Efficacy and Safety Study of Benralizumab in Patient With... | NCT04157335

ID	Type	Description	Link
2023-507987-38-00	Registry Identifier	CTIS
2021-000267-72	EudraCT Number

Efficacy and Safety Study of Benralizumab in Patient With... | NCT04157335 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Benralizumab	Experimental	Benralizumab administered subcutaneously	Biological: Benralizumab 30 mg
Placebo	Placebo Comparator	Placebo administered subcutaneously	Biological: Matched placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Benralizumab 30 mg	Biological	Benralizumab is 30 mg/ml solution for injection in accessorized pre-filled syringe, 1 ml fill volume. Benralizumab 30 mg subcutaneously will be injected every 4 weeks for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks thereafter (Weeks 16, 24, 32, 40 and 48). For OLE, Benralizumab 30 mg subcutaneously will be injected every 4 weeks for the first 3 doses and every 8 weeks for the rest 5 doses. For the patients on Benralizumab treatment during double blind period, placebo will be dosed at the second dose during OLE.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Endoscopic Total Nasal Polyp Score (NPS) at Week 56	The total nasal polyp score (NPS) is the sum of the right and left nostril scores (maximum of 8), as evaluated by nasal endoscopy. Higher scores indicate greater symptom severity. The left and right score will be based on a central read with a scale from 0 to 4. Each nasal endoscopy is evaluated by two independent physician reviewers.	Baseline to Week 56
Change From Baseline in Mean Nasal Blockage Score (NBS) at Week 56.	The NBS is an item in the NPSD. Patients were asked to rate the severity of their worst nasal blockage over the past 24 hours using the following response options: 0 - none; 1 - mild; 2 - moderate; 3 - severe. Higher scores indicate greater symptom severity. The NBS and the changes from baseline were summarised every two weeks (bi-weekly). Baseline was the average of daily responses from Day -13 to Day 1. Bi-weekly mean were calculated if at least 8 days in each 14-day period had evaluable data; otherwise, the biweekly mean was set to missing.	Baseline to week 56

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Difficulty With Sense of Smell (DSS) Score at Week 56.	The DSS is an item in the NPSD. Patients were asked to rate the severity of their worst difficulty with sense of smell over the past 24 hours using the following response options: 0-none; 1-mild; 2-moderate; 3-severe. Higher scores indicate greater symptom severity. The DSS and the changes from baseline were summarised every two weeks (bi-weekly). Baseline was the average of daily responses from Day -13 to Day 1. Bi-weekly mean of DSS was calculated if at least 8 days in each 14-day period have evaluable data; otherwise the bi-weekly mean was set to missing.

Contacts/Locations Module

Name	Affiliation	Role
Luo Zhang, Prof. Dr.	Beijing Tongren Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Huntington Beach	California	92647	United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33710614	Derived	Chong LY, Piromchai P, Sharp S, Snidvongs K, Webster KE, Philpott C, Hopkins C, Burton MJ. Biologics for chronic rhinosinusitis. Cochrane Database Syst Rev. 2021 Mar 12;3(3):CD013513. doi: 10.1002/14651858.CD013513.pub3.

Label	URL
CSR Synopsis	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Double Blind Benralizumab	30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
FG001	Double Blind Placebo

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 20, 2024	Nov 28, 2025

Type	Comment	Reasons
IP discontinuation		FG0001 subjects FG0011 subjects
Withdrawal by Subject		FG0009 subjects FG0016 subjects
Pregnancy		FG0001 subjects FG0010 subjects
Physician Decision		FG0001 subjects FG0012 subjects
Lost to Follow-up		FG0000 subjects FG0012 subjects
Adverse Event		FG0001 subjects FG0011 subjects
Site closure		FG0002 subjects FG0010 subjects
Patient did not meet randomization criteria		FG0000 subjects FG0011 subjects

Open-Label Extension Period

Type	Comment	Milestone Data
STARTED	All participants in Open-Label extension period took Benralizumab. 30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 56, 60, 64) and Q8W thereafter (Weeks 72, 80, 88, 96 and 104).	FG000122 subjects FG001125 subjects
COMPLETED		FG00080 subjects FG00186 subjects
NOT COMPLETED		FG00042 subjects FG00139 subjects

