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Trial · NCT04543409

Registered outcomes29

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
SecondaryPatient Reported Overall Severity of Disease as Measured by Patient Global Impression of Severity (PGI-S) at Week 24Week 24
Patient Global Impression of Severity (PGI-S) is an assessment of the patient's perceived disease severity. The answer options are "no symptoms," "very mild," "mild," "moderate," "severe," and "very severe." The number analyzed represents the participants with evaluable PGI-S results at that timepoint.
SecondaryPatient Reported Overall Severity of Disease as Measured by Patient Global Impression of Severity (PGI-S) at Week 52Week 52
Patient Global Impression of Severity (PGI-S) is an assessment of the patient's perceived disease severity. The answer options are "no symptoms," "very mild," "mild," "moderate," "severe," and "very severe." The number analyzed represents the participants with evaluable PGI-S results at that timepoint.
SecondaryPatient Reported Change in Health Status Since Baseline as Measured by Patient Global Impression of Change (PGI-C) at Week 24Week 24
Patient Global Impression of Change (PGI-C) measures the patient's overall impression of response to treatment since the initial dose. The answer options are "much better," "moderately better," "a little better," "about the same/no change," "a little worse," "moderately worse," and "much worse." The number analyzed represents the participants with evaluable PGI-C results at that timepoint.
SecondaryPatient Reported Change in Health Status Since Baseline as Measured by Patient Global Impression of Change (PGI-C) at Week 52Week 52
Patient Global Impression of Change (PGI-C) measures the patient's overall impression of response to treatment since the initial dose. The answer options are "much better," "moderately better," "a little better," "about the same/no change," "a little worse," "moderately worse," and "much worse." The number analyzed represents the participants with evaluable PGI-C results at that timepoint.
OtherBenralizumab PharmacokineticsUp to week 52Serum concentrations of benralizumab through Week 52. Geometric mean calculated using log transformed data.
OtherImmunogenicity of Benralizumab in Double Blind PeriodUp to Week 24Immunogenicity of benralizumab assessed by ADA and nAb in the Double Blind period.
OtherImmunogenicity of Benralizumab in Double Blind + Open Label PeriodsUp to Week 52Immunogenicity of benralizumab assessed by ADA and nAb in the Double Blind and Open Label periods.
OtherSafety and Tolerability in Double Blind PeriodUp to Week 24Percentage of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) in the Double Blind treatment period (up to Week 24).
OtherSafety and Tolerability in the Open Label PeriodFrom Week 24 up to Week 52Percentage of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) in the Open Label treatment period (past week 24).

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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