0 Ratings
ID

37359

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 should be filled in in case of a serious adverse event.

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

    Serious Adverse Event

    1 forms  
    1. StudyEvent: ODM
      1. Serious Adverse Event
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Cohort
    Description

    Cohort

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0599755
    Date/Time of Assessment
    Description

    Date/Time of Assessment

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C1516048
    UMLS CUI [1,2]
    C1264639
    Subject ID
    Description

    Subject ID

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Type of Report
    Description

    Type of Report

    Alias
    UMLS CUI-1
    C0585733
    Initial Report
    Description

    Initial Report

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0684224
    UMLS CUI [1,2]
    C0205265
    Follow-Up Report
    Description

    Follow-Up Report

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1704685
    Randomisation
    Description

    Randomisation

    Alias
    UMLS CUI-1
    C0034656
    Did SAE occur after initiation of study medication?
    Description

    SAE after initiation of study medication

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0332282
    UMLS CUI [1,3]
    C1704686
    UMLS CUI [1,4]
    C0304229
    Serious adverse event Entry
    Description

    Serious adverse event Entry

    Alias
    UMLS CUI-1
    C1519255
    Sequence Number
    Description

    Hidden

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2348184
    Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
    Description

    SAE Diagnosis or Sign/Symptom

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0011900
    UMLS CUI [2,1]
    C1519255
    UMLS CUI [2,2]
    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
    Adverse Event Start Date and Time
    Description

    Adverse Event Start Date/Time

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C2826806
    Adverse Event Outcome
    Description

    if Recovered/Resolved (with or without sequelae) provide End Date and Time if Fatal, record Date and Time of Death

    Data type

    integer

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

    if applicable

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C2826793
    Serious Adverse Event Frequency
    Description

    Serious Adverse Event Frequency

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0439603
    UMLS CUI [1,2]
    C1519255
    SAE Maximum Intensity
    Description

    SAE Maximum Intensity

    Data type

    text

    Alias
    UMLS CUI [1]
    C1710066
    SAE Maximum Grade
    Description

    [hidden]

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0441799
    UMLS CUI [1,2]
    C1710066
    SAE 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]
    C1519255
    Action Taken with Investigational Product(s) as a Result of the AE
    Description

    Action regarding Investigational Product

    Data type

    text

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

    subject withdrawal because of AE

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0566251
    UMLS CUI [1,3]
    C0877248
    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]
    C0332149
    UMLS CUI [1,3]
    C0085978
    UMLS CUI [1,4]
    C0877248
    Duration of AE if < 24 hours
    Description

    [hidden]

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0449238
    UMLS CUI [1,2]
    C1519255
    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]
    C1519255
    Was SAE caused by activities related to study participation (e.g. procedures)?
    Description

    SAE caused by activities related to study participation

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0085978
    UMLS CUI [1,3]
    C0441655
    UMLS CUI [1,4]
    C2348568
    Was the event serious?
    Description

    [hidden]

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1547644
    Seriousness
    Description

    Seriousness

    Alias
    UMLS CUI-1
    C0566251
    UMLS CUI-2
    C1547644
    Results in death
    Description

    Adverse Event Results in death

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1320832
    Adverse event is life-threatening
    Description

    Adverse event is life-threatening

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1517874
    Requires hospitalisation or prolongation of existing hospitalisation
    Description

    adverse event requires hospitalisation or prolongation of hospitalisation

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2826664
    UMLS CUI [1,2]
    C1519255
    UMLS CUI [2,1]
    C0745041
    UMLS CUI [2,2]
    C1519255
    Results in disability/incapacity
    Description

    Serious adverse event results in disability/incapacity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3176592
    UMLS CUI [1,2]
    C1519255
    UMLS CUI [2,1]
    C0231170
    UMLS CUI [2,2]
    C1519255
    Serious adverse event: Congenital anomaly/birth defect
    Description

    Serious adverse event: Congenital anomaly/birth defect

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0000768
    UMLS CUI [1,2]
    C1519255
    Other reason
    Description

    specify within general narrative comment

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3840932
    UMLS CUI [1,2]
    C1519255
    Is associated with liver injury and impaired liver function that in the judgment of the investigator and medical monitor causes prolongation of hospitalisation out of what would be expected for normal clinical course
    Description

    ALT >= 5xULN and bilirubin >= 2xULN (>35% direct).

