System organ class preferred term | KB003 (n=78) | Placebo (n=82) | Total (n=160) |
---|---|---|---|
Participants reporting at least 1 serious adverse event | 5 | 2 | 7 |
All serious adverse events reported* | 6 | 4 | 10 |
Cardiac disorders | 1 | 0 | 1 |
Acute myocardial infarction | 1 | 0 | 1 |
Gastrointestinal disorders | 0 | 1 | 1 |
Diarrhoea | 0 | 1 | 1 |
General disorders and administrative conditions | 0 | 1 | 1 |
Thrombosis in device | 0 | 1 | 1 |
Immune system disorders | 0 | 1 | 1 |
Anaphylactic reactions | 0 | 1 | 1 |
Infections and Infestations | 3 | 1 | 4 |
Appendicitis | 1 | 0 | 1 |
Arthritis bacterial | 0 | 1 | 1 |
Pneumonia | 2 | 0 | 2 |
Psychiatric disorders | 1 | 0 | 1 |
Suicide attempt | 1 | 0 | 1 |
Respiratory, thoracic and mediastinal disorders | 1 | 0 | 1 |
Hypoxia* | 1 | 0 | 1 |
Source: Listing 16.2.7.5 (appendix 16.2).
*Hypoxia was reported as a separate event concurrent with one of the pneumonia cases.