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Survival in adult patients with BRAF V600 mutation-positive advanced melanoma: a non-interventional ambispective study of a cohort of patients treated with cobimetinib during the French early access program (TAU)

France, 2016 - 2018
Reference ID
FRESH-PEF74085-en
Metadata
DDI/XML JSON
Study website Interactive tools
Created on
Dec 18, 2025
Last modified
Dec 18, 2025
Page views
7
  • Study Description
  • Get Microdata
  • Identification
  • Scope
  • Coverage
  • Producers and sponsors
  • Sampling
  • Survey instrument
  • Data collection
  • Study activities
  • Quality standards
  • Data Access
  • Contacts
  • Metadata production
  • Identification

    Survey ID number

    FRESH-PEF74085-en

    Title

    Survival in adult patients with BRAF V600 mutation-positive advanced melanoma: a non-interventional ambispective study of a cohort of patients treated with cobimetinib during the French early access program (TAU)

    Abbreviation or Acronym

    MELANIS

    Country
    Name Country code
    France fr
    Kind of Data

    ['Clinical data','Participant-reported health data']

    Unit of Analysis

    Individuals

    Scope

    Topics
    Topic Vocabulary
    Oncology health theme
    Dermatology health theme
    Malignant neoplasms, stated or presumed to be primary, of specified sites, except of lymphoid, haematopoietic, central nervous system or related tissues cim-11
    Healthcare system determinants: Use of care health determinant
    Healthcare system determinants health determinant
    Keywords
    cobimetinib

    Coverage

    Universe

    {
    "level_sex_clusion_I": [
    {
    "value": "Male",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D008297"
    }
    },
    {
    "value": "Female",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D005260"
    }
    }
    ],
    "level_age_clusion_I": [
    {
    "value": "Young Adult (19 to 24 years)",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D055815"
    }
    },
    {
    "value": "Adult (25 to 44 years)",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D000328"
    }
    },
    {
    "value": "Middle Aged (45 to 64 years)",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D008875"
    }
    },
    {
    "value": "Aged (65 to 79 years)",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D000368"
    }
    },
    {
    "value": "Aged, 80 and over (80 years and more)",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D000369"
    }
    }
    ],
    "level_type_clusion_I": "Patients population",
    "level_type_clusion_other": "",
    "clusion_I": "",
    "clusion_E": ""
    }

    Producers and sponsors

    Producers
    Name
    F. HOFFMANN-LA ROCHE AG

    Sampling

    Sample frame

    Unit Type

    ['Through organizations (health services or institutions, schools, businesses, etc.)']

    Sampling Procedure

    ['{"concept":{"vocabURI":"Other","vocab":"CESSDA"},"value":"Other"}']

    Survey instrument

    Questionnaires

    Access on specific project only

    Methodology notes

    Observational Study

    Data collection

    Dates of Data Collection
    Start End
    2016-01-01 2018-01-01
    Mode of data collection
    • {"concept":{"vocabURI":"Transcription","vocab":"CESSDA"},"value":"Converting or copying information into a structured record"}

    Study activities

    Study activities
    Study activities
    Type
    primary evaluation
    Description
    Health event/morbidity Health event/mortality Health care consumption and services

    Quality standards

    Other quality statement

    ['GCP/GVP']

    Data Access

    Availability Status

    {"value":"Restricted access","extLink":[{"title":"COAR","uri":"http://purl.org/coar/access_right/c_16ec"}]}

    Contacts

    Contacts
    Name Email
    ;Medical data center data_sharing.france@roche.com

    Metadata production

    DDI Document ID

    FRESH-PEF74085-en

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