Trial Outcomes & Findings for Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma (NCT NCT01928771)
NCT ID: NCT01928771
Last Updated: 2017-05-03
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
2681 participants
Primary outcome timeframe
Immediately following the first administration of study drug through Study Week 48.
Results posted on
2017-05-03
Participant Flow
2681 participants signed informed consent form, 2232 participants entered screening/run-in period,1205 participants were randomised to receive treatment with benralizumab 30 mg Q4W, Q8W, or placebo. Of the 1205 patients randomised, 1204 patients received treatment with the study drug.
Participant milestones
| Measure |
Benralizumab 30 mg q.4 Weeks
Benralizumab administered every 4 weeks subcutaneously.
|
Benralizumab 30 mg q.8 Weeks
Benralizumab administered every 8 weeks subcutaneously.
|
Placebo
Placebo administered subcutaneously
|
|---|---|---|---|
|
Overall Study
STARTED
|
400
|
398
|
407
|
|
Overall Study
Received Treatment
|
399
|
398
|
407
|
|
Overall Study
COMPLETED
|
354
|
358
|
367
|
|
Overall Study
NOT COMPLETED
|
46
|
40
|
40
|
Reasons for withdrawal
| Measure |
Benralizumab 30 mg q.4 Weeks
Benralizumab administered every 4 weeks subcutaneously.
|
Benralizumab 30 mg q.8 Weeks
Benralizumab administered every 8 weeks subcutaneously.
|
Placebo
Placebo administered subcutaneously
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
5
|
1
|
|
Overall Study
Death
|
2
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
5
|
6
|
3
|
|
Overall Study
Withdrawal by Subject
|
20
|
15
|
17
|
|
Overall Study
Study-Specific Withdrawal Criteria
|
0
|
1
|
1
|
|
Overall Study
Other Reasons
|
9
|
9
|
14
|
|
Overall Study
Severe Non-Compliance to Protocol
|
4
|
2
|
2
|
Baseline Characteristics
Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma
Baseline characteristics by cohort
| Measure |
Benralizumab 30 mg q.4 Weeks
n=399 Participants
Benralizumab administered every 4 weeks subcutaneously.
|
Benralizumab 30 mg q.8 Weeks
n=398 Participants
Benralizumab administered every 8 weeks subcutaneously.
|
Placebo
n=407 Participants
Placebo administered subcutaneously
|
Total
n=1204 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.1 Years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
47.6 Years
STANDARD_DEVIATION 14.5 • n=7 Participants
|
48.7 Years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
48.8 Years
STANDARD_DEVIATION 14.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
275 Participants
n=5 Participants
|
252 Participants
n=7 Participants
|
269 Participants
n=5 Participants
|
796 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
124 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
408 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 48.Population: Full analysis set, Baseline eosinophils \>=300/uL
The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF
Outcome measures
| Measure |
Benralizumab 30 mg q.4 Weeks
n=275 Participants
Benralizumab administered every 4 weeks subcutaneously.
|
Benralizumab 30 mg q.8 Weeks
n=267 Participants
Benralizumab administered every 8 weeks subcutaneously.
|
Placebo
n=267 Participants
Placebo administered subcutaneously
|
|---|---|---|---|
|
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL
|
0.73 events/year
Interval 0.6 to 0.89
|
0.65 events/year
Interval 0.53 to 0.8
|
1.33 events/year
Interval 1.12 to 1.58
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 48.Population: Full analysis set, Baseline eosinophils \<300/uL
The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF
Outcome measures
| Measure |
Benralizumab 30 mg q.4 Weeks
n=124 Participants
Benralizumab administered every 4 weeks subcutaneously.
|
Benralizumab 30 mg q.8 Weeks
n=131 Participants
Benralizumab administered every 8 weeks subcutaneously.
