Please select the outcome measures that correspond to the clinical trial below.
Title: Open-label, Multi-center Phase III Extension of the Double-blind, Placebo-controlled BENEFIT Study (no. 92012/304747) to Obtain Long-term Follow-up Data of Patients With Clinically Definite Multiple Sclerosis (MS) and Patients With a First Demyelinating Event Suggestive of MS Treated With 8 MIU (250 µg) Interferon Beta-1b (Betaferon® / Betaseron®) Given Subcutaneously Every Other Day for at Least 36 Months.
Brief Summary: This study will primarily compare the long-term effects of an early and continued treatment with Betaferon/Betaseron (patients who were treated with active medication during the double-blind BENEFIT study) to treatment initiated either after Clinically Definite Multiple Sclerosis (CDMS) has been diagnosed or after two years (those patients who were treated with placebo during the double-blind BENEFIT study).

Analyses are based on the integrated data of the initial BENEFIT study and this follow-up study.


Options:
A: Rate of Development of Clinical Definite Multiple Sclerosis (CDMS) Over 10 Years (10 years)
B: Time to First Relapse by Kaplan-Meier Estimates (Up to Year 11 (Day 3960)); Time to Clinically Definite Multiple Sclerosis (CDMS) Represented by Kaplan-Meier Estimates (Up to Year 11 (Day 3960)); Number of Subjects With Diagnosis of Multiple Sclerosis Within Eleven years after Clinically-Isolated Syndrome (CIS) According to McDonald 2001 and 2010 Criteria (Year 11); Disease Course as Assessed at the Time of BENEFIT 11 (Year 11); Percentage of Subjects Converting to Secondary Progressive Multiple Sclerosis (SPMS) (Year 11); Time to Secondary Progressive Multiple Sclerosis (SPMS) Represented by Kaplan-Meier Estimates (Up to Year 11 (Day 3960)); Expanded Disability Status Scale (EDSS) at Year 11 (Year 11); Number of Subjects With Confirmed and Sustained 1-point Expanded Disability Status Scale (EDSS) Progression at Year 11 (Year 11); Number of Subjects With Confirmed 2.5-point Expanded Disability Status Scale (EDSS) Progression at Year 11 (Year 11); Percentage of Subjects who Ever Reached a Disability Status Scale (DSS) 3 and 6 (Year 11); Disability Based Efficacy Domain: Time to Disability Status Scale (DSS) 3 by Kaplan-Meier Estimates (Up to Year 11 (Day 3960)); Disability Based Efficacy Domain: Time to Disability Status Scale (DSS) 6 by Kaplan-Meier Estimates (Up to Year 11 (Day 3960)); Multiple Sclerosis Functional Composite (MSFC) at Year 11 (Year 11); Multiple Sclerosis Severity Score (MSSS) at Year 11 (Year 11); Cognitive Function: Paced Auditory Serial Addition Test-3 (PASAT-3) at Year 11 (Year 11); Cognitive function: Symbol Digit Modalities Test (SDMT) (Year 11); Relapse-Based Efficacy domain: Hazard Ratio for Recurrent Relapses (Year 11); Relapse Based Efficacy Domain: Annualized Relapse Rate (Year 11); Time to use of Ambulatory Device Represented by Kaplan-Meier Estimates (Up to Year 11 (Day 3960)); Time to Dependence of Ambulatory Device for Walking Represented by Kaplan-Meier Estimates (Up to Year 11 (Day 3960)); Number of Subjects With Wheelchair Use After 11 years (Year 11)
C: ITP: Time to Clinically Definite Multiple Sclerosis (CDMS) Conversion Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS (ITP: Baseline up to Week 96)
D: Time to Clinically Definite Multiple Sclerosis (CDMS) Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS at Selected Points in Time (up to 60 months after start of treatment); Time to Confirmed Expanded Disability Status Scale (EDSS) Progression Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With Confirmed EDSS Progression at Selected Points in Time (up to 60 months after start of treatment); Functional Assessment of Multiple Sclerosis (FAMS) Trial Outcome Index (TOI) at Month 60 (60 months after start of treatment)

Answer: D