Please select the outcome measures that correspond to the clinical trial below.
Title: Icatibant Outcome Survey (IOS) Registry
Brief Summary: The Icatibant Outcome Survey (IOS) is a prospective, observational disease registry designed to document the routine clinical outcomes over time in participants with angioedema treated with Firazyr® (icatibant) and/or Cinryze® (C1 inhibitor \[human\]) in countries where it is currently approved. The data collected will be used to evaluate the safety of Firazyr (icatibant) and Cinryze (C1 inhibitor \[human\]) in routine clinical practice and as a data source for post-marketing investigations.


Options:
A: Number of Participants With Serious Adverse Events (SAE) and Treatment-Emergent Adverse Events (TEAE) (From Day 1 up to final follow-up (Day 123))
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: Number of Confirmed HAE Attacks (Investigators collected data from patient diaries from the first day of dosing through to Day 29 or last day of dosing +24 hrs (the effective dosing period).); Proportion of Subjects Who Were HAE Attack-free During the Entire Dosing Period (Investigators collected data from patient diaries from the first day of dosing through to Day 29 or last day of dosing +24 hrs (the effective dosing period).)
D: The mean acute angioedema attack rate (12 weeks)

Answer: B