Table 2

Exposure-adjusted incidence rate of patients with AEs in the overall treatment period

	Placebo (n=131)*			Deutetrabenazine												All Patients in OLE (N=343)
	Placebo (n=131)*			12 mg/day (n=74)			24 mg/day (n=73)			36 mg/day (n=74)			ARM-TD (n=58)			All Patients in OLE (N=343)
	EAIR	N	P-Y	EAIR	N	P-Y	EAIR	N	P-Y	EAIR	N	P-Y	EAIR	N	P-Y	EAIR	N	P-Y
Any AE	3.92	70	17.9	3.07	36	11.7	2.85	32	11.2	3.79	38	10.0	6.50	41	6.3	1.68	233	138.4
SAEs	0.33	9	27.6	0.13	2	15.9	0.39	6	15.3	0.26	4	15.2	0.25	3	12.1	0.15	45	308.3
Treatment-related AEs	1.81	40	22.1	0.88	13	14.7	0.77	11	14.3	1.40	18	12.9	3.35	28	8.4	0.55	126	228.0
AEs leading to:
Death	0	0	28.6	0	0	16.0	0.06	1	15.7	0.06	1	15.5	0	0	12.4	0.01	4	331.3
Dose reduction	0.11	3	28.0	0	0	16.0	0.06	1	15.5	0.20	3	15.2	0.51	6	11.7	0.17	48	290.1
Dose suspension	0.25	7	27.9	0.19	3	15.7	0.06	1	15.7	0.07	1	15.3	0.25	3	12.2	0.06	20	318.2
Study withdrawal	0.14	4	28.6	0.25	4	16.0	0.13	2	15.7	0.19	3	15.4	0.08	1	12.4	0.08	26	329.4
Common n ervous s ystem and p sychiatric AEs of i nterest
Headache	0.37	10	27.0	0.32	5	15.8	0.13	2	15.3	0.34	5	14.5	0.25	3	12.1	0.07	23	309.7
Somnolence	0.34	9	26.7	0	0	16.0	0.06	1	15.6	0.20	3	15.0	0.72	8	11.1	0.09	29	309.7
Depression†	0.04	1	28.5	0.06	1	16.0	0.20	3	15.3	0.13	2	15.2	0	0	12.4	0.09	27	314.0
Anxiety	0.21	6	28.0	0.19	3	15.8	0.13	2	15.2	0.20	3	15.2	0.16	2	12.2	0.09	29	311.0
Other c ommon AEs (EAIR ≥ 0.06 in all OLE patients )
Diarrhoea	0.18	5	27.8	0.06	1	15.8	0.20	3	15.2	0.34	5	14.7	0.25	3	12.1	0.06	18	313.9
Nasopharyngitis	0.07	2	28.2	0.26	4	15.5	0.20	3	15.3	0.13	2	15.1	0.16	2	12.1	0.06	18	316.5
Urinary tract infection	0.07	2	28.5	0.13	2	15.5	0.06	1	15.7	0.13	2	15.3	0.08	1	12.3	0.06	18	319.0

*n pooled from the AIM-TD (placebo n=72) and ARM-TD (placebo n=59) studies.
†Includes dysthymic disorder.
AE, adverse event; EAIR, exposure-adjusted incidence rate; n, number of patients; OLE, open-label extension; P-Y, patient-years; SAE, serious adverse event.