ID

33141

Beschreibung

Study ID: 107806 Clinical Study ID: RA3107806 Study Title: An open label study to determine the safety, tolerability, excretion balance and pharmacokinetics of [14C]GW856553, 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 filled in for screening.

Link

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

Stichworte

Versionen (2)
  1. 28.11.18 28.11.18 -
  2. 29.11.18 29.11.18 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

29. November 2018

DOI

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Lizenz

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

Englisch

Demography

1 Formulare  
  1. StudyEvent: ODM
    1. Demography
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject identifier
Beschreibung

Subject identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Date of Visit
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Volunteer Identifier
Beschreibung

Volunteer Identifier

Datentyp

text

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

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

For participation to study the subject has to be masculine

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Beschreibung

Ethnicity

Alias
UMLS CUI-1
C0015031
Hispanic or Latino
Beschreibung

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"

Datentyp

integer

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

Geographic Ancestry

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

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

Datentyp

boolean

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

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

Datentyp

boolean

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

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

Datentyp

boolean

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

A person having origins in China, Korea

Datentyp

boolean

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

A person having origins in Japan

Datentyp

boolean

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

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

Datentyp

boolean

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

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

Datentyp

boolean

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

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

Datentyp

boolean

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

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0043157
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Ähnliche Modelle

Demography

1 Formulare
  1. StudyEvent: ODM
    1. Demography
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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