0 Ratings
ID

37358

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 is to be filled in (repeatedly, if necessary) during the study and/or at the end of the study in case of non-serious adverse events.

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

    Non-serious AE

    1 forms  
    1. StudyEvent: ODM
      1. Non-serious AE
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Date/Time of Assessment
    Description

    Date/Time of Assessment

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C2985720
    UMLS CUI [1,2]
    C1264639
    Subject ID
    Description

    Subject ID

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Non-serious adverse event
    Description

    Non-serious adverse event

    Alias
    UMLS CUI-1
    C1518404
    Sequence Number
    Description

    Hidden

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2348184
    UMLS CUI [1,2]
    C1518404
    Event Diagnosis Only (if known) Otherwise Sign/Symptom
    Description

    Diagnosis or Sign/Symptom

    Data type

    text

    Alias
    UMLS CUI [1]
    C0011900
    UMLS CUI [2]
    C3540840
    Adverse Event Modified Reported Term
    Description

    Hidden

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826798
    MedDRA synonym
    Description

    Hidden

    Data type

    text

    Alias
    UMLS CUI [1]
    C1140263
    MedDRA lower level term code
    Description

    Hidden

    Data type

    text

    Alias
    UMLS CUI [1]
    C3898442
    Failed coding
    Description

    Hidden

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0805701
    UMLS CUI [1,2]
    C0231175
    Start Date and Time
    Description

    Start Date/Time

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C2826806
    Outcome
    Description

    if Recovered/Resolved (with or without sequelae) provide End Date and Time

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1705586
    End Date and Time
    Description

    if applicable

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C2826793
    Non-serious adverse event frequency
    Description

    Non-serious adverse event frequency

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0439603
    UMLS CUI [1,2]
    C1518404
    Adverse Event Maximum Intensity
    Description

    Adverse Event Maximum Intensity

    Data type

    text

    Alias
    UMLS CUI [1]
    C1710066
    Adverse Event Maximum Grade
    Description

    [hidden]

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0441799
    UMLS CUI [1,2]
    C1710066
    Adverse Event Maximum Grade or Intensity
    Description

    [hidden]

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0441799
    UMLS CUI [1,2]
    C1710066
    UMLS CUI [2,1]
    C0518690
    UMLS CUI [2,2]
    C1518404
    Action Taken with Investigational Product(s) as a Result of the AE
    Description

    Action regarding Investigational Product because of non-serious adverse event

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1704758
    UMLS CUI [1,2]
    C0566251
    UMLS CUI [1,3]
    C1518404
    Did the subject withdraw from study as a result of this AE?
    Description

    subject withdrawal because of non-serious adverse event

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0566251
    UMLS CUI [1,3]
    C1518404
    Is there a reasonable possibility that the AE may have been caused by the investigational product(s)?
    Description

    AE possibly caused by investigational product

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0085978
    UMLS CUI [1,3]
    C1518404
    Duration of AE if < 24 hours
    Description

    [hidden]

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0449238
    UMLS CUI [1,2]
    C1518404
    Time to Onset Since Last Dose
    Description

    [hidden]

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1272706
    UMLS CUI [1,2]
    C1517741
    UMLS CUI [1,3]
    C0178602
    UMLS CUI [1,4]
    C0439659
    UMLS CUI [1,5]
    C1518404
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    Similar models

