Trial Outcomes & Findings for Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History (NCT NCT02155660)

Last Updated: 2019-06-26

Results Overview

A COPD exacerbation is defined by symptomatic worsening of COPD requiring: * Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or * Use of antibiotics; and/or * An inpatient hospitalization or death due to COPD Annual COPD exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2255 participants

Primary outcome timeframe

Immediately following the first IP dose through week 56

Results posted on

2019-06-26

Participant Flow

2255 patients signed informed consent and were randomized to received treatment with benralizumab 10 mg,30 mg, 100 mg or placebo. One participant was excluded from the analysis. Therefore results are provided for 2254 participants.

Participant milestones

Participant milestones
Measure	Benralizumab 10 mg Every 8 weeks administered subcutaneously	Benralizumab 30 mg Every 8 weeks administered subcutaneously	Benralizumab 100 mg Every 8 weeks administered subcutaneously	Placebo Every 8 weeks administered subcutaneously
Overall Study STARTED	562	562	562	568
Overall Study COMPLETED	504	489	502	507
Overall Study NOT COMPLETED	58	73	60	61

Reasons for withdrawal

Reasons for withdrawal
Measure	Benralizumab 10 mg Every 8 weeks administered subcutaneously	Benralizumab 30 mg Every 8 weeks administered subcutaneously	Benralizumab 100 mg Every 8 weeks administered subcutaneously	Placebo Every 8 weeks administered subcutaneously
Overall Study Other Reason	8	6	10	10
Overall Study Study-specific withdrawal criteria	0	1	1	1
Overall Study Severe non-compliance	0	4	0	1
Overall Study Adverse Event	2	6	3	1
Overall Study Lost to Follow-up	3	6	5	8
Overall Study Death	17	19	17	19
Overall Study Withdrawal by Subject	28	31	24	21

Baseline Characteristics

Full analysis set

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Benralizumab 10 mg n=562 Participants Every 8 weeks administered subcutaneously	Benralizumab 30 mg n=562 Participants Every 8 weeks administered subcutaneously	Benralizumab 100 mg n=562 Participants Every 8 weeks administered subcutaneously	Placebo n=568 Participants Every 8 weeks administered subcutaneously	Total n=2254 Participants Total of all reporting groups
Age, Continuous	64.7 Years STANDARD_DEVIATION 8.47 • n=5 Participants • Full analysis set	65.6 Years STANDARD_DEVIATION 8.61 • n=7 Participants • Full analysis set	65.0 Years STANDARD_DEVIATION 8.23 • n=5 Participants • Full analysis set	65.3 Years STANDARD_DEVIATION 8.44 • n=4 Participants • Full analysis set	65.2 Years STANDARD_DEVIATION 8.44 • n=21 Participants • Full analysis set
Sex: Female, Male Female	196 Participants n=5 Participants • Full analysis set	194 Participants n=7 Participants • Full analysis set	207 Participants n=5 Participants • Full analysis set	209 Participants n=4 Participants • Full analysis set	806 Participants n=21 Participants • Full analysis set
Sex: Female, Male Male	366 Participants n=5 Participants • Full analysis set	368 Participants n=7 Participants • Full analysis set	355 Participants n=5 Participants • Full analysis set	359 Participants n=4 Participants • Full analysis set	1448 Participants n=21 Participants • Full analysis set
Race/Ethnicity, Customized White	441 participants n=5 Participants • Full analysis set	444 participants n=7 Participants • Full analysis set	443 participants n=5 Participants • Full analysis set	446 participants n=4 Participants • Full analysis set	1774 participants n=21 Participants • Full analysis set
Race/Ethnicity, Customized Black or African American	8 participants n=5 Participants • Full analysis set	12 participants n=7 Participants • Full analysis set	16 participants n=5 Participants • Full analysis set	19 participants n=4 Participants • Full analysis set	55 participants n=21 Participants • Full analysis set
Race/Ethnicity, Customized Asian	70 participants n=5 Participants • Full analysis set	69 participants n=7 Participants • Full analysis set	67 participants n=5 Participants • Full analysis set	67 participants n=4 Participants • Full analysis set	273 participants n=21 Participants • Full analysis set
Race/Ethnicity, Customized Other	43 participants n=5 Participants • Full analysis set	37 participants n=7 Participants • Full analysis set	36 participants n=5 Participants • Full analysis set	36 participants n=4 Participants • Full analysis set	152 participants n=21 Participants • Full analysis set

