Demographic and Baseline Characteristics. Demographic and baseline characteristics will be summarized by lens sequence and overall. Counts and percentages will be presented for categorical variables such as sex, age group, race, and ethnicity. Number of observations, mean, SD, median, minimum, and maximum will be presented for continuous variables such as age.
Demographic and Baseline Characteristics. Demographic information (age, sex, ethnicity, race) will be summarized on the Safety Analysis Set. Baseline data pertaining to habitual lens (lens brand, lens care brand) will be summarized on the Safety Analysis Set as well.
Demographic and Baseline Characteristics. Demographic information (age, sex, ethnicity, race) will be summarized on the Safety Analysis Set.
Demographic and Baseline Characteristics. Demographic information, recent lens-wearing experience (including wear modality and wear success), and habitual lens information will be presented by lens group and overall. Counts and percentages will be presented for categorical variables such as sex, age group, race, an ethnicity. Number of observations, mean, SD, median, minimum, and maximum will be presented for continuous variables such as age.
Demographic and Baseline Characteristics. For all analysis datasets (Safety Analysis Set, AAS and BAS), demographics (sex, age [<60, 60-69, 70-79, ≥80], systemic complication [None/Yes, details] and past ocular surgery [None/Yes, details]) will be summarized with the number and percent of subjects in each category for the variable. Age will also be summarized with descriptive statistics (mean, standard deviation, number of subjects or eyes, median, min and max).
Demographic and Baseline Characteristics. The following details will be recorded at Visit 1: • Demographic information including gender, ethnic origin, date of birth, height, weight • History of COPD including duration of COPD, subject-reported number of exacerbations in the previous 12 months that required oral corticosteroids and/or antibiotics and/or hospitalisations • History of myocardial infarctions • Assessment of dyspnoea using the MRC dyspnoea scale (see Appendix 1) • Measurement of oxygen saturation (PO2%) using oximetry in those investigational sites where this is possible • Smoking history Smoking history should include both the number of cigarettes (or equivalent if subject smoked cigars or a pipe) smoked, and for how long. From this information, the pack years will be calculated using the calculation below. One pack of 20 cigarettes smoked / day for one year = one pack year. One cigar is equivalent to 7 cigarettes and one gram of tobacco is equivalent to one cigarette. Total pack years = No. cigarettes smoked / day 20 x No. years of smoking All subjects randomised to the study will be stratified according to their smoking status i.e., current or ex-smoker. (Ex-smokers are defined as those who have stopped smoking for at least 6 months prior to visit 1. Ex-smokers are eligible to enter the study provided they have at least 10 pack years smoking history). • Current medical conditions and concurrent medication (both COPD and non-COPD). All concurrent medications must be entered in the Concurrent Medications sections of the CRF throughout the study. All medications stopped at entry to the study should be recorded in the CRF. • Use of corticosteroids (inhaled and oral) and/or long-acting β2-agonists during year prior to Visit 1. • Previous participation in study SFCB3024.
Demographic and Baseline Characteristics. Patient demographic and baseline characteristics, including medical history, prior medications, and physical examination and 12-lead ECG findings, will be summarized by treatment group and stratification factors and overall. For continuous variables, the descriptive summary statistics will include number (n), mean, standard deviation (SD), standard error (SE), median, minimum, and maximum. For categorical variables, patient counts and percentages will be provided. Categories for missing data will be presented if necessary.
Demographic and Baseline Characteristics. Demographic and baseline variables will be summarized by cohort, part, and sub-study participation, including race, gender, age, CFTR genotype, height, weight, and spirometry. Continuous variables will be summarized using descriptive summary statistics including: number of subjects (N), mean, standard deviation (SD), median, minimum and maximum. Categorical variables will be summarized using counts and percentages. For categorical demographic characteristics, Xxxxxx’x exact test will be used to compare cohorts (Part A only). Part A, Cohort 3 enrollment will be monitored throughout the study for genotype (F508del homozygous, heterozygous, and other), FEV1 % predicted, and age distribution. Should imbalance occur, sites may be encouraged to recruit under-enrolling strata and enrollment may close for certain genotype-FEV1-age criteria.
Demographic and Baseline Characteristics. Demographic information (age, sex, ethnicity, and race) will be summarized on the safety, full, and PP analysis sets. Baseline characteristics on habitual lens and lens care information as well as activities, CLDEQ-8, , will be summarized on the full and PP analysis sets. Due to the crossover design, demographic and baseline data will be presented by lens care sequence group and overall.
