Created at Source Raw Value Validated value
Oct. 26, 2020, 8:29 a.m. oms

Patient is not expected to survive for more than 24 hoursPatient is on invasive mechanical ventilation with intubation for more than 48 hours prior to ScreeningSevere pre-existing cardiac disease (ie, New York Heart Association Class 3 or Class 4, acute coronary syndrome or persistent ventricular tachyarrhythmias)Patient has an unresolved Neisseria meningitidis infectionUse of the following medications and therapies: Current treatment with a complement inhibitor and Intravenous immunoglobulin (IVIg) within 4 weeks prior to randomization.Participation in another interventional treatment study within 30 days before initiation of ravulizumab on Day 1 in this study or within 5 half-lives of that investigational product, whichever is greater.Female patients who are breastfeeding or who have a positive pregnancy test result at Screening or on Day 1.History of hypersensitivity to any ingredient contained in the study drug, including hypersensitivity to murine proteins

Patient is not expected to survive for more than 24 hoursPatient is on invasive mechanical ventilation with intubation for more than 48 hours prior to ScreeningSevere pre-existing cardiac disease (ie, New York Heart Association Class 3 or Class 4, acute coronary syndrome or persistent ventricular tachyarrhythmias)Patient has an unresolved Neisseria meningitidis infectionUse of the following medications and therapies: Current treatment with a complement inhibitor and Intravenous immunoglobulin (IVIg) within 4 weeks prior to randomization.Participation in another interventional treatment study within 30 days before initiation of ravulizumab on Day 1 in this study or within 5 half-lives of that investigational product, whichever is greater.Female patients who are breastfeeding or who have a positive pregnancy test result at Screening or on Day 1.History of hypersensitivity to any ingredient contained in the study drug, including hypersensitivity to murine proteins