Table 3.
Grade 3 to 5 AEs With More Than 5% Incidence in Regorafenib Arm
| Type of AE* | No. (%) | |
|---|---|---|
| Regorafenib (n = 97) | Placebo (n = 50) | |
| Anorexia | 6 (6) | 3 (6) |
| AST level increased | 9 (9) | 0 (0) |
| Abdominal pain | 5 (5) | 1 (2) |
| Hypertension | 10 (10) | 1 (2) |
| γ-glutamyltransferase level increased | 6 (6) | 4 (8) |
| ALT level increased | 8 (8) | 3 (6) |
| Skin and subcutaneous tissue disorders, other† | 6 (6) | 0 (0) |
| Pain | 5 (5) | 2 (4) |
| Hypophosphatemia | 5 (5) | 0 (0) |
| At least one grade 3 to 5 AE | 65 (67) | 26 (52) |
NOTE. If a patient had more than one event of the same type, that with the worst grade was used to populate each row of the table.
Abbreviation: AE, adverse event.
*
From National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0).
†
When all AE terms falling within the skin and subcutaneous tissue disorder class (except for alopecia) were combined, there were nine (9%) grade 3 events for regorafenib and two (4%) for placebo. For palmar-plantar erythrodysesthesia syndrome alone, there were two (2%) grade 3 events for regorafenib and one (2%) for placebo.