Long-term safety and tolerability of atabecestat (JNJ-54861911), an oral BACE1 inhibitor, in early Alzheimer’s disease spectrum patients: a randomized, double-blind, placebo-controlled study and a two-period extension study

Table 4 Summary of the overall treatment-mergent adverse events by the treatment group for parent study ALZ2002 and extension study ALZ2004 (safety analysis set)

Safety analysis set	Treatment group at start ALZ2002				Treatment group in ALZ2004
	Double-blind parent				Double-blind period^†				Open-label period^‡
	Placebo	10 mg	50 mg	Total	Placebo	10 mg	25 mg	Total	Atabecestat
	Placebo	10 mg	50 mg	Total	Placebo	10 mg	25 mg	Total	PBO→5 mg	PBO→25 mg	10 mg → 5 mg	25 mg	Total
N	39	37	38	114	35	29	26	90	15	14	26	22	77
Total patients with TEAEs,n(%)	27 (69.2)	23 (62.6)	31 (81.6)	81 (71.1)	22 (62.9)	15 (51.7)	21 (80.8)	58 (64.4)	10 (66.7)	11 (78.6)	19 (73.1)	16 (72.7)	56 (72.7)
Serious TEAEs,n(%)	4 (10.3)	2 (5.4)	8 (21.1)	14 (12.3)	3 (8.6)	4 (13.8)	4 (15.4)	11 (12.2)	2 (13.3)	4 (28.6)	0 (0)	1 (4.5)	7 (9.1)
TEAEs leading to death,n(%)	0 (0)	1 (2.7)	0 (0)	1 (0.9)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
Any AE leading to discontinuation or withdrawal (%)	1 (2.6)	2 (5.4)	5 (13.2)	8 (7.0)	0 (0)	2 (6.9)	1 (3.8)	3 (3.3)	2 (13.3)	2 (14.3)	0 (0)	0 (0)	4 (5.2)

TEAE treatment-emergent adverse events, coded using MedDRA version 21.0
^†Adverse events (AEs) with onset on or after the first dose of study drug in ALZ2004 through the last dose in period 1 are included. For a participant who withdrew during period 1, adverse events through the day of the last dose plus 7 days are included
^‡AEs with onset on or after the first dose of study drug in period 2 of ALZ2004 through the day of the last dose in period 2 plus 7 days are included

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