    Non-serious AE

    1 forms
    1. StudyEvent: ODM
      1. Non-serious AE
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Date/Time of Assessment
    Item
    Date/Time of Assessment
    datetime
    C2985720 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
    Subject ID
    Item
    Subject ID
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Non-serious adverse event
    C1518404 (UMLS CUI-1)
    Non-serious AE Sequence Number
    Item
    Sequence Number
    text
    C2348184 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Diagnosis or Sign/Symptom
    Item
    Event Diagnosis Only (if known) Otherwise Sign/Symptom
    text
    C0011900 (UMLS CUI [1])
    C3540840 (UMLS CUI [2])
    Adverse Event Modified Reported Term
    Item
    Adverse Event Modified Reported Term
    text
    C2826798 (UMLS CUI [1])
    MedDRA synonym
    Item
    MedDRA synonym
    text
    C1140263 (UMLS CUI [1])
    MedDRA lower level term code
    Item
    MedDRA lower level term code
    text
    C3898442 (UMLS CUI [1])
    Failed coding
    Item
    Failed coding
    boolean
    C0805701 (UMLS CUI [1,1])
    C0231175 (UMLS CUI [1,2])
    Start Date/Time
    Item
    Start Date and Time
    datetime
    C2826806 (UMLS CUI [1])
    Item
    Outcome
    integer
    C1705586 (UMLS CUI [1])
    Outcome
    Code List
    Outcome
    CL Item
    Recovered/Resolved,  (1)
    CL Item
    Recovering/Resolving (2)
    CL Item
    Not recovered/Not resolved (3)
    CL Item
    Recovered/Resolved with sequelae (4)
    End Date/Time
    Item
    End Date and Time
    datetime
    C2826793 (UMLS CUI [1])
    Item
    Non-serious adverse event frequency
    integer
    C0439603 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Frequency
    Code List
    Non-serious adverse event frequency
    CL Item
    Single Episode (1)
    CL Item
    Intermittent (2)
    Item
    Adverse Event Maximum Intensity
    text
    C1710066 (UMLS CUI [1])
    Maximum Intensity
    Code List
    Adverse Event Maximum Intensity
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    Not applicable (X)
    Item
    Adverse Event Maximum Grade
    text
    C0441799 (UMLS CUI [1,1])
    C1710066 (UMLS CUI [1,2])
    Maximum Grade
    Code List
    Adverse Event Maximum Grade
    CL Item
    Grade 1 (1)
    CL Item
    Grade 2 (2)
    CL Item
    Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    CL Item
    Not applicable (X)
    Item
    Adverse Event Maximum Grade or Intensity
    text
    C0441799 (UMLS CUI [1,1])
    C1710066 (UMLS CUI [1,2])
    C0518690 (UMLS CUI [2,1])
    C1518404 (UMLS CUI [2,2])
    Maximum Grade
    Code List
    Adverse Event Maximum Grade or Intensity
    CL Item
    Mild or Grade 1 (1)
    CL Item
    Moderate or Grade 2 (2)
    CL Item
    Severe or Grade 3 (3)
    CL Item
    Grade 4 (4)
    CL Item
    Grade 5 (5)
    CL Item
    Not applicable (X)
    Item
    Action Taken with Investigational Product(s) as a Result of the AE
    text
    C1704758 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    C1518404 (UMLS CUI [1,3])
    Action regarding Investigational Product
    Code List
    Action Taken with Investigational Product(s) as a Result of the AE
    CL Item
    Investigational product(s) withdrawn (1)
    CL Item
    Dose reduced (2)
    CL Item
    Dose increased (3)
    CL Item
    Dose not changed (4)
    CL Item
    Dose interrupted (5)
    CL Item
    Not applicable (X)
    subject withdrawal because of non-serious adverse event
    Item
    Did the subject withdraw from study as a result of this AE?
    boolean
    C0422727 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    C1518404 (UMLS CUI [1,3])
    AE possibly caused by investigational product
    Item
    Is there a reasonable possibility that the AE may have been caused by the investigational product(s)?
    boolean
    C0304229 (UMLS CUI [1,1])
    C0085978 (UMLS CUI [1,2])
    C1518404 (UMLS CUI [1,3])
    Duration of AE
    Item
    Duration of AE if < 24 hours
    time
    C0449238 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Interval between Last Dose and AE Onset
    Item
    Time to Onset Since Last Dose
    time
    C1272706 (UMLS CUI [1,1])
    C1517741 (UMLS CUI [1,2])
    C0178602 (UMLS CUI [1,3])
    C0439659 (UMLS CUI [1,4])
    C1518404 (UMLS CUI [1,5])
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