ID

34245

Beschrijving

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.

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  1. 15-01-19 15-01-19 -
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GlaxoSmithKline

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15 januari 2019

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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)

Engels

Electrocardiogram Abnormalities Form

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschrijving

Subject number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Electrocardiogram
Beschrijving

Electrocardiogram

Alias
UMLS CUI-1
C1623258
Date of ECG
Beschrijving

Day Month Year

Datatype

date

Alias
UMLS CUI [1]
C2826640
Time of ECG
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
Ventricular rate/heart rate
Beschrijving

Ventricular rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C2189285
bpm
ECG
Beschrijving

In this form, the answer 'abnormalities present' is preselected.

Datatype

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0456984
Were any of the abnormalities clinically significant?
Beschrijving

In this form, the answer 'YES' was preselected. If YES, tick all that apply.

Datatype

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0456984
Rhythm
Beschrijving

Rhythm

Alias
UMLS CUI-1
C0232201
Sinus bradycardia
Beschrijving

Sinus bradycardia

Datatype

boolean

Alias
UMLS CUI [1]
C0085610
Sinus tachycardia
Beschrijving

Sinus tachycardia

Datatype

boolean

Alias
UMLS CUI [1]
C0039239
Sinus pause
Beschrijving

Sinus pause

Datatype

boolean

Alias
UMLS CUI [1]
C1955864
Ectopic supraventricular beats
Beschrijving

Ectopic supraventricular beats

Datatype

boolean

Alias
UMLS CUI [1]
C0033036
Junctional rhythm (<= 100/min)
Beschrijving

Junctional rhythm

Datatype

boolean

Alias
UMLS CUI [1]
C0232208
Supraventricular tachycardia (>100/min)
Beschrijving

Supraventricular tachycardia

Datatype

boolean

Alias
UMLS CUI [1]
C0039240
Atrial flutter
Beschrijving

Atrial flutter

Datatype

boolean

Alias
UMLS CUI [1]
C0004239
Atrial Fibrillation
Beschrijving

Atrial Fibrillation

Datatype

boolean

Alias
UMLS CUI [1]
C0004238
Ectopic ventricular beats
Beschrijving

Ectopic ventricular beats

Datatype

boolean

Alias
UMLS CUI [1]
C0151636
Ventricular rhythm
Beschrijving

comment below

Datatype

boolean

Alias
UMLS CUI [1]
C0232216
If Ventricular rhythm, Comment
Beschrijving

Comment Ventricular rhythm

Datatype

text

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C3845569
Pacemaker
Beschrijving

Pacemaker

Datatype

boolean

Alias
UMLS CUI [1]
C0030163
P-Wave Morphology
Beschrijving

P-Wave Morphology

Alias
UMLS CUI-1
C2216025
Left atrial abnormality (P mitrale)
Beschrijving

Left atrial abnormality (P mitrale)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0344711
UMLS CUI [1,2]
C0232310
Right atrial abnormality (P pulmonale)
Beschrijving

Right atrial abnormality (P pulmonale)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0344696
UMLS CUI [1,2]
C0232308
Conduction
Beschrijving

Conduction

Alias
UMLS CUI-1
C0232217
First degree AV block (PR interval> 0.20 sec)
Beschrijving

First degree AV block

Datatype

boolean

Alias
UMLS CUI [1]
C0085614
Second degree AV block (Mobitz type 1)
Beschrijving

Second degree AV block (Mobitz type 1)

Datatype

boolean

Alias
UMLS CUI [1]
C0264907
Second degree AV block (Mobitz type 2)
Beschrijving

Second degree AV block (Mobitz type 2)

Datatype

boolean

Alias
UMLS CUI [1]
C0155700
Third degree AV block
Beschrijving

Third degree AV block

Datatype

boolean

Alias
UMLS CUI [1]
C0151517
Left axis deviation
Beschrijving

definied as: QRS axis more negative than - 30 degrees

Datatype

boolean

Alias
UMLS CUI [1]
C0232297
Right axis deviation
Beschrijving

defined as: QRS axis more positive than + 110 degrees

Datatype

boolean

Alias
UMLS CUI [1]
C0232296
Incomplete right bundle branch block
Beschrijving

Incomplete right bundle branch block

Datatype

boolean

Alias
UMLS CUI [1]
C0262525
Right bundle branch block
Beschrijving

Right bundle branch block

Datatype

boolean

Alias
UMLS CUI [1]
C0085615
Left bundle branch block
Beschrijving

Left bundle branch block

Datatype

boolean

Alias
UMLS CUI [1]
C0023211
Nonspecific intraventricular conduction delay
Beschrijving

defined as: QRS greater than 0,12sec

Datatype

boolean

Alias
UMLS CUI [1]
C1882112
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
Beschrijving

Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)

Datatype

boolean

Alias
UMLS CUI [1]
C0264897
UMLS CUI [2]
C0043202
UMLS CUI [3]
C0024054
QT/QTc prolongation
Beschrijving

QT/QTc prolongation

Datatype

boolean

Alias
UMLS CUI [1]
C0855333
Depolarization/Repolarization (QRS-T)
Beschrijving

Depolarization/Repolarization (QRS-T)

Alias
UMLS CUI-1
C1331539
UMLS CUI-2
C3279217
Myocardial infarction, old
Beschrijving

Myocardial infarction, old

Datatype

boolean

Alias
UMLS CUI [1]
C0155668
Myocardial infarction, other
Beschrijving

comment below

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0205394
If Myocardial infarction, other, Comment
Beschrijving

