Table 2

Treatment-emergent adverse events

Patients, n (%)Placebo (n=17)CenerimodTotal
(N=67)
0.5 mg (n=12)1 mg (n=12)2 mg (n=13)4 mg (n=13)
Any AE10 (58.8)5 (41.7)5 (41.7)6 (46.2)5 (38.5)31 (46.3)
 SAE1 (5.9)1 (1.5)
 Severe AE1 (5.9)1 (8.3)2 (3.0)
 AE leading to discontinuation2 (11.8)2 (3.0)
 Drug-related AE3 (17.6)3 (25.0)1 (8.3)3 (23.1)2 (15.4)12 (17.9)
 Serious drug-related AE
 AESI1 (5.9)2 (16.7)1 (8.3)1 (7.7)1 (7.7)6 (9.0)
Most frequent AEs*
 Headache1 (5.9)2 (16.7)3 (4.5)
 Nasopharyngitis2 (11.8)1 (7.7)3 (4.5)
 Neutropoenia1 (5.9)2 (16.7)3 (4.5)
  • AEs by preferred term. Safety set (N=67).

  • *AE occurred in three or more patients.

  • AE, adverse event; AESI, adverse event of special interest; SAE, serious adverse event.