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Benralizumab Efficacy in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History (GALATHEA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02138916
Recruitment Status : Completed
First Posted : May 15, 2014
Results First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Interventions Drug: Benralizumab Arm A
Drug: Benralizumab Arm B
Drug: Placebo
Enrollment 1656
Recruitment Details  
Pre-assignment Details 1656 patients randomized to Benralizumab 30 mg, Benralizumab 100 mg, or Placebo. All randomized patients were treated. 554 (33.5%) were randomized to Benralizumab 30 mg, 552 (33.3%) were randomized to Benralizumab 100 mg, and 550 (33.2%) were randomized to Placebo.
Arm/Group Title Benralizumab 30 mg Benralizumab 100 mg Placebo
Hide Arm/Group Description Every 8 weeks administered subcutaneously Every 8 weeks administered subcutaneously Every 8 weeks administered subcutaneously
Period Title: Overall Study
Started 554 552 550
Completed 497 492 491
Not Completed 57 60 59
Reason Not Completed
eg., meds change, lack of efficacy, etc.             6             9             7
Death             14             11             12
Withdrawal by Subject             27             31             32
Study specific withdrawal criteria             0             0             1
incorrect enrolment             1             1             0
Severe non-compliance             1             2             1
Lost to Follow-up             4             2             3
Adverse Event             4             4             3
Arm/Group Title Benralizumab 30 mg Benralizumab 100 mg Placebo Total
Hide Arm/Group Description Every 8 weeks administered subcutaneously Every 8 weeks administered subcutaneously Every 8 weeks administered subcutaneously Total of all reporting groups
Overall Number of Baseline Participants 554 552 550 1656
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Year
Number Analyzed 554 participants 552 participants 550 participants 1656 participants
65.9  (7.77) 65.3  (8.05) 65.2  (8.22) 65.5  (8.01)
[1]
Measure Analysis Population Description: Full analysis set
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 554 participants 552 participants 550 participants 1656 participants
Female
172
  31.0%
180
  32.6%
175
  31.8%
527
  31.8%
Male
382
  69.0%
372
  67.4%
375
  68.2%
1129
  68.2%
[1]
Measure Analysis Population Description: Full analysis set
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 554 participants 552 participants 550 participants 1656 participants
White
496
  89.5%
493
  89.3%
488
  88.7%
1477
  89.2%
Black or African American
4
   0.7%
11
   2.0%
10
   1.8%
25
   1.5%
Asian
48
   8.7%
46
   8.3%
46
   8.4%
140
   8.5%
Other
6
   1.1%
2
   0.4%
6
   1.1%
14
   0.8%
[1]
Measure Analysis Population Description: Full analysis set
1.Primary Outcome
Title Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL
Hide Description

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.
Time Frame From first IP to week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with baseline EOS>=220/uL
Arm/Group Title Benralizumab 30 mg Benralizumab 100 mg Placebo
Hide Arm/Group Description:
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Overall Number of Participants Analyzed 382 379 359
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Exacerbations per year
1.19
(1.04 to 1.36)
1.03
(0.9 to 1.19)
1.24
(1.08 to 1.42)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6490
Comments [Not Specified]
Method Negative binomial
Comments Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.8 to 1.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0525
Comments [Not Specified]
Method Negative binomial
Comments Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.69 to 1.00
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS<220/uL
Hide Description

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.
Time Frame From first IP to week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with baseline EOS<220/uL
Arm/Group Title Benralizumab 30 mg Benralizumab 100 mg Placebo
Hide Arm/Group Description:
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Overall Number of Participants Analyzed 172 173 191
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Exacerbations per year
1.4
(1.19 to 1.64)
1.32
(1.12 to 1.56)
1.30
(1.11 to 1.52)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5236
Comments [Not Specified]
Method Negative binomial
Comments Model includes treatment group, region, number of exacerbations in the previous year.
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.86 to 1.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8812
Comments [Not Specified]
Method Negative binomial
Comments Model includes treatment group, EOS cohort, region, number of exacerbations in the previous year.
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.82 to 1.27
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline EOS>=220/uL
Hide Description 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.
Time Frame First IP up to end of treatment Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, baseline EOS>=220/uL
Arm/Group Title Benralizumab 30 mg Benralizumab 100 mg Placebo
Hide Arm/Group Description:
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Overall Number of Participants Analyzed 329 326 317
Mean (Standard Deviation)
Unit of Measure: Liter
0.014  (0.282) 0.031  (0.294) 0.010  (0.275)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7550
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.007
Confidence Interval (2-Sided) 95%
-0.035 to 0.048
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3285
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.021
Confidence Interval (2-Sided) 95%
-0.021 to 0.062
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Mean Change From Baseline in SGRQ Total Score for Patients With Baseline EOS>=220/uL
Hide Description 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.
