ID

33002

Description

Study ID: 101877 Clinical Study ID: SAS101877 Study Title: A randomised, open label, 5-way crossover study to assess the systemic exposure of FP and salmeterol from SERETIDE/ADVAIR 250 without spacer, with Aerochamber -Plus and with -Max spacer, with VOLUMATIC spacer and SERETIDE/ADVAIR 500 DISKUS/ACCUHALER in adult subjects with mild or intermittent asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Advair DISKUS,Seretide Accuhaler; Viani,Seretide Diskus,Seretide Accuhaler,Seretide,Advair DISKUS Study Indication: Asthma The study consists of 5 treatment periods and a follow-up visit. The Screening includes Session 1 Treatment Period 1 includes Session 2 Treatment Period 2 includes Session 3 Treatment Period 3 includes Session 4 Treatment Period 4 includes Session 5 Treatment Period 5 includes Session 6 The Follow-up includes Session 7. This document contains the form for ECG-abnormalities. It has to be filled in if ECG-abnormalities occur during study.

Keywords

Versions (3)
  1. 11/14/18 11/14/18 -
  2. 11/22/18 11/22/18 -
  3. 11/23/18 11/23/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

November 23, 2018

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

No comments

In order to download data models you must be logged in. Please log in or register for free.

Systemic exposure of fluticasone propionate (FP) and salmeterol from different inhalation devices in adults with mild or intermittent asthma, (Study-)ID: 101877

English

Electrocardiogram Abnormalities Form

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Session Number
Description

Session Number

Data type

integer

Alias
UMLS CUI [1,1]
C1883017
UMLS CUI [1,2]
C0750480
Electrocardiogram
Description

Electrocardiogram

Alias
UMLS CUI-1
C1623258
Date of ECG
Description

Day Month Year

Data type

date

Alias
UMLS CUI [1]
C2826640
Time of ECG
Description

00:00-23:59

Data type

time

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

Ventricular rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C2189285
bpm
ECG
Description

ECG result

Data type

text

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

If YES, tick all that apply

Data type

text

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

Rhythm

Alias
UMLS CUI-1
C0232201
Sinus bradycardia
Description

Sinus bradycardia

Data type

boolean

Alias
UMLS CUI [1]
C0085610
Sinus tachycardia
Description

Sinus tachycardia

Data type

boolean

Alias
UMLS CUI [1]
C0039239
Sinus pause
Description

Sinus pause

Data type

boolean

Alias
UMLS CUI [1]
C1955864
Ectopic supraventricular beats
Description

Ectopic supraventricular beats

Data type

boolean

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

Junctional rhythm

Data type

boolean

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

Supraventricular tachycardia

Data type

boolean

Alias
UMLS CUI [1]
C0039240
Atrial flutter
Description

Atrial flutter

Data type

boolean

Alias
UMLS CUI [1]
C0004239
Atrial Fibrillation
Description

Atrial Fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C0004238
Ectopic ventricular beats
Description

Ectopic ventricular beats

Data type

boolean

Alias
UMLS CUI [1]
C0151636
Ventricular rhythm
Description

comment below

Data type

boolean

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

Comment Ventricular rhythm

Data type

text

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

Pacemaker

Data type

boolean

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

P-Wave Morphology

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

Left atrial abnormality (P mitrale)

Data type

boolean

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

Right atrial abnormality (P pulmonale)

Data type

boolean

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

Conduction

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

First degree AV block

Data type

boolean

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

Second degree AV block (Mobitz type 1)

Data type

boolean

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

Second degree AV block (Mobitz type 2)

Data type

boolean

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

Third degree AV block

Data type

boolean

Alias
UMLS CUI [1]
C0151517
Left axis deviation
Description

definied as: QRS axis more negative than - 30 degrees

Data type

boolean

Alias
UMLS CUI [1]
C0232297
Right axis deviation
Description

defined as: QRS axis more positive than + 110 degrees

Data type

boolean

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

Incomplete right bundle branch block

Data type

boolean

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

Right bundle branch block

Data type

boolean

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

Left bundle branch block

Data type

boolean

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

defined as: QRS greater than 0,12sec

Data type

boolean

Alias
UMLS CUI [1]
C1882112
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
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
QT/QTc prolongation
Description

QT/QTc prolongation

Data type

boolean

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

Depolarization/Repolarization (QRS-T)

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

Myocardial infarction, old

Data type

boolean

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

comment below

Data type

boolean

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

Comment Myocardial infarction, other

Data type

text

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

Non-specific ST-T changes

Data type

boolean

Alias
UMLS CUI [1]
C1112720
Low QRS voltage
Description

Low QRS voltage

Data type

boolean

Alias
UMLS CUI [1]
C2349945
Other
Description

Other

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

Other

Data type

boolean

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

Comment other abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C3845569
Back to the top of the page

Similar models

Electrocardiogram Abnormalities Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item
Session Number
integer
C1883017 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Session Number
Code List
Session Number
CL Item
Session 1 (1)
CL Item
Session 2 (2)
CL Item
Session 3 (3)
CL Item
Session 4 (4)
CL Item
Session 5 (5)
CL Item
Session 6 (6)
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])
Back to the top of the page 

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial