ID

29274

Beschreibung

Study ID: 102932 Clinical Study ID: HZA102932 Study Title:An open-label, randomised, 3-way crossover single dose study to demonstrate dose proportionality of fluticasone furoate (FF) and equivalence of vilanterol (VI) when administered as FF/VI inhalation powder from the novel dry powder inhaler in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01213849 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma Documentation part: 12-lead ECG Abnormalities

Stichworte

Versionen (1)
  1. 15.03.18 15.03.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

15. März 2018

DOI

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Creative Commons BY-NC 3.0
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Dose proportionality of fluticasone furoate and equivalence of vilanterol in healthy adults GSK102932

Englisch

12-lead ECG Abnormalities

1 Formulare  
12-lead ECG Abnormalities
Beschreibung

12-lead ECG Abnormalities

Alias
UMLS CUI-1
C0522055
UMLS CUI-2
C0430456
Date of ECG
Beschreibung

Date of ECG

Datentyp

date

Alias
UMLS CUI [1,1]
C2826640
UMLS CUI [1,2]
C0430456
Time of ECG
Beschreibung

Time of ECG

Datentyp

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
Other abnormal rhythm, enter comment
Beschreibung

Rhythm Abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0199556
Record clinically significant abnormalities: P Wave Morphology
Beschreibung

P Wave Morphology Abnormalities

Datentyp

integer

Alias
UMLS CUI [1,1]
C2216025
UMLS CUI [1,2]
C0429098
UMLS CUI [1,3]
C0430456
Other morphology, enter comment
Beschreibung

P Wave Morphology Abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C2216025
UMLS CUI [1,2]
C0429098
UMLS CUI [1,3]
C0430456
Other conduction, enter comment
Beschreibung

Conduction Abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0232219
UMLS CUI [1,2]
C0430456
Record clinically significant abnormalities: Myocardial Infarction
Beschreibung

Myocardial Infarction ECG

Datentyp

integer

Alias
UMLS CUI [1,1]
C3854475
UMLS CUI [1,2]
C0430456
Other myocardial infarction, enter comment
Beschreibung

Myocardial Infarction ECG

Datentyp

text

Alias
UMLS CUI [1,1]
C3854475
UMLS CUI [1,2]
C0430456
Other depolarisation/repolarisation, enter comment
Beschreibung

Depolarisation/Repolarisation Abnormalities

Datentyp

text

Alias
UMLS CUI [1]
C0948857
Other abnormalities
Beschreibung

12-lead ECG Abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C0430456
Record clinically significant abnormalities: Rhythm
Beschreibung

Rhythm Abnormalities

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0199556
Record clinically significant abnormalities: Conduction
Beschreibung

Conduction Abnormalities

Datentyp

integer

Alias
UMLS CUI [1,1]
C0232219
UMLS CUI [1,2]
C0430456
Record clinically significant abnormalities: Depolarisation/Repolarisation (QRS-T)
Beschreibung

Depolarisation/Repolarisation Abnormalities

Datentyp

integer

Alias
UMLS CUI [1]
C0948857
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Ähnliche Modelle

