Table 2.
Serious adverse events regardless of relationship to study drug
| Preferred term | ||
|---|---|---|
| Pt | Before ESA | After ESA |
| 1 | Cholesteatoma | |
| 2 | Respiratory tract infection | General physical deteriorationa |
| Respiratory tract infectiona | ||
| Renal failure, acute | ||
| 5 | NA | Hip fracture |
| Septic shock | ||
| Pneumonitis | ||
| Depressed consciousness | ||
| 6 | Pulmonary arterial hypertension | Ascites |
| Anemiab | Encephalopathy | |
| Varices esophageal | Enterococcal sepsis | |
| Upper gastrointestinal hemorrhage | ||
| 8 | NA | Herpes zoster |
| Pulmonary embolism | ||
| Cardiac failure | ||
| 9 | NA | Abdominal pain |
| Urinary tract infection | ||
| Anemiaa,b | ||
| Radius fracture | ||
| Lung infiltration | ||
| Pneumonia | ||
| Sepsis | ||
| Renal failure | ||
| Supraventricular tachycardia | ||
| Hepatic failure | ||
| Tachypnea | ||
| Hyperuricemia | ||
| Lumbar vertebral fracture | ||
| Thoracic vertebral fracture | ||
| Respiratory failure | ||
| 10 | NA | Traumatic fracture |
| 13 | NA | Gastroenteritis |
ESA erythropoiesis-stimulating agent, NA not applicable (no SAE reported), pt patient, SAE serious adverse event
aSuspected by the investigator to have a relationship to the study drug
bCommon Toxicity Criteria Grade 3 anemia