Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Year Treatment With Teriflunomide 7 mg Once Daily and 14 mg Once Daily Versus Placebo in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis Plus a Long Term Extension Period
Brief Summary: The primary objective was to demonstrate the effect of teriflunomide (HMR1726) (14 milligram per day \[mg/day\] and 7 mg/day), in comparison to placebo, for reducing conversion of participants presenting with their first clinical episode consistent with multiple sclerosis (MS) to clinically definite multiple sclerosis (CDMS).

The secondary objectives were:

* To demonstrate the effect of teriflunomide, in comparison to placebo, on:

  * Reducing conversion to definite multiple sclerosis (DMS)
  * Reducing annualized relapse rate (ARR)
  * Reducing disease activity/progression as measured by Magnetic Resonance Imaging (MRI)
  * Reducing accumulation of disability for at least 12 weeks as measured by the Expanded Disability Status Scale (EDSS)
  * Proportion of disability-free participants as assessed by the EDSS
  * Reducing participant-reported fatigue
* To evaluate the safety and tolerability of teriflunomide
* To evaluate the pharmacokinetics (PK) of teriflunomide
* Optional pharmacogenomic testing aimed at assessing the association between the main enzyme systems of teriflunomide metabolism and hepatic safety, and other potential associations between gene variations and clinical outcomes


Options:
A: Core Treatment Period: Time to Conversion to Clinically Deﬁnite Multiple Sclerosis (CDMS) (Up to a maximum of 108 weeks depending on time of enrollment)
B: Rate of Development of Clinical Definite Multiple Sclerosis (CDMS) Over 10 Years (10 years)
C: 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)
D: Total Number of Gadolinium-Enhancing T1 Lesions Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain (Week 12 to Week 24)

Answer: A