Table 5.
Most frequent TEAEs (≥5% of patients) in either treatment group across all cycles (safety population)
| AE by preferred term | Placebo (N = 125) | Lipegfilgrastim 6 mg SC (N = 248) | ||
|---|---|---|---|---|
| n | % | n | % | |
| Alopecia | 42 | 33.6 | 101 | 40.7 |
| Anemia | 30 | 24.0 | 63 | 25.4 |
| Nausea | 27 | 21.6 | 59 | 23.8 |
| Neutropenia | 44 | 35.2 | 51 | 20.6 |
| Thrombocytopenia | 10 | 8.0 | 32 | 12.9 |
| Asthenia | 23 | 18.4 | 28 | 11.3 |
| Vomiting | 15 | 12.0 | 28 | 11.3 |
| Decreased appetite | 12 | 9.6 | 23 | 9.3 |
| Hypokalemia | 3 | 2.4 | 20 | 8.1 |
| Leukopenia | 14 | 11.2 | 16 | 6.5 |
| Fatigue | 6 | 4.8 | 16 | 6.5 |
| Disease progression | 5 | 4.0 | 16 | 6.5 |
| NSCLC | 4 | 3.2 | 16 | 6.5 |
| Chest pain | 8 | 6.4 | 14 | 5.6 |
| Febrile neutropenia | 10 | 8.0 | 11 | 4.4 |
| Dyspnea | 9 | 7.2 | 11 | 4.4 |
TEAEs include all AEs except those specifically rated by investigators as unrelated to study drug. Multiple mentions per patient are possible. TEAEs with onset after the start of prophylactic open-label lipegfilgrastim treatment are excluded.
AE adverse event, NSCLC non-small cell lung cancer, SC subcutaneously, TEAEs treatment-emergent adverse events.