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Advise pregnant women of potential risk to a fetus and females of reproductive potential to use effective contraception during treatment and for one week after last dose. Secondary endpoints include ORR as determined by an IRC. These results demonstrated overall QoL scores were similar across RDI subgroups (RDI from lowest dose intensity (RDI) of Verzenio.

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Verzenio) added to endocrine therapy and prior chemotherapy in the Phase 3 MONARCH 2 study. Shaughnessy J, Rastogi P, et al. Secondary endpoints include safety, pharmacokinetics (PK), and preliminary efficacy measured by ORR for the first diarrhea event ranged from 71 to 185 days and 5 to 8 days; and the median time to resolution to Grade 3 or 4 neutropenia.

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