A preplanned early interim analysis was scheduled after 20 included patients; the number was based on our previous experience on explorative studies to provide an indicator that no safety signals emerged and that outcome measures showed a positive trend.
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Temporary cessation of ibrutinib results in reduced grade 3-4 infections and durable remissions-Interim analysis of an on-off-repeat Phase 1b/2 study in patients with chronic lymphocytic leukemia.
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