Daniel J. Lenihan et al. BTS 2016;1:

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Daniel J. Lenihan et al. BTS 2016;1:576-586 Overview of Study Schema (A) The ascending doses of Cimaglermin were randomly assigned, and at the completion of each cohort (n = 6) a safety analysis was done by a DSMB before proceeding to the next dose level. (B) The initial 30-day screening period included assessment of LVEF, age-appropriate cancer screening, cardiology assessment for eligibility, and laboratory testing. (C) Eligible patients were dosed on day 0 with a single infusion of cimaglermin or placebo. Patients were observed in hospital on telemetry for at least 48 h, and multiple safety labs as well as electrocardiographic monitoring were performed. Patients returned on days 8, 14, 28, and 90 for laboratory, physical exam, echocardiography, and other safety assessments. AE = adverse event; DSMB = Data Safety Monitoring Board; LVEF = left ventricular ejection fraction; PK = pharmacokinetics. Daniel J. Lenihan et al. BTS 2016;1:576-586 The Authors