Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

1 to 12 of 12

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Clearance of Benralizumab	Pre-dose on Days 0, 28, 56, 112, 168 and post-dose on Days 1, 7, 14, 84, 336; and at early discontinuation or withdrawal visit	The PK analysis set consisted of all participants who received at least 1 dose of benralizumab for whom PK blood samples were not assumed to be affected by factors such as protocol violations and who had at least 1 post dose quantifiable serum PK observation.	liter (L) per day	MEAN
PRIMARY	Area Under the Serum Concentration-Time Curve From Time Zero to Day 28 (AUC0-28) of Benralizumab	Pre-dose on Days 0, 28 and post-dose on Days 1, 7, 14	The Non-compartmental analysis (NCA) set consisted of all participants who received the first dose of benralizumab for whom PK blood samples were not assumed to be affected by factors such as protocol violations and who had at least 3 quantifiable serum PK observations post first dose on Days 1, 7, 14, and 28. Only those participants with data available were analyzed.	nanogramday per milliliter (ngday/mL)	GEOMETRIC_MEAN
PRIMARY	Maximum Observed Serum Concentration (Cmax) of Benralizumab	Pre-dose on Days 0, 28, 56, 112, 168 and post-dose on Days 1, 7, 14, 84, 336; and at early discontinuation or withdrawal visit	The NCA set consisted of all participants who received the first dose of benralizumab for whom PK blood samples were not assumed to be affected by factors such as protocol violations and who had at least 3 quantifiable serum PK observations post first dose on Days 1, 7, 14, and 28.	ng/mL	GEOMETRIC_MEAN
PRIMARY	Terminal Phase Elimination Half-Life (t1/2) of Benralizumab	Pre-dose on Days 0, 28, 56, 112, 168 and post-dose on Days 1, 7, 14, 84, 336; and at early discontinuation or withdrawal visit	The PK analysis set consisted of all participants who received at least 1 dose of benralizumab for whom PK blood samples were not assumed to be affected by factors such as protocol violations and who had at least 1 post dose quantifiable serum PK observation.	day	MEDIAN
PRIMARY	Time to Achieve Maximum Observed Serum Concentration (Tmax) of Benralizumab	Pre-dose on Days 0, 28, 56, 112, 168 and post-dose on Days 1, 7, 14, 84, 336; and at early discontinuation or withdrawal visit	The NCA set consisted of all participants who received the first dose of benralizumab for whom PK blood samples were not assumed to be affected by factors such as protocol violations and who had at least 3 quantifiable serum PK observations post first dose on Days 1, 7, 14, and 28.	day	MEDIAN
PRIMARY	Trough Concentration of Benralizumab at Week 16 (Ctrough16)	Pre-dose on Day 112	The NCA set consisted of all participants who received the first dose of benralizumab for whom PK blood samples were not assumed to be affected by factors such as protocol violations and who had at least 3 quantifiable serum PK observations post first dose on Days 1, 7, 14, and 28. Only those participants with data available were analyzed.	ng/mL	GEOMETRIC_MEAN
PRIMARY	Change From Baseline in Peripheral Blood Eosinophil Count up to Week 48	Baseline (Day 0) and at Weeks 4, 8, 12, 16, 24 and 48	The Safety Analysis set consisted of all participants who received at least 1 dose of benralizumab. Only those participants with data available were analyzed.	cells/microliters	MEAN
SECONDARY	Body Weight-Adjusted Clearance of Benralizumab	Pre-dose on Days 0, 28, 56, 112, 168 and post-dose on Days 1, 7, 14, 84, 336; and at early discontinuation or withdrawal visit	The PK analysis set consisted of all participants who received at least 1 dose of benralizumab for whom PK blood samples were not assumed to be affected by factors such as protocol violations and who had at least 1 post dose quantifiable serum PK observation.	L/day/kilogram	MEAN
SECONDARY	Number of Participants With Anti-Drug Antibodies (ADA) Response to Benralizumab	Pre-dose at Baseline (Day 0), Weeks 8, 16 and 24 and post-dose at Week 48; and at early discontinuation or withdrawal visit	The Safety Analysis set consisted of all participants who received at least 1 dose of benralizumab. Only those participants with data available were analyzed.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) up to Week 48	Baseline (Day 0) and at Weeks 16 and 48	The Safety Analysis set consisted of all participants who received at least 1 dose of benralizumab. Only those participants with data available were analyzed.	liters	MEAN
SECONDARY	Change From Baseline in Interviewer-Administered Asthma Control Questionnaire (ACQ-IA) Score up to Week 48	Baseline (Day 0), at Weeks 16 and 48; and at early discontinuation or withdrawal visit	The Safety Analysis set consisted of all participants who received at least 1 dose of benralizumab. Only those participants with data available were analyzed.	scores on a scale	MEAN
SECONDARY	Number of Responders in Interviewer-Administered Patient Global Impression of Change (PGIC)-IA and Clinician Global Impression of Change (CGIC) Questionnaires	At Weeks 16 and 48; and at early discontinuation or withdrawal visit	The Safety Analysis set consisted of all participants who received at least 1 dose of benralizumab.	Participants	COUNT_OF_PARTICIPANTS

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.

For software

Read this list from software.

Twenty rows a page, as JSON. No key.

GET https://conductscience.org/api/trials/v1/NCT04305405/outcomes

API reference For AI assistants