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Table 3 Summary of adverse events by treatment time interval

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

  Treatment time interval
Event, n (%) 0–3 months*(n = 9) >3–6 months*(n = 6) >6–12 months*(n = 6)
Any TEAE 8 (89) 5 (83) 6 (100)
Any related TEAE 4 (44) 1 (17) 3 (50)
Any IAR 3 (33) 2 (33) 3 (50)
Any serious TEAE 7 (78) 4 (67) 4 (67)
Any related serious TEAE 1 (11) 0 0
Dose modification due to a TEAE 3 (33) 1 (17) 1 (17)
Discontinuation due to a TEAE 0 0 0
Death 3 (33) 0 1 (17)
Death related to treatment 0 0 0
  1. IAR infusion-associated reaction, TEAE treatment-emergent adverse event
  2. *Non-serious adverse event data were unavailable for one patient from week 0 to week 39 (~month 9)
  3. 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)