Table 5.
Adverse events reported in Zolgensma®-related ICSRs collected in the EudraVigilance spontaneous reporting system from 2019 to 22 September 2023, belonging to the Cardiac disorders MedDRA System Organ Class.
| Adverse Events Belonging to the Cardiac Disorders MedDRA SOC (n = 59) |
n | % |
|---|---|---|
| Tachycardia | 14 | 23.70% |
| Bradycardia | 11 | 18.60% |
| Cardiac arrest | 9 | 15.30% |
| Cardio-respiratory arrest | 4 | 6.80% |
| Tachyarrhythmia | 3 | 5.10% |
| Arrhythmia | 2 | 3.40% |
| Cardiac failure | 2 | 3.40% |
| Pericardial effusion | 2 | 3.40% |
| Pericarditis | 2 | 3.40% |
| Bradyarrhythmia | 1 | 1.70% |
| Cardiac disorder | 1 | 1.70% |
| Cardiomegaly | 1 | 1.70% |
| Myocardial hypoxia | 1 | 1.70% |
| Myocardial injury | 1 | 1.70% |
| Pulseless electrical activity | 1 | 1.70% |
| Sinus tachycardia | 1 | 1.70% |
| Toxic cardiomyopathy | 1 | 1.70% |
| Ventricular extrasystoles | 1 | 1.70% |
| Ventricular hypertrophy | 1 | 1.70% |