Table 2.
Pharmacovigilance metrics for reported cases of osimertinib-related myotoxicity
| Myotoxicity AEs | Case Number, N | ROR (ROR025) | PRR (χ2) | IC (IC025) |
|---|---|---|---|---|
| Total | 137 | 3.11 (2.63) | 3.10 (194.51) | 1.62 (1.37) |
| Blood CPK increased | 83 | 6.20 (5.00) | 6.18 (358.27) | 2.58 (2.07) |
| Rhabdomyolysis | 23 | 1.08 (0.72) | 1.08 (0.14) | 0.11 (0.07) |
| Myositis | 20 | 4.22 (2.72) | 4.22 (48.85) | 1.96 (1.26) |
| Myopathy | 11 | 2.32 (1.28) | 2.32 (8.23) | 1.13 (0.63) |
Abbreviations AE Adverse events, CPK Creatine phosphokinase, ROR Reporting odds ratio, ROR 025 The lower limit of the 95% confidence interval of the ROR, PRR Proportional reporting ratio, χ2 Chi-squared, IC Information component, IC025 The lower limit of the 95% confidence interval of the IC