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Table 3 Adverse events occurring in ≥10% LOPD subjects

From: A study on the safety and efficacy of reveglucosidase alfa in patients with late-onset Pompe disease

Subjects with any AE, n (%)a 5 mg/kg (N = 3) 10 mg/kg (N = 3) 20 mg/kg (N = 16) Total (N = 22)
 Hypoglycemia 0 (0) 1 (33) 14 (88) 15 (68)
 Dizziness 1 (33) 1 (33) 10 (63) 12 (55)
 Fall 3 (100) 3 (100) 6 (38) 12 (55)
 Headache 2 (67) 2 (67) 8 (50) 12 (55)
 Nausea 1 (33) 1 (33) 10 (63) 12 (55)
 Fatigue 2 (67) 1 (33) 7 (44) 10 (45)
 Chest discomfort 2 (67) 1 (33) 6 (38) 9 (41)
 Vomiting 1 (33) 1 (33) 6 (38) 8 (36)
 Dyspnea 0 (0) 1 (33) 6 (38) 7 (32)
 Malaise 1 (33) 0 (0) 6 (38) 7 (32)
 Chills 0 (0) 1 (33) 5 (31) 6 (27)
 Nervousness 1 (33) 0 (0) 5 (31) 6 (27)
 Tachycardia 0 (0) 1 (33) 8 (50) 6 (27)
 Abdominal pain upper 1 (33) 0 (0) 4 (25) 5 (23)
 Feeling hot 0 (0) 1 (33) 4 (25) 5 (23)
 Flushing 1 (33) 0 (0) 4 (25) 5 (23)
 Rash 1 (33) 0 (0) 4 (25) 5 (23)
 Urticaria 1 (33) 1 (33) 3 (19) 5 (23)
 Cold sweat 0 (0) 0 (0) 4 (25) 4 (18)
 Erythema 1 (33) 0 (0) 3 (19) 4 (18)
 Feeling cold 0 (0) 1 (33) 3 (19) 4 (18)
 Hyperhidrosis 0 (0) 0 (0) 4 (25) 4 (18)
 Hypertension 0 (0) 0 (0) 4 (25) 4 (18)
 Hypotension 0 (0) 0 (0) 4 (25) 4 (18)
 Edema peripheral 0 (0) 0 (0) 3 (19) 3 (14)
 Hot flush 1 (33) 0 (0) 2 (13) 3 (14)
 Infusion-related reaction 2 (67) 0 (0) 1 (6) 3 (14)
 Pallor 0 (0) 0 (0) 3 (19) 3 (14)
 Pruritus 0 (0) 0 (0) 3 (19) 3 (14)
 Rash pruritic 1 (33) 1 (33) 1 (6) 3 (14)
 Tremor 0 (0) 0 (0) 3 (19) 3 (14)
Subjects with any serious AE, n (%)
 Hypoglycemia 0 (0) 0 (0) 2 (13) 2 (9)
 Acute cardiac failure 0 (0) 0 (0) 1 (6) 1 (5)
 Hypersensitivity 0 (0) 0 (0) 1 (6) 1 (5)
 Presyncope 0 (0) 0 (0) 1 (6) 1 (5)
  1. Abbreviations:
  2. AE adverse event, LOPD late-onset Pompe disease
  3. aAll 22 subjects reported ≥1 AE