Trial Outcomes & Findings for Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study) (NCT NCT05251909)
NCT ID: NCT05251909
Last Updated: 2025-07-14
Results Overview
the proportion of patients achieving a histological response at Week 24, is defined as below: * 6 eosinophils/hpf in the stomach for the patients with only gastric disease at baseline. * 6 eosinophils/hpf in the stomach and ≤15 eosinophils/hpf in the duodenum for the patients with gastric + duodenal disease at baseline. * 15 eosinophils/hpf in the duodenum for the patients with only duodenal disease at baseline.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
12 participants
Primary outcome timeframe
at week 24
Results posted on
2025-07-14
Participant Flow
A total of 34 participants were screened. Of those, 12 participants were randomised to either the treatment (6 participants) or placebo (participants) arms of the double-blinded treatment period.
All participants complete a 4-week to 8-week run-in period during which inclusion/exclusion criteria was assessed.
Participant milestones
| Measure |
Benralizumab
Patients received benralizumab 30mg every 4 weeks for the 24 weeks treatment period
|
Placebo
Patients received matching Placebo every 4 weeks for the 24 weeks treatment period
|
|---|---|---|
|
Double Blind Period
STARTED
|
6
|
6
|
|
Double Blind Period
COMPLETED
|
6
|
3
|
|
Double Blind Period
NOT COMPLETED
|
0
|
3
|
|
Open Label Extension
STARTED
|
6
|
3
|
|
Open Label Extension
COMPLETED
|
5
|
2
|
|
Open Label Extension
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Benralizumab
Patients received benralizumab 30mg every 4 weeks for the 24 weeks treatment period
|
Placebo
Patients received matching Placebo every 4 weeks for the 24 weeks treatment period
|
|---|---|---|
|
Open Label Extension
Subjects who discontinued treatment with study drug in OLE but completed study follow-up
|
1
|
1
|
Baseline Characteristics
Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)
Baseline characteristics by cohort
| Measure |
Benralizumab
n=6 Participants
Patients received benralizumab 30mg every 4 weeks for the 24 weeks treatment period
|
Placebo
n=6 Participants
Patients received matching Placebo every 4 weeks for the 24 weeks treatment period
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at week 24the proportion of patients achieving a histological response at Week 24, is defined as below: * 6 eosinophils/hpf in the stomach for the patients with only gastric disease at baseline. * 6 eosinophils/hpf in the stomach and ≤15 eosinophils/hpf in the duodenum for the patients with gastric + duodenal disease at baseline. * 15 eosinophils/hpf in the duodenum for the patients with only duodenal disease at baseline.
Outcome measures
| Measure |
Benralizumab
n=6 Participants
Patients received benralizumab 30mg every 4 weeks for the 24 weeks treatment period
|
Placebo
n=6 Participants
Patients received matching Placebo every 4 weeks for the 24 weeks treatment period
|
|---|---|---|
|
Proportion of Patients With a Histologic Response at Week 24
|
5 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: at week 24The Symptom Assessment for Gastrointestinal Eosinophilic Diseases (SAGED) instrument was developed to measure gastrointestinal symptoms in participants diagnosed with EG/EGE. It is a daily diary completed by participants each evening from screening until week 76 to record symptoms during the past 24 hours. Severity for each concept is assessed using an 11-point numerical rating scale (0 = 'none' and 10 = 'worst imaginable'). The total SAGED score (range 0-50) is calculated as a 14-day mean of the sum of individual severity items of abdominal pain, nausea, bloating, early satiety and loss of appetite daily. Higher scores indicate greater symptom severity. Three additional items are collected that aren't part of the total SAGED score and are considered separately: severity of vomiting, severity of diarrhoea and frequency of vomiting. Change in SAGED score at week 24 is the week 24 score (study days 155 to 168) minus the baseline score (study days -14 to -1).
Outcome measures
| Measure |
Benralizumab
n=5 Participants
Patients received benralizumab 30mg every 4 weeks for the 24 weeks treatment period
|
Placebo
n=3 Participants
Patients received matching Placebo every 4 weeks for the 24 weeks treatment period
|
|---|---|---|
|
Change From Baseline in SAGED Score at Week 24
|
-9.59 score
Standard Error 7.26
|
-13.69 score
Standard Error 4.37
|
Adverse Events
Benralizumab
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Open Label Benralizumab
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Benralizumab
n=6 participants at risk
Patients received benralizumab 30mg every 4 weeks for the 24 weeks treatment period
|
Placebo
n=6 participants at risk
Patients received matching Placebo every 4 weeks for the 24 weeks treatment period
|
Open Label Benralizumab
n=9 participants at risk
Patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Number of events 2 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
16.7%
1/6 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/9 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Gastrointestinal disorders
Toothache
|
16.7%
1/6 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/9 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
11.1%
1/9 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
General disorders
Injection site reaction
|
16.7%
1/6 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/9 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
General disorders
Pyrexia
|
33.3%
2/6 • Number of events 2 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/9 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
11.1%
1/9 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Infections and infestations
Bronchitis
|
16.7%
1/6 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/9 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
16.7%
1/6 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
22.2%
2/9 • Number of events 2 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
11.1%
1/9 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Infections and infestations
Genitourinary tract infection
|
16.7%
1/6 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/9 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/9 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Infections and infestations
Herpes zoster
|
16.7%
1/6 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/9 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
16.7%
1/6 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/9 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Infections and infestations
Parotitis
|
16.7%
1/6 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/9 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Infections and infestations
Sialoadenitis
|
16.7%
1/6 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/9 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Infections and infestations
Tooth abscess
|
16.7%
1/6 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/9 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/9 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • Number of events 2 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/9 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
11.1%
1/9 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
11.1%
1/9 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
16.7%
1/6 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/9 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
11.1%
1/9 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
16.7%
1/6 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/9 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
11.1%
1/9 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
11.1%
1/9 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
11.1%
1/9 • Number of events 2 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
16.7%
1/6 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/9 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
11.1%
1/9 • Number of events 2 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Nervous system disorders
Migraine
|
16.7%
1/6 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/9 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Psychiatric disorders
Eating disorder
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
16.7%
1/6 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/9 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Renal and urinary disorders
Nephrolithiasis
|
16.7%
1/6 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
11.1%
1/9 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Reproductive system and breast disorders
Menstrual discomfort
|
16.7%
1/6 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/9 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Ear and labyrinth disorders
Vertigo
|
16.7%
1/6 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/9 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
11.1%
1/9 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
16.7%
1/6 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/9 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
11.1%
1/9 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Eye disorders
Myopic chorioretinal degeneration
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
11.1%
1/9 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
16.7%
1/6 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/9 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
22.2%
2/9 • Number of events 2 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
0.00%
0/6 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
11.1%
1/9 • Number of events 1 • AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.
Benralizumab = All patients who received benralizumab 30mg every 4 weeks in the double-blind period. Placebo= All patients received matching Placebo every 4 weeks in the double-blind period. Open Label Benralizumab= All patients received benralizumab 30mg every 4 weeks during the open-label extension period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place