Table 4.

Adverse Events.^*

Adverse Event	Elexacaftor–Tezacaftor–Ivacaftor (N = 132)	Active Control: Ivacaftor or Tezacaftor–Ivacaftor (N = 126)
	number of patients (percent)
Any adverse event	88 (66.7)	83 (65.9)
Adverse event according to maximum severity
Mild	58 (43.9)	50 (39.7)
Moderate	25 (18.9)	29 (23.0)
Severe	5 (3.8)	4 (3.2)
Life-threatening	0	0
Serious adverse event	5 (3.8)	11 (8.7)
Infective pulmonary exacerbation of cystic fibrosis†	2 (1.5)	7 (5.6)
Adverse event leading to treatment discontinuation	1 (0.8)	2 (1.6)
Adverse event leading to death	0	0
Most common adverse events‡
Headache	11 (8.3)	19 (15.1)
Alanine aminotransferase increased	8 (6.1)	0
Aspartate aminotransferase increased	8 (6.1)	0
Abdominal pain	7 (5.3)	2 (1.6)
Sputum increased	6 (4.5)	8 (6.3)
Diarrhea	5 (3.8)	8 (6.3)
Cough	3 (2.3)	18 (14.3)
Infective pulmonary exacerbation of cystic fibrosis	3 (2.3)	13 (10.3)
Nausea	2 (1.5)	9 (7.1)
Any adverse event involving rash§	4 (3.0)	5 (4.0)
Any adverse event involving elevated aminotransferase level¶	8 (6.1)	1 (0.8)‖

^*A patient with multiple events within a category was counted only once in that category.

^†Infective pulmonary exacerbation of cystic fibrosis was the only serious adverse event that occurred in two or more patients in either treatment group.

^‡Shown are adverse events that occurred in at least 5% of the patients in either group. Adverse events are listed according to the preferred term in the Medical Dictionary for Regulatory Activities (MedDRA), version 23.0.

^§Adverse events involving rash included the MedDRA terms rash, rash erythematous, rash maculopapular, rash papular, skin exfoliation, and urticaria.

^¶Shown are adverse events that included the MedDRA terms alanine aminotransferase increased, aspartate aminotransferase increased, and liver function test increased.

^‖This adverse event was reported as the MedDRA term liver function test increased.