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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