Trial Outcomes & Findings for Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist (NCT NCT01914757)
NCT ID: NCT01914757
Last Updated: 2017-01-25
Results Overview
The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2508 participants
Primary outcome timeframe
Immediately following the first administration of study drug through Study Week 56.
Results posted on
2017-01-25
Participant Flow
2505 participants signed informed consent, 2181 entered screening/run-in period, 1306 participants were randomised to receive treatment with benralizumab 30 mg Q4W, Q8W, or placebo. Of the 1306 patients randomised, all (100.0%) received treatment with study drug.
Participant milestones
| Measure |
Benralizumab 30 mg q.4 Weeks
Benralizumab administered subcutaneously every 4 weeks
|
Benralizumab 30 mg q.8 Weeks
Benralizumab administered subcutaneously every 8 weeks
|
Placebo
Placebo administered subcutaneously
|
|---|---|---|---|
|
Overall Study
STARTED
|
425
|
441
|
440
|
|
Overall Study
COMPLETED
|
389
|
390
|
402
|
|
Overall Study
NOT COMPLETED
|
36
|
51
|
38
|
Reasons for withdrawal
| Measure |
Benralizumab 30 mg q.4 Weeks
Benralizumab administered subcutaneously every 4 weeks
|
Benralizumab 30 mg q.8 Weeks
Benralizumab administered subcutaneously every 8 weeks
|
Placebo
Placebo administered subcutaneously
|
|---|---|---|---|
|
Overall Study
Severe non-compliance to protocol
|
3
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
5
|
8
|
6
|
|
Overall Study
Withdrawal by Subject
|
15
|
27
|
19
|
|
Overall Study
Death
|
2
|
2
|
1
|
|
Overall Study
Adverse Event
|
4
|
3
|
4
|
|
Overall Study
Study specific withdrawal criteria
|
0
|
1
|
0
|
|
Overall Study
Eligibility criteria not fulfilled
|
2
|
0
|
2
|
|
Overall Study
Other reasons
|
5
|
9
|
4
|
Baseline Characteristics
Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist
Baseline characteristics by cohort
| Measure |
Benralizumab 30 mg q.4 Weeks
n=425 Participants
Benralizumab administered subcutaneously every 4 weeks
|
Benralizumab 30 mg q.8 Weeks
n=441 Participants
Benralizumab administered subcutaneously every 8 weeks
|
Placebo
n=440 Participants
Placebo administered subcutaneously
|
Total
n=1306 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.0 Years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
49 Years
STANDARD_DEVIATION 14.3 • n=7 Participants
|
48.8 Years
STANDARD_DEVIATION 15.1 • n=5 Participants
|
49.2 Years
STANDARD_DEVIATION 14.3 • n=4 Participants
|
|
Gender
Female
|
270 Participants
n=5 Participants
|
273 Participants
n=7 Participants
|
264 Participants
n=5 Participants
|
807 Participants
n=4 Participants
|
|
Gender
Male
|
155 Participants
n=5 Participants
|
168 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
499 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 56.Population: Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS.
The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF.
Outcome measures
| Measure |
Placebo
n=248 Participants
Placebo administered subcutaneously
|
Benralizumab 30 mg q.4 Weeks
n=241 Participants
Benralizumab administered subcutaneously every 4 weeks
|
Benralizumab 30 mg q.8 Weeks
n=239 Participants
Benralizumab administered subcutaneously every 8 weeks
|
|---|---|---|---|
|
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL
|
0.93 Events/year
Interval 0.77 to 1.12
|
0.6 Events/year
Interval 0.48 to 0.74
|
0.66 Events/year
Interval 0.54 to 0.82
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 56.Population: Full analysis set, Baseline eosinophils \<300/uL, High-dose ICS.
The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF.
