Takhzyro is an approved treatment for hereditary angioedema (HAE) in South Korea. HAE is a rare condition which causes sudden swelling under the skin and inside the body, like in the belly, throat, or genitals. The main aim of this study is to check how safe Takhzyro is in teenagers and adults with HAE in everyday medical care in South Korea. Another aim is to see how well Takhzyro works in everyday medical care. The treatment of participants and any check-ups will be determined by the treating doctors according to their normal practice. Participants may visit the study clinic several times during the study.
Study Type
OBSERVATIONAL
Enrollment
35
This is a non-interventional study.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a study participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events.
Time frame: Up to approximately 12 months
Number of Participants With Expected and Unexpected AEs and SAEs
Unexpected AE is defined as AE that differs from the information in the product label in nature, severity, specificity, or outcome.
Time frame: Up to approximately 12 months
Number of Participants With Adverse Drug Reactions (ADRs), Expected and Unexpected ADRs, Serious ADRs (SADRs), Expected and Unexpected SADRs
An ADR is an AE for which there is at least a reasonable suspicion of a causal relationship between an AE and a suspected medicinal product. Unexpected ADR is defined as an ADR that differs from the information in the ADR section of the product label in nature, severity, specificity, or outcome.
Time frame: Up to approximately 12 months
Number of HAE Attacks
Number of HAE attacks will be estimated across the pre- and post-treatment periods.
Time frame: Up to approximately 12 months
Monthly HAE Attack Rate
Monthly HAE attack rate is defined as the number of HAE attacks collected from each study participant, adjusted to 28 days (1 month).
Time frame: Up to approximately 12 months
Number of HAE Attacks Requiring Acute Treatment
Number of HAE attacks requiring acute treatment will be reported.
Time frame: Up to approximately 12 months
Monthly HAE Attack Rate Requiring Acute Treatment
Monthly HAE attack rate requiring acute treatment will be reported.
Time frame: Up to approximately 12 months
Number of Moderate or Severe HAE Attacks
Number of participants with HAE attack based on attack severity (Mild, moderate or severe) will be reported.
Time frame: Up to approximately 12 months
Monthly HAE Attack Rate With Moderate or Severe Severity
Monthly HAE attack rate with moderate or severe severity will be reported.
Time frame: Up to approximately 12 months
Change From Baseline in the Monthly HAE Attack Rate
Change from baseline in the monthly HAE attack rate will be reported.
Time frame: Up to approximately 12 months
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