Table 2.

Early (from 0 to 1 month) and late (from 2 to 18 months) serious adverse events

Parameter	ORBCEL-M/Placebo	Sex	Event	Relationship with Treatment	Intensity	Outcome
Early SAEs
	Placebo	Male	Bronchospasm	Yes	Moderate	Recovered
Late SAEs
	ORBCEL-M	Male	Acute myocardial infarction	No	Severe	Recovered with sequelae
			Congestive heart failure	No	Severe	Fatal
	ORBCEL-M	Male	COVID-19 test positive	No	Mild	Recovered
	ORBCEL-M	Male	Anemia with increased dyspnea	No	Moderate	Recovered
			Left hip fracture	No	Severe	Unknown
			Respiratory tract infection	No	Moderate	Recovered
			Complicated duodenal diverticulitis	No	Moderate	Unknown
			Respiratory failure	No	Severe	Unknown
			Hyperkalemia	No	Severe	Recovered
			Multiple myeloma	No	Severe	Fatal
	ORBCEL-M	Male	Headache	No	Moderate	Recovered

SAE, serious adverse event; COVID-19, coronavirus disease 2019.