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ID

30780

Description

Study ID: 107979 Clinical Study ID: TXA107979 Study Title: TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00843024 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan/naproxen Trade Name: Treximet Study Indication: Migraine Disorders CRF Seiten: 879-993

Keywords

Versions (1)
  1. 6/20/18 6/20/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 20, 2018

DOI

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License

Creative Commons BY-NC 3.0
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    TXA107979: Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine NCT00843024

    German English

    LOG Visit

    1 forms  
    1. StudyEvent: ODM
      1. LOG Visit
    Date of Visit/Assessment
    Description

    Date of Visit/Assessment

    Alias
    UMLS CUI-1
    C1320303
    Date of Visit
    Description

    Date of Visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Adverse event
    Description

    Adverse event

    Alias
    UMLS CUI-1
    C0877248
    non-serious adverse events
    Description

    non-serious adverse events

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1518404
    Log status
    Description

    Log status

    Alias
    UMLS CUI-1
    C1708728
    UMLS CUI-2
    C0449438
    serious adverse events
    Description

    serious adverse events

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    concomitant medications
    Description

    concomitant medications

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    Concomitant Medications
    Description

    Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852
    Sequence number
    Description

    Sequence number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348184
    Drug name
    Description

    Drug name

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013227
    Modified reported term
    Description

    Modified reported term

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826302
    UMLS CUI [2]
    C2347852
    Unit Dose
    Description

    Unit Dose

    Data type

    float

    Alias
    UMLS CUI [1]
    C0869039
    Units
    Description

    Units

    Data type

    text

    Alias
    UMLS CUI [1]
    C1519795
    Frequency
    Description

    Frequency

    Data type

    text

    Alias
    UMLS CUI [1]
    C3476109
    Route
    Description

    Route

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013153
    Reason for Medication
    Description

    Reason for Medication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0013227
    Generic Dispensed
    Description

    Generic Dispensed

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3242750
    Prescription or OTC
    Description

    Prescription or OTC

    Data type

    text

    Alias
    UMLS CUI [1]
    C3166216
    UMLS CUI [2]
    C0013231
    Medication start datetime
    Description

    Medication start datetime

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C3173309
    Taken Prior to Study?
    Description

    Taken Prior to Study?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826667
    medication ongoing
    Description

    medication ongoing

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826666
    Concomitant Medication End Date
    Description

    Concomitant Medication End Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826744
    Device used to administer medication
    Description

    Device used to administer medication

    Data type

    text

    Alias
    UMLS CUI [1]
    C0699733
    Total Daily Dose
    Description

    Total Daily Dose

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348070
    drug adminstered for an exacerbation
    Description

    drug adminstered for an exacerbation

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3469597
    UMLS CUI [1,2]
    C4086268
    Rescue Medication
    Description

    Rescue Medication

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0884980
    kumulative Dosis
    Description

    Total Dose

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2986497
    drug use
    Description

    drug use

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0242510
    Total duration
    Description

    Total duration

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0449238
    duration
    Description

    duration

    Data type

    text

    Alias
    UMLS CUI [1]
    C0449238
    Non-serious adverse event
    Description

    Non-serious adverse event

    Sequence Number
    Description

    Sequence Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348184
    Non-serious adverse event
    Description

    Non-serious adverse event

    Data type

    text

    Alias
    UMLS CUI [1]
    C1518404
    Modified term
    Description

    Modified term

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826302
    MedDRA synonym
    Description

    MedDRA synonym

    Data type

    text

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

    MedDRA lower level term code

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2826302
    UMLS CUI [1,2]
    C1518404
    Start Date
    Description

    Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0808070
    Outcome
    Description

    Outcome

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1705586
    End date
    Description

    End date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0806020
    Maximum Intensity
    Description

    Maximum Intensity

    Data type

    text

    Alias
    UMLS CUI [1]
    C1710066
    Intensity at onset of event
    Description

    Intensity at onset of event

    Data type

    text

    Alias
    UMLS CUI [1]
    C1710066
    Maximum Grade
    Description

    Maximum Grade

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0441799
    Grade at onset of event
    Description

    Grade at onset of event

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2985916
    UMLS CUI [1,2]
    C0441799
    Maximum Grade or Intensity
    Description

    Maximum Grade or Intensity

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0441799
    UMLS CUI [1,2]
    C1710066
    Grade or Intensity at onset of event
    Description

    Grade or Intensity at onset of event

    Data type

    text

    Alias
    UMLS CUI [1]
    C1710066
    Action Taken with Investigational Product
    Description

