Efficacy and tolerability of the investigational topical cream SD-101 (6% allantoin) in patients with epidermolysis bullosa: a phase 3, randomized, double-blind, vehicle-controlled trial (ESSENCE study)

Table 3 Summary of treatment-emergent adverse events^a (safety population)

n (%)	SD-101 6% n = 82	Vehicle n = 87
Overall Summary
Any AE	71 (86.6)	61 (70.1)
Any serious AE	4 (4.9)	8 (9.2)
Any AE leading to death	0	1 (1.1)^b
Any AE leading to discontinuation	5 (6.1)	3 (3.4)
AEs Occurring in ≥ 5% of Patients in Either Treatment Arm
Worsening pruritus	9 (11.0)	8 (9.2)
Nasopharyngitis	11 (13.4)	3 (3.4)
Pyrexia	7 (8.5)	9 (10.3)
Wound infection	6 (7.3)	5 (5.7)
Upper respiratory tract infection	4 (4.9)	9 (10.3)
All skin infection	3 (3.7)	9 (10.3)
Staphylococcal skin infection	1 (1.2)	7 (8.0)
AEs of Special Interest
Patients who had skin infection^c	15 (18.3)	29 (33.3)^d

AE adverse event
^aDefined as AEs that began or changed in severity or relationship to treatment on or after the date of the first dose of study medication
^bOne case of a non-treatment-related death occurred on Day 62 after initiation of treatment owing to cardiac disorders and cardiopulmonary failure
^cPatients were considered to have a skin infection if meeting one of the following preferred terms: skin infection, wound infection, staphylococcal skin infection, bacterial skin infection, staphylococcal wound infection, folliculitis, bacterial wound infection, cellulitis, staphylococcal cellulitis, impetigo, infected skin ulcer, postoperative wound infection, or pustular rash
^dP = 0.026 based on Chi-square test

ISSN: 1750-1172