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Table 7 safety outcome results identified in studies included for review

From: Safety and efficacy of tinea pedis and onychomycosis treatment in people with diabetes: a systematic 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
  1. RCT-Randomised controlled trial
  2. N/R-Not reported
  3. N/A-Not applicable
  4. According to Health Care Financing Administration [54] guidelines for 4 months.