    Action Taken with Investigational Product

    Data type

    text

    Alias
    UMLS CUI [1]
    C1704758
    Withdrawal from study
    Description

    Withdrawal from study

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0422727
    AE caused by investigational product
    Description

    AE caused by investigational product

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013230
    UMLS CUI [1,2]
    C1518404
    Duration of AE hours
    Description

    Duration of AE hours

    Data type

    integer

    Measurement units
    • h
    Alias
    UMLS CUI [1,1]
    C0449238
    UMLS CUI [1,2]
    C1519255
    h
    Duration of AE minutes
    Description

    Duration of AE minutes

    Data type

    integer

    Measurement units
    • min
    Alias
    UMLS CUI [1,1]
    C0449238
    UMLS CUI [1,2]
    C1518404
    min
    Time to Onset Since Last Dose hours
    Description

    Time to Onset Since Last Dose hours

    Data type

    integer

    Measurement units
    • h
    Alias
    UMLS CUI [1,1]
    C0449244
    UMLS CUI [1,2]
    C1762893
    UMLS CUI [1,3]
    C1518404
    h
    Time to Onset Since Last Dose minutes
    Description

    Time to Onset Since Last Dose minutes

    Data type

    integer

    Measurement units
    • min
    Alias
    UMLS CUI [1,1]
    C0449244
    UMLS CUI [1,2]
    C1762893
    UMLS CUI [1,3]
    C1518404
    min
    Report
    Description

    Report

    Initial report
    Description

    Initial report

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0684224
    Follow-up report
    Description

    Follow-up report

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1704685
    Randomisation
    Description

    Randomisation

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

    SAE after initiation of study medication

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2826666
    UMLS CUI [1,2]
    C1519255
    Serious Adverse Event
    Description

    Serious Adverse Event

    Alias
    UMLS CUI-1
    C1519255
    Sequence Number
    Description

    Sequence Number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2348184
    Modified term
    Description

    Modified term

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2826302
    UMLS CUI [1,2]
    C1519255
    MedDRA synonym
    Description

    MedDRA synonym

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1140263
    UMLS CUI [1,2]
    C1519255
    MedDRA lower level term code
    Description

    MedDRA lower level term code

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3898442
    UMLS CUI [1,2]
    C1519255
    serious adverse event
    Description

    serious adverse event

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    Did SAE occur after initiation of study medication
    Description

    Did SAE occur after initiation of study medication

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0304229
    Serious Adverse Event
    Description

    Serious Adverse Event

    Data type

    text

    Alias
    UMLS CUI [1]
    C1519255
    Serious Adverse Event Start Date
    Description

    Serious Adverse Event Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2697888
    Start Time Serious Adverse Event
    Description

    Start Time Serious Adverse Event

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2697889
    Serious Adverse Event End Date
    Description

    Serious Adverse Event End Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2697886
    Serious Adverse Event End Time
    Description

    Serious Adverse Event End Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2826658
    Outcome
    Description

    Outcome

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1624730
    UMLS CUI [1,2]
    C1519255
    Date of Death
    Description

    Date of Death

    Data type

    date

    Alias
    UMLS CUI [1]
    C1148348
    Intensity (maximum)
    Description

    Intensity (maximum)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0518690
    UMLS CUI [1,2]
    C1519255
    Intensity at onset of event
    Description

    Intensity at onset of event

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0518690
    Maximum Grade
    Description

    Maximum Grade

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0441799
    Grade at onset of event
    Description

    Grade at onset of event

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2985911
    Maximum Grade or Intensity
    Description

    Maximum Grade or Intensity

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0441799
    UMLS CUI [1,2]
    C1710066
    Grade or Intensity at onset of event
    Description

    Grade or Intensity at onset of event

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0518690
    Action Taken
    Description

    Action Taken

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1547656
    Relationship investigational product
    Description

    Relationship investigational product

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0085978
    UMLS CUI [1,3]
    C1519255
    Did the subject withdraw from study as a result of this AE?
    Description

    Did the subject withdraw from study as a result of this AE?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1710677
    UMLS CUI [1,2]
    C1519255
    Duration of AE if < 24 hours
    Description

    Duration of AE if < 24 hours

    Data type

    integer

    Measurement units
    • Hr(s)
    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0449238
    Hr(s)
    Time to Onset Since Last Dose
    Description

    Time to Onset Since Last Dose

    Data type

    integer

    Measurement units
    • Min(s)
    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0946444
    UMLS CUI [1,3]
    C0449244
    Min(s)
    SAE Causation
    Description

    SAE Causation

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3641099
    UMLS CUI [1,2]
    C1519255
    Serious Adverse Event
    Description

