Table 5.
Serious and non-serious adverse events reported by day 14
| Event | No. of patients (%) | Relationship with study drug, n (%) |
|---|---|---|
| Serious adverse events | ||
| Mechanical ventilation | 4 (4.4) | None reported to be related |
| Hypoxemia prolonging hospitalization | 11 (12.2) | None reported to be related |
| Death | 3 (3.3) | None reported to be related |
| Non-serious adverse events | ||
| Increase of aminotransferases | 56 (62.2) | |
| Grade I | 52 (57.8) | Probably-related 1 (1.1); possibly related 16 (17.7) |
| Grade II | 4 (4.4) | Possibly related 1 (1.1) |
| Electrolyte abnormalities | ||
| Grade I hyperkalemia | 7 (7.7) | None reported to be related |
| Grade I hypokalemia | 12 (13.3) | None reported to be related |
| Grade II hypokalemia | 2 (2.2) | None reported to be related |
| Grade I hyponatremia | 17 (18.9) | None reported to be related |
| Grade II hyponatremia | 2 (2.2) | None reported to be related |
| Grade I hypocalcemia | 3 (3.3) | None reported to be related |
| Gastrointestinal events | ||
| Mild diarrhea | 16 (17.1) | Probably related 3 (3.3); possibly related 8 (8.8) |
| Moderate diarrhea | 2 (2.2) | Possibly related 1 (1.1) |
| Mild vomiting | 2 (2.2) | Possibly related 2 (2.2) |
| Moderate vomiting | 1 (1.1) | None reported to be related |
| Grade I bilirubin increase | 3 (3.3) | Possibly related 2 (2.2) |
| Grade I amylase increase | 7 (7.7) | None reported to be related |
| Metabolic events | ||
| Grade I hyperglycemia | 24 (26.7) | None reported to be related |
| Grade II hyperglycemia | 7 (7.7) | None reported to be related |
| Grade I hypoglycemia | 7 (7.7) | None reported to be related |
| Grade I hypertriglyceridemia | 8 (8.8) | None reported to be related |
| Blood and lymphatic tissue | ||
| Grade I anemia | 16 (17.1) | None reported to be related |
| Grade II anemia | 2 (2.2) | None reported to be related |
| Grade I decrease of neutrophils | 2 (2.2) | None reported to be related |
| Grade II decrease of neutrophils | 1 (1.1) | None reported to be related |
| Grade I decrease of lymphocytes | 11 (12.2) | None reported to be related |
| Grade II decrease of lymphocytes | 11 (12.2) | None reported to be related |
| Grade I decrease of platelets | 6 (6.6) | None reported to be related |
| Grade II decrease of platelets | 1 (1.1) | None reported to be related |
| Grade I increase of INR | 3 (3.3) | None reported to be related |
| Grade II increase of INR | 3 (3.3) | None reported to be related |
| Grade I increase of aPTT | 1 (1.1) | None reported to be related |
| Mild allergy | 4 (4.4) | Possibly related 1 (1.1) |
| Grade I creatinine increase | 8 (8.9) | None reported to be related |
| Cardiovascular events | ||
| Grade I tachycardia | 1 (1.1) | None reported to be related |
| Grade I bradycardia | 6 (6.6) | None reported to be related |
| Grade I increase of blood pressure | 1 (1.1) | None reported to be related |
| Episode of chest pain | 1 (1.1) | None reported to be related |
aPTT activated partial thromboplastin time, INR international normalized ratio