Table 2.
Clinical Characteristics of Reports with Olaparib from the FAERS Database (January 2015–March 2021)
| Characteristics | Case Number, n | Case Proportion, % |
|---|---|---|
| Number of events | 6402 | |
| Gender | ||
| Female | 5019 | 78.40 |
| Male | 849 | 13.26 |
| Unknown | 534 | 8.34 |
| Age (years) | ||
| <18 | 7 | 0.11 |
| 18≤ and ≤65 | 2002 | 31.27 |
| >65 | 1422 | 22.21 |
| Unknown | 2971 | 46.41 |
| Indications (top five) | ||
| Ovarian cancer | 3112 | 48.61 |
| Breast cancer | 516 | 8.06 |
| Prostate cancer | 322 | 5.03 |
| Pancreatic carcinoma | 152 | 2.37 |
| Fallopian tube cancer | 64 | 1.00 |
| Serious outcome | ||
| Death (DE) | 2025 | 31.63 |
| Life-threatening (LT) | 242 | 3.78 |
| Hospitalization – initial or prolonged (HO) | 1206 | 18.84 |
| Disability (DS) | 77 | 1.20 |
| Congenital anomaly (CA) | 6 | 0.09 |
| Other serious (important medical event) (OT) | 3083 | 48.16 |
| Reported countries (top five) | ||
| America (US) | 3353 | 52.37 |
| Japan (JP) | 833 | 13.01 |
| France (FR) | 485 | 7.58 |
| Germany (DE) | 188 | 2.94 |
| China (CN) | 172 | 2.69 |
| Reported person | ||
| Health profession | ||
| Physician (MD) | 2248 | 35.11 |
| Pharmacist (PH) | 233 | 3.64 |
| Other health-professional (OT) | 716 | 11.19 |
| Non-healthcare professional | ||
| Consumer (CN) | 1216 | 18.99 |
| Unknown | 1989 | 31.07 |
| Reporting year | ||
| 2021Q1 | 625 | 9.76 |
| 2020 | 2187 | 31.16 |
| 2019 | 1333 | 20.82 |
| 2018 | 824 | 12.87 |
| 2017 | 616 | 9.62 |
| 2016 | 519 | 8.11 |
| 2015 | 298 | 4.66 |
| Role code | ||
| Primary suspect (PS) | 5515 | 86.14 |
| Secondary suspect (SS) | 1992 | 31.12 |
| Concomitant (C) | 168 | 2.62 |
| Interacting (I) | 48 | 0.75 |
Note: 2021Q1, the first quarter of 2021.