    Serious Adverse Event

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    investigational product
    Description

    investigational product

    Data type

    text

    Alias
    UMLS CUI [1]
    C0304229
    Intensity changes
    Description

    Intensity changes

    Serious Adverse Event Intensity changes
    Description

    Serious Adverse Event Intensity changes

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0518690
    Start Date of event segment
    Description

    Start Date of event segment

    Data type

    date

    Alias
    UMLS CUI [1]
    C2697888
    Start Time of event segment
    Description

    Start Time of event segment

    Data type

    time

    Alias
    UMLS CUI [1]
    C2697889
    Intensity of event segment
    Description

    Intensity of event segment

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0518690
    Grade of event segment
    Description

    Grade of event segment

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2985911
    Grade or Intensity of event segment
    Description

    Grade or Intensity of event segment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0518690
    Seriousness
    Description

    Seriousness

    Alias
    UMLS CUI-1
    C0871902
    UMLS CUI-2
    C1519255
    Seriousness
    Description

    Seriousness

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1710056
    Seriousness Other
    Description

    Seriousness Other

    Data type

    text

    Alias
    UMLS CUI [1]
    C1710056
    Relevant concomitant/treatment medications
    Description

    Relevant concomitant/treatment medications

    CM Sequence Number
    Description

    CM Sequence Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348184
    Drug name
    Description

    Drug name

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013227
    Modified reported term
    Description

    Modified reported term

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826819
    Dose
    Description

    Dose

    Data type

    text

    Alias
    UMLS CUI [1]
    C3174092
    units of medication
    Description

    units of medication

    Data type

    text

    Alias
    UMLS CUI [1]
    C1519795
    Frequency
    Description

    Frequency

    Data type

    text

    Alias
    UMLS CUI [1]
    C3476109
    Route of medication
    Description

    Route of medication

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013153
    Start Date
    Description

    Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0808070
    Ongoing medication
    Description

    Ongoing medication

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826666
    End date medication
    Description

    End date medication

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1521826
    UMLS CUI [1,2]
    C0806020
    Primary Indication
    Description

    Primary Indication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3146298
    UMLS CUI [1,2]
    C2347852
    UMLS CUI [1,3]
    C1519255
    Modified reported term
    Description

    Modified reported term

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826819
    Drug Type
    Description

    Drug Type

    Data type

    text

    Alias
    UMLS CUI [1]
    C0457591
    Relevant diagnostic results
    Description

    Relevant diagnostic results

    Lab Sequence Number
    Description

    Lab Sequence Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348184
    Test Name
    Description

    Test Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C0022885
    Test Date
    Description

    Test Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826247
    Test Result
    Description

    Test Result

    Data type

    text

    Alias
    UMLS CUI [1]
    C0456984
    Test Units
    Description

    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]
    C2700150
    Normal High Range
    Description

    Normal High Range

    Data type

    text

    Alias
    UMLS CUI [1]
    C2700149
    Relevant diagnostic results not noted above
    Description

    Relevant diagnostic results not noted above

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0430022
    UMLS CUI [1,2]
    C1274040
    Rechallenge
    Description

    Rechallenge

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0085978
    UMLS CUI [1,2]
    C0877248
    investigational product
    Description

    investigational product

    Alias
    UMLS CUI-1
    C0304229
    Drug
    Description

    Drug

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013227
    start date
    Description

    start date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0808070
    stop date
    Description

    stop date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0806020
    Regimen
    Description

    Regimen

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1276413
    UMLS CUI [1,2]
    C0013227
    General narrative comments
    Description

    General narrative comments

    General narrative comments
    Description

    General narrative comments

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0678257
    UMLS CUI [1,2]
    C1519255
    Non clinical
    Description

    Non clinical

    incomplete SAE data GSK Safety
    Description

    incomplete SAE data GSK Safety

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1710056
    Receipt by GSK date
    Description

    Receipt by GSK date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985846
    Receipt by GSK date
    Description

    Receipt by GSK date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985846
    serious SAE
    Description

    serious SAE

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    SAE Sequence Number
    Description

    SAE Sequence Number

    Data type

    text

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

    Version Number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2985700
    Case ID
    Description

    Case ID

    Data type

    text

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

    Randomisation Number

    Data type

    text

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

    OCEANS Code

    Data type

    text

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

    Email Flag

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013849
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    LOG Visit