Type	Comment	Reasons
Study terminated by sponsor		FG00019 subjects FG00126 subjects
Withdrawal by Subject		FG00018 subjects FG001

Arm/Group Information

ID	Title	Description
BG000	Double Blind Benralizumab	30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
BG001	Double Blind Placebo	30 mg Placebo administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00049.5± 12.7 BG00149.8± 12.7 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00061 BG00154 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG00077 BG00173 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Endoscopic Total Nasal Polyp Score (NPS) at Week 56

The total nasal polyp score (NPS) is the sum of the right and left nostril scores (maximum of 8), as evaluated by nasal endoscopy. Higher scores indicate greater symptom severity. The left and right score will be based on a central read with a scale from 0 to 4. Each nasal endoscopy is evaluated by two independent physician reviewers.

Primary full analysis set (All CRSwNP participants with asthma who were randomized and received any IP. N=139 in treatment group and N=135 in placebo). The analysis included all participants with baseline and at least one evaluable post-baseline assessment and all the participants with a baseline assessment who are rescued by surgery and/or SCS use for CRSwNP.

Posted

Mean

Standard Deviation

Score

Baseline to Week 56

ID	Title	Description
OG000	Double Blind Benralizumab	30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
OG001	Double Blind Placebo	30 mg Placebo administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.

Units	Counts
Participants	OG000127 OG001121

Title

Denominators

Categories

Title	Measurements
	OG000-0.3± 1.6 OG001-0.1± 1.3

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null Hypothesis: Difference in mean change from baseline in NPS at 56 weeks (Benralizumab minus placebo) = 0	ANCOVA	Model: Change from baseline in NPS = Treatment + Region + Baseline BMI + Baseline total NPS	0.1707		Difference in Least Squares Means	-0.247			2-Sided	95	-0.599	0.106					Superiority	WP (worst possible value) for subjects rescued by surgery for CRSwNP and WOCF (worst-observation carried forward) for subjects rescued by SCS use for CRSwNP. Missing data not due to intercurrent events were imputed using MI (MAR). Analysis was repeated on 100 imputed datasets, and results were combined using Rubin's formula.

Primary

Change From Baseline in Mean Nasal Blockage Score (NBS) at Week 56.

The NBS is an item in the NPSD. Patients were asked to rate the severity of their worst nasal blockage over the past 24 hours using the following response options: 0 - none; 1 - mild; 2 - moderate; 3 - severe. Higher scores indicate greater symptom severity. The NBS and the changes from baseline were summarised every two weeks (bi-weekly). Baseline was the average of daily responses from Day -13 to Day 1. Bi-weekly mean were calculated if at least 8 days in each 14-day period had evaluable data; otherwise, the biweekly mean was set to missing.

Posted

Mean

Standard Deviation

Score

Baseline to week 56

ID	Title	Description
OG000	Double Blind Benralizumab	30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
OG001	Double Blind Placebo	30 mg Placebo administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.

Secondary

Change From Baseline in Difficulty With Sense of Smell (DSS) Score at Week 56.

The DSS is an item in the NPSD. Patients were asked to rate the severity of their worst difficulty with sense of smell over the past 24 hours using the following response options: 0-none; 1-mild; 2-moderate; 3-severe. Higher scores indicate greater symptom severity. The DSS and the changes from baseline were summarised every two weeks (bi-weekly). Baseline was the average of daily responses from Day -13 to Day 1. Bi-weekly mean of DSS was calculated if at least 8 days in each 14-day period have evaluable data; otherwise the bi-weekly mean was set to missing.

Posted

Mean

Standard Deviation

Score

Baseline to Week 56

ID	Title	Description
OG000	Double Blind Benralizumab	30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
OG001	Double Blind Placebo	30 mg Placebo administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.

Secondary

Sinus Opacification by CT Scan at Week 56.

Change from baseline in Lund- Mackay score (LMS). The Lund-Mackay score scoring system is used to provide a quantitative assessment of nasal sinuses on sinus CT scans. Based on the sinus CT images, the five sinuses (maxillary, anterior ethmoid, posterior ethmoid, sphenoid and frontal) on each site are score by central radiologist as follows: (0-Normal; 1-Partial Opacification; 2-Total Opacification). The osteomeatal complex is scored for right and left sides (0 - Not occluded; 2- Occluded). The total score ranges from 0 to 24 (higher scores indicate poorer outcomes).