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0160390
    UMLS CUI [1,2]
    C0678227
    UMLS CUI [1,3]
    C0745041
    UMLS CUI [2,1]
    C0086565
    UMLS CUI [2,2]
    C0678227
    UMLS CUI [2,3]
    C0745041
    UMLS CUI [3,1]
    C0008961
    UMLS CUI [3,2]
    C0022423
    Relevant concomitant/treatment medications Entry
    Description

    Relevant concomitant/treatment medications Entry

    Alias
    UMLS CUI-1
    C2347852
    UMLS CUI-2
    C2347946
    UMLS CUI-3
    C0304229
    CM Sequence Number
    Description

    [hidden]

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2348184
    UMLS CUI [1,2]
    C2347852
    Drug name
    Description

    (Trade Name preferred)

    Data type

    text

    Alias
    UMLS CUI [1]
    C2360065
    Dose
    Description

    Dose

    Data type

    text

    Alias
    UMLS CUI [1]
    C3174092
    Unit
    Description

    Unit of concomitant medication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519795
    UMLS CUI [1,2]
    C2347852
    Frequency
    Description

    Concomitant medication Frequency

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3476109
    UMLS CUI [1,2]
    C2347852
    Route
    Description

    Route of concomitant medication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013153
    UMLS CUI [1,2]
    C2347852
    Start Date
    Description

    Concomitant Medication Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C2347852
    Ongoing?
    Description

    if no, specify End Date

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826666
    If no ongoing medication, specify end date
    Description

    Concomitant medication end date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0806020
    Primary Indication
    Description

    Concomitant Medication Primary Indication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C3146298
    UMLS CUI [1,3]
    C0205225
    Drug Type
    Description

    Drug Type

    Data type

    text

    Alias
    UMLS CUI [1]
    C0457591
    Relevant Medical Conditions/Risk Factors
    Description

    Relevant Medical Conditions/Risk Factors

    Alias
    UMLS CUI-1
    C2347946
    UMLS CUI-2
    C0012634
    UMLS CUI-3
    C0035648
    MHx Sequence Number
    Description

    [hidden]

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2348184
    UMLS CUI [1,2]
    C0262926
    Specific Condition Name
    Description

    Specific Condition

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C2348235
    Date of onset
    Description

    Date of onset

    Data type

    date

    Alias
    UMLS CUI [1]
    C0574845
    Is medical condition continuing?
    Description

    If no, specify date of last occurrence

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0549178
    If no, specify date of last occurrence
    Description

    Date of last disease occurence

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C1517741
    UMLS CUI [1,3]
    C2745955
    UMLS CUI [1,4]
    C0011008
    Relevant Medical History / Risk Factors not noted above
    Description

    Relevant Other Medical History / Risk Factors

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347946
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0262926
    UMLS CUI [2,1]
    C2347946
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [2,3]
    C0035648
    Relevant Diagnostic Results
    Description

    Relevant Diagnostic Results

    Alias
    UMLS CUI-1
    C2347946
    UMLS CUI-2
    C0430022
    UMLS CUI-3
    C0456984
    Lab Sequence Number
    Description

    [hidden]

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C2348184
    Lab Test Name
    Description

    Lab Test Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C0022885
    Test Date
    Description

    Test Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826247
    Laboratory Test Result
    Description

    Laboratory Test Result

    Data type

    text

    Alias
    UMLS CUI [1]
    C0587081
    Laboratory Test Units
    Description

    Laboratory Test Units

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519795
    UMLS CUI [1,2]
    C0587081
    Normal Low Range
    Description

    Normal Low Range

    Data type

    text

    Alias
    UMLS CUI [1]
    C1272773
    Normal High Range
    Description

    Normal High Range

    Data type

    text

    Alias
    UMLS CUI [1]
    C1299400
    Relevant diagnostic results not noted above
    Description

    Relevant other diagnostic laboratory results

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347946
    UMLS CUI [1,2]
    C0587081
    UMLS CUI [1,3]
    C0205394
    Investigational Product
    Description

    Investigational Product

    Alias
    UMLS CUI-1
    C0304229
    If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
    Description

    event recurence after investigational product administered again

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0034897
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [1,3]
    C1517331
    UMLS CUI [1,4]
    C0304229
    General narrative comments
    Description

    General narrative comments

    Alias
    UMLS CUI-1
    C0947611
    General narrative comment
    Description

    General comment

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    Non clinical
    Description

