Hereditary Angioedema (HAE)
Conditions
Brief summary
1. Number of Participants with Treatment Emergent Adverse Events (TEAEs), 2. Percentage of Participants with TEAEs, 3. Number of TEAEs, 4. Rate of TEAEs per injection, 5. Rate of TEAEs per participant year
Detailed description
1. Number of Participants With: Serious Adverse Events (SAEs), Deaths, Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, Laboratory Findings Reported as an AE, and Adverse Events of Special Interest (AESI), 2. Percentage of Participants With: SAEs, Deaths, Treatment Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, Laboratory Findings Reported as an AE, and AESI, 3. Number of SAEs, Deaths, Treatment Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, AESI and Laboratory Findings Reported as an AE, and AESI, 4. Rate per injection of: SAEs, Deaths, Treatment Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, Laboratory Findings Reported as an AE, and AESI, 5. Rate per participant year of: SAEs, Deaths, Treatment Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, Laboratory Findings Reported as an AE, and AESI, 6. Number of Participants with Anti-garadacimab Antibodies, 7. Percentage of Participants with Anti-garadacimab Antibodies, 8. Plasma Concentrations of Garadacimab, 9. Percentage of Participants who Indicated Their Preference for Garadacimab
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number of Participants with Treatment Emergent Adverse Events (TEAEs), 2. Percentage of Participants with TEAEs, 3. Number of TEAEs, 4. Rate of TEAEs per injection, 5. Rate of TEAEs per participant year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of Participants With: Serious Adverse Events (SAEs), Deaths, Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, Laboratory Findings Reported as an AE, and Adverse Events of Special Interest (AESI), 2. Percentage of Participants With: SAEs, Deaths, Treatment Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, Laboratory Findings Reported as an AE, and AESI, 3. Number of SAEs, Deaths, Treatment Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, AESI and Laboratory Findings Reported as an AE, and AESI, 4. Rate per injection of: SAEs, Deaths, Treatment Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, Laboratory Findings Reported as an AE, and AESI, 5. Rate per participant year of: SAEs, Deaths, Treatment Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, Laboratory Findings Reported as an AE, and AESI, 6. Number of Participants with Anti-garadacimab Antibodies, 7. | — |
Countries
Germany