Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovas
Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks in Patients Treated With Fingolimod
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
Results by group
Participants Who Experienced at Least One Qualifying Cardiovascular Adverse Event
Within 6 months of qualifying event up to 64 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Fingolimod | 0 participants | 6 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Fingolimod | 6 | 2 (33.3%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Participants Who Experienced at Least One Qualifying Cardiovascular Adverse Event
Within 6 months of qualifying event up to 64 months
Safety
Who could take part
Relapsing MS · 18 to 60
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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
Papers
Loading reviews and guidelines…
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History
Started
Sept 2014
Main results due
Jan 2020
Finished
Jan 2020
Results posted
Feb 2021