| PMC full text: | Published online 2014 Dec 8. doi: 10.1200/JCO.2013.54.3298
|
Table 3.
Safety Summary
| Adverse Event | Linifanib 17.5 mg Once Daily (n = 510) | Sorafenib 400 mg Twice per Day (n = 519) | ||
|---|---|---|---|---|
| No. of Patients | % | No. of Patients | % | |
| Any AE | 508 | 99.6 | 511 | 98.5 |
| Any AE that could be related to SD | 483 | 94.7 | 481 | 92.7 |
| Any AE grade ≥ 3 | 435 | 85.3* | 389 | 75.0 |
| Any serious AE | 267 | 52.4* | 200 | 38.5 |
| Any AE leading to SD discontinuation | 185 | 36.3* | 132 | 25.4 |
| Any AE leading to SD interruption | 389 | 76.3* | 261 | 50.3 |
| Any AE leading to SD reduction | 231 | 45.3* | 162 | 31.2 |
| Any fatal AEs | 83 | 16.3 | 73 | 14.1 |
| Deaths | 351 | 68.8 | 338 | 67.1 |
| Grade 3 or 4 AEs occurring in > 3% of patients in either arm | ||||
 Hypertension | 106 | 20.8* | 45 | 10.6 |
| Palmar-plantar erythrodysesthesia syndrome | 70 | 13.7 | 77 | 14.8 |
| AST increased | 62 | 12.2 | 65 | 12.5 |
| Diarrhea | 61 | 12.0 | 48 | 9.2 |
| Fatigue | 49 | 9.6† | 25 | 4.8 |
| Hepatic encephalopathy | 37 | 7.3† | 17 | 3.3 |
| Asthenia | 36 | 7.1* | 11 | 2.1 |
| Hyperbilirubinemia | 32 | 6.3 | 21 | 4.0 |
| Ascites | 31 | 6.1† | 17 | 3.3 |
| Thrombocytopenia | 27 | 5.3† | 11 | 2.1 |
| Hypokalemia | 24 | 4.7† | 12 | 2.3 |
| Blood bilirubin increased | 23 | 4.5 | 18 | 3.5 |
| Abdominal pain | 23 | 4.5 | 14 | 2.7 |
| Decreased appetite | 22 | 4.3 | 13 | 2.5 |
| Vomiting | 22 | 4.3* | 4 | 0.8 |
| Neutropenia | 20 | 3.9 | 12 | 2.3 |
| Hyponatremia | 19 | 3.7 | 17 | 3.3 |
| Leukopenia | 18 | 3.5 | 12 | 2.3 |
| Platelet count decreased | 17 | 3.3 | 10 | 1.9 |
| Hypoglycemia | 16 | 3.1† | 4 | 0.8 |
| Anemia | 15 | 2.9 | 28 | 5.4 |
| ALT increased | 11 | 2.2 | 25 | 4.8† |
Abbreviations: AE, adverse event; SD, study drug.
*P < .001 for comparison between the sorafenib and linifanib groups.
†P < .05 for comparison between the sorafenib and linifanib groups.