ID

34100

Beskrivning

tudy 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

Nyckelord

Versioner (1)
  1. 2019-01-14 2019-01-14 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

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)

Engelsk

24hrs Ambulatory Blood Pressure Monitoring

1 Formulär  
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beskrivning

Subject number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Session number
Beskrivning

Session number 1 means screening procedure.

Datatyp

integer

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

Day numbers can only be selected in Session 2.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0750729
UMLS CUI [1,2]
C0439228
Time documentation
Beskrivning

Time documentation

Alias
UMLS CUI-1
C0040223
UMLS CUI-2
C0920316
UMLS CUI-3
C0026426
Start date
Beskrivning

Start date

Datatyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0026426
Actual time monitoring commenced
Beskrivning

Actual time monitoring commenced

Datatyp

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0026426
Stop date
Beskrivning

Stop date

Datatyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0026426
Actual time monitoring completed
Beskrivning

Actual time monitoring completed

Datatyp

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0026426
24hrs Ambulatory Blood pressure monitoring
Beskrivning

24hrs Ambulatory Blood pressure monitoring

Alias
UMLS CUI-1
C0026426
UMLS CUI-2
C0549178
UMLS CUI-3
C0439841
Row number
Beskrivning

Row number 1 refers to 0hr-12hrs, Row number 2 refers to 12hrs-24hrs.

Datatyp

integer

Alias
UMLS CUI [1]
C2348184
Planned relative time
Beskrivning

Time relative dosing

Datatyp

text

Alias
UMLS CUI [1]
C0439564
Maximum systolic blood pressure
Beskrivning

Maximum systolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0806909
mmHg
Time of maximum systolic blood pressure
Beskrivning

Time of maximum systolic blood pressure

Datatyp

time

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0806909
UMLS CUI [1,3]
C0040223
Maximum diastolic blood pressure
Beskrivning

Maximum diastolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0806909
mmHg
Time of maximum diastolic blood pressure
Beskrivning

Time of maximum diastolic blood pressure

Datatyp

time

Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0806909
UMLS CUI [1,3]
C0040223
Minimum systolic blood pressure
Beskrivning

Minimum systolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C1524031
mmHg
Time of minimum systolic blood pressure
Beskrivning

Time of minimum systolic blood pressure

Datatyp

time

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C1524031
UMLS CUI [1,3]
C0040223
Mean systolic blood pressure
Beskrivning

Mean systolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0444504
mmHg
Mean diastolic blood pressure
Beskrivning

Mean diastolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0444504
mmHg
Maximum MAP
Beskrivning

MAP means Mean arterial pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0428886
UMLS CUI [1,2]
C0806909
mmHg
Minimum MAP
Beskrivning

MAP means Mean arterial pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0428886
UMLS CUI [1,2]
C1524031
mmHg
Mean MAP
Beskrivning

MAP means Mean arterial pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0428886
UMLS CUI [1,2]
C0444504
mmHg
Abnormalities
Beskrivning

Abnormalities

Alias
UMLS CUI-1
C1704258
UMLS CUI-2
C0026426
Were any clinically significant abnormalities observed?
Beskrivning

If YES, EXCLUDE subject from the study.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026426
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C2985739
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Similar models

24hrs Ambulatory Blood Pressure Monitoring

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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)
(Comment:en)
CL Item
4 (4)
(Comment:en)
CL Item
6 (6)
(Comment:en)
CL Item
9 (9)
(Comment:en)
CL Item
11 (11)
(Comment:en)
CL Item
13 (13)
(Comment:en)
Item Group
Time documentation
C0040223 (UMLS CUI-1)
C0920316 (UMLS CUI-2)
C0026426 (UMLS CUI-3)
Start date
Item
Start date
date
C0808070 (UMLS CUI [1,1])
C0026426 (UMLS CUI [1,2])
Actual time monitoring commenced
Item
Actual time monitoring commenced
time
C1301880 (UMLS CUI [1,1])
C0026426 (UMLS CUI [1,2])
Stop date
Item
Stop date
date
C0806020 (UMLS CUI [1,1])
C0026426 (UMLS CUI [1,2])
Actual time monitoring completed
Item
Actual time monitoring completed
time
C1522314 (UMLS CUI [1,1])
C0026426 (UMLS CUI [1,2])
Item Group
24hrs Ambulatory Blood pressure monitoring
C0026426 (UMLS CUI-1)
C0549178 (UMLS CUI-2)
C0439841 (UMLS CUI-3)
Item
Row number
integer
C2348184 (UMLS CUI [1])
Row number
Code List
Row number
CL Item
1 (1)
CL Item
2 (2)
Item
Planned relative time
text
C0439564 (UMLS CUI [1])
Planned relative time
Code List
Planned relative time
CL Item
0hr-12hrs (0hr-12hrs)
CL Item
12hrs-24hrs (12hrs-24hrs)
Maximum systolic blood pressure
Item
Maximum systolic blood pressure
integer
C0871470 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
Time of maximum systolic blood pressure
Item
Time of maximum systolic blood pressure
time
C0871470 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Maximum diastolic blood pressure
Item
Maximum diastolic blood pressure
integer
C0428883 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
Time of maximum diastolic blood pressure
Item
Time of maximum diastolic blood pressure
time
C0428883 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Minimum systolic blood pressure
Item
Minimum systolic blood pressure
integer
C0871470 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
Time of minimum systolic blood pressure
Item
Time of minimum systolic blood pressure
time
C0871470 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Mean systolic blood pressure
Item
Mean systolic blood pressure
integer
C0871470 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
Mean diastolic blood pressure
Item
Mean diastolic blood pressure
integer
C0428883 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
Maximum MAP
Item
Maximum MAP
integer
C0428886 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
Minimum MAP
Item
Minimum MAP
integer
C0428886 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
Mean MAP
Item
Mean MAP
integer
C0428886 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
Item Group
Abnormalities
C1704258 (UMLS CUI-1)
C0026426 (UMLS CUI-2)
Clinically significant abnormalities
Item
Were any clinically significant abnormalities observed?
boolean
C0026426 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
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