Table 3.

Participants Experiencing Serious Adverse Events by Treatment Group

System Organ Classification∗	Pre-Assign	Post-Assign (n = 37)	Allo-MSC (n = 20)	Placebo (n = 17)
Cardiac disorders	0	8 (21.6)	4 (20.0)	4 (23.5)
Gastrointestinal disorders	0	1 (2.7)	0 (0.0)	1 (5.8)
General disorders and administration site conditions	0	1 (2.7)	1 (5.0)	0 (0.0)
Hepatobiliary disorders	0	1 (2.7)	0 (0.0)	1 (5.8)
Infections and infestations	1	2 (5.4)	0 (0.0)	2 (11.7)
Injury, poisoning, and procedural complications	1	2 (5.4)	1 (5.0)	1 (5.8)
Metabolism and nutrition disorders	0	2 (5.4)	1 (5.0)	1 (5.8)
Musculoskeletal and connective tissue disorders	1	1 (2.7)	1 (5.0)	0 (0.0)
Neoplasms benign, malignant, and unspecified (including cysts and polyps)	1	0 (0.0)	0 (0.0)	0 (0.0)
Nervous system disorders	0	2 (5.4)	1 (5.0)	1 (5.8)
Product issues	0	1 (2.7)	0 (0.0)	1 (5.8)
Renal and urinary disorders	0	2 (5.4)	1 (5.0)	1 (5.8)
Reproductive system and breast disorders	0	1 (2.7)	0 (0.0)	1 (5.8)
Vascular disorders	0	2 (5.4)	1 (5.0)	1 (5.8)

Values are n (%).

Abbreviations as in Table 2.

^∗System Organ Classification by MedDRA version 19.1.