Posted

Mean

Standard Deviation

Score

Baseline to Week 56

ID	Title	Description
OG000	Double Blind Benralizumab	30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
OG001	Double Blind Placebo	30 mg Placebo administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.

Secondary

Disease Specific Health-related Quality of Life (HRQoL): Change From Baseline in SinoNasal Outcome Test (SNOT-22) Score at Week 56.

SinoNasal Outcome Test 22 scores are participant-reported and assess physical problems, functional limitations and emotional consequences of SinoNasal conditions. Patient-reported symptom severity and symptom impact over the past 2 weeks are captured via a 6-point scale (0-No Problem to 5-Problem as bad as it can be). The total score is the sum of item scores and has a range from 0 to 110 (higher scores indicate poorer outcomes).

Posted

Mean

Standard Error

Score

Baseline to Week 56

ID	Title	Description
OG000	Double Blind Benralizumab	30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
OG001	Double Blind Placebo	30 mg Placebo administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.

Secondary

Time to First Nasal Polyp Surgery

Time to the first surgery for CRSwNP= Start date of the first surgery for CRSwNP - date of randomisation + 1

Primary full analysis set (All CRSwNP participants with asthma who were randomized and received any IP. N=139 in treatment group and N=135 in placebo).

Posted

Median

Full Range

Months

Baseline to Week 56

ID	Title	Description
OG000	Double Blind Benralizumab	30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
OG001	Double Blind Placebo	30 mg Placebo administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.

Units	Counts
Participants	OG000

Secondary

Time to First SCS Course for CRSwNP

Time to the first SCS use for CRSwNP = Start date of the first SCS use for CRSwNP - date of randomisation + 1

Primary full analysis set (All CRSwNP participants with asthma who were randomized and received any IP. N=139 in treatment group and N=135 in placebo).

Posted

Median

Full Range

Months

Baseline to Week 56

ID	Title	Description
OG000	Double Blind Benralizumab	30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
OG001	Double Blind Placebo	30 mg Placebo administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.

Units	Counts
Participants	OG000

Secondary

Time to First NP Surgery and/or SCS Use for CRSwNP

Time to first surgery and/or SCS use for CRSwNP = earlier date of (start date of first surgery for CRSwNP, start date of first SCS use for CRSwNP) - date of randomisation + 1

Primary full analysis set (All CRSwNP participants with asthma who were randomized and received any IP. N=139 in treatment group and N=135 in placebo).

Posted

Median

Full Range

Months

Baseline to Week 56

ID	Title	Description
OG000	Double Blind Benralizumab	30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
OG001	Double Blind Placebo	30 mg Placebo administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Bi-weekly Mean Nasal Polyps Symptom Diary Total Symptom Score at Week 56.

The participant completed the nasal polyposis symptom diary each morning throughout the study. The participant was asked to consider their experience with nasal polyposis/nasal polyps over the past 24 hours when responding to each question. Participants were asked to report their experience with nasal polyposis symptoms (nasal blockage, nasal congestion, runny nose, postnasal drip (mucus drainage down the throat), headache, facial pain, facial pressure, difficulty with sense of smell). Participants reported the severity of each symptom and symptom impact at its worst using a 4-point verbal rating scale (0-None to 3-Severe). A total symptom score (range from 0 to 24) was calculated by taking the sum of the 8 equally weighted symptom items. Higher scores indicate greater symptom severity.

Posted

Mean

Standard Deviation

Score

Baseline to Week 56

ID	Title	Description
OG000	Double Blind Benralizumab	30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
OG001	Double Blind Placebo

Secondary

Percentage of Participants With Surgery and/or Use SCS for CRSwNP

Nasal polyps surgery is defined as any procedure involving instruments resulting in incision and removal of tissue (e.g. polypectomy, endoscopic sinus surgery).

An SCS course can be considered as a new course if the start date is preceded by at least 7 days after the end date of the last SCS course for CRSwNP (i.e. start date of the new course - end date of the last course > 7)

Primary full analysis set (All CRSwNP participants with asthma who were randomized and received any IP. N=139 in treatment group and N=135 in placebo).

Posted

Count of Participants

Participants

Baseline to Week 56

ID	Title	Description
OG000	Double Blind Benralizumab	30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
OG001	Double Blind Placebo	30 mg Placebo administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.

