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%) |