Overview
This is a multicenter, single-arm, non-interventional study (NIS) with a central registration system and an all-case surveillance system. The observation period is 48 weeks after the start of treatment with Fabhalta.
Description
The observation period will be 48 weeks after the start of treatment with Fabhalta.
For patients in whom treatment with Fabhalta is discontinued within 48 weeks after the start of the treatment, adverse events occurring by the last day of the treatment + 30 days and concomitant drugs will be monitored and recorded in CRFs.
Eligibility
Inclusion Criteria:
All patients who received Fabhalta.
·
Exclusion Criteria:
Patients receiving Fabhalta for an unapproved indication under the Clinical Trials Act or GCP.