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    1. StudyEvent: ODM
      1. LOG Visit
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1320303 (UMLS CUI-1)
    Date of Visit
    Item
    date
    C1320303 (UMLS CUI [1])
    Item Group
    C0877248 (UMLS CUI-1)
    non-serious adverse events
    Item
    boolean
    C1518404 (UMLS CUI [1])
    Item Group
    C1708728 (UMLS CUI-1)
    C0449438 (UMLS CUI-2)
    serious adverse events
    Item
    boolean
    C1519255 (UMLS CUI [1])
    concomitant medications
    Item
    boolean
    C2347852 (UMLS CUI [1])
    Item Group
    C2347852 (UMLS CUI-1)
    Sequence number
    Item
    integer
    C2348184 (UMLS CUI [1])
    Drug name
    Item
    text
    C0013227 (UMLS CUI [1])
    Modified reported term
    Item
    text
    C2826302 (UMLS CUI [1])
    C2347852 (UMLS CUI [2])
    Unit Dose
    Item
    float
    C0869039 (UMLS CUI [1])
    Units
    Item
    text
    C1519795 (UMLS CUI [1])
    Frequency
    Item
    text
    C3476109 (UMLS CUI [1])
    Route
    Item
    text
    C0013153 (UMLS CUI [1])
    Reason for Medication
    Item
    text
    C0392360 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Generic Dispensed
    Item
    boolean
    C3242750 (UMLS CUI [1])
    Item
    text
    C3166216 (UMLS CUI [1])
    C0013231 (UMLS CUI [2])
    Prescription or OTC
    Code List
    Prescription or OTC
    CL Item
     (1)
    CL Item
     (2)
    Medication start datetime
    Item
    datetime
    C3173309 (UMLS CUI [1])
    Taken Prior to Study?
    Item
    boolean
    C2826667 (UMLS CUI [1])
    medication ongoing
    Item
    boolean
    C2826666 (UMLS CUI [1])
    Concomitant Medication End Date
    Item
    date
    C2826744 (UMLS CUI [1])
    Device used to administer medication
    Item
    text
    C0699733 (UMLS CUI [1])
    Total Daily Dose
    Item
    integer
    C2348070 (UMLS CUI [1])
    drug adminstered for an exacerbation
    Item
    boolean
    C3469597 (UMLS CUI [1,1])
    C4086268 (UMLS CUI [1,2])
    Rescue Medication
    Item
    boolean
    C0013227 (UMLS CUI [1,1])
    C0884980 (UMLS CUI [1,2])
    Total Dose
    Item
    kumulative Dosis
    integer
    C2986497 (UMLS CUI [1])
    drug use
    Item
    boolean
    C0242510 (UMLS CUI [1])
    Total duration
    Item
    integer
    C2347852 (UMLS CUI [1,1])
    C0449238 (UMLS CUI [1,2])
    duration
    Item
    text
    C0449238 (UMLS CUI [1])
    Sequence Number
    Item
    text
    C2348184 (UMLS CUI [1])
    Non-serious adverse event
    Item
    text
    C1518404 (UMLS CUI [1])
    Modified term
    Item
    text
    C2826302 (UMLS CUI [1])
    MedDRA synonym
    Item
    text
    C1140263 (UMLS CUI [1])
    MedDRA lower level term code
    Item
    text
    C2826302 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Start Date
    Item
    date
    C0808070 (UMLS CUI [1])
    Item
    integer
    C1705586 (UMLS CUI [1])
    Outcome / End Date
    Code List
    Outcome
    CL Item
     (1)
    C1709863 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (2)
    C1709864 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (3)
    C1709277 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (4)
    C1709862 (UMLS CUI-1)
    (Comment:en)
    End date
    Item
    date
    C0806020 (UMLS CUI [1])
    Item
    text
    C1710066 (UMLS CUI [1])
    Maximum Intensity
    Code List
    Maximum Intensity
    CL Item
     (1)
    C2945599 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (2)
    C0205081 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (3)
    C0205082 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (X)
    C1272460 (UMLS CUI-1)
    (Comment:en)
    Item
    text
    C1710066 (UMLS CUI [1])
    Maximum Intensity
    Code List
    Intensity at onset of event
    CL Item
     (1)
    C2945599 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (2)
    C0205081 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (3)
    C0205082 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (X)
    C1272460 (UMLS CUI-1)
    (Comment:en)
    Item
    integer
    C0441799 (UMLS CUI [1])
    Maximum Grade
    Code List
    Maximum Grade
    CL Item
     (1)
    C0687695 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (2)
    C1522446 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (3)
    C0450094 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (4)
