ID
41685
Beschreibung
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.
Stichworte
Versionen (1)
- 17.12.20 17.12.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
17. Dezember 2020
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY-NC 4.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122
12-Lead ECG Abnormalities
- StudyEvent: ODM
Beschreibung
ECG Abnormalities
Alias
- UMLS CUI-1
- C0522055
Beschreibung
12-Lead ECG Rhythm
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0199556
Beschreibung
sinus bradycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschreibung
sinus bradycardia (heart rate 40-50 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Beschreibung
Sinus bradycardia (heart rate 30-39 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Beschreibung
Sinus bradycardia (heart rate < 30 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Beschreibung
Sinus pause
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1955864
Beschreibung
Sinus tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0039239
- UMLS CUI [1,2]
- C0018810
Beschreibung
Ectopic supraventricular beats
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0033036
Beschreibung
Ectopic supraventricular rhythm
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348376
Beschreibung
Wandering atrial pacemaker
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1321523
Beschreibung
Multifocal atrial tachycardia (wandering atrial pacemaker with heart rate > 100 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0221158
- UMLS CUI [1,2]
- C1321523
- UMLS CUI [1,3]
- C0018810
Beschreibung
Supraventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0039240
- UMLS CUI [1,2]
- C0018810
Beschreibung
Atrial flutter
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004239
Beschreibung
Atrial fibrillation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004238
Beschreibung
Junctional rhythm (heart rate <= 100 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0232208
- UMLS CUI [1,2]
- C0018810
Beschreibung
Junctional rhythm
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0232208
Beschreibung
Junctional tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0039235
- UMLS CUI [1,2]
- C0018810
Beschreibung
Ectopic ventricular beats
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0151636
Beschreibung
Ventricular couplets
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0429001
Beschreibung
Bigeminy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0262662
Beschreibung
Trigeminy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0428999
Beschreibung
Electrical alternans
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1142551
Beschreibung
R on T phenomenon
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0877658
Beschreibung
Ventricular fibrillation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0042510
Beschreibung
ldioventricular rhythm
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0700363
Beschreibung
Sustained ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0750197
Beschreibung
Non-sustained ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0750194
Beschreibung
ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0042514
Beschreibung
Monomorphic ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0344431
Beschreibung
Torsades de Pointes
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0040479
Beschreibung
Polymorphic (sustained and non-sustained) ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0344432
- UMLS CUI [1,2]
- C0750197
- UMLS CUI [2,1]
- C0344432
- UMLS CUI [2,2]
- C0750194
Beschreibung
Artificial Pacemaker
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0030163
Beschreibung
Other abnormal rhythm
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0199556
- UMLS CUI [1,3]
- C0205161
Beschreibung
12 lead ecg, other abnormal rythm, specification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0199556
- UMLS CUI [1,4]
- C2348235
Beschreibung
P-Wave Morphology
Alias
- UMLS CUI-1
- C2216025
- UMLS CUI-2
- C0430456
Beschreibung
Left atrial abnormality (P mitrale)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0344711
- UMLS CUI [1,2]
- C0232310
Beschreibung
Right atrial abnormality (P pulmonale)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0344696
- UMLS CUI [1,2]
- C0232308
Beschreibung
Right ventricular hypertrophy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0162770
Beschreibung
Intraatrial conduction delay
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2346510
Beschreibung
Increased voltage consistent with left ventricular hypertrophy
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1112650
- UMLS CUI [1,2]
- C0332290
- UMLS CUI [1,3]
- C0149721
Beschreibung
Other P-wave morphology
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2216025
Beschreibung
12 lead ECG, other abnormality in P-wave morphology, specification
Datentyp
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
Beschreibung
Conduction
Alias
- UMLS CUI-1
- C0264886
Beschreibung
First degree AV block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085614
Beschreibung
Second degree AV block (Mobitz type 1)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0264907
Beschreibung
Second degree AV block (Mobitz type 2)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0155700
Beschreibung
2: 1 AV block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2346542
Beschreibung
Third degree AV block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0151517
Beschreibung
Left axis deviation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0232297
Beschreibung
Right axis deviation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0232296
Beschreibung
Incomplete right bundle branch block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0262525
Beschreibung
Incomplete left bundle branch block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0281878
Beschreibung
Right bundle branch block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085615
Beschreibung
left anterior fascicular block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0264912
Beschreibung
left posterior fascicular block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0264913
Beschreibung
Left bundle branch block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0023211
Beschreibung
Bifascicular block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0264914
Beschreibung
Non-specific intraventricular conduction delay
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3697597
Beschreibung
Accessory pathway in Wolff-Parkinson White/Lown-Ganong-Levine Syndrome
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1963785
- UMLS CUI [1,2]
- C0043202
- UMLS CUI [2,1]
- C1963785
- UMLS CUI [2,2]
- C0024054
Beschreibung
QT/QTc prolongation by QTc time
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0855333
- UMLS CUI [2]
- C0489625
Beschreibung
AV dissociation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004331
Beschreibung
Other conduction abnormality
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0340494
Beschreibung
12-lead ecg, other conduction abnormality, specification
Datentyp
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
Beschreibung
Myocardial Infarction
Alias
- UMLS CUI-1
- C0027051
Beschreibung
Myocardial infarction, old
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0155668
Beschreibung
Myocardial infarction, anterior
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0340293
Beschreibung
Myocardial infarction, lateral
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0340312
Beschreibung
Myocardial infarction, posterior
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0340319
Beschreibung
Myocardial infarction, inferior
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0340305
Beschreibung
Myocardial infarction, septal
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0746727
Beschreibung
Myocardial infarction, Non Q-wave
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0542269
Beschreibung
Other myocardial infarction
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0027051
Beschreibung
other myocardial infarction, specification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschreibung
Depolarisation/Repolarisation (QRS-T)
Alias
- UMLS CUI-1
- C0948857
- UMLS CUI-2
- C1331539
Beschreibung
Non-specific ST-T changes
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1112720
Beschreibung
J point elevation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2346597
Beschreibung
ST elevation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0520886
Beschreibung
ST-elevation - pericarditis
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348119
Beschreibung
ST depression
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0520887
Beschreibung
U waves abnormal
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0438169
Beschreibung
T wave inversion
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0520888
Beschreibung
T wave peaked
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0239242
Beschreibung
T waves flat
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2215959
Beschreibung
T waves biphasic
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348639
Beschreibung
Notched T-waves
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2347367
Beschreibung
Low QRS voltage
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2349945
Beschreibung
T-wave flattening/inversion
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0520888
- UMLS CUI [2]
- C0429059
Beschreibung
Other depolarisation/repolarisation
Datentyp
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
Beschreibung
other depolarisation/repolarisation, specification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1331539
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2,1]
- C0948857
- UMLS CUI [2,2]
- C2348235
Beschreibung
Other abnormalities
Alias
- UMLS CUI-1
- C0522055
- UMLS CUI-2
- C0205394
Beschreibung
12 lead ECG, Abnormality, Other
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
Beschreibung
other 12-lead ECG abnormalities, specification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Ähnliche Modelle
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])