Time Frame First IP up to Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, baseline EOS>=220/uL
Arm/Group Title Benralizumab 30 mg Benralizumab 100 mg Placebo
Hide Arm/Group Description:
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Overall Number of Participants Analyzed 338 331 317
Mean (Standard Deviation)
Unit of Measure: Percentage
-5.025  (14.677) -6.723  (15.723) -3.913  (15.039)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2906
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.011
Confidence Interval (2-Sided) 95%
-2.887 to 0.865
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0264
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.136
Confidence Interval (2-Sided) 95%
-4.020 to -0.251
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Mean Change From Baseline in CAT Total Score for Patients With Baseline EOS>=220/uL
Hide Description 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.
Time Frame First IP up to Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, baseline EOS>=220/uL
Arm/Group Title Benralizumab 30 mg Benralizumab 100 mg Placebo
Hide Arm/Group Description:
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Overall Number of Participants Analyzed 338 335 319
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-1.50  (6.89) -2.43  (6.34) -1.22  (6.53)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6782
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-1.08 to 0.70
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0753
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.81
Confidence Interval (2-Sided) 95%
-1.70 to 0.08
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Mean Change From Baseline in E-RS: COPD Total Score for Patients With Baseline EOS>=220/uL
Hide Description 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.
Time Frame First IP up to Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, baseline EOS>=220/uL
Arm/Group Title Benralizumab 30 mg Benralizumab 100 mg Placebo
Hide Arm/Group Description:
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Overall Number of Participants Analyzed 324 328 295
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-1.085  (5.273) -1.354  (5.599) -0.504  (5.674)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0889
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.585
Confidence Interval (2-Sided) 95%
-1.260 to 0.089
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0413
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.703
Confidence Interval (2-Sided) 95%
-1.378 to -0.028
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Mean Change From Baseline in Total Rescue Medication Use (Number of Puffs Per Day) for Patients With Baseline EOS>=220/uL
Hide Description 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.
Time Frame First IP up to Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, baseline EOS>=220/uL
Arm/Group Title Benralizumab 30 mg Benralizumab 100 mg Placebo
Hide Arm/Group Description:
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Overall Number of Participants Analyzed 321 322 291
Mean (Standard Deviation)
Unit of Measure: Puffs/day
-0.05  (3.21) -0.27  (2.71) 0.29  (3.03)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0728
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.348
Confidence Interval (2-Sided) 95%
-0.728 to 0.032
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0121
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.487
Confidence Interval (2-Sided) 95%
-0.868 to -0.107
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Mean Change From Baseline in Proportion of Nights Awakenings Due to Respiratory Symptoms for Patients With Baseline EOS>=220/uL
Hide Description Change from baseline to week 56 in proportion of nights awakenings due to respiratory symptoms.
Time Frame First IP up to Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, baseline EOS>=220/uL
Arm/Group Title Benralizumab 30 mg Benralizumab 100 mg Placebo
Hide Arm/Group Description:
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Overall Number of Participants Analyzed 325 323 297
Mean (Standard Deviation)
Unit of Measure: Proportion of nights
-0.088  (0.310) -0085  (0.283) -0.049  (0.307)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0235
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.041
Confidence Interval (2-Sided) 95%
-0.077 to -0.006
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0158
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.044
Confidence Interval (2-Sided) 95%
-0.080 to -0.008
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Number of Participants by Number of COPD Exacerbations Based on EXACT-PRO for Patients With Baseline EOS>=220/uL
Hide Description 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 onsidering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Exacerbation 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 exacerbation event has occurred.
Time Frame Immediately following first IP up to week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, EOS>=220/uL
Arm/Group Title Benralizumab 30 mg Benralizumab 100 mg Placebo
Hide Arm/Group Description:
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Overall Number of Participants Analyzed 382 378 358
Measure Type: Count of Participants
Unit of Measure: Participants
0
180
  47.1%
184
  48.7%
179
  50.0%
1
101
  26.4%
103
  27.2%
99
  27.7%
2
42
  11.0%
49
  13.0%
34
   9.5%
3
25
   6.5%
14
   3.7%
15
   4.2%
4
17
   4.5%
13
   3.4%
14
   3.9%
5
5
   1.3%
6
   1.6%
5
   1.4%
6
4
   1.0%
4
   1.1%
2
   0.6%
7
6
   1.6%
1
   0.3%
5
   1.4%
8
1
   0.3%
1
   0.3%
4
   1.1%
9
1
   0.3%
2
   0.5%
1
   0.3%
10
0
   0.0%
1
   0.3%
0
   0.0%
10.Secondary Outcome
Title Severity of EXACT-PRO for Patients With Baseline EOS>=220/uL
Hide Description 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 onsidering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Severity for the study is the highest score of EXACT-PRO.