    Non clinical

    Alias
    UMLS CUI-1
    C1320722
    Send incomplete SAE data to GSK Safety
    Description

    [hidden]

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1519246
    UMLS CUI [1,2]
    C0205257
    UMLS CUI [1,3]
    C1519255
    UMLS CUI [1,4]
    C1511726
    UMLS CUI [1,5]
    C2347796
    Receipt by GSK date
    Description

    [hidden]

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C2985846
    UMLS CUI [1,2]
    C2347796
    Was the event serious?
    Description

    [hidden]

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    SAE Sequence Number
    Description

    [hidden]

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2348184
    Version Number
    Description

    [hidden]

    Data type

    text

    Alias
    UMLS CUI [1]
    C2985700
    Case ID
    Description

    [hidden]

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1698493
    UMLS CUI [1,2]
    C0600091
    Randomisation Number
    Description

    [hidden]

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0237753
    OCEANS Code
    Description

    [hidden]

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0805701
    UMLS CUI [1,2]
    C1516728
    Email Flag
    Description

    [hidden]

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013849
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    Similar models

    Serious Adverse Event

    1 forms
    1. StudyEvent: ODM
      1. Serious Adverse Event
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Cohort
    Item
    Cohort
    integer
    C0599755 (UMLS CUI [1])
    Date/Time of Assessment
    Item
    Date/Time of Assessment
    datetime
    C1516048 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
    Subject ID
    Item
    Subject ID
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Type of Report
    C0585733 (UMLS CUI-1)
    Initial Report
    Item
    Initial Report
    boolean
    C0684224 (UMLS CUI [1,1])
    C0205265 (UMLS CUI [1,2])
    Follow-Up Report
    Item
    Follow-Up Report
    boolean
    C1704685 (UMLS CUI [1])
    Item Group
    Randomisation
    C0034656 (UMLS CUI-1)
    SAE after initiation of study medication
    Item
    Did SAE occur after initiation of study medication?
    boolean
    C1519255 (UMLS CUI [1,1])
    C0332282 (UMLS CUI [1,2])
    C1704686 (UMLS CUI [1,3])
    C0304229 (UMLS CUI [1,4])
    Item Group
    Serious adverse event Entry
    C1519255 (UMLS CUI-1)
    SAE Sequence Number
    Item
    Sequence Number
    text
    C1519255 (UMLS CUI [1,1])
    C2348184 (UMLS CUI [1,2])
    SAE Diagnosis or Sign/Symptom
    Item
    Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
    text
    C1519255 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [2,1])
    C3540840 (UMLS CUI [2,2])
    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])
    Adverse Event Start Date/Time
    Item
    Adverse Event Start Date and Time
    datetime
    C2826806 (UMLS CUI [1])
    Item
    Adverse Event Outcome
    integer
    C1705586 (UMLS CUI [1])
    Outcome
    Code List
    Adverse Event 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)
    CL Item
    Fatal (5)
    Adverse Event End Date/Time
    Item
    Adverse Event End Date and Time
    datetime
    C2826793 (UMLS CUI [1])
    Item
    Serious Adverse Event Frequency
    integer
    C0439603 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Frequency
    Code List
    Serious Adverse Event Frequency
    CL Item
    Single Episode (1)
    CL Item
    Intermittent (2)
    Item
    SAE Maximum Intensity
    text
    C1710066 (UMLS CUI [1])
    Maximum Intensity
    Code List
    SAE Maximum Intensity
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    CL Item
    Not applicable (X)
    Item
    SAE Maximum Grade
    text
    C0441799 (UMLS CUI [1,1])
    C1710066 (UMLS CUI [1,2])
    Maximum Grade
    Code List
    SAE 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
    SAE Maximum Grade or Intensity
    text
    C0441799 (UMLS CUI [1,1])
    C1710066 (UMLS CUI [1,2])
    C0518690 (UMLS CUI [2,1])
    C1519255 (UMLS CUI [2,2])
    Maximum Grade
    Code List
