Table 5.
Adverse events of special interest
| All reports | Mild/moderate | Severe or life-threatening | ||||
|---|---|---|---|---|---|---|
|
| ||||||
| n | % | n | % | n | % | |
| ALT increased | 3 | 1.2% | 2 | 0.8% | 1 | 0.4% |
| AST increased | 1 | 0.4% | 1 | 0.4% | ||
| Cardiac disorders* | 21 | 8.3% | 6 | 5.3% | 15 | 5.9% |
| Edema/fluid retention | 26 | 10.2% | 26 | 9.1% | ||
| Hypertension | 8 | 3.1% | 7 | 2.3% | 1 | 0.4% |
| Hypokalemia | 3 | 1.2% | 3 | 1.1% | ||
*
Cardiac disorders included acute coronary syndrome (n=1), angina pectoris (n=1), atrial fibrillation (n=6), atrioventricular block complete (n=2), bradycardia (n=2), cardiac arrest (n=1), congestive heart failure (n=3), myocardial infarction (n=3), and palpitation (n=2).
ALT: alanine aminotransferase; AST: aspartate aminotransferase.