Table 4

 Number of women with drug related adverse events occurring in at least 1% of patients in either treatment group (intent to treat/safety population)

Adverse eventMoxifloxacin (n = 378)Ofloxacin plus metronidazole (n = 363)
No (%)No (%)
No of women with an event85 (22.5)112 (30.9)
Gastrointestinal disorder54 (14.3)71 (19.6)
    Nausea31 (8.2)51 (14.0)
    Diarrhoea9 (2.4)6 (1.7)
    Vomiting9 (2.4)6 (1.7)
    Abdominal pain (upper)4 (1.1)5 (1.4)
    Abdominal pain4 (1.1)4 (1.1)
    Dyspepsia4 (1.1)2 (0.6)
    Dry mouth1 (0.3)4 (1.1)
    Flatulence4 (1.1)
General and administration site conditions13 (3.4)7 (1.9)
    Asthenia7 (1.9)4 (1.1)
Infections and infestations11 (2.9)17 (4.7)
    Vaginal candidiasis5 (1.3)9 (2.5)
    Vaginal mycosis4 (1.1)7 (1.9)
Nervous system disorders18 (4.8)32 (8.8)
    Headache6 (1.6)17 (4.7)
    Dizziness9 (2.4)9 (2.5)
    Taste disturbance3 (0.8)14 (3.9)
Psychiatric disorders2 (0.5)5 (1.4)
Reproductive system and breast disorders3 (0.8)6 (1.7)
    Genital pruritus2 (0.5)4 (1.1)
Skin and subcutaneous tissue disorders6 (1.6)8 (2.2)