Table 3.
Camostat mesilate (N = 77) | Placebo (N = 76) | Total (N = 153) | |
---|---|---|---|
Number of patients with | |||
Any adverse events | 25 (32.5) | 31 (40.8) | 56 (36.6) |
Any serious adverse events | 1 (1.3) | 0 | 1 (0.7) |
Any adverse events that led to discontinuation of treatment | 2 (2.6) | 0 | 2 (1.3) |
Any adverse drug reactions | 9 (11.7) | 7 (9.2) | 16 (10.5) |
Serious adverse drug reactions | 0 | 0 | 0 |
Adverse drug reactions that led to discontinuation of treatment | 2 (2.6) | 0 | 2 (1.3) |
Adverse events or adverse drug reactions resulting in death | 0 | 0 | 0 |
Adverse drug reactions by system organ class/preferred term | |||
Gastrointestinal disorders | 4 (5.2) | 5 (6.6) | 9 (5.9) |
Abdominal discomfort | 1 (1.3) | 1 (1.3) | 2 (1.3) |
Constipation | 1 (1.3) | 0 | 1 (0.7) |
Diarrhea | 2 (2.6) | 1 (1.3) | 3 (2.0) |
Nausea | 0 | 1 (1.3) | 1 (0.7) |
Stomatitis | 0 | 1 (1.3) | 1 (0.7) |
Vomiting | 0 | 1 (1.3) | 1 (0.7) |
Hepatobiliary disorders | 1 (1.3) | 1 (1.3) | 2 (1.3) |
Hepatic function abnormal | 1 (1.3) | 1 (1.3) | 2 (1.3) |
Laboratory tests | 3 (3.9) | 2 (2.6) | 5 (3.3) |
Alanine aminotransferase increased | 1 (1.3) | 2 (2.6) | 3 (2.0) |
Aspartate aminotransferase increased | 0 | 1 (1.3) | 1 (0.7) |
Blood potassium increased | 2 (2.6) | 0 | 2 (1.3) |
Blood alkaline phosphatase increased | 0 | 1 (1.3) | 1 (0.7) |
Skin and subcutaneous tissue disorders | 1 (1.3) | 1 (1.3) | 2 (1.3) |
Drug eruption | 1 (1.3) | 0 | 1 (0.7) |
Rash papular | 0 | 1 (1.3) | 1 (0.7) |
Values are n (%)