    SAE 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])
    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 AE
    Item
    Did the subject withdraw from study as a result of this AE?
    boolean
    C0422727 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    C0877248 (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])
    C0332149 (UMLS CUI [1,2])
    C0085978 (UMLS CUI [1,3])
    C0877248 (UMLS CUI [1,4])
    Duration of AE
    Item
    Duration of AE if < 24 hours
    time
    C0449238 (UMLS CUI [1,1])
    C1519255 (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])
    C1519255 (UMLS CUI [1,5])
    SAE caused by activities related to study participation
    Item
    Was SAE caused by activities related to study participation (e.g. procedures)?
    boolean
    C1519255 (UMLS CUI [1,1])
    C0085978 (UMLS CUI [1,2])
    C0441655 (UMLS CUI [1,3])
    C2348568 (UMLS CUI [1,4])
    Event seriousness
    Item
    Was the event serious?
    boolean
    C1547644 (UMLS CUI [1])
    Item Group
    Seriousness
    C0566251 (UMLS CUI-1)
    C1547644 (UMLS CUI-2)
    Adverse Event Results in death
    Item
    Results in death
    boolean
    C1320832 (UMLS CUI [1])
    Adverse event is life-threatening
    Item
    Adverse event is life-threatening
    boolean
    C1517874 (UMLS CUI [1])
    adverse event requires hospitalisation or prolongation of hospitalisation
    Item
    Requires hospitalisation or prolongation of existing hospitalisation
    boolean
    C2826664 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    C0745041 (UMLS CUI [2,1])
    C1519255 (UMLS CUI [2,2])
    Serious adverse event results in disability/incapacity
    Item
    Results in disability/incapacity
    boolean
    C3176592 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    C0231170 (UMLS CUI [2,1])
    C1519255 (UMLS CUI [2,2])
    Serious adverse event: Congenital anomaly/birth defect
    Item
    Serious adverse event: Congenital anomaly/birth defect
    boolean
    C0000768 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Other reason for event seriousness
    Item
    Other reason
    boolean
    C3840932 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Liver injury and impaired liver function causing prolongation of hospitalisation, by investigator judgement
    Item
    Is associated with liver injury and impaired liver function that in the judgment of the investigator and medical monitor causes prolongation of hospitalisation out of what would be expected for normal clinical course
    boolean
    C0160390 (UMLS CUI [1,1])
    C0678227 (UMLS CUI [1,2])
    C0745041 (UMLS CUI [1,3])
    C0086565 (UMLS CUI [2,1])
    C0678227 (UMLS CUI [2,2])
    C0745041 (UMLS CUI [2,3])
    C0008961 (UMLS CUI [3,1])
    C0022423 (UMLS CUI [3,2])
    Item Group
    Relevant concomitant/treatment medications Entry
    C2347852 (UMLS CUI-1)
    C2347946 (UMLS CUI-2)
    C0304229 (UMLS CUI-3)
    Concomitant Medication Sequence Number
    Item
    CM Sequence Number
    text
    C2348184 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Drug name
    Item
    Drug name
    text
    C2360065 (UMLS CUI [1])
    Dose
    Item
    Dose
    text
    C3174092 (UMLS CUI [1])
    Item
    Unit
    text
    C1519795 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    units of medication
    Code List
    Unit
    CL Item
    Actuation (ACTU)
    CL Item
    Ampoule  (AMP)
    CL Item
    Application  (AP)
    CL Item
    Bottle  (BT)
    CL Item
    Capsule (CAP)
    CL Item
    Cubic centimeter (CC)
    CL Item
    Drops  (031)
    CL Item
    Gram (002)
    CL Item
    International units (025)
    CL Item
    International units per kilogram (028)
    CL Item
    International units per millilitre (IUML)
    CL Item
    Litre (011)
    CL Item
    Litre per minute (LM)
    CL Item
    Lozenge (LOZ)
    CL Item
    Megaunits (million units) (MEGU)
    CL Item
    Microgram (UG) (004)
    CL Item
    Microgram (UG) (004)
    CL Item
    Microgram/kilogram  (008)
    CL Item
    Microgram/kilogram per minute (MCG/KG/MIN)
    CL Item
    Micrograms per minute (MCG/MIN)
    CL Item
    Microlitre (013)