Time Frame Immediately following first IP up to week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, baseline EOS>=220/uL
Arm/Group Title Benralizumab 30 mg Benralizumab 100 mg Placebo
Hide Arm/Group Description:
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Overall Number of Participants Analyzed 202 194 179
Mean (Standard Deviation)
Unit of Measure: Score on a scale
51.5  (11.30) 50.8  (10.70) 52.0  (11.20)
11.Secondary Outcome
Title Duration of EXACT-PRO for Patients With Baseline EOS>=220/uL
Hide Description 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 onsidering 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. Calculation of event duration 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.
Time Frame Immediately following first IP up to week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, baseline EOS>=220/uL
Arm/Group Title Benralizumab 30 mg Benralizumab 100 mg Placebo
Hide Arm/Group Description:
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Overall Number of Participants Analyzed 202 194 179
Mean (Standard Deviation)
Unit of Measure: Days
82.2  (95.80) 88.3  (105.30) 101.7  (113.70)
12.Secondary Outcome
Title Annual EXACT-PRO Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL
Hide Description 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 onsidering 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.
Time Frame Immediately following first IP up to week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, baseline EOS>=220/uL
Arm/Group Title Benralizumab 30 mg Benralizumab 100 mg Placebo
Hide Arm/Group Description:
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Overall Number of Participants Analyzed 382 378 358
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Exacerbations per year
1.14
(0.98 to 1.31)
1.02
(0.88 to 1.19)
1.04
(0.90 to 1.21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4080
Comments [Not Specified]
Method Negative binomial
Comments Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.89 to 1.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8688
Comments [Not Specified]
Method Negative binomial
Comments Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.80 to 1.21
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Number of Participants Having at Least 1 COPD Exacerbation for Patients With Baseline EOS>=220/uL
Hide Description A COPD exacerbation is defined by symptomatic worsening COPD requiring systemic corticosteroids, antibiotics, or an inpatient hospitalization/death due to COPD.
Time Frame Immediately following first IP up to week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, baseline EOS>=220/uL
Arm/Group Title Benralizumab 30 mg Benralizumab 100 mg Placebo
Hide Arm/Group Description:
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Overall Number of Participants Analyzed 382 379 359
Measure Type: Count of Participants
Unit of Measure: Participants
204
  53.4%
203
  53.6%
198
  55.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg, Placebo
Comments Proportion of participants with >=1 COPD exacerbation.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4850
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH test controlling for EOS cohort, region, and background therapy.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.66 to 1.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 100 mg, Placebo
Comments Proportion of participants with >=1 COPD exacerbation.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4489
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH test controlling for EOS cohort, region, and background therapy.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.65 to 1.21
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Time to First COPD Exacerbation
Hide Description Time to first COPD exacerbation is from the randomization date to the first occurrence of COPD exacerbation
Time Frame Immediately following first IP up to week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, baseline EOS>=220/uL
Arm/Group Title Benralizumab 30 mg Benralizumab 100 mg Placebo
Hide Arm/Group Description:
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Overall Number of Participants Analyzed 382 379 359
Median (95% Confidence Interval)
Unit of Measure: Days
333
(273 to 400)
329
(262 to 396)
337
(261 to 390)
15.Secondary Outcome
Title Annual COPD Exacerbation Rate Associated With ER or Hospitalization Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL
Hide Description 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.
Time Frame Immediately following first IP up to week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, baseline EOS>=220/uL
Arm/Group Title Benralizumab 30 mg Benralizumab 100 mg Placebo
Hide Arm/Group Description:
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Overall Number of Participants Analyzed 382 379 359
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Exacerbations per year
0.27
(0.20 to 0.35)
0.15
(0.11 to 0.20)
0.25
(0.19 to 0.33)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7733
Comments [Not Specified]
Method Negative binomial
Comments Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.73 to 1.53
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benralizumab 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0114
Comments [Not Specified]
Method Nagative binomial
Comments Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.58
Confidence Interval (2-Sided) 95%
0.39 to 0.89
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Number of Participants Had COPD-related Healthcare Encounter for Patient With Baseline EOS>=220/uL
Hide Description 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.
