2.5 Statistical analysis
Regarding safety, the frequencies, and proportions of possibly
treatment-related adverse events (AEs) were calculated. All AEs having
at least a possible relation with the study drug were described (details
see supporting information). Of all AEs reported the frequency and
proportion per severity category, course, outcome, and drug adjustment
in response to the AE were calculated.
To test whether the occurrence of any AE changed over time, the
occurrence of any AE at 1 week, 3 months and 1 year was compared to the
occurrence shortly after the first administration using multilevel
modelling to account for the repeated observations within patients.
Treatment compliance was estimated and categorized by treating
physician: 100-80% (compliant), between 50% and 80%, or less than
50% and described per visit (n (%)).
Treatment satisfaction experienced by patients and observed by
physicians (very satisfied, satisfied, unsatisfied, very unsatisfied)
and treatment tolerability (very good, good, moderate, poor) were
described as proportions.