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Highlights • The overall safety profile of adjuvant abemaciclib in combination with ET is consistent with its established safety profile. • Abemaciclib+ET has an acceptable, reversible, and manageable safety profile in high risk EBC. • The patient-reported outcomes support the tolerability of abemaciclib+ET in EBC. • Abemaciclib demonstrated a positive benefit-risk in patients with HR+, HER2- high risk EBC.
Highlights • Hyperglycemia, rash, and diarrhea were the most common grade 3/4 adverse events in patients receiving alpelisib. • These adverse events were predictable, manageable with concomitant medications, and generally reversible. • Implementation of more detailed AE management guidelines improved various markers of safety during the study.
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