Table 2

Most frequent AEs occurring in two or more patients reported during double-blind period

AE preferred termsPlacebo
n=9
n (%)
Ianalumab 3 mg/kg
n=6
n (%)
Ianalumab 10 mg/kg
n=12
n (%)
Total
n=27
n (%)
Infusion-related reaction1 (11.1)6 (100.0)9 (75.0)16 (59.3)
Nasopharyngitis1 (11.1)4 (66.7)2 (16.7)7 (25.9)
Headache2 (22.2)1 (16.7)2 (16.7)5 (18.5)
Gastrointestinal infection1 (11.1)0 (0.0)1 (8.3)2 (7.4)
Influenza0 (0.0)1 (16.7)1 (8.3)2 (7.4)
Sinusitis1 (11.1)0 (0.0)1 (8.3)2 (7.4)
Rash1 (11.1)0 (0.0)1 (8.3)2 (7.4)
Tooth infection1 (11.1)1 (16.7)0 (0.0)2 (7.4)
Oropharyngeal pain1 (11.1)1 (16.7)0 (0.0)2 (7.4)
Non-cardiac chest pain2 (22.2)0 (0.0)0 (0.0)2 (7.4)
  • All infusion-related reactions occurred within 24 hours after dosing.

  • AE, adverse event.