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Table 4 Safety outcomes in all patients receiving at least one dose of study drug

From: Auxora vs. placebo for the treatment of patients with severe COVID-19 pneumonia: a randomized-controlled clinical trial

 

Placebo (n = 140)

Auxora (n = 141)

Discontinuation due to AEs, n (%)

5 (3.6%)

3 (2.1%)

Serious adverse events ≥ 4%, n (%)

Respiratory failure

26 (18.6%)

22 (15.6%)

ARDS

11 (7.9%)

7 (5.0%)

Pneumonia

7 (5.0%)

6 (4.3%)

Cardiac arrest

6 (4.3%)

6 (4.3%)

Septic shock

8 (5.7%)

2 (1.4%)

Most common treatment-emergent adverse events ≥ 4%, n (%)

Respiratory failure

26 (18.6%)

22 (15.6%)

Blood triglycerides increased

5 (3.6%)

16 (11.3%)

Hypertriglyceridemia

4 (2.9%)

2 (1.4%)

Hyperglycemia

11 (7.9%)

11 (7.8%)

Acute kidney injury

16 (11.4%)

10 (7.1%)

Increased transaminases

5 (3.6%)

8 (5.7%)

Liver function test increased

1 (0.7%)

5 (3.5%)

ARDS

11 (7.9%)

7 (5.0%)

DVT

7 (5.0%)

7 (5.0%)

Pneumonia

7 (5.0%)

7 (5.0%)

Pneumothorax

6 (4.3%)

7 (5.0%)

Pneumomediastinum

2 (1.4%)

6 (4.3%)

Hypoxia

7 (5.0%)

6 (4.3%)

Cardiac arrest

6 (4.3%)

6 (4.3%)

Hyperkalemia

6 (4.3%)

4 (2.8%)

Anemia

9 (6.4%)

3 (2.1%)

Septic Shock

13 (9.3%)

2 (1.4%)

  1. AEs adverse events, ARDS acute respiratory distress syndrome, DVT deep vein thrombosis