Statistical analyses
Pharmacodynamic and immunogenicity (ADA) outcomes were assessed in the full analysis set and the safety analysis set, respectively, both of which included all randomized patients who received at least one dose of ravulizumab. The pharmacokinetics analysis set included all treated patients with at least one post-baseline pharmacokinetic concentration available.Pharmacokinetic parameters (estimated using non-compartmental analyses) and absolute values and changes from baseline in free C5 serum concentrations are summarized using descriptive statistics (Phoenix™ Pharmacokinetic and Pharmacodynamic Platform Version 8.3; Certara, Princeton, NJ, USA). The incidence of ADAs and neutralizing antibodies was analyzed by summarizing the number and percentage of patients who developed detectable ADAs or neutralizing antibodies in the ravulizumab-treated population.