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 |