Table 7.

safety outcome results identified in studies included for review

Study	Design	Treatment	Treatment regimen	Sample size (males)	Age [mean (SD)] years	Safety assessment (week)	% of patients experienced to adverse events	% of patients experienced to adverse events due to treatment intervention	Reported adverse events likely to be related to treatment intervention
Pollak [44]	Case series	Terbinafine	250 mg oral terbinafine once daily for 12 weeks†	77 (N/R)	N/R	6, 12,18, 24, 30, 36, 48, 72	61% (47/77)	10.4% (8/77)	Gastrointestinal
Albreski [45]	RCT	Itraconazole Palliative	200 mg of oral itraconazole taken twice a day for the first week of three consecutive months Toenail trimming, cleaning and soaking†	27 (26) 25 (25)	70.52 (7.99) 72.32 (4.42)	32 32	15% (4/27) 0%	4% (1/27) 0%	Elevated liver function test N/A
Brenner [43]	Case series	Ciclopirox 8%	Ciclopirox 8% nail lacquer applied daily to nail and 5 mm surrounding skin for 48 weeks. Nails care every 8 weeks.	49(36)	63.8 (12.0)	48	44.9% (22/49)	29% (14/49)	Toenail disorders and infection
Farkas [46]	Case series	Terbinafine	250 mg oral terbinafine once daily for 12 weeks.	89 (47)	55.7 (11.7)	36	13.5% (12/89)	7.9% (7/89)	Gastrointestinal disturbance, headache, change in taste sensation and
Gupta [42]	RCT	Itraconazole Terbinafine	200 mg of oral itraconazole taken twice a day for the first week of three consecutive months 250 mg oral terbinafine once daily for 12 weeks.	35 (16) 35 (18)	57.77 (2.3) 63.65 (1.9)	48 48	Not reported Not reported	8.6% (3/35) 0%	Gastrointestinal N/A

RCT-Randomised controlled trial

N/R-Not reported

N/A-Not applicable

^† According to Health Care Financing Administration [54] guidelines for 4 months.