PRIMARY outcome

Timeframe: Immediately following the first IP dose through week 56

Population: Full analysis set, baseline EOS\>=220/uL

Outcome measures

Outcome measures
Measure	Benralizumab 10 mg n=377 Participants Every 8 weeks administered subcutaneously	Benralizumab 30 mg n=394 Participants Every 8 weeks administered subcutaneously	Benralizumab 100 mg n=386 Participants Every 8 weeks administered subcutaneously	Placebo n=388 Participants Every 8 weeks administered subcutaneously
Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL	0.99 Exacerbations per year Interval 0.87 to 1.13	1.21 Exacerbations per year Interval 1.08 to 1.37	1.09 Exacerbations per year Interval 0.96 to 1.23	1.17 Exacerbations per year Interval 1.04 to 1.32

SECONDARY outcome

Timeframe: Immediately following the first IP dose through week 56

Population: Full analysis set, baseline EOS\<220/uL

Outcome measures

Outcome measures
Measure	Benralizumab 10 mg n=185 Participants Every 8 weeks administered subcutaneously	Benralizumab 30 mg n=168 Participants Every 8 weeks administered subcutaneously	Benralizumab 100 mg n=176 Participants Every 8 weeks administered subcutaneously	Placebo n=180 Participants Every 8 weeks administered subcutaneously
Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS<220/uL	1.23 Exacerbations per year Interval 1.03 to 1.46	1.27 Exacerbations per year Interval 1.05 to 1.53	1.21 Exacerbations per year Interval 1.0 to 1.45	1.18 Exacerbations per year Interval 0.98 to 1.41

SECONDARY outcome

Timeframe: First IP up to end of treatment Week 56

Population: Full analysis set, baseline EOS\>=220/uL

Pre-bronchodilator FEV1 (L) is collected at Weeks 0, 4, 8, 16, 24, 32, 40, 48, and 56. Baseline is the last non-missing value with quality (acceptable or borderline quality grade) prior to the first dose of study treatment.

Outcome measures

Outcome measures
Measure	Benralizumab 10 mg n=325 Participants Every 8 weeks administered subcutaneously	Benralizumab 30 mg n=322 Participants Every 8 weeks administered subcutaneously	Benralizumab 100 mg n=347 Participants Every 8 weeks administered subcutaneously	Placebo n=344 Participants Every 8 weeks administered subcutaneously
Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline EOS>=220/uL	0.021 Liter Standard Deviation 0.346	0.011 Liter Standard Deviation 0.289	0.033 Liter Standard Deviation 0.291	0.016 Liter Standard Deviation 0.292

SECONDARY outcome

Timeframe: First IP up to Week 56

Population: Full analysis set, baseline EOS\>=220/uL

SGRQ is from 50-item PRO instrument. The SGRQ total score is expressed as a percentage of overall impairment, in which 100% means the worst possible health status and 0 indicates the best possible health status.

Outcome measures

Outcome measures
Measure	Benralizumab 10 mg n=331 Participants Every 8 weeks administered subcutaneously	Benralizumab 30 mg n=329 Participants Every 8 weeks administered subcutaneously	Benralizumab 100 mg n=354 Participants Every 8 weeks administered subcutaneously	Placebo n=349 Participants Every 8 weeks administered subcutaneously
Mean Change From Baseline in SGRQ Total Score for Patients With Baseline EOS>=220/uL	-7.733 Percentage Standard Deviation 14.996	-8.674 Percentage Standard Deviation 17.910	-7.257 Percentage Standard Deviation 15.989	-6.863 Percentage Standard Deviation 16.344

SECONDARY outcome

Timeframe: First IP up to Week 56

Population: Full analysis set, baseline EOS\>=220/uL

CAT is an 8-item PRO developed to measure the impact of COPD on health status. The instrument uses semantic differential six-point response scales. A CAT total score is the sum of item responses. Score ranges from 0 to 40 with higher scores indicative of greater COPD impact on health status.

