (UMLS CUI [2,1])
C0024054 (UMLS CUI [2,2])
C0489625 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0232217 (UMLS CUI [1,4])
C0947611 (UMLS CUI [1,5])
C0027051 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C1331539 (UMLS CUI-2)
C0429059 (UMLS CUI [2])
C0205161 (UMLS CUI [1,2])
C2746082 (UMLS CUI [1,3])
C0948857 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [1,2])
C0948857 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])