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17655

Beskrivning

Sponsor: OSI Pharmaceuticals Information provided by (Responsible Party): Astellas Pharma Inc (OSI Pharmaceuticals) A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent Tarceva® (erlotinib) following complete tumor resection with or without adjuvant chemotherapy in patients with stage IB-IIIA non-small cell lung carcinoma who have EGFR-positive tumors. See https://clinicaltrials.gov/ct2/show/NCT00373425 Part of study: Prevention and Treatment of Skin, Hair and Nail Reactions Due to Study Drug Administration

Länk

https://clinicaltrials.gov/ct2/show/NCT00373425

Nyckelord

  1. 2016-08-01 2016-08-01 -
  2. 2016-09-27 2016-09-27 -
Uppladdad den

27 september 2016

DOI

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Licens

Creative Commons BY 4.0

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    Prevention and Treatment of Skin, Hair and Nail Reactions, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425

    Prevention and Treatment of Skin, Hair and Nail Reactions Due to Study Drug Administration, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

    Prevention and Treatment of Skin, Hair and Nail Reactions
    Beskrivning

    Prevention and Treatment of Skin, Hair and Nail Reactions

    Interventions used to prevent and treat skin, hair and nail reactions: None
    Beskrivning

    Prevention and Treatment of Skin, Hair and Nail Reactions Due to Study Drug Administration

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [1,2]
    C0221743 (Skin reaction)
    SNOMED
    251348006
    UMLS CUI [2,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [2,2]
    C0018500 (Hair Diseases)
    SNOMED
    279425004
    UMLS CUI [3,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [3,2]
    C0234909 (Nail changes)
    SNOMED
    416596008
    Prevention and Treatment of Skin, Hair and Nail Reactions Due to Study Drug Administration
    Beskrivning

    Prevention and Treatment of Skin, Hair and Nail Reactions Due to Study Drug Administration

    Intervention (Use generic name when possible)
    Beskrivning

    Record all topical creams, gels, oral or IV medications, and/or other interventions used to prevent and treat skin, hair and nail reactions (includes rash, skin fissures, nail and hair changes, etc) due to study drug administration. Moisturizers and sunscreens used to prevent and treat skin reactions should be recorded on the Moisturizers and Sunscreens CRF page.

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [1,2]
    C0221743 (Skin reaction)
    SNOMED
    251348006
    UMLS CUI [2,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [2,2]
    C0018500 (Hair Diseases)
    SNOMED
    279425004
    UMLS CUI [3,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [3,2]
    C0234909 (Nail changes)
    SNOMED
    416596008
    Prophylaxis
    Beskrivning

    Indication Prophylaxis

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3146298 (Indication)
    UMLS CUI [1,2]
    C0199176 (Prophylactic treatment)
    SNOMED
    360271000
    Route
    Beskrivning

    Drug Administration Route

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0013153 (Drug Administration Routes)
    SNOMED
    410675002
    LOINC
    LP40261-7
    If other, please specify
    Beskrivning

    Drug Administration Route

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0013153 (Drug Administration Routes)
    SNOMED
    410675002
    LOINC
    LP40261-7
    Indication
    Beskrivning

    Specific Indication should be reported on the Adverse Event (Including Baseline Signs/Symptoms) CRF page, unless the intervention was given as a prophylaxis.

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C3146298 (Indication)
    If other, please specify
    Beskrivning

    Indication

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C3146298 (Indication)
    Date Started
    Beskrivning

    Date Started

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C3173309 (Date treatment or therapy started)
    LOINC
    LP262646-5
    Date Stopped
    Beskrivning

    Date Stopped

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1531784 (Date treatment stopped)
    SNOMED
    413947000
    Date stopped: Post treatment
    Beskrivning

    Date Stopped

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1531784 (Date treatment stopped)
    SNOMED
    413947000

    Similar models

    Prevention and Treatment of Skin, Hair and Nail Reactions Due to Study Drug Administration, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Prevention and Treatment of Skin, Hair and Nail Reactions
    Prevention and Treatment of Skin, Hair and Nail Reactions Due to Study Drug Administration
    Item
    Interventions used to prevent and treat skin, hair and nail reactions: None
    boolean
    C0087111 (UMLS CUI [1,1])
    C0221743 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [2,1])
    C0018500 (UMLS CUI [2,2])
    C0087111 (UMLS CUI [3,1])
    C0234909 (UMLS CUI [3,2])
    Item Group
    Prevention and Treatment of Skin, Hair and Nail Reactions Due to Study Drug Administration
    Intervention
    Item
    Intervention (Use generic name when possible)
    text
    C0087111 (UMLS CUI [1,1])
    C0221743 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [2,1])
    C0018500 (UMLS CUI [2,2])
    C0087111 (UMLS CUI [3,1])
    C0234909 (UMLS CUI [3,2])
    Indication Prophylaxis
    Item
    Prophylaxis
    boolean
    C3146298 (UMLS CUI [1,1])
    C0199176 (UMLS CUI [1,2])
    Item
    Route
    integer
    C0013153 (UMLS CUI [1])
    Code List
    Route
    CL Item
    Topical (1)
    CL Item
    Oral (2)
    CL Item
    IV (3)
    CL Item
    Procedure (4)
    CL Item
    Other (specify) (5)
    Drug Administration Route
    Item
    If other, please specify
    text
    C0013153 (UMLS CUI [1])
    Item
    Indication
    integer
    C3146298 (UMLS CUI [1])
    Code List
    Indication
    CL Item
    Skin Reaction (1)
    CL Item
    Hair Changes (2)
    CL Item
    Nail Changes (3)
    CL Item
    Other (specify) (4)
    Indication
    Item
    If other, please specify
    text
    C3146298 (UMLS CUI [1])
    Date Started
    Item
    Date Started
    date
    C3173309 (UMLS CUI [1])
    Date Stopped
    Item
    Date Stopped
    date
    C1531784 (UMLS CUI [1])
    Date Stopped
    Item
    Date stopped: Post treatment
    boolean
    C1531784 (UMLS CUI [1])

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