Time Frame Immediately following first IP up to week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, baseline EOS>=220/uL
Arm/Group Title Benralizumab 30 mg Benralizumab 100 mg Placebo
Hide Arm/Group Description:
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Overall Number of Participants Analyzed 382 379 359
Measure Type: Count of Participants
Unit of Measure: Participants
Hospitalisations
60
  15.7%
38
  10.0%
50
  13.9%
Emergency Department Visits
36
   9.4%
35
   9.2%
43
  12.0%
Unscheduled Outpatient Visits
219
  57.3%
236
  62.3%
202
  56.3%
Home Visits
18
   4.7%
22
   5.8%
18
   5.0%
Telephone calls
110
  28.8%
111
  29.3%
104
  29.0%
Ambulance transports
16
   4.2%
12
   3.2%
20
   5.6%
17.Secondary Outcome
Title Duration of Study Treatment Administration
Hide Description Duration of study treatment is calculated from first dose date to last dose date + 1 day.
Time Frame From first dose date to last dose date, 48 weeks per protocol.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set
Arm/Group Title Benralizumab 30 mg Benralizumab 100 mg Placebo
Hide Arm/Group Description:
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Overall Number of Participants Analyzed 554 552 550
Mean (Standard Deviation)
Unit of Measure: Days
302.4  (85.73) 304.0  (82.40) 302.5  (88.47)
18.Secondary Outcome
Title Serum Concentration of Benralizumab
Hide Description PK serum samples were collected pre-dose at each visit.
Time Frame Pre-first dose and pre-dose at end of treatment (week 56)
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set
Arm/Group Title Benralizumab 30 mg Benralizumab 100 mg
Hide Arm/Group Description:
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Overall Number of Participants Analyzed 553 550
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Baseline Number Analyzed 548 participants 544 participants
NA [1] 
(NA%)
NA [1] 
(NA%)
Week 56 Number Analyzed 375 participants 391 participants
219.45
(233.21%)
699.89
(243.20%)
[1]
<LLOQ (Lower limit of quantification)
19.Secondary Outcome
Title Immunogenicity of Benralizumab
Hide Description Antidrug antibody (ADA) responses such as ADA prevalence, ADA incidence, ADA persistently positive counts, etc. were presented
Time Frame Pre-treatment until end of follow-up, week 60 per protocol.
Hide Outcome Measure Data
Hide Analysis Population Description
safety analysis set. For each parameter, the number of subjects at risk is to be analyzed.
Arm/Group Title Benralizumab 30 mg Benralizumab 100 mg Placebo
Hide Arm/Group Description:
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Every 8 weeks administered subcutaneously
Overall Number of Participants Analyzed 554 552 550
Measure Type: Count of Participants
Unit of Measure: Participants
ADA prevalence Number Analyzed 554 participants 552 participants 550 participants
53
   9.6%
64
  11.6%
39
   7.1%
ADA incidence Number Analyzed 547 participants 542 participants 535 participants
44
   8.0%
47
   8.7%
24
   4.5%
Both base/post-baseline positive Number Analyzed 547 participants 542 participants 535 participants
5
   0.9%
7
   1.3%
17
   3.2%
Only post baseline positive Number Analyzed 551 participants 547 participants 537 participants
43
   7.8%
46
   8.4%
20
   3.7%
Only baseline positive Number Analyzed 550 participants 547 participants 548 participants
5
   0.9%
11
   2.0%
2
   0.4%
ADA persistently positive Number Analyzed 547 participants 542 participants 535 participants
28
   5.1%
34
   6.3%
14
   2.6%
ADA transiently positive Number Analyzed 547 participants 542 participants 535 participants
15
   2.7%
12
   2.2%
6
   1.1%
nAb prevalence Number Analyzed 554 participants 552 participants 550 participants
43
   7.8%
43
   7.8%
25
   4.5%
nAb incidence Number Analyzed 547 participants 542 participants 535 participants
41
   7.5%
37
   6.8%
18
   3.4%
Time Frame From the time the patient signed informed consent through the treatment period up to the follow-up visit (week 60).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Benralizumab 30 mg Benralizumab 100 mg Placebo
Hide Arm/Group Description Every 8 weeks administered subcutaneously Every 8 weeks administered subcutaneously Every 8 weeks administered subcutaneously
All-Cause Mortality
Benralizumab 30 mg Benralizumab 100 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/554 (2.71%)      11/552 (1.99%)      13/550 (2.36%)    
Hide Serious Adverse Events
Benralizumab 30 mg Benralizumab 100 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   151/554 (27.26%)      177/552 (32.07%)      176/550 (32.00%)    
Blood and lymphatic system disorders       
Anaemia  1  0/554 (0.00%)  0 0/552 (0.00%)  0 2/550 (0.36%)  3
Hypochromic anaemia  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Iron deficiency anaemia  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Cardiac disorders       
Acute coronary syndrome  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Acute myocardial infarction  1  2/554 (0.36%)  2 1/552 (0.18%)  1 4/550 (0.73%)  4
Acute right ventricular failure  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Angina pectoris  1  1/554 (0.18%)  1 3/552 (0.54%)  3 0/550 (0.00%)  0
