Table 2.

Treatment-related serious adverse events

	Levofloxacin group (n=489)			Placebo group (n=488)
	Grade 1–2 (n=37)	Grade 3 (n=26)	Grade 4 (n=8)	Grade 1–2 (n=17)	Grade 3 (n=14)	Grade 4 (n=3)
Blood and lymphatic system disorders
Anaemia	2 (5%)	2 (8%)	0	0	0	0
Febrile neutropenia	0	0	1 (13%)	0	0	0
Cardiac disorders
Atrial fibrillation	0	1 (4%)	1 (13%)	0	0	0
Sinus bradycardia	1 (3%)	0	0	0	1 (7%)	0
Ear and labyrinth disorders
Vertigo	0	0	0	1 (6%)	0	0
Gastrointestinal disorders
Abdominal distension	0	1 (4%)	0	0	0	0
Abdominal pain	0	0	0	1 (6%)	0	0
Diarrhoea	3 (8%)	2 (8%)	0	3 (18%)	5 (36%)	0
Nausea	3 (8%)	1 (4%)	0	0	0	0
Gastric obstruction	1 (3%)	0	0	0	0	0
Vomiting	3 (8%)	1 (4%)	0	0	1 (7%)	0
Other	0	0	0	1 (6%)	0	0
General disorders and administration site conditions
Chills	1 (3%)	0	0	0	0	0
Fever	5 (14%)	0	0	3 (18%)	2 (14%)	0
Immune system disorders
Allergic reaction	1 (3%)	0	0	0	1 (7%)	0
Infections and infestations
Bladder infection	0	1 (4)	0	0	0	0
Infectious enterocolitis	1 (3%)	0	0	0	0	0
Lung infection	0	2 (8%)	0	0	0	0
Pustular rash	0	0	0	1 (6%)	0	0
Sepsis	0	0	2 (25%)	0	0	1 (33%)
Small intestine infection	0	1 (4%)	0	0	0	0
Injury, poisoning, and procedural complications
Vascular access complication	0	1 (4%)	0	0	0	0
Investigations
Increased alanine aminotransferase	0	1 (4%)	0	0	1 (7%)	0
Increased creatinine	1 (3%)	0	0	0	0	0
Decreased neutrophil count	0	0	1 (13%)	0	0	0
Metabolism and nutrition disorders
Anorexia	0	0	0	1 (6%)	0	0
Dehydration	0	0	0	1 (6%)	0	0
Hypernatraemia	0	0	0	1 (6%)	0	0
Hyponatraemia	0	0	1 (13%)	0	0	0
Musculoskeletal and connective tissue disorders
Chest wall pain	0	0	0	0	1 (7%)	0
Myalgia	1 (3%)	0	0	0	0	0
Neck pain	1 (3%)	0	0	0	0	0
Extremity pain	1 (3%)	0	0	0	0	0
Tendonitis	3 (8%)	2 (8%)	0	0	0	0
Other	0	1 (4%)	0	0	0	0
Nervous system disorders
Dizziness	1 (3%)	0	0	0	0	0
Peripheral sensory neuropathy	1 (3%)	0	0	0	0	0
Vasovagal reaction	0	1 (4%)	0	0	0	0
Psychiatric disorders
Confusion	1 (3%)	0	0	0	0	0
Delirium	0	0	1 (13%)	0	0	0
Renal and urinary disorders
Acute kidney injury	3 (8%)	0	1 (13%)	1 (6%)	0	1 (33%)
Chronic kidney disease	0	1 (4%)	0	0	0	0
Respiratory, thoracic, and mediastinal disorders
Hypoxia	0	0	0	0	1 (7%)	0
Skin and subcutaneous tissue disorders
Erythroderma	0	0	0	0	1 (7%)	0
Pruritus	1 (3%)	0	0	0	0	0
Maculopapular rash	2 (5%)	4 (15%)	0	1 (6%)	0	0
Skin ulceration	0	0	0	1 (6%)	0	0
Stevens-Johnson syndrome	0	0	0	0	0	1 (33%)
Other	0	2 (8%)	0	0	0	0
Missing	0	0	0	1 (6%)	0	0
Vascular disorders
Hypotension	0	1 (4%)	0	0	0	0

Data are n (%; for each column denominator).