Please select the outcome measures that correspond to the clinical trial below.
Title: BENEFIT 11 a Long-term Follow-up Study of the BENEFIT (Betaferon/Betaseron in Newly Emerging Multiple Sclerosis for Initial Treatment, 304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to Further Evaluate the Progress of Patients With First Demyelinating Event Suggestive of Multiple Sclerosis
Brief Summary: This study assesses clinical and imaging long-term data, after early or delayed interferon-beta-1b treatment in patients with a first demyelinating event suggestive of multiple sclerosis (MS), 11 years after enrollment in the Betaferon/Betaseron in Newly Emerging Multiple Sclerosis for Initial Treatment (BENEFIT) study (304747). The main objectives are to describe the disease course, change in disability, cognitive function, resource use and employment status, in relation to Interferon beta-1b in the long term.


Options:
A: Total Number of Gadolinium-Enhancing T1 Lesions Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain (Week 12 to Week 24)
B: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Defined by Either a Second Attack or a Sustained Increase (Greater Than or Equal to 1.5 Points) in the Expanded Disability Status Scale (EDSS) Score up to 36 Months (Baseline (Day 1 of Study 27025) up to 36 Months)
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 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)

Answer: D