|
Placebo
n=140 Participants
Placebo administered subcutaneously
|
|---|---|---|---|
|
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils < 300/uL
|
0.85 events/year
Interval 0.65 to 1.11
|
1.00 events/year
Interval 0.78 to 1.28
|
1.21 events/year
Interval 0.96 to 1.52
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 48.Population: Full analysis set, Baseline eosinophils \>=300/uL
The annual exacerbation rate associated with an emergency room visit or a hospitalization (adjudicated)
Outcome measures
| Measure |
Benralizumab 30 mg q.4 Weeks
n=275 Participants
Benralizumab administered every 4 weeks subcutaneously.
|
Benralizumab 30 mg q.8 Weeks
n=267 Participants
Benralizumab administered every 8 weeks subcutaneously.
|
Placebo
n=267 Participants
Placebo administered subcutaneously
|
|---|---|---|---|
|
Annual Asthma Exacerbation Rate Resulting Emergency Room Visits and Hospitalizations
|
0.11 events/year
Interval 0.07 to 0.16
|
0.06 events/year
Interval 0.04 to 0.11
|
0.18 events/year
Interval 0.13 to 0.25
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 48.Population: Full analysis set, Baseline eosinophils \>=300/uL
Outcome measures
| Measure |
Benralizumab 30 mg q.4 Weeks
n=275 Participants
Benralizumab administered every 4 weeks subcutaneously.
|
Benralizumab 30 mg q.8 Weeks
n=267 Participants
Benralizumab administered every 8 weeks subcutaneously.
|
Placebo
n=267 Participants
Placebo administered subcutaneously
|
|---|---|---|---|
|
Number of Patients With >=1 Asthma Exacerbations
|
100 Participants
84.227
|
93 Participants
72.002
|
135 Participants
74.434
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 48.Population: Full analysis set, Baseline eosinophils \>=300/uL
Outcome measures
| Measure |
Benralizumab 30 mg q.4 Weeks
n=275 Participants
Benralizumab administered every 4 weeks subcutaneously.
|
Benralizumab 30 mg q.8 Weeks
n=267 Participants
Benralizumab administered every 8 weeks subcutaneously.
|
Placebo
n=267 Participants
Placebo administered subcutaneously
|
|---|---|---|---|
|
Time to First Asthma Exacerbation
|
NA Days
95% Confidence Interval 84.227
Median time is not estimable due to less than 50% patients had exacerbations occurred.
|
NA Days
95% Confidence Interval 72.002
Median time is not estimable due to less than 50% patients had exacerbations occurred.
|
300 Days
95% Confidence Interval 74.434 • Interval 199.0 to
Upper 95% CI for median is not estimable due to the curve representing the upper confidence limit of the survival function is above 50%
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 48.Population: Full analysis set, Baseline eosinopiles \>=300/uL
Outcome measures
| Measure |
Benralizumab 30 mg q.4 Weeks
n=236 Participants
Benralizumab administered every 4 weeks subcutaneously.
|
Benralizumab 30 mg q.8 Weeks
n=235 Participants
Benralizumab administered every 8 weeks subcutaneously.
|
Placebo
n=233 Participants
Placebo administered subcutaneously
|
|---|---|---|---|
|
Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils >=300/uL
|
0.353 Liter
Standard Deviation 0.503
|
0.398 Liter
Standard Deviation 0.546
|
0.237 Liter
Standard Deviation 0.508
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 48.Population: Full analysis set, Baseline eosinopiles \<300/uL
Outcome measures
| Measure |
Benralizumab 30 mg q.4 Weeks
n=105 Participants
Benralizumab administered every 4 weeks subcutaneously.
|
Benralizumab 30 mg q.8 Weeks
n=119 Participants
Benralizumab administered every 8 weeks subcutaneously.
|
Placebo
n=125 Participants
Placebo administered subcutaneously
|
|---|---|---|---|
|
Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils <300/uL
|
0.115 Liter
Standard Deviation 0.417
|
0.238 Liter
Standard Deviation 0.483
|
0.140 Liter
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 48.Population: Full analysis set, Baseline eosinophils \>=300/uL
Asthma symptoms during night time and daytime are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma), and total asthma symptom score is the sum of the daytime and night time score (0 to 6). Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each time point 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 |
Benralizumab 30 mg q.4 Weeks
n=197 Participants
Benralizumab administered every 4 weeks subcutaneously.
