Table 2.
Adverse events that occurred in ≥5% of patients
| Adverse eventsa by preferred termsb | Any grade n (%) | Grade 3–4 n (%) |
|---|---|---|
| Any adverse events | 39 (92.9) | 10 (23.8)c |
| Palmar-plantar erythrodysesthesia syndrome | 16 (38.1) | 0 (0.0) |
| Abdominal pain | 13 (31.0) | 0 (0.0) |
| Alopecia | 11 (26.2) | 0 (0.0) |
| Skin rash | 10 (23.8) | 0 (0.0) |
| Fatigue | 10 (23.8) | 0 (0.0) |
| AST increased | 10 (23.8) | 2 (4.8) |
| Pyrexia | 7 (16.7) | 0 (0.0) |
| Dyspepsia | 7 (16.7) | 0 (0.0) |
| Decreased appetite | 6 (14.3) | 0 (0.0) |
| Dysphonia | 5 (11.9) | 0 (0.0) |
| Hypothyroidism | 5 (11.9) | 0 (0.0) |
| Diarrhea | 5 (11.9) | 0 (0.0) |
| Cough | 5 (11.9) | 0 (0.0) |
| Pruritus | 4 (9.5) | 0 (0.0) |
| Stomatitis | 4 (9.5) | 0 (0.0) |
| ALT increased | 4 (9.5) | 0 (0.0) |
| Hypoalbuminemia | 4 (9.5) | 1 (2.4) |
| Abdominal distension | 4 (9.5) | 0 (0.0) |
| Body weight decreased | 4 (9.5) | 0 (0.0) |
| Back pain | 4 (9.5) | 0 (0.0) |
| Proteinuria | 4 (9.5) | 0 (0.0) |
| Platelet count decreased | 3 (7.1) | 0 (0.0) |
| Urticaria | 3 (7.1) | 0 (0.0) |
| Insomnia | 3 (7.1) | 0 (0.0) |
aThe adverse events reported here were all events and were not limited to those considered to be causally related to study treatment.
bPreferred terms were defined according to the Medical Dictionary for Regulatory Activities terminology version 24.0. All participants who were administered any dose of any study intervention were included for safety analysis. Adverse event severity was scored using the NCI-CTCAE version 5.0.
cGrade 3 adverse events occurred in 10 patients, and three patients experienced two or more kinds of grade 3 adverse events. Other grade 3 adverse events not listed in the table include ascites (n = 1), gastrointestinal hemorrhage (n = 2), hyperkalemia (n = 1), hyperglycemia (n = 1), hypotension (n = 1), acute kidney injury (n = 2), pneumonia (n = 1), cardiovascular accident (n = 1) and jaundice (n = 1).