Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma (NCT NCT01238861)

NCT ID: NCT01238861

Last Updated: 2016-11-17

Results Overview

The annual asthma exacerbation rate (AER) was calculated as the total number of observed exacerbations in each group up to week 52, divided by total duration of person-year follow-up in each group. An asthma exacerbation is defined as a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 days as prescribed or administered by the investigator or healthcare provider; or 2) participant initiation of systemic corticosteroids (tablets, suspension or injection) for a duration of at least 3 days as outlined in the Asthma Action Plan provided to the participant by the investigator on Day 1.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

964 participants

Primary outcome timeframe

Week 1 up to Week 52

Results posted on

2016-11-17

Participant Flow

Participants were stratified based on the protocol defined eosinophilic phenotype (EOS+ versus EOS-) and inhaled corticosteroid (ICS) use during a 3-week screening period. A total of 964 participants were screened out of which 609 were randomized in the study, and of which 606 participants received at least one dose of investigational product.

Participant milestones

Participant milestones
Measure
Eosinophilic Phenotype (EOS+) Placebo
EOS+ (defined as ELEN Index \[proprietary mathematical algorithm to predict sputum eosinophil's greater than or equal to 2 percent\] positive and/or FeNO \[fraction of exhaled nitric oxide\] greater than or equal to \[\>=\] 50 parts per billion \[ppb\]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 2 mg
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 20 mg
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 100 mg
EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Non-eosinophil Phenotype (EOS-) Placebo
EOS- (defined as ELEN Index negative and FeNO \<50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Benralizumab, 100 mg
EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Overall Study
STARTED
80
81
81
82
142
140
Overall Study
COMPLETED
69
73
70
69
129
125
Overall Study
NOT COMPLETED
11
8
11
13
13
15

Reasons for withdrawal

Reasons for withdrawal
Measure
Eosinophilic Phenotype (EOS+) Placebo
EOS+ (defined as ELEN Index \[proprietary mathematical algorithm to predict sputum eosinophil's greater than or equal to 2 percent\] positive and/or FeNO \[fraction of exhaled nitric oxide\] greater than or equal to \[\>=\] 50 parts per billion \[ppb\]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 2 mg
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 20 mg
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 100 mg
EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Non-eosinophil Phenotype (EOS-) Placebo
EOS- (defined as ELEN Index negative and FeNO \<50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Benralizumab, 100 mg
EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Overall Study
Lost to Follow-up
4
2
3
1
1
2
Overall Study
Unplanned surgery
1
0
0
0
0
0
Overall Study
Did not meet entry ACQ-6 criteria
0
0
1
0
1
1
Overall Study
Incorrect enrollment/randomization
0
0
1
0
1
0
Overall Study
Subject traveled to Argentina by 1 year
0
0
1
0
0
0
Overall Study
Subject moved out of state/area
0
0
1
1
0
0
Overall Study
Strongyloides stercoralis antibodies +
0
0
0
1
0
0
Overall Study
Personal problems
0
0
0
1
0
0
Overall Study
Unable to continue visits
0
0
0
1
0
1
Overall Study
Serious adverse event
0
0
0
0
0
1
Overall Study
Lack of compliance
0
0
0
0
0
1
Overall Study
Adverse Event
0
1
0
0
0
0
Overall Study
Withdrawal by Subject
6
5
4
8
10
9

Baseline Characteristics

Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Eosinophilic Phenotype (EOS+) Placebo
n=80 Participants
EOS+ (defined as ELEN Index \[proprietary mathematical algorithm to predict sputum eosinophil's greater than or equal to 2 percent\] positive and/or FeNO \[fraction of exhaled nitric oxide\] greater than or equal to \[\>=\] 50 parts per billion \[ppb\]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 2 mg
n=81 Participants
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 20 mg
n=81 Participants
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 100 mg
n=82 Participants
EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Non-eosinophil Phenotype (EOS-) Placebo
n=142 Participants
EOS- (defined as ELEN Index negative and FeNO \<50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Benralizumab, 100 mg
n=140 Participants
EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Total
n=606 Participants
Total of all reporting groups
Age, Continuous
45.6 years
STANDARD_DEVIATION 11.7 • n=5 Participants
47.1 years
STANDARD_DEVIATION 12.8 • n=7 Participants
46.6 years
STANDARD_DEVIATION 13.2 • n=5 Participants
47.8 years
STANDARD_DEVIATION 12.9 • n=4 Participants
50.0 years
STANDARD_DEVIATION 12.3 • n=21 Participants
50.0 years
STANDARD_DEVIATION 11.5 • n=10 Participants
48.3 years
STANDARD_DEVIATION 12.4 • n=115 Participants
Sex: Female, Male
Female
53 Participants
n=5 Participants
58 Participants
n=7 Participants
48 Participants
n=5 Participants
60 Participants
n=4 Participants
100 Participants
n=21 Participants
98 Participants
n=10 Participants
417 Participants
n=115 Participants
Sex: Female, Male
Male
27 Participants
n=5 Participants
23 Participants
n=7 Participants
33 Participants
n=5 Participants
22 Participants
n=4 Participants
42 Participants
n=21 Participants
42 Participants
n=10 Participants
189 Participants
n=115 Participants

PRIMARY outcome

Timeframe: Week 1 up to Week 52

Population: The modified intent-to-treat (mITT) population included all randomized participants who received any dose of investigational product.

