Table 4.

Overview of treatment‐emergent adverse events and serious adverse events

	Usual care/NB + CLI (N = 89)	NB + CLI (N = 153)
Subjects with a TEAE leading to discontinuation from full participation, n (%)
Before week 26	1 (1.1)	35 (22.9)
On or after week 26 and before week 52	12 (13.5)	0 (0.0)
On or after week 52	0 (0.0)	0 (0.0)
Entire study	14 (15.7)	37 (24.2)
Subjects with a SAE, n (%)
Before week 26	0 (0.0)	1 (0.7)
On or after week 26 and before week 52	0 (0.0)	1 (0.7)
On or after week 52	0 (0.0)	0 (0.0)
Entire study	0 (0.0)	2 (1.3)

CLI, comprehensive lifestyle intervention; NB, naltrexone/bupropion; SAE, serious adverse event; TEAE, treatment‐emergent adverse event.