Table 2. Top 10 Ranked PTs for US Adverse Event Reports Submitted to the US FDA Adverse Event Reporting System for Sipuleucel-T, Overall and According to Seriousness, April 29, 2010, to December 31, 2017.
| PT | No. (Rank) | |
|---|---|---|
| All Reports | Serious Reports Only | |
| Total | 9800 | 7488 |
| Chills | 318 (1) | 166 (1) |
| Malaise | 196 (2) | 117 (5) |
| Pyrexia | 189 (3) | 118 (4) |
| Culture positive | 184 (4) | Ranked >10 |
| Fatigue | 180 (5) | 118 (4) |
| Nausea | 173 (6) | 110 (8) |
| Disease progressiona | 147 (7) | 138 (2) |
| Asthenia | 144 (8) | 120 (3) |
| Ill-defined disorder | 138 (9) | Ranked >10 |
| Dizziness | 124 (10) | Ranked >10 |
| Anemia | Ranked >10 | 115 (6) |
| Hospitalization | Ranked >10 | 111 (7) |
| Fall | Ranked >10 | 101 (9) |
| Dehydration | Ranked >10 | 95 (10) |
Abbreviations: FDA, Food and Drug Administration; PTs, preferred terms.
a
Confounded by the indication for sipuleucel-T therapy.