Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) Versus Avonex® (Interferon β 1a) in Patients With Relapsing-Remitting Multiple Sclerosis
Brief Summary: The primary study objective is to test the superiority of Daclizumab High Yield Process (DAC HYP) compared to interferon β 1a (IFN β-1a) in preventing multiple sclerosis (MS) relapse in participants with relapsing remitting multiple sclerosis.

The secondary study objectives are to test the superiority of DAC HYP compared to IFN β-1a in slowing functional decline and disability progression and maintaining quality of life in this participant population.


Options:
A: Total Number of Gadolinium-Enhancing (GdE) Lesions Assessed on Brain Magnetic Resonance Imaging (MRI) From Week 12 to Week 24 (From Week 12 to Week 24; MRI was performed at Weeks 12, 16, 20, and 24)
B: 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)
C: Adjusted Annualized Relapse Rate (ARR) (Up to 144 weeks)
D: Small effect of an intervention (immediate after completion of study); Moderate effect of an intervention (immediate after completion of study); Large effect of an intervention (immediate after completion of study)

Answer: C