Table 2.

Summary of adverse drug reactions

		RS8 (n=151)	RC8 (n=146)	Total (n=297)
Any adverse event		20 (13%)	9 (6%)	29 (10%)
	Serious adverse event*	1 (1%)	0	1 (<1%)
	Adverse event, not serious	19 (13%)	9 (6%)	29 (10%)
Otovestibular toxicity		8 (5%)	1 (1%)	9 (3%)
	Ototoxicity, >25 dB hearing loss	3 (2%)	1 (1%)	4 (1%)
	Vestibular toxicity	5 (3%)	0	5 (2%)
Mucocutaneous manifestations		3 (2%)	0	3 (1%)
	Skin rash (grades 1–2 only)	2 (1%)	0	2 (1%)
	Conjunctivitis	1 (1%)	0	1 (<1%)
Constitutional symptoms		1 (1%)	0	1 (<1%)
	Fever	1 (1%)	0	1 (<1%)
Headache		1 (1%)	2 (1%)	3 (1%)
Malaise		0	1 (1%)	1 (<1%)
Lymphadenopathy		1 (1%)	1 (1%)	2 (1%)
Cough		0	1 (1%)	1 (<1%)
Gastrointestinal		2 (1%)	0	2 (1%)
	Nausea and vomiting	1 (1%)	0	1 (<1%)
	Abdominal pain	1 (1%)	0	1 (<1%)
Confusion		0	0	0
ECG changes		4 (3%)	3 (2%)	7 (2%)
	QTc prolongation (but <490 msec)	3 (2%)	2 (1%)	5 (2%)
	Other (down-slope ST, P wave increase)	1 (1%)	1 (1%)	2 (1%)

Data are n (%). RC8=oral rifampicin 10 mg/kg plus clarithromycin 15 mg/kg extended release once daily for 8 weeks. RS8=oral rifampicin 10 mg/kg plus intramuscular streptomycin 15 mg/kg once daily for 8 weeks. ECG=electrocardiogram.

^*Older patient with hearing loss, dizziness, and imbalance leading to discontinuation at week 6.