Phase 4
Completed N=6
Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks
Source: ClinicalTrials.gov NCT02232061 ↗Enrolled (actual)
6
Serious AEs
33.3%
Results posted
Feb 2021
Primary outcomePrimary: Participants Who Experienced at Least One Qualifying Cardiovascular Adverse Event — 0 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study will evaluate if patients who had a serious cardiovascular event upon initiation of fingolimod are at risk to delevop long term other cardiovascular events
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Who Experienced at Least One Qualifying Cardiovascular Adverse Event |
— | — |
Eligibility Criteria
Inclusion Criteria
- Patients participating in study FTY720D2406 who experienced a serious cardiovascular event during their fingolimod treatment initiation or re-initiation which led to overnight monitoring or met seriousness criteria.
- Patients still on fingolimod after the this first dose serious event
Exclusion Criteria
-Treatment with any investigational drug unless it is received as part of a Novartis sponsored MS study lasting less than 1 month
Data sourced from ClinicalTrials.gov (NCT02232061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.