Outcome measures
| Measure |
Placebo
n=122 Participants
Placebo administered subcutaneously
|
Benralizumab 30 mg q.4 Weeks
n=116 Participants
Benralizumab administered subcutaneously every 4 weeks
|
Benralizumab 30 mg q.8 Weeks
n=125 Participants
Benralizumab administered subcutaneously every 8 weeks
|
|---|---|---|---|
|
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL
|
1.21 Events/year
Interval 0.96 to 1.52
|
0.78 Events/year
Interval 0.59 to 1.02
|
0.73 Events/year
Interval 0.55 to 0.95
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 56.Population: Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS
Outcome measures
| Measure |
Placebo
n=221 Participants
Placebo administered subcutaneously
|
Benralizumab 30 mg q.4 Weeks
n=216 Participants
Benralizumab administered subcutaneously every 4 weeks
|
Benralizumab 30 mg q.8 Weeks
n=211 Participants
Benralizumab administered subcutaneously every 8 weeks
|
|---|---|---|---|
|
Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils >=300/uL
|
0.206 Liter
Standard Deviation 0.471
|
0.34 Liter
Standard Deviation 0.469
|
0.332 Liter
Standard Deviation 0.518
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 56.Population: Full analysis set, Baseline eosinophils \<300/uL, High-dose ICS
Outcome measures
| Measure |
Placebo
n=99 Participants
Placebo administered subcutaneously
|
Benralizumab 30 mg q.4 Weeks
n=101 Participants
Benralizumab administered subcutaneously every 4 weeks
|
Benralizumab 30 mg q.8 Weeks
n=98 Participants
Benralizumab administered subcutaneously every 8 weeks
|
|---|---|---|---|
|
Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils <300/uL
|
0.135 Liter
Standard Deviation 0.437
|
0.221 Liter
Standard Deviation 0.441
|
0.164 Liter
Standard Deviation 0.358
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 56.Population: Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS
Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.
Outcome measures
| Measure |
Placebo
n=187 Participants
Placebo administered subcutaneously
|
Benralizumab 30 mg q.4 Weeks
n=184 Participants
Benralizumab administered subcutaneously every 4 weeks
|
Benralizumab 30 mg q.8 Weeks
n=185 Participants
Benralizumab administered subcutaneously every 8 weeks
|
|---|---|---|---|
|
Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils >=300/uL
|
-1.2 Scores on a scale
Standard Deviation 1.19
|
-1.33 Scores on a scale
Standard Deviation 1.23
|
-1.4 Scores on a scale
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 56.Population: Full analysis set, Baseline eosinophils \<300/uL, High-dose ICS
Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.
Outcome measures
| Measure |
Placebo
n=89 Participants
Placebo administered subcutaneously
|
Benralizumab 30 mg q.4 Weeks
n=88 Participants
Benralizumab administered subcutaneously every 4 weeks
|
Benralizumab 30 mg q.8 Weeks
n=85 Participants
Benralizumab administered subcutaneously every 8 weeks
|
|---|---|---|---|
|
Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils <300/uL
|
-0.88 Scores on a scale
Standard Deviation 1.12
|
-1.05 Scores on a scale
Standard Deviation 1.14
|
-0.95 Scores on a scale
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 56.Population: Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS
Change from Baseline to Week 56 in number of Rescue medication use (puffs/day)
Outcome measures
| Measure |
Placebo
n=187 Participants
Placebo administered subcutaneously
|
Benralizumab 30 mg q.4 Weeks
n=184 Participants
Benralizumab administered subcutaneously every 4 weeks
|
Benralizumab 30 mg q.8 Weeks
n=185 Participants
Benralizumab administered subcutaneously every 8 weeks
|
|---|---|---|---|
|
Change in Asthma Rescue Medication Use
|
-2.65 Puffs per day
Standard Deviation 9.57
|
-2.0 Puffs per day
Standard Deviation 3.64
|
-2.92 Puffs per day
Standard Deviation 3.60
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 56.Population: Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS
Change from Baseline to Week 56 in Home lung function (morning and evening Peak expiratory flow \[PEF\])
Outcome measures
| Measure |
Placebo
n=248 Participants
Placebo administered subcutaneously
|
Benralizumab 30 mg q.4 Weeks
n=241 Participants
Benralizumab administered subcutaneously every 4 weeks
|
Benralizumab 30 mg q.8 Weeks
n=239 Participants
Benralizumab administered subcutaneously every 8 weeks
|
|---|---|---|---|
|
Home Lung Function Assessments Based on PEF
Change at Week 56, Morning (n=194, 193, 197)
|
23.961 L/min
Standard Deviation 71.509
|
41.745 L/min
Standard Deviation 78.534
|
43.375 L/min
Standard Deviation 91.865
|
|
Home Lung Function Assessments Based on PEF
Change at Week 56, Evening (n=194, 192, 197)
|
15.448 L/min
Standard Deviation 78.341
|
35.142 L/min
Standard Deviation 75.489
|
39.270 L/min
Standard Deviation 89.772
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 56.Population: Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS
Change from Baseline to Week 56 on Proportion of Nights with awakening due to asthma
Outcome measures
| Measure |
Placebo
n=203 Participants
Placebo administered subcutaneously
|
Benralizumab 30 mg q.4 Weeks
n=196 Participants
Benralizumab administered subcutaneously every 4 weeks
|
Benralizumab 30 mg q.8 Weeks
n=198 Participants
Benralizumab administered subcutaneously every 8 weeks
|
|---|---|---|---|
|
Proportion of Nights With Awakening Due to Asthma
|
-0.372 Proportion of nights
Standard Deviation 0.405
|
-0.373 Proportion of nights
Standard Deviation 0.388
|
-0.431 Proportion of nights
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 56.Population: Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS
ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of \<=0.75 indicates well-controlled asthma, scores between 0.75 to \<=1.5 indicate partly controlled asthma, and \>1.5 indicates not well controlled asthma.
