Adverse events during the study
. | PCT, %; n = 318 . | Control, %; n = 327 . | P . |
|---|---|---|---|
| Any adverse event* | 99.7 | 98.2 | .12 |
| Grade III or IV adverse event | 78.9 | 78.6 | .92 |
| Serious adverse event† | 27.0 | 24.8 | .53 |
| Treatment-related adverse event‡ | 26.4 | 29.4 | .43 |
| Death§ | 3.5 | 5.2 | .34 |
. | PCT, %; n = 318 . | Control, %; n = 327 . | P . |
|---|---|---|---|
| Any adverse event* | 99.7 | 98.2 | .12 |
| Grade III or IV adverse event | 78.9 | 78.6 | .92 |
| Serious adverse event† | 27.0 | 24.8 | .53 |
| Treatment-related adverse event‡ | 26.4 | 29.4 | .43 |
| Death§ | 3.5 | 5.2 | .34 |
Adverse events were graded I to IV using the National Cancer Institute Common Toxicity Criteria (NCI-CTC)38 and coded to Preferred Term by using Medical Directory for Regulatory Affairs (MedDRA)39
Serious adverse events were defined by using Food and Drug Administration (FDA) criteria40
Treatment-related adverse events were reported as possibly or probably related to the study platelet transfusions by the blinded investigator at each site
One patient in each group died of hemorrhage; both deaths involved pulmonary alveolar hemorrhage thought to result from toxicity of the myeloablative preparative regimen