ID
34245
Beschreibung
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.
Stichworte
Versionen (1)
- 15.01.19 15.01.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
15. Januar 2019
DOI
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Lizenz
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
Beschreibung
Electrocardiogram
Alias
- UMLS CUI-1
- C1623258
Beschreibung
Day Month Year
Datentyp
date
Alias
- UMLS CUI [1]
- C2826640
Beschreibung
00:00-23:59
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013798
Beschreibung
Ventricular rate
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1]
- C2189285
Beschreibung
In this form, the answer 'abnormalities present' is preselected.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0456984
Beschreibung
In this form, the answer 'YES' was preselected. If YES, tick all that apply.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0456984
Beschreibung
Rhythm
Alias
- UMLS CUI-1
- C0232201
Beschreibung
Sinus bradycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschreibung
Sinus tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0039239
Beschreibung
Sinus pause
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1955864
Beschreibung
Ectopic supraventricular beats
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0033036
Beschreibung
Junctional rhythm
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0232208
Beschreibung
Supraventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0039240
Beschreibung
Atrial flutter
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004239
Beschreibung
Atrial Fibrillation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004238
Beschreibung
Ectopic ventricular beats
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0151636
Beschreibung
comment below
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0232216
Beschreibung
Comment Ventricular rhythm
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C3845569
Beschreibung
Pacemaker
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0030163
Beschreibung
P-Wave Morphology
Alias
- UMLS CUI-1
- C2216025
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
Conduction
Alias
- UMLS CUI-1
- C0232217
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
Third degree AV block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0151517
Beschreibung
definied as: QRS axis more negative than - 30 degrees
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0232297
Beschreibung
defined as: QRS axis more positive than + 110 degrees
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0232296
Beschreibung
Incomplete right bundle branch block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0262525
Beschreibung
Right bundle branch block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085615
Beschreibung
Left bundle branch block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0023211
Beschreibung
defined as: QRS greater than 0,12sec
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1882112
Beschreibung
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0264897
- UMLS CUI [2]
- C0043202
- UMLS CUI [3]
- C0024054
Beschreibung
QT/QTc prolongation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0855333
Beschreibung
Depolarization/Repolarization (QRS-T)
Alias
- UMLS CUI-1
- C1331539
- UMLS CUI-2
- C3279217
Beschreibung
Myocardial infarction, old
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0155668
Beschreibung
comment below
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
Beschreibung
Comment Myocardial infarction, other
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C3845569
Beschreibung
Non-specific ST-T changes
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1112720
Beschreibung
Low QRS voltage
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2349945
Beschreibung
Other
Alias
- UMLS CUI-1
- C0205394
Ähnliche Modelle
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])