    CL Item
    Milliequivalent (029)
    CL Item
    Milliequivalent per 24 hours (MEQ24)
    CL Item
    Milligram (003)
    CL Item
    Milligrams percent (MGPER)
    CL Item
    Milligram per hour (MGH)
    CL Item
    Milligram/kilogram (007)
    CL Item
    Milligram/kilogram per hour (MGKH)
    CL Item
    Milligram/kilogram per minute (MGKM)
    CL Item
    Milligram/metre squared (009)
    CL Item
    Milligram/millilitre (MGML)
    CL Item
    Millilitre (012)
    CL Item
    Millilitre per hour (MLH)
    CL Item
    Millilitre per minute (MLM)
    CL Item
    Millimole (023)
    CL Item
    Million international units (027)
    CL Item
    Minimum alveolar concentration (MAC)
    CL Item
    Nebule (NEB)
    CL Item
    Patch (PAT)
    CL Item
    Percent (030)
    CL Item
    Puff (PUFF)
    CL Item
    Sachet (SAC)
    CL Item
    Spray (SPR)
    CL Item
    Suppository (SUP)
    CL Item
    Tablespoon (TBS)
    CL Item
    Tablet (TAB)
    CL Item
    Teaspoon (TSP)
    CL Item
    Units (UNT)
    CL Item
    Unknown (U)
    CL Item
    Vial (VIA)
    Item
    Frequency
    text
    C3476109 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Frequency
    Code List
    Frequency
    CL Item
    3 times per week (2W)
    CL Item
    3 times per week (2W)
    CL Item
    4 times per week (4W)
    CL Item
    5 times per day (5D)
    CL Item
    5 times per week (5W)
    CL Item
    AC (AC)
    CL Item
    Q12H (2D)
    CL Item
    Continuous infusion (CO)
    CL Item
    Every 2 weeks (FO)
    CL Item
    Every 3 weeks (Q3W)
    CL Item
    Every 3 months (Q3M)
    CL Item
    Every other day (AD)
    CL Item
    QPM (1N)
    CL Item
    Once a month (MO)
    CL Item
    Once a week (WE)
    CL Item
    Once daily (1D)
    CL Item
    Once only (1S)
    CL Item
    PC (PC)
    CL Item
    PRN (PRN)
    CL Item
    Q2H (12D)
    CL Item
    Q3D (Q3D)
    CL Item
    Q4D (Q4D)
    CL Item
    Q4H (6D)
    CL Item
    QID (4D)
    CL Item
    TID (3D)
    CL Item
    Q12H (2D)
    CL Item
    QAM (1M)
    CL Item
    QH (24D)
    CL Item
    QID (4D)
    CL Item
    QPM (1N)
    CL Item
    TID (3D)
    CL Item
    Unknown (U)
    Item
    Route
    text
    C0013153 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Route of medication
    Code List
    Route
    CL Item
    Both eyes (047)
    C0229118 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Epidural (008)
    C0014537 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Gastrostomy tube (GT)
    C0017196 (UMLS CUI-1)
    C0041281 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Inhalation (055)
    C0004048 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Injection (INJ)
    C1272883 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Intra-arterial (013)
    C0694634 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Intra-bursa (IBU)
    C0230212 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Intralesional (026)
    C1512954 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Intramuscular (030)
    C0442117 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Nasal (045)
    C0442118 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Intraocular (031)
    CL Item
    Intraosteal (IOS)
    CL Item
    Intraperitoneal (033)
    CL Item
    Intrathecal (037)
    CL Item
    Intrauterine (015)
    CL Item
    Intravenous (042)
    CL Item
    Nasal (045)
    CL Item
    Oral (048)
    CL Item
    Rectal (054)
    CL Item
    Subcutaneous (058)
    CL Item
    Sublingual (060)
    CL Item
    Topical (061)
    CL Item
    Transdermal (062)
    CL Item
    Unknown (065)
    CL Item
    Vaginal (067)
    Concomitant Medication Start Date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Ongoing concomitant medication
    Item
    Ongoing?
    boolean
    C2826666 (UMLS CUI [1])
    Concomitant medication end date
    Item
    If no ongoing medication, specify end date
    date
    C2347852 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Concomitant Medication Primary Indication
    Item
    Primary Indication
    text
    C2347852 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    C0205225 (UMLS CUI [1,3])
