Table 5– Overview of adverse events for intent-to-treat patients/safety population
Adverse eventMoxifloxacin#Amoxicillin/clavulanic acid
Any adverse event220 (32.5)218 (32.3)
Drug-related53 (7.8)41 (6.1)
 Diarrhoea6 (0.9)12 (1.8)
 Nausea10 (1.5)4 (0.6)
 Headache5 (0.7)3 (0.4)
Serious46 (6.8)51 (7.6)
Drug-related serious adverse events4 (0.6)2 (0.3)
Premature discontinuation due to drug-related12 (1.8)9 (1.3)
Adverse-event related death3 (0.4)3 (0.4)
  • Data are presented as number with adverse event (%). No significant differences were observed between treatments for any type of safety event (p>0.10 for all categories). #: n=677; : n=675.