Table 5.
TEAEs by preferred term in the safety population.
| TEAE, n (%) | Low-dose group (n = 17) | High-dose group (n = 18) | Overall population (n = 35) |
|---|---|---|---|
| Patients reporting ≥1 TEAE | 15 (88.2) | 18 (100.0) | 33 (94.3) |
| TEAE occurring in ≥20% of either the low-dose or high-dose group | |||
| Back pain | 4 (23.5) | 7 (38.9) | 11 (31.4) |
| Headache | 4 (23.5) | 5 (27.8) | 9 (25.7) |
| Peripheral edema | 4 (23.5) | 5 (27.8) | 9 (25.7) |
| Nausea | 3 (17.7) | 5 (27.8) | 8 (22.9) |
| Pain in extremity | 4 (23.5) | 4 (22.2) | 8 (22.9) |
| Diarrhea | 4 (23.5) | 3 (16.7) | 7 (20.0) |
| Dizziness | 3 (17.7) | 4 (22.2) | 7 (20.0) |
| Arthralgia | 2 (11.8) | 4 (22.2) | 6 (17.1) |
| Dyspepsia | 1 (5.9) | 4 (22.2) | 5 (14.3) |
| Myalgia | 1 (5.9) | 4 (22.2) | 5 (14.3) |
| Abdominal pain | 0 | 4 (22.2) | 4 (11.4) |
TEAE, treatment-emergent adverse event.