Table 3.
Treatment-Related Adverse Events of Any Grade and Grade 3/4 AEs in All Patients
| Adverse Events | Any Grade n=246 (%) | Grade 3/4 n=246 (%) | |
|---|---|---|---|
| General | Asthenia | 8 (3.2) | 0 |
| Hypoproteinemia | 1 (0.4) | 1 (0.4) | |
| Gastrointestinal system | Elevated hepatic enzymes& | 3 (1.2) | 0 |
| Nausea, vomit or diarrhea | 21 (8.5) | 0 | |
| Renal system | Proteinuria | 7 (2.8) | 0 |
| Musculoskeletal system | Pain and arthralgia# | 45 (18.3) | 5 (2.0) |
| Hematologic system | Leukopenia | 14 (5.7) | 8 (3.2) |
| Thrombocytopelemia | 4 (1.6) | 0 | |
| Cardiovascular system | Hypertension | 24 (9.8) | 4 (1.6) |
| Bradycardia | 1 (0.4) | 1 (0.4) | |
| Atrial fibrillation | 1 (0.4) | 1 (0.4) | |
| Dermatologic system | Ulcer* | 7 (2.8) | 2 (0.8) |
| PPE/ rash | 5 (2.0) | 0 | |
| Others | Fistula | 1 (0.4) | 0 |
| Hemorrhage | 10 (4.0) | 3 (1.2) | |
| Thrombosis | 2 (0.8) | 3 (1.2) |
Notes: *Including oral and virginal ulcers. #Mainly hand and foot pain and arthralgia. &Elevated hepatic enzymes included aspartate aminotransferase increased, alanine transaminase increased, and γ-glutamyl transpeptidase increased.
Abbreviation: PPE, palmoplantar erythrodysesthesia.