    C0547054 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (5)
    C2985911 (UMLS CUI-1)
    (Comment:en)
    Item
    integer
    C2985916 (UMLS CUI [1,1])
    C0441799 (UMLS CUI [1,2])
    Maximum Grade
    Code List
    Grade at onset of event
    CL Item
     (1)
    C0687695 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (2)
    C1522446 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (3)
    C0450094 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (4)
    C0547054 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (5)
    C2985911 (UMLS CUI-1)
    (Comment:en)
    Item
    text
    C0441799 (UMLS CUI [1,1])
    C1710066 (UMLS CUI [1,2])
    Maximum Grade or Intensity
    Code List
    Maximum Grade or Intensity
    CL Item
     (1)
    CL Item
     (2)
    CL Item
     (3)
    CL Item
     (4)
    CL Item
     (5)
    CL Item
     (X)
    Item
    text
    C1710066 (UMLS CUI [1])
    Maximum Grade or Intensity
    Code List
    Grade or Intensity at onset of event
    CL Item
     (1)
    CL Item
     (2)
    CL Item
     (3)
    CL Item
     (4)
    CL Item
     (5)
    CL Item
     (X)
    Item
    text
    C1704758 (UMLS CUI [1])
    Action Taken with Investigational Product
    Code List
    Action Taken with Investigational Product
    CL Item
     (1)
    C0304229 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (X)
    C1272460 (UMLS CUI-1)
    (Comment:en)
    Withdrawal from study
    Item
    boolean
    C0422727 (UMLS CUI [1])
    AE caused by investigational product
    Item
    boolean
    C0013230 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Duration of AE hours
    Item
    integer
    C0449238 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Duration of AE minutes
    Item
    integer
    C0449238 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Time to Onset Since Last Dose hours
    Item
    integer
    C0449244 (UMLS CUI [1,1])
    C1762893 (UMLS CUI [1,2])
    C1518404 (UMLS CUI [1,3])
    Time to Onset Since Last Dose minutes
    Item
    integer
    C0449244 (UMLS CUI [1,1])
    C1762893 (UMLS CUI [1,2])
    C1518404 (UMLS CUI [1,3])
    Item Group
    Initial report
    Item
    boolean
    C0684224 (UMLS CUI [1])
    Follow-up report
    Item
    boolean
    C1704685 (UMLS CUI [1])
    Item Group
    C0034656 (UMLS CUI-1)
    SAE after initiation of study medication
    Item
    boolean
    C2826666 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item Group
    C1519255 (UMLS CUI-1)
    Sequence Number
    Item
    text
    C1519255 (UMLS CUI [1,1])
    C2348184 (UMLS CUI [1,2])
    Modified term
    Item
    text
    C2826302 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    MedDRA synonym
    Item
    text
    C1140263 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    MedDRA lower level term code
    Item
    text
    C3898442 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    serious adverse event
    Item
    boolean
    C1519255 (UMLS CUI [1])
    Did SAE occur after initiation of study medication
    Item
    boolean
    C1519255 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    Serious Adverse Event
    Item
    text
    C1519255 (UMLS CUI [1])
    Serious Adverse Event Start Date
    Item
    date
    C1519255 (UMLS CUI [1,1])
    C2697888 (UMLS CUI [1,2])
    Start Time Serious Adverse Event
    Item
    time
    C1519255 (UMLS CUI [1,1])
    C2697889 (UMLS CUI [1,2])
    Serious Adverse Event End Date
    Item
    date
    C1519255 (UMLS CUI [1,1])
    C2697886 (UMLS CUI [1,2])
    Serious Adverse Event End Time
    Item
    time
    C1519255 (UMLS CUI [1,1])
    C2826658 (UMLS CUI [1,2])
    Item
    integer
    C1624730 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Outcome
    Code List
    Outcome
    CL Item
     (1)
    CL Item
     (2)
    CL Item
     (3)
    CL Item
     (4)
    CL Item
     (5)
    Date of Death
    Item
    date
    C1148348 (UMLS CUI [1])
    Item
    text
    C0518690 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Intensity (maximum)
    Code List
    Intensity (maximum)
    CL Item
     (1)
    (Comment:en)
    CL Item
     (2)
    (Comment:en)
    CL Item
     (3)
    (Comment:en)
    CL Item
     (X)
    (Comment:en)
    Item
    text
    C0877248 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Intensity (maximum)