    Item
    Drug Type
    text
    C0457591 (UMLS CUI [1])
    Drug Type
    Code List
    Drug Type
    CL Item
    Concomitant (2)
    CL Item
    Treatment (T)
    CL Item
    Cause of SAE (1)
    Item Group
    Relevant Medical Conditions/Risk Factors
    C2347946 (UMLS CUI-1)
    C0012634 (UMLS CUI-2)
    C0035648 (UMLS CUI-3)
    MHx Sequence Number
    Item
    MHx Sequence Number
    text
    C2348184 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    Specific Condition
    Item
    Specific Condition Name
    text
    C0012634 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Date of onset
    Item
    Date of onset
    date
    C0574845 (UMLS CUI [1])
    Item
    Is medical condition continuing?
    text
    C0012634 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Continuing?
    Code List
    Is medical condition continuing?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Unknown (U)
    Date of last disease occurence
    Item
    If no, specify date of last occurrence
    date
    C0012634 (UMLS CUI [1,1])
    C1517741 (UMLS CUI [1,2])
    C2745955 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Relevant Other Medical History / Risk Factors
    Item
    Relevant Medical History / Risk Factors not noted above
    text
    C2347946 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0262926 (UMLS CUI [1,3])
    C2347946 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C0035648 (UMLS CUI [2,3])
    Item Group
    Relevant Diagnostic Results
    C2347946 (UMLS CUI-1)
    C0430022 (UMLS CUI-2)
    C0456984 (UMLS CUI-3)
    Lab Sequence Number
    Item
    Lab Sequence Number
    text
    C0022885 (UMLS CUI [1,1])
    C2348184 (UMLS CUI [1,2])
    Item
    Lab Test Name
    text
    C0022885 (UMLS CUI [1])
    Test Name
    Code List
    Lab Test Name
    CL Item
    Activated partical tromboplastin time (Activated partical tromboplastin time)
    CL Item
    Albumin (Albumin)
    CL Item
    Alkaline phosphatase (Alkaline phosphatase)
    CL Item
    Amylase (Amylase)
    CL Item
    Basophils (Basophils)
    CL Item
    Bicarbonate (Bicarbonate)
    CL Item
    Bilirubin (Bilirubin)
    CL Item
    Bilirubin direct (Bilirubin direct)
    CL Item
    Bilirubin total (Bilirubin total)
    CL Item
    Blood myoglobin (Blood myoglobin)
    CL Item
    Blood pH (Blood pH)
    CL Item
    Blood Pressure (Blood Pressure)
    CL Item
    Blood urea nitrogen (Blood urea nitrogen)
    CL Item
    Body temperature (Body temperature)
    CL Item
    Calcium (Calcium)
    CL Item
    CD4 Lymphocytes (CD4 Lymphocytes)
    CL Item
    CD8 lymphocytes (CD8 lymphocytes)
    CL Item
    Chloride (Chloride)
    CL Item
    Cholesterol total (Cholesterol total)
    CL Item
    C-reactive protein (C-reactive protein)
    CL Item
    Creatine (Creatine)
    CL Item
    Creatine phosphokinase (Creatine phosphokinase)
    CL Item
    Creatine phosphokinase MB (Creatine phosphokinase MB)
    CL Item
    Creatinine (Creatinine)
    CL Item
    Creatinine clearance (Creatinine clearance)
    CL Item
    Diastolic blood pressure (Diastolic blood pressure)
    CL Item
    Eosinophils (Eosinophils)
    CL Item
    Erithrocyte sedimentation rate (Erithrocyte sedimentation rate)
    CL Item
    Fasting blood glucose (Fasting blood glucose)
    CL Item
    FEV 1 (FEV 1)
    CL Item
    Gamma-glutamyltransferase (Gamma-glutamyltransferase)
    CL Item
    Glutamic-oxaloacetic transaminase (Glutamic-oxaloacetic transaminase)
    CL Item
    Glutamic-pyruvate transaminase (Glutamic-pyruvate transaminase)
    CL Item
    HbA1c (HbA1c)
    CL Item
    HBV-DNA decreased (HBV-DNA decreased)
    CL Item
    HBV-DNA increased (HBV-DNA increased)
    CL Item
    Heart rate (Heart rate)
    CL Item
    Hematocrit (Hematocrit)
    CL Item
    Hemoglobin (Hemoglobin)
    CL Item
    High density lipoprotein (High density lipoprotein)
    CL Item
    HIV viral load (HIV viral load)
    CL Item
    INR (INR)
    CL Item
    Lactic dehydrogenase (Lactic dehydrogenase)
    CL Item
    Lipase (Lipase)
    CL Item
    Low density lipoprotein (Low density lipoprotein)
    CL Item
