Nonhematologic Adverse Events in 41 Patients Who Received Study Drug
| . | Placebo + Filgrastim (n = 10) . | PEG-rHuMGDF* + Filgrastim (n = 31) . |
|---|---|---|
| Local | ||
| Injection site reaction | 0 (0)5-151 | 2 (6) |
| Systemic | ||
| Lethargy/drowsiness | 1 (10) | 17 (55) |
| Hot flushes/fever5-150 | 6 (60) [1]5-152 | 8 (26) |
| Bone pain | 3 (30) | 8 (26) |
| Neurologic | ||
| Headache | 6 (60) | 13 (42) |
| Dizziness | 3 (30) | 12 (38) |
| Respiratory | ||
| Cough | 1 (10) | 8 (26) |
| Dyspnea | 3 (30) | 12 (38) [3] |
| Gastrointestinal | ||
| Nausea and/or vomiting | 9 (90) [1] | 22 (71) [4] |
| Diarrhea | 3 (30) | 15 (48) [2] |
| Mucositis | 5 (50) | 8 (26) |
| Metabolic | ||
| Hypokalemia | 2 (20) | 5 (16) |
| Thromboembolic | ||
| Thrombophlebitis | 0 (0) | 1 (3) |
| Pulmonary embolism | 0 (0) | 1 (3) [1]ρ |
| . | Placebo + Filgrastim (n = 10) . | PEG-rHuMGDF* + Filgrastim (n = 31) . |
|---|---|---|
| Local | ||
| Injection site reaction | 0 (0)5-151 | 2 (6) |
| Systemic | ||
| Lethargy/drowsiness | 1 (10) | 17 (55) |
| Hot flushes/fever5-150 | 6 (60) [1]5-152 | 8 (26) |
| Bone pain | 3 (30) | 8 (26) |
| Neurologic | ||
| Headache | 6 (60) | 13 (42) |
| Dizziness | 3 (30) | 12 (38) |
| Respiratory | ||
| Cough | 1 (10) | 8 (26) |
| Dyspnea | 3 (30) | 12 (38) [3] |
| Gastrointestinal | ||
| Nausea and/or vomiting | 9 (90) [1] | 22 (71) [4] |
| Diarrhea | 3 (30) | 15 (48) [2] |
| Mucositis | 5 (50) | 8 (26) |
| Metabolic | ||
| Hypokalemia | 2 (20) | 5 (16) |
| Thromboembolic | ||
| Thrombophlebitis | 0 (0) | 1 (3) |
| Pulmonary embolism | 0 (0) | 1 (3) [1]ρ |
There was no difference in the frequency of any toxicity between patients given placebo and those admininstered PEG-rHuMGDF (Fisher's Exact test).
Not related to neutropenia.
No. of patients (percentage).
Numbers in brackets represent number of events that were grade 3.
ρ This event was grade 4.