Bleeding events
| Treatment group no. transfusion recipients4-150 no. transfusion recipients reporting bleeding events (%)4-151 . | Placebo n = 59 18 (31%) . | PEG-rHuMGDF . | ||||||
|---|---|---|---|---|---|---|---|---|
| 1 μg/kg . | 3 μg/kg . | Combined . | ||||||
| n = 15 . | n = 46 . | N = 61 . | ||||||
| 2 (13%) . | 12 (26%) . | 14 (23%) . | ||||||
| Organ system . | N . | % . | N . | % . | N . | % . | N . | % . |
| Gastrointestinal‡ | 5 | 8 | 1 | 7 | 2 | 4 | 3 | 5 |
| Hematemesis | 3 | 5 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hematochezia | 2 | 3 | 1 | 7 | 2 | 4 | 3 | 5 |
| Hemorrhage | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Cutaneous/mucosal‡ | 7 | 12 | 1 | 7 | 5 | 11 | 6 | 10 |
| Ecchymoses | 2 | 3 | 0 | 0 | 2 | 4 | 2 | 3 |
| Hematoma | 2 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hemorrhage | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Petechiae | 4 | 7 | 1 | 7 | 4 | 9 | 5 | 8 |
| Respiratory‡ | 8 | 14 | 0 | 0 | 5 | 11 | 5 | 8 |
| Epistaxis | 7 | 12 | 0 | 0 | 5 | 11 | 5 | 8 |
| Hemoptysis | 2 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Genitourinary | ||||||||
| Hematuria | 7 | 12 | 0 | 0 | 5 | 11 | 5 | 8 |
| Treatment group no. transfusion recipients4-150 no. transfusion recipients reporting bleeding events (%)4-151 . | Placebo n = 59 18 (31%) . | PEG-rHuMGDF . | ||||||
|---|---|---|---|---|---|---|---|---|
| 1 μg/kg . | 3 μg/kg . | Combined . | ||||||
| n = 15 . | n = 46 . | N = 61 . | ||||||
| 2 (13%) . | 12 (26%) . | 14 (23%) . | ||||||
| Organ system . | N . | % . | N . | % . | N . | % . | N . | % . |
| Gastrointestinal‡ | 5 | 8 | 1 | 7 | 2 | 4 | 3 | 5 |
| Hematemesis | 3 | 5 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hematochezia | 2 | 3 | 1 | 7 | 2 | 4 | 3 | 5 |
| Hemorrhage | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Cutaneous/mucosal‡ | 7 | 12 | 1 | 7 | 5 | 11 | 6 | 10 |
| Ecchymoses | 2 | 3 | 0 | 0 | 2 | 4 | 2 | 3 |
| Hematoma | 2 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hemorrhage | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Petechiae | 4 | 7 | 1 | 7 | 4 | 9 | 5 | 8 |
| Respiratory‡ | 8 | 14 | 0 | 0 | 5 | 11 | 5 | 8 |
| Epistaxis | 7 | 12 | 0 | 0 | 5 | 11 | 5 | 8 |
| Hemoptysis | 2 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Genitourinary | ||||||||
| Hematuria | 7 | 12 | 0 | 0 | 5 | 11 | 5 | 8 |
Data are for unique, first study transfusion only recipients.
Total number of subjects affected for any of the indicated organ systems—ie, some patients had both hematologic and respiratory bleeding.
Total number of subjects affected for the indicated organ system—ie, some patients had both ecchymoses and petechiae.