Adverse Event Reporting
Adverse events (AEs) were reported using NCI CTCAE v4.0. Routine
reporting included all Grade 3 and higher AEs with the exception of CNS
AEs (Grade 2 and higher) and osteonecrosis (referred to as avascular
necrosis, AVN) AEs (Grade 1 and higher). Reportable hematologic AEs were
any Grade 3 or higher event that resulted in therapy delay
>1 week or hospitalization.