Outcome measures

Outcome measures
Measure	Benralizumab 10 mg n=332 Participants Every 8 weeks administered subcutaneously	Benralizumab 30 mg n=331 Participants Every 8 weeks administered subcutaneously	Benralizumab 100 mg n=354 Participants Every 8 weeks administered subcutaneously	Placebo n=350 Participants Every 8 weeks administered subcutaneously
Mean Change From Baseline in CAT Total Score for Patients With Baseline EOS>=220/uL	-2.18 Score on a scale Standard Deviation 6.78	-2.43 Score on a scale Standard Deviation 7.18	-2.36 Score on a scale Standard Deviation 6.67	-2.36 Score on a scale Standard Deviation 6.54

SECONDARY outcome

Timeframe: First IP up to Week 56

Population: Full analysis set, baseline EOS\>=220/uL

The E-RS: COPD is an 11-item PRO developed to evaluate the severity of respiratory symptoms of COPD. Summation of E-RS: COPD item responses produces a total score ranging from 0 to 40, with higher scores indicating greater severity.

Outcome measures

Outcome measures
Measure	Benralizumab 10 mg n=316 Participants Every 8 weeks administered subcutaneously	Benralizumab 30 mg n=302 Participants Every 8 weeks administered subcutaneously	Benralizumab 100 mg n=317 Participants Every 8 weeks administered subcutaneously	Placebo n=325 Participants Every 8 weeks administered subcutaneously
Mean Change From Baseline in E-RS: COPD Total Score for Patients With Baseline EOS>=220/uL	-1.657 Score on a scale Standard Deviation 5.701	-2.219 Score on a scale Standard Deviation 6.381	-1.593 Score on a scale Standard Deviation 5.665	-1.137 Score on a scale Standard Deviation 5.935

SECONDARY outcome

Timeframe: First IP up to Week 56

Population: Full analysis set, baseline EOS\>=220/uL

The number of rescue medication inhalations and nebulizer treatments taken are recorded by the patient in the eDiary twice daily. Total rescue medication use is the sum of daytime and night-time use.

Outcome measures

Outcome measures
Measure	Benralizumab 10 mg n=305 Participants Every 8 weeks administered subcutaneously	Benralizumab 30 mg n=290 Participants Every 8 weeks administered subcutaneously	Benralizumab 100 mg n=310 Participants Every 8 weeks administered subcutaneously	Placebo n=314 Participants Every 8 weeks administered subcutaneously
Mean Change From Baseline in Total Rescue Medication Use (Number of Puffs Per Day) for Patients With Baseline EOS>=220/uL	-0.36 Puffs/day Standard Deviation 3.04	-0.24 Puffs/day Standard Deviation 3.36	-0.17 Puffs/day Standard Deviation 3.02	0.23 Puffs/day Standard Deviation 3.55

SECONDARY outcome

Timeframe: First IP up to Week 56

Population: Full analysis set, baseline EOS\>=220/uL

Change from baseline to Week 56 in proportion of nights with awakenings due to respiratory symptoms.

Outcome measures

Outcome measures
Measure	Benralizumab 10 mg n=316 Participants Every 8 weeks administered subcutaneously	Benralizumab 30 mg n=298 Participants Every 8 weeks administered subcutaneously	Benralizumab 100 mg n=321 Participants Every 8 weeks administered subcutaneously	Placebo n=322 Participants Every 8 weeks administered subcutaneously
Mean Change From Baseline in Proportion of Nights With Awakenings Due to Respiratory Symptoms for Patients With Baseline EOS>=220/uL	-0.092 Proportion of nights Standard Deviation 0.297	-0.131 Proportion of nights Standard Deviation 0.332	-0.084 Proportion of nights Standard Deviation 0.334	-0.053 Proportion of nights Standard Deviation 0.345

SECONDARY outcome

Timeframe: Immediately following first IP up to week 56

Population: Full analysis set, EOS\>=220/uL

The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while considering their experiences "today". The daily EXACT-PRO total score is recorded and has a range of 0-100 with higher scores indicative of greater severity. COPD exacerbation event frequency is calculated based on comparison of the baseline score with daily total scores. An increase of EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicates a COPD exacerbation event has occurred.

