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) |
ALK anaplastic lymphoma kinase
aExcludes 3 ALK-positive patients
bIncludes 3 ALK-positive patients from the dose-escalation cohort