Procedures
toxicity, toxicities, PD
ADVERSE EVENT
Each participant was involved in the study for up to 33 weeks, including a 27-day screening visit period (day –28 to day –2), a 4-day confinement period (day –1 to day 4), and an outpatient assessment period (day 5 up to week 29) (Fig. Study design. DLT, dose-limiting toxicity; IV, intravenous; SMC, safety monitoring committeeDosing commenced with cohort 1. Participants remained at the clinical facility and were monitored for 72 h after the infusion for the occurrence of dose-limiting toxicities (defined as any grade 3 or higher adverse event (AE) considered related to inclacumab). A safety monitoring committee reviewed AE and clinical safety laboratory data from cohort 1 participants. Cohort 2 dosing started once the safety and tolerability of cohort 1 dosing were judged to have been established by the safety monitoring committee.After the 4-day confinement period, participants returned to the clinical facility at various intervals (weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 17, 20, 23, and 26) for study visits assessing safety, PK, and PD, and for an end-of-study visit (week 29). AEs and concomitant medications were recorded throughout the study.