    Code List
    Intensity at onset of event
    CL Item
     (1)
    (Comment:en)
    CL Item
     (2)
    (Comment:en)
    CL Item
     (3)
    (Comment:en)
    CL Item
     (X)
    (Comment:en)
    Item
    integer
    C0441799 (UMLS CUI [1])
    Serious Adverse Event Maximum Grade
    Code List
    Maximum Grade
    CL Item
     (1)
    CL Item
     (2)
    CL Item
     (3)
    CL Item
     (4)
    CL Item
     (5)
    Item
    integer
    C2985911 (UMLS CUI [1])
    Serious Adverse Event Maximum Grade
    Code List
    Grade at onset of event
    CL Item
     (1)
    CL Item
     (2)
    CL Item
     (3)
    CL Item
     (4)
    CL Item
     (5)
    Item
    text
    C0441799 (UMLS CUI [1,1])
    C1710066 (UMLS CUI [1,2])
    Serious Adverse Event Maximum Grade
    Code List
    Maximum Grade or Intensity
    CL Item
     (1)
    CL Item
     (2)
    CL Item
     (3)
    CL Item
     (4)
    CL Item
     (5)
    CL Item
     (X)
    Item
    text
    C0877248 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Serious Adverse Event Maximum Grade
    Code List
    Grade or Intensity at onset of event
    CL Item
     (1)
    CL Item
     (2)
    CL Item
     (3)
    CL Item
     (4)
    CL Item
     (5)
    CL Item
     (X)
    Item
    integer
    C1547656 (UMLS CUI [1])
    Action Taken
    Code List
    Action Taken
    CL Item
     (1)
    CL Item
     (2)
    CL Item
     (3)
    CL Item
     (4)
    CL Item
     (5)
    CL Item
     (6)
    Relationship investigational product
    Item
    boolean
    C0304229 (UMLS CUI [1,1])
    C0085978 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [1,3])
    Did the subject withdraw from study as a result of this AE?
    Item
    boolean
    C1710677 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Duration of AE if < 24 hours
    Item
    integer
    C1519255 (UMLS CUI [1,1])
    C0449238 (UMLS CUI [1,2])
    Time to Onset Since Last Dose
    Item
    integer
    C1519255 (UMLS CUI [1,1])
    C0946444 (UMLS CUI [1,2])
    C0449244 (UMLS CUI [1,3])
    SAE Causation
    Item
    boolean
    C3641099 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Serious Adverse Event
    Item
    boolean
    C1519255 (UMLS CUI [1])
    investigational product
    Item
    text
    C0304229 (UMLS CUI [1])
    Serious Adverse Event Intensity changes
    Item
    text
    C1519255 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Start Date of event segment
    Item
    date
    C2697888 (UMLS CUI [1])
    Start Time of event segment
    Item
    time
    C2697889 (UMLS CUI [1])
    Item
    integer
    C0877248 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Maximum Intensity
    Code List
    Intensity of event segment
    CL Item
     (1)
    CL Item
     (2)
    CL Item
     (3)
    Item
    integer
    C2985911 (UMLS CUI [1])
    Grade at onset of event
    Code List
    Grade of event segment
    CL Item
     (1)
    CL Item
     (2)
    CL Item
     (3)
    CL Item
     (4)
    CL Item
     (5)
    Item
    text
    C0877248 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Grade or Intensity at onset of event
    Code List
    Grade or Intensity of event segment
    CL Item
     (1)
    CL Item
     (2)
    CL Item
     (3)
    CL Item
     (4)
    CL Item
     (5)
    Item Group
    C0871902 (UMLS CUI-1)
    C1519255 (UMLS CUI-2)
    Item
    integer
    C1710056 (UMLS CUI [1])
    Seriousness
    Code List
    Seriousness
    CL Item
     (1)
    CL Item
     (2)
    CL Item
     (3)
    CL Item
     (4)
    CL Item
     (5)
    CL Item
     (6)
    Seriousness Other
    Item
    text
    C1710056 (UMLS CUI [1])
    CM Sequence Number
    Item
    text
    C2348184 (UMLS CUI [1])
    Drug name
    Item
    text
    C0013227 (UMLS CUI [1])
    Modified reported term
    Item
    text
    C2826819 (UMLS CUI [1])
    Dose
    Item
    text
    C3174092 (UMLS CUI [1])
    Item
    text
    C1519795 (UMLS CUI [1])
    units of medication
    Code List
    units of medication
    CL Item
     (ACTU)
    CL Item
     (AMP)
    CL Item
     (AP)
    CL Item
     (BT)
    CL Item
     (CAP)
    CL Item
     (CC)
    CL Item
     (031)
    CL Item
     (002)
    CL Item
     (025)
    CL Item
     (028)
    CL Item
     (IUML)
    CL Item
     (011)
    CL Item
     (LM)
    CL Item
     (LOZ)
    CL Item
     (MEGU)
    CL Item