The annual asthma exacerbation rate (AER) was calculated as the total number of observed exacerbations in each group up to week 52, divided by total duration of person-year follow-up in each group. An asthma exacerbation is defined as a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 days as prescribed or administered by the investigator or healthcare provider; or 2) participant initiation of systemic corticosteroids (tablets, suspension or injection) for a duration of at least 3 days as outlined in the Asthma Action Plan provided to the participant by the investigator on Day 1.

Outcome measures

Outcome measures
Measure
Eosinophilic Phenotype (EOS+) Placebo
n=80 Participants
EOS+ (defined as ELEN Index \[proprietary mathematical algorithm to predict sputum eosinophil's greater than or equal to 2 percent\] positive and/or FeNO \[fraction of exhaled nitric oxide\] greater than or equal to \[\>=\] 50 parts per billion \[ppb\]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 2 mg
n=81 Participants
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 20 mg
n=81 Participants
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 100 mg
n=82 Participants
EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Placebo
EOS- (defined as ELEN Index negative and FeNO \<50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Benralizumab, 100 mg
EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Annual Asthma Exacerbation Rate (AER) for Eosinophilic Phenotype (EOS+) Participants
0.57 AER events/person-year
0.65 AER events/person-year
0.37 AER events/person-year
0.34 AER events/person-year

SECONDARY outcome

Timeframe: Baseline up to Week 66

Population: Due to change in planned analysis after unblinding of study data, dose response was not performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose (0 hour), Post-dose on Day 1, 6, Week 4, 16, 24, 32, 40, and 52

Population: The Pharmacokinetic (PK) Population included all participants who received at least one dose of benralizumab and had at least one quantifiable PK observation. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for PK in the 100 mg benralizumab group.

Outcome measures

Outcome measures
Measure
Eosinophilic Phenotype (EOS+) Placebo
n=81 Participants
EOS+ (defined as ELEN Index \[proprietary mathematical algorithm to predict sputum eosinophil's greater than or equal to 2 percent\] positive and/or FeNO \[fraction of exhaled nitric oxide\] greater than or equal to \[\>=\] 50 parts per billion \[ppb\]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 2 mg
n=81 Participants
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 20 mg
n=223 Participants
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 100 mg
EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Placebo
EOS- (defined as ELEN Index negative and FeNO \<50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Benralizumab, 100 mg
EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ss)
34.7 microgram per milliliter
Standard Deviation 131
182 microgram per milliliter
Standard Deviation 180
869 microgram per milliliter
Standard Deviation 665

SECONDARY outcome

Timeframe: Pre-dose (0 hour), Post-dose on Day 1, 6, Week 4, 16, 24, 32, 40, and 52

Population: The PK Population included all participants who received at least one dose of benralizumab and had at least one quantifiable PK observation. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for PK in the 100 mg benralizumab group.

Outcome measures

Outcome measures
Measure
Eosinophilic Phenotype (EOS+) Placebo
n=81 Participants
EOS+ (defined as ELEN Index \[proprietary mathematical algorithm to predict sputum eosinophil's greater than or equal to 2 percent\] positive and/or FeNO \[fraction of exhaled nitric oxide\] greater than or equal to \[\>=\] 50 parts per billion \[ppb\]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 2 mg
n=81 Participants
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 20 mg
n=223 Participants
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 100 mg
EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Placebo
EOS- (defined as ELEN Index negative and FeNO \<50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Benralizumab, 100 mg
EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Dose-Normalized Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ssD)
17.3 microgram per milliliter
Standard Deviation 65.3
9.10 microgram per milliliter
Standard Deviation 9.02
8.69 microgram per milliliter
Standard Deviation 6.65

SECONDARY outcome

Timeframe: Baseline up to Week 92

Population: The mITT population included all randomized participants who received any dose of investigational product.

Immunogenicity assessment included determination of anti-drug (benralizumab) antibodies in serum samples. ADA positive was defined as a titer \>=50 at any point in the study. It was observed at baseline and any visit during the study.

Outcome measures

Outcome measures
Measure
Eosinophilic Phenotype (EOS+) Placebo
n=80 Participants
EOS+ (defined as ELEN Index \[proprietary mathematical algorithm to predict sputum eosinophil's greater than or equal to 2 percent\] positive and/or FeNO \[fraction of exhaled nitric oxide\] greater than or equal to \[\>=\] 50 parts per billion \[ppb\]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 2 mg
n=81 Participants
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 20 mg
n=81 Participants
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 100 mg
n=82 Participants
EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Placebo
EOS- (defined as ELEN Index negative and FeNO \<50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Benralizumab, 100 mg
EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Percentage of Participants With Anti-Drug Antibodies (ADA) to Benralizumab in Eosinophilic Phenotype (EOS+) Participants
3.8 percentage of participants
42.0 percentage of participants
30.9 percentage of participants
25.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.

Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score was the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score. ACQ-6 score was summarized together for all participants.

