ID

34111

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

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Versies (1)
  1. 14-01-19 14-01-19 -
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GlaxoSmithKline

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14 januari 2019

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)

Engels

24hrs Holter Monitoring

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschrijving

Subject number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Session number
Beschrijving

Session number 1 means screening procedure.

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]
C0750729
UMLS CUI [1,2]
C0439228
24hrs Holter Monitoring
Beschrijving

24hrs Holter Monitoring

Alias
UMLS CUI-1
C2046759
Start date
Beschrijving

Start date

Datatype

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C2046759
Planned relative time
Beschrijving

Time relative to dosing. Screening should be selected in Session number 1, 0-24hrs in Session number 2.

Datatype

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C2046759
Actual time monitoring commenced
Beschrijving

Actual time monitoring commenced

Datatype

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C2046759
Stop date
Beschrijving

Stop date

Datatype

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C2046759
Actual time monitoring completed
Beschrijving

Actual time monitoring completed

Datatype

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C2046759
Maximum HR
Beschrijving

HR means Heart Rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0806909
UMLS CUI [1,3]
C2046759
beats/min
Minimum HR
Beschrijving

HR means Heart Rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C1524031
UMLS CUI [1,3]
C2046759
beats/min
Mean HR
Beschrijving

HR means Heart Rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0444504
UMLS CUI [1,3]
C2046759
beats/min
Number of QRS complexes
Beschrijving

Number of QRS complexes

Datatype

text

Alias
UMLS CUI [1,1]
C1287080
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C2046759
Number of supraventricular ectopics
Beschrijving

Number of supraventricular ectopics

Datatype

integer

Alias
UMLS CUI [1,1]
C0033036
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C2046759
Number of ventricular ectopics
Beschrijving

Number of ventricular ectopics

Datatype

integer

Alias
UMLS CUI [1,1]
C0428994
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C2046759
Number of ventricular couplets
Beschrijving

Number of ventricular couplets

Datatype

integer

Alias
UMLS CUI [1,1]
C0429001
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C2046759
Number of ventricular triplets
Beschrijving

Number of ventricular triplets

Datatype

integer

Alias
UMLS CUI [1,1]
C4087466
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C2046759
Number of ventricular runs
Beschrijving

Number of ventricular runs

Datatype

integer

Alias
UMLS CUI [1,1]
C0042514
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C2046759
Were any clinically significant abnormalities observed?
Beschrijving

Session 1: If YES, record abnormality as an Adverse Event on the ADVERSE EVENT FORM. Session 2: If YES, record abnormality as an Adverse Event on the ADVERSE EVENT FORM.

Datatype

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C2046759
QTc Results.
Beschrijving

QTc Results.

Alias
UMLS CUI-1
C0489625
UMLS CUI-2
C2046759
Row number
Beschrijving

Row number

Datatype

integer

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C0489625
UMLS CUI [1,3]
C2046759
Date
Beschrijving

Date

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0489625
UMLS CUI [1,3]
C2046759
Planned relative time. Perform a measurement at each time specified.
Beschrijving

Time relative to dosing.

Datatype

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0489625
UMLS CUI [1,3]
C2046759
Mean
Beschrijving

Mean

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0444504
UMLS CUI [1,2]
C0489625
UMLS CUI [1,3]
C2046759
msec
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Similar models