Outcome measures
| Measure |
Placebo
n=197 Participants
Placebo administered subcutaneously
|
Benralizumab 30 mg q.4 Weeks
n=192 Participants
Benralizumab administered subcutaneously every 4 weeks
|
Benralizumab 30 mg q.8 Weeks
n=185 Participants
Benralizumab administered subcutaneously every 8 weeks
|
|---|---|---|---|
|
Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils >=300/uL
|
-1.21 Scores on a scale
Standard Deviation 1.12
|
-1.34 Scores on a scale
Standard Deviation 1.13
|
-1.49 Scores on a scale
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 56.Population: Full analysis set, Baseline eosinophils \<300/uL, High-dose ICS
ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of \<=0.75 indicates well-controlled asthma, scores between 0.75 to \<=1.5 indicate partly controlled asthma, and \>1.5 indicates not well controlled asthma.
Outcome measures
| Measure |
Placebo
n=92 Participants
Placebo administered subcutaneously
|
Benralizumab 30 mg q.4 Weeks
n=88 Participants
Benralizumab administered subcutaneously every 4 weeks
|
Benralizumab 30 mg q.8 Weeks
n=83 Participants
Benralizumab administered subcutaneously every 8 weeks
|
|---|---|---|---|
|
Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils <300/uL
|
-0.83 Scores on a scale
Standard Deviation 1.07
|
-1.22 Scores on a scale
Standard Deviation 1.16
|
-1.06 Scores on a scale
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 56Population: Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS
Outcome measures
| Measure |
Placebo
n=248 Participants
Placebo administered subcutaneously
|
Benralizumab 30 mg q.4 Weeks
n=241 Participants
Benralizumab administered subcutaneously every 4 weeks
|
Benralizumab 30 mg q.8 Weeks
n=239 Participants
Benralizumab administered subcutaneously every 8 weeks
|
|---|---|---|---|
|
Number of Patients With >=1 Asthma Exacerbation
|
126 Participants
|
84 Participants
|
95 Participants
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 56Population: Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS
Outcome measures
| Measure |
Placebo
n=248 Participants
Placebo administered subcutaneously
|
Benralizumab 30 mg q.4 Weeks
n=241 Participants
Benralizumab administered subcutaneously every 4 weeks
|
Benralizumab 30 mg q.8 Weeks
n=239 Participants
Benralizumab administered subcutaneously every 8 weeks
|
|---|---|---|---|
|
Time to First Asthma Exacerbation
|
126 Participants
|
84 Participants
|
95 Participants
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 56.Population: Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS
Annual rate of asthma exacerbations that are associated with an emergency room visit or a hospitalization (adjudicated)
Outcome measures
| Measure |
Placebo
n=248 Participants
Placebo administered subcutaneously
|
Benralizumab 30 mg q.4 Weeks
n=241 Participants
Benralizumab administered subcutaneously every 4 weeks
|
Benralizumab 30 mg q.8 Weeks
n=239 Participants
Benralizumab administered subcutaneously every 8 weeks
|
|---|---|---|---|
|
Annual Rate of Asthma Exacerbation Resulting Emergency Room Visits and Hospitalizations
|
0.04 Events/year
Interval 0.02 to 0.07
|
0.04 Events/year
Interval 0.02 to 0.06
|
0.05 Events/year
Interval 0.03 to 0.08
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56, Week 60Population: PK analysis set
Mean PK Concentration at each visit
Outcome measures
| Measure |
Placebo
Placebo administered subcutaneously
|
Benralizumab 30 mg q.4 Weeks
n=435 Participants
Benralizumab administered subcutaneously every 4 weeks
|
Benralizumab 30 mg q.8 Weeks
n=424 Participants
Benralizumab administered subcutaneously every 8 weeks
|
|---|---|---|---|
|
Pharmacokinetics of Benralizumab
Week 60 (n=49, 45)
|
—
|
53.63 ng/mL
Geometric Coefficient of Variation 1782.96
|
18.63 ng/mL
Geometric Coefficient of Variation 756.47
|
|
