Safety and efficacy of pegunigalsidase alfa in patients with Fabry disease who were previously treated with agalsidase alfa: results from BRIDGE, a phase 3 open-label study

Table 2 Overview of TEAEs (safety population)

Parameter	Men n = 15	Women n = 7	Overall N = 22
Patients with ≥ 1 TEAE, n (%)	14 (93)	7 (100)	21 (96)
Patients with ≥ 1 severe TEAE, n (%)	4 (27)	0	4 (18)
Patients with ≥ 1 serious TEAE, n (%)	4 (27)	0	4 (18)
Patients with ≥ 1 TEAE related^a to study treatment, n (%)	5 (33)	0	5 (23)
Patients with ≥ 1 TEAE leading to study discontinuation, n (%)	2 (13)	0	2 (9)^b
Patients with ≥ 1 infusion-related reaction (IRR),^c n (%)	5 (33)	0	5 (23)^b
TEAEs reported in > 2 patients
Nasopharyngitis, n (%)	5 (33)	2 (29)	7 (32)
Headache, n (%)	3 (20)	2 (29)	5 (23)
Dyspnea, n (%)	2 (13)	1 (14)	3 (14)

IRR infusion-related reaction, TEAE treatment-emergent adverse event
^aPossibly, probably, or definitely related
^bTwo patients each experienced one type 1 hypersensitivity infusion-related reaction which led to study discontinuation
^cTEAEs occurring during infusion or within 2 h after completion of infusion that were reported as possibly, probably, or definitely related to study treatment, excluding injection-site reactions

ISSN: 1750-1172