Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Compare Cessation Versus Continuation of Long-term Mepolizumab Treatment in Patients With Severe Eosinophilic Asthma (201810)
Brief Summary: Primary objective of the study is to evaluate whether patients with severe eosinophilic asthma who have received long-term treatment with mepolizumab (at least 3 years) need to maintain treatment with mepolizumab to continue to receive benefit. Subjects who participated in the open-label studies MEA115666 or 201312 with at least 6 months of treatment with mepolizumab prior to Visit 1 and who have no more than 2 consecutive missed doses of mepolizumab treatment will be eligible to participate in this study. This study will be conducted in 4 parts in approximately 300 subjects. Part A will be Variable Open-Label Run-in (for subjects with less than 3 years of mepolizumab treatment). Once the required 3 year exposure is reached, subjects will enter Part B- Fixed Open-Label Run-In (4 weeks to 8 weeks). During Part A and B subjects will be administered Open-label mepolizumab (100 milligram \[mg\] Subcutaneous \[SC\]) every 4 weeks. Part C will be the randomized double-blinded part. Upon completion of Part B, eligible subjects will be randomized to mepolizumab (100 mg SC) every 4 weeks or placebo administered SC every 4 weeks for 52 weeks.

Subjects discontinuing investigational product (IP) due to a clinically significant asthma exacerbation will then enter optional Part D of the study. During Part D, subjects receive open-label mepolizumab in addition to their standard of care therapy for the remainder of the study, through Part D up to 52-weeks post-randomization. An Exit Visit will be conducted 52 weeks after randomization in order to assess subject's efficacy parameters, immunogenicity status, and to conduct additional safety assessments. Eligible subjects will participate in the study ranging from 56 to192 weeks, depending on the duration of Part A (0 to 132 weeks) and Part B (4 to 8 weeks).


Options:
A: Percentage of Participants With First Clinically Significant Exacerbation in Part C (Weeks 12, 24, 36 and 52)
B: Persistency of Response and Non-response as Based on Investigator's Global Evaluation of Treatment Effectiveness (GETE) (Weeks 16 and 32)
C: Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108); Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in Leukocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108); Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in Lymphocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108); Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in Neutrophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108); Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in Eosinophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108); Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in ALT, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108); Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in AST, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108); Change From Baseline in Bilirubin, Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in Bilirubin, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108)
D: Percentage of Participants With Asthma Exacerbations at Week 12 (Week 12)

Answer: A