Table 2.
Clinical characteristics of reports with sotorasib from the FAERS database (2021–2023 Q2).
| Characteristics | Available case number, n | Case proportion, % |
|---|---|---|
| Number of case | 1538 | 100 |
| Sex | 1142 | 74.25 |
| Female | 610 | 53.42 |
| Male | 532 | 46.58 |
| Age (year) | 655 | 42.59 |
| <65 | 255 | 38.93 |
| ≥65 | 400 | 61.07 |
| IQR | 68 (61–74) | / |
| Weight (kg) | 173 | 11.25 |
| <70 | 109 | 63.01 |
| ≥70 | 64 | 36.99 |
| IQR | 64.1 (52–75.2) | / |
| Indications | 992 | 64.50 |
| Lung cancer | 890 | 89.72 |
| Intestinal cancer | 39 | 3.93 |
| Cumulative dose (g) | 107 | 6.96 |
| <50 | 59 | 55.14 |
| ≥50 | 48 | 44.86 |
| IQR | 47.04 (21.12–66.24) | / |
| Time to onset (day) | 442 | 28.74 |
| ≤30 | 189 | 42.76 |
| >30 | 253 | 57.24 |
| IQR | 42 (14–86.75) | / |
| Serious outcome | 1086 | 70.61 |
| Death (DE) | 336 | 30.94 |
| Life-threatening (LT) | 19 | 1.75 |
| Hospitalization (HO) | 285 | 26.24 |
| Disability (DS) | 7 | 0.64 |
| Congenital anomaly (CA) | 22 | 2.03 |
| Required intervention to prevent permanent impairment/damage (RI) | 1 | 0.09 |
| Other serious medical events (OT) | 788 | 71.64 |
| Combination medication (Top five) | 360 | 23.41 |
| Acetaminophen | 60 | 16.67 |
| Folic acid | 39 | 10.83 |
| Gabapentin | 38 | 10.56 |
| Atorvastatin | 34 | 9.44 |
| Dexamethasone | 33 | 9.17 |
| Reported countries (Top five) | 1538 | 100 |
| America (US) | 791 | 51.43 |
| France (FR) | 257 | 16.71 |
| Japan (JP) | 185 | 12.03 |
| Germany (DE) | 52 | 3.38 |
| Italy (IT) | 43 | 2.80 |
| Reporter type | 1489 | 96.81 |
| Physician (MD) | 830 | 55.74 |
| Pharmacist (PH) | 142 | 9.54 |
| Health-professional (HP) | 217 | 14.57 |
| Consumer (CN) | 300 | 20.15 |
| Reporting year | 1538 | 100 |
| 2023 Q2 | 763 | 49.61 |
| 2022 | 629 | 40.90 |
| 2021 | 146 | 9.49 |
IQR, interquartile range; Q2, the second quarter.