Angina unstable  1  2/554 (0.36%)  2 2/552 (0.36%)  2 2/550 (0.36%)  2
Aortic valve disease  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Aortic valve stenosis  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Atrial fibrillation  1  4/554 (0.72%)  4 8/552 (1.45%)  8 2/550 (0.36%)  2
Atrial flutter  1  1/554 (0.18%)  1 0/552 (0.00%)  0 2/550 (0.36%)  2
Atrioventricular block complete  1  0/554 (0.00%)  0 1/552 (0.18%)  1 1/550 (0.18%)  1
Cardiac arrest  1  1/554 (0.18%)  1 0/552 (0.00%)  0 1/550 (0.18%)  1
Cardiac failure  1  3/554 (0.54%)  3 2/552 (0.36%)  2 1/550 (0.18%)  1
Cardiac failure acute  1  0/554 (0.00%)  0 1/552 (0.18%)  2 1/550 (0.18%)  1
Cardiac failure congestive  1  2/554 (0.36%)  2 2/552 (0.36%)  2 1/550 (0.18%)  1
Cardiomyopathy  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Cor pulmonale chronic  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Coronary artery disease  1  1/554 (0.18%)  1 1/552 (0.18%)  1 0/550 (0.00%)  0
Coronary artery insufficiency  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Coronary artery occlusion  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Coronary artery stenosis  1  0/554 (0.00%)  0 0/552 (0.00%)  0 3/550 (0.55%)  3
Left ventricular failure  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Myocardial infarction  1  4/554 (0.72%)  4 3/552 (0.54%)  3 1/550 (0.18%)  1
Myocarditis  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Supraventricular tachycardia  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Congenital, familial and genetic disorders       
Exomphalos  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Gastrointestinal disorders       
Abdominal wall haematoma  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Ascites  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Colitis  1  0/554 (0.00%)  0 2/552 (0.36%)  2 1/550 (0.18%)  1
Constipation  1  2/554 (0.36%)  2 1/552 (0.18%)  2 0/550 (0.00%)  0
Diverticulum  1  0/554 (0.00%)  0 2/552 (0.36%)  2 0/550 (0.00%)  0
Enterocolitis  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Gastric polyps  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Gastritis  1  1/554 (0.18%)  2 1/552 (0.18%)  1 0/550 (0.00%)  0
Gastrointestinal haemorrhage  1  0/554 (0.00%)  0 1/552 (0.18%)  1 2/550 (0.36%)  2
Gastrointestinal necrosis  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Gastrooesophageal reflux disease  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Haematochezia  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Haemorrhoids  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Ileus  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Inguinal hernia  1  0/554 (0.00%)  0 3/552 (0.54%)  3 0/550 (0.00%)  0
Intestinal obstruction  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Intestinal perforation  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Intestinal polyp  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Irritable bowel syndrome  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Large intestine perforation  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Large intestine polyp  1  0/554 (0.00%)  0 2/552 (0.36%)  2 2/550 (0.36%)  2
Mallory-Weiss syndrome  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Melaena  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Nausea  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Oesophageal spasm  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Pancreatitis  1  1/554 (0.18%)  1 2/552 (0.36%)  2 0/550 (0.00%)  0
Pancreatitis acute  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Pancreatitis chronic  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Peritoneal haemorrhage  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Rectal haemorrhage  1  1/554 (0.18%)  1 0/552 (0.00%)  0 2/550 (0.36%)  2
Salivary gland calculus  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Small intestinal obstruction  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Umbilical hernia  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Upper gastrointestinal haemorrhage  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
General disorders       
Chest discomfort  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Death  1  1/554 (0.18%)  1 1/552 (0.18%)  1 1/550 (0.18%)  1
Multiple organ dysfunction syndrome  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Non-cardiac chest pain  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Oedema peripheral  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Sudden cardiac death  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Systemic inflammatory response syndrome  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Hepatobiliary disorders       
Cholangitis acute  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Cholecystitis  1  0/554 (0.00%)  0 0/552 (0.00%)  0 2/550 (0.36%)  2
Cholelithiasis  1  2/554 (0.36%)  2 0/552 (0.00%)  0 1/550 (0.18%)  1
Immune system disorders       
Anaphylactic shock  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Infections and infestations       