Units	Counts
Participants

Secondary

Percentage of Participants With Surgery for CRSwNP

Nasal polyps surgery is defined as any procedure involving instruments resulting in incision and removal of tissue (e.g. polypectomy, endoscopic sinus surgery).

Primary full analysis set (All CRSwNP participants with asthma who were randomized and received any IP. N=139 in treatment group and N=135 in placebo).

Posted

Count of Participants

Participants

Baseline to Week 56

ID	Title	Description
OG000	Double Blind Benralizumab	30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
OG001	Double Blind Placebo	30 mg Placebo administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With SCS Use for CRSwNP

Primary full analysis set (All CRSwNP participants with asthma who were randomized and received any IP. N=139 in treatment group and N=135 in placebo).

Posted

Count of Participants

Participants

Baseline to Week 56

ID	Title	Description
OG000	Double Blind Benralizumab	30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
OG001	Double Blind Placebo	30 mg Placebo administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Double Blind Benralizumab	30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.	144	12	144	78	144
EG001	Double Blind Placebo	30 mg Placebo administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.	143	12	143	59	143
EG002	Double Blind Benralizumab First, Then Open Label Benralizumab	All participants who received Benralizumab in the double-blind (DB) period and continued to receive Benralizumab in the open-label extension (OLE) period. 30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 56, 60, 64) and Q8W thereafter (Weeks 72, 80, 88, 96 and 104).	122	6	122	37	122
EG003	Double Blind Placebo First, Then Open Label Benralizumab	All participants who initially received Placebo in the DB period, then switched to receive Benralizumab in the open-label extension (OLE) period. 30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 56, 60, 64) and Q8W thereafter (Weeks 72, 80, 88, 96 and 104).	125	9	125	33	125

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
COVID-19	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected143 at risk EG0020 events0 affected122 at risk EG0030 events0 affected125 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0010 events0 affected143 at risk EG0022 events2 affected122 at risk EG003
Infective exacerbation of asthma	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0010 events0 affected143 at risk EG0020 events0 affected122 at risk EG003
Influenza	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0010 events0 affected143 at risk EG0021 events1 affected122 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected143 at risk EG0021 events1 affected122 at risk EG003
Otitis media	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected143 at risk EG0020 events0 affected122 at risk EG003
Pneumonia	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected143 at risk EG0020 events0 affected122 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0002 events1 affected144 at risk EG0010 events0 affected143 at risk EG0020 events0 affected122 at risk EG003
Fibula fracture	Injury, poisoning and procedural complications	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected143 at risk EG0020 events0 affected122 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0010 events0 affected143 at risk EG0021 events1 affected122 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0010 events0 affected143 at risk EG0020 events0 affected122 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0010 events0 affected143 at risk EG0020 events0 affected122 at risk EG003
Colorectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected143 at risk EG0020 events0 affected122 at risk EG003
Invasive breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0010 events0 affected143 at risk EG0021 events1 affected122 at risk EG003
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0010 events0 affected143 at risk EG0020 events0 affected122 at risk EG003
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0011 events1 affected143 at risk EG0020 events0 affected122 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected143 at risk EG0020 events0 affected122 at risk EG003
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected143 at risk EG0020 events0 affected122 at risk EG003
Guillain-Barre syndrome	Nervous system disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected143 at risk EG0020 events0 affected122 at risk EG003
Calculus urinary	Renal and urinary disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected143 at risk EG0020 events0 affected122 at risk EG003
Adenomyosis	Reproductive system and breast disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected143 at risk EG0020 events0 affected122 at risk EG003
Vulval leukoplakia	Reproductive system and breast disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected143 at risk EG0020 events0 affected122 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected143 at risk EG0020 events0 affected122 at risk EG003
Asthmatic crisis	Respiratory, thoracic and mediastinal disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected143 at risk EG0020 events0 affected122 at risk EG003
Chronic rhinosinusitis with nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0010 events0 affected143 at risk EG0021 events1 affected122 at risk EG003
Cataract	Eye disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0010 events0 affected143 at risk EG0020 events0 affected122 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected143 at risk EG0020 events0 affected122 at risk EG003
Chronic gastritis	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected143 at risk EG0020 events0 affected122 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected143 at risk EG0020 events0 affected122 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected143 at risk EG0020 events0 affected122 at risk EG003
Reflux gastritis	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected143 at risk EG0020 events0 affected122 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0010 events0 affected143 at risk EG0020 events0 affected122 at risk EG003
Chest discomfort	General disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected143 at risk EG0020 events0 affected122 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA version 27.0	Systematic Assessment	EG0002 events1 affected144 at risk EG0010 events0 affected143 at risk EG0020 events0 affected122 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
COVID-19	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG00023 events22 affected144 at risk EG00116 events16 affected143 at risk EG0029 events9 affected122 at risk EG0037 events7 affected125 at risk
Influenza	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0013 events3 affected143 at risk EG0024 events4 affected122 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG00012 events11 affected144 at risk EG00110 events9 affected143 at risk EG00210 events9 affected122 at risk EG003
Pneumonia	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0003 events3 affected144 at risk EG0011 events1 affected143 at risk EG0021 events1 affected122 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG00016 events13 affected144 at risk EG00118 events14 affected143 at risk EG00210 events9 affected122 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA version 27.0	Systematic Assessment	EG0002 events2 affected144 at risk EG0016 events6 affected143 at risk EG0022 events2 affected122 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA version 27.0	Systematic Assessment	EG0007 events7 affected144 at risk EG0011 events1 affected143 at risk EG0021 events1 affected122 at risk EG003
Headache	Nervous system disorders	MedDRA version 27.0	Systematic Assessment	EG00015 events11 affected144 at risk EG00110 events7 affected143 at risk EG0021 events1 affected122 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA version 27.0	Systematic Assessment	EG00020 events16 affected144 at risk EG00131 events22 affected143 at risk EG0028 events7 affected122 at risk EG003
Chronic gastritis	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0007 events6 affected144 at risk EG0011 events1 affected143 at risk EG0020 events0 affected122 at risk EG003
Influenza like illness	General disorders	MedDRA version 27.0	Systematic Assessment	EG0008 events7 affected144 at risk EG0016 events4 affected143 at risk EG0022 events2 affected122 at risk EG003
Pyrexia	General disorders	MedDRA version 27.0	Systematic Assessment	EG0007 events7 affected144 at risk EG0013 events3 affected143 at risk EG0021 events1 affected122 at risk EG003

