LTFU
6 evidence topics · 2 sources
Objective
No evidence found.
Location and study date
Reported follow-up analysis: data cutoff
Study design
Subsequent long-term follow-up study
Eligibility criteria
No evidence found.
Treatment
Previous treatment before entry into long-term follow-up
Study outcomes
Rationale for using long-term safety as the primary endpoint
Not applicable.
Statistical analysis description
Number of participants (Planned and analyzed)
Reported 50-mg long-term follow-up subgroup
Description of analysis sets
No evidence found.
Results
Participant disposition
No evidence found.
Baseline characteristics
No evidence found.
Efficacy results
Health-related quality of life and patient-reported outcomes
No evidence found.
Safety results
Safety in the 17-participant long-term follow-up subgroup
Study limitations
Summary
The separately identified long-term follow-up safety subgroup included 17 participants previously treated with 50 mg. The presentation reported no serious adverse events or treatment-related adverse events in that subgroup. The attack-free results in the same presentation combine parent-study and long-term follow-up observations and should not be interpreted as an independent 17-participant efficacy analysis. The subgroup size does not exclude uncommon delayed adverse effects.