Table 2 Adverse events and adverse drug reactions
Safety events | Number of patients, n (%) | Number of events, n (%) | Event rate* |
|---|---|---|---|
Any AEs | 36 (72.0) | 122 (100) | 201.7 |
Serious AEs | 13 (26.0) | 37 (30.3) | 61.2 |
Unexpected AEs | 27 (54.0) | 55 (45.1) | 90.9 |
Organ systems commonly affected by AEs** | |||
Gastrointestinal disorders | 21 (42.0) | 41 (33.6) | 67.8 |
Skin and subcutaneous disorders | 15 (30.0) | 17 (13.9) | 28.1 |
Musculoskeletal disorders | 14 (28.0) | 16 (13.1) | 26.5 |
Infectious disorders | 12 (24.0) | 14 (11.5) | 23.1 |
Any ADRs | 12 (24.0) | 28 (23.0) | 46.3 |
Serious ADRs | 4 (8.0) | 11 (9.0) | 18.2 |
Unexpected ADRs | 7 (14.0) | 9 (7.4) | 14.9 |
ADRs of interest | |||
Infections*** | 4 (8.0) | 4 (3.3) | 6.6 |
Tuberculosis**** | 1 (2.0) | 1 (0.8) | 1.7 |