Problem: Clinical Assessments.
Each patient recorded angioedema symptoms, attacks, and treatments in an electronic diary. The investigator reviewed the diary at each study visit to confirm whether an event represented an attack due to angioedema. Samples for pharmacodynamic and pharmacokinetic analyses were obtained at each study visit in accordance with the schedule of activities provided in the protocol. Vital signs were measured, clinical history was obtained, and physical examinations, laboratory tests, and electrocardiography were performed before the infusion and at each visit. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. Need Assignment Help?