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<docDscr>
  <citation>
    <titlStmt>
      <titl>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)</titl>
      <IDNo>FRESH-PEF74085-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="F. HOFFMANN-LA ROCHE AG" role="">Camille BACHOT</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                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)            </titl>
      <altTitl>
                    MELANIS                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF74085-en            </IDNo>
      <IDNo agency="PEF">
                    74085                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF74085                </IDNo>
      <IDNo agency="NCT">
                    NCT03139513                </IDNo>
    </titlStmt>
    <rspStmt>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            F. HOFFMANN-LA ROCHE AG                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="F. HOFFMANN-LA ROCHE AG" email="data_sharing.france@roche.com">
                    ;Medical data center
                                            <ExtLink title="ROR" URI="https://ror.org/01mqmer16" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="775752140" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-16"/>
      <distDate date="2026-06-16"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    cobimetinib</keyword>
      <topcClas vocab="health theme">
                        Oncology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/5784b7f1-c7ce-49d9-9f38-aebcda0ff41d"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D008495"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Dermatology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/5375c411-6db9-40ed-a854-6554102a587b"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D003880"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Malignant neoplasms, stated or presumed to be primary, of specified sites, except of lymphoid, haematopoietic, central nervous system or related tissues                                            </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">Primary Objective: To estimate the OS of patients treated with cobimetinib in combination with vemurafenib Secondary Objectives: - To assess the PFS - To identify prognostic factors of OS - To identify prognostic factors of PFS - To describe response to treatment (overall assessment of the physician) - To describe time to treatment discontinuation. - To characterize the targeted AE of cobimetinib in combination with vemurafenib under real-world conditions of useTo describe the long term safety profile of cobimetinib in association with vemurafenib under real-world conditions of use Exploratory Objectives: - To describe population of patients treated with cobimetinib in combination with vemurafenib - To describe the use of cobimetinib in combination with vemurafenib</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2016-01-01"/>
      <collDate event="end" date="2018-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Young Adult (19 to 24 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D055815"/>
                                                    </universe>
      <universe level="age" clusion="I">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000328"/>
                                                    </universe>
      <universe level="age" clusion="I">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008875"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000368"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged, 80 and over (80 years and more)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000369"/>
                                                    </universe>
      <universe clusion="I">Inclusion criteria: - Patients at least 18 years-old  - Patients included in the TAU from 26 February 2015  - Patients with BRAF V600 mutation-positive unresectable or metastatic melanoma treated with cobimetinib in combination with Zelboraf® (vemurafenib)  - For alive patients: patients who have been informed verbally and in writing about this study who do not object to their data being electronically processed or subjected to data quality control and who have signed the consent form  OR - For patients who died before the inclusion period: patients who did not expressed their opposition when they were alive.                     </universe>
      <universe clusion="E">Alive patients unable to give informed consent- patients previously included in cobimetinib clinical trial.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
    </sumDscr>
    <qualityStatement>
      <standardsCompliance>
        <standard>
          <standardName>CDISC like</standardName>
        </standard>
      </standardsCompliance>
      <otherQualityStatement>GCP/GVP</otherQualityStatement>
    </qualityStatement>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health event/mortality
Health care consumption and services</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through organizations (health services or institutions</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>schools</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>businesses</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>etc.)</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>&lt; 500 individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Converting or copying information into a structured record                                                            <concept vocab="CESSDA" vocabURI="Transcription"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Cohort study                    </notes>
    <anlyInfo>
      <respRate>198</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
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<dataDscr>
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