Table 3.
Grades 3–4 treatment-emergent adverse events (TEAE)
| System organ classa | Number (%) of patients with TEAE (n = 331) |
|---|---|
| Patients reporting at least one serious TEAE (whether or not related to DC vaccine treatment) | 137 (41.1%) |
| Nervous system disorders | 93 (28.1%) |
| Infectionsb | 23 (6.9%) |
| General disorders and injection site reactions | 22 (6.6%) |
| Respiratory, thoracic and mediastinal disorders | 17 (5.1%) |
| Psychiatric disorders | 16 (4.8%) |
| Gastrointestinal disorders | 16 (4.8%) |
| Injury, poisoning, and procedural complications | 12 (3.6%) |
| Vascular disorders | 6 (1.8%) |
| Musculoskeletal and connective tissue disorders | 5 (1.5%) |
| Neoplasms benign, malignant and unspecified | 5 (1.5%) |
| Hematological disorders | 5 (1.5%) |
| Metabolism and nutrition disorders | 3 (0.9%) |
| Hepatobiliary disorders | 2 (0.6%) |
| Renal and urinary disorders | 2 (0.6%) |
| Cardiac disorders | 1 (0.3%) |
| Ear and labyrinth disorders | 1 (0.3%) |
| Immune system disordersc | 1 (0.3%) |
| Reproductive system and breast disorders | 1 (0.3%) |
aCoded per MedDRA 16.0. Patients may have had more than one adverse event, so subcategories do not total
bIncludes surgical wound infections, meningitis, urinary tract infections, and others
cIncludes drug hypersensitivity