Table 3.
Adverse events (AEs) overall and most frequent events: n (%) of subjects (>5% in any group)
| Secukinumab 2×10 mg/kg n=39 n (%) | Placebo n=20 n (%) | |
|---|---|---|
| Patients with AE(s) | 29 (74.4) | 10 (50.0) |
| Preferred term | ||
| Crohn’s disease | 6 (15.4) | 3 (15.0) |
| Abdominal pain | 5 (12.8) | 2 (10.0) |
| Vomiting | 5 (12.8) | 1 (5.0) |
| Arthralgia | 4 (10.3) | 0 |
| Headache | 3 (7.7) | 3 (15.0) |
| Upper respiratory tract infection | 3 (7.7) | 0 |
| Aphthous stomatitis | 2 (5.1) | 0 |
| Blood pressure diastolic decreased | 2 (5.1) | 0 |
| Candidiasis | 2 (5.1) | 0 |
| Dehydration | 2 (5.1) | 0 |
| Diarrhoea | 2 (5.1) | 1 (5.0) |
| ECG QT prolonged | 2 (5.1) | 0 |
| Fatigue | 2 (5.1) | 2 (10.0) |
| Hypokalaemia | 2 (5.1) | 0 |
| Myalgia | 2 (5.1) | 0 |
| Nasopharyngitis | 2 (5.1) | 0 |
| Nausea | 2 (5.1) | 3 (15.0) |
| Fever | 2 (5.1) | 1 (5.0) |
| Insomnia | 0 | 2 (10.0) |
| Patients with SAEs* | 7 (17.9)* | 3 (15.0) |
| Patients with infections | 17 (43.6) | 0 |
| Patients with severe infections | 1 (2.6) | 0 |
| Patients with leucopenia (≥grade 2) | 2 (5.1) | 0 |
| Patients with neutropenia | 4 (10.3) | 1 (2.6) |
*
Table lists only SAEs that were reported before patients completed or discontinued from study. Two additional SAEs were reported for two patients on secukinumab after discontinuation from study.
SAE, serious adverse event.