Adverse Event Monitoring in Alisertib-Fulvestrant Trial
Adverse events (AEs) were documented using Common Terminology Criteria for Adverse Events, version 4. Alisertib dose levels/modifications are provided in eTable 1 in Supplement 2. Fulvestrant was not modified for AEs. If treatment with alisertib was paused due to toxic effects, then so was fulvestrant. Within 14 days of registration, before each cycle, and at PD, patients underwent toxic effect assessments. Tumor assessments were performed after every 2 cycles.
Other organizations :
Mayo Clinic, Mayo Clinic in Florida, Dana-Farber Cancer Institute, The University of Texas MD Anderson Cancer Center, University of Michigan–Ann Arbor, Duke University, Georgetown University, Albert Einstein College of Medicine, Montefiore Medical Center, University of Pennsylvania, Vanderbilt University Medical Center
If treatment with alisertib was paused due to toxic effects, then so was fulvestrant
controls
Positive control: Not specified
Negative control: Not specified
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