ID

33150

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 Physical examination and vital signs . It has to be filled in for follow-up.

Link

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

Keywords

Versions (2)
  1. 11/29/18 11/29/18 -
  2. 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

Physical examination and vital signs

1 forms  
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
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Date of Assessment
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C2985720
Physical examination
Description

Indicate current physical findings by tick the appropriate box(es) below.

Data type

integer

Alias
UMLS CUI [1]
C0031809
Examination status
Description

"Not done" only applicable for: Breasts, Urogenital, Pelvis and Rectal. They are prefilled for this study.

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0449438
Abnormal examination status
Description

If you tick abnormal in "Examination status", describe concisely: [different findings should be separated by either a (;) or a (/)]

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C1704258
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

Physical examination and vital signs

1 forms
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
Physical Examination
C0031809 (UMLS CUI-1)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
Physical examination
integer
C0031809 (UMLS CUI [1])
Physical examination
Code List
Physical examination
CL Item
Hair and skin  (1)
CL Item
Lymph nodes (2)
CL Item
Eyes (3)
CL Item
Ears, Nose and Throat (4)
CL Item
Breasts (5)
CL Item
Respiratory (6)
CL Item
Cardiovascular (7)
CL Item
Abdomen (8)
CL Item
Urogenital (9)
CL Item
Pelvic (10)
CL Item
Rectal (11)
CL Item
Musculoskeletal (12)
CL Item
Neurological (13)
CL Item
Mental Status (14)
Item
Examination status
text
C0031809 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Examination status
Code List
Examination status
CL Item
Normal (N)
CL Item
Abnormal (AN)
CL Item
Not Done (ND)
Abnormal examination status
Item
Abnormal examination status
text
C0031809 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
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
Follow-up (1)
CL Item
Unscheduled (2)
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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