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Table 3 Incidence of potentially drug-related treatment-emergent adverse events (TEAEs) - Safety Analysis Set

From: Efficacy and safety of rebamipide liquid for chemoradiotherapy-induced oral mucositis in patients with head and neck cancer: a multicenter, randomized, double-blind, placebo-controlled, parallel-group phase II study

  Placebo
N = 31
n (%)
Rebamipide 2%
N = 31
n (%)
Rebamipide 4%
N = 32
n (%)
Total number of subjects with TEAEs 5 (16) 8 (26) 4 (13)
Nausea 2 (7) 2 (7) 0
Vomiting 0 3 (10) 0
Constipation 0 1 (3) 0
Stomatitis 1 (3) 0 0
Hepatic function abnormal 1 (3) 1 (3) 1 (3)
Oral fungal infection 1 (3) 0 0
Blood creatinine increased 0 1 (3) 1 (3)
Gamma-glutamyltransferase increased 0 1 (3) 1 (3)
Blood alkaline phosphatase increased 0 0 1 (3)
Decreased appetite 0 1 (3) 0
Irritability 1 (3) 0 1 (3)
Renal impairment 0 1 (3) 0
Rash 0 1 (3) 0