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.
Keywords
Versions (1)
- 12/17/20 12/17/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
December 17, 2020
DOI
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License
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
Data type
boolean
Alias
- UMLS CUI [1]
- C0085610
Description
sinus bradycardia (heart rate 40-50 beats/min)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Description
Sinus bradycardia (heart rate 30-39 beats/min)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Description
Sinus bradycardia (heart rate < 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 (wandering atrial pacemaker with heart rate > 100 beats/min)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0221158
- UMLS CUI [1,2]
- C1321523
- UMLS CUI [1,3]
- C0018810
Description
Supraventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0039240
- UMLS CUI [1,2]
- 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 (heart rate <= 100 beats/min)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0232208
- UMLS CUI [1,2]
- C0018810
Description
Junctional rhythm
Data type
boolean
Alias
- UMLS CUI [1]
- C0232208
Description
Junctional tachycardia
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0039235
- UMLS CUI [1,2]
- C0018810
Description
Ectopic ventricular beats
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
Sustained ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0750197
Description
Non-sustained ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0750194
Description
ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0042514
Description
Monomorphic ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0344431
Description
Torsades de Pointes
Data type
boolean
Alias
- UMLS CUI [1]
- C0040479
Description
Polymorphic (sustained and non-sustained) ventricular tachycardia
Data type
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
Data type
boolean
Alias
- UMLS CUI [1]
- C0030163
Description
Other abnormal rhythm
Data type
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
Data type
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)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0344711
- UMLS CUI [1,2]
- C0232310
Description
Right atrial abnormality (P pulmonale)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0344696
- UMLS CUI [1,2]
- C0232308
Description
Right ventricular hypertrophy
Data type
boolean
Alias
- UMLS CUI [1]
- C0162770
Description
Intraatrial conduction delay
Data type
boolean
Alias
- UMLS CUI [1]
- C2346510
Description
Increased voltage consistent with left ventricular hypertrophy
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1112650
- UMLS CUI [1,2]
- C0332290
- UMLS CUI [1,3]
- C0149721
Description
Other P-wave morphology
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2216025
Description
12 lead ECG, other abnormality in P-wave morphology, specification
Data type
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
Data type
boolean
Alias
- UMLS CUI [1]
- C0085614
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 fascicular block
Data type
boolean
Alias
- UMLS CUI [1]
- C0264912
Description
left posterior fascicular block
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
Other conduction abnormality
Data type
boolean
Alias
- UMLS CUI [1]
- C0340494
Description
12-lead ecg, other conduction abnormality, specification
Data type
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
Data type
boolean
Alias
- UMLS CUI [1]
- C0155668
Description
Myocardial infarction, anterior
Data type
boolean
Alias
- UMLS CUI [1]
- C0340293
Description
Myocardial infarction, lateral
Data type
boolean
Alias
- UMLS CUI [1]
- C0340312
Description
Myocardial infarction, posterior
Data type
boolean
Alias
- UMLS CUI [1]
- C0340319
Description
Myocardial infarction, inferior
Data type
boolean
Alias
- UMLS CUI [1]
- C0340305
Description
Myocardial infarction, septal
Data type
boolean
Alias
- UMLS CUI [1]
- C0746727
Description
Myocardial infarction, Non Q-wave
Data type
boolean
Alias
- UMLS CUI [1]
- C0542269
Description
Other myocardial infarction
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0027051
Description
other myocardial infarction, specification
Data type
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
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-elevation - pericarditis
Data type
boolean
Alias
- UMLS CUI [1]
- C2348119
Description
ST depression
Data type
boolean
Alias
- UMLS CUI [1]
- C0520887
Description
U waves abnormal
Data type
boolean
Alias
- UMLS CUI [1]
- C0438169
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 flat
Data type
boolean
Alias
- UMLS CUI [1]
- C2215959
Description
T waves biphasic
Data type
boolean
Alias
- UMLS CUI [1]
- C2348639
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 flattening/inversion
Data type
boolean
Alias
- UMLS CUI [1]
- C0520888
- UMLS CUI [2]
- C0429059
Description
Other depolarisation/repolarisation
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
other depolarisation/repolarisation, specification
Data type
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
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
Description
other 12-lead ECG abnormalities, specification
Data type
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])