0 Ratings

ID

38550

Description

Study ID: 110948 Clinical Study ID: 110948 Study Title: Assessment of the effect of sumatriptan and naproxen sodium combination tablet, sumatriptan tablet, and naproxen sodium tablet treatment on blood pressure when administered intermittently for six months for the acute treatment of migraine attacks, with or without aura, in adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00792636 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: sumatriptan and naproxen sodium combination tablet Trade Name: sumatriptan tablet, naproxen sodium tablet Study Indication: Migraine Disorders

Keywords

  1. 10/6/19 10/6/19 -
  2. 10/24/19 10/24/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 24, 2019

DOI

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License

Creative Commons BY-NC 3.0

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    Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine Attacks; NCT00792636

    Common CRF: Concomitant Medications

    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Site
    Description

    Study Site

    Data type

    text

    Alias
    UMLS CUI [1]
    C2825164 (Study Site)
    Patient
    Description

    Patient name

    Data type

    text

    Alias
    UMLS CUI [1]
    C1299487 (Patient name)
    SNOMED
    371484003
    Patient No
    Description

    Patients, Identification number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0030705 (Patients)
    SNOMED
    116154003
    UMLS CUI [1,2]
    C1300638 (Identification number)
    SNOMED
    396278008
    Concomitant Medications
    Description

    Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852 (Concomitant Agent)
    Were any medications recorded on the In-Clinic Medications Taken Diary?
    Description

    Concomitant Agent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2347852 (Concomitant Agent)
    Sequence Number
    Description

    Concomitant Agent, Sequence Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C2348184 (Sequence Number)
    Drug Name (Trade Name preferred)
    Description

    Concomitant Agent, Medication name

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C2360065 (Medication name)
    LOINC
    MTHU027854
    Modified reported term
    Description

    Concomitant Agent, Medication name, Reported Term

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C2360065 (Medication name)
    LOINC
    MTHU027854
    UMLS CUI [1,3]
    C2826302 (Reported Term)
    GSK Drug synonym
    Description

    Concomitant Agent, Pharmaceutical Preparations, Synonym

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,3]
    C0871468 (Synonym)
    GSK Drug Collection code
    Description

    Concomitant Agent, Code

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C0805701 (Code)
    Failed coding
    Description

    Concomitant Agent, Code, Failed

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C0805701 (Code)
    UMLS CUI [1,3]
    C0231175 (Failed)
    Reason for Medication
    Description

    Concomitant Agent, Indication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C3146298 (Indication)
    Start Date
    Description

    Concomitant Medication Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826734 (Concomitant Medication Start Date)
    Taken Prior to Study?
    Description

    Concomitant Medication Previous Occurrence

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826667 (Concomitant Medication Previous Occurrence)
    Ongoing?
    Description

    Concomitant Medication Ongoing

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826666 (Concomitant Medication Ongoing)
    No, specify End Date
    Description

    Concomitant Medication End Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826744 (Concomitant Medication End Date)

    Similar models

    Common CRF: Concomitant Medications

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Study Site
    Item
    Site
    text
    C2825164 (UMLS CUI [1])
    Patient name
    Item
    Patient
    text
    C1299487 (UMLS CUI [1])
    Patients, Identification number
    Item
    Patient No
    integer
    C0030705 (UMLS CUI [1,1])
    C1300638 (UMLS CUI [1,2])
    Item Group
    Concomitant Medications
    C2347852 (UMLS CUI-1)
    Concomitant Agent
    Item
    Were any medications recorded on the In-Clinic Medications Taken Diary?
    boolean
    C2347852 (UMLS CUI [1])
    Concomitant Agent, Sequence Number
    Item
    Sequence Number
    integer
    C2347852 (UMLS CUI [1,1])
    C2348184 (UMLS CUI [1,2])
    Concomitant Agent, Medication name
    Item
    Drug Name (Trade Name preferred)
    text
    C2347852 (UMLS CUI [1,1])
    C2360065 (UMLS CUI [1,2])
    Concomitant Agent, Medication name, Reported Term
    Item
    Modified reported term
    text
    C2347852 (UMLS CUI [1,1])
    C2360065 (UMLS CUI [1,2])
    C2826302 (UMLS CUI [1,3])
    Concomitant Agent, Pharmaceutical Preparations, Synonym
    Item
    GSK Drug synonym
    text
    C2347852 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C0871468 (UMLS CUI [1,3])
    Concomitant Agent, Code
    Item
    GSK Drug Collection code
    text
    C2347852 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    Concomitant Agent, Code, Failed
    Item
    Failed coding
    text
    C2347852 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    C0231175 (UMLS CUI [1,3])
    Concomitant Agent, Indication
    Item
    Reason for Medication
    text
    C2347852 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    Concomitant Medication Start Date
    Item
    Start Date
    date
    C2826734 (UMLS CUI [1])
    Concomitant Medication Previous Occurrence
    Item
    Taken Prior to Study?
    boolean
    C2826667 (UMLS CUI [1])
    Concomitant Medication Ongoing
    Item
    Ongoing?
    boolean
    C2826666 (UMLS CUI [1])
    Concomitant Medication End Date
    Item
    No, specify End Date
    date
    C2826744 (UMLS CUI [1])

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