Outcome measures

Outcome measures
Measure
Eosinophilic Phenotype (EOS+) Placebo
n=80 Participants
EOS+ (defined as ELEN Index \[proprietary mathematical algorithm to predict sputum eosinophil's greater than or equal to 2 percent\] positive and/or FeNO \[fraction of exhaled nitric oxide\] greater than or equal to \[\>=\] 50 parts per billion \[ppb\]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 2 mg
n=81 Participants
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 20 mg
n=81 Participants
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 100 mg
n=82 Participants
EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Placebo
n=142 Participants
EOS- (defined as ELEN Index negative and FeNO \<50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Benralizumab, 100 mg
n=140 Participants
EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Change From Baseline in Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 52
Baseline (n=80,80,80,82,142,140)
2.7479 units on a scale
Standard Deviation 0.9762
2.6479 units on a scale
Standard Deviation 0.9908
2.4750 units on a scale
Standard Deviation 0.9106
2.5346 units on a scale
Standard Deviation 0.9728
2.4742 units on a scale
Standard Deviation 0.8408
2.6381 units on a scale
Standard Deviation 0.8330
Change From Baseline in Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 52
Change at Week 52 (n=34,42,40,39,64,73)
-0.8922 units on a scale
Standard Deviation 1.1969
-1.1032 units on a scale
Standard Deviation 1.1207
-1.2500 units on a scale
Standard Deviation 1.2247
-1.1239 units on a scale
Standard Deviation 1.2852
-0.8418 units on a scale
Standard Deviation 1.1343
-1.1295 units on a scale
Standard Deviation 1.1301

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.

Total Nasal Symptoms Score (TNSS) is a 3-item questionnaire, the sum of nasal symptoms, namely, nasal obstruction (rhinorrhea), nasal congestion, and nasal itching/sneezing. Each symptom was rated on a scale from 0-3, with 0 representing no symptoms, 1 mild, 2 moderate, and 3 severe symptoms. TNSS score was a summation of the 3 individual nasal symptom. TNSS score could range from 0 to 9 where higher score indicates worsening. Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.

Outcome measures

Outcome measures
Measure
Eosinophilic Phenotype (EOS+) Placebo
n=222 Participants
EOS+ (defined as ELEN Index \[proprietary mathematical algorithm to predict sputum eosinophil's greater than or equal to 2 percent\] positive and/or FeNO \[fraction of exhaled nitric oxide\] greater than or equal to \[\>=\] 50 parts per billion \[ppb\]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 2 mg
n=81 Participants
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 20 mg
n=81 Participants
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 100 mg
n=222 Participants
EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Placebo
EOS- (defined as ELEN Index negative and FeNO \<50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Benralizumab, 100 mg
EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Change From Baseline in Mean Total Nasal Symptoms Score (TNSS) at Week 52
Baseline (n=71,27,25,81)
4.3 units on a scale
Standard Deviation 2.0
4.8 units on a scale
Standard Deviation 2.0
5.3 units on a scale
Standard Deviation 1.8
4.4 units on a scale
Standard Deviation 2.1
Change From Baseline in Mean Total Nasal Symptoms Score (TNSS) at Week 52
Change at Week 52 (n=89,39,39,106)
-0.4 units on a scale
Standard Deviation 2.90
-0.8 units on a scale
Standard Deviation 2.01
-1.0 units on a scale
Standard Deviation 2.96
-0.8 units on a scale
Standard Deviation 2.24

SECONDARY outcome

Timeframe: Baseline up to Week 51-52

Population: The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.

Asthma Symptom Diary included 7 questions about the participant symptom and the overall impact of treatment on the disease during the study period. Mean scores of the 7 questions were calculated to identify asthma symptom-free days. Asthma Symptom Diary Scores were analyzed on a bi-weekly basis and compared to baseline scores. Overall symptom score=(daytime frequency score + daytime severity score + nighttime severity score)/3, where total score ranges from 0 to 9. Higher score represents worsening. Mean asthma symptom diary score were summarized together for all participants. Mean asthma symptom diary score were summarized together for all participants. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.

Outcome measures

Outcome measures
Measure
Eosinophilic Phenotype (EOS+) Placebo
n=222 Participants
EOS+ (defined as ELEN Index \[proprietary mathematical algorithm to predict sputum eosinophil's greater than or equal to 2 percent\] positive and/or FeNO \[fraction of exhaled nitric oxide\] greater than or equal to \[\>=\] 50 parts per billion \[ppb\]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 2 mg
n=81 Participants
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 20 mg
n=81 Participants
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 100 mg
n=222 Participants
EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Placebo
EOS- (defined as ELEN Index negative and FeNO \<50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Benralizumab, 100 mg
EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Change From Baseline in Mean Asthma Symptom Diary Score at Week 51-52
Baseline (n=204,72,74,210)
1.58 units on a scale
Standard Deviation 0.60
1.65 units on a scale
Standard Deviation 0.65
1.60 units on a scale
Standard Deviation 0.61
1.60 units on a scale
Standard Deviation 0.62
Change From Baseline in Mean Asthma Symptom Diary Score at Week 51-52
Change at Week 51-52 (n=111,36,39,111)
-0.37 units on a scale
Standard Deviation 0.61
-0.56 units on a scale
Standard Deviation 0.76
-0.56 units on a scale
Standard Deviation 0.69
-0.53 units on a scale
Standard Deviation 0.67

SECONDARY outcome

Timeframe: Baseline up to Week 51-52

Population: The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. Data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.

Participants were provided inhalers of the same dose (medium- or high-dose) inhaled corticosteroid (ICS) plus long-acting beta antagonist (LABA) combination product as baseline prophylactic medication and continued with same dose throughout the study. Rescue medications such as short-term beta2 agonists were used as first-line treatment for worsening asthma symptoms. Investigator prescribed additional short term asthma controller medications included additional ICS, theophylline, inhaled cromones or antimuscarinics; if asthma symptoms remained mild but not resolved. If asthma symptoms worsened, participants received an oral corticosteroid burst. All rescue medications use with prophylactic medication (+ prophylactic) and without prophylactic medication (- prophylactic) was recorded in asthma symptom dairy by participant. Rescue medication use was analyzed on a bi-weekly basis and compared to baseline scores.

