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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/Assessment
    Description

    Date of Visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    AE status
    Description

    AE status

    Alias
    UMLS CUI-1
    C0877248
    Did the subject experience any non-serious adverse events during the study?
    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
    4. Did the subject experience any serious adverse events during the study?
    Description

    serious adverse events

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    5. Were any Non-Diary concomitant medications taken by the subject prior to screening and/or during the study?
    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 (Trade name preferred)
    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
    Stat Date
    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
    Ongoing
    Description

    If No, specify End Date

    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
    Was drug administered for an exacerbation?
    Description

    drug adminstered for an exacerbation

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3469597
    UMLS CUI [1,2]
    C4086268
    Was drug administered as a rescue medication?
    Description

    Rescue Medication

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0884980
    Cumulative Dose used?
    Description

    Total Dose

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2986497
    Was drug ever used
    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 unit
    Description

    duration

    Data type

    text

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

    Non-serious adverse event

    Sequence Number
    Description

    [hidden]

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348184
    Event
    Description

    Diagnosis Only (if known) Otherwise Sign/Symptom

    Data type

    text

    Alias
    UMLS CUI [1]
    C1518404
    Modified term
    Description

    [hidden]

    Data type

    text

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

    Condition item Start Time is conditional. If times of intensity/toxicity change are being collected, AE start times must also be collected.

    Data type

    date

    Alias
    UMLS CUI [1]
    C0808070
    Outcome
    Description

    Outcome

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1705586
    End date
    Description

    If outcome "Recovered/Resolved" or "Recovered/Resolved with sequelae", provide End Date.

    Data type

    date

    Alias
    UMLS CUI [1]
    C0806020
    Maximum Intensity
    Description

    Record maximum intensity throughout duration of event. Optional item: This item may be hidden if either the Maximum Grade or Maximum Grade or Intensity item has been used.

    Data type

    text

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

    Record intensity at the onset of the event [hidden]. Conditional item: Conditional on the use of the Intensity change section. If the section is not used then the item must be hidden. This item may be hidden if either the Grade/Grade or Intensity at onset of event item has been used.

    Data type

    text

    Alias
    UMLS CUI [1]
    C1710066
    Maximum Grade
    Description

    Record maximum grade throughout duration of event [hidden]. Optional item: This item may be hidden if either the Maximum Intensity or Maximum Grade or Intensity item has been used. Grade 5 is optional.

    Data type

    integer

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

    Conditional item Conditional on using the Intensity change section. If the section is not used the item must be hidden. This item may be hidden if either the Intensity/Grade or Intensity at onset of event item has been used. Grade 5 is optional

    Data type

    integer

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

    Record maximum grade or intensity throughout duration of event [hidden]. Optional item: This item may be hidden if either the Maximum Intensity or Maximum Grade item has been used. Grade 5 is optional.

    Data type

    text

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

    Record grade or intensity at the onset of the event [hidden]. Conditional item Conditional on the use of the Intensity change section. If the section is not used then the item must be hidden. This item may be hidden if either the Intensity or Grade at onset of event item has been used. Grade 5 is optional

    Data type

    text

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

    Action Taken with Investigational Product

    Data type

    text

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

    Withdrawal from study

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0422727
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    Description

    Use best judgment at initial entry. May be amended when additional information becomes available. If the study has multiple IP then remove Yes and keep Yes, select appropriate investigational product(s)' and set selection value to Y. Otherwise remove Yes, select appropriate investigational product(s) and keep Yes.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013230
    UMLS CUI [1,2]
    C1518404
    Duration of AE if < 24 hours (hours)
    Description

    If AE start and end time are used this item must be hidden.

    Data type

    integer

    Measurement units
    • h
    Alias
    UMLS CUI [1,1]
    C0449238
    UMLS CUI [1,2]
    C1519255
    h
    Duration of AE if < 24 hours (minutes)
    Description

    If AE start and end time are used this item must be hidden.

