ID
41685
Beskrivning
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.
Nyckelord
Versioner (1)
- 2020-12-17 2020-12-17 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
17 december 2020
DOI
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Licens
Creative Commons BY-NC 4.0
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GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122
12-Lead ECG Abnormalities
- StudyEvent: ODM
Beskrivning
ECG Abnormalities
Alias
- UMLS CUI-1
- C0522055
Beskrivning
12-Lead ECG Rhythm
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0199556
Beskrivning
sinus bradycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0085610
Beskrivning
sinus bradycardia (heart rate 40-50 beats/min)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Beskrivning
Sinus bradycardia (heart rate 30-39 beats/min)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Beskrivning
Sinus bradycardia (heart rate < 30 beats/min)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Beskrivning
Sinus pause
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1955864
Beskrivning
Sinus tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0039239
- UMLS CUI [1,2]
- C0018810
Beskrivning
Ectopic supraventricular beats
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0033036
Beskrivning
Ectopic supraventricular rhythm
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2348376
Beskrivning
Wandering atrial pacemaker
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1321523
Beskrivning
Multifocal atrial tachycardia (wandering atrial pacemaker with heart rate > 100 beats/min)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0221158
- UMLS CUI [1,2]
- C1321523
- UMLS CUI [1,3]
- C0018810
Beskrivning
Supraventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0039240
- UMLS CUI [1,2]
- C0018810
Beskrivning
Atrial flutter
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0004239
Beskrivning
Atrial fibrillation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0004238
Beskrivning
Junctional rhythm (heart rate <= 100 beats/min)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0232208
- UMLS CUI [1,2]
- C0018810
Beskrivning
Junctional rhythm
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0232208
Beskrivning
Junctional tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0039235
- UMLS CUI [1,2]
- C0018810
Beskrivning
Ectopic ventricular beats
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0151636
Beskrivning
Ventricular couplets
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0429001
Beskrivning
Bigeminy
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0262662
Beskrivning
Trigeminy
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0428999
Beskrivning
Electrical alternans
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1142551
Beskrivning
R on T phenomenon
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0877658
Beskrivning
Ventricular fibrillation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0042510
Beskrivning
ldioventricular rhythm
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0700363
Beskrivning
Sustained ventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0750197
Beskrivning
Non-sustained ventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0750194
Beskrivning
ventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0042514
Beskrivning
Monomorphic ventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0344431
Beskrivning
Torsades de Pointes
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0040479
Beskrivning
Polymorphic (sustained and non-sustained) ventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0344432
- UMLS CUI [1,2]
- C0750197
- UMLS CUI [2,1]
- C0344432
- UMLS CUI [2,2]
- C0750194
Beskrivning
Artificial Pacemaker
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0030163
Beskrivning
Other abnormal rhythm
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0199556
- UMLS CUI [1,3]
- C0205161
Beskrivning
12 lead ecg, other abnormal rythm, specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0199556
- UMLS CUI [1,4]
- C2348235
Beskrivning
P-Wave Morphology
Alias
- UMLS CUI-1
- C2216025
- UMLS CUI-2
- C0430456
Beskrivning
Left atrial abnormality (P mitrale)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0344711
- UMLS CUI [1,2]
- C0232310
Beskrivning
Right atrial abnormality (P pulmonale)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0344696
- UMLS CUI [1,2]
- C0232308
Beskrivning
Right ventricular hypertrophy
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0162770
Beskrivning
Intraatrial conduction delay
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2346510
Beskrivning
Increased voltage consistent with left ventricular hypertrophy
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1112650
- UMLS CUI [1,2]
- C0332290
- UMLS CUI [1,3]
- C0149721
Beskrivning
Other P-wave morphology
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2216025
Beskrivning
12 lead ECG, other abnormality in P-wave morphology, specification
Datatyp
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
Beskrivning
Conduction
Alias
- UMLS CUI-1
- C0264886
Beskrivning
First degree AV block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0085614
Beskrivning
Second degree AV block (Mobitz type 1)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0264907
Beskrivning
Second degree AV block (Mobitz type 2)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0155700
Beskrivning
2: 1 AV block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2346542
Beskrivning
Third degree AV block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0151517
Beskrivning
Left axis deviation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0232297
Beskrivning
Right axis deviation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0232296
Beskrivning
Incomplete right bundle branch block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0262525
Beskrivning
Incomplete left bundle branch block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0281878
Beskrivning
Right bundle branch block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0085615
Beskrivning
left anterior fascicular block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0264912
Beskrivning
left posterior fascicular block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0264913
Beskrivning
Left bundle branch block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0023211
Beskrivning
Bifascicular block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0264914
Beskrivning
Non-specific intraventricular conduction delay
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3697597
Beskrivning
Accessory pathway in Wolff-Parkinson White/Lown-Ganong-Levine Syndrome
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1963785
- UMLS CUI [1,2]
- C0043202
- UMLS CUI [2,1]
- C1963785
- UMLS CUI [2,2]
- C0024054
Beskrivning
QT/QTc prolongation by QTc time
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0855333
- UMLS CUI [2]
- C0489625
Beskrivning
AV dissociation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0004331
Beskrivning
Other conduction abnormality
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0340494
Beskrivning
12-lead ecg, other conduction abnormality, specification
Datatyp
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
Beskrivning
Myocardial Infarction
Alias
- UMLS CUI-1
- C0027051
Beskrivning
Myocardial infarction, old
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0155668
Beskrivning
Myocardial infarction, anterior
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0340293
Beskrivning
Myocardial infarction, lateral
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0340312
Beskrivning
Myocardial infarction, posterior
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0340319
Beskrivning
Myocardial infarction, inferior
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0340305
Beskrivning
Myocardial infarction, septal
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0746727
Beskrivning
Myocardial infarction, Non Q-wave
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0542269
Beskrivning
Other myocardial infarction
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0027051
Beskrivning
other myocardial infarction, specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Depolarisation/Repolarisation (QRS-T)
Alias
- UMLS CUI-1
- C0948857
- UMLS CUI-2
- C1331539
Beskrivning
Non-specific ST-T changes
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1112720
Beskrivning
J point elevation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2346597
Beskrivning
ST elevation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0520886
Beskrivning
ST-elevation - pericarditis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2348119
Beskrivning
ST depression
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0520887
Beskrivning
U waves abnormal
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0438169
Beskrivning
T wave inversion
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0520888
Beskrivning
T wave peaked
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0239242
Beskrivning
T waves flat
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2215959
Beskrivning
T waves biphasic
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2348639
Beskrivning
Notched T-waves
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2347367
Beskrivning
Low QRS voltage
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2349945
Beskrivning
T-wave flattening/inversion
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0520888
- UMLS CUI [2]
- C0429059
Beskrivning
Other depolarisation/repolarisation
Datatyp
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
Beskrivning
other depolarisation/repolarisation, specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1331539
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2,1]
- C0948857
- UMLS CUI [2,2]
- C2348235
Beskrivning
Other abnormalities
Alias
- UMLS CUI-1
- C0522055
- UMLS CUI-2
- C0205394
Beskrivning
12 lead ECG, Abnormality, Other
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
Beskrivning
other 12-lead ECG abnormalities, specification
Datatyp
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])