Incidence of adverse events reported in all donor cycles
| . | Placebo n = 70 . | All PEG-rHuMGDF n = 46 . | PEG-rHuMGDF 1.0 μg/kg/d n = 23 . | PEG-rHuMGDF 3.0 μg/kg/d n = 23 . |
|---|---|---|---|---|
| No. of adverse events reported in any donor cycle (%) | 28 (40) | 18 (39) | 7 (30) | 11 (48) |
| Specific adverse events reported in at least 4% of all cycles, no. (%) | ||||
| Headache | 5 (7) | 8 (17) | 2 (9) | 6 (26) |
| Paresthesia | 6 (9) | 2 (4) | 0 (0) | 2 (9) |
| Gastrointestinal (nausea, diarrhea, pain) | 5 (7) | 3 (7) | 1 (4) | 2 (9) |
| Apheresis access problems | 4 (6) | 2 (4) | 1 (4) | 1 (4) |
| Upper respiratory tract congestion | 3 (4) | 2 (4) | 2 (9) | 0 (0) |
| Upper respiratory infection | 4 (6) | 1 (2) | 1 (4) | 0 (0) |
| Apheresis access site ecchymosis | 4 (6) | 1 (2) | 0 (0) | 1 (4) |
| . | Placebo n = 70 . | All PEG-rHuMGDF n = 46 . | PEG-rHuMGDF 1.0 μg/kg/d n = 23 . | PEG-rHuMGDF 3.0 μg/kg/d n = 23 . |
|---|---|---|---|---|
| No. of adverse events reported in any donor cycle (%) | 28 (40) | 18 (39) | 7 (30) | 11 (48) |
| Specific adverse events reported in at least 4% of all cycles, no. (%) | ||||
| Headache | 5 (7) | 8 (17) | 2 (9) | 6 (26) |
| Paresthesia | 6 (9) | 2 (4) | 0 (0) | 2 (9) |
| Gastrointestinal (nausea, diarrhea, pain) | 5 (7) | 3 (7) | 1 (4) | 2 (9) |
| Apheresis access problems | 4 (6) | 2 (4) | 1 (4) | 1 (4) |
| Upper respiratory tract congestion | 3 (4) | 2 (4) | 2 (9) | 0 (0) |
| Upper respiratory infection | 4 (6) | 1 (2) | 1 (4) | 0 (0) |
| Apheresis access site ecchymosis | 4 (6) | 1 (2) | 0 (0) | 1 (4) |