aAdverse reactions were graded per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
bSafety data from 1 study site enrolling 6 patients were excluded.
cIncludes peripheral neuropathy, peripheral sensorimotor neuropathy, peripheral motor neuropathy, polyneuropathy, peripheral sensory neuropathy, and paresthesia.
dIncludes abdominal pain, upper abdominal pain, lower abdominal pain, and abdominal discomfort.
eNot applicable; grading system does not specify greater than Grade 2 for alopecia.
Other clinically important adverse reactions occurring in ≥10% of the HALAVEN-treated patients were nausea (41%), vomiting (19%), diarrhea (17%), asthenia/fatigue (62%), peripheral edema (12%), decreased appetite (19%), arthralgia/myalgia (16%), back pain (16%), and cough (18%)1
The median duration of exposure was 2.3 months (range: 21 days to 26 months) for patients receiving HALAVEN1
fEach test incidence is based on the number of patients who had both baseline and at least 1 on-study measurement and at least 1 grade increase from baseline. HALAVEN group (range 221-222) and dacarbazine group (range 214-215).
gLaboratory results were graded per NCI CTCAE version 4.03.
Reference: 1. HALAVEN [package insert]. Woodcliff Lake, NJ: Eisai Inc; 2016.