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ID

16710

Descrizione

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

collegamento

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

Keywords

versioni (2)
  1. 01/08/16 01/08/16 -
  2. 27/09/16 27/09/16 -
Caricato su

1 agosto 2016

DOI

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Licenza

Creative Commons BY-NC 3.0
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    Prevention and Treatment of Skin, Hair and Nail Reactions, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

    Inglese

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

    1 moduli  
    Prevention and Treatment of Skin, Hair and Nail Reactions
    Descrizione

    Prevention and Treatment of Skin, Hair and Nail Reactions

    Interventions used to prevent and treat skin, hair and nail reactions
    Descrizione

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

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0221743
    UMLS CUI [2,1]
    C0087111
    UMLS CUI [2,2]
    C0018500
    UMLS CUI [3,1]
    C0087111
    UMLS CUI [3,2]
    C0234909
    Prevention and Treatment of Skin, Hair and Nail Reactions Due to Study Drug Administration
    Descrizione

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

    Intervention (Use generic name when possible)
    Descrizione

    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.

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0221743
    UMLS CUI [2,1]
    C0087111
    UMLS CUI [2,2]
    C0018500
    UMLS CUI [3,1]
    C0087111
    UMLS CUI [3,2]
    C0234909
    Prophylaxis
    Descrizione

    Indication Prophylaxis

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C3146298
    UMLS CUI [1,2]
    C0199176
    Route
    Descrizione

    Drug Administration Route

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0013153
    If other, please specify
    Descrizione

    Drug Administration Route

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0013153
    Indication
    Descrizione

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

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C3146298
    If other, please specify
    Descrizione

    Indication

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C3146298
    Date Started
    Descrizione

    Date Started

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C3173309
    Date Stopped
    Descrizione

    Date Stopped

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C1531784
    Date stopped: Post treatment
    Descrizione

    Date Stopped

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1531784
    Ritorna all'inizio della pagina

    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

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    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
    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])
    Type
    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])
    Indication
    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])
    Ritorna all'inizio della pagina 

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