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Table 3 Number (n) and percentage (%) of treatment-emergent adverse events, regardless of study drug relationship, by primary system organ class, preferred term, and maximum severitya (safety population)

From: Efficacy of 8 mg lidocaine and 2 mg cetylpyridinium chloride (CPC) fixed-combination lozenges on sore throat pain intensity compared with 1 mg lidocaine and 2 mg CPC fixed-combination lozenges in subjects with sore throat due to upper respiratory tract infection: a randomized double-blind parallel-group single-dose study

System organ class and preferred term 8 mg lidocaine + 2 mg CPC (n = 125) 1 mg lidocaine + 2 mg CPC (n = 125)
Mild Moderate Mild Moderate
Gastrointestinal disorders 1 (0.8) 0 (0.0) 1 (0.8) 0 (0.0)
 Throat irritation 1 (0.8) 0 (0.0) 1 (0.8) 0 (0.0)
Respiratory, thoracic and mediastinal disorders 1 (0.8) 0 (0.0) 1 (0.8) 0 (0.0)
 Asthma 0 (0.0) 0 (0.0) 1 (0.8) 0 (0.0)
 Stridor 1 (0.8) 0 (0.0) 0 (0.0) 0 (0.0)
Nervous system disorders 8 (6.4) 1 (0.8) 6 (4.8) 1 (0.8)
 Dizziness 0 (0.0) 0 (0.0) 1 (0.8) 0 (0.0)
 Headache 7 (5.6) 0 (0.0) 5 (4.0) 1 (0.8)
 Hyperesthesia 0 (0.0) 1 (0.8) 0 (0.0) 0 (0.0)
 Vertigo 1 (0.8) 0 (0.0) 0 (0.0) 0 (0.0)
Skin and subcutaneous tissue disorders 1 (0.8) 0 (0.0) 0 (0.0) 0 (0.0)
 Rash 1 (0.8) 0 (0.0) 0 (0.0) 0 (0.0)
Any primary system organ class 9 (7.2) 1 (0.8) 8 (6.4) 1 (0.8)
  1. A subject with multiple occurrences of an AE under one treatment is counted only once in the AE category for that treatment. A subject with multiple AEs within a primary system organ class is counted only once in the total row
  2. CPC cetylpyridinium chloride, AE adverse event
  3. aNo severe AEs were reported during the assessment period