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

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 severity^a (safety population)

System organ class and preferred term	8 mg lidocaine + 2 mg CPC (n = 125)		1 mg lidocaine + 2 mg CPC (n = 125)
System organ class and preferred term	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)

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
CPC cetylpyridinium chloride, AE adverse event
^aNo severe AEs were reported during the assessment period

ISSN: 1745-6215