Anal abscess  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Appendicitis  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Arthritis bacterial  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Atypical mycobacterial infection  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Atypical mycobacterial lower respiratory tract infection  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Bronchitis  1  1/554 (0.18%)  1 3/552 (0.54%)  3 3/550 (0.55%)  3
Bronchopulmonary aspergillosis  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Cellulitis  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Cellulitis pharyngeal  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Cystitis  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Disseminated tuberculosis  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Diverticulitis  1  0/554 (0.00%)  0 0/552 (0.00%)  0 2/550 (0.36%)  3
Gastroenteritis  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Infectious pleural effusion  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Influenza  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Lower respiratory tract infection  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Periorbital cellulitis  1  0/554 (0.00%)  0 1/552 (0.18%)  1 1/550 (0.18%)  1
Peritonsillar abscess  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Pneumonia  1  22/554 (3.97%)  24 18/552 (3.26%)  19 16/550 (2.91%)  16
Pneumonia bacterial  1  5/554 (0.90%)  5 8/552 (1.45%)  9 10/550 (1.82%)  10
Pneumonia haemophilus  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Pneumonia klebsiella  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Pneumonia moraxella  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Pneumonia necrotising  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Pneumonia pneumococcal  1  2/554 (0.36%)  2 0/552 (0.00%)  0 1/550 (0.18%)  1
Pneumonia pseudomonal  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Pneumonia streptococcal  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Pneumonia viral  1  0/554 (0.00%)  0 1/552 (0.18%)  1 1/550 (0.18%)  1
Pulmonary sepsis  1  0/554 (0.00%)  0 1/552 (0.18%)  1 1/550 (0.18%)  1
Pulmonary tuberculosis  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Respiratory syncytial virus infection  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Rhinovirus infection  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Sepsis  1  0/554 (0.00%)  0 2/552 (0.36%)  2 0/550 (0.00%)  0
Septic shock  1  1/554 (0.18%)  1 1/552 (0.18%)  1 0/550 (0.00%)  0
Staphylococcal infection  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Upper respiratory tract infection  1  0/554 (0.00%)  0 1/552 (0.18%)  1 1/550 (0.18%)  1
Urinary tract infection  1  2/554 (0.36%)  2 2/552 (0.36%)  2 0/550 (0.00%)  0
Injury, poisoning and procedural complications       
Airway burns  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Ankle fracture  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Arterial bypass occlusion  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Asbestosis  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Chest injury  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Dural tear  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Facial bones fracture  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Femoral neck fracture  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Femur fracture  1  0/554 (0.00%)  0 2/552 (0.36%)  2 0/550 (0.00%)  0
Foot fracture  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Fractured coccyx  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Hip fracture  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Joint dislocation  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Lower limb fracture  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Patella fracture  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Rib fracture  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Skin flap necrosis  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Spinal compression fracture  1  1/554 (0.18%)  1 0/552 (0.00%)  0 1/550 (0.18%)  1
Subarachnoid haemorrhage  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Subdural haematoma  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Tendon rupture  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Thoracic vertebral fracture  1  1/554 (0.18%)  1 1/552 (0.18%)  2 1/550 (0.18%)  1
Traumatic haematoma  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Upper limb fracture  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Vascular bypass dysfunction  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Vascular graft occlusion  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Vascular procedure complication  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Wound  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Wound dehiscence  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Investigations       
Electrocardiogram ST-T change  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration  1  0/554 (0.00%)  0 0/552 (0.00%)  0 2/550 (0.36%)  2
Diabetes mellitus  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Hyperglycaemia  1  0/554 (0.00%)  0 1/552 (0.18%)  1 1/550 (0.18%)  1
