AE, n (%) | De novo, n = 379 | Rollover, n = 85 | Total, N = 464 |
---|---|---|---|
TEAEs | 323 (85.2) | 51 (60.0) | 374 (80.6) |
Serious TEAEs | 27 (7.1) | 3 (3.5) | 30 (6.5) |
Nonserious TEAEs | 318 (83.9) | 49 (57.6) | 367 (79.1) |
Severe TEAEs | 39 (10.3) | 2 (2.4) | 41 (8.8) |
Discontinued AOM 400 due to TEAEs | 44 (11.6) | 3 (3.5) | 47 (10.1) |
Discontinued AOM 400 due to AE/death | 45 (11.9) | 3 (3.5) | 48 (10.3) |
Deaths | 1 (0.3) | 0 | 1 (0.2) |