ID

33004

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 vital signs form. It has to be filled in at screnning, for session 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

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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

Vital signs

1 forms  
  1. StudyEvent: ODM
    1. Vital signs
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
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Row no.
Description

Row no.

Data type

integer

Alias
UMLS CUI [1]
C0237753
Date of vital signs
Description

Date of vital signs

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0518766
Planned relative time
Description

Time relative to dosing. Please fill out at least one measurement for screening and one pre-dose measurement for each treatment period. For all additional measurements choose "unscheduled".

Data type

text

Alias
UMLS CUI [1]
C0439564
Actual time
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1]
C0040223
Blood pressure: systolic
Description

NOTE: HR and BP measurements will be made with the subject in a supine position having rested in this position for at least 10 minutes before each reading.

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure: diastolic
Description

NOTE: HR and BP measurements will be made with the subject in a supine position having rested in this position for at least 10 minutes before each reading.

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Description

NOTE: HR and BP measurements will be made with the subject in a supine position having rested in this position for at least 10 minutes before each reading.

Data type

integer

Measurement units
  • beats / min
Alias
UMLS CUI [1]
C0018810
beats / min
Body Temperature
Description

Only for session 2-6.

Data type

integer

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
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Similar models

Vital signs

1 forms
  1. StudyEvent: ODM
    1. Vital signs
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
Vital Signs
C0518766 (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)
Date of vital signs
Item
Date of vital signs
date
C0011008 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
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
Unscheduled (U)
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Blood pressure: systolic
Item
Blood pressure: systolic
integer
C0871470 (UMLS CUI [1])
Blood pressure: diastolic
Item
Blood pressure: diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Body Temperature
Item
Body Temperature
integer
C0005903 (UMLS CUI [1])
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