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Activity Number:
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359
- Contributed Poster Presentations: Biopharmacutical Section
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Type:
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Contributed
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Date/Time:
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Tuesday, July 31, 2018 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #330811
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Title:
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PFS2: Event or Censor?
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Author(s):
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Dongmei Lan* and JIll Stankowski
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Companies:
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ICON Plc and ICON Plc
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Keywords:
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PFS2;
Bayesian model ;
MNAR
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Abstract:
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Progression on next-line therapy (PFS2) is encouraged by EMA as additional endpoint to investigate the survival benefit when clinically meaningful survival benefit cannot be properly demonstrated. PFS2 defined as time from randomization to objective disease progression on next-line therapy or death from any cause. The difficulty to collect the progression information after next-line therapy leads subjects treated as censor instead of event. This may not be random between the treatment groups. Using a Bayesian model to generate the progression time for the group who are censored prior to the event of interest and who are missing not at random, is illustrated and evaluated.
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Authors who are presenting talks have a * after their name.
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