Pharmacokinetics of Benralizumab
Baseline (n=435, 419)
|
—
|
NA ng/mL
Geometric Coefficient of Variation NA
Value is less than lower limit of quantification
|
NA ng/mL
Geometric Coefficient of Variation NA
Value is less than lower limit of quantification
|
|
Pharmacokinetics of Benralizumab
Week 4 (n=430, 416)
|
—
|
650.04 ng/mL
Geometric Coefficient of Variation 154.61
|
703.16 ng/mL
Geometric Coefficient of Variation 89.48
|
|
Pharmacokinetics of Benralizumab
Week 8 (n=414, 395)
|
—
|
894.86 ng/mL
Geometric Coefficient of Variation 148.91
|
939.45 ng/mL
Geometric Coefficient of Variation 98.99
|
|
Pharmacokinetics of Benralizumab
Week 16 (n=390, 378)
|
—
|
936.43 ng/mL
Geometric Coefficient of Variation 247.46
|
252.54 ng/mL
Geometric Coefficient of Variation 274.74
|
|
Pharmacokinetics of Benralizumab
Week 24 (n=388, 361)
|
—
|
827.09 ng/mL
Geometric Coefficient of Variation 370.64
|
188.99 ng/mL
Geometric Coefficient of Variation 308.38
|
|
Pharmacokinetics of Benralizumab
Week 32 (n=345, 323)
|
—
|
823.21 ng/mL
Geometric Coefficient of Variation 362.43
|
166.53 ng/mL
Geometric Coefficient of Variation 289.34
|
|
Pharmacokinetics of Benralizumab
Week 40 (n=370, 338)
|
—
|
859.69 ng/mL
Geometric Coefficient of Variation 364.28
|
172.28 ng/mL
Geometric Coefficient of Variation 298.6
|
|
Pharmacokinetics of Benralizumab
Week 48 (n=355, 337)
|
—
|
888.09 ng/mL
Geometric Coefficient of Variation 333.98
|
186.5 ng/mL
Geometric Coefficient of Variation 290.28
|
|
Pharmacokinetics of Benralizumab
Week 56 (n=358, 344)
|
—
|
763.98 ng/mL
Geometric Coefficient of Variation 309.18
|
173.41 ng/mL
Geometric Coefficient of Variation 235.86
|
SECONDARY outcome
Timeframe: Pre-treatment until end of follow-upPopulation: Safety analysis set
Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at \>=2 post-baseline assessments (with \>=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive.
Outcome measures
| Measure |
Placebo
n=440 Participants
Placebo administered subcutaneously
|
Benralizumab 30 mg q.4 Weeks
n=438 Participants
Benralizumab administered subcutaneously every 4 weeks
|
Benralizumab 30 mg q.8 Weeks
n=427 Participants
Benralizumab administered subcutaneously every 8 weeks
|
|---|---|---|---|
|
Immunogenicity of Benralizumab
Positive at any visit (n=438, 427, 440)
|
13 Participants
|
63 Participants
|
64 Participants
|
|
Immunogenicity of Benralizumab
Base- and Post-baseline Postive (n=431, 414, 430)
|
5 Participants
|
5 Participants
|
5 Participants
|
|
Immunogenicity of Benralizumab
Only post-baseline positive (n=431, 420, 436)
|
8 Participants
|
55 Participants
|
57 Participants
|
|
Immunogenicity of Benralizumab
Persistently positive (n=431, 420, 436)
|
7 Participants
|
44 Participants
|
42 Participants
|
|
Immunogenicity of Benralizumab
Transient positive (n=431, 420, 436)
|
6 Participants
|
16 Participants
|
20 Participants
|
|
Immunogenicity of Benralizumab
Only baseline positive (n=438, 421, 434)
|
0 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 56Population: Safety analysis set
Extent of exposure is defined as the duration of treatment in days
Outcome measures
| Measure |
Placebo
n=440 Participants
Placebo administered subcutaneously
|
Benralizumab 30 mg q.4 Weeks
n=438 Participants
Benralizumab administered subcutaneously every 4 weeks
|
Benralizumab 30 mg q.8 Weeks
n=428 Participants
Benralizumab administered subcutaneously every 8 weeks
|
|---|---|---|---|
|
Extent of Exposure
|
336.69 Days
Standard Deviation 82.148
|
344.14 Days
Standard Deviation 73.129
|
331.64 Days
Standard Deviation 88.839
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 56Population: Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS
AQLQ(S)+12 overall score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment). Total or domain score change of \>=0.5 are considered clinically meaningful.
