Adverse events occurring in at least 3 patients by preferred term during the entire study (study duration: 33 months)
| Adverse event, n (%) | Study cohort (N=20) |
|---|---|
| Any adverse event | 20 (100) |
| Nasopharyngitis | 12 (60) |
| Abdominal pain | 11 (55) |
| Headache | 11 (55) |
| Oropharyngeal pain | 11 (55) |
| Fever | 10 (50) |
| Diarrhoea | 9 (45) |
| Arthralgia | 8 (40) |
| Vomiting | 8 (40) |
| Fatigue | 7 (35) |
| Upper respiratory tract infection | 7 (35) |
| Cough | 6 (30) |
| Musculoskeletal pain | 6 (30) |
| Myalgia | 6 (30) |
| Dizziness | 5 (25) |
| Rhinitis | 5 (25) |
| Abdominal pain upper | 4 (20) |
| Bronchitis | 4 (20) |
| Condition aggravated | 4 (20) |
| Pharyngitis | 4 (20) |
| Back pain | 3 (15) |
| Chest pain* | 3 (15) |
| Cystitis | 3 (15) |
| Ear pain | 3 (15) |
| Epistaxis | 3 (15) |
| Lower respiratory tract infection | 3 (15) |
| Pain in extremity | 3 (15) |
| Paraesthesia | 3 (15) |
| Rash | 3 (15) |
| Respiratory tract infection | 3 (15) |
| Toothache | 3 (15) |
| Viral infection | 3 (15) |
*Of these three events, two were non-cardiac chest pain and the other was related to tumour necrosis factor receptor-associated periodic syndrome (TRAPS) disease activity. None were considered related to canakinumab by the investigator.