Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis
Brief Summary: The primary objective of this study is to determine the efficacy of peginterferon beta-1a in reducing the annualized relapse rate (ARR) in participants with relapsing multiple sclerosis (RMS) at 1 year. The secondary objectives of this study are to determine whether peginterferon beta-1a, at 1 year when compared with placebo, is effective in reducing the total number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans, reducing the proportion of participants who relapse, and slowing the progression of disability.


Options:
A: The primary objectives of this study are to determine whether natalizumab, when compared with placebo, is effective in reducing the rate of clinical relapses at 1 year and, in slowing the progression of disability at 2 years. (1 year and 2 years)
B: Annualized Relapse Rate (ARR) at 1 Year (1 Year)
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: Adjusted Annualized Relapse Rate (ARR) (Up to 144 weeks)

Answer: B