Table 4.
Patients with treatment emergent adverse event, n (%) | Efbemalenograstim alfa | Pegfilgrastim 6 mg N = 65 |
||
---|---|---|---|---|
80 μg/kg N = 35 |
240 μg/kg N = 67 |
320 μg/kg N = 65 |
||
Any TEAE | 32 (91.4) | 63 (94.0) | 61 (93.8) | 59 (90.8) |
Treatment-related TEAE | 10 (28.6) | 21 (31.3) | 24 (36.9) | 24 (36.9) |
AE leading to discontinuation | 1 (2.9) | 1 (1.5) | 2 (3.1) | 3 (4.6) |
Any SAE | 0 | 1 (1.5) | 1 (1.5) | 4 (6.2) |
Febrile neutropenia | 0 | 0 | 2 (3.1) | 2 (3.1) |
TEAEs > 10% in any treatment group: | ||||
Alopecia | 27 (77.1) | 49 (73.1) | 44 (67.7) | 52 (80.0) |
Nausea | 17 (48.6) | 22 (32.8) | 23 (35.4) | 28 (43.1) |
Asthenia | 11 (31.4) | 13 (19.4) | 21 (32.3) | 20 (30.8) |
Neutropenia | 6 (17.1) | 25 (37.3) | 21 (32.3) | 17 (26.2) |
Bone pain | 7 (20.0) | 11 (16.4) | 11 (16.9) | 12 (18.5) |
Fatigue | 5 (14.3) | 3 (19.4) | 12 (18.5) | 10 (15.4) |
Leukopenia | 3 (8.6) | 12 (17.9) | 8 (12.3) | 7 (10.8) |
Diarrhea | 3 (8.6) | 4 (6.0) | 4 (6.2) | 7 (10.8) |
Headache | 5 (14.3) | 5 (7.5) | 7 (10.8) | 4 (6.2) |
SAE Serious adverse event; TEAE Treatment-emergent adverse event