Table 3.

Adverse Events.

	Tezacaftor/Ivacaftor (n=52)	Elexacaftor/Tezacaftor/ Ivacaftor (n=55)
	number of participants (percent)
Any adverse event	33 (63)	32 (58)
Adverse event related to trial drug†	9 (17)	12 (22)
Adverse event, according to maximum severity
Mild	21 (40)	23 (42)
Moderate	11 (21)	9 (16)
Severe	1 (2)	0
Life Threatening	0	0
Grade 3 or 4 adverse event	1 (2)	0
Serious adverse event	1 (2)	2 (4)
Serious adverse event related to trial drug†	0	1 (2)
Adverse event leading to discontinuation of trial drug	0	0
Adverse event leading to death	0	0
Most common adverse events‡
Cough	4 (8)	8 (15)
Nasopharyngitis	2 (4)	4 (7)
Oropharyngeal pain	0	4 (7)
Upper respiratory tract infection	2 (4)	4 (7)
Headache	4 (8)	3 (5)
Haemoptysis	5 (10)	2 (4)
Pulmonary exacerbation§	6 (12)	1 (2)

Adverse events were coded using MedDRA version 21·1. When summarizing number and percent of participants, a participant with multiple events within a category was counted only once in that category.

^†The determination of relatedness to trial drug was made by the investigators. When summarizing number of participants with (serious) adverse events related to the trial drug, adverse events with relationship of related, possibly related, and missing were counted.

^‡The most common adverse events were those that occurred in at least four participants in either trial group.

^§Per MedDRA 21·1, this adverse event is coded as infective pulmonary exacerbation of cystic fibrosis.