Table 3.
TEAEs reported at any grade in ≥10% of patients, irrespective of causality
| TEAE | Patients, n (%) (n = 24) |
|
|---|---|---|
| All grades | Grade 3a | |
| Edema (composite term) | 14 (58.3) | 3 (12.5) |
| Peripheral edema | 12 (50.0) | 2 (8.3) |
| Generalized edema | 5 (20.8) | 2 (8.3) |
| Edema (preferred term) | 5 (20.8) | 1 (4.2) |
| Constipation | 10 (41.7) | 1 (4.2) |
| Dyspnea | 7 (29.2) | 1 (4.2) |
| Asthenia | 5 (20.8) | 1 (4.2) |
| Blood creatinine increased | 5 (20.8) | 0 (0) |
| Diarrhea | 5 (20.8) | 0 (0) |
| Hypoalbuminemia | 5 (20.8) | 2 (8.3) |
| Nausea | 4 (16.7) | 1 (4.2) |
| Abdominal pain | 3 (12.5) | 1 (4.2) |
| Alanine aminotransferase increased | 3 (12.5) | 1 (4.2) |
| Anemia | 3 (12.5) | 1 (4.2) |
| Aspartate aminotransferase increased | 3 (12.5) | 0 (0) |
| Cough | 3 (12.5) | 0 (0) |
| Disease progression | 3 (12.5) | 0 (0) |
| Hypoproteinemia | 3 (12.5) | 0 (0) |
| Pneumonia | 3 (12.5) | 1 (4.2) |
| Productive cough | 3 (12.5) | 0 (0) |
| Pyrexia | 3 (12.5) | 0 (0) |
| Vomiting | 3 (12.5) | 0 (0) |
TEAE, treatment-emergent adverse event.
a
For the events shown, there were no grade 4 TEAEs, and the only grade 5 TEAEs were disease progression (n = 3; 12.5%) and pneumonia (n = 1; 4.2%), which were unrelated to treatment.