Outcome measures

Outcome measures
Measure	Benralizumab 10 mg n=377 Participants Every 8 weeks administered subcutaneously	Benralizumab 30 mg n=394 Participants Every 8 weeks administered subcutaneously	Benralizumab 100 mg n=385 Participants Every 8 weeks administered subcutaneously	Placebo n=388 Participants Every 8 weeks administered subcutaneously
Number of Participants by Number of COPD Exacerbations Based on EXACT-PRO for Patients With Baseline EOS>=220/uL 0	166 Participants	173 Participants	162 Participants	159 Participants
Number of Participants by Number of COPD Exacerbations Based on EXACT-PRO for Patients With Baseline EOS>=220/uL 1	108 Participants	107 Participants	113 Participants	119 Participants
Number of Participants by Number of COPD Exacerbations Based on EXACT-PRO for Patients With Baseline EOS>=220/uL 2	45 Participants	51 Participants	56 Participants	46 Participants
Number of Participants by Number of COPD Exacerbations Based on EXACT-PRO for Patients With Baseline EOS>=220/uL 3	21 Participants	27 Participants	25 Participants	27 Participants
Number of Participants by Number of COPD Exacerbations Based on EXACT-PRO for Patients With Baseline EOS>=220/uL 4	14 Participants	16 Participants	13 Participants	13 Participants
Number of Participants by Number of COPD Exacerbations Based on EXACT-PRO for Patients With Baseline EOS>=220/uL 5	8 Participants	8 Participants	9 Participants	12 Participants
Number of Participants by Number of COPD Exacerbations Based on EXACT-PRO for Patients With Baseline EOS>=220/uL 6	7 Participants	6 Participants	4 Participants	7 Participants
Number of Participants by Number of COPD Exacerbations Based on EXACT-PRO for Patients With Baseline EOS>=220/uL 7	2 Participants	4 Participants	1 Participants	2 Participants
Number of Participants by Number of COPD Exacerbations Based on EXACT-PRO for Patients With Baseline EOS>=220/uL 8	4 Participants	1 Participants	2 Participants	1 Participants
Number of Participants by Number of COPD Exacerbations Based on EXACT-PRO for Patients With Baseline EOS>=220/uL 9	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants by Number of COPD Exacerbations Based on EXACT-PRO for Patients With Baseline EOS>=220/uL 10	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants by Number of COPD Exacerbations Based on EXACT-PRO for Patients With Baseline EOS>=220/uL 11	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Immediately following first IP up to week 56

Population: Full analysis set, baseline EOS\>=220/uL

Outcome measures

Outcome measures
Measure	Benralizumab 10 mg n=211 Participants Every 8 weeks administered subcutaneously	Benralizumab 30 mg n=221 Participants Every 8 weeks administered subcutaneously	Benralizumab 100 mg n=223 Participants Every 8 weeks administered subcutaneously	Placebo n=229 Participants Every 8 weeks administered subcutaneously
Severity of EXACT-PRO for Patients With Baseline EOS>=220/uL	50.3 Score on a scale Standard Deviation 12.30	52.1 Score on a scale Standard Deviation 11.3	51.2 Score on a scale Standard Deviation 11.0	51.0 Score on a scale Standard Deviation 11.7

SECONDARY outcome

Timeframe: Immediately following first IP up to week 56

Population: Full analysis set, baseline EOS\>=220/uL

The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while considering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. COPD exacerbation event frequency is identified by comparing the baseline score with daily total scores. An increase in EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicate an event has occurred. Event duration is calculated after identification of the following five parameters: 1) onset; 2) three-day rolling average; 3) maximum observed value; 4) threshold for improvement; and 5) recovery. That is, duration of the exacerbation is the time elapse between onset and recovery of the event.

Outcome measures

Outcome measures
Measure	Benralizumab 10 mg n=211 Participants Every 8 weeks administered subcutaneously	Benralizumab 30 mg n=221 Participants Every 8 weeks administered subcutaneously	Benralizumab 100 mg n=223 Participants Every 8 weeks administered subcutaneously	Placebo n=229 Participants Every 8 weeks administered subcutaneously
Duration of COPD Exacerbation Based on EXACT-PRO Score for Patients With Baseline EOS>=220/uL	110.1 Days Standard Deviation 114.0	96.1 Days Standard Deviation 109.3	99.8 Days Standard Deviation 114.8	99.9 Days Standard Deviation 113.9

SECONDARY outcome

Timeframe: Immediately following the first IP dose through week 56

Population: Full analysis set, baseline EOS\>=220/uL

The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while considering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Event frequency is calculated by comparing the baseline with daily total scores. An increase in EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicate an event has occurred. Annual EXACT-PRO exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.

