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Table 3 Summary of treatment-emergent adverse eventsa (safety population)

From: 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)

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 infectionc 15 (18.3) 29 (33.3)d
  1. AE adverse event
  2. 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
  3. bOne case of a non-treatment-related death occurred on Day 62 after initiation of treatment owing to cardiac disorders and cardiopulmonary failure
  4. 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
  5. dP = 0.026 based on Chi-square test