Ancestor Terms

ID	Term
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D010038	Otorhinolaryngologic Diseases
D011127	Polyps
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D001982	Bronchial Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012130	Respiratory Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null Hypothesis: Difference in mean change from baseline in bi-weekly mean NBS at 56 weeks (Benralizumab minus placebo) = 0	ANCOVA	Model: Change from baseline in bi-weekly mean NBS = Treatment + Region + Baseline BMI + baseline bi-weekly mean NBS	0.1831		Difference in Least Squares Means	-0.155			2-Sided	95	-0.383	0.073					Superiority	WP (worst possible value) for subjects rescued by surgery for CRSwNP and WOCF (worst-observation carried forward) for subjects rescued by SCS use for CRSwNP. Missing data not due to intercurrent events were imputed using MI (MAR). Analysis was repeated on 100 imputed datasets, and results were combined using Rubin's formula.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null Hypothesis: Difference in mean change from baseline in bi-weekly mean DSS at 56 weeks (Benralizumab minus placebo) = 0	ANCOVA	Model: Change from baseline in NPS = Treatment + Region + Baseline BMI + baseline bi-weekly mean DSS	0.0196	The p-value is unadjusted.	Difference in Least Squares Means	-0.191			2-Sided	95	-0.351	-0.031					Superiority	WP (worst possible value) for subjects rescued by surgery for CRSwNP and WOCF (worst-observation carried forward) for subjects rescued by SCS use for CRSwNP. Missing data not due to intercurrent events were imputed using MI (MAR). Analysis was repeated on 100 imputed datasets, and results were combined using Rubin's formula.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null Hypothesis: Difference in mean change from baseline in LMS at 56 weeks (Benralizumab minus placebo) = 0	ANCOVA	Model: Change from baseline in LMS = Treatment + Region + Baseline BMI + baseline LMS	0.1456		Difference in Least Squares Means	-0.663			2-Sided	95	-1.559	0.232					Superiority	WP (worst possible value) for subjects rescued by surgery for CRSwNP. Missing data not due to intercurrent events were imputed using MI (MAR). Analysis was repeated on 100 imputed datasets, and results were combined using Rubin's formula.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null Hypothesis: Difference in mean change from baseline in SNOT-22 at 56 weeks (Benralizumab minus placebo) = 0	ANCOVA	Model: Change from baseline in SNOT-22 = Treatment + Region + Baseline BMI + baseline SNOT-22 score	0.5844		Difference in Least Squares Means	-1.783			2-Sided	95	-8.171	4.606					Superiority	WP (worst possible value) for subjects rescued by surgery for CRSwNP and WOCF (worst-observation carried forward) for subjects rescued by SCS use for CRSwNP. Missing data not due to intercurrent events were imputed using MI (MAR). Analysis was repeated on 100 imputed datasets, and results were combined using Rubin's formula.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null Hypothesis: Hazard ratio of time to first surgery for CRSwNP (Benralizumab/placebo) = 1	Regression, Cox	Cox proportional hazards model including covariates treatment group, region, and baseline BMI	0.6776	This endpoint was not a part of the pre-specified testing strategy and was not multiplicity protected. The p-value was considered nominal.	Hazard Ratio (HR)	0.82			2-Sided	95	0.31	2.09			A hazard ratio less than 1 indicates a lower rate of incidence for subjects on Benralizumab.		Superiority

