Further analyses of the safety of verubecestat in the phase 3 EPOCH trial of mild-to-moderate Alzheimer’s disease

Table 6 Most severe treatment-emergent suicidal ideation/behavior event summary

Category	12 mg, n/m (%)	40 mg, n/m (%)	Placebo, n/m (%)
With one or more ideation or behavior events	35/651 (5.4)	35/651 (5.4)	21/651 (3.2)
Suicidal ideation	33/651 (5.1)	35/651 (5.4)	21/651 (3.2)
Passive-wish to be dead	18/639 (2.8)	17/642 (2.6)	16/637 (2.5)
Active-non-specific (without regard to method, intent, or plan)	9/645 (1.4)	7/650 (1.1)	1/647 (0.2)
Active-method (without regard to intent or plan)	3/647 (0.5)	5/650 (0.8)	3/649 (0.5)
Active-method and intent (without regard to plan)	2/651 (0.3)	3/651 (0.5)	0/651 (0.0)
Active-method, intent, and plan	1/651 (0.2)	3/651 (0.5)	1/651 (0.2)
Suicidal behavior	3/651 (0.5)	3/651 (0.5)	1/651 (0.2)
Preparatory actions or behaviors	1/651 (0.2)	0/651 (0.0)	0/651 (0.0)
Aborted attempt	0/651 (0.0)	0/651 (0.0)	1/651 (0.2)
Interrupted attempt	0/651 (0.0)	1/651 (0.2)	0/651 (0.0)
Suicide attempt	0/651 (0.0)	2/651 (0.3)	0/651 (0.0)
Completed suicide	2/651 (0.3)	0/651 (0.0)	0/651 (0.0)
Non-suicidal self-injurious behavior	1/651 (0.2)	1/651 (0.2)	0/651 (0.0)

This analysis uses the time frame between the screening and baseline clinic visits as the reference period for determining “treatment-emergent.” For each category, the population (= m) only includes treated participants for whom worsening from the reference period was possible. For suicidal ideation categories, worsening is defined as an increasing progression from one category to another along the spectrum (from passive down to active—method, intent, and plan). For suicidal behavior categories, worsening is defined as an increasing progression from one category to another along the spectrum (from preparatory actions or behaviors down to completed suicide)

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