ID

33151

Description

Study ID: 107806 Clinical Study ID: RA3107806 Study Title: An open label study to determine the safety, tolerability, excretion balance and pharmacokinetics of Losmapimod, administered as a single dose of an oral solution to healthy adult male subjects Patient Level Data: Clinicaltrials.gov Identifier: NCT00599612 https://clinicaltrials.gov/ct2/show/NCT00599612 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: losmapimod Trade Name: losmapimod Study Indication: Pulmonary Disease, Chronic Obstructive The study consists of a screening, study visit and follow-up. The protocol identifier for all: RA3107806 This document contains Vital signs . It has to be filled in for study visit.

Link

https://clinicaltrials.gov/ct2/show/NCT00599612

Keywords

Versions (1)
  1. 11/29/18 11/29/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 29, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612

English

Vital signs

1 forms  
  1. StudyEvent: ODM
    1. Vital signs
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject identifier
Description

Subject identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of Visit
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C0011008
Vital Signs, cardiac
Description

Vital Signs, cardiac

Alias
UMLS CUI-1
C0518766
Date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C0011008
Planned Relative Time
Description

Planned Relative Time

Data type

integer

Alias
UMLS CUI [1]
C0439564
Actual Time
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1]
C0040223
Blood Pressure Supine, systolic
Description

Blood Pressure Supine, systolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
Blood Pressure Supine, diastolic
Description

Blood Pressure Supine, diastolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
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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 identifier
Item
Subject identifier
text
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C0011008 (UMLS CUI [1])
Item Group
Vital Signs, cardiac
C0518766 (UMLS CUI-1)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Pre-dose (1)
CL Item
15 mins (2)
CL Item
30 mins (3)
CL Item
1 hr (4)
CL Item
2 hrs (5)
CL Item
4 hrs (6)
CL Item
6 hrs (7)
CL Item
8 hrs (8)
CL Item
24 hrs (9)
CL Item
48 hrs (10)
CL Item
unscheduled (11)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Blood Pressure Supine, systolic
Item
Blood Pressure Supine, systolic
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Blood Pressure Supine, diastolic
Item
Blood Pressure Supine, diastolic
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
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