Table 5.

Summary of the most frequent treatment-emergent adverse events (TEAEs) [≥ 5%] by system organ class

TEAEs	TRZ30 (n = 43)	TRZ60 (n = 51)	PLB (n = 48)
Ear and labyrinth disorders, n (%)
Vertigo	2 (3.8)	2 (5.7)	0 (0)
Gastrointestinal disorders, n (%)
Nausea	3 (5.7)	0 (0)	3 (6.7)
General disorders, n (%)
Fatigue	1 (1.9)	2 (5.7)	0 (0)
Peripheral swelling	2 (3.8)	2 (5.7)	3 (6.7)
Investigations, n (%)
Electrocardiogram QT prolonged	4 (7.5)	5 (14.3)	8 (17.8)
Metabolism and nutrition disorders, n (%)
Hypoglycemia	1 (1.9)	0 (0)	3 (6.7)
Musculoskeletal and connective tissue disorders, n (%)
Back pain	3 (5.7)	2 (5.7)	1 (2.2)
Nervous system disorders, n (%)
Disturbance in attention	0 (0)	4 (11.4)	0 (0)
Dizziness	2 (3.8)	1 (2.9)	5 (11.1)
Somnolence	4 (7.5)	2 (5.7)	2 (4.4)

All investigational groups also received gabapentin as background therapy

PLB placebo, TRZ trazodone