24hrs Holter Monitoring

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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)
Item
Day number
integer
C0750729 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Day number
Code List
Day number
CL Item
2 (2)
CL Item
4 (4)
CL Item
6 (6)
CL Item
9 (9)
CL Item
11 (11)
CL Item
13 (13)
Item Group
24hrs Holter Monitoring
C2046759 (UMLS CUI-1)
Start date
Item
Start date
date
C0808070 (UMLS CUI [1,1])
C2046759 (UMLS CUI [1,2])
Item
Planned relative time
text
C0439564 (UMLS CUI [1,1])
C2046759 (UMLS CUI [1,2])
Planned relative time
Code List
Planned relative time
CL Item
Screening (Screening)
CL Item
0-24hrs (0-24hrs)
Actual time monitoring commenced
Item
Actual time monitoring commenced
time
C1301880 (UMLS CUI [1,1])
C2046759 (UMLS CUI [1,2])
Stop date
Item
Stop date
date
C0806020 (UMLS CUI [1,1])
C2046759 (UMLS CUI [1,2])
Actual time monitoring completed
Item
Actual time monitoring completed
time
C1522314 (UMLS CUI [1,1])
C2046759 (UMLS CUI [1,2])
Maximum HR
Item
Maximum HR
integer
C0018810 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
C2046759 (UMLS CUI [1,3])
Minimum HR
Item
Minimum HR
integer
C0018810 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
C2046759 (UMLS CUI [1,3])
Mean HR
Item
Mean HR
integer
C0018810 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C2046759 (UMLS CUI [1,3])
Number of QRS complexes
Item
Number of QRS complexes
text
C1287080 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2046759 (UMLS CUI [1,3])
Number of supraventricular ectopics
Item
Number of supraventricular ectopics
integer
C0033036 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2046759 (UMLS CUI [1,3])
Number of ventricular ectopics
Item
Number of ventricular ectopics
integer
C0428994 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2046759 (UMLS CUI [1,3])
Number of ventricular couplets
Item
Number of ventricular couplets
integer
C0429001 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2046759 (UMLS CUI [1,3])
Number of ventricular triplets
Item
Number of ventricular triplets
integer
C4087466 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2046759 (UMLS CUI [1,3])
Number of ventricular runs
Item
Number of ventricular runs
integer
C0042514 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2046759 (UMLS CUI [1,3])
Clinically significant abnormalities
Item
Were any clinically significant abnormalities observed?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2046759 (UMLS CUI [1,3])
Item Group
QTc Results.
C0489625 (UMLS CUI-1)
C2046759 (UMLS CUI-2)
Row number
Item
Row number
integer
C2348184 (UMLS CUI [1,1])
C0489625 (UMLS CUI [1,2])
C2046759 (UMLS CUI [1,3])
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0489625 (UMLS CUI [1,2])
C2046759 (UMLS CUI [1,3])
Item
Planned relative time. Perform a measurement at each time specified.
text
C0439564 (UMLS CUI [1,1])
C0489625 (UMLS CUI [1,2])
C2046759 (UMLS CUI [1,3])
Planned relative time
Code List
Planned relative time. Perform a measurement at each time specified.
CL Item
-0.5hr-0.5hr (-0.5hr-0.5hr)
CL Item
0.5hr-1.5hrs (0.5hr-1.5hrs)
CL Item
1.5hrs-2.5hrs (1.5hrs-2.5hrs)
CL Item
2.5hrs-3.5hrs (2.5hrs-3.5hrs)
CL Item
3.5hrs-4.5hrs (3.5hrs-4.5hrs)
CL Item
4.5hrs-5.5hrs (4.5hrs-5.5hrs)
CL Item
5.5hrs-6.5hrs (5.5hrs-6.5hrs)
CL Item
11.5hrs-12.5hrs (11.5hrs-12.5hrs)
CL Item
7.5hrs-8.5hrs (7.5hrs-8.5hrs)
CL Item
8.5hrs-9.5hrs (8.5hrs-9.5hrs)
CL Item
9.5hrs-10.5hrs (9.5hrs-10.5hrs)
CL Item
12.5hrs-13.5hrs (12.5hrs-13.5hrs)
CL Item
13.5hrs-14.5hrs (13.5hrs-14.5hrs)
CL Item
14.5hrs-15.5hrs (14.5hrs-15.5hrs)
CL Item
15.5hrs-16.5hrs (15.5hrs-16.5hrs)
CL Item
18.5hrs-19.5hrs (18.5hrs-19.5hrs)
CL Item
6.5hrs-7.5hrs (6.5hrs-7.5hrs)
CL Item
10.5hrs-11.5hrs (10.5hrs-11.5hrs)
CL Item
16.5hrs-17.5hrs (16.5hrs-17.5hrs)
CL Item
17.5hrs-18.5hrs (17.5hrs-18.5hrs)
CL Item
19.5hrs-20.5hrs (19.5hrs-20.5hrs)
CL Item
20.5hrs-21.5hrs (20.5hrs-21.5hrs)
CL Item
21.5hrs-22.5hrs (21.5hrs-22.5hrs)
CL Item
22.5hrs-23.5hrs (22.5hrs-23.5hrs)
Mean
Item
Mean
integer
C0444504 (UMLS CUI [1,1])
C0489625 (UMLS CUI [1,2])
C2046759 (UMLS CUI [1,3])
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