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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 AE71 (86.6)61 (70.1)
 Any serious AE4 (4.9)8 (9.2)
 Any AE leading to death01 (1.1)b
 Any AE leading to discontinuation5 (6.1)3 (3.4)
AEs Occurring in ≥ 5% of Patients in Either Treatment Arm
 Worsening pruritus9 (11.0)8 (9.2)
 Nasopharyngitis11 (13.4)3 (3.4)
 Pyrexia7 (8.5)9 (10.3)
 Wound infection6 (7.3)5 (5.7)
 Upper respiratory tract infection4 (4.9)9 (10.3)
 All skin infection3 (3.7)9 (10.3)
 Staphylococcal skin infection1 (1.2)7 (8.0)
AEs of Special Interest
 Patients who had skin infectionc15 (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