Table 3

Incidence rates of serious adverse events by preferred term (≥2 events)

N=177Rate per 100 patient-years
n (%)Events
Serious adverse events64 (36.2)19440.68
Preferred term
 Juvenile idiopathic arthritis17 (9.6)255.24
 Histiocytosis haematophagic (MAS)*10 (5.6)173.56
 Fever8 (4.5)81.68
 Gastroenteritis5 (2.8)51.05
 Abdominal pain4 (2.3)40.84
 Pneumonia3 (1.7)40.84
 Hepatitis2 (1.1)30.63
 Hepatic enzyme increased3 (1.7)30.63
 Septic shock2 (1.1)20.42
 Arthralgia2 (1.1)20.42
 Lymphadenopathy2 (1.1)20.42
 Gastrointestinal viral infection2 (1.1)20.42
 Subcutaneous abscess2 (1.1)20.42
 Tonsillitis streptococcal2 (1.1)20.42
 Musculoskeletal chest pain2 (1.1)20.42
 Varicella2 (1.1)20.42
 Vomiting2 (1.1)20.42
 Drug reaction with eosinophilia and systemic symptoms2 (1.1)20.42
 C-reactive protein increased2 (1.1)20.42
 Serum ferritin increased2 (1.1)20.42
 Paraesthesia2 (1.1)20.42
 Anxiety2 (1.1)20.42
 Traumatic fracture2 (1.1)20.42
 Rash2 (1.1)20.42
  • N denotes the total number of patients; serious adverse events occurring after pivotal study baseline are presented in this table.

  • *MAS: macrophage activation syndrome is the terminology used in the literature.30–33