|
Benralizumab 30 mg q.8 Weeks
n=178 Participants
Benralizumab administered every 8 weeks subcutaneously.
|
Placebo
n=180 Participants
Placebo administered subcutaneously
|
|---|---|---|---|
|
Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils >=300/uL
|
-1.15 Scores on a scale
Standard Deviation 1.31
|
-1.34 Scores on a scale
Standard Deviation 1.27
|
-1.03 Scores on a scale
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 48.Population: Full analysis set, Baseline eosinophils \<300/uL
Asthma symptoms during night time and daytime are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma), and total asthma symptom score is the sum of the daytime and night time score (0 to 6). Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each time point 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 |
Benralizumab 30 mg q.4 Weeks
n=93 Participants
Benralizumab administered every 4 weeks subcutaneously.
|
Benralizumab 30 mg q.8 Weeks
n=91 Participants
Benralizumab administered every 8 weeks subcutaneously.
|
Placebo
n=99 Participants
Placebo administered subcutaneously
|
|---|---|---|---|
|
Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils <300/uL
|
-0.98 Scores on a scale
Standard Deviation 1.19
|
-1.04 Scores on a scale
Standard Deviation 1.24
|
-0.78 Scores on a scale
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 48.Population: Full analysis set, Baseline eosinophils \>=300/uL
Change from baseline to week 48 in number of rescue medication use (puffs/day)
Outcome measures
| Measure |
Benralizumab 30 mg q.4 Weeks
n=197 Participants
Benralizumab administered every 4 weeks subcutaneously.
|
Benralizumab 30 mg q.8 Weeks
n=178 Participants
Benralizumab administered every 8 weeks subcutaneously.
|
Placebo
n=180 Participants
Placebo administered subcutaneously
|
|---|---|---|---|
|
Change in Asthma Rescue Medication
|
-2.74 Puffs/day
Standard Deviation 4.29
|
-2.78 Puffs/day
Standard Deviation 3.90
|
-2.18 Puffs/day
Standard Deviation 4.38
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 48.Population: Full analysis set, Baseline eosinophils \>=300/uL
Change from baseline to week 48 in home lung function morning peak expiratory flow \[PEF\]
Outcome measures
| Measure |
Benralizumab 30 mg q.4 Weeks
n=205 Participants
Benralizumab administered every 4 weeks subcutaneously.
|
Benralizumab 30 mg q.8 Weeks
n=181 Participants
Benralizumab administered every 8 weeks subcutaneously.
|
Placebo
n=189 Participants
Placebo administered subcutaneously
|
|---|---|---|---|
|
Home Lung Function Assessment Based on Morning PEF
|
45.857 L/min
Standard Deviation 84.227
|
36.994 L/min
Standard Deviation 72.002
|
22.059 L/min
Standard Deviation 74.434
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 48.Population: Full analysis set, Baseline eosinophils \>=300/uL
Change from baseline to week 48 in home lung function evening peak expiratory flow \[PEF\]
Outcome measures
| Measure |
Benralizumab 30 mg q.4 Weeks
n=203 Participants
Benralizumab administered every 4 weeks subcutaneously.
|
Benralizumab 30 mg q.8 Weeks
n=187 Participants
Benralizumab administered every 8 weeks subcutaneously.
|
Placebo
n=189 Participants
Placebo administered subcutaneously
|
|---|---|---|---|
|
Home Lung Function Assessment Based on Evening PEF
|
36.806 L/min
Standard Deviation 86.271
|
33.460 L/min
Standard Deviation 74.017
|
14.784 L/min
Standard Deviation 68.799
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 48.Population: Full analysis set, Baseline eosinophils \>=300/uL
Change from baseline to Week 48 on proportion of night awakening due to asthma
Outcome measures
| Measure |
Benralizumab 30 mg q.4 Weeks
n=210 Participants
Benralizumab administered every 4 weeks subcutaneously.
