Table 3.

Rate of TEAEs (%) reported by ≥5% of patients in any treatment group in the six regulatory RCTs of brivaracetam

Side effect	Brivaracetam 20 mg		Brivaracetam 50 mg		Brivaracetam 100 mg		Brivaracetam 150 mg		Brivaracetam 200 mg		Overall incidence rate
	RR	p	RR	p	RR	p	RR	p	RR	p
At least one TEAE	1.06 (0.86–1.30)	0.59	1.07 (0.91–1.25)	0.42	1.16 (1.04–1.30)	0.818	0.95 (0.73–1.22)	0.67	1.13 (0.99–1.29)	0.08	NA
Headache	0.82 (0.48–1.40)	0.46	1.28 (0.82–1.99)	0.27	0.86 (0.52–1.41)	0.545	1.00 (0.26–3.79)	1.00	0.95 (0.53–1.70)	0.86	10.4%
Dizziness	1.11 (0.60–2.06)	0.74	1.44 (0.83–2.48)	0.19	1.77 (1.01–3.09)	0.047	1.67 (0.42–6.62)	0.46	2.89 (1.57–5.32)	0.001	9.6%
Somnolence	1.47 (0.81–2.66)	0.20	1.54 (0.90–2.64)	0.12	2.25 (1.45–3.49)	<0.001	1.00 (0.21–4.73)	1.00	2.19 (1.33–3.63)	0.002	12.4%
Fatigue	3.00 (1.21–7.47)	0.02	2.38 (1.16–4.89)	0.02	2.31 (1.19–4.48)	0.014	0.75 (0.18–3.19)	0.69	3.03 (1.51–6.08)	0.002	7.7%
Nasopharyngitis	5.99 (1.36–26.35)	0.02	2.16 (0.77–6.08)	0.15	2.00 (0.18–21.7)	0.569	1.33 (0.31–5.67)	0.69	NA	NA	4.2%
Nausea	0.99 (0.36–2.69)	0.98	0.83 (0.38–1.82)	0.64	1.50 (0.44–5.16)	0.520	0.67 (0.20–2.23)	0.51	NA	NA	4.9%
Insomnia	1.47 (0.25–8.61)	0.67	2.59 (0.70–9.60)	0.15	NA	NA	3.00 (0.32–27.91	0.33	NA	NA	2.5%
Irritability	1.96 (0.37–10.46)	0.43	2.95 (1.03–8.44)	0.04	6.48 (1.17–35.9)	0.033	0.50 (0.05–5.35)	0.56	7.31 (0.91–58.97)	0.062	2.8%

Notes: Data from Lattanzi et al.²³ The p-values are bold where they are significant.

Abbreviations: RR, Mantel-Haenszel risk ratios; TEAEs, treatment-emergent adverse events; NA, not applicable.