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null Hypothesis: Hazard ratio of time to first SCS use for CRSwNP (Benralizumab/placebo) = 1	Regression, Cox	Cox proportional hazards model including covariates treatment group, region, and baseline BMI.	0.8033	This endpoint was not a part of the pre-specified testing strategy and was not multiplicity protected. The p-value was considered nominal.	Hazard Ratio (HR)	0.93			2-Sided	95	0.51	1.69			A hazard ratio less than 1 indicates a lower rate of incidence for subjects on Benralizumab.		Superiority

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null Hypothesis: Hazard ratio of time to first surgery and/or SCS use for CRSwNP (Benralizumab/placebo) = 1	Regression, Cox	Cox proportional hazards model including covariates treatment group, region, and baseline BMI.	0.5226	This endpoint was not a part of the pre-specified testing strategy and was not multiplicity protected. The p-value was considered nominal.	Hazard Ratio (HR)	0.84			2-Sided	95	0.49	1.43			A hazard ratio less than 1 indicates a lower rate of incidence for subjects on Benralizumab.		Superiority

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null Hypothesis: Difference in mean change from baseline in NPSD TSS at 56 weeks (Benralizumab minus placebo) = 0	ANCOVA	Model: Change from baseline in NPSD TSS = Treatment + Region + Baseline BMI + baseline NPSD TSS	0.2201	This endpoint was not a part of the pre-specified testing strategy and was not multiplicity protected. The p-value was considered nominal.	Difference in Least Squares Means	-0.860				95	-2.235	0.515					Superiority	WP (worst possible value) for subjects rescued by surgery for CRSwNP and WOCF (worst-observation carried forward) for subjects rescued by SCS use for CRSwNP. Missing data not due to intercurrent events were imputed using MI (MAR). Analysis was repeated on 100 imputed datasets, and results were combined using Rubin's formula.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel	Controlling for region (North America, Europe, Asia, Others), and baseline BMI status (<= 30 vs >30).	0.5130	This endpoint was not a part of the pre-specified testing strategy and was not multiplicity protected. The p-value was considered nominal.	Odds Ratio (OR)	0.82			2-Sided	95	0.45	1.48			An odds ratio less than 1 favors Benralizumab.		Superiority

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel	Controlling for region (North America, Europe, Asia, Others), and baseline BMI status (<= 30 vs >30).	0.5662	This endpoint was not a part of the pre-specified testing strategy and was not multiplicity protected. The p-value was considered nominal.	Odds Ratio (OR)	0.75			2-Sided	95	0.28	1.99			An odds ratio less than 1 favors Benralizumab.		Superiority

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel	Controlling for region (North America, Europe, Asia, Others), and baseline BMI status (<= 30 vs >30).	0.8454	This endpoint was not a part of the pre-specified testing strategy and was not multiplicity protected. The p-value was considered nominal.	Odds Ratio (OR)	0.94			2-Sided	95	0.49	1.81			An odds ratio less than 1 favors Benralizumab.		Superiority