Outcome measures

Outcome measures
Measure
Eosinophilic Phenotype (EOS+) Placebo
n=222 Participants
EOS+ (defined as ELEN Index \[proprietary mathematical algorithm to predict sputum eosinophil's greater than or equal to 2 percent\] positive and/or FeNO \[fraction of exhaled nitric oxide\] greater than or equal to \[\>=\] 50 parts per billion \[ppb\]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 2 mg
n=81 Participants
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 20 mg
n=81 Participants
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 100 mg
n=222 Participants
EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Placebo
EOS- (defined as ELEN Index negative and FeNO \<50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Benralizumab, 100 mg
EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Change From Baseline in Rescue Medication Use at Week 51-52
Change Week 51-52 -prophylactic(n=111,36,39,111)
-1.2540 rescue medication per 2 weeks
Standard Deviation 2.4571
-1.4116 rescue medication per 2 weeks
Standard Deviation 2.8722
-1.8804 rescue medication per 2 weeks
Standard Deviation 5.3129
-1.1589 rescue medication per 2 weeks
Standard Deviation 2.0086
Change From Baseline in Rescue Medication Use at Week 51-52
Baseline without prophylactic (n=204,72,74,210)
3.09 rescue medication per 2 weeks
Standard Deviation 2.55
3.57 rescue medication per 2 weeks
Standard Deviation 3.67
3.82 rescue medication per 2 weeks
Standard Deviation 4.34
3.16 rescue medication per 2 weeks
Standard Deviation 2.82
Change From Baseline in Rescue Medication Use at Week 51-52
Baseline with prophylactic (n=204,72,74,210)
4.07 rescue medication per 2 weeks
Standard Deviation 3.34
4.71 rescue medication per 2 weeks
Standard Deviation 5.56
5.24 rescue medication per 2 weeks
Standard Deviation 6.40
4.22 rescue medication per 2 weeks
Standard Deviation 3.90
Change From Baseline in Rescue Medication Use at Week 51-52
Change Week 51-52 +prophylactic(n=111,36,39,111)
-1.6855 rescue medication per 2 weeks
Standard Deviation 3.2875
-1.6810 rescue medication per 2 weeks
Standard Deviation 4.2247
-2.5118 rescue medication per 2 weeks
Standard Deviation 7.6814
-1.4693 rescue medication per 2 weeks
Standard Deviation 2.5603

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.

FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.

Outcome measures

Outcome measures
Measure
Eosinophilic Phenotype (EOS+) Placebo
n=222 Participants
EOS+ (defined as ELEN Index \[proprietary mathematical algorithm to predict sputum eosinophil's greater than or equal to 2 percent\] positive and/or FeNO \[fraction of exhaled nitric oxide\] greater than or equal to \[\>=\] 50 parts per billion \[ppb\]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 2 mg
n=81 Participants
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 20 mg
n=81 Participants
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 100 mg
n=222 Participants
EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Placebo
EOS- (defined as ELEN Index negative and FeNO \<50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Benralizumab, 100 mg
EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 52
Baseline (n=215,80,81,218)
2.033 liters
Standard Deviation 0.669
1.978 liters
Standard Deviation 0.701
2.080 liters
Standard Deviation 0.751
2.012 liters
Standard Deviation 0.672
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 52
Change at Week 52 (n=150,51,58,160)
0.0098 liters
Standard Deviation 0.3615
0.1631 liters
Standard Deviation 0.4691
0.1847 liters
Standard Deviation 0.5234
0.0998 liters
Standard Deviation 0.3541

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.

Forced Vital Capacity (FVC) was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.

Outcome measures

Outcome measures
Measure
Eosinophilic Phenotype (EOS+) Placebo
n=80 Participants
EOS+ (defined as ELEN Index \[proprietary mathematical algorithm to predict sputum eosinophil's greater than or equal to 2 percent\] positive and/or FeNO \[fraction of exhaled nitric oxide\] greater than or equal to \[\>=\] 50 parts per billion \[ppb\]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 2 mg
n=81 Participants
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 20 mg
n=81 Participants
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 100 mg
n=82 Participants
EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Placebo
n=142 Participants
EOS- (defined as ELEN Index negative and FeNO \<50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Benralizumab, 100 mg
n=140 Participants
EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Change From Baseline in Mean Forced Vital Capacity (FVC) at Week 52
Baseline (n=80,80,81,82,135,136)
3.282 liters
Standard Deviation 1.030
3.069 liters
Standard Deviation 0.957
3.285 liters
Standard Deviation 1.028
3.110 liters
Standard Deviation 0.851
3.043 liters
Standard Deviation 0.864
3.126 liters
Standard Deviation 0.981
Change From Baseline in Mean Forced Vital Capacity (FVC) at Week 52
Change at Week 52 (n=51,51,58,59,99,101)
0.029 liters
Standard Deviation 0.514
0.129 liters
Standard Deviation 0.565
0.190 liters
Standard Deviation 0.586
0.166 liters
Standard Deviation 0.445
-0.030 liters
Standard Deviation 0.426
0.056 liters
Standard Deviation 0.371

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.