12-lead ECG Abnormalities

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
12-lead ECG Abnormalities
C0522055 (UMLS CUI-1)
C0430456 (UMLS CUI-2)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Time of ECG
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Rhythm Abnormalities
Item
Other abnormal rhythm, enter comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
Item
Record clinically significant abnormalities: P Wave Morphology
integer
C2216025 (UMLS CUI [1,1])
C0429098 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,3])
P Wave Morphology Abnormalities
Code List
Record clinically significant abnormalities: P Wave Morphology
CL Item
Left atrial abnormality (P mltrale) (1)
CL Item
Right atrial abnormality (P pulmonale) (2)
CL Item
Right ventricular hypertrophy (3)
CL Item
Intraatrial conduction delay (4)
CL Item
Increased voltage consistent with left ventricular hypertrophy (5)
CL Item
Other morphology, enter comment (6)
P Wave Morphology Abnormalities
Item
Other morphology, enter comment
text
C2216025 (UMLS CUI [1,1])
C0429098 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,3])
Conduction Abnormalities
Item
Other conduction, enter comment
text
C0232219 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Item
Record clinically significant abnormalities: Myocardial Infarction
integer
C3854475 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Myocardial Infarction ECG
Code List
Record clinically significant abnormalities: Myocardial Infarction
CL Item
Myocardial infarction, old  (1)
CL Item
Myocardial infarction, anterior (2)
CL Item
Myocardial infarction, lateral (3)
CL Item
Myocardial infarction, posterior (4)
CL Item
Myocardial infarction, inferior (5)
CL Item
Myocardial infarction, septal (6)
CL Item
Myocardial infarction, non Q-wave (7)
CL Item
Other myocardial infarction, enter comment (8)
Myocardial Infarction ECG
Item
Other myocardial infarction, enter comment
text
C3854475 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Depolarisation/Repolarisation Abnormalities
Item
Other depolarisation/repolarisation, enter comment
text
C0948857 (UMLS CUI [1])
12-lead ECG Abnormalities
Item
Other abnormalities
text
C0522055 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Item
Record clinically significant abnormalities: Rhythm
integer
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
Rhythm Abnormalities
Code List
Record clinically significant abnormalities: Rhythm
CL Item
Sinus bradycardia (heart rate 40-50 beats/min) (1)
CL Item
Sinus bradycardia (heart rate 30-39 beats/min) (2)
CL Item
Sinus bradycardia (heart rate < 30 beats/min) (3)
CL Item
Sinus pause (4)
CL Item
Sinus tachycardia (heart rate >100 beats/min) (5)
CL Item
Ectopic supraventricular beats (6)
CL Item
Ectopic supraventricular rhythm (7)
CL Item
Wandering atrial pacemaker (8)
CL Item
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min) (9)
CL Item
Supraventricular tachycardia (heart rate >100 beats/min) (10)
CL Item
Atrial flutter (11)
CL Item
Atrial fibrillation (12)
CL Item
unctional rhythm (heart rate ≤100 beats/min) (13)
CL Item
Junctional rhythm (14)
CL Item
Junctional tachycardia (heart rate > 100 beats/min) (15)
CL Item
Ectopic ventricular beats (16)
CL Item
Ventricular couplets (17)
CL Item
Bigeminy (18)
CL Item
Trigeminy (19)
CL Item
Electrical alternans (20)
CL Item
R on T phenomenon (21)
CL Item
Ventricular fibrillation (22)
CL Item
Idioventricular rhythm (heart rate < 100 beats/min) (23)
CL Item
Sustained ventricular tachycardia (24)
CL Item
Non-sustained ventricular tachycardia (25)
CL Item
Ventricular tachycardia (26)
CL Item
Monomorphic ventricular tachycardia (27)
CL Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (28)
CL Item
Polymorphic (sustained and non-sustained) ventricular tachycardia (29)
CL Item
Artificial pacemaker (30)
CL Item
Other abnormal rhythm (31)
Item
Record clinically significant abnormalities: Conduction
integer
C0232219 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Conduction Abnormalities
Code List
Record clinically significant abnormalities: Conduction
CL Item
First degree AV block (PR interval > 200 msec) (1)
CL Item
Second degree AV block (Mobitz type 1) (2)
CL Item
Second degree AV block (Mobitz type 2) (3)
CL Item
2:1 AV block (4)
CL Item
Third degree AV block (5)
CL Item
Left axis deviation (QRS axis more negative than -30°) (6)
CL Item
Right axis deviation (QRS axis more positive than +110°) (7)
CL Item
Incomplete right bundle branch block (8)
CL Item
Incomplete left bundle branch block (9)
CL Item
Right bundle branch block (10)
CL Item
Left anterior hemiblock (synonymous to left anterior fascicular block) (11)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block) (12)
CL Item
Left bundle branch block (13)
CL Item
Bifascicular block (14)
CL Item
Non-specific intraventricular conduction delay (QRS ≥ 120 msec) (15)
CL Item
QT/QTc prolongation ≥ 500 msec (17)
CL Item
AV dissociation (18)
CL Item
Other conduction (19)
Item
Record clinically significant abnormalities: Depolarisation/Repolarisation (QRS-T)
integer
C0948857 (UMLS CUI [1])
Repolarisation Abnormalities
Code List
Record clinically significant abnormalities: Depolarisation/Repolarisation (QRS-T)
CL Item
Non-specific ST-T changes (1)
CL Item
J point elevation (2)
CL Item
ST elevation (3)
CL Item
ST elevation-pericarditis (4)
CL Item
ST depression (5)
CL Item
U waves abnormal (6)
CL Item
T wave inversion (7)
CL Item
T wave peaked (8)
CL Item
T waves flat (9)
CL Item
T waves biphasic (10)
CL Item
Notched T-waves (11)
CL Item
Low QRS voltage (12)
CL Item
T-wave flattening/inversion (13)
CL Item
Other depolarisation/repolarisation (14)
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