Table 2. Cumulative summary tabulation of serious adverse events (SAEs).
The Medical Dictionary for Regulatory Activities (MedDRA) version 15.1 was used for the coding of adverse events (AEs). The summary tabulations of SAEs are arranged by the primary System Organ Class (SOC) and Preferred Term (PT) level.
| System organ class | Active study drug (DCVAC/PCa) |
|---|---|
| Preferred term | |
| Blood and lymphatic system disorders | |
| Anaemia | 4 |
| Bone marrow failure | 1 |
| Febrile neutropenia | 2 |
| Leukopenia | 1 |
| Pancytopenia | 1 |
| Thrombocytopenia | 1 |
| Cardiac disorders | |
| Myocardial infarction | 1 |
| Pulmonary oedema | 1 |
| General disorders and administration site conditions | |
| Death | 2 |
| Immune system disorders | |
| Hypogammaglobulinaemia | 1 |
| Injury, poisoning and procedural complications | |
| Myopathy toxic | 1 |
| Spinal compression fracture | 1 |
| Metabolism and nutrition disorders | |
| Diabetes mellitus | 1 |
| Hypokalaemia | 1 |
| Musculoskeletal and connective tissue disorders | |
| Pain in extremity | 1 |
| Osteonecrosis of jaw | 1 |
| Pathological fracture | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | |
| Choroid melanoma | 1 |
| Meningioma | 1 |
| Neuroendocrine carcinoma | 1 |
| Nervous system disorders | |
| Cognitive disorder | 1 |
| Epilepsy | 1 |
| Hemiparesis | 1 |
| Paraparesis | 1 |
| Paraplegia | 1 |
| Renal and urinary disorders | |
| Hydronephrosis | 1 |
| Incontinence | 1 |
| Renal failure | 1 |
| Urinary retention | 2 |
| Urinary tract inflammation | 1 |
| Urinary tract obstruction | 2 |
| Respiratory, thoracic and mediastinal disorders | |
| Pulmonary embolism | 1 |
| Vascular disorders | |
| Circulatory collapse | 1 |
| Hypotension | 1 |
| Thrombosis | 3 |
| TOTAL | 44 |