Table 4.

Device- and medication-associated treatment-emergent AEs

n (%)	BPI disorder (n=22)	MDD (n=12)	Schizophrenia (n=15)	Total (n=49)
Any device-associated AEa	9 (40.9)	8 (66.7)	0	17 (34.7)
Hyperesthesia	1 (4.5)	0	0	1 (2)
Skin and subcutaneous tissue disorders
Rash	5 (22.7)	6 (50)	0	11 (22.4)
Erythema	2 (9.1)	0	0	2 (4.1)
Pruritus	1 (4.5)	1 (8.3)	0	2 (4.1)
Skin irritation	0	1 (8.3)	0	1 (2)
Any medication-associated AEb	2 (9.1)	5 (41.7)	1 (6.7)	8 (16.3)
Nausea	1 (4.5)	0	0	1 (2)
Peripheral swelling	0	0	1 (6.7)	1 (2)
Sinusitis	0	1 (8.3)	0	2 (4.1)
Upper respiratory tract infection	1 (4.5)	1 (8.3)	0	2 (4.1)
Meniscus injury	0	1 (8.3)	0	1 (2)
Sunburn	0	1 (8.3)	0	1 (2)
Pain in extremity	0	0	1 (6.7)	1 (2)
Headache	1 (4.5)	1 (8.3)	0	2 (4.1)
Syncope	0	1 (8.3)	0	1 (2)

Notes:

^aEvents associated with any part of the Digital Medicine System, except aripiprazole;

^bevents reported as “general” AEs (ie, not device-associated AEs).

Abbreviations: AEs, adverse events; BP, bipolar; MDD, major depressive disorder.