Overall Summary of Adverse Events
| Control (n=100) | Voclosporin (n=116) | |
|---|---|---|
| n (%) | n (%) | |
| Any AE | 80 (80.0) | 100 (86.2) |
| Treatment-related AE | 21 (21.0) | 28 (24.1) |
| Serious AE | 23 (23.0) | 21 (18.1) |
| Serious Treatment-related AE | 2 (2.0) | 1 (0.9) |
| AE Leading to Study Drug Discontinuation | 17 (17.0) | 11 (9.5) |
| Death* | 4 (4.0) | 0 |
| Treatment-related Death | 0 | 0 |
*The four deaths in the control arm were due to pulmonary embolism (n=1) and coronavirus infection (n=3). Includes adverse events starting on or after the first dose of study drug in AURORA 2 up to 30 days after the last dose and all events of death reported during study follow-up. Adverse events were aggregated by System Organ Class and Preferred Term and coded using Medical Dictionary for Regulatory Activities (MedDRA) Version 20.0. AE, adverse event.