Table 3

Treatment-emergent adverse events occurring at any grade in ≥10 patients, and corresponding rates of drug-related treatment-emergent adverse events*

Adverse events, %Regorafenib
(N=100)
Treatment-emergentDrug-related treatment-emergent
Any gradeGrade 3Grade 4Any gradeGrade 3Grade 4
Hand–foot skin reaction295NA275NA
Hyperbilirubinaemia251311351
Anorexia21701650
Fatigue209NA188NA
Hypertension20701650
Weight loss201NA130NA
Hypophosphataemia1915015110
AST increased1780840
Diarrhoea17301520
Anaemia1630920
Hoarseness130NA90NA
Hypothyroidism13101110
Alkaline phosphatase increased1260310
ALT increased1250750
  • Categories and severity by NCI-CTCAE V.4.0.

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

  • ALT, alanine aminotransferase; AST, aspartate aminotransferase; NA, not applicable; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events.