Table 3.

Statistical analysis plan.

Parameter	Observation period	Definition	Evaluation
Percentage of patients with immunomodulatory therapy	2010–2012 2013–2015 2016–2017	Immunomodulatory therapy YES for ≥3 months in index year	Number of patients, % patients
Percentage of newly diagnosed patients with first immunomodulatory therapy	2010–2012 2013–2015 2016–2017	First diagnosis of RRMS in index year AND First immunomodulatory therapy within ≤ 6 months in index year	Number of patients, % patients
Time from first symptom to initiation of immunomodulatory therapy	2010–2012 2013–2015 2016–2017	Number of days from date of first symptom diagnosis (first manifestation) to date of initiation of first immunomodulatory therapy	Descriptive evaluation (mean)
Time from therapy initiation to discontinuation	2010–2012 2013–2015 2016–2017	Time from the initiation of therapy until discontinuation in the index period in months	Descriptive evaluation (mean)
Annualized relapse rate under immunomodulatory therapy	2010–2012 2013–2015 2016–2017	Treatment with immunomodulatory therapy ≥3 months at the time of relapse	Descriptive evaluation (mean)
Time to first relapse under immunomodulatory therapy	2010–2012 2013–2015 2016–2017	Treatment with immunomodulatory therapy ≥3 months at the time of relapse Time from initiation of therapy until first relapse in index period in days	Descriptive evaluation (mean)
Time from first symptom to confirmed disability progression according to EDSS-score	2010–2012 2013–2015 2016–2017	Confirmed disability progression: Increase of EDSS score ≥1, 0 points compared to previous EDSS score, confirmed by EDSS measurement with same or worse score within 4–8 months At the time of first assessment of disability progression ≥3 months under treatment with immunomodulatory therapy	Descriptive evaluation (mean)