The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed while sitting or standing prior to using any medication (if needed) for asthma. Home PEF was determined separately for morning and evening, and were averaged for each participant. Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.

Outcome measures

Outcome measures
Measure
Eosinophilic Phenotype (EOS+) Placebo
n=222 Participants
EOS+ (defined as ELEN Index \[proprietary mathematical algorithm to predict sputum eosinophil's greater than or equal to 2 percent\] positive and/or FeNO \[fraction of exhaled nitric oxide\] greater than or equal to \[\>=\] 50 parts per billion \[ppb\]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 2 mg
n=81 Participants
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 20 mg
n=81 Participants
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 100 mg
n=222 Participants
EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Placebo
EOS- (defined as ELEN Index negative and FeNO \<50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Benralizumab, 100 mg
EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Change From Baseline in Peak Expiratory Flow (PEF) at Week 52
Baseline (n=215,80,81,218)
319.3 liters per minute
Standard Deviation 104.7
325.5 liters per minute
Standard Deviation 101.6
323.1 liters per minute
Standard Deviation 100.8
323.8 liters per minute
Standard Deviation 101.7
Change From Baseline in Peak Expiratory Flow (PEF) at Week 52
Change at Week 52 (n=150,51,58,160)
13.0 liters per minute
Standard Deviation 64.6
29.0 liters per minute
Standard Deviation 64.1
45.9 liters per minute
Standard Deviation 95.5
26.6 liters per minute
Standard Deviation 66.3

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. Data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.

AQLQ: a 32-item questionnaire evaluating quality of life of participants with asthma including 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). The AQLQ(S) responses were categorized as improvement (defined as change from baseline \>=0.5), no change (defined as change from baseline \>= -0.5 to less than \[\<\] 0.5), and worse (defined as change from baseline \< -0.5). Data was summarized by each treatment group.

Outcome measures

Outcome measures
Measure
Eosinophilic Phenotype (EOS+) Placebo
n=222 Participants
EOS+ (defined as ELEN Index \[proprietary mathematical algorithm to predict sputum eosinophil's greater than or equal to 2 percent\] positive and/or FeNO \[fraction of exhaled nitric oxide\] greater than or equal to \[\>=\] 50 parts per billion \[ppb\]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 2 mg
n=81 Participants
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 20 mg
n=81 Participants
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 100 mg
n=222 Participants
EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Placebo
EOS- (defined as ELEN Index negative and FeNO \<50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Benralizumab, 100 mg
EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Score at Week 52
Baseline (n=214,78,80,217)
3.72 units on a scale
Standard Deviation 1.04
3.72 units on a scale
Standard Deviation 1.17
3.79 units on a scale
Standard Deviation 1.06
3.72 units on a scale
Standard Deviation 1.01
Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Score at Week 52
Change at Week 52 (n=88,39,38,105)
0.9634 units on a scale
Standard Deviation 1.3342
1.2612 units on a scale
Standard Deviation 1.2082
1.4474 units on a scale
Standard Deviation 1.4262
1.1223 units on a scale
Standard Deviation 1.2636

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.

The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The health state valuation was the summary score of mobility, self-care, usual activities, pain/discomfort and anxiety/depression on a 3 category scale (no problem, moderate problem, severe problems). Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.

Outcome measures

Outcome measures
Measure
Eosinophilic Phenotype (EOS+) Placebo
n=222 Participants
EOS+ (defined as ELEN Index \[proprietary mathematical algorithm to predict sputum eosinophil's greater than or equal to 2 percent\] positive and/or FeNO \[fraction of exhaled nitric oxide\] greater than or equal to \[\>=\] 50 parts per billion \[ppb\]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 2 mg
n=81 Participants
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 20 mg
n=81 Participants
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 100 mg
n=222 Participants
EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Placebo
EOS- (defined as ELEN Index negative and FeNO \<50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Benralizumab, 100 mg
EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Change From Baseline in European Quality of Life - 5 Dimensions (EQ-5D) Health State Evaluation at Week 52
Baseline (n=213,79,74,209)
0.7629 units on a scale
Standard Deviation 0.2153
0.7418 units on a scale
Standard Deviation 0.2376
0.7877 units on a scale
Standard Deviation 0.1878
0.7679 units on a scale
Standard Deviation 0.1623
Change From Baseline in European Quality of Life - 5 Dimensions (EQ-5D) Health State Evaluation at Week 52
Change at Week 52 (n=148,58,53,161)
0.0853 units on a scale
Standard Deviation 0.2096
0.0822 units on a scale
Standard Deviation 0.3137
0.1223 units on a scale
Standard Deviation 0.2132
0.0824 units on a scale
Standard Deviation 0.2179

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.

The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The EQ-5D VAS was measured from 0 (worst imaginable health state) to 100 (best imaginable health state). Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.

