TABLE 1.
Clinical characteristics of reports with PARPi‐associated hematological toxicities in the FAERS database (January 2015 to September 2021)
| Characteristics | Report number, n | Report proportion, % |
|---|---|---|
| Number of reports | 4088 | |
| Gender | ||
| Female | 3367 | 82.36 |
| Male | 155 | 3.79 |
| Unknown or missing | 566 | 13.85 |
| Age (years) | ||
| <18 | 6 | 0.15 |
| 18 ≤ and ≤ 65 | 1195 | 29.23 |
| >65 | 1066 | 26.08 |
| Unknown or missing | 1821 | 44.55 |
| Median (IQR) | 64.95 (51–71) | / |
| PARPis as suspected drug | ||
| Olaparib | 1350 | 33.02 |
| Niraparib | 1821 | 44.55 |
| Rucaparib | 766 | 18.74 |
| Talazoparib | 151 | 3.69 |
| The time to onset (days) | ||
| 0–30 | 934 | 22.85 |
| 31–60 | 206 | 5.04 |
| 61–90 | 176 | 4.31 |
| 91–180 | 175 | 4.28 |
| 181–360 | 128 | 3.13 |
| >361 | 188 | 4.60 |
| Unknown or missing | 2281 | 55.80 |
| Median (IQR) | 28 (10–101) | / |
| Indications | ||
| Ovarian cancer | 2779 | 67.98 |
| Breast cancer | 189 | 4.62 |
| Others | 786 | 19.23 |
| Unknown or missing | 334 | 8.17 |
| Serious outcome | ||
| Death | 358 | 8.76 |
| Life‐threatening | 414 | 10.13 |
| Hospitalization | 1178 | 28.82 |
| Disability | 35 | 0.86 |
| Others | 2751 | 67.29 |
| Reported Countries (Top five) | ||
| America | 2647 | 64.75 |
| Japan | 402 | 9.83 |
| France | 216 | 5.28 |
| Italy | 103 | 2.52 |
| Germany | 92 | 2.25 |
| Reported Person | ||
| Healthcare profession | ||
| Physician | 1175 | 28.74 |
| Pharmacist | 111 | 2.72 |
| Other health‐professional | 723 | 17.69 |
| Non‐healthcare professional | ||
| Consumer | 1664 | 40.70 |
| Unknown | 415 | 10.15 |
| Reporting year | ||
| 2021 Q3 a | 871 | 21.31 |
| 2020 | 1013 | 24.78 |
| 2019 | 836 | 20.45 |
| 2018 | 836 | 20.45 |
| 2017 | 364 | 8.90 |
| 2016 | 111 | 2.72 |
| 2015 | 57 | 1.39 |
a
The third quarter of 2021. IQR, interquartile range.