Table 2 Summary of AEs possibly or probably related to study drug occurring in ≥2 patients in either cohort
Dose-escalation cohort | Dose-expansion cohort (ALK-positive) | Both cohorts | |
|---|---|---|---|
Total (n = 30)a | 525 mg (n = 16)b | Total (n = 46) | |
Overall | 20 (67) | 15 (94) | 35 (76) |
Nausea | 7 (23) | 10 (63) | 17 (37) |
Vomiting | 6 (20) | 10 (63) | 16 (35) |
Fatigue | 13 (43) | 3 (19) | 16 (35) |
Decreased appetite | 1 (3) | 4 (25) | 5 (11) |
Diarrhea | 3 (10) | 2 (13) | 5 (11) |
Rash | 0 | 3 (19) | 3 (7) |
Headache | 1 (33) | 2 (13) | 3 (7) |
Constipation | 2 (7) | 1 (6) | 3 (7) |
Peripheral neuropathy | 0 | 2 (13) | 2 (4) |
Cataract nuclear | 0 | 2 (13) | 2 (4) |
Periorbital edema | 0 | 2 (13) | 2 (4) |
Blurred vision | 0 | 2 (13) | 2 (4) |
Anemia | 2 (7) | 0 | 2 (4) |
Increased blood creatinine | 2 (7) | 0 | 2 (4) |