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Table 2 Summary of AEs possibly or probably related to study drug occurring in ≥2 patients in either cohort

From: First-in-human, open-label dose-escalation and dose-expansion study of the safety, pharmacokinetics, and antitumor effects of an oral ALK inhibitor ASP3026 in patients with advanced solid tumors

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