AE preferred terms | Placebo n=9 n (%) | Ianalumab 3 mg/kg n=6 n (%) | Ianalumab 10 mg/kg n=12 n (%) | Total n=27 n (%) |
Infusion-related reaction | 1 (11.1) | 6 (100.0) | 9 (75.0) | 16 (59.3) |
Nasopharyngitis | 1 (11.1) | 4 (66.7) | 2 (16.7) | 7 (25.9) |
Headache | 2 (22.2) | 1 (16.7) | 2 (16.7) | 5 (18.5) |
Gastrointestinal infection | 1 (11.1) | 0 (0.0) | 1 (8.3) | 2 (7.4) |
Influenza | 0 (0.0) | 1 (16.7) | 1 (8.3) | 2 (7.4) |
Sinusitis | 1 (11.1) | 0 (0.0) | 1 (8.3) | 2 (7.4) |
Rash | 1 (11.1) | 0 (0.0) | 1 (8.3) | 2 (7.4) |
Tooth infection | 1 (11.1) | 1 (16.7) | 0 (0.0) | 2 (7.4) |
Oropharyngeal pain | 1 (11.1) | 1 (16.7) | 0 (0.0) | 2 (7.4) |
Non-cardiac chest pain | 2 (22.2) | 0 (0.0) | 0 (0.0) | 2 (7.4) |
All infusion-related reactions occurred within 24 hours after dosing.
AE, adverse event.