Outcome measures

Outcome measures
Measure	Benralizumab 10 mg n=377 Participants Every 8 weeks administered subcutaneously	Benralizumab 30 mg n=394 Participants Every 8 weeks administered subcutaneously	Benralizumab 100 mg n=385 Participants Every 8 weeks administered subcutaneously	Placebo n=388 Participants Every 8 weeks administered subcutaneously
Annual EXACT-PRO Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL	1.20 Exacerbations per year Interval 1.05 to 1.37	1.21 Exacerbations per year Interval 1.06 to 1.37	1.13 Exacerbations per year Interval 0.99 to 1.29	1.23 Exacerbations per year Interval 1.08 to 1.4

SECONDARY outcome

Timeframe: Immediately following first IP dose up to week 56

Population: Full analysis set, baseline EOS\>=220/uL

A COPD exacerbation is defined by symptomatic worsening COPD requiring systemic corticosteroids, antibiotics, or an inpatient hospitalization/death due to COPD.

Outcome measures

Outcome measures
Measure	Benralizumab 10 mg n=377 Participants Every 8 weeks administered subcutaneously	Benralizumab 30 mg n=394 Participants Every 8 weeks administered subcutaneously	Benralizumab 100 mg n=386 Participants Every 8 weeks administered subcutaneously	Placebo n=388 Participants Every 8 weeks administered subcutaneously
Number of Participants Having at Least 1 COPD Exacerbation for Patients With Baseline EOS>=220/uL	203 Participants	241 Participants	214 Participants	208 Participants

SECONDARY outcome

Timeframe: Immediately following IP dose to Week 56

Population: Full analysis set, baseline EOS\>=220/uL

Time to first COPD exacerbation is from the randomization date to the first occurrence of COPD exacerbation.

Outcome measures

Outcome measures
Measure	Benralizumab 10 mg n=377 Participants Every 8 weeks administered subcutaneously	Benralizumab 30 mg n=394 Participants Every 8 weeks administered subcutaneously	Benralizumab 100 mg n=386 Participants Every 8 weeks administered subcutaneously	Placebo n=388 Participants Every 8 weeks administered subcutaneously
Time to First COPD Exacerbation	315 Days Interval 244.0 to 380.0	260 Days Interval 225.0 to 291.0	322 Days Interval 278.0 to 373.0	337 Days Interval 261.0 to 400.0

SECONDARY outcome

Timeframe: Immediately following the first IP dose through week 56

Population: Full analysis set, baseline EOS\>=220/uL

Annual COPD exacerbations rate that result in ER or hospitalization is calculated by number of exacerbations resulting ER or hospitalization divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.

Outcome measures

Outcome measures
Measure	Benralizumab 10 mg n=377 Participants Every 8 weeks administered subcutaneously	Benralizumab 30 mg n=394 Participants Every 8 weeks administered subcutaneously	Benralizumab 100 mg n=386 Participants Every 8 weeks administered subcutaneously	Placebo n=388 Participants Every 8 weeks administered subcutaneously
Annual COPD Exacerbation Rate Associated With ER or Hospitalization Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL	0.22 Exacerbations per year Interval 0.17 to 0.29	0.29 Exacerbations per year Interval 0.23 to 0.36	0.22 Exacerbations per year Interval 0.17 to 0.28	0.32 Exacerbations per year Interval 0.26 to 0.4

SECONDARY outcome

Timeframe: Immediately following first IP dose up to Week 56

Population: Full analysis set, baseline EOS\>=220/uL

Types of healthcare encounter: Hospitalisations (inc. intensive care and/or general care), Emergency department visits, Unscheduled outpatients visits, Home visits, Telephone calls, and ambulance transports.

Outcome measures

Outcome measures
Measure	Benralizumab 10 mg n=377 Participants Every 8 weeks administered subcutaneously	Benralizumab 30 mg n=394 Participants Every 8 weeks administered subcutaneously	Benralizumab 100 mg n=386 Participants Every 8 weeks administered subcutaneously	Placebo n=388 Participants Every 8 weeks administered subcutaneously
Number of Participants Had COPD-related Healthcare Encounter for Patient With Baseline EOS>=220/uL Hospitalisations	45 Participants	67 Participants	48 Participants	59 Participants
Number of Participants Had COPD-related Healthcare Encounter for Patient With Baseline EOS>=220/uL Emergency department	49 Participants	72 Participants	58 Participants	71 Participants
Number of Participants Had COPD-related Healthcare Encounter for Patient With Baseline EOS>=220/uL Unscheduled outpatient visits	208 Participants	230 Participants	225 Participants	211 Participants
Number of Participants Had COPD-related Healthcare Encounter for Patient With Baseline EOS>=220/uL Home visits	14 Participants	20 Participants	17 Participants	14 Participants
Number of Participants Had COPD-related Healthcare Encounter for Patient With Baseline EOS>=220/uL Telephone calls	98 Participants	112 Participants	109 Participants	114 Participants
Number of Participants Had COPD-related Healthcare Encounter for Patient With Baseline EOS>=220/uL Ambulance transports	10 Participants	19 Participants	20 Participants	22 Participants