Outcome measures
| Measure |
Placebo
n=191 Participants
Placebo administered subcutaneously
|
Benralizumab 30 mg q.4 Weeks
n=186 Participants
Benralizumab administered subcutaneously every 4 weeks
|
Benralizumab 30 mg q.8 Weeks
n=180 Participants
Benralizumab administered subcutaneously every 8 weeks
|
|---|---|---|---|
|
Mean Change From Baseline to Week 56 in AQLQ(S)+12
|
1.32 Scores on a scale
Standard Deviation 1.19
|
1.44 Scores on a scale
Standard Deviation 1.15
|
1.61 Scores on a scale
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 56Population: Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS
EQ-5D-5L VAS is to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state.
Outcome measures
| Measure |
Placebo
n=191 Participants
Placebo administered subcutaneously
|
Benralizumab 30 mg q.4 Weeks
n=183 Participants
Benralizumab administered subcutaneously every 4 weeks
|
Benralizumab 30 mg q.8 Weeks
n=179 Participants
Benralizumab administered subcutaneously every 8 weeks
|
|---|---|---|---|
|
Change From Baseline to Week 56 in EQ-5D-5L VAS
|
12.1 Scores on a scale
Standard Deviation 20.13
|
13.8 Scores on a scale
Standard Deviation 21.52
|
15.5 Scores on a scale
Standard Deviation 20.36
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 56Population: Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS, who were employed
WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Work productivity loss is derived by sum of percentage of missed work due to asthma and product of percentage of actual working hours times degree of asthma affecting work productivity while working. Percentage of missed work due to asthma is calculated by number of hours missed work due to asthma divided by total number of hours missed work plus number of hours actually worked. This is only applicable to patients who were employed.
Outcome measures
| Measure |
Placebo
n=85 Participants
Placebo administered subcutaneously
|
Benralizumab 30 mg q.4 Weeks
n=92 Participants
Benralizumab administered subcutaneously every 4 weeks
|
Benralizumab 30 mg q.8 Weeks
n=74 Participants
Benralizumab administered subcutaneously every 8 weeks
|
|---|---|---|---|
|
Mean Work Productivity Loss Due to Asthma
|
27.29 Percent of productivity loss
Standard Deviation 25.802
|
26.56 Percent of productivity loss
Standard Deviation 25.589
|
24.44 Percent of productivity loss
Standard Deviation 24.689
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 56Population: Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS, who took classes
WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Classroom productivity loss is derived by sum of percentage of missed classes due to asthma and product of percentage of actual hours attending classes times degree of asthma affecting classroom productivity. Percentage of missed classes due to asthma is calculated by number of hours missed classes due to asthma divided by total number of hours missed classes plus number of hours actually attending classes. This is only applicable for patients who took classes.
Outcome measures
| Measure |
Placebo
n=5 Participants
Placebo administered subcutaneously
|
Benralizumab 30 mg q.4 Weeks
n=14 Participants
Benralizumab administered subcutaneously every 4 weeks
|
Benralizumab 30 mg q.8 Weeks
n=5 Participants
Benralizumab administered subcutaneously every 8 weeks
|
|---|---|---|---|
|
Mean Productivity Loss Due to Asthma in Classroom
|
33.5 percent of productivity loss
Standard Deviation 25.593
|
19.92 percent of productivity loss
Standard Deviation 23.765
|
14 percent of productivity loss
Standard Deviation 16.733
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 56Population: Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS
Outcome measures
| Measure |
Placebo
n=248 Participants
Placebo administered subcutaneously
|
Benralizumab 30 mg q.4 Weeks
n=241 Participants
Benralizumab administered subcutaneously every 4 weeks
|
Benralizumab 30 mg q.8 Weeks
n=239 Participants
Benralizumab administered subcutaneously every 8 weeks
|
|---|---|---|---|
|
Number of Participants That Utilized Health Care Resources
Hospitalizations
|
12 Participants
|
11 Participants
|
14 Participants
|
|
Number of Participants That Utilized Health Care Resources
Emergency department visits
|
18 Participants
|
11 Participants
|
12 Participants
|
|
Number of Participants That Utilized Health Care Resources
Unscheduled outpatient visits
|
83 Participants
|
72 Participants
|
75 Participants
|
|
Number of Participants That Utilized Health Care Resources
Home visits
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants That Utilized Health Care Resources
Telephone calls
|
58 Participants
|
50 Participants
|
63 Participants
|
|
Number of Participants That Utilized Health Care Resources
Ambulance transports
|
5 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 56Population: Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS
CGIC (clinician global impression of change), and PGIC (patient global impression of change) are overall evaluation of response to treatment, conducted separately by investigator and patient using a 7-point rating scale, ranging from 1 (Very much Improved), to 7 (Very much Worse). This endpoint was added after the second protocol amendment, thus not all patients had data to be analyzed.