     (004)
    CL Item
     (004)
    CL Item
     (008)
    CL Item
     (MCG/KG/MIN)
    CL Item
     (MCG/MIN)
    CL Item
     (013)
    CL Item
     (029)
    CL Item
     (MEQ24)
    CL Item
     (003)
    CL Item
     (MGPER)
    CL Item
     (MGH)
    CL Item
     (007)
    CL Item
     (MGKH)
    CL Item
     (MGKM)
    CL Item
     (009)
    CL Item
     (MGML)
    CL Item
     (012)
    CL Item
     (MLH)
    CL Item
     (MLM)
    CL Item
     (023)
    CL Item
     (027)
    CL Item
     (MAC)
    CL Item
     (NEB)
    CL Item
     (PAT)
    CL Item
     (030)
    CL Item
     (PUFF)
    CL Item
     (SAC)
    CL Item
     (SPR)
    CL Item
     (SUP)
    CL Item
     (TBS)
    CL Item
     (TAB)
    CL Item
     (TSP)
    CL Item
     (UNT)
    CL Item
     (U)
    CL Item
     (VIA)
    Item
    text
    C3476109 (UMLS CUI [1])
    Frequency
    Code List
    Frequency
    CL Item
     (2W)
    CL Item
     (2W)
    CL Item
     (4W)
    CL Item
     (5D)
    CL Item
     (5W)
    CL Item
     (AC)
    CL Item
     (2D)
    CL Item
     (CO)
    CL Item
     (FO)
    CL Item
     (Q3W)
    CL Item
     (Q3M)
    CL Item
     (AD)
    CL Item
     (1N)
    CL Item
     (MO)
    CL Item
     (WE)
    CL Item
     (1D)
    CL Item
     (1S)
    CL Item
     (PC)
    CL Item
     (PRN)
    CL Item
     (12D)
    CL Item
     (Q3D)
    CL Item
     (Q4D)
    CL Item
     (6D)
    CL Item
     (4D)
    CL Item
     (3D)
    CL Item
     (2D)
    CL Item
     (1M)
    CL Item
     (24D)
    CL Item
     (4D)
    CL Item
     (1N)
    CL Item
     (3D)
    CL Item
     (U)
    Item
    text
    C0013153 (UMLS CUI [1])
    Route of medication
    Code List
    Route of medication
    CL Item
     (047)
    C0229118 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (008)
    C0014537 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (GT)
    C0017196 (UMLS CUI-1)
    C0041281 (UMLS CUI-2)
    (Comment:en)
    CL Item
     (055)
    C0004048 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (INJ)
    C1272883 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (013)
    C0694634 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (IBU)
    C0230212 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (026)
    C1512954 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (030)
    C0442117 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (045)
    C0442118 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (031)
    CL Item
     (IOS)
    CL Item
     (033)
    CL Item
     (037)
    CL Item
     (015)
    CL Item
     (042)
    CL Item
     (045)
    CL Item
     (048)
    CL Item
     (054)
    CL Item
     (058)
    CL Item
     (060)
    CL Item
     (061)
    CL Item
     (062)
    CL Item
     (065)
    CL Item
     (067)
    Start Date
    Item
    date
    C0808070 (UMLS CUI [1])
    Ongoing medication
    Item
    boolean
    C2826666 (UMLS CUI [1])
    End date medication
    Item
    date
    C1521826 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Primary Indication
    Item
    text
    C3146298 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [1,3])
    Modified reported term
    Item
    text
    C2826819 (UMLS CUI [1])
    Item
    text
    C0457591 (UMLS CUI [1])
    Drug Type
    Code List
    Drug Type
    CL Item
     (2)
    CL Item
     (T)
    CL Item
     (1)
    Lab Sequence Number
    Item
    text
    C2348184 (UMLS CUI [1])
    Item
    text
    C0022885 (UMLS CUI [1])
    Test Name
    Code List
    Test Name
    CL Item
     (Activated partial thromboplastin time)
    C0030605 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (Alanine aminotransferase)
    C0201899 (UMLS CUI-1)
    C0201836 (UMLS CUI-2)
    (Comment:en)
    CL Item
     (Albumin)
    C0201838 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (Alkaline phosphatase)
    C0201850 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (Amylase)
    C0201883 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (Aspartate aminotransferase)
    C0201899 (UMLS CUI-1)
    C0201836 (UMLS CUI-2)
    (Comment:en)
    CL Item
     (Basophils)
    C0004827 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (Bicarbonate)
    C0202059 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (Bilirubin)
    C1278039 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (Bilirubin direct)