    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

    [hidden] This item is optional

    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

    [hidden] This item is optional

    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
    Did SAE occur 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
    SAE 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
    Did the subject experience a serious adverse event during the study?
    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 Diagnosis Only (if known) Otherwise Sign/Symptom
    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
    Maximum Intensity
    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

    Record maximum grade throughout duration of event [hidden]. Optional item: This item may be hidden if either the Maximum Intensity or Maximum Grade or Intensity item has been used. Grade 5 is optional.

    Data type

    integer

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

    Record grade at the onset of the event [hidden]. Conditional item Conditional on using the Intensity change section. If the section is not used the item must be hidden. This item may be hidden if either the Intensity/Grade or Intensity at onset of event item has been used. Grade 5 is optional

    Data type

    integer

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

    Record maximum grade or intensity throughout duration of event [hidden]. Optional item: This item may be hidden if either the Maximum Intensity or Maximum Grade item has been used. Grade 5 is optional.

    Data type

    text

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

    Record grade or intensity at the onset of the event [hidden]. Conditional item Conditional on the use of the Intensity change section. If the section is not used then the item must be hidden. This item may be hidden if either the Intensity or Grade at onset of event item has been used. Grade 5 is optional

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0518690
    Action Taken with Respect to Investigational Drug
    Description

    Action Taken

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1547656
    Is there a reasonable possibility that the AE may have been caused by the 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)
    Was SAE caused by activities related to study participation (e.g.procedures)?
    Description

    SAE Causation

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3641099
    UMLS CUI [1,2]
    C1519255
    Was the event serious?
    Description

    Serious Adverse Event

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    Related investigational product
    Description

    investigational product

    Data type

    text

    Alias
    UMLS CUI [1]
    C0304229
    Intensity changes
    Description

    Intensity changes

    Serious Adverse Event
    Description

    Diagnosis Only (if known) Otherwise Sign/Symptom Include ONE event term only

    Data type

    text

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

    If the decision has been made to record every change in intensity, time must be collected to differentiate between, and to indicate the order of, changes that occur within a single day.

    Data type

    date

    Alias
    UMLS CUI [1]
    C2697888
    Start Time of event segment Hr:Min (00:00-23:59)
    Description

    If the decision has been made to record every change in intensity, time must be collected to differentiate between, and to indicate the order of, changes that occur within a single day.

    Data type

    time

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

    Optional item: This item may be hidden if either the Grade of event segment or Grade or Intensity of event segment item has been used and item not included in the section.

    Data type

    integer

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

    Optional item: This item may be hidden if either the Intensity of event segment or Grade or intensity of event segment item has been used and item not included in the section. Grade 5 is optional.

    Data type

    integer

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

    Optional item: This item may be hidden if either the Grade of event segment or Grade or Intensity of event segment item has been used and item not included in the section. Grade 5 is optional.

    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: Specify reason(s) for considering this a SAE, tick all that apply:
    Description

    Seriousness

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1710056
    Seriousness: If other, specify:
    Description

    Seriousness Other

    Data type

    text

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

    Relevant concomitant / treatment medications

    CM Sequence Number
    Description

    [hidden]

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348184
    Drug name
    Description

    Enter drug name, not description (Generic name preferred. If combination product, enter Trade name).

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013227
    Modified reported term
    Description

    [hidden]

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826819
    Dose
    Description

    Dose

    Data type

    text

    Alias
    UMLS CUI [1]
    C3174092
    Unit
    Description

    units of medication

    Data type

    text

    Alias
    UMLS CUI [1]
    C1519795
    Frequency
    Description

    Frequency

    Data type

    text

    Alias
    UMLS CUI [1]
    C3476109
    Route
    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?
    Description

    Ongoing medication

    Data type

    boolean

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

    End date medication

    Data type

    date

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

    Enter a medical diagnosis not description

    Data type

    text

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

    [hidden]

    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

    [hidden]

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348184
    Test Name
    Description

    Only allow site to choose from List of Values.