Outcome measures

Outcome measures
Measure
Eosinophilic Phenotype (EOS+) Placebo
n=222 Participants
EOS+ (defined as ELEN Index \[proprietary mathematical algorithm to predict sputum eosinophil's greater than or equal to 2 percent\] positive and/or FeNO \[fraction of exhaled nitric oxide\] greater than or equal to \[\>=\] 50 parts per billion \[ppb\]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 2 mg
n=81 Participants
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 20 mg
n=81 Participants
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 100 mg
n=222 Participants
EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Placebo
EOS- (defined as ELEN Index negative and FeNO \<50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Benralizumab, 100 mg
EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Change From Baseline in EQ-5D Visual Analog Scale (VAS) at Week 52
Baseline (n=213,79,74,208)
65.0798 units on a scale
Standard Deviation 17.8903
65.4937 units on a scale
Standard Deviation 18.5063
64.3378 units on a scale
Standard Deviation 18.1427
64.6250 units on a scale
Standard Deviation 19.7778
Change From Baseline in EQ-5D Visual Analog Scale (VAS) at Week 52
Change at Week 52 (n=148,58,53,161)
12.8041 units on a scale
Standard Deviation 19.1036
12.5517 units on a scale
Standard Deviation 20.8008
15.4906 units on a scale
Standard Deviation 21.7297
13.7391 units on a scale
Standard Deviation 20.5139

SECONDARY outcome

Timeframe: Baseline up to Week 51-52

Population: The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.

Percentage of nocturnal awakening-free nights were analyzed on a bi-weekly basis and compared to baseline scores. Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.

Outcome measures

Outcome measures
Measure
Eosinophilic Phenotype (EOS+) Placebo
n=222 Participants
EOS+ (defined as ELEN Index \[proprietary mathematical algorithm to predict sputum eosinophil's greater than or equal to 2 percent\] positive and/or FeNO \[fraction of exhaled nitric oxide\] greater than or equal to \[\>=\] 50 parts per billion \[ppb\]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 2 mg
n=81 Participants
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 20 mg
n=81 Participants
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 100 mg
n=222 Participants
EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Placebo
EOS- (defined as ELEN Index negative and FeNO \<50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Benralizumab, 100 mg
EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Change From Baseline in Percentage of Nocturnal Awakening-Free Nights at Week 51-52
Baseline (n=204,72,74,210)
52.05 percent nocturnal awakening-free nights
Standard Deviation 36.96
45.07 percent nocturnal awakening-free nights
Standard Deviation 40.04
51.57 percent nocturnal awakening-free nights
Standard Deviation 39.72
50.92 percent nocturnal awakening-free nights
Standard Deviation 37.72
Change From Baseline in Percentage of Nocturnal Awakening-Free Nights at Week 51-52
Change at Week 51-52 (n=111,36,39,111)
19.7595 percent nocturnal awakening-free nights
Standard Deviation 39.1388
27.1749 percent nocturnal awakening-free nights
Standard Deviation 41.7342
29.6181 percent nocturnal awakening-free nights
Standard Deviation 38.4315
23.3054 percent nocturnal awakening-free nights
Standard Deviation 36.2761

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.

Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.

Outcome measures

Outcome measures
Measure
Eosinophilic Phenotype (EOS+) Placebo
n=222 Participants
EOS+ (defined as ELEN Index \[proprietary mathematical algorithm to predict sputum eosinophil's greater than or equal to 2 percent\] positive and/or FeNO \[fraction of exhaled nitric oxide\] greater than or equal to \[\>=\] 50 parts per billion \[ppb\]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 2 mg
n=81 Participants
EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 20 mg
n=81 Participants
EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS+ Benralizumab, 100 mg
n=222 Participants
EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Placebo
EOS- (defined as ELEN Index negative and FeNO \<50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
EOS- Benralizumab, 100 mg
EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Change From Baseline in Mean Fraction Exhaled Nitric Oxide (FeNO) at Week 52
Baseline (n=222,81,81,222)
26.88 parts per billion
Standard Deviation 23.57
39.52 parts per billion
Standard Deviation 32.67
40.79 parts per billion
Standard Deviation 31.03
26.68 parts per billion
Standard Deviation 23.10
Change From Baseline in Mean Fraction Exhaled Nitric Oxide (FeNO) at Week 52
Change at Week 52 (n=148,57,56,157)
1.2523 parts per billion
Standard Deviation 16.0200
-3.2222 parts per billion
Standard Deviation 33.2543
-6.1905 parts per billion
Standard Deviation 30.1103
1.4384 parts per billion
Standard Deviation 28.9090

