Table 2.
Overview of treatment-related TEAEs.
| Cohort 1 37.5 μg GM-CSF N = 20 | Cohort 2 75 μg GM-CSF N = 10 | Combined N = 30 | ||||
|---|---|---|---|---|---|---|
| Number of patients (percent) | ||||||
| Adverse event | Any grade | Grade 3 | Any grade | Grade 3 | Any grade | Grade 3 |
| Related to treatmenta | ||||||
| Any | 14 (70.0) | 5 (25.0) | 7 (70.0) | 1 (10.0) | 21 (70.0) | 6 (20.0) |
| Occurring in more than 1 patient or grade ≥ 3 | ||||||
| Fatigue | 7 (35.0) | 0 | 3 (30.0) | 0 | 10 (33.3) | 0 |
| Injection site reaction | 3 (15.0) | 0 | 3 (30.0) | 0 | 6 (20.0) | 0 |
| Hypothyroidism | 5 (25.0) | 0 | 1 (10.0) | 0 | 6 (20.0) | 0 |
| Colitis | 4 (20.0) | 1 (5.0) | 1 (10.0) | 1 (10.0) | 5 (16.7) | 2 (6.7) |
| Diarrhea | 2 (10.0) | 0 | 3 (30.0) | 0 | 5 (16.7) | 0 |
| Pruritus | 2 (10.0) | 0 | 2 (20.0) | 0 | 4 (13.3) | 0 |
| Hyperthyroidism | 3 (15.0) | 1 (5.0) | 1 (10.0) | 0 | 4 (13.3) | 1 (3.3) |
| Rash | 2 (10.0) | 0 | 1 (10.0) | 0 | 3 (10.0) | 0 |
| Arthritis | 2 (10.0) | 2 (10.0) | 0 | 0 | 2 (6.7) | 2 (6.7) |
| Dyspnea | 2 (10.0) | 0 | 0 | 0 | 2 (6.7) | 0 |
| Chorioretinitis | 1 (5.0) | 1 (5.0) | 0 | 0 | 1 (3.3) | 1 (3.3) |
| Diabetes mellitus | 1 (5.0) | 1 (5.0) | 0 | 0 | 1 (3.3) | 1 (3.3) |
Note: TEAEs were defined as all adverse events that occurred after the first dose of study medication up to 3 months ± 2 weeks after the last vaccine dose. Patients with events in more than one category were counted once within each category.
aThe investigators determined the relatedness of adverse events to study drugs.