    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
    If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
    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
    Study drug
    Description

    Study 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

    Provide a brief narrative description of SAE, possible other causes of the event (e.g. lack of efficacy, withdrawal of investigational product, the disease under study or other medical conditions) and details of the treatment.

    Data type

    text

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

    Non clinical

    22. [3] Incomplete SAE
    Description

    Send incomplete SAE data to GSK Safety [hidden]. This item is optional

    Data type

    boolean

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

    [hidden]

    Data type

    date

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

    [hidden]

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985846
    24. Was the event serious?
    Description

    [hidden]

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    25. SAE Sequence Number
    Description

    [read-only]

    Data type

    text

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

    [hidden]

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2985700
    27. Case ID
    Description

    [hidden]

    Data type

    text

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

    [hidden]

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0237753
    29. 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
    Back to the top of the page

    Similar models

    LOG Visit

    1 forms
    1. StudyEvent: ODM
      1. LOG Visit
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Date of Visit/Assessment
    C1320303 (UMLS CUI-1)
    Date of Visit
    Item
    Date of Visit/Assessment
    date
    C1320303 (UMLS CUI [1])
    Item Group
    AE status
    C0877248 (UMLS CUI-1)
    non-serious adverse events
    Item
    Did the subject experience any non-serious adverse events during the study?
    boolean
    C1518404 (UMLS CUI [1])
    Item Group
    Log status
    C1708728 (UMLS CUI-1)
    C0449438 (UMLS CUI-2)
    serious adverse events
    Item
    4. Did the subject experience any serious adverse events during the study?
    boolean
    C1519255 (UMLS CUI [1])
    concomitant medications
    Item
    5. Were any Non-Diary concomitant medications taken by the subject prior to screening and/or during the study?
    boolean
    C2347852 (UMLS CUI [1])
    Item Group
    Concomitant Medications
    C2347852 (UMLS CUI-1)
    Sequence number
    Item
    Sequence number
    integer
    C2348184 (UMLS CUI [1])
    Drug name
    Item
    Drug name (Trade name preferred)
    text
    C0013227 (UMLS CUI [1])
    Modified reported term
    Item
    Modified reported term
    text
    C2826302 (UMLS CUI [1])
    C2347852 (UMLS CUI [2])
    Unit Dose
    Item
    Unit Dose
    float
    C0869039 (UMLS CUI [1])
    Units
    Item
    Units
    text
    C1519795 (UMLS CUI [1])
    Frequency
    Item
    Frequency
    text
    C3476109 (UMLS CUI [1])
    Route
    Item
    Route
    text
    C0013153 (UMLS CUI [1])
    Reason for Medication
    Item
    Reason for Medication
    text
    C0392360 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Generic Dispensed
    Item
    Generic Dispensed?
    boolean
    C3242750 (UMLS CUI [1])
    Item
    Prescription or OTC?
    text
    C3166216 (UMLS CUI [1])
    C0013231 (UMLS CUI [2])
    Prescription or OTC
    Code List
    Prescription or OTC?
    CL Item
    Prescription (1)
    CL Item
    OTC (2)
    Medication start datetime
    Item
    Stat Date
    datetime
    C3173309 (UMLS CUI [1])
    Taken Prior to Study?
    Item
    Taken Prior to Study?
    boolean
    C2826667 (UMLS CUI [1])
    medication ongoing
    Item
    Ongoing
    boolean
    C2826666 (UMLS CUI [1])
    Concomitant Medication End Date
    Item
    Concomitant Medication: End Date
    date
    C2826744 (UMLS CUI [1])
    Device used to administer medication
    Item
    Device used to administer medication
    text
    C0699733 (UMLS CUI [1])
    Total Daily Dose
    Item
    Total Daily Dose
    integer
    C2348070 (UMLS CUI [1])
    drug adminstered for an exacerbation
    Item
    Was drug administered for an exacerbation?
    boolean
