. 2023 Oct 27;209(3):299–306. doi: 10.1164/rccm.202308-1525OC

Table 1.

Incidence of Depression and Depression-related Adverse Events in ELX/TEZ/IVA Pivotal Phase 3 Trial (Study 445-102) and Pooled Clinical Trial Data

Event	Pivotal Study 445-102		Pooled Data
Event	Placebo (n = 201), 100 PY Events/100 PY	ELX/TEZ/IVA (n = 202), 100 PY Events/100 PY	Placebo^* (n = 1,369), 709 PY Events/100 PY	ELX/TEZ/IVA^† (n = 1,711), 3,857 PY Events/100 PY
Any depression AE	5.0	2.0	3.24	3.32
Suicide attempt	0	0	0.14	0.08
Suicidal ideation	1.00	0	0.28	0.23
Completed suicide	0	0	0	0

Definition of abbreviations: AE = adverse event; ELX/TEZ/IVA = elexacaftor/tezacaftor/ivacaftor; PY = person years.

*The placebo column includes data from 10 studies in the VX-445, VX-659, VX-809, VX-661, and VX-770 programs in participants 6 yr and older (see online supplement for the list of included trials).

^{^†}

The ELX/TEZ/IVA column contains data from 14 completed studies in participants 6 yr and older (see online supplement for the list of included trials).