|
Benralizumab 30 mg q.8 Weeks
n=193 Participants
Benralizumab administered every 8 weeks subcutaneously.
|
Placebo
n=195 Participants
Placebo administered subcutaneously
|
|---|---|---|---|
|
Proportion of Night Awakening Due to Asthma
|
-0.314 Proportion of nights
Standard Deviation 0.366
|
-0.380 Proportion of nights
Standard Deviation 0.385
|
-0.26 Proportion of nights
Standard Deviation 0.344
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 48.Population: Full analysis set, Baseline eosinophils \>=300/uL
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 |
Benralizumab 30 mg q.4 Weeks
n=198 Participants
Benralizumab administered every 4 weeks subcutaneously.
|
Benralizumab 30 mg q.8 Weeks
n=191 Participants
Benralizumab administered every 8 weeks subcutaneously.
|
Placebo
n=186 Participants
Placebo administered subcutaneously
|
|---|---|---|---|
|
Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils >=300/uL
|
-1.33 Scores on a scale
Standard Deviation 1.18
|
-1.47 Scores on a scale
Standard Deviation 1.05
|
-1.12 Scores on a scale
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 48.Population: Full analysis set, Baseline eosinophils \<300/uL
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 |
Benralizumab 30 mg q.4 Weeks
n=89 Participants
Benralizumab administered every 4 weeks subcutaneously.
|
Benralizumab 30 mg q.8 Weeks
n=94 Participants
Benralizumab administered every 8 weeks subcutaneously.
|
Placebo
n=97 Participants
Placebo administered subcutaneously
|
|---|---|---|---|
|
Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils <300/uL
|
-0.77 Scores on a scale
Standard Deviation 1.07
|
-1.14 Scores on a scale
Standard Deviation 1.11
|
-0.89 Scores on a scale
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: Baseline, week 4, week 4 day 6, week 8, week 16, week 24, week 32, week 40, week 48, week 56Population: PK analysis set
Mean PK concentrations at each visit
Outcome measures
| Measure |
Benralizumab 30 mg q.4 Weeks
n=399 Participants
Benralizumab administered every 4 weeks subcutaneously.
|
Benralizumab 30 mg q.8 Weeks
n=391 Participants
Benralizumab administered every 8 weeks subcutaneously.
|
Placebo
Placebo administered subcutaneously
|
|---|---|---|---|
|
Pharmacokinetics of Benralizumab
Baseline (n=395, 386)
|
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=393, 375)
|
632.84 ng/mL
Geometric Coefficient of Variation 152.14
|
629.89 ng/mL
Geometric Coefficient of Variation 169.22
|
—
|
|
Pharmacokinetics of Benralizumab
Week 4 day 6 (n=54, 63)
|
1368.98 ng/mL
Geometric Coefficient of Variation 633.33
|
1273.7 ng/mL
Geometric Coefficient of Variation 688.20
|
—
|
|
Pharmacokinetics of Benralizumab
Week 8 (n=377, 366)
|
916.25 ng/mL
Geometric Coefficient of Variation 142.53
|
881.57 ng/mL
Geometric Coefficient of Variation 156.12
|
—
|
|
Pharmacokinetics of Benralizumab
Week 16 (n=358, 350)
|
1024.26 ng/mL
Geometric Coefficient of Variation 174.08
|
250.84 ng/mL
Geometric Coefficient of Variation 228.25
|
—
|
|
Pharmacokinetics of Benralizumab
Week 24 (n=349, 344)
|
926.62 ng/mL
Geometric Coefficient of Variation 231.75
|
184.08 ng/mL
Geometric Coefficient of Variation 298.92
|
—
|
|
Pharmacokinetics of Benralizumab
Week 32 (n=260, 267)
|
853.67 ng/mL
Geometric Coefficient of Variation 248.6
|
152.73 ng/mL
Geometric Coefficient of Variation 394.18
|
—
|
|
Pharmacokinetics of Benralizumab
Week 40 (n=328, 333)
|
967.15 ng/mL
Geometric Coefficient of Variation 218.32
|
157.22 ng/mL
Geometric Coefficient of Variation 364.6
|
—
|
|
Pharmacokinetics of Benralizumab
Week 48 (n=333, 333)
|
864.37 ng/mL
Geometric Coefficient of Variation 283.87
|
162.51 ng/mL
Geometric Coefficient of Variation 352.46
|
—
|
|
Pharmacokinetics of Benralizumab
Week 56 (n=63, 67)
|
51.7 ng/mL
Geometric Coefficient of Variation 833.91
|
6.66 ng/mL
Geometric Coefficient of Variation 321.88
|
—
|
SECONDARY outcome
Timeframe: Pre-treatment until end of follow-upPopulation: Safety analysis set, note that 4 patients who were randomized to q.8 regimen treated with q.4 regimen. Thus 403 patients treated with q.4 rather than 399, 394 patients treated with q.8 rather than 398. However, data were only available for 402 patients in q.4, and 393 patients in q.8.
