Table 4.
Treatment-emergent serious adverse events occurring in ≥1% of patients for the ORION-8 study participants
| Treatment-emergent serious adverse events | Total, N = 3274, n (%) |
|---|---|
| Patients with at least one TESAE | 989 (30.2) |
| Coronary artery disease | 64 (2.0) |
| COVID-19 | 49 (1.5) |
| Acute myocardial infarction | 44 (1.3) |
| Angina pectoris | 43 (1.3) |
| Osteoarthritis | 36 (1.1) |
| Atrial fibrillation | 35 (1.1) |
| Pneumonia | 35 (1.1) |
| COVID-19 pneumonia | 35 (1.1) |
| Death | 33 (1.0) |
| Myocardial infarction | 33 (1.0) |
Preferred terms (MedDRA version 25.1) are sorted in descending order of frequency.
COVID-19, coronavirus disease 2019; MedDRA, Medical Dictionary for Regulatory Activities; N, total number of patients; n, number of patients in each category; TESAE, treatment-emergent serious adverse event.