Table 4. Characterization of Deaths for US Adverse Event Reports Submitted to the US FDA Adverse Event Reporting System for Sipuleucel-T, April 29, 2010, to December 31, 2017.
| Characteristic | Total, No (%) |
|---|---|
| Total death reports | 314 (100) |
| Total death reports with date of last sipuleucel-T infusion and date of death | |
| Without imputation | 210 (66.9) |
| With imputation | 249 (79.3) |
| Age, ya | |
| <50 | 1 (0.3) |
| 50-64 | 31 (9.9) |
| 65-74 | 106 (33.8) |
| 75-84 | 95 (30.3) |
| ≥85 | 32 (10.2) |
| Not specified | 49 (15.6) |
| Time from last infusion to death, db | |
| <31 | 128 (51.4) |
| 31-90 | 59 (23.7) |
| 91-180 | 20 (8.0) |
| >180 | 42 (16.9) |
| Cause of death according to SOCb | |
| Total deathsc | |
| Neoplasms | 83 (33.3) |
| Cardiac disorders | 38 (15.3) |
| Nervous system disorders | 33 (13.3) |
| Infections and infestations | 14 (5.6) |
| General | 8 (3.2) |
| Respiratory tract | 7 (2.8) |
| Vascular | 4 (1.6) |
| Renal | 3 (1.2) |
| Other specified | 5 (2.0) |
| Not specified | 54 (21.7) |
| Deaths occurring within 30 d of sipuleucel-T infusionc | |
| Neoplasm | 37 (28.9) |
| Cardiac | 25 (19.5) |
| Neurologic | 18 (14.1) |
| Infections and infestations | 9 (7.0) |
| General | 3 (2.3) |
| Respiratory tract | 5 (3.9) |
| Vascular | 3 (2.3) |
| Other specified | 4 (3.1) |
| Not specified | 24 (18.8) |
Abbreviations: FDA, US Food and Drug Administration; SOC, system organ class.
a
Based on total deaths (n = 314).
b
Based on 249 deaths (with available dates of death and last sipuleucel-T infusion, including imputed dates).
c
Causes of death associated with fewer than 3 cases were grouped in the “other specified” category to maintain patient anonymity.