ID

34097

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

Trefwoorden

Versies (1)
  1. 14-01-19 14-01-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

14 januari 2019

DOI

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Licentie

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

Vital signs

1 Formulieren  
  1. StudyEvent: ODM
    1. Vital signs
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschrijving

Subject number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Session number
Beschrijving

Session number 1 means screening procedure, session number 3 means follow-up.

Datatype

integer

Alias
UMLS CUI [1,1]
C1883017
UMLS CUI [1,2]
C0750480
Day number
Beschrijving

Day numbers can only be selected in session 2.

Datatype

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0237753
Vital signs
Beschrijving

Vital signs

Alias
UMLS CUI-1
C0518766
Row number
Beschrijving

The field Row number is not to be filled in for "mean pre-dose".

Datatype

integer

Alias
UMLS CUI [1]
C2348184
Date
Beschrijving

The field Date is not to be filled in for "mean pre-dose".

Datatype

date

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

Time relative to dosing. The row numbers denote the time values under "planned relative time". Session 1: Three measurements for screening (at least 5 minutes apart). Session 2, day 1: Three measurements for "pre-dose" (at least 5 minutes apart), the mean value recorded pre-dose will be classed as baseline. Then measurements at 20mins, 40mins, 1hr, 2hrs, 3hrs, 4hrs, 6hrs, 8hrs, 10hrs, 12hrs, 16hrs, 24hrs. Session 2, day 3,5,8,10,12: One measurement for "pre-dose", remaining measurements as at day 1. Session 2, day 7: One measurement at "pre-dose". Session 2, day 14: one measurement at 24hrs. Session 3: One measurement for Follow-up. Measurements at 24hrs are performed immediately prior to dosing on the following day. Planned relative time "unscheduled" can be filled in at each session and each day if neccessary.

Datatype

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0518766
Actual time
Beschrijving

The field Actual time is not to be filled in for "mean pre-dose".

Datatype

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0518766
Systolic blood pressure
Beschrijving

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

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0518766
mmHg
Diastolic blood pressure
Beschrijving

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

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0518766
mmHg
Heart rate
Beschrijving

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

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0518766
beats/min
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Similar models

Vital signs

1 Formulieren
  1. StudyEvent: ODM
    1. Vital signs
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
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)
Item
Day number
integer
C0439228 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Day number
Code List
Day number
CL Item
1 (1)
(Comment:en)
CL Item
3 (3)
(Comment:en)
CL Item
5 (5)
(Comment:en)
CL Item
7 (7)
(Comment:en)
CL Item
8 (8)
(Comment:en)
CL Item
10 (10)
(Comment:en)
CL Item
12 (12)
(Comment:en)
CL Item
14 (14)
(Comment:en)
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Row number
Item
Row number
integer
C2348184 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Item
Planned relative time
text
C0439564 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Planned relative time
Code List
Planned relative time
CL Item
Pre-dose (Pre-dose)
(Comment:en)
CL Item
Mean Pre-dose (Mean pre-dose)
(Comment:en)
CL Item
20mins (20mins)
(Comment:en)
CL Item
40mins (40mins)
(Comment:en)
CL Item
1hr (1hr)
(Comment:en)
CL Item
2hrs (2hrs)
(Comment:en)
CL Item
3hrs (3hrs)
(Comment:en)
CL Item
4hrs (4hrs)
(Comment:en)
CL Item
6hrs (6hrs)
(Comment:en)
CL Item
8hrs (8hrs)
(Comment:en)
CL Item
10hrs (10hrs)
(Comment:en)
CL Item
12hrs (12hrs)
(Comment:en)
CL Item
16hrs (16hrs)
(Comment:en)
CL Item
24hrs (24hrs)
(Comment:en)
CL Item
unscheduled (unscheduled)
(Comment:en)
CL Item
Screening (Screening)
CL Item
Follow-up (Follow-up)
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
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