Table 4.
Adverse events reported in Zolgesma®-related ICSRs collected in the EudraVigilance spontaneous reporting system from 2019 to 22 September 2023, belonging to the Investigations MedDRA System Organ Class (frequency > 1.00%).
| Adverse Events Belonging to the Investigation MedDRA SOC (n = 982) | n | % |
|---|---|---|
| Aspartate aminotransferase increased | 129 | 13.10% |
| Alanine aminotransferase increased | 120 | 12.20% |
| Transaminases increased | 91 | 9.30% |
| Hepatic enzyme increased | 77 | 7.80% |
| Platelet count decreased | 49 | 5.00% |
| Troponin I increased | 40 | 4.10% |
| Liver function test increased | 35 | 3.60% |
| Gamma-glutamyltransferase increased | 23 | 2.30% |
| Blood lactate dehydrogenase increased | 22 | 2.20% |
| Body temperature increased | 22 | 2.20% |
| Troponin increased | 18 | 1.80% |
| Oxygen saturation decreased | 15 | 1.50% |
| Troponin T increased | 15 | 1.50% |
| C-reactive protein increased | 14 | 1.40% |
| Heart rate increased | 13 | 1.30% |
| Monocyte count increased | 13 | 1.30% |
| Blood bilirubin increased | 11 | 1.10% |