TABLE 3.

Primary endpoint: Safety

Adverse event	Adverse events
	UC‐MSC treatment (n = 12), n (%)	Control (n = 12), n (%)
1a. An increase in vasopressor dose	1 a	1
1b. In patients receiving mechanical ventilation: worsening hypoxemia	0	0
1c. In patients receiving high flow oxygen therapy: worsening hypoxemia, as indicated by requirement of intubation and mechanical ventilation	0	0
1d. New cardiac arrhythmia requiring cardioversion	0	1
1e. New ventricular tachycardia, ventricular fibrillation, or asystole	0	1
1f. A clinical scenario consistent with transfusion incompatibility or transfusion‐related infection	0	0
2. Cardiac arrest or death within 24 h postinfusion	0	0

Note: Safety: as defined by the occurrence of prespecified infusion‐associated adverse events within 6 hours (1a‐1f) and occurrence of cardiac arrest or death within 24 hours postinfusion (2).

^a The vasopressor dose increase was ordered by the primary treating physician before the infusion started, but it was not given until hours later, after the infusion.