Table 4.

Overview of drug-related AEs

n (%)Refametinib-related(n = 70)Sorafenib-related(n = 70)
Any drug-related AE70 (100)70 (100)
Worst CTCAE grade of drug-related AE
 Grade 11 (1.4)0
 Grade 28 (11.4)9 (12.9)
 Grade 346 (65.7)46 (65.7)
 Grade 411 (15.7)11 (15.7)
Any drug-related serious AE30 (42.9)30 (42.9)
Deatha4 (5.7)4 (5.7)
Drug-related AE leading to dose modificationb63 (90.0)63 (90.0)
Drug-related AE leading to permanent discontinuation of study drugc12 (17.1)12 (17.1)

Abbreviation: CTCAE, Common Terminology Criteria for Adverse Events.

  • aIncluding during treatment or within 30 days after last dose of study treatment was taken.

  • bModifications include delays, interruptions, and reductions.

  • cIncluding discontinuation due to death.