ID

44252

Beschreibung

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

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Versionen (2)
  1. 14.01.19 14.01.19 -
  2. 20.09.21 20.09.21 -
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GlaxoSmithKline

Hochgeladen am

20. September 2021

DOI

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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)

Englisch

12-Lead Electrocardiogram

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Session number
Beschreibung

Session number 1 means Screening, Session number 3 means Follow-up.

Datentyp

integer

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

Day numbers can only be selected in Session number 2.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0750729
UMLS CUI [1,2]
C0439228
12-Lead Electrocardiogram
Beschreibung

12-Lead Electrocardiogram

Alias
UMLS CUI-1
C0430456
Row number
Beschreibung

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

Datentyp

integer

Alias
UMLS CUI [1]
C2348184
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Planned relative time
Beschreibung

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: 3 measurements (at least 5 minutes apart) at pre-dose. 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.

Datentyp

text

Alias
UMLS CUI [1]
C0439564
Actual time
Beschreibung

Actual time

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0430456
Ventricular Rate
Beschreibung

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

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1,1]
C2189285
UMLS CUI [1,2]
C0430456
beats/min
PR interval
Beschreibung

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

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0429087
UMLS CUI [1,2]
C0430456
msec
QRS duration
Beschreibung

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

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0429025
UMLS CUI [1,2]
C0430456
msec
QT interval
Beschreibung

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

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C1287082
UMLS CUI [1,2]
C0430456
msec
QTc(B) interval
Beschreibung

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

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0489625
UMLS CUI [1,2]
C0430456
msec
ECG
Beschreibung

ECG normal or abnormal

Datentyp

text

Alias
UMLS CUI [1]
C0522054
UMLS CUI [2]
C0522055
Is the abnormality clinically significant?
Beschreibung

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.

Datentyp

text

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C2985739
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Ähnliche Modelle

12-Lead Electrocardiogram

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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)
Item
Day number
integer
C0750729 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Day number
Code List
Day number
CL Item
1 (1)
CL Item
3 (3)
CL Item
5 (5)
CL Item
7 (7)
CL Item
8 (8)
CL Item
10 (10)
CL Item
12 (12)
CL Item
14 (14)
Item Group
12-Lead Electrocardiogram
C0430456 (UMLS CUI-1)
Row number
Item
Row number
integer
C2348184 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item
Planned relative time
text
C0439564 (UMLS CUI [1])
Planned relative time
Code List
Planned relative time
CL Item
Screening (Screening)
CL Item
Pre-dose (Pre-dose)
CL Item
Mean (Mean)
CL Item
20mins (20mins)
CL Item
40mins (40mins)
CL Item
1hr (1hr)
CL Item
2hrs (2hrs)
CL Item
3hrs (3hrs)
CL Item
4hrs (4hrs)
CL Item
6hrs (6hrs)
CL Item
8hrs (8hrs)
CL Item
10hrs (10hrs)
CL Item
12hrs (12hrs)
CL Item
16hrs (16hrs)
CL Item
24hrs (24hrs)
CL Item
Unscheduled (Unscheduled)
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Ventricular rate
Item
Ventricular Rate
integer
C2189285 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
PR interval
Item
PR interval
integer
C0429087 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
QRS duration
Item
QRS duration
integer
C0429025 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
QT interval
Item
QT interval
integer
C1287082 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
QTc(B) interval
Item
QTc(B) interval
integer
C0489625 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Item
ECG
text
C0522054 (UMLS CUI [1])
C0522055 (UMLS CUI [2])
ECG normal or abnormal
Code List
ECG
CL Item
normal (normal)
CL Item
Abnormalities present (Abnormalities present)
Item
Is the abnormality clinically significant?
text
C0522055 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Is the abnormality clinically significant?
Code List
Is the abnormality clinically significant?
CL Item
Yes (Yes)
CL Item
No (No)
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