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Table 2 Summary of adverse events

From: Survival in infants treated with sebelipase Alfa for lysosomal acid lipase deficiency: an open-label, multicenter, dose-escalation study

Event, n (%) Overall (N = 9)
Any TEAE 9 (100)
Any related TEAE 6 (67)
Any IAR 5 (56)
Any serious TEAE 9 (100)
Any related serious TEAE 1 (11)
Dose modification due to a TEAE* 7 (78)
Discontinuation due to a TEAE 0
Death 4 (44)
Death related to treatment 0
  1. IAR infusion-associated reaction, TEAE treatment-emergent adverse event
  2. *All dose modifications were dose escalations based on inadequate clinical response. These symptoms of inadequate clinical response were also captured as adverse events (see Additional file 1)