Table 2.
Overview of adverse events*
| Adverse events, n (%) | Regorafenib (N=100) |
||
| Treatment-emergent | Drug-related treatment-emergent | ||
| Any | 96 (96) | 80 (80) | |
| Worst grade | 1† | 6 (6) | 9 (9) |
| 2† | 13 (13) | 19 (19) | |
| 3 | 57 (57) | 42 (42) | |
| 4 | 10 (10) | 6 (6) | |
| 5 (death) | 10 (10) | 4 (4)‡ | |
| Serious | 36 (36) | 15 (15) | |
| Leading to dose modification§ | 70 (70) | 55 (55) | |
| Leading to dose reduction | 30 (30) | NA | |
| Leading to dose interruption | 62 (62) | NA | |
| Leading to permanent discontinuation | 28 (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.