Outcome measures
| Measure |
Placebo
n=248 Participants
Placebo administered subcutaneously
|
Benralizumab 30 mg q.4 Weeks
n=241 Participants
Benralizumab administered subcutaneously every 4 weeks
|
Benralizumab 30 mg q.8 Weeks
n=239 Participants
Benralizumab administered subcutaneously every 8 weeks
|
|---|---|---|---|
|
Patient and Clinician Assessment of Response to Treatment
CGIC, Improved
|
97 Participants
|
109 Participants
|
96 Participants
|
|
Patient and Clinician Assessment of Response to Treatment
CGIC, Much Improved
|
65 Participants
|
82 Participants
|
71 Participants
|
|
Patient and Clinician Assessment of Response to Treatment
CGIC, Very Much Improved
|
14 Participants
|
26 Participants
|
23 Participants
|
|
Patient and Clinician Assessment of Response to Treatment
CGIC, Total
|
176 Participants
|
217 Participants
|
190 Participants
|
|
Patient and Clinician Assessment of Response to Treatment
PGIC, Improved
|
99 Participants
|
109 Participants
|
95 Participants
|
|
Patient and Clinician Assessment of Response to Treatment
PGIC, Much Improved
|
66 Participants
|
83 Participants
|
80 Participants
|
|
Patient and Clinician Assessment of Response to Treatment
PGIC, Very Much Improved
|
17 Participants
|
34 Participants
|
30 Participants
|
|
Patient and Clinician Assessment of Response to Treatment
PGIC, Total
|
182 Participants
|
226 Participants
|
205 Participants
|
Adverse Events
Benralizumab 30 mg q.4 Weeks
Serious events: 46 serious events
Other events: 244 other events
Deaths: 0 deaths
Benralizumab 30 mg q.8 Weeks
Serious events: 41 serious events
Other events: 232 other events
Deaths: 0 deaths
Placebo
Serious events: 61 serious events
Other events: 264 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Benralizumab 30 mg q.4 Weeks
n=438 participants at risk
Benralizumab administered subcutaneously every 4 weeks
|
Benralizumab 30 mg q.8 Weeks
n=428 participants at risk
Benralizumab administered subcutaneously every 8 weeks
|
Placebo
n=440 participants at risk
Placebo administered subcutaneously
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/438
|
0.23%
1/428 • Number of events 1
|
0.00%
0/440
|
|
Cardiac disorders
Acute myocardial infarction
|
0.23%
1/438 • Number of events 1
|
0.00%
0/428
|
0.23%
1/440 • Number of events 2
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/438
|
0.23%
1/428 • Number of events 1
|
0.00%
0/440
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/438
|
0.23%
1/428 • Number of events 1
|
0.00%
0/440
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
0.23%
1/438 • Number of events 1
|
0.00%
0/428
|
0.00%
0/440
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.23%
1/438 • Number of events 1
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/438
|
0.00%
0/428
|
0.45%
2/440 • Number of events 2
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Eye disorders
Cataract
|
0.00%
0/438
|
0.23%
1/428 • Number of events 1
|
0.00%
0/440
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.00%
0/438
|
0.23%
1/428 • Number of events 1
|
0.00%
0/440
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.23%
1/438 • Number of events 1
|
0.00%
0/428
|
0.00%
0/440
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.23%
1/438 • Number of events 1
|
0.00%
0/428
|
0.00%
0/440
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
General disorders
Chest pain
|
0.23%
1/438 • Number of events 1
|
0.23%
1/428 • Number of events 1
|
0.00%
0/440
|
|
General disorders
Death
|
0.00%
0/438
|
0.23%
1/428 • Number of events 1
|
0.00%
0/440
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/438
|
0.23%
1/428 • Number of events 1
|
0.00%
0/440
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.23%
1/438 • Number of events 1
|
0.00%
0/428
|
0.00%
0/440
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.23%
1/438 • Number of events 1
|
0.00%
0/428
|
0.00%
0/440
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.23%
1/438 • Number of events 1
|
0.00%
0/428
|
0.00%
0/440
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/438
|
0.23%
1/428 • Number of events 1
|
0.00%
0/440
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/438
|
0.23%
1/428 • Number of events 1
|
0.23%
1/440 • Number of events 1
|
|
Infections and infestations
Appendicitis
|
0.00%
0/438
|
0.23%
1/428 • Number of events 1
