Most frequent AEs, >5% of the patients, by SOC and preferred term
| SOC | Overall* | 80 mg* | 160 mg* | |||
| Patients | Events | Patients | Events | Patients | Events | |
| ISRs | 13 | 25 | 3 | 5 | 10 | 20 |
| Infections/infestations | 11 | 19 | 3 | 7 | 9 | 12 |
| Musculoskeletal and CT disorders | 9 | 39 | 3 | 4 | 8 | 35 |
| Gastrointestinal disorders | 8 | 13 | 1 | 1 | 8 | 12 |
| Nervous system disorders† | 4 | 8 | 1 | 1 | 4 | 7 |
| Condition aggravated‡ | 3 | 5 | 0 | 0 | 3 | 5 |
| Asthaenia and fatigue | 5 | 5 | 2 | 2 | 3 | 3 |
| Fever | 1 | 5 | 0 | 0 | 1 | 5 |
*Events were recorded according to the dose that the patient was exposed to at the moment of the event.
†Comprising headache, dysaesthesia, sciatica and tension headache.
‡A worsening of disease components that were present at the onset of the study or are components of the primary disease (comprising global aggravated condition (n=1 patient), worsening of arthralgia or myalgia (n=1 patient), and an increase of global pain and skin rash (n=1 patient)).
AEs, adverse events; CT, connective tissue; ISRs, injection site reactions; SOC, System Organ Class.