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    <IdentifierDoi>10.3205/25gmds079</IdentifierDoi>
    <IdentifierUrn>urn:nbn:de:0183-25gmds0798</IdentifierUrn>
    <ArticleType>Meeting Abstract</ArticleType>
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      <Title language="en">Methods for Analyzing Multiple Time-to-Event Endpoints in Randomized Clinical Trials: A Comprehensive Overview</Title>
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        <PersonNames>
          <Lastname>Alidan</Lastname>
          <LastnameHeading>Alidan</LastnameHeading>
          <Firstname>Duoerkongjiang</Firstname>
          <Initials>D</Initials>
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          <Affiliation>Universit&#228;tsklinikum Hamburg-Eppendorf, Hamburg, Germany</Affiliation>
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        <Creatorrole corresponding="no" presenting="no">author</Creatorrole>
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      <Creator>
        <PersonNames>
          <Lastname>Ozga</Lastname>
          <LastnameHeading>Ozga</LastnameHeading>
          <Firstname>Ann-Kathrin</Firstname>
          <Initials>AK</Initials>
        </PersonNames>
        <Address>
          <Affiliation>Institut f&#252;r Medizinische Biometrie und Epidemiologie, Universit&#228;tsklinikum Hamburg-Eppendorf, Hamburg, Germany</Affiliation>
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        <Creatorrole corresponding="no" presenting="no">author</Creatorrole>
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          <Corporatename>German Medical Science GMS Publishing House</Corporatename>
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        <Address>D&#252;sseldorf</Address>
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    <SubjectGroup>
      <SubjectheadingDDB>610</SubjectheadingDDB>
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    <DatePublishedList>
      <DatePublished>20251103</DatePublished>
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    <Language>engl</Language>
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      <AltText language="en">This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License.</AltText>
      <AltText language="de">Dieser Artikel ist ein Open-Access-Artikel und steht unter den Lizenzbedingungen der Creative Commons Attribution 4.0 License (Namensnennung).</AltText>
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      <Meeting>
        <MeetingId>M0631</MeetingId>
        <MeetingSequence>079</MeetingSequence>
        <MeetingCorporation>Deutsche Gesellschaft f&#252;r Medizinische Informatik, Biometrie und Epidemiologie</MeetingCorporation>
        <MeetingName>70. Jahrestagung der Deutschen Gesellschaft f&#252;r Medizinische Informatik, Biometrie und Epidemiologie e. V. (GMDS)</MeetingName>
        <MeetingTitle></MeetingTitle>
        <MeetingSession>V: Medical Biometry 2: Analysemethoden</MeetingSession>
        <MeetingCity>Jena</MeetingCity>
        <MeetingDate>
          <DateFrom>20250907</DateFrom>
          <DateTo>20250911</DateTo>
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    <ArticleNo>Abstr. 33</ArticleNo>
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      <MainHeadline>Text</MainHeadline><Pgraph><Mark1>Introduction:</Mark1> In clinical trials, time-to-event analyses are essential for evaluating treatment efficacy and understanding patient outcomes. Traditional methods such as the Cox proportional hazards model or Kaplan-Meier estimation typically focus on time-to-first events. However, this approach may overlook recurrent and competing events, which are common in chronic disease settings and can provide critical insights into disease progression and treatment impact.</Pgraph><Pgraph><Mark1>Methods:</Mark1> We present a systematic overview of statistical methods for multiple time-to-event outcomes, including recurrent and terminal events. These methods include the weighted hazard ratio by Rauch, Wei-Lachin approach, Andersen-Gill (AG) model, Wei-Lin-Weissfeld model, Prentice-Williams-Peterson (PWP) models, joint frailty models, Ghosh and Lin&#8217;s approach, and prioritized composite outcome analyses (e.g., win ratio, win odds). We applied these methods to data from a randomized, controlled cardiovascular trial.</Pgraph><Pgraph><Mark1>Results:</Mark1> Each method yielded consistent but nuanced differences in estimating treatment effects. For instance, prioritized outcomes (e.g., win ratio) highlighted early benefits in non-fatal events, while joint models better captured long-term competing risks. The AG and PWP models offered different event-order interpretations. These findings demonstrate that model choice significantly influences interpretation, especially regarding the clinical prioritization of events.</Pgraph><Pgraph><Mark1>Discussion:</Mark1> Our results underscore that no single model is universally optimal. Instead, each method answers a slightly different clinical question. We discuss practical implementation considerations, the interpretability of effect measures, and model assumptions in the context of RCTs.</Pgraph><Pgraph><Mark1>Conclusion:</Mark1> Moving beyond the time-to-first-event paradigm allows for richer, more clinically relevant analyses. This work aims to support applied researchers in selecting and interpreting appropriate methods for multiple-event survival data in randomized trials.</Pgraph><Pgraph>The authors declare that they have no competing interests.</Pgraph><Pgraph>The authors declare that a positive ethics committee vote has been obtained.</Pgraph></TextBlock>
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