Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying Therapy

Time to First Relapse

Time to first relapse was defined as the time from the first day of treatment to the first day of a new neurological symptom or worsening of an existing one.

Time frame: first day of treatment to the first day of a new neurological symptom or worsening of an existing one, up to 12 months

Change From Baseline in Expanded Disability Status Scale (EDSS) Score

The EDSS is an ordinal clinical rating scale ranging from a total score of 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments. A negative change from baseline indicates improvement.

Time frame: baseline, 12 months

Change From Baseline in Cerebral Volume

Cerebral volume was assessed by magnetic resonance imaging (MRI). A negative change from baseline indicates improvement.

Time frame: baseline, 12 months

Percentage of Participants With Mild, Moderate or Severe Relapse

The investigator classified a relapse as moderate-severe if oral or intravenous (IV) treatment (according to the local clinical practice) with steroids and/or hospitalization was needed. If neither oral nor IV treatment with steroids nor hospitalization was needed, the relapse was considered as mild.

Time frame: 12 months

Percentage of Relapse-free Participants

Relapse-free participants were defined as participants who experienced no new neurological symptom or worsening of an existing one (relapses) during the 12-month treatment period with 0.5 mg fingolimod.