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Table 3 Safety data

From: A multicenter, double-blind, randomized, parallel-group, placebo-controlled study to evaluate the efficacy and safety of camostat mesilate in patients with COVID-19 (CANDLE study)

 

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)

  1. Values are n (%)