Canakinumab | |||
---|---|---|---|
n (%) | No of events | Event rate by patient-year | |
No of patients | 166 | ||
At least one AE | 150 (90.4) | 1019 | 5.93 |
Abdominal pain | 13 (7.8) | 14 | 0.08 |
Diarrhoea | 18 (10.8) | 21 | 0.12 |
Nausea | 11 (6.6) | ||
Vomiting | 16 (9.6) | 18 | 0.10 |
Bronchitis | 18 (10.8) | 19 | 0.11 |
Rhinitis | 27 (16.3) | 29 | 0.17 |
Upper respiratory tract infection | 17 (10.2) | 22 | 0.13 |
Arthralgia | 24 (14.5) | 29 | 0.17 |
Back pain | 12 (7.2) | 19 | 0.11 |
Pain in extremity | 9 (5.4) | 9 | 0.05 |
Headache | 34 (20.5) | 59 | 0.34 |
Cough | 16 (9.6) | 23 | 0.13 |
Oropharyngeal pain | 14 (8.4) | 16 | 0.93 |
SAE/severity | Relationship with study drug | No of events | Event rate by patient-year |
At least one SAE, n (%) | 18 (10.8) | ||
Adults | |||
Forearm fracture left side/moderate | Not suspected | 1 | 0.006 |
Tonsillitis*/severe | Not suspected | 1 | 0.006 |
Pneumonia* /mild | Not suspected | 1 | 0.006 |
Carpal tunnel syndrome /severe | Not suspected | 1 | 0.006 |
Dental cyst/asymptomatic | Not suspected | 1 | 0.006 |
Spontaneous abortion in the patient's wife/severe | Suspected | 1 | 0.006 |
Cellulitis*/severe | Not suspected | 1 | 0.006 |
Elective abortion/severe | Not suspected | 1 | 0.006 |
Pregnancy/severe | Not suspected | 2 | 0.012 |
Worsening of headache/moderate | Not suspected | 1 | 0.006 |
Worsening of synovial cyst in the lumbar spine/moderate | Not suspected | 1 | 0.006 |
Children | |||
Chronic tonsillitis*/mild | Not suspected | 1 | 0.006 |
Intra-abdominal abscess following appendicitis/severe | Suspected | 1 | 0.006 |
Tonsillitis*/severe | Suspected | 2 | 0.012 |
Bronchitis/H1N1/severe infection* | Not suspected | 1 | 0.006 |
Pneumonia* | Not suspected | 1 | 0.006 |
Patients with tonsillitis had a history of predisposing factors at baseline— adenoidectomy (adult); Varicella infection and feet oedema (child). Paediatric patients with pneumonia or H1N1 infection had underlying respiratory disease. Adult patients experiencing serious cellulitis had risk factors for infection at baseline—glandular fever, mouth ulcers and conjunctivitis.
Infections
↵* = 8 (4.8).
AE, adverse event; SAE, serious adverse event.