ID

34831

Beschreibung

Study ID: 101888 Clinical Study ID: FFR101888 Study Title: A randomised, placebo-controlled, four way crossover study to evaluate the effect of double-blind 4000 mcg of orally inhaled GW685698X and of 6.25 mg cellobiose octa-acetate on electrocardiographic parameters, with single-blind 400 mg of oral moxifloxacin as a positive control, in 40 healthy male and female subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Rhinitis, Allergic, Perennial The study consists of a screening, 4 treatment periods (TP) and a follow-up visit. For each TP there is a Day-1 (D-1) and a Day1 (D1). This document contains the demography form. It has to be filled in for screening.

Stichworte

Versionen (3)
  1. 30.01.19 30.01.19 -
  2. 31.01.19 31.01.19 - Sarah Riepenhausen
  3. 20.09.21 20.09.21 -
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GlaxoSmithKline

Hochgeladen am

30. Januar 2019

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Effect of inhaled Fluticasone furoate and cellobiose octa-acetate on electrocardiographic parameters in healthy subjects, Study-ID: 101888

Englisch

Demography

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

Administrative data

Alias
UMLS CUI-1
C1320722
Protocol Identifier
Beschreibung

Protocol Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2826693
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Demography
Beschreibung

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Sex

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Beschreibung

Tick one. 1: 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. 2: Neither Hispanic or Latino

Datentyp

integer

Alias
UMLS CUI [1]
C0015031
Race
Beschreibung

Race

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

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085756
UMLS CUI [1,2]
C0027567
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 and Indian Subcontinent (India, Pakistan, Bangladesh and Sri Lanka)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0238696
UMLS CUI [1,2]
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 [1,1]
C0238604
UMLS CUI [1,2]
C1552588
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)
Protocol Identifier
Item
Protocol Identifier
integer
C2826693 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
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)
C0086582 (UMLS CUI-1)
(Comment:en)
CL Item
Female (F)
C0015780 (UMLS CUI-1)
(Comment:en)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item Group
Race
C0034510 (UMLS CUI-1)
African American/African Heritage
Item
African American/African Heritage
boolean
C0085756 (UMLS CUI [1,1])
C0027567 (UMLS CUI [1,2])
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 [1,1])
C1519427 (UMLS CUI [1,2])
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 [1,1])
C1552588 (UMLS CUI [1,2])
White - White/Caucasian/European Heritage
Item
White - White/Caucasian/European Heritage
boolean
C0043157 (UMLS CUI [1])
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