ID

43728

Description

Study ID: 100527 Clinical Study ID: B2E100527 Study Title: A randomised, double blind, placebo controlled, parellel group study to examine the efficacy, safety, tolerability and systemic pharmacokinetic profile of repeated inhaled doses of GSK159797 Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: Milveterol Study Indication: Pulmonary Disease, Chronic Obstructive

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Versions (2)
  1. 18/06/2017 18/06/2017 -
  2. 20/09/2021 20/09/2021 -
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20 septembre 2021

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Electrocardiogram Abnormalities Form - GSK Milveterol COPD 100527

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Electrocardiogram Abnormalities Form - GSK Milveterol COPD 100527

1 Formulaires  
Electrocardiogram Abnormalities Form
Description

Electrocardiogram Abnormalities Form

Alias
UMLS CUI-1
C0522055
Date of ECG
Description

Date of ECG

Type de données

date

Unités de mesure
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C2826640
dd.mm.yyyy
Time of ECG
Description

Time of ECG

Type de données

time

Unités de mesure
  • hh:mm
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
hh:mm
Ventricular rate/heart rate
Description

Ventricular rate

Type de données

integer

Unités de mesure
  • beats/min
Alias
UMLS CUI [1]
C2189285
beats/min
ECG
Description

ECG finding

Type de données

integer

Alias
UMLS CUI [1]
C0438154
Were any of the abnormalities clinically significant?
Description

ECG abnormality clinically significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C2985739
A. Rhythm
Description

Arrhythmia

Type de données

integer

Alias
UMLS CUI [1]
C0003811
B. P-Wave Morphology
Description

P Wave

Type de données

integer

Alias
UMLS CUI [1]
C0429084
C. Conduction
Description

Conduction

Type de données

integer

Alias
UMLS CUI [1]
C0264886
D. Depolarization/Repolarization (QRS-T)
Description

Depolarization, Repolarization

Type de données

integer

Alias
UMLS CUI [1]
C0948857
UMLS CUI [2,1]
C1331539
UMLS CUI [2,2]
C1704258
E. Other (specify in comments)
Description

Other ECG abnormalities

Type de données

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0522055
Comment
Description

Comment ECG abnormality

Type de données

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0522055
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Similar models

Electrocardiogram Abnormalities Form - GSK Milveterol COPD 100527

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Electrocardiogram Abnormalities Form
C0522055 (UMLS CUI-1)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Ventricular rate
Item
Ventricular rate/heart rate
integer
C2189285 (UMLS CUI [1])
Item
ECG
integer
C0438154 (UMLS CUI [1])
ECG finding
Code List
ECG
CL Item
Normal (1)
CL Item
Abnormalities present (2)
ECG abnormality clinically significant
Item
Were any of the abnormalities clinically significant?
boolean
C0522055 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item
A. Rhythm
integer
C0003811 (UMLS CUI [1])
Arrhythmia
Code List
A. Rhythm
CL Item
Sinus bradycardia (1)
CL Item
Sinus tachycardia (2)
CL Item
Sinus pause (3)
CL Item
Ectopic supraventricular beats (4)
CL Item
Junctional rhythm (≤100/min) (5)
CL Item
Supraventricular tachycardia (>100/min) (6)
CL Item
Atrial flutter (7)
CL Item
Atrial fibrillation (8)
CL Item
Ectopic ventricular beats (9)
CL Item
Ventricular rhythm (10)
CL Item
Pacemaker (11)
Item
B. P-Wave Morphology
integer
C0429084 (UMLS CUI [1])
P Wave
Code List
B. P-Wave Morphology
CL Item
Left atrial abnormality (P mitrale) (1)
CL Item
Right atrial abnormality (P pulmonale) (2)
Item
C. Conduction
integer
C0264886 (UMLS CUI [1])
Conduction
Code List
C. Conduction
CL Item
First degree AV block (PR interval > 0.20 sec) (1)
CL Item
Second degree AV block (Mobitz type 1) (2)
CL Item
Second degree AV block (Mobitz type 2) (3)
CL Item
Third degree AV block (4)
CL Item
Left axis deviation (QRS axis more negative than - 30 degrees) (5)
CL Item
Right axis deviation (QRS axis more positive than + 110 degrees) 3s (6)
CL Item
lncomplete right bundle branch block (7)
CL Item
Right bundle branch block (8)
CL Item
Left bundle branch block (9)
CL Item
Nonspecific intraventricular conduction delay (QRS ≥0.12sec) (10)
CL Item
Accessory pathway (Wolff-Parkinson-White, Lown-Ganong-Levine) (11)
CL Item
QT/QTc prolongation (12)
Item
D. Depolarization/Repolarization (QRS-T)
integer
C0948857 (UMLS CUI [1])
C1331539 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
Depolarization, Repolarization
Code List
D. Depolarization/Repolarization (QRS-T)
CL Item
Myocardial infarction, old (1)
CL Item
Myocardial infarction, other (2)
CL Item
Non-specific ST-T changes (3)
CL Item
Low QRS voltage (4)
Other ECG abnormalities
Item
E. Other (specify in comments)
boolean
C0205394 (UMLS CUI [1,1])
C0522055 (UMLS CUI [1,2])
Comment ECG abnormality
Item
Comment
text
C0947611 (UMLS CUI [1,1])
C0522055 (UMLS CUI [1,2])
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