ID

39731

Beschrijving

Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the demography form. It has to be filled in for screening.

Link

https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201

Trefwoorden

Versies (1)
  1. 14-02-20 14-02-20 -
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GlaxoSmithKline

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14 februari 2020

DOI

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Licentie

Creative Commons BY-NC 3.0
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Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201

Engels

Demography

1 Formulieren  
  1. StudyEvent: ODM
    1. Demography
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Subject Number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Date of visit/ assessment
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Demography
Beschrijving

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Beschrijving

day month year. Enter subject's date of birth, if you unable to provide a full date of birth, enter a partial date of birth.

Datatype

partialDate

Alias
UMLS CUI [1]
C0421451
Sex
Beschrijving

Sex

Datatype

text

Alias
UMLS CUI [1]
C0079399
If female, record child-bearing potential
Beschrijving

Child-bearing potential

Datatype

integer

Alias
UMLS CUI [1]
C3831118
Ethnicity
Beschrijving

Ethnicity

Datatype

integer

Alias
UMLS CUI [1]
C0015031
Geographic ancestry
Beschrijving

Geographic ancestry

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

African American/African Heritage

Datatype

boolean

Alias
UMLS CUI [1]
C0085756
UMLS CUI [2]
C0027567
American Indian or Alaskan Native
Beschrijving

American Indian or Alaskan Native

Datatype

boolean

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

Asian - Central/South Asian Heritage

Datatype

boolean

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

Asian - East Asian Heritage

Datatype

boolean

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

Asian - Japanese Heritage

Datatype

boolean

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

Asian - South East Asian Heritage

Datatype

boolean

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

Native Hawaiian or Other Pacific Islander

Datatype

boolean

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

White - Arabic/North African Heritage

Datatype

boolean

Alias
UMLS CUI [1]
C0238604
UMLS CUI [2]
C2698217
White - White/Caucasian/European Heritage
Beschrijving

White - White/Caucasian/European Heritage

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 Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date of visit/ assessment
Item
Date of visit/ assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
partialDate
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
(Comment:en)
CL Item
Female (F)
(Comment:en)
Item
If female, record child-bearing potential
integer
C3831118 (UMLS CUI [1])
Sex
Code List
If female, record child-bearing potential
CL Item
Post-menopausal (2)
CL Item
Sterile (of child-bearing age) (3)
CL Item
Potentially able to bear children (4)
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
Geographic ancestry
C0034510 (UMLS CUI-1)
African American/African Heritage
Item
African American/African Heritage
boolean
C0085756 (UMLS CUI [1])
C0027567 (UMLS CUI [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])
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])
C2698217 (UMLS CUI [2])
White - White/Caucasian/European Heritage
Item
White - White/Caucasian/European Heritage
boolean
C0043157 (UMLS CUI [1])
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