AEs occurring in ≥2% of patients—safety population
| Enrolment period | ||||||
|---|---|---|---|---|---|---|
| 2005–2007 | 2008–2013 | Total | ||||
| Preferred term* | Percent of patients† | Number of AEs | Percent of patients† | Number of AEs | Percent of patients† | Number of AEs |
| Total | 56.4 | 650 | 53.3 | 503 | 54.7 | 1153 |
| Arthralgia | 9.3 | 30 | 7.2 | 35 | 8.1 | 64 |
| Back pain | 9.3 | 33 | 6.1 | 18 | 7.5 | 51 |
| Pain in extremity | 6.4 | 18 | 5.6 | 21 | 5.9 | 39 |
| Nasopharyngitis | 8.6 | 20 | 5.6 | 14 | 6.9 | 34 |
| Fatigue | 6.4 | 23 | 2.2 | 5 | 4.1 | 28 |
| Neck pain | 7.9 | 20 | 1.1 | 3 | 4.1 | 23 |
| Sinusitis | 5.0 | 14 | 6.1 | 8 | 5.6 | 22 |
| Hypoaesthesia | 5.0 | 10 | 2.8 | 12 | 3.8 | 22 |
| Nausea | 4.3 | 13 | 2.8 | 8 | 3.4 | 21 |
| Pain | 7.9 | 18 | 1.7 | 3 | 4.4 | 21 |
| Upper respiratory tract infection | 5.7 | 12 | 3.9 | 7 | 4.7 | 19 |
| Diarrhoea | 3.6 | 5 | 4.4 | 13 | 4.1 | 18 |
| Headache | 5.0 | 10 | 3.9 | 8 | 4.4 | 18 |
| Pruritus | 4.3 | 9 | 3.9 | 9 | 4.1 | 18 |
| Rash | 5.7 | 13 | 1.7 | 4 | 3.4 | 17 |
| Oropharyngeal pain | 3.6 | 13 | 1.7 | 3 | 2.5 | 16 |
| Infusion-related reaction | 3.6 | 6 | 2.2 | 9 | 2.8 | 15 |
| Chest pain | 2.1 | 6 | 2.8 | 8 | 2.5 | 14 |
| Dyspepsia | 2.9 | 9 | 1.7 | 5 | 2.2 | 14 |
| Hepatic enzyme increased | 2.1 | 4 | 3.9 | 10 | 3.1 | 14 |
| Urinary tract infection | 3.6 | 7 | 2.2 | 7 | 2.8 | 14 |
| Cough | 2.1 | 3 | 3.9 | 10 | 3.1 | 13 |
| Pharyngitis | 4.3 | 6 | 2.2 | 7 | 3.1 | 13 |
| Musculoskeletal stiffness | 1.4 | 5 | 2.8 | 7 | 2.2 | 12 |
| Uveitis | 2.9 | 7 | 2.2 | 5 | 2.5 | 12 |
| Gastroenteritis | 5.7 | 9 | 1.1 | 2 | 3.1 | 11 |
| Influenza | 5.7 | 8 | 1.7 | 3 | 3.4 | 11 |
| Fever | 3.6 | 8 | 1.1 | 2 | 2.2 | 10 |
| Vomiting | 2.9 | 4 | 3.3 | 6 | 3.1 | 10 |
| Fall | 2.9 | 4 | 1.7 | 5 | 2.2 | 9 |
| Hypertension | 4.3 | 7 | 1.1 | 2 | 2.5 | 9 |
| Ear infection | 2.9 | 4 | 1.7 | 3 | 2.2 | 7 |
*MedDRA V.13.0.
†Patients experiencing the same AE or SAE multiple times were only counted once for the corresponding preferred term.
AEs, adverse events; MedDRA, Medical Dictionary for Regulatory Activities; SAEs, serious adverse events.