Comment Myocardial infarction, other

Datatype

text

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C3845569
Non-specific ST-T changes
Beschrijving

Non-specific ST-T changes

Datatype

boolean

Alias
UMLS CUI [1]
C1112720
Low QRS voltage
Beschrijving

Low QRS voltage

Datatype

boolean

Alias
UMLS CUI [1]
C2349945
Other
Beschrijving

Other

Alias
UMLS CUI-1
C0205394
Other, specify in comments
Beschrijving

Other

Datatype

boolean

Alias
UMLS CUI [1]
C0205394
If other abnormalities, Comment
Beschrijving

Comment other abnormalities

Datatype

text

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C3845569
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Similar models

Electrocardiogram Abnormalities Form

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Electrocardiogram
C1623258 (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
text
C1623258 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
ECG result
Code List
ECG
CL Item
Normal (N)
CL Item
Abnormalities present (A)
Item
Were any of the abnormalities clinically significant?
text
C1623258 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
ECG Result
Code List
Were any of the abnormalities clinically significant?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Rhythm
C0232201 (UMLS CUI-1)
Sinus bradycardia
Item
Sinus bradycardia
boolean
C0085610 (UMLS CUI [1])
Sinus tachycardia
Item
Sinus tachycardia
boolean
C0039239 (UMLS CUI [1])
Sinus pause
Item
Sinus pause
boolean
C1955864 (UMLS CUI [1])
Ectopic supraventricular beats
Item
Ectopic supraventricular beats
boolean
C0033036 (UMLS CUI [1])
Junctional rhythm
Item
Junctional rhythm (<= 100/min)
boolean
C0232208 (UMLS CUI [1])
Supraventricular tachycardia
Item
Supraventricular tachycardia (>100/min)
boolean
C0039240 (UMLS CUI [1])
Atrial flutter
Item
Atrial flutter
boolean
C0004239 (UMLS CUI [1])
Atrial Fibrillation
Item
Atrial Fibrillation
boolean
C0004238 (UMLS CUI [1])
Ectopic ventricular beats
Item
Ectopic ventricular beats
boolean
C0151636 (UMLS CUI [1])
Ventricular rhythm
Item
Ventricular rhythm
boolean
C0232216 (UMLS CUI [1])
Comment Ventricular rhythm
Item
If Ventricular rhythm, Comment
text
C0522055 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])
Pacemaker
Item
Pacemaker
boolean
C0030163 (UMLS CUI [1])
Item Group
P-Wave Morphology
C2216025 (UMLS CUI-1)
Left atrial abnormality (P mitrale)
Item
Left atrial abnormality (P mitrale)
boolean
C0344711 (UMLS CUI [1,1])
C0232310 (UMLS CUI [1,2])
Right atrial abnormality (P pulmonale)
Item
Right atrial abnormality (P pulmonale)
boolean
C0344696 (UMLS CUI [1,1])
C0232308 (UMLS CUI [1,2])
Item Group
Conduction
C0232217 (UMLS CUI-1)
First degree AV block
Item
First degree AV block (PR interval> 0.20 sec)
boolean
C0085614 (UMLS CUI [1])
Second degree AV block (Mobitz type 1)
Item
Second degree AV block (Mobitz type 1)
boolean
C0264907 (UMLS CUI [1])
Second degree AV block (Mobitz type 2)
Item
Second degree AV block (Mobitz type 2)
boolean
C0155700 (UMLS CUI [1])
Third degree AV block
Item
Third degree AV block
boolean
C0151517 (UMLS CUI [1])
Left axis deviation
Item
Left axis deviation
boolean
C0232297 (UMLS CUI [1])
Right axis deviation
Item
Right axis deviation
boolean
C0232296 (UMLS CUI [1])
Incomplete right bundle branch block
Item
Incomplete right bundle branch block
boolean
C0262525 (UMLS CUI [1])
Right bundle branch block
Item
Right bundle branch block
boolean
C0085615 (UMLS CUI [1])
Left bundle branch block
Item
Left bundle branch block
boolean
C0023211 (UMLS CUI [1])
Nonspecific intraventricular conduction delay
Item
Nonspecific intraventricular conduction delay
boolean
C1882112 (UMLS CUI [1])
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
boolean
C0264897 (UMLS CUI [1])
C0043202 (UMLS CUI [2])
C0024054 (UMLS CUI [3])
QT/QTc prolongation
Item
QT/QTc prolongation
boolean
C0855333 (UMLS CUI [1])
Item Group
Depolarization/Repolarization (QRS-T)
C1331539 (UMLS CUI-1)
C3279217 (UMLS CUI-2)
Myocardial infarction, old
Item
Myocardial infarction, old
boolean
C0155668 (UMLS CUI [1])
Myocardial infarction, other
Item
Myocardial infarction, other
boolean
C0027051 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Comment Myocardial infarction, other
Item
If Myocardial infarction, other, Comment
text
C0522055 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])
Non-specific ST-T changes
Item
Non-specific ST-T changes
boolean
C1112720 (UMLS CUI [1])
Low QRS voltage
Item
Low QRS voltage
boolean
C2349945 (UMLS CUI [1])
Item Group
Other
C0205394 (UMLS CUI-1)
Other
Item
Other, specify in comments
boolean
C0205394 (UMLS CUI [1])
Comment other abnormalities
Item
If other abnormalities, Comment
text
C0522055 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])
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