    C3469597 (UMLS CUI [1,1])
    C4086268 (UMLS CUI [1,2])
    Rescue Medication
    Item
    Was drug administered as a rescue medication?
    boolean
    C0013227 (UMLS CUI [1,1])
    C0884980 (UMLS CUI [1,2])
    Total Dose
    Item
    Cumulative Dose used?
    integer
    C2986497 (UMLS CUI [1])
    drug use
    Item
    Was drug ever used
    boolean
    C0242510 (UMLS CUI [1])
    Total duration
    Item
    Total duration
    integer
    C2347852 (UMLS CUI [1,1])
    C0449238 (UMLS CUI [1,2])
    duration
    Item
    Duration unit
    text
    C0449238 (UMLS CUI [1])
    Item Group
    Non-serious adverse event
    Sequence Number
    Item
    Sequence Number
    text
    C2348184 (UMLS CUI [1])
    Non-serious adverse event
    Item
    Event
    text
    C1518404 (UMLS CUI [1])
    Modified term
    Item
    Modified term
    text
    C2826302 (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
    C2826302 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Start Date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1])
    Item
    Outcome
    integer
    C1705586 (UMLS CUI [1])
    Outcome / End Date
    Code List
    Outcome
    CL Item
    Recovered/Resolved, provide End Date (1)
    C1709863 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Recovering/Resolving (2)
    C1709864 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Not recovered/Not resolved (3)
    C1709277 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Recovered/Resolved with sequelae, provide End Date (4)
    C1709862 (UMLS CUI-1)
    (Comment:en)
    End date
    Item
    End date
    date
    C0806020 (UMLS CUI [1])
    Item
    Maximum Intensity
    text
    C1710066 (UMLS CUI [1])
    Maximum Intensity
    Code List
    Maximum Intensity
    CL Item
    Mild (1)
    C2945599 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Moderate (2)
    C0205081 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Severe (3)
    C0205082 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Not applicable (X)
    C1272460 (UMLS CUI-1)
    (Comment:en)
    Item
    Intensity at onset of event
    text
    C1710066 (UMLS CUI [1])
    Maximum Intensity
    Code List
    Intensity at onset of event
    CL Item
    Mild (1)
    C2945599 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Moderate (2)
    C0205081 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Severe (3)
    C0205082 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Not applicable (X)
    C1272460 (UMLS CUI-1)
    (Comment:en)
    Item
    Maximum Grade
    integer
    C0441799 (UMLS CUI [1])
    Maximum Grade
    Code List
    Maximum Grade
    CL Item
    Grade 1 (1)
    C0687695 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Grade 2 (2)
    C1522446 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Grade 3 (3)
    C0450094 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Grade 4 (4)
    C0547054 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Grade 5 (5)
    C2985911 (UMLS CUI-1)
    (Comment:en)
    Item
    Grade at onset of event
    integer
    C2985916 (UMLS CUI [1,1])
    C0441799 (UMLS CUI [1,2])
    Maximum Grade
    Code List
    Grade at onset of event
    CL Item
    Grade 1 (1)
    C0687695 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Grade 2 (2)
    C1522446 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Grade 3 (3)
    C0450094 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Grade 4 (4)
    C0547054 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Grade 5 (5)
    C2985911 (UMLS CUI-1)
    (Comment:en)
    Item
    Maximum Grade or Intensity
    text
    C0441799 (UMLS CUI [1,1])
    C1710066 (UMLS CUI [1,2])
    Maximum Grade or Intensity
    Code List
    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
    Grade or Intensity at onset of event
    text
    C1710066 (UMLS CUI [1])
    Maximum Grade or Intensity
    Code List
    Grade or Intensity at onset of event
    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 Taken with Investigational Product
    Code List
    Action Taken with Investigational Product(s) as a Result of the AE
    CL Item
    Investigational product(s) withdrawn (1)
    C0304229 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Not applicable (X)
    C1272460 (UMLS CUI-1)
    (Comment:en)
    Withdrawal from study
    Item
    Did the subject withdraw from study as a result of this AE?
