TABLE 3.
Safety of tepotinib in Japanese patients.
| AEs in Japanese patients (n = 38) | All‐cause AEs, n (%) | Treatment‐related AEs, n (%) |
|---|---|---|
| Any grade | 38 (100.0) | 37 (97.4) |
| Grade ≥3 | 23 (60.5) | 19 (50.0) |
| Leading to death | 3 a (7.9) | 0 |
| Treatment‐related AEs (any grade) occurring in ≥10% of patients, n (%) | ||
|---|---|---|
| Any grade | Grade ≥ 3 | |
| Blood creatinine increased | 25 (65.8) | 0 |
| Peripheral edema | 23 (60.5) | 5 (13.2) |
| Hypoalbuminemia | 13 (34.2) | 4 (10.5) |
| Diarrhea | 11 (28.9) | 1 (2.6) |
| Nausea | 6 (15.8) | 0 |
| Alanine aminotransferase increased | 6 (15.8) | 0 |
| Amylase increased | 6 (15.8) | 1 (2.6) |
| Aspartate aminotransferase increased | 5 (13.2) | 0 |
| Dysgeusia | 5 (13.2) | 0 |
| Lipase increased | 5 (13.2) | 1 (2.6) |
| Edema | 5 (13.2) | 1 (2.6) |
| Anemia | 4 (10.5) | 1 (2.6) |
| White blood cell count decreased | 4 (10.5) | 0 |
| Decreased appetite | 4 (10.5) | 1 (2.6) |
| Interstitial lung disease | 4 (10.5) | 0 |
| Pruritus | 4 (10.5) | 0 |
Abbreviation: AEs, adverse events.
a
Two patients died due to disease progression and one patient died due to pulmonary hemorrhage.