Table 2

Overview of adverse events*

Adverse events, n (%)Regorafenib
Treatment-emergentDrug-related treatment-emergent
Any96 (96)80 (80)
Worst grade1†6 (6)9 (9)
2†13 (13)19 (19)
357 (57)42 (42)
410 (10)6 (6)
5 (death)10 (10)4 (4)‡
Serious36 (36)15 (15)
Leading to dose modification§70 (70)55 (55)
Leading to dose reduction30 (30)NA
Leading to dose interruption62 (62)NA
Leading to permanent discontinuation28 (28)17 (17)
  • Severity graded by NCI-CTCAE V.4.0.

  • *Includes events occurring during treatment through the 30-day post-treatment follow-up period.

  • †The number of drug-related TEAEs can be larger than the number of TEAEs for a given grade because a patient is counted only once for each category. In the overall summary of TEAEs, a patient is counted once in the category of worst grade regardless of relationship to study drug. To find the drug-related TEAEs, a subset is first generated for any TEAEs that are drug related, and then the patient is counted once in the worst grade category. For a given patient, the worst grade of drug-related TEAEs may be different than the worst grade of overall TEAEs.

  • ‡The grade 5 regorafenib-related TEAEs were pulmonary embolism (1), malaise (as reported by the investigator) (1), sepsis (1) and thromboembolic event (1).

  • §Dose modifications include delays, reductions and interruptions.

  • NA, not available; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; TEAE, treatment-emergent adverse event.