Problem:
An adverse event was defined as any event that started or worsened after the administration of NTLA-2002. For the analysis of end points related to angioedema attacks, the number of attacks per month at baseline was based on attacks that occurred during the screening period (≤42 days before the infusion of NTLA-2002). Statistical Analysis The percentage of patients with dose-limiting toxic effects was calculated in the evaluable population, defined as all the patients who received at least a partial dose of NTLA-2002 and had at least one dose-limiting toxic effect and all the patients who received the full assigned dose without a dose-limiting toxic effect and were assessed on day 29. Safety analyses included all the patients who received at least a partial dose of NTLA-2002 (safety population). Pharmacodynamic analyses included all the patients in the safety population in whom the total plasma kallikrein protein level was measured at least once before and at least once after the administration of NTLA-2002. Pharmacokinetic analyses included patients in the safety population who had at least one blood sample in which concentrations of any of the four plasma analytes (the two exogenous lipid components and the two RNA components) of NTLA-2002 could be evaluated. Need Assignment Help?