Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects With Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY)
Brief Summary: The purpose of this extension trial was to further evaluate the safety and tolerability of oral cladribine in subjects who have previously completed treatment within Trial 25643 (CLARITY). This trial also explored clinical benefit of prolonged 192-week versus 96-week treatment.


Options:
A: 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)
B: Kaplan-Meier Estimate of the Risk of 3-month Confirmed Disability Progression Based on Composite Endpoint (up to 36 months after the last patient was randomized)
C: Annualized Relapse Rate (ARR) at 1 Year (1 Year)
D: Placebo-Controlled Phase: Time to Confirmed Disease Progression (CDP) Confirmed After At Least 3 Months (Number of Participants With CDP After At Least 3 Months) (Baseline to Month 24)

Answer: A