TABLE 3

Treatment periods and safety follow-up visits: randomised controlled studies in patients with the F508del/F508del genotype: VX17-659-103 and VX17-445-103

Event/assessmentTEZ/IVA run-inDay 1Day 15Week 4ETT visit#Safety follow-up
Day −28Day −14
Clinic visit+++++++
CFQ-R++++++
Weight and height§++++++
Spirometry++++++
Sweat chloride concentration+++++
Haematology/serum chemistry++++++
Pharmacokinetics sampling+++
Study drug count++++
AEs and SAEsf+++++++

TEZ: tezacaftor; IVA: ivacaftor; ETT: early termination of treatment; CFQ-R: Cystic Fibrosis Questionnaire-Revised; AE: adverse event; SAE: serious AE. #: an ETT visit should be scheduled as soon as possible if a patient prematurely discontinues study treatment. : 28±7 days after the last dose of study drug (if applicable). +: the CFQ-R must be completed before any other assessment. In these randomised controlled studies the CFQ-R is followed by the Treatment Satisfaction Questionnaire for Medication (patients aged ≥12 to <18 years at the date of informed consent); remaining assessment may be performed in any order when more than one assessment is required at a particular clinic visit. §: weight and height will be measured with shoes off. Following screening, height will be collected only for subjects ≤21 years of age on the date of informed consent. f: AEs and SAEs continuously assessed through completion of study participation.