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Table 3 Treatment-emergent adverse events related or possibly related to patisiran (ITT [safety] population)

From: Efficacy and safety of patisiran for familial amyloidotic polyneuropathy: a phase II multi-dose study

Preferred term, n (%) Patisiran
0.01 mg/kg 0.05 mg/kg 0.15 mg/kg 0.3 mg/kg 0.3 mg/kg  
Q4W Q4W Q4W Q4W Q3W Overall
(n = 4) (n = 3) (n = 3) (n = 7) (n = 12) (n = 29)
Infusion-related reaction 0 0 0 3 (42.9) 0 3 (10.3)
Back pain 0 0 0 2 (28.6) 0 2 (6.9)
Asthenia 0 0 0 1 (14.3) 1 (8.3) 2 (6.9)
Leukocytosis 0 0 0 0 1 (8.3) 1 (3.4)
Neutrophilia 0 0 0 0 1 (8.3) 1 (3.4)
Cellulitisa 0 0 0 1 (14.3) 0 1 (3.4)
Lymphangitis 0 0 0 1 (14.3) 0 1 (3.4)
Polyuria 0 0 0 1 (14.3) 0 1 (3.4)
Nausea/vomiting 0 0 0 0 1 (8.3) 1 (3.4)
Facial erythema 0 0 0 0 1 (8.3) 1 (3.4)
Dry mouth 0 0 0 0 1 (8.3) 1 (3.4)
Pyrexia 0 0 0 0 1 (8.3) 1 (3.4)
Dysphagia 0 0 0 0 1 (8.3) 1 (3.4)
  1. aDue to drug extravasation
  2. ITT intent-to-treat; Q3W every 3 weeks; Q4W every 4 weeks