Table 2.
Patient safety data
| N = 8 patients | Grades 1-2 | Grade ≥3 |
|---|---|---|
|
Possible immune related |
||
| Rash/immune system disorder | 4 | 3 |
| Colitis | 0 | 1 |
| Cough/pneumonitis | 4 | 0 |
| LFT elevation | 5 | 0 |
| Cytopenias | ||
| Anemia | 4 | 4 |
| Thrombocytopenia | 0 | 2 |
| Neutropenia | 0 | 1 |
| Other | ||
| Chills | 2 | 0 |
| Constipation/abdominal pain | 4 | 0 |
| Fatigue | 5 | 1 |
| Infection∗ | 4 | 9 |
| Injection site reaction | 3 | 0 |
| GI bleeding | 2 | 0 |
| Mucositis | 3 | 1 |
| Myalgia | 3 | 1 |
Grading for adverse events was recorded throughout the study and assigned by the investigators according to the Common Terminology Criteria for Adverse Events version 4.0.
GI, gastrointestinal; LFT, -liver function test.
∗
Some patients enrolled in study had multiple adverse events due to infection.