|
0.00%
0/440
|
|
Infections and infestations
Bacterial infection
|
0.23%
1/438 • Number of events 1
|
0.00%
0/428
|
0.00%
0/440
|
|
Infections and infestations
Bronchitis
|
0.23%
1/438 • Number of events 1
|
0.23%
1/428 • Number of events 1
|
0.00%
0/440
|
|
Infections and infestations
Bronchitis haemophilus
|
0.00%
0/438
|
0.23%
1/428 • Number of events 1
|
0.00%
0/440
|
|
Infections and infestations
Chronic sinusitis
|
0.23%
1/438 • Number of events 1
|
0.00%
0/428
|
0.00%
0/440
|
|
Infections and infestations
Cytomegalovirus hepatitis
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/438
|
0.23%
1/428 • Number of events 1
|
0.00%
0/440
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/438
|
0.23%
1/428 • Number of events 1
|
0.00%
0/440
|
|
Infections and infestations
Influenza
|
0.00%
0/438
|
0.47%
2/428 • Number of events 2
|
0.00%
0/440
|
|
Infections and infestations
Liver abscess
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.46%
2/438 • Number of events 2
|
0.00%
0/428
|
0.91%
4/440 • Number of events 6
|
|
Infections and infestations
Pneumonia bacterial
|
0.46%
2/438 • Number of events 2
|
0.00%
0/428
|
0.68%
3/440 • Number of events 3
|
|
Infections and infestations
Pseudomonas bronchitis
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.23%
1/438 • Number of events 1
|
0.00%
0/428
|
0.00%
0/440
|
|
Infections and infestations
Sepsis
|
0.23%
1/438 • Number of events 1
|
0.00%
0/428
|
0.00%
0/440
|
|
Infections and infestations
Sinusitis
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/438
|
0.23%
1/428 • Number of events 1
|
0.00%
0/440
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/438
|
0.23%
1/428 • Number of events 1
|
0.00%
0/440
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer
|
0.00%
0/438
|
0.23%
1/428 • Number of events 1
|
0.00%
0/440
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/438
|
0.23%
1/428 • Number of events 1
|
0.00%
0/440
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/438
|
0.23%
1/428 • Number of events 1
|
0.00%
0/440
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.23%
1/438 • Number of events 1
|
0.00%
0/428
|
0.00%
0/440
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/438
|
0.23%
1/428 • Number of events 1
|
0.00%
0/440
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/438
|
0.23%
1/428 • Number of events 1
|
0.00%
0/440
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/438
|
0.23%
1/428 • Number of events 1
|
0.00%
0/440
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.00%
0/438
|
0.23%
1/428 • Number of events 1
|
0.00%
0/440
|
|
Musculoskeletal and connective tissue disorders
Epiphysiolysis
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.23%
1/438 • Number of events 1
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Jaw cyst
|
0.23%
1/438 • Number of events 1
|
0.00%
0/428
|
0.00%
0/440
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.23%
1/438 • Number of events 1
|
0.00%
0/428
|
0.00%
0/440
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.23%
1/438 • Number of events 1
|
0.23%
1/428 • Number of events 1
|
0.23%
1/440 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.23%
1/438 • Number of events 1
|
0.00%
0/428
|
0.00%
0/440
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.23%
1/438 • Number of events 1
|
0.00%
0/428
|
0.00%
0/440
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.00%
0/438
|
0.23%
1/428 • Number of events 1
|
0.00%
0/440
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.23%
1/438 • Number of events 1
|
0.00%
0/428
|
0.00%
0/440
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.23%
1/438 • Number of events 1
|
0.00%
0/428
|
0.00%
0/440
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.23%
1/438 • Number of events 1
|
0.00%
0/428
|
0.00%
0/440
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 2
|
|
Nervous system disorders
Sciatica
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Nervous system disorders
Seizure
|
0.00%
0/438
|
0.23%
1/428 • Number of events 1
|
0.00%
0/440
|
|
Nervous system disorders
Syncope
|
0.23%
1/438 • Number of events 1
|
0.23%
1/428 • Number of events 1
|
0.00%
0/440
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Psychiatric disorders
Completed suicide
|
0.23%
1/438 • Number of events 1
|
0.00%
0/428
|
0.00%
0/440
|
|
