Table 3.
Incidence of drug-related adverse effects
| Toxicities | SHARP
|
Asia-Pacific
|
||||||
|---|---|---|---|---|---|---|---|---|
| Sorafenib
|
Placebo
|
Sorafenib
|
Placebo
|
|||||
| All | Grade 3/4 | All | Grade 3/4 | All | Grade 3/4 | All | Grade 3/4 | |
| Hand-foot skin reaction | 21a | 8 | 3 | <1 | 45 | 11 | 3 | 0 |
| Diarrhea | 39 | 8 | 11 | 2 | 26 | 6 | 5 | 0 |
| Alopecia | 14 | 0 | 2 | 0 | 25 | 0 | 1 | 0 |
| Fatigue | 22 | 4 | 16 | 4 | 20 | 3 | 8 | 1 |
| Rash/desquamation | 16 | 1 | 11 | 0 | 20 | 1 | 7 | 0 |
| Hypertension | 5 | 2 | 2 | 1 | 19 | 2 | 1 | 0 |
| Nausea/vomiting | 16 | 2 | 11 | 2 | 11 | 1 | 11 | 1 |
| Anorexia | 14 | <1 | 3 | 1 | 13 | 0 | 3 | 0 |
| Dose reductionb | 26 | 7 | 31 | 3 | ||||
| Drug discontinuationb | 38 | 37 | 20 | 13 | ||||
Notes:
a
Variables are expressed as percentages;
b
due to adverse events.