Table 3.

Treatment-emergent adverse events by preferred term (Safety analysis set)

Variable	Invimestrocel group (N = 20)	Standard treatment group (N = 10)
≥ 1 TEAE	20 (100)	10 (100)
≥ 1 serious TEAE	10 (50)	4 (40)
≥ 1 TEAE leading to death	3 (15)	1 (10)
≥ 1 TEAE possibly related to invimestrocel	5 (25)	0
≥ 1 serious TEAE possibly related to invimestrocel	1 (5)	0
TEAEs occurring in ≥ 2 patients in the invimestrocel groups
Insomnia	9 (45)	5 (50)
Diarrhea	7 (35)	1 (10)
Constipation	6 (30)	3 (30)
Pyrexia	6 (30)	0
Anemia	5 (25)	0
Decubitus ulcer	4 (20)	2 (20)
Hepatic function abnormal	4 (20)	1 (10)
Pneumonia	3 (15)	1 (10)
Atrial fibrillation	3 (15)	1 (10)
Acute kidney injury	3 (15)	1 (10)
Acute respiratory distress syndrome	2 (10)	1 (10)
Hypernatremia	2 (10)	2 (20)
Atelectasis	2 (10)	0
Cough	2 (10)	1 (10)
Pneumothorax	2 (10)	0
Skin exfoliation	2 (10)	0
Drug eruption	1 (5)	1 (10)
Arthralgia	2 (10)	0
Chills	2 (10)	0
ALT increased	2 (10)	0
AST increased	2 (10)	0

Data are n (%)

ALT alanine transaminase, AST aspartate transaminase, TEAE treatment-emergent adverse event