    boolean
    C0422727 (UMLS CUI [1])
    AE caused by investigational product
    Item
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    boolean
    C0013230 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Duration of AE hours
    Item
    Duration of AE if < 24 hours (hours)
    integer
    C0449238 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Duration of AE minutes
    Item
    Duration of AE if < 24 hours (minutes)
    integer
    C0449238 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Time to Onset Since Last Dose hours
    Item
    Time to Onset Since Last Dose (hours)
    integer
    C0449244 (UMLS CUI [1,1])
    C1762893 (UMLS CUI [1,2])
    C1518404 (UMLS CUI [1,3])
    Time to Onset Since Last Dose minutes
    Item
    Time to Onset Since Last Dose (minutes)
    integer
    C0449244 (UMLS CUI [1,1])
    C1762893 (UMLS CUI [1,2])
    C1518404 (UMLS CUI [1,3])
    Item Group
    Report
    Initial report
    Item
    Initial report
    boolean
    C0684224 (UMLS CUI [1])
    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
    C2826666 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item Group
    Serious Adverse Event
    C1519255 (UMLS CUI-1)
    Sequence Number
    Item
    SAE Sequence Number
    text
    C1519255 (UMLS CUI [1,1])
    C2348184 (UMLS CUI [1,2])
    Modified term
    Item
    Modified term
    text
    C2826302 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    MedDRA synonym
    Item
    MedDRA synonym
    text
    C1140263 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    MedDRA lower level term code
    Item
    MedDRA lower level term code
    text
    C3898442 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    serious adverse event
    Item
    Did the subject experience a serious adverse event during the study?
    boolean
    C1519255 (UMLS CUI [1])
    Did SAE occur after initiation of study medication
    Item
    Did SAE occur after initiation of study medication?
    boolean
    C1519255 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    Serious Adverse Event
    Item
    Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
    text
    C1519255 (UMLS CUI [1])
    Serious Adverse Event Start Date
    Item
    Serious Adverse Event Start Date
    date
    C1519255 (UMLS CUI [1,1])
    C2697888 (UMLS CUI [1,2])
    Start Time Serious Adverse Event
    Item
    Start Time Serious Adverse Event
    time
    C1519255 (UMLS CUI [1,1])
    C2697889 (UMLS CUI [1,2])
    Serious Adverse Event End Date
    Item
    Serious Adverse Event End Date
    date
    C1519255 (UMLS CUI [1,1])
    C2697886 (UMLS CUI [1,2])
    Serious Adverse Event End Time
    Item
    Serious Adverse Event End Time
    time
    C1519255 (UMLS CUI [1,1])
    C2826658 (UMLS CUI [1,2])
    Item
    Outcome
    integer
    C1624730 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    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)
    CL Item
    Fatal, record Date of Death  (5)
    Date of Death
    Item
    Date of Death
    date
    C1148348 (UMLS CUI [1])
    Item
    Maximum Intensity
    text
    C0518690 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Intensity (maximum)
    Code List
    Maximum Intensity
    CL Item
    Mild (1)
    (Comment:en)
    CL Item
    Moderate (2)
    (Comment:en)
    CL Item
    Severe (3)
    (Comment:en)
    CL Item
    Not applicable (X)
    (Comment:en)
    Item
    Intensity at onset of event
    text
    C0877248 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Intensity (maximum)
    Code List
    Intensity at onset of event
    CL Item
    Mild (1)
    (Comment:en)
    CL Item
    Moderate (2)
    (Comment:en)
    CL Item
    Severe (3)
    (Comment:en)
    CL Item
    Not applicable (X)
    (Comment:en)
    Item
    Maximum Grade
    integer
    C0441799 (UMLS CUI [1])
    Serious Adverse Event Maximum Grade
    Code List
    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)
    Item
    Grade at onset of event
    integer
    C2985911 (UMLS CUI [1])
    Serious Adverse Event Maximum Grade
    Code List
    Grade at onset of event
    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)
    Item
    Maximum Grade or Intensity
    text
    C0441799 (UMLS CUI [1,1])
    C1710066 (UMLS CUI [1,2])
    Serious Adverse Event Maximum Grade