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 the first and the 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 |
Benralizumab 30 mg q.4 Weeks
n=402 Participants
Benralizumab administered every 4 weeks subcutaneously.
|
Benralizumab 30 mg q.8 Weeks
n=393 Participants
Benralizumab administered every 8 weeks subcutaneously.
|
Placebo
n=407 Participants
Placebo administered subcutaneously
|
|---|---|---|---|
|
Immunogenicity of Benralizumab
Positive at any visit (n=402, 393, 407)
|
47 Participants
|
58 Participants
|
21 Participants
|
|
Immunogenicity of Benralizumab
Base- and post baseline positive (n=393, 381, 396)
|
2 Participants
|
3 Participants
|
10 Participants
|
|
Immunogenicity of Benralizumab
Only post baseline positive (n=396, 389, 402)
|
39 Participants
|
49 Participants
|
10 Participants
|
|
Immunogenicity of Benralizumab
Persistently positive (n=396, 389, 402)
|
23 Participants
|
39 Participants
|
16 Participants
|
|
Immunogenicity of Benralizumab
Transiently positive (n=396, 389, 402)
|
18 Participants
|
13 Participants
|
4 Participants
|
|
Immunogenicity of Benralizumab
Only baseline positive (n=399, 385, 401)
|
6 Participants
|
6 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 48.Population: Safety analysis set, note that 4 patients who were randomized to q.8 regimen treated with q.4 regimen. Thus 403 patients treated with q.4 rather than 399, 394 patients treated with q.8 rather than 398.
Extend of exposure is defined as duration of treatment in days
Outcome measures
| Measure |
Benralizumab 30 mg q.4 Weeks
n=403 Participants
Benralizumab administered every 4 weeks subcutaneously.
|
Benralizumab 30 mg q.8 Weeks
n=394 Participants
Benralizumab administered every 8 weeks subcutaneously.
|
Placebo
n=407 Participants
Placebo administered subcutaneously
|
|---|---|---|---|
|
Extend of Exposure
|
285.86 Days
Standard Deviation 67.446
|
288.02 Days
Standard Deviation 66.683
|
289.38 Days
Standard Deviation 61.527
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 48.Population: Full analysis set, Baseline eosinophils \>=300/uL
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 |
Benralizumab 30 mg q.4 Weeks
n=192 Participants
Benralizumab administered every 4 weeks subcutaneously.
|
Benralizumab 30 mg q.8 Weeks
n=187 Participants
Benralizumab administered every 8 weeks subcutaneously.
|
Placebo
n=180 Participants
Placebo administered subcutaneously
|
|---|---|---|---|
|
Mean Change From Baseline to Week 48 in AQLQ(S)+12
|
1.44 Scores on a scale
Standard Deviation 1.18
|
1.56 Scores on a scale
Standard Deviation 1.17
|
1.25 Scores on a scale
Standard Deviation 1.18
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 48.Population: Full analysis set, Baseline eosinophils \>=300/uL
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 |
Benralizumab 30 mg q.4 Weeks
n=191 Participants
Benralizumab administered every 4 weeks subcutaneously.
