TRAEs by preferred term occurring in at least 10% of the prior systemic therapy pooled safety population
| TRAE, n (%) . | Prior systemic therapy pooled safety population (n = 53) . | |
|---|---|---|
| Any grade . | Grade ≥3 . | |
| Patients with ≥1 event | 50 (94) | 30 (57) |
| Peripheral edema | 24 (45) | 0 |
| Thrombocytopenia | 17 (32) | 7 (13) |
| Periorbital edema | 16 (30) | 1 (2) |
| Diarrhea | 11 (21) | 1 (2) |
| Anemia | 10 (19) | 6 (11) |
| Eyelid edema | 9 (17) | 0 |
| Face edema | 9 (17) | 0 |
| Cognitive disorder | 8 (15) | 2 (4) |
| Hair color changes | 8 (15) | 0 |
| Neutropenia | 8 (15) | 8 (15) |
| Vomiting | 7 (13) | 1 (2) |
| Fatigue | 7 (13) | 1 (2) |
| Dysgeusia | 7 (13) | 0 |
| Arthralgia | 6 (11) | 1 (2) |
| Headache | 6 (11) | 0 |
| Asthenia | 6 (11) | 1 (2) |
| Platelet count decreased | 6 (11) | 4 (8) |
| TRAE, n (%) . | Prior systemic therapy pooled safety population (n = 53) . | |
|---|---|---|
| Any grade . | Grade ≥3 . | |
| Patients with ≥1 event | 50 (94) | 30 (57) |
| Peripheral edema | 24 (45) | 0 |
| Thrombocytopenia | 17 (32) | 7 (13) |
| Periorbital edema | 16 (30) | 1 (2) |
| Diarrhea | 11 (21) | 1 (2) |
| Anemia | 10 (19) | 6 (11) |
| Eyelid edema | 9 (17) | 0 |
| Face edema | 9 (17) | 0 |
| Cognitive disorder | 8 (15) | 2 (4) |
| Hair color changes | 8 (15) | 0 |
| Neutropenia | 8 (15) | 8 (15) |
| Vomiting | 7 (13) | 1 (2) |
| Fatigue | 7 (13) | 1 (2) |
| Dysgeusia | 7 (13) | 0 |
| Arthralgia | 6 (11) | 1 (2) |
| Headache | 6 (11) | 0 |
| Asthenia | 6 (11) | 1 (2) |
| Platelet count decreased | 6 (11) | 4 (8) |
Percentages have been rounded to whole numbers.