Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and A Second Controller Medication
Brief Summary: This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will assess the efficacy and safety of lebrikizumab in patients with asthma whose disease remains uncontrolled despite daily therapy with an inhaled corticosteroid and a second controller medication. Patients will be randomized in a 1:1:1:1 ratio to receive double-blind treatment with subcutaneous lebrikizumab ("highest", "middle", "lowest" dose) or placebo every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. The anticipated time on study treatment is up to 104 weeks. There will be a safety follow-up of 24 weeks after the last dose of study drug for all patients.


Options:
A: Healthcare utilization- hospitalizations, clinic Visits, and asthma exacerbations (At baseline, every 6 months, through study completion, assessed up to 7 years.); Asthma treatment (At baseline, every 6 months, through study completion, assessed up to 7 years.); Treatment adherence (At baseline, every 1 month, through study completion, assessed up to 7 years.); Asthma control test (ACT) (Change from baseline, every 1 month, through study completion, assessed up to 4 years.); Patient-reported asthma exacerbations (Change from baseline, every 1 month, through study completion, assessed up to 4 years.); Asthma Impairment and Risk Questionnaire (AIRQ) (At baseline, every 1 month, through study completion, assessed up to 4 years); Work Productivity and Activity Impairment Asthma questionnaire (WPAI-Asthma) (At baseline, every 3 months, through study completion, assessed up to 7 years.); St. George's Respiratory Questionnaire (SGRQ) (At baseline, every 6 months, through study completion, assessed up to 7 years.); Global evaluation of treatment effectiveness (GETE) (At baseline, every 6 months, through study completion, assessed maximum up to 7 years.); Number of Participants With Adverse Events associated with corticosteroid therapy (At baseline, every 6 months, through study completion, assessed up to 7 years.); Relevant respiratory medical events (At baseline, every 6 months, through study completion,assessed up to 7 years.); Respiratory comorbidities (At baseline, every 6 months, through study completion, assessed up to 7 years.); Non-respiratory comorbidities (At baseline, every 6 months, through study completion, assessed up to 7 years.); Events of special interest (At baseline, every 6 months, through study completion, assessed up to 7 years.); Complete blood count with differential including blood eosinophil count. (Change from baseline, every 6 months, through study completion, assessed up to 7 years.); Total immunoglobulin E (IgE) (Change from baseline, every 6 months, through study completion, assessed up to 7 years.); Radiographic changes in asthma evaluation. (Change from baseline, every 6 months, through study completion, assessed up to 7 years.); Forced Vital Capacity (FVC) (Change from baseline, every 6 months, through study completion, assessed up to 7 years.); Forced Expiratory Volume in 1 second (FEV1) (Change from baseline, every 6 months, through study completion, assessed up to 7 years.); Fractional exhaled nitric oxide (FENO) (Change from baseline, every 6 months, through study completion, assessed up to 7 years.)
B: Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL (Immediately following the first administration of study drug through Study Week 48.)
C: Rate of asthma exacerbations during the 52-week placebo-controlled period (weeks 0-52)
D: The primary outcome measure is the late asthmatic response (LAR) in patients treated with huMAb OX40L versus placebo (16 weeks after the first dose)

Answer: C