Table 3 Serious adverse events (SAEs) reported according to assigned treatment arm
From: FX06 to rescue SARS-CoV-2-induced acute respiratory distress syndrome: a randomized clinical trial
Serious adverse events | FX06 | Placebo | p-value |
|---|---|---|---|
Patients with at least one, n (%) | 22/25 (88) | 21/24 (88) | 1.0 |
Number | 94 | 72 | 0.36 |
SAE type* | |||
VV-ECMO rescue | 2 | 1 | 0.59 |
Infectious event | 22 | 18 | 0.11 |
Bacteriemia | 4 | 9 | 0.11 |
Ventilator-associated pneumonia, n (%) | 16 (64%) | 6 (24%) | 0.009 |
Septic shock | 2 | 2 | 1.0 |
Ischemic stroke | 1 | 0 | 1.0 |
Hemorrhagic stroke | 0 | 2 | 0.23 |
Cardiac rhythm disorder | 0 | 2 | 0.23 |
Cardiogenic shock | 0 | 1 | 0.49 |
Gastrointestinal ulcer | 1 | 0 | 1.0 |
Liver cytolysis/cholestasis | 1 | 3 | 0.35 |
Acute kidney injury | 4 | 4 | 1.0 |
Anemia | 1 | 0 | 1.0 |
Thrombocytopenia | 0 | 2 | 1.0 |
Bleeding episode | 3 | 2 | 1.0 |
Thrombosis | 0 | 2 | 1.0 |
Cutaneous reaction | 1 | 0 | 1.0 |
Rhabdomyolysis | 0 | 1 | 0.49 |