TABLE 5

Treatment periods and safety follow-up visits: open-label extension studies: VX17-659-105 and VX17-445-105

Event/assessmentDay 1Day 15Weeks 4, 8, 16, 24, 36Week 48Weeks 60, 72, 84Week 96ETT visit#Safety follow-up
Clinic visit+++++++++
CFQ-R+Weeks 4, 8, 24+Week 72+++
Weight and height§,f+++++++
Spirometry++++++++
Sweat chloride concentration++Weeks 4, 8, 16, 24+
Haematology/serum chemistry++++++++
Pharmacokinetics samplingWeek 4
Study drug count+++++++
AEs and SAEs##++++++++

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 weeks 12, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88 and 92. §: on day 15, weight and height measurements will be taken in study VX17-445-105, but not in study VX17-659-105. f: weight and height will be measured with shoes off. Height will be collected only for subjects ≤21 years of age on the date of informed consent. For subjects >21 years of age, the height value obtained from the screening visit in the parent study will be used for the body mass index calculations. ##: AEs and SAEs continuously assessed through completion of study participation.