Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2/3, Multi-center, Randomized, Double-blind, Placebo-controlled (Part A) and Double-blind, Double-dummy, Active-controlled (Part B), Parallel Group Study to Evaluate the Efficacy and Safety of RPC1063 Administered Orally to Relapsing Multiple Sclerosis Patients
Brief Summary: This study is a two-part trial consisting of Part A (see NCT01628393) and Part B, presented within this record.

The primary objective of Part B is to assess whether the clinical efficacy of ozanimod (RPC1063) is superior to interferon beta-1a (IFN β-1a; Avonex®) in reducing the rate of clinical relapses at the end of Month 24 in patients with relapsing multiple sclerosis (RMS).


Options:
A: Adjusted Annualized Relapse Rate (ARR) at the End of Month 24 (At the end of month 24)
B: Proportion of Subjects Relapsed (2 years)
C: Safety Population: Percentage of Participants With at Least 1 Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 4 Hematologic and Hepatic Toxicity (Baseline up to Week 120); Safety Population: Mean Change From Baseline in Absolute Lymphocyte Count, Platelet, Neutrophils and Leukocytes at Week 120 (Baseline, Week 120); Safety Population: Mean Change From Baseline in Hemoglobin at Week 120 (Baseline, Week 120); Safety Population: Mean Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase at Week 120 (Baseline, Week 120); Safety Population: Mean Change From Baseline in Bilirubin at Week 120 (Baseline, Week 120); Safety Population: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs (Baseline up to Week 120); SAFUP Analysis Set: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs (Baseline up to Week 120); Safety Population: Number of Participants Who Developed Infections (Herpes Viral Infection, Viral Infectious Disorder and Opportunistic Infection), Infection-related Adverse Events and Malignancies (Baseline up to Week 120); SAFUP Analysis Set: Number of Participants Who Developed Infections (Herpes Viral Infection, Viral Infectious Disorder and Opportunistic Infection), Infection-related Adverse Events and Malignancies (Baseline up to Week 120); Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity (Baseline up to Week 120); Safety Population: Median Time to Recovery From Grade 3 or 4 Hematological and Hepatic Toxicity (Baseline up to Week 120); Safety Population: Mean Time to Recovery From Grade 3 or 4 Hematological and Liver Toxicity (Baseline up to Week 120); Safety Population: Median Time to Nadir of Absolute Lymphocyte Count (Baseline up to Week 120); Safety Population: Mean Time to Nadir of Absolute Lymphocyte Count (Baseline up to Week 120); Safety Population: Mean Time to Recovery From Nadir of Absolute Lymphocyte Count to Normal Value (Baseline up to Week 120); Safety Population: Mean Change in Corrected QT (QTc) Interval From Baseline (Baseline, Week 5, 48, 52 and 96)
D: Primary objectives of this study are to determine if natalizumab is effective in reducing the rate of clinical relapse at 1 year and in slowing the progression of disability at 2 years as measured by EDSS. (1 year and 2 years)

Answer: A