    Code List
    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
    Grade or Intensity at onset of event
    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
    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 Respect to Investigational Drug
    integer
    C1547656 (UMLS CUI [1])
    Action Taken
    Code List
    Action Taken with Respect to Investigational Drug
    CL Item
    lnvestigational 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 (6)
    Relationship investigational product
    Item
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    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
    Did the subject withdraw from study as a result of this AE?
    boolean
    C1710677 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Duration of AE if < 24 hours
    Item
    Duration of AE if < 24 hours
    integer
    C1519255 (UMLS CUI [1,1])
    C0449238 (UMLS CUI [1,2])
    Time to Onset Since Last Dose
    Item
    Time to Onset Since Last Dose
    integer
    C1519255 (UMLS CUI [1,1])
    C0946444 (UMLS CUI [1,2])
    C0449244 (UMLS CUI [1,3])
    SAE Causation
    Item
    Was SAE caused by activities related to study participation (e.g.procedures)?
    boolean
    C3641099 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Serious Adverse Event
    Item
    Was the event serious?
    boolean
    C1519255 (UMLS CUI [1])
    investigational product
    Item
    Related investigational product
    text
    C0304229 (UMLS CUI [1])
    Item Group
    Intensity changes
    Serious Adverse Event Intensity changes
    Item
    Serious Adverse Event
    text
    C1519255 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Start Date of event segment
    Item
    Start Date of event segment
    date
    C2697888 (UMLS CUI [1])
    Start Time of event segment
    Item
    Start Time of event segment Hr:Min (00:00-23:59)
    time
    C2697889 (UMLS CUI [1])
    Item
    Intensity of event segment
    integer
    C0877248 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Maximum Intensity
    Code List
    Intensity of event segment
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Grade of event segment
    integer
    C2985911 (UMLS CUI [1])
    Grade at onset of event
    Code List
    Grade of event segment
    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)
    Item
    Grade or Intensity of event segment
    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
    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)
    Item Group
    Seriousness
    C0871902 (UMLS CUI-1)
    C1519255 (UMLS CUI-2)
    Item
    Seriousness: Specify reason(s) for considering this a SAE, tick all that apply:
    integer
    C1710056 (UMLS CUI [1])
    Seriousness
    Code List
    Seriousness: Specify reason(s) for considering this a SAE, tick all that apply:
    CL Item
    Results in death (1)
    CL Item
    Is life-threatening (2)
    CL Item
    Requires hospitalisation or prolongation of existing hospitalisation (3)
    CL Item
    Results in disability/incapacity (4)
    CL Item
    Congenital anomaly/birth defect (5)
    CL Item
    Other (6)
    Seriousness Other
    Item
    Seriousness: If other, specify:
    text
    C1710056 (UMLS CUI [1])
    Item Group
    Relevant concomitant / treatment medications
    CM Sequence Number
    Item
    CM Sequence Number
    text
    C2348184 (UMLS CUI [1])
    Drug name
    Item
    Drug name
    text
    C0013227 (UMLS CUI [1])
    Modified reported term
    Item
    Modified reported term
    text
    C2826819 (UMLS CUI [1])
    Dose
    Item
    Dose
    text
    C3174092 (UMLS CUI [1])
    Item
    Unit
    text
    C1519795 (UMLS CUI [1])
    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])
    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])
    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)
    Start Date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1])
    Ongoing medication
    Item
    Ongoing?
    boolean
    C2826666 (UMLS CUI [1])
    End date medication
    Item
    If no ongoing medication, specify end date
    date
    C1521826 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Primary Indication
    Item
    Primary Indication
    text
    C3146298 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [1,3])
    Modified reported term
    Item
    Modified reported term
