Table 3.
Treatment-emergent adverse events occurring in ≥ 3% of patients for the ORION-8 study participants
| Treatment-emergent adverse events | Total, N = 3274, n (%) |
|---|---|
| Patients with at least one TEAE | 2548 (77.8) |
| COVID-19 | 453 (13.8) |
| Diabetes mellitus inadequate control | 229 (7.0) |
| Hypertension | 229 (7.0) |
| Diabetes mellitus | 206 (6.3) |
| Arthralgia | 205 (6.3) |
| Urinary tract infection | 158 (4.8) |
| Osteoarthritis | 149 (4.6) |
| Back pain | 131 (4.0) |
| Nasopharyngitis | 110 (3.4) |
| Upper respiratory tract infection | 110 (3.4) |
| Atrial fibrillation | 100 (3.1) |
| Coronary artery disease | 99 (3.0) |
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; TEAE, treatment-emergent adverse event.