Psychiatric disorders
Depression
|
0.00%
0/438
|
0.23%
1/428 • Number of events 1
|
0.00%
0/440
|
|
Renal and urinary disorders
Calculus ureteric
|
0.23%
1/438 • Number of events 1
|
0.00%
0/428
|
0.00%
0/440
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.46%
2/438 • Number of events 3
|
0.00%
0/428
|
0.00%
0/440
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
4.8%
21/438 • Number of events 25
|
4.4%
19/428 • Number of events 27
|
5.2%
23/440 • Number of events 38
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
0.23%
1/438 • Number of events 1
|
0.00%
0/428
|
0.00%
0/440
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.23%
1/438 • Number of events 1
|
0.00%
0/428
|
0.00%
0/440
|
|
Skin and subcutaneous tissue disorders
Parakeratosis
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.23%
1/438 • Number of events 1
|
0.00%
0/428
|
0.00%
0/440
|
|
Skin and subcutaneous tissue disorders
Urticaria papular
|
0.00%
0/438
|
0.23%
1/428 • Number of events 1
|
0.00%
0/440
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.00%
0/438
|
0.23%
1/428 • Number of events 1
|
0.23%
1/440 • Number of events 1
|
|
Vascular disorders
Hypertensive crisis
|
0.23%
1/438 • Number of events 1
|
0.00%
0/428
|
0.00%
0/440
|
|
Vascular disorders
Phlebitis
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/438
|
0.00%
0/428
|
0.23%
1/440 • Number of events 1
|
Other adverse events
| Measure |
Benralizumab 30 mg q.4 Weeks
n=438 participants at risk
Benralizumab administered subcutaneously every 4 weeks
|
Benralizumab 30 mg q.8 Weeks
n=428 participants at risk
Benralizumab administered subcutaneously every 8 weeks
|
Placebo
n=440 participants at risk
Placebo administered subcutaneously
|
|---|---|---|---|
|
General disorders
Pyrexia
|
3.7%
16/438 • Number of events 20
|
3.0%
13/428 • Number of events 13
|
1.4%
6/440 • Number of events 6
|
|
Infections and infestations
Acute sinusitis
|
1.4%
6/438 • Number of events 6
|
1.2%
5/428 • Number of events 6
|
3.2%
14/440 • Number of events 19
|
|
Infections and infestations
Bronchitis
|
9.1%
40/438 • Number of events 51
|
10.5%
45/428 • Number of events 54
|
12.3%
54/440 • Number of events 72
|
|
Infections and infestations
Influenza
|
5.5%
24/438 • Number of events 27
|
2.8%
12/428 • Number of events 17
|
5.7%
25/440 • Number of events 27
|
|
Infections and infestations
Nasopharyngitis
|
20.5%
90/438 • Number of events 132
|
19.2%
82/428 • Number of events 131
|
20.9%
92/440 • Number of events 147
|
|
Infections and infestations
Pharyngitis
|
3.9%
17/438 • Number of events 21
|
2.3%
10/428 • Number of events 10
|
1.8%
8/440 • Number of events 9
|
|
Infections and infestations
Rhinitis
|
2.7%
12/438 • Number of events 13
|
4.2%
18/428 • Number of events 24
|
3.9%
17/440 • Number of events 22
|
|
Infections and infestations
Sinusitis
|
5.3%
23/438 • Number of events 31
|
4.9%
21/428 • Number of events 30
|
8.9%
39/440 • Number of events 56
|
|
Infections and infestations
Upper respiratory tract infection
|
6.6%
29/438 • Number of events 35
|
8.6%
37/428 • Number of events 53
|
9.5%
42/440 • Number of events 53
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.8%
8/438 • Number of events 10
|
3.3%
14/428 • Number of events 16
|
2.3%
10/440 • Number of events 14
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.9%
17/438 • Number of events 18
|
2.6%
11/428 • Number of events 11
|
3.6%
16/440 • Number of events 20
|
|
Nervous system disorders
Headache
|
7.5%
33/438 • Number of events 63
|
7.9%
34/428 • Number of events 65
|
7.3%
32/440 • Number of events 57
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
11.4%
50/438 • Number of events 76
|
7.5%
32/428 • Number of events 50
|
11.8%
52/440 • Number of events 96
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.3%
10/438 • Number of events 11
|
3.3%
14/428 • Number of events 18
|
1.8%
8/440 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
4.8%
21/438 • Number of events 25
|
3.7%
16/428 • Number of events 19
|
5.5%
24/440 • Number of events 28
|
|
Vascular disorders
Hypertension
|
2.7%
12/438 • Number of events 12
|
4.2%
18/428 • Number of events 23
|
5.0%
22/440 • Number of events 24
|
Additional Information
Mitchell Goldman, Medical Science Director
AstraZeneca
Phone: +1 301 398 0323
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