ID

33117

Beschrijving

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 the Medical condition, physical examination and vital signs (general). It has to be filled in for screening. The Physical examination also has to be filled in for follow-up. The form "Vital signs, cardiac" also has to be filled in for study visit and follow-up.

Link

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

Trefwoorden

Versies (2)
  1. 28-11-18 28-11-18 -
  2. 29-11-18 29-11-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

28 november 2018

DOI

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Licentie

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

Engels

Medical condition, physical examination and vital signs (general)

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject identifier
Beschrijving

Subject identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Date of Visit
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C0011008
Visit type
Beschrijving

Visit type

Datatype

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Medical condition
Beschrijving

Medical condition

Alias
UMLS CUI-1
C0012634
Diagnosis of medical condition
Beschrijving

Only in the absence of a diagnosis, record the signs and symptoms on separate lines

Datatype

text

Alias
UMLS CUI [1]
C0011900
Current disease
Beschrijving

Conditions from which the subject is currently suffering, regardless of how long they have been present. If the subject has had a recurring condition that is not present at the time of the assessmen, it can be classed as current if, in the Investigator's opinion it is likely to recur during the study.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521116
Past disease
Beschrijving

Conditions from which the subject has sufferedin the past, but are no longer present. A past condition may have stopped as recently as the day prior to being assessed.

Datatype

boolean

Alias
UMLS CUI [1,1]
C1444637
UMLS CUI [1,2]
C0012634
Physical Examination
Beschrijving

Physical Examination

Alias
UMLS CUI-1
C0031809
Date of Assessment
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C2985720
Physical examination
Beschrijving

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

Datatype

integer

Alias
UMLS CUI [1]
C0031809
Examination status
Beschrijving

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

Datatype

text

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

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

Datatype

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C1704258
Vital Signs general
Beschrijving

Vital Signs general

Alias
UMLS CUI-1
C0518766
Height
Beschrijving

Height

Datatype

integer

Maateenheden
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschrijving

Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Beschrijving

Body mass index

Datatype

float

Maateenheden
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
Vital Signs, cardiac
Beschrijving

Vital Signs, cardiac

Alias
UMLS CUI-1
C0518766
Date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C0011008
Planned Relative Time
Beschrijving

3-12: Only for Study visit

Datatype

integer

Alias
UMLS CUI [1]
C0439564
Actual Time
Beschrijving

00:00-23:59

Datatype

time

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

Blood Pressure Supine, systolic

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
Blood Pressure Supine, diastolic
Beschrijving

Blood Pressure Supine, diastolic

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
Heart Rate
Beschrijving

Heart Rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
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Similar models

Medical condition, physical examination and vital signs (general)

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
Visit type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Screening (1)
CL Item
Study visit (2)
CL Item
Follow-up (3)
Item Group
Medical condition
C0012634 (UMLS CUI-1)
Diagnosis of medical condition
Item
Diagnosis of medical condition
text
C0011900 (UMLS CUI [1])
Current disease
Item
Current disease
boolean
C0012634 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Past disease
Item
Past disease
boolean
C1444637 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
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 general
C0518766 (UMLS CUI-1)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (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
Screening (1)
CL Item
Unscheduled (2)
CL Item
Pre-dose (3)
CL Item
15 mins (4)
CL Item
30 mins  (5)
CL Item
1 hr (6)
CL Item
2 hrs (7)
CL Item
4 hrs (8)
CL Item
6 hrs (9)
CL Item
8 hrs (10)
CL Item
24 hrs (11)
CL Item
48 hrs (12)
CL Item
Follow-up (13)
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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