Table 2. Summary of adverse events.
AEs, n | Patients, n (%) N = 95 |
|
---|---|---|
Any AEa | 105 | 39 (41) |
Infections and infestations | 27 | 18 (19) |
Musculoskeletal and connective tissue disorders | 20 | 12 (13) |
General disorders and administration-site conditions | 17 | 10 (11) |
Drug-related AEb | 25 | 15 (16) |
General disorders and administration site conditions | 10 | 6 (6) |
Infections and infestations | 9 | 6 (6) |
Serious AE | 7 | 4 (4) |
Severe AE | 2 | 2 (2) |
AEs leading to discontinuation | 5 | 3 (3) |
Fatal AE | 0 | 0 |
aThose occurring in > 10% are listed; bthose occurring in > 5% are listed (listed as system organ class). AE = adverse event; SAE = serious adverse event.