Table 2.

Treatment-Emergent Adverse Events (Safety Population)

System Organ Class Preferred Term, n (%)	2.5×106 Cells, n=6	5.0×106 Cells, n=6	10×106 Cells, n=6	Pooled Cells, N=18
Any TEAE*	6 (100.0)	6 (100.0)	6 (100.0)	18 (100.0)
Headache/procedural headache†	6 (100.0)	4 (66.7)	4 (66.7)	14 (77.8)
Nausea	0 (0.0)	3 (50.0)	3 (50.0)	6 (33.3)
Vomiting	0 (0.0)	2 (33.3)	2 (33.3)	4 (22.2)
Depression	0 (0.0)	2 (33.3)	2 (33.3)	4 (22.2)
Muscle spasticity	2 (33.3)	1 (16.7)	1 (16.7)	4 (22.2)
Fatigue	0 (0.0)	1 (16.7)	2 (33.3)	3 (16.7)
Blood glucose increased	2 (33.3)	1 (16.7)	0 (0.0)	3 (16.7)
C-reactive protein increased	1 (16.7)	1 (16.7)	1 (16.7)	3 (16.7)
Convulsion	1 (16.7)	1 (16.7)	0 (0.0)	2 (11.1)
Dizziness	1 (16.7)	1 (16.7)	0 (0.0)	2 (11.1)
Pneumocephalus	0 (0.0)	2 (33.3)	0 (0.0)	2 (11.1)
Subdural hematoma	0 (0.0)	2 (33.3)	0 (0.0)	2 (11.1)
Constipation	0 (0.0)	1 (16.7)	1 (16.7)	2 (11.1)
Diarrhea	0 (0.0)	1 (16.7)	1 (16.7)	2 (11.1)
Arthralgia	2 (33.3)	0 (0.0)	0 (0.0)	2 (11.1)
Musculoskeletal pain	1 (16.7)	1 (16.7)	0 (0.0)	2 (11.1)
Pain in extremity	1 (16.7)	1 (16.7)	0 (0.0)	2 (11.1)
Pneumonia	0 (0.0)	0 (0.0)	2 (33.3)	2 (11.1)
Urinary tract infection	1 (16.7)	0 (0.0)	1 (16.7)	2 (11.1)
Decreased appetite	0 (0.0)	2 (33.3)	0 (0.0)	2 (11.1)

TEAE indicates treatment-emergent adverse event.

^*A TEAE is defined as any event not present before the initiation of treatment or any event already present that worsened in either intensity or frequency after exposure to study treatment.

^†Headache/procedural headache: because of reporting verbatim differences, headaches were coded into 2 terms.