TABLE 4.
Description of severe adverse events (SAE) after W0 by system organ class and preferred term
| System organ class (SOC) | Preferred term (PT) |
n (%) |
||
|---|---|---|---|---|
| Placebo (n = 7) | Vaccine (n = 8) | Total (n = 15) | ||
| Infections and infestations | Peritonitis | 1 (14.3) | 1 (6.7) | |
| Bacterial rectitis | 1 (12.5) | 1 (6.7) | ||
| Transmitting the HIV infection | 1 (14.3) | 1 (6.7) | ||
| Injury, poisoning, and procedural complications | Accident on the public highway | 1 (12.5) | 1 (6.7) | |
| Artery stenosis | 1 (12.5) | 1 (6.7) | ||
| Toxicity of various agents | 1 (12.5) | 1 (6.7) | ||
| Musculoskeletal and connective tissue disorders | Arthralgia | 1 (14.3) | 1 (6.7) | |
| Rheumatoid arthritis | 1 (12.5) | 1 (6.7) | ||
| Heart disorders | Congestive cardiomyopathy | 1 (14.3) | 1 (6.7) | |
| Reproductive system and breast disorders | Benign prostatic hypertrophy | 1 (14.3) | 1 (6.7) | |
| Nervous system disorders | Craniocerebral injuries plus loss of consciousness | 1 (12.5) | 1 (6.7) | |
| Blood and lymphatic system disorders | Iron deficiency anemia | 1 (14.3) | 1 (6.7) | |
| Psychiatric disorders | Suicide | 1 (14.3) | 1 (6.7) | |
| Respiratory, thoracic, and mediastinal disorders | Pulmonary disorder | 1 (12.5) | 1 (6.7) | |
| Metabolism and nutrition disorders | Diabetes | 1 (12.5) | 1 (6.7) | |