The purpose of the study is to describe the safety profile of fingolimod in the Taiwanese multiple sclerosis population. This study aims to collect the safety data in patients newly initiated on fingolimod for one year.
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Patients with the diagnosis of neuromyelitis optica.
Patients who are being treated with any investigational drug at the time of study entry.
In the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization or Class III/IV heart failure
A history or presence of Mobitz Type II second-degree or third-degree atrioventricular block or sick sinus syndrome, unless patient has a functioning pacemaker
Single group
Fingolimod
DrugFingolimod 0.5 mg QD, oral
Number of Adverse Events of Special Interest(AESI)
The adverse events of special interest (AESI) include bradycardia and Grade 2 or higher AV block during First Dose Observation.
Number of Adverse Events of Special Interest (AESI)
The adverse events of special interest (AESI) include macular edema, abnormal liver function(ALT, AST or GGT \> 5x upper normal limit), and severe lymphocytopenia(lymphocyte \< 200 cells/μL).
Annualized relapse reate (ARR)
The ARR will be calculated as total number of relapses experienced divided by total number of days of follow-up, and the ratio multiplied by 365. For patients withdraw from the study or switch to an alternative MS therapy prior to 12 month, the total number of days in study is defined as the number of days from baseline to the last date in study.
Change from baseline of Pulse (beats/min)
Pulse (beats/min - bpm) data will be summarized as descriptive statistics for change from baseline value (both for the period 6-hours post first dose and for further visit assessments). The frequency and percentage of notable vital sign abnormalities will be summarized. Notable criteria for pulse is \> 120bpm or Increase of ≥15 bpm from baseline Or \< 50bpm or Decrease of ≥15 bpm from baseline
Change from baseline of blood pressure (mmHg)
Blood pressure(BP)(mmHg) data will be summarized as descriptive statistics for change from baseline value (both for the period 6-hours post first dose and for further visit assessments). The frequency and percentage of notable vital sign abnormalities will be summarized. Notable criteria for systolic BP is ≥160 mm Hg or Increase of ≥20 mm Hg from baseline Or ≤ 90 mm Hg or Decrease of ≥ 20 mm Hg from baseline. Notable criteria for diastolic BP is ≥ 100 mmHg or Increase of ≥ 15 mm Hg from baseline Or ≤ 50 mmHg or Decrease of ≥ 15 mm Hg from baseline.
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