|
Benralizumab 30 mg q.8 Weeks
n=186 Participants
Benralizumab administered every 8 weeks subcutaneously.
|
Placebo
n=181 Participants
Placebo administered subcutaneously
|
|---|---|---|---|
|
Mean Change From Baseline to Week 48 in EQ-5D-5L VAS
|
13.5 Scores on a scale
Standard Deviation 21.82
|
16.5 Scores on a scale
Standard Deviation 23.66
|
12.5 Scores on a scale
Standard Deviation 21.41
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 48.Population: Full analysis set, Baseline eosinophils \>=300/uL for patients who 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. The work productivity loss is only applicable to patients who employed, which is only subset of the study population.
Outcome measures
| Measure |
Benralizumab 30 mg q.4 Weeks
n=85 Participants
Benralizumab administered every 4 weeks subcutaneously.
|
Benralizumab 30 mg q.8 Weeks
n=79 Participants
Benralizumab administered every 8 weeks subcutaneously.
|
Placebo
n=76 Participants
Placebo administered subcutaneously
|
|---|---|---|---|
|
Mean Work Productivity Loss Due to Asthma
|
23.31 Percent of productivity loss
Standard Deviation 24.169
|
26.11 Percent of productivity loss
Standard Deviation 23.06
|
35.36 Percent of productivity loss
Standard Deviation 24.537
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 48.Population: Full analysis set, Baseline eosinophils \>=300/uL who attending 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 to patients who attending classes
Outcome measures
| Measure |
Benralizumab 30 mg q.4 Weeks
n=8 Participants
Benralizumab administered every 4 weeks subcutaneously.
|
Benralizumab 30 mg q.8 Weeks
n=6 Participants
Benralizumab administered every 8 weeks subcutaneously.
|
Placebo
n=18 Participants
Placebo administered subcutaneously
|
|---|---|---|---|
|
Mean Productivity Loss Due to Asthma in Classroom
|
30.97 Percent of productivity loss
Standard Deviation 25.311
|
27.17 Percent of productivity loss
Standard Deviation 38.456
|
49.1 Percent of productivity loss
Standard Deviation 25.801
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 48.Population: Full analysis set, Baseline eosinophils \>=300=/uL
Outcome measures
| Measure |
Benralizumab 30 mg q.4 Weeks
n=275 Participants
Benralizumab administered every 4 weeks subcutaneously.
|
Benralizumab 30 mg q.8 Weeks
n=267 Participants
Benralizumab administered every 8 weeks subcutaneously.
|
Placebo
n=267 Participants
Placebo administered subcutaneously
|
|---|---|---|---|
|
Number of Participants That Utilized Health Care Resources
Hospitalizations
|
14 Participants
|
12 Participants
|
20 Participants
|
|
Number of Participants That Utilized Health Care Resources
Emergency department visits
|
20 Participants
|
10 Participants
|
26 Participants
|
|
Number of Participants That Utilized Health Care Resources
Unscheduled outpatient visits
|
77 Participants
|
87 Participants
|
109 Participants
|
|
Number of Participants That Utilized Health Care Resources
Home visits
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants That Utilized Health Care Resources
Telephone calls
|
46 Participants
|
41 Participants
|
62 Participants
|
|
Number of Participants That Utilized Health Care Resources
Ambulance transports
|
6 Participants
|
3 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Immediately following the first administration of study drug through Study Week 48Population: Full analysis set, Baseline eosinophils \>=300/uL
CGIC (Clinical 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 7-point rating scale, ranging from 1 (very much improved), to 7 (very much worse). This is additional measures collected after second Amendment, thus not all patients had data to be analyzed.
