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ID

16550

Beskrivning

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

Nyckelord

  1. 2015-12-08 2015-12-08 -
  2. 2016-07-23 2016-07-23 -
Uppladdad den

23 juli 2016

DOI

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Licens

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
    Beskrivning

    Adverse Event

    Alias
    UMLS CUI-1
    C0877248
    AE: Sheet number
    Beskrivning

    AE: Sheet number

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1704732
    UMLS CUI [1,2]
    C0237753
    AE: Signature date
    Beskrivning

    AE: Signature date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0807937
    Comment Adverse Event
    Beskrivning

    Comment Adverse Event

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0947611
    Adverse Event Questionaire
    Beskrivning

    Adverse Event Questionaire

    Alias
    UMLS CUI-1
    C0877248
    UMLS CUI-2
    C0034394
    AE: Number
    Beskrivning

    AE: Number

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0237753
    AE: Term
    Beskrivning

    AE: Term

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2826302
    AE: Start date
    Beskrivning

    AE: Start date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0808070
    AE: Start time
    Beskrivning

    AE: Start time, if relevant

    Datatyp

    time

    Alias
    UMLS CUI [1]
    C1301880
    AE: Serious event
    Beskrivning

    AE: Serious event

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2985919
    AE: Severity
    Beskrivning

    AE: Severity

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C1710066
    AE: Related to study medication
    Beskrivning

    AE: Related to study medication

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0877248
    AE: Action taken with study treatment
    Beskrivning

    AE: Action taken with study treatment

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C1704758
    AE that caused study discontinuation
    Beskrivning

    AE that caused study discontinuation

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0457454
    UMLS CUI [1,2]
    C0877248
    AE: End date
    Beskrivning

    AE: End date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0806020
    AE: End time
    Beskrivning

    AE: End time, if relevant

    Datatyp

    time

    Alias
    UMLS CUI [1]
    C1522314
    AE: Ongoing
    Beskrivning

    AE: Ongoing

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0549178
    AE: Outcome
    Beskrivning

    AE: Outcome

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C1705586

    Similar models

    Adverse Event Psoriasis MIPSO EudraCT 2014-003022-40

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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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