Table 2.
Treatment-related adverse events
| Event-no.(%) | Cohort 1 (N = 7) | Cohort 2 (N = 10) | ||
|---|---|---|---|---|
| All grades | Grade 3 or 4 | All grades | Grade 3 or 4 | |
| Any event | 7 (100) | 3 (43) | 10 (100) | 5 (50) |
| Injection Site Reactions** | ||||
| GVAX | 7 (100) | 0 | 8 (80) | 0 |
| Guadecitabine | 5 (71) | 0 | 7 (70) | 0 |
| Generalized Symptoms | ||||
| Fatigue | 5 (71) | 0 | 8 (80) | 3 (30) |
| Fever/Chills | 3 (43) | 0 | 2 (20) | 0 |
| Myalgia | 2 (29) | 0 | 1 (10) | 0 |
| Headache | 1 (14) | 0 | 3 (30) | 0 |
| Flu-like illness | 0 | 0 | 1 (10) | 0 |
| Dizziness | 1 (14) | 0 | 0 | 0 |
| Gastrointestinal | ||||
| Constipation | 2 (29) | 0 | 2 (20) | 0 |
| Nausea/vomiting | 3 (43) | 0 | 2 (20) | 0 |
| Diarrhea | 0 | 0 | 1 (10) | 0 |
| Flatulence | 1 (14) | 0 | 0 | 0 |
| Hematologic | ||||
| Neutropenia | 3 (43) | 3 (43) | 4 (40) | 4 (40) |
| Leukopenia | 0 | 0 | 1 (10) | 1 (10) |
| Anemia | 1 (14) | 0 | 0 | 0 |
| Dermatologic | ||||
| Rash/Pruritis | 0 | 0 | 2 (20) | 0 |
| Hives | 1 (14) | 0 | 0 | 0 |
| Other | ||||
| Cough | 1 (14) | 0 | 0 | 0 |
| Warmth, thighs | 1 (14) | 0 | 0 | 0 |
*Events were counted once for each patient using the highest grading
**Includes erythema, induration, pruritis, hyperpigmentation, tenderness