SECONDARY outcome

Timeframe: From first dose date to last dose date, 48 weeks per protocol.

Population: Safety analysis set

Duration of study treatment is calculated from first dose date to last dose date + 1 day.

Outcome measures

Outcome measures
Measure	Benralizumab 10 mg n=561 Participants Every 8 weeks administered subcutaneously	Benralizumab 30 mg n=563 Participants Every 8 weeks administered subcutaneously	Benralizumab 100 mg n=562 Participants Every 8 weeks administered subcutaneously	Placebo n=568 Participants Every 8 weeks administered subcutaneously
Duration of Study Treatment Administration	307.4 Days Standard Deviation 80.38	302.2 Days Standard Deviation 84.62	303.0 Days Standard Deviation 88.48	308.8 Days Standard Deviation 78.95

SECONDARY outcome

Timeframe: Pre-first dose and pre-dose at end of treatment (week 56).

Population: PK analysis set

PK serum samples were collected pre-dose at each visit.

Outcome measures

Outcome measures
Measure	Benralizumab 10 mg n=558 Participants Every 8 weeks administered subcutaneously	Benralizumab 30 mg n=560 Participants Every 8 weeks administered subcutaneously	Benralizumab 100 mg n=552 Participants Every 8 weeks administered subcutaneously	Placebo Every 8 weeks administered subcutaneously
Serum Concentration of Benralizumab Baseline	NA ng/mL Geometric Coefficient of Variation NA \<LLOQ (Lower limit of quantification)	NA ng/mL Geometric Coefficient of Variation NA \<LLOQ (Lower limit of quantification)	NA ng/mL Geometric Coefficient of Variation 51.95 \<LLOQ (Lower limit of quantification)	—
Serum Concentration of Benralizumab Week 56	42.51 ng/mL Geometric Coefficient of Variation 384.81	222.92 ng/mL Geometric Coefficient of Variation 248.24	594.33 ng/mL Geometric Coefficient of Variation 321.66	—

SECONDARY outcome

Timeframe: Pre-treatment until end of follow-up, week 60 per protocol.

Population: Safety analysis set. For each parameter, the number of subjects at risk is to be analyzed.

Anti-drug antibody (ADA) responses such as ADA prevalence, ADA incidence, ADA persistently positive counts, etc. were presented.

Outcome measures

Outcome measures
Measure	Benralizumab 10 mg n=561 Participants Every 8 weeks administered subcutaneously	Benralizumab 30 mg n=563 Participants Every 8 weeks administered subcutaneously	Benralizumab 100 mg n=562 Participants Every 8 weeks administered subcutaneously	Placebo n=568 Participants Every 8 weeks administered subcutaneously
Immunogenicity of Benralizumab nAb prevalence	55 Participants	37 Participants	59 Participants	13 Participants
Immunogenicity of Benralizumab ADA prevalence	70 Participants	52 Participants	77 Participants	26 Participants
Immunogenicity of Benralizumab ADA incidence	60 Participants	39 Participants	65 Participants	16 Participants
Immunogenicity of Benralizumab Both base/post-baseline positive	9 Participants	8 Participants	5 Participants	10 Participants
Immunogenicity of Benralizumab Only post baseline	57 Participants	38 Participants	64 Participants	14 Participants
Immunogenicity of Benralizumab Only baseline	4 Participants	6 Participants	8 Participants	2 Participants
Immunogenicity of Benralizumab ADA persistently positive	42 Participants	30 Participants	43 Participants	6 Participants
Immunogenicity of Benralizumab ADA transiently positive	15 Participants	8 Participants	21 Participants	8 Participants
Immunogenicity of Benralizumab nAb incidence	50 Participants	33 Participants	52 Participants	9 Participants

