Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Benralizumab (MEDI-563) in Reducing Eosinophilia in Subjects With Hypereosinophilic Syndrome (HES)
Brief Summary: Background:

- Eosinophils are white blood cells that help fight infections. High eosinophil levels can damage people s organs, causing hypereosinophilic syndrome (HES). Researchers want to study if the drug benralizumab can help people with HES.

Objective:

- To test if benralizumab can safely decrease eosinophils in people with HES.

Eligibility:

- Adults age 18-65 who have been on stable HES therapy for at least 1 month but still have symptoms and high eosinophil levels.

Design:

* Participants will be screened with medical history, physical exam, and urine and blood tests. They will take simple heart and lung tests.
* Participants will also have a bone marrow biopsy. A numbing medicine is injected into the outer covering of the bone. Then a needle is inserted into the bone. A fast suction movement takes bone marrow cells.
* Phase 1: Participants will randomly receive either the study drug or placebo as an injection.
* They will have daily visits for the next 3 days, then 4 weekly visits, and then 4 biweekly visits. Each time, they will have medical history, physical exam, blood tests, and a check of side effects.
* They will receive another dose of the study drug or placebo at 1 month and 2 months after the first injection.
* Phase 2 repeats the Phase 1 schedule. All participants will receive the study drug.
* At 1 visit, participants will also receive a vaccine. At 4 visits, they will repeat the heart and lung tests. They will also have one other bone marrow biopsy.
* After week 24, participants will receive the study drug either 6 times over 6 months or twice over 6 months.


Options:
A: Maximum Observed Serum Concentration (Cmax) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Maximum Observed Serum Concentration (Cmax) for CAT-354 After Second Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 28; Day 35); Maximum Observed Serum Concentration (Cmax) for CAT-354 After Third Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 56; Day 63, 84, 105 and 147); Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - t]) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0 - Infinity]) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Apparent Terminal Elimination Phase Half-Life (t[1/2]el) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Clearance (CL) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Volume of Distribution (Vd) for CAT-354 After First Dose (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21); Observed Serum Drug Concentration for CAT-354 28 Days (C28) After First Dose (Pre-dose on Day 28); Observed Serum Drug Concentration for CAT-354 28 Days (C28) After Second Dose (Pre-dose on Day 56); Observed Serum Concentration for CAT-354 28 Days (C28) After Third Dose (Day 84); Accumulation Ratio (R0) for CAT-354 (Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0 and 56; Pre-dose on Day 28; Day 4, 7, 14, 21, 63 and 84)
B: Number of Participants With 50% Reduction in Peripheral Blood Eosinophilia (3 months)
C: Evaluate the safety and tolerability of MEDI-563 in adults with atopic asthma and evaluate the effects of MEDI-563 on eosinophil counts in airway mucosal biopsies 28 days after completion of dosing in adults with atopic asthma. (Study Day 84 or Day 140 - (dose-driven))
D: Number of Clinically Significant Exacerbations of Asthma Per Year (From randomization (Week 0) to Week 52 or early withdrawal (EW))

Answer: B