Table 1. . Number of men who experienced grade 3 and higher adverse effects reported in major clinical trials of sipuleucel-T.
| Name of study | Phase I/II trial | Integrated analysis of Phase III trials | IMPACT Phase III trial |
|---|---|---|---|
| Year of publication (reference) Number of men who received sipuleucel-T |
2000‡ n = 31 |
2009§ n = 147 |
2010¶ n = 127 |
| Any grade 3 or greater toxicity | 2 | 37 | 69 |
| Pain (includes back, limb, musculoskeletal pain, myalgias) | –† | 10 | 39† |
| Fatigue | – | 2† | 10† |
| Chills | – | 7† | 4† |
| Anemia | – | 6 | 5 |
| Fever | 2† | 3† | 1 |
| Dyspnea | – | 5 | |
| GI upset including nausea/vomiting/diarrhea | – | 2 | 3 |
| Headache | – | 2 | 1 |
| Hypertension | – | – | 2 |
| Weight loss | – | – | 2 |
| Anorexia | – | – | 1 |
| Depression | – | – | 1 |