Table 4.
Adverse Events Graded at ≥ 3 per the National Cancer Institute Common Toxicity Criteria for Adverse Events Version 323 and Occurring in Two or More Patients
| Adverse Event | All Patients |
No. of Events |
||||
|---|---|---|---|---|---|---|
| Pomalidomide (2 mg/d) + Placebo | Pomalidomide (2 mg/d) + Prednisone | Pomalidomide (0.5 mg/d) + Placebo | Prednisone | |||
| No. | % | |||||
| No. of patients | 84 | 22 | 19 | 22 | 21 | |
| Fatigue/asthenia | 10 | 12 | 1 | 4 | 3 | 2 |
| Pneumonia/sepsis | 9 | 11 | 3 | 3 | 2 | 1 |
| Thrombocytopenia | 9 | 11 | 3 | 3 | 2 | 1 |
| Anemia | 8 | 10 | 2 | 3 | 1 | 2 |
| Neutropenia | 7 | 8 | 2 | 3 | 1 | 1 |
| Hyperglycemia/diabetes | 4 | 5 | 0 | 1 | 1 | 2 |
| Dyspnea | 4 | 5 | 2 | 0 | 2 | 0 |
| Venous thrombosis | 3 | 4 | 2 | 1 | 0 | 0 |
| Bleeding | 3 | 4 | 2 | 0 | 0 | 1 |
| Diarrhea | 3 | 4 | 0 | 2 | 0 | 1 |
| Memory impairment | 3 | 4 | 1 | 1 | 1 | 0 |
| Nausea/vomiting | 2 | 2 | 0 | 2 | 0 | 0 |
| Abdominal pain | 2 | 2 | 0 | 0 | 0 | 2 |
| Pulmonary hypertension | 2 | 2 | 1 | 0 | 0 | 1 |
| Respiratory failure | 2 | 2 | 1 | 1 | 0 | 0 |
| Hyperuricemia | 2 | 2 | 0 | 0 | 1 | 1 |
| Arrhythmia/bradycardia | 2 | 2 | 0 | 2 | 0 | 1 |
| Cardiac failure | 2 | 2 | 1 | 0 | 0 | 1 |
| Hyperbilirubinemia | 2 | 2 | 0 | 1 | 0 | 1 |
| Myalgia | 2 | 2 | 1 | 0 | 1 | 0 |
| Dizziness | 2 | 2 | 0 | 1 | 1 | 0 |