Table 4.
Grade 3–5 adverse events related to regorafenib
| Adverse event | Grade 3 n (%) | Grade 4 n (%) | Grade 5 n (%) | Total (Grade3–5) n % |
|---|---|---|---|---|
| Hypertension | 14 (30) | 1 (2.1) | 0 | 15 (32)a |
| Fatigue | 14 (30) | 0 | 14 (30) | |
| Hypophosphatemia | 6 (13) | 0 | 0 | 6 (13) |
| HFSRa | 4 (8.5) | 0 | 0 | 4 (8.5) |
| Diarrhea | 4 (8.5) | 0 | 0 | 4 (8.5) |
| Increased AST | 3 (6.4) | 0 | 0 | 3 (6.4) |
| Increased GGT | 3 (6.4) | 0 | 0 | 3 (6.4) |
| Mucositis | 3 (6.4) | 0 | 0 | 3 (6.4) |
| Anorexia | 2 (4.3) | 0 | 0 | 2 (4.3) |
| Increased bilirubin | 2 (4.3) | 0 | 0 | 2 (4.3) |
| Increased lipase | 1 (2.1) | 1 (2.1) | 0 | 2 (4.3) |
| Rectal bleeding | 1 (2.1) | 0 | 1 (2.1) | 2 (4.3) |
| Hyperuricemia | 0 | 1 (2.1) | 0 | 1 (2.1) |
| Sudden death | 0 | 0 | 1 (2.1) | 1 (2.1) |
| Stroke | 1 (2.1) | 0 | 0 | 1 (2.1) |
| Pancreatitis | 1 (2.1) | 0 | 0 | 1 (2.1) |
| Stomathitis | 1 (2.1) | 0 | 0 | 1 (2.1) |
| Hyperglucemia | 1 (2.1) | 0 | 0 | 1 (2.1) |
| Skin rash | 1 (2.1) | 0 | 0 | 1 (2.1) |
| Proteinuria | 1 (2.1) | 0 | 0 | 1 (2.1) |
| Pancreatitis | 1 (2.1) | 0 | 0 | 1 (2.1) |
| Nausea | 1 (2.1) | 0 | 0 | 1 (2.1) |
| Constipation | 1 (2.1) | 0 | 0 | 1 (2.1) |
| Vaginitis | 1 (2.1) | 0 | 0 | 1 (2.1) |
| Aphonia | 1 (2.1) | 0 | 0 | 1 (2.1) |
| Somnolence | 1 (2.1) | 0 | 0 | 1 (2.1) |
| Dry mouth | 1 (2.1) | 0 | 0 | 1 (2.1) |
| Abdominal pain | 1 (2.1) | 0 | 0 | 1 (2.1) |
| Increased ALT | 1 (2.1) | 0 | 0 | 1 (2.1) |
| Tumor abscess | 1 (2.1) | 0 | 0 | 1 (2.1) |
| Pneumonia | 1 (2.1) | 0 | 0 | 1 (2.1) |
| Intestinal perforation | 1 (2.1) | 0 | 0 | 1 (2.1) |
a12 out 15 patients (89%) who experienced hypertension, presented hypertension at baseline
Abbreviations: HFSR Hand Foot Skin Reaction