    Lymphocytes (Lymphocytes)
    CL Item
    Magnesium (Magnesium)
    CL Item
    Mean cell hemoglobin concentration (Mean cell hemoglobin concentration)
    CL Item
    Mean corpuscular hemoglobin (Mean corpuscular hemoglobin)
    CL Item
    Mean corpuscular volume (Mean corpuscular volume)
    CL Item
    Monocytes (Monocytes)
    CL Item
    Neutrophils (Neutrophils)
    CL Item
    Oxygen saturation (Oxygen saturation)
    CL Item
    pCO2 (pCO2)
    CL Item
    pH (pH)
    CL Item
    Phosphate (Phosphate)
    CL Item
    Palatelet count (Palatelet count)
    CL Item
    pO2 (pO2)
    CL Item
    Potassium (Potassium)
    CL Item
    Protein total (Protein total)
    CL Item
    Prothrombin time (Prothrombin time)
    CL Item
    Red blood cell count (Red blood cell count)
    CL Item
    Respiratory rate (Respiratory rate)
    CL Item
    Reticulocyte count (Reticulocyte count)
    CL Item
    Serum glucose (Serum glucose)
    CL Item
    Serum uric acid (Serum uric acid)
    CL Item
    Sodium (Sodium)
    CL Item
    Systolic blood pressure (Systolic blood pressure)
    CL Item
    Thrombin time (Thrombin time)
    CL Item
    Total lung capacity (Total lung capacity)
    CL Item
    Triglycerides (Triglycerides)
    CL Item
    Troponin (Troponin)
    CL Item
    Troponin I (Troponin I)
    CL Item
    Troponin T (Troponin T)
    CL Item
    Urine myoglobin (Urine myoglobin)
    CL Item
    Urine pH (Urine pH)
    CL Item
    Vital capacity (Vital capacity)
    CL Item
    White blood cell count (White blood cell count)
    Test Date
    Item
    Test Date
    date
    C2826247 (UMLS CUI [1])
    Laboratory Test Result
    Item
    Laboratory Test Result
    text
    C0587081 (UMLS CUI [1])
    Laboratory Test Units
    Item
    Laboratory Test Units
    text
    C1519795 (UMLS CUI [1,1])
    C0587081 (UMLS CUI [1,2])
    Normal Low Range
    Item
    Normal Low Range
    text
    C1272773 (UMLS CUI [1])
    Normal High Range
    Item
    Normal High Range
    text
    C1299400 (UMLS CUI [1])
    Relevant other diagnostic laboratory results
    Item
    Relevant diagnostic results not noted above
    text
    C2347946 (UMLS CUI [1,1])
    C0587081 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    Item Group
    Investigational Product
    C0304229 (UMLS CUI-1)
    Item
    If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
    text
    C0034897 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C1517331 (UMLS CUI [1,3])
    C0304229 (UMLS CUI [1,4])
    event recurence after investigational product administered again
    Code List
    If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    CL Item
    Unknown at this time (U)
    CL Item
    Not applicable (X)
    Item Group
    General narrative comments
    C0947611 (UMLS CUI-1)
    General comment
    Item
    General narrative comment
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Non clinical
    C1320722 (UMLS CUI-1)
    send incomplete SAE data to sponsoring company
    Item
    Send incomplete SAE data to GSK Safety
    boolean
    C1519246 (UMLS CUI [1,1])
    C0205257 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [1,3])
    C1511726 (UMLS CUI [1,4])
    C2347796 (UMLS CUI [1,5])
    Receipt date by sponsoring company
    Item
    Receipt by GSK date
    datetime
    C2985846 (UMLS CUI [1,1])
    C2347796 (UMLS CUI [1,2])
    Serious Adverse Event
    Item
    Was the event serious?
    boolean
    C1519255 (UMLS CUI [1])
    SAE Sequence Number
    Item
    SAE Sequence Number
    text
    C1519255 (UMLS CUI [1,1])
    C2348184 (UMLS CUI [1,2])
    Version Number
    Item
    Version Number
    text
    C2985700 (UMLS CUI [1])
    Case ID
    Item
    Case ID
    text
    C1698493 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Randomisation Number
    Item
    Randomisation Number
    text
    C0034656 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    OCEANS Code
    Item
    OCEANS Code
    text
    C0805701 (UMLS CUI [1,1])
    C1516728 (UMLS CUI [1,2])
    Email
    Item
    Email Flag
    text
    C0013849 (UMLS CUI [1])
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