Table 2.
Sorafenib-related adverse events in previous trials and the current study
| Adverse events | SHARP (%) | Asia-Pacific (%) | Current study, number, (%) | |||
|---|---|---|---|---|---|---|
|
|
|
|
||||
| All | Grade 2-3 | All | Grade 2-3 | All | Grade 2-3 | |
| Overall number of incidents | 80 | 52 | 98 | 47.7 | 310 (19.1) | 19 (1.2) |
| Constitutional symptoms | ||||||
| Fatigue | 22 | 4 | 20.1 | 3.4 | 13 (11.2) | - |
| Weight loss | 9 | 2 | - | - | 15 (12.9) | - |
| Dermatologic events | - | |||||
| Alopecia | 14 | - | 24.8 | - | 20 (17.2) | - |
| Hand-foot syndrome | 21 | 8 | 45 | 10.7 | 75 (64.7) | 13 (11.2) |
| Rash | 16 | 1 | 20.1 | 0.7 | 22 (16.4) | - |
| Gastrointestinal events | ||||||
| Anorexia | 14 | < 1 | 12.8 | 0 | 18 (15.5) | - |
| Diarrhea | 39 | 8 | 7.4 | 0 | 63 (54.3) | 2 (1.7) |
| Nausea | 11 | < 1 | 11.4 | 0.7 | 2 (1.7) | - |
| Vomiting | 5 | 1 | - | - | 2 (1.7) | - |
| Voice change | 6 | - | - | - | 9 (7.8) | - |
| Hypertension | 5 | 2 | 18.8 | 2 | 24 (20.7) | 4 (3.4) |
| Liver dysfunction | < 1 | < 1 | 0.7 | - | 13 (11.2) | - |
| Abdominal pain, unspecified | 8 | 2 | - | - | 24 (20.7) | - |
| Bleeding | 7 | 1 | 2.7 | - | 10 (8.6) | - |
SHARP, Sorafenib HCC Assessment Randomized Protocol.