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ID

37355

Descrição

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 documents blood (products) and IV fluids given to the participant and is to be filled in repeatedly during the study, as appropriate.

Link

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

Palavras-chave

Versões (1)
  1. 20/07/2019 20/07/2019 -
Titular dos direitos

GlaxoSmithKline

Transferido a

20 de julho de 2019

DOI

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Licença

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

    Inglês

    Blood Products

    1 Formulários  
    1. StudyEvent: ODM
      1. Blood Products
    Administrative data
    Descrição

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject ID
    Descrição

    Subject ID

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Date/Time of Assessment
    Descrição

    Date/Time of Assessment

    Tipo de dados

    datetime

    Alias
    UMLS CUI [1,1]
    C2985720 (Assessment Date)
    UMLS CUI [1,2]
    C1264639 (Date/Time)
    SNOMED
    118575009
    Blood Products and Blood Supportive Care Products
    Descrição

    Blood Products and Blood Supportive Care Products

    Alias
    UMLS CUI-1
    C0456388 (Blood product)
    SNOMED
    410652009
    LOINC
    LP32808-5
    UMLS CUI-2
    C0018938 (Hematologic Agents)
    SNOMED
    373708006
    Sequence Number
    Descrição

    hidden

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2348184 (Sequence Number)
    Blood Products and Blood Supportive Care Products
    Descrição

    please specify "OTBP = Other Blood Product" and "OTBSC = Other Blood Supportive Care Product"

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0456388 (Blood product)
    SNOMED
    410652009
    LOINC
    LP32808-5
    UMLS CUI [2]
    C0018938 (Hematologic Agents)
    SNOMED
    373708006
    Other Blood Product specifation
    Descrição

    if applicable

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1521902 (To specify)
    UMLS CUI [1,2]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [1,3]
    C0456388 (Blood product)
    SNOMED
    410652009
    LOINC
    LP32808-5
    Other Blood Supportive Care Product specifation
    Descrição

    if applicable

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1521902 (To specify)
    UMLS CUI [1,2]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [1,3]
    C0018938 (Hematologic Agents)
    SNOMED
    373708006
    Quantity or Dose
    Descrição

    Quantity or Dose

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    UMLS CUI [2]
    C1265611 (Quantity)
    SNOMED
    246205007
    LOINC
    LP202968-6
    Blood Products and Blood Supportive Care Products Units
    Descrição

    Blood Products and Blood Supportive Care Products Unit

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1519795 (Unit of Measure)
    SNOMED
    767524001
    UMLS CUI [1,2]
    C0456388 (Blood product)
    SNOMED
    410652009
    LOINC
    LP32808-5
    UMLS CUI [2,1]
    C0018938 (Hematologic Agents)
    SNOMED
    373708006
    UMLS CUI [2,2]
    C1519795 (Unit of Measure)
    SNOMED
    767524001
    Start Date/Time
    Descrição

    Start Date/Time

    Tipo de dados

    datetime

    Alias
    UMLS CUI [1]
    C3897500 (Start Date and Time of Procedure)
    Voltar ao início da página

    Similar models

    Blood Products

    1 Formulários
    1. StudyEvent: ODM
      1. Blood Products
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject ID
    Item
    Subject ID
    integer
    C2348585 (UMLS CUI [1])
    Date/Time of Assessment
    Item
    Date/Time of Assessment
    datetime
    C2985720 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
    Item Group
    Blood Products and Blood Supportive Care Products
    C0456388 (UMLS CUI-1)
    C0018938 (UMLS CUI-2)
    Sequence Number
    Item
    Sequence Number
    text
    C2348184 (UMLS CUI [1])
    Item
    Blood Products and Blood Supportive Care Products
    text
    C0456388 (UMLS CUI [1])
    C0018938 (UMLS CUI [2])
    Blood Products and Blood Supportive Care Products
    Code List
    Blood Products and Blood Supportive Care Products
    CL Item
    Red Blood Cells (RBC)
    CL Item
    Platelets (PLTS)
    CL Item
    Whole Blood (WB)
    CL Item
    Plasma - FFP (FFP)
    CL Item
    Cryoprecipitate (CRYOP)
    CL Item
    Other Blood Product, specify (OTBP)
    CL Item
    IV Fluids (i.e. normal saline, lactated ringers solution) (OTBSCIV)
    CL Item
    Other Blood Supportive Care Product, specify (OTBSC)
    Other Blood Product specifation
    Item
    Other Blood Product specifation
    text
    C1521902 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0456388 (UMLS CUI [1,3])
    Other Blood Supportive Care Product specifation
    Item
    Other Blood Supportive Care Product specifation
    text
    C1521902 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0018938 (UMLS CUI [1,3])
    Quantity or Dose
    Item
    Quantity or Dose
    integer
    C0178602 (UMLS CUI [1])
    C1265611 (UMLS CUI [2])
    Item
    Blood Products and Blood Supportive Care Products Units
    text
    C1519795 (UMLS CUI [1,1])
    C0456388 (UMLS CUI [1,2])
    C0018938 (UMLS CUI [2,1])
    C1519795 (UMLS CUI [2,2])
    Unit
    Code List
    Blood Products and Blood Supportive Care Products Units
    CL Item
    Microgram (MCG)
    CL Item
    Bags (BAGS)
    CL Item
    Units (UNITS)
    CL Item
    Cubic Centimeters (CC)
    Start Date/Time
    Item
    Start Date/Time
    datetime
    C3897500 (UMLS CUI [1])
    Voltar ao início da página 

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