Adverse Events

EOS POS Placebo

Serious events: 7 serious events
Other events: 44 other events
Deaths: 0 deaths

EOS POS Benralizumab 2 mg

Serious events: 10 serious events
Other events: 54 other events
Deaths: 0 deaths

EOS POS Benralizumab 20 mg

Serious events: 6 serious events
Other events: 57 other events
Deaths: 0 deaths

EOS POS Benralizumab 100 mg

Serious events: 6 serious events
Other events: 68 other events
Deaths: 0 deaths

EOS NEG Placebo

Serious events: 16 serious events
Other events: 94 other events
Deaths: 0 deaths

EOS NEG Benralizumab 100 mg

Serious events: 18 serious events
Other events: 93 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
EOS POS Placebo
n=80 participants at risk
EOS+ participants received two placebo injections subcutaneously.
EOS POS Benralizumab 2 mg
n=81 participants at risk
EOS+ participants received single benralizumab 2 milligram (mg) injection followed by a single placebo injection subcutaneously.
EOS POS Benralizumab 20 mg
n=81 participants at risk
EOS+ participants received single benralizumab 20 mg injection followed by a single placebo injection subcutaneously.
EOS POS Benralizumab 100 mg
n=82 participants at risk
EOS+ participants received two benralizumab 50 mg injections subcutaneously.
EOS NEG Placebo
n=141 participants at risk
EOS- participants received two placebo injections subcutaneously.
EOS NEG Benralizumab 100 mg
n=141 participants at risk
EOS- participants received two benralizumab 50 mg injections subcutaneously.
Cardiac disorders
Acute myocardial infarct
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
1.2%
1/81 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Cardiac disorders
Atrial fibrillation
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Cardiac disorders
Cardiac failure acute
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Cardiac disorders
Myocardial ischaemia
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
2.5%
2/81 • Number of events 2 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Cardiac disorders
Supraventricular tachyca
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Gastrointestinal disorders
Abdominal hernia
1.2%
1/80 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Gastrointestinal disorders
Abdominal pain
1.2%
1/80 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
1.2%
1/82 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 4 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Gastrointestinal disorders
Gastrooesophageal reflux
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Gastrointestinal disorders
Intestinal obstruction
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Hepatobiliary disorders
Cholecystitis
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Hepatobiliary disorders
Cholecystitis acute
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Immune system disorders
Drug hypersensitivity
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
1.2%
1/82 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Infections and infestations
Bronchitis
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Infections and infestations
Cholecystitis infective
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Infections and infestations
Eczema infected
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Infections and infestations
Enteritis infectious
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Infections and infestations
Gastritis viral
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
1.2%
1/82 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Infections and infestations
Herpes zoster
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Infections and infestations
Pneumonia
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
1.2%
1/81 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
1.2%
1/82 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 2 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
2.1%
3/141 • Number of events 3 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Injury, poisoning and procedural complications
Abdominal wound dehiscen
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Metabolism and nutrition disorders
Hypercholesterolaemia
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
1.2%
1/81 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
2.5%
2/81 • Number of events 2 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
1.2%
1/81 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Musculoskeletal and connective tissue disorders
Osteochondrosis
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
1.2%
1/81 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibrous histiocytoma
1.2%
1/80 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
1.2%
1/81 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Nervous system disorders
Convulsion
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
1.2%
1/81 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Nervous system disorders
Grand mal convulsion
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
1.2%
1/81 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Nervous system disorders
Ischaemic stroke
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Nervous system disorders
Syncope
1.2%
1/80 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Psychiatric disorders
Depression
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Psychiatric disorders
Insomnia
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Respiratory, thoracic and mediastinal disorders
Asthma
2.5%
2/80 • Number of events 2 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
2.5%
2/81 • Number of events 2 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
2.4%
2/82 • Number of events 3 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
5.7%
8/141 • Number of events 14 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
3.5%
5/141 • Number of events 5 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
1.2%
1/80 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
1.2%
1/81 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Respiratory, thoracic and mediastinal disorders
Nasal polyps
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
1.2%
1/82 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Skin and subcutaneous tissue disorders
Erythema nodosum
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
1.2%
1/81 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Skin and subcutaneous tissue disorders
Urticaria
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Gastrointestinal disorders
Umbilical hernia
1.2%
1/80 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Immune system disorders
Anaphylactic reaction
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Infections and infestations
Gastroenteritis
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Infections and infestations
Lower respiratory tract
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Infections and infestations
Post procedural cellulit
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
1.2%
1/81 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Infections and infestations
Postoperative wound infe
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
1.2%
1/82 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Infections and infestations
Tonsillitis bacterial
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
1.2%
1/82 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Injury, poisoning and procedural complications
Ulna fracture
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
1.2%
1/81 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
1.2%
1/81 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
1.2%
1/82 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Respiratory, thoracic and mediastinal disorders
Interstitial lung diseas
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Skin and subcutaneous tissue disorders
Eczema
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Vascular disorders
Hypertension
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
1.2%
1/82 • Number of events 3 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Vascular disorders
Polyarteritis nodosa
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/82 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .

Other adverse events

Other adverse events
Measure
EOS POS Placebo
n=80 participants at risk
EOS+ participants received two placebo injections subcutaneously.
EOS POS Benralizumab 2 mg
n=81 participants at risk
EOS+ participants received single benralizumab 2 milligram (mg) injection followed by a single placebo injection subcutaneously.
EOS POS Benralizumab 20 mg
n=81 participants at risk
EOS+ participants received single benralizumab 20 mg injection followed by a single placebo injection subcutaneously.
EOS POS Benralizumab 100 mg
n=82 participants at risk
EOS+ participants received two benralizumab 50 mg injections subcutaneously.
EOS NEG Placebo
n=141 participants at risk
EOS- participants received two placebo injections subcutaneously.
EOS NEG Benralizumab 100 mg
n=141 participants at risk
EOS- participants received two benralizumab 50 mg injections subcutaneously.
Nervous system disorders
Headache
10.0%
8/80 • Number of events 13 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
9.9%
8/81 • Number of events 13 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
7.4%
6/81 • Number of events 10 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
11.0%
9/82 • Number of events 10 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
5.7%
8/141 • Number of events 9 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
9.2%
13/141 • Number of events 17 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Respiratory, thoracic and mediastinal disorders
Asthma
37.5%
30/80 • Number of events 51 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
34.6%
28/81 • Number of events 59 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
29.6%
24/81 • Number of events 42 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
31.7%
26/82 • Number of events 36 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
29.8%
42/141 • Number of events 67 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
29.8%
42/141 • Number of events 77 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
3.8%
3/80 • Number of events 3 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
3.7%
3/81 • Number of events 5 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
9.9%
8/81 • Number of events 13 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
7.3%
6/82 • Number of events 8 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
2.8%
4/141 • Number of events 8 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
3.5%
5/141 • Number of events 11 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Vascular disorders
Hypertension
1.2%
1/80 • Number of events 2 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
3.7%
3/81 • Number of events 3 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/81 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
3.7%
3/82 • Number of events 3 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
2.8%
4/141 • Number of events 4 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
7.1%
10/141 • Number of events 12 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
General disorders
Injection site erythema
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
2.5%
2/81 • Number of events 2 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
2.5%
2/81 • Number of events 4 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
9.8%
8/82 • Number of events 17 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
7.1%
10/141 • Number of events 17 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Infections and infestations
Influenza
5.0%
4/80 • Number of events 4 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
3.7%
3/81 • Number of events 5 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
8.6%
7/81 • Number of events 7 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
7.3%
6/82 • Number of events 6 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
7.1%
10/141 • Number of events 11 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
4.3%
6/141 • Number of events 6 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Infections and infestations
Acute sinusitis
3.8%
3/80 • Number of events 7 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
4.9%
4/81 • Number of events 6 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
2.5%
2/81 • Number of events 2 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
3.7%
3/82 • Number of events 3 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
1.4%
2/141 • Number of events 4 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
4.3%
6/141 • Number of events 8 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Infections and infestations
Sinusitis
3.8%
3/80 • Number of events 6 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
4.9%
4/81 • Number of events 7 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
3.7%
3/81 • Number of events 3 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
2.4%
2/82 • Number of events 3 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
1.4%
2/141 • Number of events 2 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.00%
0/141 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Gastrointestinal disorders
Nausea
2.5%
2/80 • Number of events 3 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
3.7%
3/81 • Number of events 3 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
2.5%
2/81 • Number of events 2 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
1.2%
1/82 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
1.4%
2/141 • Number of events 2 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
1.4%
2/141 • Number of events 2 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
General disorders
Injection site pain
0.00%
0/80 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
7.4%
6/81 • Number of events 6 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
4.9%
4/81 • Number of events 17 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
2.4%
2/82 • Number of events 3 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
4.3%
6/141 • Number of events 12 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
1.4%
2/141 • Number of events 4 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
General disorders
Pyrexia
1.2%
1/80 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
4.9%
4/81 • Number of events 4 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
3.7%
3/81 • Number of events 3 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
1.2%
1/82 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
1.4%
2/141 • Number of events 2 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Infections and infestations
Bronchitis
3.8%
3/80 • Number of events 4 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
9.9%
8/81 • Number of events 10 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
7.4%
6/81 • Number of events 8 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
3.7%
3/82 • Number of events 4 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
9.2%
13/141 • Number of events 20 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
6.4%
9/141 • Number of events 11 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Infections and infestations
Nasopharyngitis
10.0%
8/80 • Number of events 13 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
13.6%
11/81 • Number of events 19 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
8.6%
7/81 • Number of events 13 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
15.9%
13/82 • Number of events 16 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
3.5%
5/141 • Number of events 6 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
9.2%
13/141 • Number of events 17 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Infections and infestations
Pharyngitis
3.8%
3/80 • Number of events 3 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
9.9%
8/81 • Number of events 10 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
3.7%
3/81 • Number of events 3 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
8.5%
7/82 • Number of events 9 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
3.5%
5/141 • Number of events 5 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
4.3%
6/141 • Number of events 6 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Infections and infestations
Rhinitis
3.8%
3/80 • Number of events 3 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
3.7%
3/81 • Number of events 3 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
3.7%
3/81 • Number of events 3 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
2.4%
2/82 • Number of events 3 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
3.5%
5/141 • Number of events 5 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
2.1%
3/141 • Number of events 7 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Infections and infestations
Upper respiratory tract
5.0%
4/80 • Number of events 6 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
8.6%
7/81 • Number of events 12 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
8.6%
7/81 • Number of events 8 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
6.1%
5/82 • Number of events 6 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
7.1%
10/141 • Number of events 12 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
7.8%
11/141 • Number of events 14 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Infections and infestations
Urinary tract infection
5.0%
4/80 • Number of events 4 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
2.5%
2/81 • Number of events 3 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
1.2%
1/81 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
3.7%
3/82 • Number of events 4 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
3.5%
5/141 • Number of events 5 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
2.1%
3/141 • Number of events 3 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Musculoskeletal and connective tissue disorders
Arthralgia
1.2%
1/80 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
4.9%
4/81 • Number of events 5 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
6.2%
5/81 • Number of events 6 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
3.7%
3/82 • Number of events 3 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
2.1%
3/141 • Number of events 3 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Musculoskeletal and connective tissue disorders
Back pain
3.8%
3/80 • Number of events 3 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
4.9%
4/81 • Number of events 4 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
2.5%
2/81 • Number of events 2 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
2.4%
2/82 • Number of events 4 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
2.1%
3/141 • Number of events 3 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Musculoskeletal and connective tissue disorders
Myalgia
1.2%
1/80 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
2.5%
2/81 • Number of events 2 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
3.7%
3/81 • Number of events 3 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
2.4%
2/82 • Number of events 3 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
0.71%
1/141 • Number of events 1 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
3.5%
5/141 • Number of events 5 • From initiation of investigational product administration up to Week 92
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .

Additional Information

Rene van der Merwe, MBChB, MFPM, Medical Officer

MedImmune, LLC

Phone: 301-398-0000

Results disclosure agreements

  • Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
  • Publication restrictions are in place

Restriction type: OTHER