0 Ratings
ID

39856

Description

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 pulmonary function test. It has to be filled in for screening, V2b, V3, V5, follow-up and if required for logs/ repeats.

Link

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

Keywords

Versions (2)
  1. 2/24/20 2/24/20 -
  2. 2/28/20 2/28/20 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

February 24, 2020

DOI

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License

Creative Commons BY-NC 4.0
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    Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201

    English

    Pulmonary function test

    1 forms  
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Number
    Description

    Subject Number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Date of Visit
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Visit type
    Description

    Please note for which visit you will fill in this document.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0545082 (Visit)
    UMLS CUI [1,2]
    C0332307 (Type - attribute)
    SNOMED
    261664005
    Pulmonary function test
    Description

    Pulmonary function test

    Alias
    UMLS CUI-1
    C0024119 (Pulmonary function tests)
    SNOMED
    23426006
    Date of test
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826247 (Test Date)
    Time of test
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1]
    C0429928 (Test time)
    SNOMED
    252127002
    Bronchodilator
    Description

    For V2b fill in for both, pre- and post-bronchodilator. For V3, V5 and follow-up only fill in for pre-bronchodilator. This item has not to be filled in for screening and follow-up.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0006280 (Bronchodilator Agents)
    SNOMED
    353866001
    Test type
    Description

    Test type

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0024119 (Pulmonary function tests)
    SNOMED
    23426006
    UMLS CUI [1,2]
    C0332307 (Type - attribute)
    SNOMED
    261664005
    Reading number
    Description

    Please fill in three readings for both test types as well as for pre- and postbronchodilator.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0024119 (Pulmonary function tests)
    SNOMED
    23426006
    UMLS CUI [1,2]
    C0449788 (Count of entities)
    SNOMED
    410681005
    UMLS CUI [1,3]
    C0456984 (Test Result)
    SNOMED
    277775005
    Test result
    Description

    Test result

    Data type

    float

    Measurement units
    • L
    Alias
    UMLS CUI [1,1]
    C0456984 (Test Result)
    SNOMED
    277775005
    UMLS CUI [1,2]
    C0024119 (Pulmonary function tests)
    SNOMED
    23426006
    L
    Test not done
    Description

    Only to fill in for logs/ repeats.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1272696 (Not Done)
    SNOMED
    385660001
    UMLS CUI [1,2]
    C0024119 (Pulmonary function tests)
    SNOMED
    23426006
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    Similar models

    Pulmonary function test

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Date of Visit
    Item
    Date of Visit
    date
    C1320303 (UMLS CUI [1])
    Item
    Visit type
    integer
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Visit type
    Code List
    Visit type
    CL Item
    Screening (1)
    CL Item
    V2b (2)
    CL Item
    V3 (3)
    CL Item
    V5 (4)
    CL Item
    Follow-up (5)
    CL Item
    Logs/ Repeats (6)
    Item Group
    Pulmonary function test
    C0024119 (UMLS CUI-1)
    Date of test
    Item
    Date of test
    date
    C2826247 (UMLS CUI [1])
    Time of test
    Item
    Time of test
    time
    C0429928 (UMLS CUI [1])
    Item
    Bronchodilator
    integer
    C0006280 (UMLS CUI [1])
    Bronchodilator
    Code List
    Bronchodilator
    CL Item
    Pre-Bronchodilator (1)
    CL Item
    Post-Bronchodilator (2)
    Item
    Test type
    integer
    C0024119 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Test type
    Code List
    Test type
    CL Item
    FEV1 (1)
    CL Item
    FVC (2)
    Item
    Reading number
    integer
    C0024119 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    C0456984 (UMLS CUI [1,3])
    Reading number
    Code List
    Reading number
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    Test result
    Item
    Test result
    float
    C0456984 (UMLS CUI [1,1])
    C0024119 (UMLS CUI [1,2])
    Test not done
    Item
    Test not done
    boolean
    C1272696 (UMLS CUI [1,1])
    C0024119 (UMLS CUI [1,2])
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