Table 3.

Adverse Events and Serious Adverse Events.^*

Event	Robot-Assisted Therapy (N = 49)	Intensive Comparison Therapy (N = 50)	Usual Care (N = 28)
Adverse event
Event related to study therapy— no. of patients (%)	12 (24)	9(18)	0
Type of event— no. of events
Any	34	12	0
Pain, stiffness, or soreness	23	7	0
Fatigue	6	0	0
Swelling or bruising	1	3	0
Cut, scratch, or irritation	2	2	0
Numbness	2	0	0
Serious adverse event†
Patients with event— no. (%)
Any	11 (22)	18 (36)	9(32)
Death	0	2(4)	1(4)
Hospitalization	19 (39)	20 (40)	15 (54)
Other event reported by investigator	0	4(8)	0
Event related to study therapy — no. of events	0	0	0
Event unrelated to study therapy — no. of events
Any	19	26	16
Cardiac disorder	1	3	3
Gastrointestinal disorder	0	3	0
General disorder	1	2	1
Hepatobiliary disorder	4	0	0
Infection or infestation	5	2	1
Injury, poisoning, or procedural complication	3	4	1
Neoplasm	0	2	0
Nervous system disorder	3	2	1
Psychiatric disorder	0	1	1
Renal or urinary disorder	1	0	2
Respiratory, thoracic, or mediastinal disorder	0	1	1
Social circumstance‡	1	2	2
Surgical or medical procedure	0	2	2
Vascular disorder	0	2	1

^*The principal investigator at each clinical site determined whether an adverse event or serious adverse event was related to a study therapy.

^†Serious adverse events are listed according to the organ-classification system used in the Medical Dictionary for Regulatory Activities.

^‡Social circumstance includes any social, lifestyle, or housing issues.