Table 2.

Incidence of Depression and Depression-related Adverse Events in ELX/TEZ/IVA Postmarketing Reports

Preferred Term	Number of Events	Reporting Rate/100 PY
Any depression AE	1,056	1.3
Suicide attempt	98	0.12
Suicidal ideation	38	0.05
Completed suicide	14	0.02

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

The cumulative exposure (e.g., number of people with CF taking ELX/TEZ/IVA who could report an event) in the postmarketing setting was 61,449 patients (82,053 PY) through October 20, 2022.