Table 1.
Summary of adverse events
| Profile of treatment emergent adverse events (TEAEs) | Patients n (%) | Events n |
|---|---|---|
| Any event | 5 (100) | 838 |
| Mild | 5 (100) | 826 |
| Moderate | 2 (40) | 12 |
| Severe | 0 | 0 |
| Serious events, deaths, discontinuations | 0 | 0 |
| Treatment related events | 4 (80) | 443 |
| Most common TEAEs (≥ 5% of all TEAEs) | ||
| Headache | 5 (100) | 69 |
| Nausea | 5 (100) | 57 |
| Abdominal pain | 5 (100) | 54 |
| Arthralgia | 4 (80) | 53 |
| Fatigue | 3 (60) | 45 |
| Infusion associated reactions | 4 (80) | 96 |
| Mild | 4 (80) | 85 |
| Moderate | 2 (40) | 11 |
| Most common infusion associated reactions (≥ 5% of all IARs) | ||
| Headache | 3 (60) | 23 |
| Nausea | 2 (40) | 13 |
| Abdominal pain | 2 (40) | 9 |
| Arthralgia | 3 (60) | 7 |
| Musculoskeletal pain | 1 (20) | 6 |
| Myalgia | 2 (40) | 6 |