Table 1.
Clinical characteristics of reports associated with osimertinib-related myotoxicity
| Characteristics | Case Number, N (%) |
|---|---|
| Number of reports | 121 |
| Age | |
| < 18 | 2 (1.6) |
| 18–65 | 34 (28.1) |
| > 65 | 56 (46.3) |
| Unknown | 29 (24.0) |
| Median age, year (range) | 68 (7–90) |
| Gender | |
| Female | 74 (61.2) |
| Male | 31 (25.6) |
| Unknown | 16 (13.2) |
| Myotoxicity adverse eventsa | |
| Blood creatine phosphokinase increased | 83 (68.6) |
| Rhabdomyolysis | 23 (19.0) |
| Myositis | 20 (16.5) |
| Myopathy | 11 (9.1) |
| Outcome of eventsb | |
| Death | 5 (4.1) |
| Life-threatening | 8 (6.6) |
| Disabled | 5 (4.1) |
| Hospitalization | 27 (22.3) |
| Non-serious | 13 (10.7) |
| Other outcomes | 94 (77.7) |
| Reporter type | |
| Consumer | 4 (3.3) |
| Healthcare Professional | 117 (96.7) |
| Reporting country/region | |
| Japan | 43 (35.5) |
| United States | 14 (11.6) |
| France | 11 (9.1) |
| Other | 11 (9.1) |
| Unknown | 42 (34.7) |
| Time to onset of adverse events | |
| 0–30 days | 15 (39.5) |
| 30–60 days | 6 (15.8) |
| 60–90 days | 4 (10.5) |
| 90–180 days | 5 (13.1) |
| 180–360 days | 6 (15.8) |
| > 360 days | 2 (5.3) |
| Median (Q1, Q3) | 40 (13.3, 164.5) |
Abbreviations Q1 Lower Quartile, Q3 Upper Quartile
aSome cases may contain more than one myotoxicity adverse events
bSome cases may contain more than one outcome