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ID

16550

Beschrijving

MIPSO Vergleichende Untersuchung der bakteriellen Mikrobiota in der Haut sowie dem Darm von Psoriasis-Patienten vor und nach systemischer Behandlung mit Adalimumab bzw. Ustekinumab oder Ciclosporin (EudraCT 2014-003022-40) Principal Investigator: Prof. Dr. Dr. h.c. Thomas A. Luger

Trefwoorden

  1. 08-12-15 08-12-15 -
  2. 23-07-16 23-07-16 -
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23 juli 2016

DOI

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Creative Commons BY-NC 3.0

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    Adverse Event Psoriasis MIPSO EudraCT 2014-003022-40 DRKS00007147

    Adverse Event Psoriasis MIPSO EudraCT 2014-003022-40

    Adverse Event
    Beschrijving

    Adverse Event

    Alias
    UMLS CUI-1
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    AE: Sheet number
    Beschrijving

    AE: Sheet number

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C1704732 (Page (document))
    UMLS CUI [1,2]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    AE: Signature date
    Beschrijving

    AE: Signature date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0807937 (Signature date)
    LOINC
    MTHU008294
    Comment Adverse Event
    Beschrijving

    Comment Adverse Event

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Adverse Event Questionaire
    Beschrijving

    Adverse Event Questionaire

    Alias
    UMLS CUI-1
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI-2
    C0034394 (Questionnaires)
    AE: Number
    Beschrijving

    AE: Number

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    AE: Term
    Beschrijving

    AE: Term

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2826302 (Reported Term)
    AE: Start date
    Beschrijving

    AE: Start date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0808070 (Start Date)
    AE: Start time
    Beschrijving

    AE: Start time, if relevant

    Datatype

    time

    Alias
    UMLS CUI [1]
    C1301880 (Start time)
    SNOMED
    398201009
    LOINC
    LP102339-1
    AE: Serious event
    Beschrijving

    AE: Serious event

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2985919 (Adverse Event Seriousness Code)
    AE: Severity
    Beschrijving

    AE: Severity

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1710066 (Severity of Adverse Event)
    AE: Related to study medication
    Beschrijving

    AE: Related to study medication

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    AE: Action taken with study treatment
    Beschrijving

    AE: Action taken with study treatment

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1704758 (Action Taken with Study Treatment)
    AE that caused study discontinuation
    Beschrijving

    AE that caused study discontinuation

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0457454 (Discontinuation (procedure))
    UMLS CUI [1,2]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    AE: End date
    Beschrijving

    AE: End date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    AE: End time
    Beschrijving

    AE: End time, if relevant

    Datatype

    time

    Alias
    UMLS CUI [1]
    C1522314 (End Time)
    SNOMED
    397898000
    AE: Ongoing
    Beschrijving

    AE: Ongoing

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0549178 (Continuous)
    SNOMED
    255238004
    LOINC
    LA16902-1
    AE: Outcome
    Beschrijving

    AE: Outcome

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1705586 (Adverse Event Outcome)

    Similar models

    Adverse Event Psoriasis MIPSO EudraCT 2014-003022-40

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Adverse Event
    C0877248 (UMLS CUI-1)
    AE: Sheet number
    Item
    integer
    C1704732 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    AE: Signature date
    Item
    date
    C0807937 (UMLS CUI [1])
    Comment Adverse Event
    Item
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Adverse Event Questionaire
    C0877248 (UMLS CUI-1)
    C0034394 (UMLS CUI-2)
    AE: Number
    Item
    integer
    C0237753 (UMLS CUI [1])
    AE: Term
    Item
    text
    C2826302 (UMLS CUI [1])
    AE: Start date
    Item
    date
    C0808070 (UMLS CUI [1])
    AE: Start time
    Item
    time
    C1301880 (UMLS CUI [1])
    AE: Serious event
    Item
    boolean
    C2985919 (UMLS CUI [1])
    Item
    integer
    C1710066 (UMLS CUI [1])
    Code List
    AE: Severity
    CL Item
    easy (1)
    CL Item
    medium (2)
    CL Item
    heavy (3)
    Item
    integer
    C0304229 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Code List
    AE: Related to study medication
    CL Item
    no causal link (0)
    CL Item
    not likely (1)
    CL Item
    possible (2)
    CL Item
    probably (3)
    CL Item
    very likely (4)
    Item
    integer
    C1704758 (UMLS CUI [1])
    Code List
    AE: Action taken with study treatment
    CL Item
    dose unchanged (0)
    CL Item
    discontinued temporarily (1)
    CL Item
    permanently discontinued (2)
    CL Item
    dose reduced (3)
    CL Item
    dose increases (4)
    CL Item
    unknown (5)
    CL Item
    not applicable (6)
    AE that caused study discontinuation
    Item
    boolean
    C0457454 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    AE: End date
    Item
    date
    C0806020 (UMLS CUI [1])
    AE: End time
    Item
    time
    C1522314 (UMLS CUI [1])
    AE: Ongoing
    Item
    boolean
    C0549178 (UMLS CUI [1])
    Item
    integer
    C1705586 (UMLS CUI [1])
    Code List
    AE: Outcome
    CL Item
    restored (0)
    CL Item
    improved (1)
    CL Item
    not yet improved (2)
    CL Item
    recovered with permanent damage (3)
    CL Item
    death (4)
    CL Item
    unknown (5)

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