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. 2022 Mar 11;22(5):611–621. doi: 10.1016/S1473-3099(22)00058-5

Table 3.

Adverse events

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.