TABLE 2

Treatment periods and safety follow-up visits: randomised controlled studies in patients with F508del/MF genotypes: VX17-659-102 and VX17-445-102

Event/assessmentDay 1Day 15Week 4Week 8Week 12Week 16Week 24ETT visit#Safety follow-up
Clinic visit++++++++++
CFQ-R§++++++++
Weight and heightf+++++++++
Spirometry+++++++++
Sweat chloride concentration++++++
Haematology/serum chemistry+++++++++
Pharmacokinetics sampling++++++
Study drug count++++++++
AEs and SAEs##+++++++++

MF: minimal function; 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). +: additional telephone contact at week 20. §: 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. f: 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. ##: AEs and SAEs continuously assessed through completion of study participation.