Table 11 (abstract O38). Summary of AEs during the combined initial 4-month and 20-month extension period (All Treated Patients)
From: Proceedings of the 23rd Paediatric Rheumatology European Society Congress: part one
2–5-year cohort (n = 32) | 6–17-year cohort (n = 173) | |
|---|---|---|
Deaths | 0 | 0 |
All AEs | 26 (81.3) | 127 (73.4) |
Related AEs | 11 (34.4) | 45 (26.0) |
AEs leading to discontinuation | 0 | 4 (2.3)a |
SAEs | 0 | 8 (4.6) |
Related SAEs | 0 | 1 (0.6) |
SAEs leading to discontinuation | 0 | 2 (1.2)b |
AEs of special interest | ||
Malignancies | 0 | 1 (0.6) |
Autoimmune disorders | 0 | 3 (1.7) |
Local injection-site reactions | 0 | 10 (5.8) |
Infections | 22 (68.8) | 90 (52.0) |