0 Ratings
ID

37360

Description

Study ID: 111592 Clinical Study ID: 111592 Study Title: A Randomized, Double-blind, Placebo-controlled, Doseescalation Study to Assess the Anti-inflammatory Activity, Efficacy, and Safety of Intravenous SB-681323 in Subjects at Risk for Development of Acute Lung Injury or ARDS Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996840 (See https://clinicaltrials.gov/ct2/show/NCT00996840) Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, SB-681323 Trade Name: N/A Study Indication: Lung Injury, Acute The primary objective of this phase 2 trial is to evaluate the safety and tolerability of intravenous dilmapimod/SB-681323 given in escalating dosages and over different intervals for three days in trauma patients at risk for the development of ALI or ARDS. This study consists of Screening, infusion of dilmapimod/SB-681323 on days 1-3, examination/sampling up to early day 5 (denoted as "Day 3 - 48 hrs") and a Follow-up on day 7. There are four cohorts, cohorts 1 and 3 receive the medication (or placebo) infusion over 4 hours, cohorts 2 and 4 over 24 hours. This form contains the participant's demographic data and is to be filled in at Screening.

Link

https://clinicaltrials.gov/ct2/show/NCT00996840)

Keywords

Versions (1)
  1. 7/20/19 7/20/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 20, 2019

DOI

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License

Creative Commons BY-NC 3.0
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    SB-681323 in ALI/ARDS risk patients - NCT00996840

    English

    Demography

    1 forms  
    1. StudyEvent: ODM
      1. Demography
    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/Time of Assessment
    Description

    Date/Time of Assessment

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C1516048 (Assessed)
    UMLS CUI [1,2]
    C1264639 (Date/Time)
    SNOMED
    118575009
    Demography
    Description

    Demography

    Alias
    UMLS CUI-1
    C0011298 (Demography)
    LOINC
    LP204151-7
    Date of Birth
    Description

    Date of Birth

    Data type

    date

    Alias
    UMLS CUI [1]
    C0421451 (Patient date of birth)
    SNOMED
    184099003
    LOINC
    LP57552-9
    Subject Initials (hidden)
    Description

    hidden and set to "---"

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440 (Person Initials)
    Gender
    Description

    Female: Record child-bearing potential

    Data type

    text

    Alias
    UMLS CUI [1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    If female, record child-bearing potential
    Description

    if applicable

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3831118 (Childbearing Potential)
    Ethnicity
    Description

    Ethnicity

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0015031 (Ethnic group)
    SNOMED
    398089004
    LOINC
    LP36231-6
    Geographic ancestry
    Description

    Geographic ancestry

    Alias
    UMLS CUI-1
    C3841890 (Your ancestry or national origin)
    LOINC
    LA15574-9
    African American/African Heritage
    Description

    African American/African Heritage

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0085756 (African American)
    SNOMED
    15086000
    LOINC
    LA10610-6
    UMLS CUI [2]
    C0027567 (African race)
    SNOMED
    413464008
    American Indian or Alaskan Native
    Description

    American Indian or Alaskan Native

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1515945 (American Indian or Alaska Native)
    SNOMED
    413490006
    LOINC
    LA10608-0
    Asian - Central/South Asian Heritage
    Description

    Central/South Asian Heritage

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0238696 (Central Asian)
    UMLS CUI [2]
    C1519427 (South Asian)
    Asian - East Asian Heritage
    Description

    East Asian Heritage

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C4540996 (East Asian ethnicity)
    Asian - Japanese Heritage
    Description

    Japanese Heritage

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1556094 (Japanese race)
    SNOMED
    414551003
    LOINC
    LA4595-0
    Asian - South East Asian Heritage
    Description

    South East Asian Heritage

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0238697 (South East Asian)
    SNOMED
    186044009
    Native Hawaiian or Other Pacific Islander
    Description

    Native Hawaiian or Other Pacific Islander

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1513907 (Native Hawaiian or Other Pacific Islander)
    LOINC
    LA10611-4
    White - Arabic/North African Heritage
    Description

    White - Arabic/North African Heritage

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0238604 (North African)
    UMLS CUI [2]
    C2698217 (Middle Eastern)
    White - White/Caucasian/European Heritage
    Description

    White/Caucasian/European Heritage

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0043157 (Caucasians)
    SNOMED
    185984009
    LOINC
    LA23729-9
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    Similar models

    Demography

    1 forms
    1. StudyEvent: ODM
      1. Demography
    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/Time of Assessment
    Item
    Date/Time of Assessment
    datetime
    C1516048 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
    Item Group
    Demography
    C0011298 (UMLS CUI-1)
    Date of Birth
    Item
    Date of Birth
    date
    C0421451 (UMLS CUI [1])
    Subject Initials
    Item
    Subject Initials (hidden)
    text
    C2986440 (UMLS CUI [1])
    Item
    Gender
    text
    C0079399 (UMLS CUI [1])
    Gender
    Code List
    Gender
    CL Item
    Male (M)
    CL Item
    Female (F)
    Item
    If female, record child-bearing potential
    integer
    C3831118 (UMLS CUI [1])
    child-bearing potential
    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
    C3841890 (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])
    Central/South Asian Heritage
    Item
    Asian - Central/South Asian Heritage
    boolean
    C0238696 (UMLS CUI [1])
    C1519427 (UMLS CUI [2])
    East Asian Heritage
    Item
    Asian - East Asian Heritage
    boolean
    C4540996 (UMLS CUI [1])
    Japanese Heritage
    Item
    Asian - Japanese Heritage
    boolean
    C1556094 (UMLS CUI [1])
    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/Caucasian/European Heritage
    Item
    White - White/Caucasian/European Heritage
    boolean
    C0043157 (UMLS CUI [1])
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