Table 3.
CD24Fc group (n=114) | Placebo group (n=115) | ||
---|---|---|---|
Total adverse events | 69 | 52 | |
Participants with adverse events | 32 (28%) | 35 (30%) | |
Treatment-related adverse events | 0 | 0 | |
Participants with treatment-related adverse events | 0 | 0 | |
Total serious adverse events | 37 | 32 | |
Participants with serious adverse events | 26 (23%) | 27 (24%) | |
Deaths | 16 (14%) | 18 (15%) | |
Total fatal serious adverse events | 17 | 19 | |
Participants with fatal serious adverse events | 15 (13%) | 18 (16%) | |
Fatal serious adverse events* | |||
Respiratory, thoracic, and mediastinal disorders | 7 (6%) | 13 (11%) | |
Respiratory failure | 5 (4%) | 12 (10%) | |
Cardiac disorders | 6 (5%) | 3 (3%) | |
Cardiac arrest | 3 (3%) | 2 (2%) | |
Total non-fatal serious adverse events | 22 | 15 | |
Participants with non-fatal serious adverse events | 17 (15%) | 12 (10%) | |
Non-fatal serious adverse events* | |||
Respiratory, thoracic, and mediastinal disorders | 7 (6%) | 7 (6%) | |
Respiratory failure | 0 | 3 (3%) | |
Blood and lymphatic system disorders | 3 (3%) | 1 (1%) | |
Anaemia | 3 (3%) | 1 (1%) | |
Renal and urinary disorders | 3 (3%) | 1 (1%) | |
Acute kidney injury | 3 (3%) | 1 (1%) | |
Grade ≥3 adverse events by system organ class* | |||
Blood and lymphatic system disorders | |||
Acute anaemia | 0 | 1 (1%) | |
Acute exacerbation of chronic anaemia | 1 (1%) | 0 | |
Anaemia | 5 (4%) | 1 (1%) | |
Worsening of anaemia | 1 (1%) | 0 | |
Cardiac disorders | |||
Asystole arrest | 1 (1%) | 0 | |
Cardiac arrest | 2 (2%) | 2 (2%) | |
Renal and urinary disorders | |||
Acute kidney injury | 1 (1%) | 1 (1%) | |
Acute renal failure | 4 (3%) | 1 (1%) | |
Oliguric acute renal failure with hyperkalaemia | 0 | 1 (1%) | |
Respiratory, thoracic, and mediastinal disorders | |||
Pneumothorax | 2 (2%) | 1 (1%) | |
Right pneumothorax | 1 (1%) | 0 | |
Exacerbation of respiratory failure | 3 (3%) | 7 (6%) | |
Hypoxic respiratory failure | 0 | 2 (2%) | |
Hypoxic respiratory failure secondary to COVID-19 | 0 | 1 (1%) | |
Respiratory failure | 4 (3%) | 6 (5%) |
Data are n or n (%). Adverse event assessment period was 28 days from randomisation.
With incidence rates of 2% or greater in one or more treatment group, by system organ class in all participants who received study treatment.