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Table 2 Patients with adverse events reported during the short-term period up to Week 16 and cumulative period (all treated patients; N = 20)

From: Intravenous abatacept in Japanese patients with polyarticular-course juvenile idiopathic arthritis: results from a phase III open-label study

Safety events Short-term period (Week 16) Cumulative period
Deathsa 0 0
SAEsb 2 (10) 4 (20)
Related SAEs 1 (5) 1 (5)
Discontinued study treatment due to AEs 0 0
AEs 20 (100) 20 (100)
Related AEs 5 (25) 6 (30)
AEs of special interest
 Infections 16 (80) 20 (100)
 Malignancies 0 0
 Autoimmune disordersc 1 (5.0) 0
 Infusion reactions
  Acute infusional 0 1 (5)
  Peri-infusionald 2 (10) 5 (25)
  Other AEs within 24 he 4 (20) 12 (60)
  1. The short-term period includes data up to 56 days after the last dose in the short-term period or start of the long-term period, whichever occurred first
  2. The cumulative period includes data from the first dose in the short-term period up to 56 days post the last dose in the cumulative period
  3. aData include deaths reported during each period including those that occurred > 56 days after the last dose
  4. bSAEs include hospitalizations for elective surgical procedures
  5. cThis event was not new onset, but worsening of the underlying disease (JIA)
  6. dDefined as AEs that occurred during the first 24 hours after the start of abatacept infusion and are included in the pre-specified Medical Dictionary for Regulatory Activities list of peri-infusional events of interest
  7. eDefined as AEs that occurred after the start of abatacept infusion but are not included in the list of peri-infusional AEs of special interest
  8. AE adverse event, JIA juvenile idiopathic arthritis, SAE serious adverse event
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Pediatric Rheumatology

ISSN: 1546-0096