ID

33005

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 Electrocardiogram. It has to be filled in at screening, sessions 2, 3, 4, 5 and 6.

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

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License

Creative Commons BY-NC 3.0
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Systemic exposure of fluticasone propionate (FP) and salmeterol from different inhalation devices in adults with mild or intermittent asthma, (Study-)ID: 101877

English

Electrocardiogram

1 forms  
  1. StudyEvent: ODM
    1. Electrocardiogram
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
12-Lead Electrocardiogram
Description

12-Lead Electrocardiogram

Alias
UMLS CUI-1
C0430456
Row no.
Description

Note: For screening there are only three rows. For sessions there are all of the five rows.

Data type

integer

Alias
UMLS CUI [1]
C0237753
Date of ECG
Description

Date of ECG

Data type

date

Alias
UMLS CUI [1]
C2826640
Planned relative time
Description

Time relative to dosing. The 12hrs and pre dose relative time are only for session 2-6, Screening only for session 1. Please choose "unscheduled" in case of additional, unplanned ECGs.

Data type

text

Alias
UMLS CUI [1]
C0439564
Actual time
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1]
C0040223
Ventricular rate
Description

Ventricular rate

Data type

integer

Measurement units
  • beats / min
Alias
UMLS CUI [1]
C2189285
beats / min
PR interval
Description

PR interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS duration
Description

QRS duration

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429025
msec
QT interval
Description

QT interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1]
C0577807
msec
QTc interval
Description

QTc interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1]
C0489625
msec
ECG normal
Description

ECG normal

Data type

boolean

Alias
UMLS CUI [1]
C0522054
ECG Abnormalities present
Description

ECG Abnormalities present

Data type

boolean

Alias
UMLS CUI [1]
C0522055
If abnormalities, is the abnormality clinically significant?
Description

If abnormalities are present which are clinically significant, complete additional ECG ABNORMALITIES FORM. Copy the session number from the top of this form and the date and time to the ECG ABNORMALITIES FORM.

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
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Similar models

Electrocardiogram

1 forms
  1. StudyEvent: ODM
    1. Electrocardiogram
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
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
Item Group
12-Lead Electrocardiogram
C0430456 (UMLS CUI-1)
Item
Row no.
integer
C0237753 (UMLS CUI [1])
Row no.
Code List
Row no.
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Item
Planned relative time
text
C0439564 (UMLS CUI [1])
Planned relative time
Code List
Planned relative time
CL Item
Screening (S)
CL Item
Pre dose (P)
CL Item
12hrs (Hrs)
CL Item
Unscheduled (U)
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Ventricular rate
Item
Ventricular rate
integer
C2189285 (UMLS CUI [1])
PR interval
Item
PR interval
integer
C0429087 (UMLS CUI [1])
QRS duration
Item
QRS duration
integer
C0429025 (UMLS CUI [1])
QT interval
Item
QT interval
integer
C0577807 (UMLS CUI [1])
QTc interval
Item
QTc interval
integer
C0489625 (UMLS CUI [1])
ECG normal
Item
ECG normal
boolean
C0522054 (UMLS CUI [1])
ECG Abnormalities present
Item
ECG Abnormalities present
boolean
C0522055 (UMLS CUI [1])
Item
If abnormalities, is the abnormality clinically significant?
text
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Abnormality clinically significant
Code List
If abnormalities, is the abnormality clinically significant?
CL Item
Yes (Y)
CL Item
No (N)
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