    C0201916 (UMLS CUI-1)
    (Comment:en)
    CL Item
     (Bilirubin total)
    CL Item
     (Blood myoglobin)
    CL Item
     (Blood pH)
    CL Item
     (Blood pressure)
    CL Item
     (Blood urea nitrogen)
    CL Item
     (Body temperature)
    CL Item
     (Calcium)
    CL Item
     (CD4 lymphocytes)
    CL Item
     (CD8 lymphocytes)
    CL Item
     (Chloride)
    CL Item
     (Cholesterol total)
    CL Item
     (C-reactive protein)
    CL Item
     (Creatine)
    CL Item
     (Creatine phosphokinase)
    CL Item
     (Creatine phosphokinase MB)
    CL Item
     (Creatinine)
    CL Item
     (Creatinine clearance)
    CL Item
     (Diastolic blood pressure)
    CL Item
     (Eosinophils)
    CL Item
     (Erythrocyte sedimentation rate)
    CL Item
     (Fasting blood glucose)
    CL Item
     (FEV 1)
    CL Item
     (Gamma-glutamyltransferase)
    CL Item
     (HbA1c)
    CL Item
     (HBV-DNA decreased)
    CL Item
     (HBV-DNA increased)
    CL Item
     (Heart rate)
    CL Item
     (Hematocrit)
    CL Item
     (Hemoglobin)
    CL Item
     (High density lipoprotein)
    CL Item
     (HIV viral load)
    CL Item
     (INR)
    CL Item
     (Lactic dehydrogenase)
    CL Item
     (Lipase)
    CL Item
     (Low density lipoprotein)
    CL Item
     (Lymphocytes)
    CL Item
     (Magnesium)
    CL Item
     (Mean cell hemoglobin concentration)
    CL Item
     (Mean corpuscular hemoglobin)
    CL Item
     (Mean corpuscular volume)
    CL Item
     (Monocytes)
    CL Item
     (Neutrophils)
    CL Item
     (Oxygen saturation)
    CL Item
     (pCO2)
    CL Item
     (pH)
    CL Item
     (Phosphate)
    CL Item
     (Platelet count)
    CL Item
     (pO2)
    CL Item
     (Potassium)
    CL Item
     (Protein total)
    CL Item
     (Prothrombin time)
    CL Item
     (Red blood cell count)
    CL Item
     (Respiratory rate)
    CL Item
     (Reticulocyte count)
    CL Item
     (Serum glucose)
    CL Item
     (Serum uric acid)
    CL Item
     (Sodium)
    CL Item
     (Systolic blood pressure)
    CL Item
     (Thrombin time)
    CL Item
     (Total lung capacity)
    CL Item
     (Triglycerides)
    CL Item
     (Troponin)
    CL Item
     (Troponin I)
    CL Item
     (Troponin T)
    CL Item
     (Urine myoglobin)
    CL Item
     (Urine pH)
    CL Item
     (Vital capacity)
    CL Item
     (White blood cell count)
    Test Date
    Item
    date
    C2826247 (UMLS CUI [1])
    Test Result
    Item
    text
    C0456984 (UMLS CUI [1])
    Test Units
    Item
    text
    C1519795 (UMLS CUI [1,1])
    C0587081 (UMLS CUI [1,2])
    Normal Low Range
    Item
    text
    C2700150 (UMLS CUI [1])
    Normal High Range
    Item
    text
    C2700149 (UMLS CUI [1])
    Relevant diagnostic results not noted above
    Item
    text
    C0430022 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Item
    text
    C0085978 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Rechallenge
    Code List
    Rechallenge
    CL Item
     (N)
    CL Item
     (Y)
    CL Item
     (U)
    CL Item
     (X)
    Item Group
    C0304229 (UMLS CUI-1)
    Drug
    Item
    text
    C0013227 (UMLS CUI [1])
    start date
    Item
    date
    C0808070 (UMLS CUI [1])
    stop date
    Item
    date
    C0806020 (UMLS CUI [1])
    Regimen
    Item
    text
    C1276413 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    General narrative comments
    Item
    text
    C0678257 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item Group
    incomplete SAE data GSK Safety
    Item
    boolean
    C1710056 (UMLS CUI [1])
    Receipt by GSK date
    Item
    date
    C2985846 (UMLS CUI [1])
    Receipt by GSK date
    Item
    date
    C2985846 (UMLS CUI [1])
    serious SAE
    Item
    boolean
    C1519255 (UMLS CUI [1])
    SAE Sequence Number
    Item
    text
    C1519255 (UMLS CUI [1,1])
    C2348184 (UMLS CUI [1,2])
    Version Number
    Item
    integer
    C2985700 (UMLS CUI [1])
    Case ID
    Item
    text
    C1698493 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Randomisation Number
    Item
    text
    C0034656 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    OCEANS Code
    Item
    text
    C0805701 (UMLS CUI [1,1])
    C1516728 (UMLS CUI [1,2])
    Email Flag
    Item
    text
    C0013849 (UMLS CUI [1])
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