Table 2.
AEs reported in ≥15% of patientsa
| Safety population (N = 43) |
||||
|---|---|---|---|---|
| TEAEs |
TRAEs |
|||
| Any grade, n (%) | Grade 3/4, n (%) | Any grade, n (%) | Grade 3/4, n (%) | |
| Any AE | 42 (97.7) | 18 (41.9) | 35 (81.4) | 8 (18.6) |
| Diarrhea | 15 (34.9) | 2 (4.7) | 7 (16.3) | 1 (2.3) |
| Nausea | 14 (32.6) | 2 (4.7) | 4 (9.3) | 0 (0) |
| Anemia | 13 (30.2) | 4 (9.3) | 2 (4.7) | 0 (0) |
| Decreased appetite | 11 (25.6) | 2 (4.7) | 0 (0) | 0 (0) |
| Fatigue | 11 (25.6) | 1 (2.3) | 9 (20.9) | 0 (0) |
| Abdominal pain | 10 (23.3) | 2 (4.7) | 3 (7.0)b | 0 (0) |
| Pruritus | 10 (23.3) | 0 (0) | 7 (16.3) | 0 (0) |
| Vomiting | 9 (20.9) | 1 (2.3) | 1 (2.3) | 1 (2.3) |
| Infusion-related reaction | 8 (18.6) | 0 (0) | 8 (18.6) | 0 (0) |
| Rash | 8 (18.6) | 0 (0) | 8 (18.6) | 0 (0) |
| Dyspnea | 8 (18.6) | 0 (0) | 2 (4.7) | 0 (0) |
| Peripheral edema | 8 (18.6) | 0 (0) | 1 (2.3) | 0 (0) |
Data cut-off 3 August 2021.
AE, adverse event; TEAE, treatment-emergent adverse event; TRAE, treatment-related adverse event.
a
Patients are counted only once by preferred term.
b
In one patient, abdominal pain was a symptom of an infusion-related reaction.