N=177 | Rate per 100 patient-years | ||
n (%) | Events | ||
Serious adverse events | 64 (36.2) | 194 | 40.68 |
Preferred term | |||
Juvenile idiopathic arthritis | 17 (9.6) | 25 | 5.24 |
Histiocytosis haematophagic (MAS)* | 10 (5.6) | 17 | 3.56 |
Fever | 8 (4.5) | 8 | 1.68 |
Gastroenteritis | 5 (2.8) | 5 | 1.05 |
Abdominal pain | 4 (2.3) | 4 | 0.84 |
Pneumonia | 3 (1.7) | 4 | 0.84 |
Hepatitis | 2 (1.1) | 3 | 0.63 |
Hepatic enzyme increased | 3 (1.7) | 3 | 0.63 |
Septic shock | 2 (1.1) | 2 | 0.42 |
Arthralgia | 2 (1.1) | 2 | 0.42 |
Lymphadenopathy | 2 (1.1) | 2 | 0.42 |
Gastrointestinal viral infection | 2 (1.1) | 2 | 0.42 |
Subcutaneous abscess | 2 (1.1) | 2 | 0.42 |
Tonsillitis streptococcal | 2 (1.1) | 2 | 0.42 |
Musculoskeletal chest pain | 2 (1.1) | 2 | 0.42 |
Varicella | 2 (1.1) | 2 | 0.42 |
Vomiting | 2 (1.1) | 2 | 0.42 |
Drug reaction with eosinophilia and systemic symptoms | 2 (1.1) | 2 | 0.42 |
C-reactive protein increased | 2 (1.1) | 2 | 0.42 |
Serum ferritin increased | 2 (1.1) | 2 | 0.42 |
Paraesthesia | 2 (1.1) | 2 | 0.42 |
Anxiety | 2 (1.1) | 2 | 0.42 |
Traumatic fracture | 2 (1.1) | 2 | 0.42 |
Rash | 2 (1.1) | 2 | 0.42 |
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