Table 3.
All Grade 3 or 4 Adverse Events Reported by >1 Patienta
| Adverse Event | Patients, No. (%) (N = 130) |
|---|---|
| Grade 3 or 4 adverse event | 57 (44) |
| Bacterial pulmonary infections (including pneumonia and bronchopneumonia) | 13 (10) |
| Acute liver injuryb | 11 (8) |
| Respiratory failure | 8 (6) |
| Hypotension | 8 (6) |
| Cardiogenic shock | 6 (5) |
| Sepsis or septic shock | 6 (5) |
| Neuropathy or neuromuscular disorder | 6 (5) |
| Acute kidney injury | 5 (4) |
| Acute respiratory distress syndrome | 4 (3) |
| Hypertension | 4 (3) |
| Anemia | 3 (2) |
| Thrombophlebitis or venous thrombosis | 3 (2) |
| Bronchopulmonary aspergillosis | 3 (2) |
| Pleural effusion | 3 (2) |
| Pulmonary embolism | 3 (2) |
| Multiorgan failure | 3 (2) |
| Atrial fibrillation | 3 (2) |
| Dyspnea | 2 (2) |
| Pneumothorax | 2 (2) |
| Encephalopathy | 2 (2) |
| Hypoalbuminemia | 2 (2) |
| Hypocalcemia | 2 (2) |
| Hypophosphatemia | 2 (2) |
| Pyrexia | 2 (2) |
| Rash | 2 (2) |
| Ventricular arrhythmia | 2 (2) |
| Hypoxia | 2 (2) |
| Bacteremiac | 2 (2) |
a Graded according to DAIDS toxicity criteria. All events recorded occurred after initiation of intravenous zanamivir treatment. Similar reported events were grouped together by organ system and mechanism. The following grade 3 or 4 adverse events were each reported by 1 patient: hemolytic anemia, bronchospasm, chronic obstructive pulmonary disease, hemothorax, lung disorder, hemoptysis or pulmonary hemorrhage, pulmonary edema, Clostridium difficile colitis, sinusitis, endocardisis, viral pericarditis, hemorrhage, peripheral ischemia, shock hemorrhagic, arrhythmia, cardiac failure congestive, left ventricular dysfunction, increased levels of aspartate aminotransferase, blood creatine phosphokinase, or blood creatine, electrocardiographic QT prolongation, ischemic stroke, agranulocytosis, lymphopenia, thrombocytopenia, hypokalemia, hyponatremia, hyperbilirubinemia, rhabdomyolysis, anxiety, depression, adrenal insufficiency, erosive gastritis, acute leukemia, and coagulopathy.
b Acute liver injury comprised all events of cytolytic hepatitis and increased levels of alanine aminotransferase, hepatic enzyme, and transaminases.
c Including 1 case of Acinetobacter bacteremia; the organism in the second bacteremia case was not documented.