Table 1.
Adverse Events Due to EGFR-TKIs in FAERS From 2016 to 2018
| Total (N = 8,450) | Osimertinib (n = 2,454) | Osimertinib + Other TKIs (n = 160) | Other TKIs (n = 5,836) | |
|---|---|---|---|---|
| Cardiac failure | 120 (1.4) | 57 (2.3) | 1 (0.6) | 62 (1.1) |
| Atrial fibrillation | 64 (0.8) | 30 (1.2) | 1 (0.6) | 33 (0.6) |
| QT prolongation | 49 (0.6) | 33 (1.3) | 4 (2.5) | 12 (0.2) |
| Myocardial infarction | 46 (0.5) | 16 (0.7) | 0 (0.0) | 30 (0.5) |
| Pericardial effusion | 36 (0.4) | 14 (0.6) | 2 (1.3) | 20 (0.3) |
| Total | 315 (3.7) | 150 (6.1) | 8 (5.0) | 157 (2.7) |
Values are n (% of total in each treatment category).
EGFR-TKI = epidermal growth factor receptor–tyrosine kinase inhibitor; FAERS = U.S. Food and Drug Administration Adverse Events Reporting System.