Outcome measures
| Measure |
Benralizumab 30 mg q.4 Weeks
n=275 Participants
Benralizumab administered every 4 weeks subcutaneously.
|
Benralizumab 30 mg q.8 Weeks
n=267 Participants
Benralizumab administered every 8 weeks subcutaneously.
|
Placebo
n=267 Participants
Placebo administered subcutaneously
|
|---|---|---|---|
|
Patient and Clinician's Responder Assessment to Treatment
CGIC improved
|
80 Participants
|
76 Participants
|
88 Participants
|
|
Patient and Clinician's Responder Assessment to Treatment
CGIC much improved
|
59 Participants
|
58 Participants
|
58 Participants
|
|
Patient and Clinician's Responder Assessment to Treatment
CGIC very much improved
|
18 Participants
|
12 Participants
|
5 Participants
|
|
Patient and Clinician's Responder Assessment to Treatment
CGIC total responder
|
157 Participants
|
146 Participants
|
151 Participants
|
|
Patient and Clinician's Responder Assessment to Treatment
PGIC improved
|
84 Participants
|
80 Participants
|
91 Participants
|
|
Patient and Clinician's Responder Assessment to Treatment
PGIC much improved
|
55 Participants
|
58 Participants
|
65 Participants
|
|
Patient and Clinician's Responder Assessment to Treatment
PGIC very much improved
|
26 Participants
|
19 Participants
|
11 Participants
|
|
Patient and Clinician's Responder Assessment to Treatment
PGIC total responder
|
165 Participants
|
157 Participants
|
167 Participants
|
Adverse Events
Benralizumab 30 mg q.4 Weeks
Serious events: 51 serious events
Other events: 214 other events
Deaths: 0 deaths
Benralizumab 30 mg q.8 Weeks
Serious events: 54 serious events
Other events: 199 other events
Deaths: 0 deaths
Placebo
Serious events: 58 serious events
Other events: 219 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Benralizumab 30 mg q.4 Weeks
n=403 participants at risk
Benralizumab administered every 4 weeks subcutaneously.
|
Benralizumab 30 mg q.8 Weeks
n=394 participants at risk
Benralizumab administered every 8 weeks subcutaneously.
|
Placebo
n=407 participants at risk
Placebo administered subcutaneously
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenolymphoma
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer
|
0.25%
1/403 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Nervous system disorders
Aphonia
|
0.25%
1/403 • Number of events 2
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.25%
1/403 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Nervous system disorders
Cerebral venous thrombosis
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Nervous system disorders
Paraesthesia
|
0.25%
1/403 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/407 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/407 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Psychiatric disorders
Panic attack
|
0.25%
1/403 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.25%
1/403 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.25%
1/403 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.25%
1/403 • Number of events 2
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.7%
23/403 • Number of events 29
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
6.1%
24/394 • Number of events 33
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
7.9%
32/407 • Number of events 42
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.50%
2/403 • Number of events 2
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/407 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.25%
1/403 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.49%
2/407 • Number of events 2
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus polyp
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/407 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.25%
1/403 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/407 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Skin and subcutaneous tissue disorders
Urticaria papular
|
0.25%
1/403 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/407 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Vascular disorders
Hypertension
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.51%
2/394 • Number of events 2
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
General disorders
Chest pain
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Blood and lymphatic system disorders
Hypercoagulation
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.25%
1/403 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/407 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Cardiac disorders
Cardiac failure
|
0.25%
1/403 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Endocrine disorders
Goitre
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Eye disorders
Cataract
|
0.25%
1/403 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Eye disorders
Optic nerve disorder
|
0.25%
1/403 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.25%
1/403 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/407 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/407 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.25%
1/403 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
General disorders
Death
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/407 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
General disorders
Injection site erythema
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/407 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
General disorders
Oedema peripheral
|
0.25%
1/403 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
General disorders
Sudden death
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.50%
2/403 • Number of events 2
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/407 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Immune system disorders
Allergic granulomatous angiitis
|
0.25%
1/403 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/407 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Infections and infestations
Atypical pneumonia
|
0.25%
1/403 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Infections and infestations
Bullous impetigo
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/407 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Infections and infestations
Influenza
|
0.50%
2/403 • Number of events 2
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/407 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Infections and infestations
Otitis media
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/407 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Infections and infestations
Parotitis
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.51%
2/394 • Number of events 3
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.74%
3/407 • Number of events 3
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/407 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Infections and infestations
Pneumonia viral
|
0.25%
1/403 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Infections and infestations
Postoperative wound infection
|
0.25%
1/403 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/407 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.49%
2/407 • Number of events 3
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/407 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Infections and infestations
Viral infection
|
0.25%
1/403 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.25%
1/403 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/407 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.25%
1/403 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/407 • Number of events 2
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/407 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/407 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.25%
1/403 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/407 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/407 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/394 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.25%
1/403 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.25%
1/403 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/407
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/407 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.25%
1/403 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.49%
2/407 • Number of events 2
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/403
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.00%
0/394
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
0.25%
1/407 • Number of events 1
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
Other adverse events
| Measure |
Benralizumab 30 mg q.4 Weeks
n=403 participants at risk
Benralizumab administered every 4 weeks subcutaneously.
