ID

33116

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 demography of subject. It has to be fillen in for screening.

Link

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

Trefwoorden

Versies (2)
  1. 28-11-18 28-11-18 -
  2. 29-11-18 29-11-18 - Sarah Riepenhausen
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

Demography

1 Formulieren  
  1. StudyEvent: ODM
    1. Demography
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
Volunteer Identifier
Beschrijving

Volunteer Identifier

Datatype

text

Alias
UMLS CUI [1,1]
C1300638
UMLS CUI [1,2]
C0020155
Demography
Beschrijving

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Beschrijving

Date of birth

Datatype

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschrijving

For participation to study the subject has to be masculine

Datatype

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Beschrijving

Ethnicity

Alias
UMLS CUI-1
C0015031
Hispanic or Latino
Beschrijving

A person of Cuban, Mexican, Puerto Rican, South American or other Spanish culture or origin, regardless of race. Note: If the subject does not meet the definition above, tick "Not Hispanic or Latino"

Datatype

integer

Alias
UMLS CUI [1]
C0086409
UMLS CUI [2]
C0086528
Geographic Ancestry
Beschrijving

Geographic Ancestry

Alias
UMLS CUI-1
C0034510
African American/African Heritage
Beschrijving

A person having origins in any of the black racial groups or Africa

Datatype

boolean

Alias
UMLS CUI [1]
C0085756
American Indian or Alaskan Native
Beschrijving

A person having origins in any of the original peoples of North and South America (including Central America) and who maintains tribal affiliation or community attachment

Datatype

boolean

Alias
UMLS CUI [1]
C1515945
Asian - Central/South Asian Heritage
Beschrijving

A person having origins in Central Asia (Kazakstan, Kyrgystan, Tajikstan, Turkmenistan and Uzbekistan) and Indian Subcontinent (India, Pakistan, Bangladeshand Sri Lanka).

Datatype

boolean

Alias
UMLS CUI [1]
C0238696
UMLS CUI [2]
C1519427
Asian - East Asian Heritage
Beschrijving

A person having origins in China, Korea

Datatype

boolean

Alias
UMLS CUI [1]
C4540996
Asian - Japanese Heritage
Beschrijving

A person having origins in Japan

Datatype

boolean

Alias
UMLS CUI [1]
C1556094
Asian - South East Asian Heritage
Beschrijving

A person having origins in Malaysia, the Philippines, Indonesia, Thailand, Vietnam, Laos, Burma or Cambodia

Datatype

boolean

Alias
UMLS CUI [1]
C0238697
Native Hawaiian or Other Pacific Islander
Beschrijving

A person having origins in any of the original peoples of Hawaii, Guam, Samoa or other Pacific Islands, Australia (Aborigines) Papua New Guinea, New Zealand, Marshalls and other island groups west and south of Japan

Datatype

boolean

Alias
UMLS CUI [1]
C1513907
White - Arabic/North African Heritage
Beschrijving

A person having origins in any of the original peoples of Middle East or North Africa

Datatype

boolean

Alias
UMLS CUI [1]
C0238604
UMLS CUI [2]
C0026068
White - White/Caucasian/European Heritage
Beschrijving

A person having origins in any of the original peoples of Europe

Datatype

boolean

Alias
UMLS CUI [1]
C0043157
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Similar models

Demography

1 Formulieren
  1. StudyEvent: ODM
    1. Demography
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])
Volunteer Identifier
Item
Volunteer Identifier
text
C1300638 (UMLS CUI [1,1])
C0020155 (UMLS CUI [1,2])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item Group
Ethnicity
C0015031 (UMLS CUI-1)
Item
Hispanic or Latino
integer
C0086409 (UMLS CUI [1])
C0086528 (UMLS CUI [2])
Hispanic or Latino
Code List
Hispanic or Latino
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item Group
Geographic Ancestry
C0034510 (UMLS CUI-1)
African American/African Heritage
Item
African American/African Heritage
boolean
C0085756 (UMLS CUI [1])
American Indian or Alaskan Native
Item
American Indian or Alaskan Native
boolean
C1515945 (UMLS CUI [1])
Asian - Central/South Asian Heritage
Item
Asian - Central/South Asian Heritage
boolean
C0238696 (UMLS CUI [1])
C1519427 (UMLS CUI [2])
Asian - East Asian Heritage
Item
Asian - East Asian Heritage
boolean
C4540996 (UMLS CUI [1])
Asian - Japanese Heritage
Item
Asian - Japanese Heritage
boolean
C1556094 (UMLS CUI [1])
Asian - South East Asian Heritage
Item
Asian - South East Asian Heritage
boolean
C0238697 (UMLS CUI [1])
Native Hawaiian or Other Pacific Islander
Item
Native Hawaiian or Other Pacific Islander
boolean
C1513907 (UMLS CUI [1])
White - Arabic/North African Heritage
Item
White - Arabic/North African Heritage
boolean
C0238604 (UMLS CUI [1])
C0026068 (UMLS CUI [2])
White - White/Caucasian/European Heritage
Item
boolean
C0043157 (UMLS CUI [1])
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