Table 3.
Overview of AEs for all patients and according to thymoma history (safety analysis set).
| Patients, n (%) | Adult patients with gMG who received eculizumab | ||
|---|---|---|---|
| All (n = 40) | With history of thymoma (n = 15) | Without history of thymoma (n = 25) | |
| AE | 16 (40.0) | 4 (26.7) | 12 (48.0) |
| ADR | 7 (17.5) | 2 (13.3) | 5 (20.0) |
| Serious AE | 10 (25.0) | 3 (20.0) | 7 (28.0) |
| Serious ADR | 4 (10.0) | 1 (6.7) | 3 (12.0) |
| Death | 2 (5.0)a | 1 (6.7) | 1 (4.0) |
| Meningococcal infection | 0 | 0 | 0 |
| Non-meningococcal infection | 6 (15.0) | 0 | 6 (24.0) |
| Non-meningococcal infection ADRs | 0 | 0 | 0 |
| Infusion reaction | 1 (2.5) | 0 | 1 (4.0) |
a
One patient who died had already discontinued treatment due to an AE, therefore the death was not included as a reason for discontinuation.
ADR, adverse drug reaction; AE, adverse event; gMG, generalized myasthenia gravis.