TABLE 2.

The outcomes of DATE-TCM study.

Primary outcomes

Annualized Aggregate Relapse Rate

Secondary outcomes

Total number of adverse events during evaluation

Percentage of participants with adverse events

Time to 3-month sustained disability progression

Time to 6-month sustained disability progression

Number of new or newly enlarging T2 hyperintense lesions as measured by magnetic resonance imaging (MRI)

Number of gadolinium-enhancing T1-weighted lesions as measured by MRI

Percent change in brain volume as measured by MRI

Change in multiple sclerosis functional composite (MSFC) score

Change in symbol digit modalities Test (SDMT) score

Chance in fatigue severity scale (FSS) score

Change in euroQol- 5 dimension (EQ-5D) score

Change in multiple sclerosis impact scale (MSIS) score