Please select the outcome measures that correspond to the clinical trial below.
Title: LEVP2006-4 CHANGE 3 Trial (C1-Inhibitor in Hereditary Angioedema Nanofiltration Generation Evaluating Efficacy): Open-Label Use of C1INH-nf (Human) for the Prophylactic Treatment to Prevent HAE Attacks and as Treatment in Acute HAE Attacks
Brief Summary: The study objective was to evaluate the safety and efficacy of prophylactic use of C1INH-nf for the prevention of acute HAE attacks.


Options:
A: Frequency of All HAE Attacks (Duration of the study)
B: Incidence of Cardiac Ischemia Events in Participants Predisposed to Cardiac Ischemia Events With Concomitant Firazyr (Icatibant) Administration (From enrollment through study participation (Approximately 13 years)); Incidence of Hypotension for Firazyr (Icatibant) (From enrollment through study participation (Approximately 13 years)); Incidence of Swelling of Mucous Membranes for Firazyr (Icatibant) (From enrollment through study participation (Approximately 13 years)); Incidence of Bronchoconstriction for Firazyr (Icatibant) (From enrollment through study participation (Approximately 13 years)); Incidence of Aggravation of Pain for Firazyr (Icatibant) (From enrollment through study participation (Approximately 13 years)); Sexual Hormones Level Measurements- Tanner Staging for Firazyr (Icatibant) (From enrollment through study participation (Approximately 13 years)); Time to Complete Resolution of the Firazyr (Icatibant)-Treated Laryngeal Attacks (From enrollment through study participation (Approximately 13 years)); Incidence of Adverse Events (AE) Related to Firazyr (Icatibant)-Treated Laryngeal Attacks (From enrollment through study participation (Approximately 13 years)); Incidence of Adverse Drug Reactions (ADR) for Firazyr (Icatibant) (From enrollment through study participation (Approximately 13 years)); Incidence of Serious Adverse Events (SAE) for Firazyr (Icatibant) (From enrollment through study participation (Approximately 13 years)); Incidence of Pregnancy and Lactation Events During Firazyr (Icatibant) Exposure (From enrollment through study participation (Approximately 13 years)); Incidence of Adverse Events (AE) for Cinryze (C1 Inhibitor [Human]) (From enrollment through study participation (Approximately 13 years)); Incidence of Adverse Drug Reactions (ADR) for Cinryze (C1 Inhibitor [Human]) (From enrollment through study participation (Approximately 13 years)); Incidence of Serious Adverse Events (SAE) for Cinryze (C1 Inhibitor [Human]) (From enrollment through study participation (Approximately 13 years)); Incidence of Thrombotic or Thromboembolic Events for Cinryze (C1 Inhibitor [Human]) (From enrollment through study participation (Approximately 13 years)); Incidence of Pregnancy and Lactation Events During Cinryze (C1 Inhibitor [Human]) Exposure (From enrollment through study participation (Approximately 13 years)); Drug Exposure Data for Cinryze (C1 Inhibitor [Human]) (From enrollment through study participation (Approximately 13 years)); Frequency of Hereditary Angioedema (HAE) Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human]) (From enrollment through study participation (Approximately 13 years)); Severity of Hereditary Angioedema Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human]) (From enrollment through study participation (Approximately 13 years)); Anatomic Location of Hereditary Angioedema Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human]) (From enrollment through study participation (Approximately 13 years)); Outcome of Severe or Laryngeal Hereditary Angioedema Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human]) (From enrollment through study participation (Approximately 13 years)); Outcome of Hereditary Angioedema Attacks for Treatment With Cinryze (C1 Inhibitor [Human]) (From enrollment through study participation (Approximately 13 years))
C: Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During Treatment Period (From Day 0 to Day 182)
D: Part 1: The Rate of Expert-confirmed HAE Attacks During Dosing in the Entire 24-week Treatment Period (Day 1 to Day 168) (24 weeks); Part 2: To Evaluate the Long-term Safety and Tolerability of Berotralstat 110 and 150 mg in Subjects With HAE (Part 1: 24 weeks (Week 0 to 24 to 52), Part 2: 28 weeks (Week 24 to 52)); Part 3: To Evaluate the Long-term Safety and Tolerability of Berotralstat Administered QD Over a 52- to up to 104-week Administration Period in Subjects With HAE. (Part 3: Week 52 to up to Week 104.)

Answer: A