Adverse events (AEs)*
| N (%) of subjects | |||
|---|---|---|---|
| Blinded phase | Open-label phase | ||
| Preferred term | Placebo (n=17) | Sifalimumab (n=33) | Sifalimumab (n=17) |
| SLE flare | 8 (47) | 9 (27) | 5 (29) |
| Headache | 3 (18) | 5 (15) | 2 (12) |
| Diarrhoea | 0 (0) | 5 (15) | 1 (6) |
| Nausea | 1 (6) | 4 (12) | 3 (18) |
| Arthralgia | 0 (0) | 4 (12) | 4 (24) |
| Laboratory abnormalities | |||
| Blood bicarbonate decreased | 1 (6) | 9 (27) | 3 (18) |
| Blood glucose decreased (random) | 5 (29) | 9 (27) | 1 (6) |
| Urine protein present | 6 (35) | 6 (18) | 4 (24) |
| Haemoglobin decreased | 6 (35) | 6 (18) | 7 (41) |
Results are shown as number (%).
↵* AEs reported by ≥10% of the sifalimumab group in the blinded phase are presented in descending frequency. Any new laboratory test result above or below the limits of normal was reported as an AE regardless of clinical significance.
SLE, systemic lupus erythematosus.