    text
    C2826819 (UMLS CUI [1])
    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 diagnostic results
    Lab Sequence Number
    Item
    Lab Sequence Number
    text
    C2348184 (UMLS CUI [1])
    Item
    Test Name
    text
    C0022885 (UMLS CUI [1])
    Test Name
    Code List
    Test Name
    CL Item
    Activated partial thromboplastin time (Activated partial thromboplastin time)
    C0030605 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Alanine Amino Transferase (Alanine aminotransferase)
    C0201899 (UMLS CUI-1)
    C0201836 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Albumin (Albumin)
    C0201838 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Alkaline phosphatase (Alkaline phosphatase)
    C0201850 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Amylase (Amylase)
    C0201883 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Aspartate Amino Transferase (Aspartate aminotransferase)
    C0201899 (UMLS CUI-1)
    C0201836 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Basophils (Basophils)
    C0004827 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Bicarbonate (Bicarbonate)
    C0202059 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Bilirubin (Bilirubin)
    C1278039 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Bilirubin direct (Bilirubin direct)
    C0201916 (UMLS CUI-1)
    (Comment:en)
    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
    Erythrocyte sedimentation rate (Erythrocyte sedimentation rate)
    CL Item
    Fasting blood glucose (Fasting blood glucose)
    CL Item
    FEV 1 (FEV 1)
    CL Item
    Gamma-glutamyltransferase (Gamma-glutamyltransferase)
    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
    Platelet count (Platelet 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])
    Test Result
    Item
    Test Result
    text
    C0456984 (UMLS CUI [1])
    Test Units
    Item
    Test Units
    text
    C1519795 (UMLS CUI [1,1])
    C0587081 (UMLS CUI [1,2])
    Normal Low Range
    Item
    Normal Low Range
    text
    C2700150 (UMLS CUI [1])
    Normal High Range
    Item
    Normal High Range
    text
    C2700149 (UMLS CUI [1])
    Relevant diagnostic results not noted above
    Item
    Relevant diagnostic results not noted above
    text
    C0430022 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Item
    If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
    text
    C0085978 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Rechallenge
    Code List
    If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    CL Item
    Unknown at this time (U)
    CL Item
    Not applicable (X)
    Item Group
    INVESTIGATIONAL PRODUCT
    C0304229 (UMLS CUI-1)
    Drug
    Item
    Study drug
    text
    C0013227 (UMLS CUI [1])
    start date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1])
    stop date
    Item
    Stop Date
    date
    C0806020 (UMLS CUI [1])
    Regimen
    Item
    Regimen
    text
    C1276413 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Item Group
    General narrative comments
    General narrative comments
    Item
    General narrative comments
    text
    C0678257 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item Group
    Non clinical
    incomplete SAE data GSK Safety
    Item
    22. [3] Incomplete SAE
    boolean
    C1710056 (UMLS CUI [1])
    Receipt by GSK date
    Item
    23. Receipt by GSK date
    date
    C2985846 (UMLS CUI [1])
    Receipt by GSK date
    Item
    23. Receipt by GSK date
    date
    C2985846 (UMLS CUI [1])
    serious SAE
    Item
    24. Was the event serious?
    boolean
    C1519255 (UMLS CUI [1])
    SAE Sequence Number
    Item
    25. SAE Sequence Number
    text
    C1519255 (UMLS CUI [1,1])
    C2348184 (UMLS CUI [1,2])
    Version Number
    Item
    26. Version Number
    integer
    C2985700 (UMLS CUI [1])
    Case ID
    Item
    27. Case ID
    text
    C1698493 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Randomisation Number
    Item
    28. Randomisation Number
    text
    C0034656 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    OCEANS Code
    Item
    29. OCEANS Code
    text
    C0805701 (UMLS CUI [1,1])
    C1516728 (UMLS CUI [1,2])
    Email Flag
    Item
    Email Flag
    text
    C0013849 (UMLS CUI [1])
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