Hypoglycaemia  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Hyponatraemia  1  0/554 (0.00%)  0 1/552 (0.18%)  2 1/550 (0.18%)  1
Musculoskeletal and connective tissue disorders       
Arthritis  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Gouty arthritis  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Intervertebral disc degeneration  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Intervertebral disc protrusion  1  1/554 (0.18%)  1 1/552 (0.18%)  1 1/550 (0.18%)  1
Lumbar spinal stenosis  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Musculoskeletal chest pain  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Osteoarthritis  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Osteonecrosis  1  0/554 (0.00%)  0 1/552 (0.18%)  1 1/550 (0.18%)  1
Spinal osteoarthritis  1  0/554 (0.00%)  0 1/552 (0.18%)  1 1/550 (0.18%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Adenocarcinoma gastric  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Adenocarcinoma of colon  1  0/554 (0.00%)  0 0/552 (0.00%)  0 2/550 (0.36%)  2
Basal cell carcinoma  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Benign lung neoplasm  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Bladder cancer  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Colon neoplasm  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Diffuse large B-cell lymphoma  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Glioblastoma multiforme  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Haemangioma of skin  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Laryngeal squamous cell carcinoma  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Lung adenocarcinoma  1  0/554 (0.00%)  0 1/552 (0.18%)  1 2/550 (0.36%)  2
Lung neoplasm malignant  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Meningioma  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Non-small cell lung cancer  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Non-small cell lung cancer metastatic  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Non-small cell lung cancer stage IIIB  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Pancreatic carcinoma  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Plasma cell myeloma  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Prostate cancer  1  2/554 (0.36%)  2 1/552 (0.18%)  1 2/550 (0.36%)  2
Prostate cancer stage II  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Renal neoplasm  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Sarcoma  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Small cell lung cancer  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Small cell lung cancer metastatic  1  0/554 (0.00%)  0 2/552 (0.36%)  2 0/550 (0.00%)  0
Squamous cell carcinoma of skin  1  0/554 (0.00%)  0 1/552 (0.18%)  1 1/550 (0.18%)  1
Tonsil cancer  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Transitional cell carcinoma  1  2/554 (0.36%)  2 0/552 (0.00%)  0 0/550 (0.00%)  0
Nervous system disorders       
Carotid artery stenosis  1  0/554 (0.00%)  0 0/552 (0.00%)  0 2/550 (0.36%)  2
Cerebral infarction  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Cerebral ischaemia  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Cerebrovascular accident  1  2/554 (0.36%)  2 1/552 (0.18%)  1 0/550 (0.00%)  0
Dizziness  1  0/554 (0.00%)  0 1/552 (0.18%)  1 1/550 (0.18%)  1
Facial paralysis  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Generalised tonic-clonic seizure  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Hyperaesthesia  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Hypoxic-ischaemic encephalopathy  1  1/554 (0.18%)  1 0/552 (0.00%)  0 1/550 (0.18%)  1
Ischaemic stroke  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Lumbar radiculopathy  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Metabolic encephalopathy  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Monoparesis  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Neuropathy peripheral  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Polyneuropathy  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Radicular syndrome  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Radiculopathy  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Sciatica  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Seizure  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Sinus headache  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Stupor  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Syncope  1  1/554 (0.18%)  1 1/552 (0.18%)  1 0/550 (0.00%)  0
Thrombotic stroke  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Transient ischaemic attack  1  0/554 (0.00%)  0 2/552 (0.36%)  2 0/550 (0.00%)  0
Psychiatric disorders       
Anxiety  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  2
Anxiety disorder  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Depression  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Mental status changes  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Renal and urinary disorders       