Adverse Events

Benra 10 mg

Serious events: 144 serious events

Other events: 251 other events

Deaths: 17 deaths

Benra 30 mg

Serious events: 177 serious events

Other events: 233 other events

Deaths: 21 deaths

Benra 100 mg

Serious events: 127 serious events

Other events: 238 other events

Deaths: 17 deaths

Placebo

Serious events: 158 serious events

Other events: 260 other events

Deaths: 19 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Benra 10 mg n=561 participants at risk Every 8 weeks administered subcutaneously	Benra 30 mg n=563 participants at risk Every 8 weeks administered subcutaneously	Benra 100 mg n=562 participants at risk Every 8 weeks administered subcutaneously	Placebo n=568 participants at risk Every 8 weeks administered subcutaneously
General disorders Oedema peripheral	2.7% 15/561 • Number of events 17 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	1.6% 9/563 • Number of events 9 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	3.0% 17/562 • Number of events 18 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	1.6% 9/568 • Number of events 10 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).
Infections and infestations Bronchitis	11.8% 66/561 • Number of events 94 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	12.4% 70/563 • Number of events 100 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	11.2% 63/562 • Number of events 87 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	11.6% 66/568 • Number of events 88 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).
Infections and infestations Influenza	2.0% 11/561 • Number of events 11 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	3.6% 20/563 • Number of events 22 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	2.7% 15/562 • Number of events 15 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	1.9% 11/568 • Number of events 12 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).
Infections and infestations Lower respiratory tract infection	4.6% 26/561 • Number of events 27 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	3.9% 22/563 • Number of events 29 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	2.7% 15/562 • Number of events 16 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	3.7% 21/568 • Number of events 27 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).
Infections and infestations Oral candidiasis	3.7% 21/561 • Number of events 25 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	2.1% 12/563 • Number of events 13 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	2.7% 15/562 • Number of events 20 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	2.1% 12/568 • Number of events 17 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).
Infections and infestations Sinusitis	2.7% 15/561 • Number of events 18 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	2.3% 13/563 • Number of events 19 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	2.7% 15/562 • Number of events 21 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	3.5% 20/568 • Number of events 24 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).
Infections and infestations Upper respiratory tract infection	12.1% 68/561 • Number of events 109 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	12.6% 71/563 • Number of events 98 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	11.9% 67/562 • Number of events 92 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	11.4% 65/568 • Number of events 89 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).
Infections and infestations Urinary tract infection	4.3% 24/561 • Number of events 34 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	4.3% 24/563 • Number of events 26 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	5.0% 28/562 • Number of events 32 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	3.2% 18/568 • Number of events 22 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).
Infections and infestations Viral upper respiratory tract infection	10.9% 61/561 • Number of events 73 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	8.3% 47/563 • Number of events 68 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	10.7% 60/562 • Number of events 92 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	12.3% 70/568 • Number of events 93 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).
Musculoskeletal and connective tissue disorders Back pain	2.0% 11/561 • Number of events 11 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	2.1% 12/563 • Number of events 12 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	3.0% 17/562 • Number of events 20 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	2.6% 15/568 • Number of events 15 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).
Nervous system disorders Headache	3.4% 19/561 • Number of events 20 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	2.8% 16/563 • Number of events 17 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	4.8% 27/562 • Number of events 34 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	4.2% 24/568 • Number of events 36 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.4% 8/561 • Number of events 10 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	1.8% 10/563 • Number of events 13 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	3.6% 20/562 • Number of events 24 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	4.2% 24/568 • Number of events 34 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).
Vascular disorders Hypertension	3.0% 17/561 • Number of events 22 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	2.8% 16/563 • Number of events 17 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	2.1% 12/562 • Number of events 12 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).	3.7% 21/568 • Number of events 22 • From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60). Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).

Additional Information

Ulbaldo Martin

AstraZeneca

Phone: 1.301.398.0163

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee ≥ 60 days prior to submission of material for publication/presentation, Institution and PI shall jointly provide AZ with material for review. No publication/presentation may include any of AZ's Confidential Information without AZ's written approval. AZ can request Inst. and PI to withhold material from submission for publication/presentation for an additional 90 days to allow AZ to establish and preserve its proprietary rights in the material being submitted for publication or presentation.
Publication restrictions are in place

Restriction type: OTHER