Table 3.
Grade 3-4 AEs, AEs leading to treatment modifications, and supportive care
| POM+LoDEX (n = 112) | POM alone (n = 107) | |
|---|---|---|
| Hematologic AEs occurring in ≥5% of patients, % | ||
| Neutropenia | 41 | 48 |
| Anemia | 22 | 24 |
| Thrombocytopenia | 19 | 22 |
| Leukopenia | 10 | 7 |
| Lymphopenia | 7 | 2 |
| Febrile neutropenia | 3 | 5 |
| Nonhematologic AEs occurring in ≥5% of patients, % | ||
| Pneumonia | 22 | 15 |
| Fatigue | 14 | 11 |
| Dyspnea | 13 | 8 |
| Back pain | 10 | 14 |
| Urinary tract infection | 9 | 2 |
| Sepsis | 5 | 6 |
| Dehydration | 5 | 5 |
| Acute renal failure | 5 | 8 |
| Muscular weakness | 4 | 6 |
| Blood creatinine increase | 3 | 6 |
| Confusional state | 3 | 7 |
| Hypercalcemia | 1 | 10 |
| AEs leading to dose reduction in ≥5% of patients, % | ||
| Thrombocytopenia | 5 | 9 |
| Neutropenia | 4 | 7 |
| AEs leading to dose interruption in ≥5% of patients, % | ||
| Neutropenia | 9 | 14 |
| Thrombocytopenia | 5 | 11 |
| Pneumonia | 18 | 12 |
| Upper respiratory tract infection | 5 | 9 |
| Fatigue | 8 | 4 |
| Pyrexia | 6 | 2 |
| Most common AEs leading to discontinuation in patients, % | ||
| Increased blood creatinine | 1 | 1 |
| Acute renal failure | 1 | 2 |
| Supportive-care use during study treatment, % | ||
| G-CSF | 46 | 58 |
| Epoetin alfa | 18 | 23 |
| Darbepoetin alfa | 12 | 26 |
| Red blood cell transfusion | 45 | 49 |
| Platelet transfusion | 14 | 20 |
Treatment-emergent AEs are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after treatment-phase end date.