Secondary clinical end-points

End-pointDescriptive details
PExProportion of subjects with protocol-defined PEx# overall and between Day 0 and Day 28
Number of PEx
Proportions of subjects receiving any additional antibiotics
Time to first PEx
Patient-reported outcomesCFQ-R, CFRSD, CRISS
Other clinical end-pointsChange in FEV1 from baseline to end of study
Change in weight and percentile from baseline to end of study
Microbiology end-pointsProportion of subjects who are negative at Day 28 and remain MRSA negative and/or are MRSA negative at 3 months and 6 months
Proportion of MRSA isolates developing resistance to any study medication
Emergence of Pseudomonas aeruginosa infection
Adverse eventsFrequency, by body system and severity
Microbiological adverse eventsEmergence of small-colony variant MRSA

PEx: pulmonary exacerbation; CFQ-R: Cystic Fibrosis Questionnaire Revised quality of life respiratory domain symptom score; CFRSD: Cystic Fibrosis Respiratory Symptom Diary; CRISS: Chronic Respiratory Infection Symptom Score; FEV1: forced expiratory volume in 1 s; MRSA: methicillin-resistant Staphylococcus aureus. #: per modified Fuchs criteria [28]; : differs between STAR-too and STAR-ter.