. 2016 Dec 23;48(2):198–207. doi: 10.1016/j.bjm.2016.12.003

Table 2.

Adverse events (AEs) reported in the included studies.

Study	No. of patients in FDC/SD group	AEs (no. of patients) in FDC group	AEs (no. of patients) in SD group	Default	Relapse	TB drug-related death
Su, 2002¹⁴	26/25	Hyperuricemia (8), skin itching (4), skin rash (2), drug fever (1), abnormal liver function (3)	Hyperuricemia (7), skin itching (7), skin rash (2), abnormal liver function (5), gastrointestinal disorders (5), blurred vision (2), sensation of numbness (1)	Not evaluated	1/57FDC	Not evaluated
Gravendeel et al., 2003²³	198/162	Gastrointestinal disorders (81), skin reaction (83), muscle-joints (64)	Gastrointestinal disorders (89), skin reaction (67), muscle-joints (73)	1/198 FDC, 2/162 SD	Not evaluated	Not evaluated
Zaka et al., 2008²⁵	194/99	Gastrointestinal disorders (28), skin reaction (8), muscle-joints (3)	Gastrointestinal disorders (23), skin reaction (3), muscle-joints (0), death (1)	53/197 FDC, 30/99 SD	0/293 FDC and SD	1 case in group C with suspected TB meningitis
Bartacek et al., 2009²²	558/564	Skin disorders (40); asthenia, headache, fever (29); musculo-skeletal disorders (20); hepatic and biliary disorders (14); others (19)	Skin disorders (30); asthenia, headache, fever (5); musculo-skeletal disorders (22); liver and biliary disorders (21); others (8)	25/558 FDC, 15/564 SD	6/344 FDC, 3/360 SD	2/558 FDC cases of hepatitis
Lienhardt et al., 2011²⁴	798/787	Rheumatological (7); dermatological (16); hepatic (5); and gastrointestinal (6) disorders; others (3)	Rheumatological (11); dermatological (15); hepatic (1); and gastrointestinal (11) disorders; others (4).	40/798 FDC, 39/787 SD	23/591 FDC, 19/579 SD	4/591 FDC, 4/579 SD