Acute kidney injury  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Reproductive system and breast disorders       
Benign prostatic hyperplasia  1  0/554 (0.00%)  0 1/552 (0.18%)  1 1/550 (0.18%)  1
Endometriosis  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Prostatitis  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Acute respiratory failure  1  0/554 (0.00%)  0 1/552 (0.18%)  1 2/550 (0.36%)  2
Bronchiectasis  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Bronchitis chronic  1  1/554 (0.18%)  1 1/552 (0.18%)  1 1/550 (0.18%)  1
Chronic obstructive pulmonary disease  1  97/554 (17.51%)  145 78/552 (14.13%)  101 100/550 (18.18%)  142
Chronic respiratory failure  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Dyspnoea  1  1/554 (0.18%)  1 0/552 (0.00%)  0 1/550 (0.18%)  1
Hypercapnia  1  1/554 (0.18%)  1 0/552 (0.00%)  0 1/550 (0.18%)  1
Hypoxia  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Lung consolidation  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Pickwickian syndrome  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Pneumonia aspiration  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Pneumothorax  1  2/554 (0.36%)  2 1/552 (0.18%)  1 5/550 (0.91%)  6
Pneumothorax spontaneous  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Pulmonary embolism  1  1/554 (0.18%)  1 1/552 (0.18%)  1 4/550 (0.73%)  5
Pulmonary fibrosis  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Pulmonary hypertension  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Pulmonary mass  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Respiratory failure  1  1/554 (0.18%)  1 0/552 (0.00%)  0 3/550 (0.55%)  3
Sleep apnoea syndrome  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Skin and subcutaneous tissue disorders       
Dermatomyositis  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Erythema nodosum  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Psoriasis  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Skin laxity  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
Vascular disorders       
Arterial haemorrhage  1  0/554 (0.00%)  0 0/552 (0.00%)  0 1/550 (0.18%)  1
Deep vein thrombosis  1  0/554 (0.00%)  0 0/552 (0.00%)  0 3/550 (0.55%)  3
Hypertension  1  1/554 (0.18%)  1 0/552 (0.00%)  0 1/550 (0.18%)  1
Hypertensive crisis  1  1/554 (0.18%)  1 1/552 (0.18%)  1 0/550 (0.00%)  0
Hypotension  1  0/554 (0.00%)  0 2/552 (0.36%)  2 0/550 (0.00%)  0
Peripheral arterial occlusive disease  1  0/554 (0.00%)  0 0/552 (0.00%)  0 2/550 (0.36%)  2
Peripheral ischaemia  1  0/554 (0.00%)  0 1/552 (0.18%)  1 0/550 (0.00%)  0
Peripheral venous disease  1  1/554 (0.18%)  1 0/552 (0.00%)  0 0/550 (0.00%)  0
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Benralizumab 30 mg Benralizumab 100 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   293/554 (52.89%)      318/552 (57.61%)      282/550 (51.27%)    
Gastrointestinal disorders       
Constipation  1  17/554 (3.07%)  19 19/552 (3.44%)  19 15/550 (2.73%)  17
Diarrhoea  1  17/554 (3.07%)  18 15/552 (2.72%)  18 6/550 (1.09%)  7
Nausea  1  13/554 (2.35%)  17 18/552 (3.26%)  22 13/550 (2.36%)  15
General disorders       
Oedema peripheral  1  11/554 (1.99%)  13 26/552 (4.71%)  28 11/550 (2.00%)  11
Infections and infestations       
Bronchitis  1  59/554 (10.65%)  74 84/552 (15.22%)  113 80/550 (14.55%)  121
Lower respiratory tract infection  1  50/554 (9.03%)  76 32/552 (5.80%)  47 29/550 (5.27%)  39
Oral candidiasis  1  17/554 (3.07%)  21 13/552 (2.36%)  18 15/550 (2.73%)  16
Respiratory tract infection  1  10/554 (1.81%)  10 11/552 (1.99%)  14 18/550 (3.27%)  26
Respiratory tract infection viral  1  15/554 (2.71%)  21 12/552 (2.17%)  18 19/550 (3.45%)  23
Sinusitis  1  13/554 (2.35%)  16 17/552 (3.08%)  22 20/550 (3.64%)  22
Upper respiratory tract infection  1  69/554 (12.45%)  87 74/552 (13.41%)  104 65/550 (11.82%)  97
Urinary tract infection  1  23/554 (4.15%)  27 22/552 (3.99%)  30 15/550 (2.73%)  22
Viral upper respiratory tract infection  1  83/554 (14.98%)  126 95/552 (17.21%)  134 66/550 (12.00%)  98
Musculoskeletal and connective tissue disorders       
Back pain  1  21/554 (3.79%)  23 25/552 (4.53%)  30 19/550 (3.45%)  19
Nervous system disorders       
Headache  1  21/554 (3.79%)  29 26/552 (4.71%)  30 20/550 (3.64%)  21
Respiratory, thoracic and mediastinal disorders       
Cough  1  16/554 (2.89%)  18 14/552 (2.54%)  20 21/550 (3.82%)  30
Dyspnoea  1  24/554 (4.33%)  30 17/552 (3.08%)  19 23/550 (4.18%)  37
Oropharyngeal pain  1  14/554 (2.53%)  15 18/552 (3.26%)  21 13/550 (2.36%)  17
Vascular disorders       
Hypertension  1  19/554 (3.43%)  19 19/552 (3.44%)  19 18/550 (3.27%)  19
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
≥ 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ulbaldo Martin
Organization: AstraZeneca
Phone: 1.301.398.0163
EMail: ulbaldo.martin@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02138916    
Other Study ID Numbers: D3251C00003
First Submitted: March 26, 2014
First Posted: May 15, 2014
Results First Submitted: March 19, 2019
Results First Posted: June 13, 2019
Last Update Posted: June 13, 2019