Table 1. Description of US Reports Submitted to the US FDA Adverse Event Reporting System for Sipuleucel-T Between April 29, 2010, and December 31, 2017.
| Report | No. (%) | |
|---|---|---|
| All Reports | Serious Reports Only | |
| Total | 3216 (100) | 2014 (100) |
| Sex | ||
| Male | 3149 (97.9) | 1952 (96.9) |
| Not specified | 67 (2.1) | 62 (3.1) |
| Age, y | ||
| <50 | 12 (0.4) | 4 (0.2) |
| 50-64 | 448 (13.9) | 286 (14.2) |
| 65-74 | 1065 (33.1) | 696 (34.5) |
| 75-84 | 860 (26.7) | 582 (28.9) |
| ≥85 | 249 (7.7) | 174 (8.6) |
| Not specified | 582 (18.1) | 272 (13.5) |
| Received at FDA, calendar year | ||
| 2010 | 44 (1.4) | 44 (2.2) |
| 2011 | 203 (6.3) | 199 (9.9) |
| 2012 | 317 (9.9) | 309 (15.3) |
| 2013 | 599 (18.6) | 390 (19.4) |
| 2014 | 261 (8.1) | 254 (12.6) |
| 2015 | 294 (9.1) | 279 (13.9) |
| 2016 | 665 (20.7) | 256 (12.7) |
| 2017 | 833 (25.9) | 283 (14.1) |
| Source of report | ||
| Health professional | 1426 (44.3) | 920 (45.7) |
| Physician | 1077 (33.5) | 712 (35.4) |
| Consumer/other specified | 547 (17.0) | 276 (13.7) |
| Registered nurse | 101 (3.1) | 72 (3.6) |
| Pharmacist | 43 (1.3) | 24 (1.2) |
| Not specified | 22 (0.7) | 10 (0.5) |
| Type of report | ||
| Expedited, 15 d | 1586 (49.3) | 1573 (78.1) |
| Not expedited | 1601 (49.8) | 412 (20.5) |
| Direct | 29 (0.9) | 29 (1.4) |
| Reported outcome, serious reports | ||
| Death | 314 (9.8) | 314 (15.6) |
| Nonfatal: hospitalization, disability, life-threatening, or required intervention | 1099 (34.2) | 1099 (54.6) |
| Nonfatal: other serious outcomesa | 600 (18.7) | 600 (29.8) |
| Not specified | 1 (<0.1) | 1 (<0.1) |
| Not applicableb | 1202 (37.4) | 0 |
Abbreviation: FDA, Food and Drug Administration.
a
Defined as important medical events based on appropriate medical judgment that may jeopardize the patient or participant and may require medical or surgical intervention to prevent one of the other specified outcomes.
b
Refers to nonserious reports. Reports that do not meet criteria for seriousness as defined in the Code of Federal Regulations18 (ie, death, hospitalization, life-threatening, disability, congenital anomaly, required intervention, or other serious outcome) are considered nonserious.