ID
34245
Description
Study ID: 101682 Clinical Study ID: B2E101682 Study Title: A randomised, double-blind, placebo-controlled, parallel group study to examine the safety, tolerability, and pharmacokinetics of repeat inhaled doses of GSK159797 in healthy subjects. Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: milveterol Study Indication: Pulmonary Disease, Chronic Obstructive. This form contains information about electrocardiogram abnormalities and should be completed only in case of abnormalities in 12-Lead ECG.
Keywords
Versions (1)
- 1/15/19 1/15/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
January 15, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Safety, tolerability and pharmacokinetics of repeat inhaled doses of milveterol in healthy subjects (Study ID: 101682)
Electrocardiogram Abnormalities Form
- StudyEvent: ODM
Description
Electrocardiogram
Alias
- UMLS CUI-1
- C1623258
Description
Day Month Year
Data type
date
Alias
- UMLS CUI [1]
- C2826640
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013798
Description
Ventricular rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C2189285
Description
In this form, the answer 'abnormalities present' is preselected.
Data type
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0456984
Description
In this form, the answer 'YES' was preselected. If YES, tick all that apply.
Data type
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0456984
Description
Rhythm
Alias
- UMLS CUI-1
- C0232201
Description
Sinus bradycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0085610
Description
Sinus tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0039239
Description
Sinus pause
Data type
boolean
Alias
- UMLS CUI [1]
- C1955864
Description
Ectopic supraventricular beats
Data type
boolean
Alias
- UMLS CUI [1]
- C0033036
Description
Junctional rhythm
Data type
boolean
Alias
- UMLS CUI [1]
- C0232208
Description
Supraventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0039240
Description
Atrial flutter
Data type
boolean
Alias
- UMLS CUI [1]
- C0004239
Description
Atrial Fibrillation
Data type
boolean
Alias
- UMLS CUI [1]
- C0004238
Description
Ectopic ventricular beats
Data type
boolean
Alias
- UMLS CUI [1]
- C0151636
Description
comment below
Data type
boolean
Alias
- UMLS CUI [1]
- C0232216
Description
Comment Ventricular rhythm
Data type
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C3845569
Description
Pacemaker
Data type
boolean
Alias
- UMLS CUI [1]
- C0030163
Description
P-Wave Morphology
Alias
- UMLS CUI-1
- C2216025
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
Conduction
Alias
- UMLS CUI-1
- C0232217
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
Third degree AV block
Data type
boolean
Alias
- UMLS CUI [1]
- C0151517
Description
definied as: QRS axis more negative than - 30 degrees
Data type
boolean
Alias
- UMLS CUI [1]
- C0232297
Description
defined as: QRS axis more positive than + 110 degrees
Data type
boolean
Alias
- UMLS CUI [1]
- C0232296
Description
Incomplete right bundle branch block
Data type
boolean
Alias
- UMLS CUI [1]
- C0262525
Description
Right bundle branch block
Data type
boolean
Alias
- UMLS CUI [1]
- C0085615
Description
Left bundle branch block
Data type
boolean
Alias
- UMLS CUI [1]
- C0023211
Description
defined as: QRS greater than 0,12sec
Data type
boolean
Alias
- UMLS CUI [1]
- C1882112
Description
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
Data type
boolean
Alias
- UMLS CUI [1]
- C0264897
- UMLS CUI [2]
- C0043202
- UMLS CUI [3]
- C0024054
Description
QT/QTc prolongation
Data type
boolean
Alias
- UMLS CUI [1]
- C0855333
Description
Depolarization/Repolarization (QRS-T)
Alias
- UMLS CUI-1
- C1331539
- UMLS CUI-2
- C3279217
Description
Myocardial infarction, old
Data type
boolean
Alias
- UMLS CUI [1]
- C0155668
Description
comment below
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
Description
Comment Myocardial infarction, other
Data type
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C3845569
Description
Non-specific ST-T changes
Data type
boolean
Alias
- UMLS CUI [1]
- C1112720
Description
Low QRS voltage
Data type
boolean
Alias
- UMLS CUI [1]
- C2349945
Description
Other
Alias
- UMLS CUI-1
- C0205394
Similar models
Electrocardiogram Abnormalities Form
- StudyEvent: ODM
C0013798 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,2])
C0232310 (UMLS CUI [1,2])
C0232308 (UMLS CUI [1,2])
C0043202 (UMLS CUI [2])
C0024054 (UMLS CUI [3])
C3279217 (UMLS CUI-2)
C0205394 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,2])