|
Benralizumab 30 mg q.8 Weeks
n=394 participants at risk
Benralizumab administered every 8 weeks subcutaneously.
|
Placebo
n=407 participants at risk
Placebo administered subcutaneously
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
2.0%
8/403 • Number of events 12
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
3.0%
12/394 • Number of events 14
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
2.0%
8/407 • Number of events 9
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
General disorders
Pyrexia
|
4.0%
16/403 • Number of events 21
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
3.0%
12/394 • Number of events 19
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
2.0%
8/407 • Number of events 8
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Infections and infestations
Acute sinusitis
|
2.5%
10/403 • Number of events 11
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
3.3%
13/394 • Number of events 14
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
2.7%
11/407 • Number of events 15
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Infections and infestations
Bronchitis
|
6.7%
27/403 • Number of events 28
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
4.8%
19/394 • Number of events 22
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
7.4%
30/407 • Number of events 41
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Infections and infestations
Gastroenteritis
|
2.5%
10/403 • Number of events 16
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
3.0%
12/394 • Number of events 14
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
1.5%
6/407 • Number of events 6
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Infections and infestations
Influenza
|
3.7%
15/403 • Number of events 19
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
4.8%
19/394 • Number of events 21
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
5.7%
23/407 • Number of events 31
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Infections and infestations
Nasopharyngitis
|
11.7%
47/403 • Number of events 62
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
11.9%
47/394 • Number of events 69
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
12.0%
49/407 • Number of events 64
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Infections and infestations
Pharyngitis
|
4.2%
17/403 • Number of events 21
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
5.8%
23/394 • Number of events 24
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
3.4%
14/407 • Number of events 20
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Infections and infestations
Rhinitis
|
4.0%
16/403 • Number of events 17
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
2.5%
10/394 • Number of events 11
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
3.7%
15/407 • Number of events 17
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Infections and infestations
Sinusitis
|
4.5%
18/403 • Number of events 23
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
5.6%
22/394 • Number of events 34
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
7.1%
29/407 • Number of events 43
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.2%
45/403 • Number of events 74
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
8.1%
32/394 • Number of events 51
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
9.1%
37/407 • Number of events 73
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.7%
11/403 • Number of events 13
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
4.6%
18/394 • Number of events 20
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
2.9%
12/407 • Number of events 19
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
12/403 • Number of events 13
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
2.0%
8/394 • Number of events 9
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
3.7%
15/407 • Number of events 15
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.74%
3/403 • Number of events 3
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
3.3%
13/394 • Number of events 13
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
1.2%
5/407 • Number of events 6
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Nervous system disorders
Headache
|
7.7%
31/403 • Number of events 38
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
9.4%
37/394 • Number of events 61
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
5.2%
21/407 • Number of events 28
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
11.9%
48/403 • Number of events 64
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
6.9%
27/394 • Number of events 38
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
14.7%
60/407 • Number of events 102
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
15/403 • Number of events 17
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
3.3%
13/394 • Number of events 14
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
2.7%
11/407 • Number of events 15
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.7%
11/403 • Number of events 11
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
3.0%
12/394 • Number of events 12
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
2.0%
8/407 • Number of events 9
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
|
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.
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Restriction type: OTHER