ID
34245
Beskrivning
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.
Nyckelord
Versioner (1)
- 2019-01-15 2019-01-15 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
15 januari 2019
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Safety, tolerability and pharmacokinetics of repeat inhaled doses of milveterol in healthy subjects (Study ID: 101682)
Electrocardiogram Abnormalities Form
- StudyEvent: ODM
Beskrivning
Electrocardiogram
Alias
- UMLS CUI-1
- C1623258
Beskrivning
Day Month Year
Datatyp
date
Alias
- UMLS CUI [1]
- C2826640
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013798
Beskrivning
Ventricular rate
Datatyp
integer
Måttenheter
- bpm
Alias
- UMLS CUI [1]
- C2189285
Beskrivning
In this form, the answer 'abnormalities present' is preselected.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0456984
Beskrivning
In this form, the answer 'YES' was preselected. If YES, tick all that apply.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0456984
Beskrivning
Rhythm
Alias
- UMLS CUI-1
- C0232201
Beskrivning
Sinus bradycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0085610
Beskrivning
Sinus tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0039239
Beskrivning
Sinus pause
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1955864
Beskrivning
Ectopic supraventricular beats
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0033036
Beskrivning
Junctional rhythm
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0232208
Beskrivning
Supraventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0039240
Beskrivning
Atrial flutter
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0004239
Beskrivning
Atrial Fibrillation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0004238
Beskrivning
Ectopic ventricular beats
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0151636
Beskrivning
comment below
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0232216
Beskrivning
Comment Ventricular rhythm
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C3845569
Beskrivning
Pacemaker
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0030163
Beskrivning
P-Wave Morphology
Alias
- UMLS CUI-1
- C2216025
Beskrivning
Left atrial abnormality (P mitrale)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0344711
- UMLS CUI [1,2]
- C0232310
Beskrivning
Right atrial abnormality (P pulmonale)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0344696
- UMLS CUI [1,2]
- C0232308
Beskrivning
Conduction
Alias
- UMLS CUI-1
- C0232217
Beskrivning
First degree AV block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0085614
Beskrivning
Second degree AV block (Mobitz type 1)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0264907
Beskrivning
Second degree AV block (Mobitz type 2)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0155700
Beskrivning
Third degree AV block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0151517
Beskrivning
definied as: QRS axis more negative than - 30 degrees
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0232297
Beskrivning
defined as: QRS axis more positive than + 110 degrees
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0232296
Beskrivning
Incomplete right bundle branch block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0262525
Beskrivning
Right bundle branch block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0085615
Beskrivning
Left bundle branch block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0023211
Beskrivning
defined as: QRS greater than 0,12sec
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1882112
Beskrivning
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0264897
- UMLS CUI [2]
- C0043202
- UMLS CUI [3]
- C0024054
Beskrivning
QT/QTc prolongation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0855333
Beskrivning
Depolarization/Repolarization (QRS-T)
Alias
- UMLS CUI-1
- C1331539
- UMLS CUI-2
- C3279217
Beskrivning
Myocardial infarction, old
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0155668
Beskrivning
comment below
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
Beskrivning
Comment Myocardial infarction, other
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C3845569
Beskrivning
Non-specific ST-T changes
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1112720
Beskrivning
Low QRS voltage
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2349945
Beskrivning
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])