Table 3.
Summary of adverse events across all treatment cycles occurring in at least 5% of the patients
| Events, n (%) | Sorafenib (n = 65) | Placebo (n = 33) | ||
|---|---|---|---|---|
| CTCAE grade | All grades | Grade ≥3 | All grades | Grade ≥3 |
| Hematologic | ||||
| Thrombocytopenia | — | 58 (89) | — | 28 (85) |
| Neutropenia | — | 58 (89) | — | 27 (82) |
| Anemia | — | 50 (77) | — | 23 (70) |
| Febrile neutropenia | — | 42 (65) | — | 18 (55) |
| Nonhematologic | ||||
| Infection/sepsis | 45 (69) | 36 (55)∗ | 18 (55) | 16 (48) |
| Nausea/vomiting | 28 (43) | 4 (6) | 11 (33) | 0 |
| Diarrhea | 25 (39) | 8 (12) | 10 (30) | 1 (3) |
| Constipation | 4 (6) | 0 | 1 (3) | 0 |
| Colitis/enterocolitis | 11 (17) | 10 (15) | 7 (21) | 5 (15) |
| Mucositis | 17 (26) | 6 (9) | 4 (12) | 2 (6) |
| Rash | 35 (54) | 7 (11) | 18 (55) | 8 (24) |
| Palmar-plantar syndrome | 10 (15) | 5 (8) | 2 (6) | 0 |
| QTc prolongation | 6 (9) | 3 (5) | 2 (6) | 0 |
| Cardiac arrest | — | — | 1 (3)† | 1 (3)† |
| Alanine aminotransferase increase | 18 (28) | 7 (11) | 9 (27) | 6 (18) |
| Bilirubin increase | 13 (20) | 6 (9) | 7 (21) | 3 (9) |
| Acute kidney injury | 3 (5) | 1 (2) | 3 (9) | 1 (3) |
| Hypokalemia | 16 (25) | 12 (18) | 6 (18) | 5 (15) |
| Hypophosphatemia | 8 (12) | 7 (11) | 1 (3) | 1 (3) |
| Fatigue | 10 (15) | 2 (3) | 2 (6) | 1 (3) |
| Hypertension | 11 (17) | 5 (8) | 2 (6) | 0 |
| Blurred vision | 4 (6) | 0 | 0 | 0 |
CTCAE, Common Terminology Criteria for Adverse Events; QTc, corrected QT interval; SAE, serious adverse event.
∗
Includes 1 patient with Klebsiella sepsis who died in induction.
†
Includes 1 patient with cardiac arrest who died in induction.