Adverse event | Placebo group (n=36) | Colchicine group (n=36) | P value |
AST transient elevation (n (%)) | 3 (8) | 4 (11) | 1 |
ALT transient elevation (n (%)) | 5 (14) | 5 (14) | 1 |
Nausea/vomiting (n (%)) | 4 (11) | 2 (6) | 0.67 |
Abdominal pain (n (%)) | 4 (11) | 4 (11) | 1 |
New or worsened diarrhoea (n (%)) | 2 (6) | 6 (17) | 0.26 |
Nosocomial pneumonia (n (%)) | 5 (14) | 3 (8) | 0.71 |
Arrythmia (n (%)) | 0 | 0 | 1 |
QT interval at day 3 (ms; median (IQR)) | 405 (388–406) | 408 (392–415) | 1 |
QT interval variation (ms; median (IQR)) | 28 (13–35) | 22 (9–29) | 0.25 |
ALT, alanine aminotransferase; AST, aspartate aminotransferase.