Study in Pediatrics With HypEREosinophilic Syndrome (SPHERE) | NCT04965636 | Trialant
NCT04965636
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Jul 6, 2026Actual
Enrollment
16Actual
Phase
Phase 3
Conditions
Hypereosinophilic Syndrome
Interventions
Mepolizumab
Countries
United States
Argentina
Brazil
Israel
Netherlands
Turkey (Türkiye)
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT04965636
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
215360
Secondary IDs
Not provided
Brief Title
Study in Pediatrics With HypEREosinophilic Syndrome (SPHERE)
Official Title
A Phase 3, 52-week, Open-label, Single Arm Study to Investigate the Efficacy and Safety of Mepolizumab SC in Participants Aged 6 to 17 Years With Hypereosinophilic Syndrome
Acronym
SPHERE
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Jul 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
YesNCT00244686No longer available
Start Date
Jul 14, 2022Actual
Primary Completion Date
Oct 28, 2025Actual
Completion Date
Oct 28, 2025Actual
First Submitted Date
Jul 7, 2021
First Submission Date that Met QC Criteria
Jul 7, 2021
First Posted Date
Jul 16, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Apr 13, 2026
Results First Submitted that Met QC Criteria
Apr 13, 2026
Results First Posted Date
May 4, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 1, 2026
Last Update Posted Date
Jul 6, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to investigate the efficacy and safety of mepolizumab in children and adolescents with hypereosinophilic syndrome (HES) who are receiving standard of care (SoC) therapy.
Detailed Description
Not provided
Conditions Module
Conditions
Hypereosinophilic Syndrome
Keywords
Hypereosinophilic Syndrome
Mepolizumab
Safety
Efficacy
Pediatric
Adolescent
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
16Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Mepolizumab 100 mg SC
Experimental
Participants in the age group of 6 to 11 years with body weight less than (<) 40 kilogram (kg) received Mepolizumab 100 milligram (mg) subcutaneous (SC) injection every 4 weeks over a treatment period of 52 weeks.
Drug: Mepolizumab
Mepolizumab 300 mg SC
Experimental
Participants in the age group of 12 to 17 years received Mepolizumab 300 mg SC injection every 4 weeks over a treatment period of 52 weeks.
Drug: Mepolizumab
Mepolizumab 200/100 mg SC
Experimental
A participant in the age group of 6 to 11 years with body weight greater than or equal to (>=) 40 kg received mepolizumab 200 mg SC injections every 4 weeks. During the conduct of the study, the mepolizumab dose was reduced to 100 mg SC injection every 4 weeks as body weight of the participant reduced to less than (<) 40 kg over a treatment period of 52 weeks.
Drug: Mepolizumab
Mepolizumab 200/300 mg SC
Experimental
A participant in the age group of 6 to 11 years with body weight >=40 kg received mepolizumab 200 mg SC injections every 4 weeks. During the conduct of the study, the mepolizumab dose was increased to 300 mg SC injection every 4 weeks as age of the participant increased to the age group of 12 to 17 years over a treatment period of 52 weeks.
Drug: Mepolizumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Mepolizumab
Drug
Mepolizumab was provided in pre-filled safety syringe
Mepolizumab 100 mg SC
Mepolizumab 200/100 mg SC
Mepolizumab 200/300 mg SC
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Who Experienced HES Flares Over the 52-Week Study Treatment Period
A HES flare is defined as a HES related clinical manifestation based on a physician-documented change in clinical signs or symptoms (worsening symptoms and/or elevated blood eosinophil level) which resulted in need for either: an increase from the most recent dose in the maintenance Oral Corticosteroid (OCS) dose (prednisone/prednisolone equivalent) by at least 10 mg per day for 5 days or an increase in or addition of any immunosuppressive and/or cytotoxic HES therapy from/to the most recent dose of HES therapy. Data is presented by the number of HES flares (0, 1, 2, 3 ,4 and >=5) in the participants.
Up to Week 52
Secondary Outcomes
Measure
Description
Time Frame
Change in Mean Daily Oral Corticosteroids (OCS) Dose (Prednisone/Prednisolone or Equivalent) for Each 4-week Period From Weeks 0-4 to Weeks 48-52
The mean daily OCS (prednisone or equivalent) dose for each 4-week period from Weeks 0-4 to Weeks 48-52 for each participant were calculated as the sum of the daily doses of OCS during each 4-week period divided by the total number of days. The change in the mean daily OCS dose for each 4-week period from Weeks 0-4 to Weeks 48-52 was calculated for each participant as the mean daily OCS dose for Weeks 48-52 minus the mean daily OCS dose for Weeks 0-4. Baseline value was derived as the sum of the daily doses of OCS during first 4 weeks following the initiation of mepolizumab treatment (Weeks 0-4) divided by total number of days. Change from Baseline was calculated as post-Baseline value minus Baseline Value.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participant must be aged 6 to 17 years inclusive, at Screening (Visit 1).
Participants who have been diagnosed with HES for at least 6 months prior to enrolment (Visit 2).
A history of 2 or more HES flares within the past 12 months prior to Screening (Visit 1).
Participants must have blood eosinophil count >=1000 cells per microliter (/mcL) present at Screening.
Participants must be on a stable dose of HES therapy for the 4 weeks prior to the first dose of mepolizumab (Visit 2)
Male and/or female
Signed written informed consent
Exclusion Criteria:
Life-threatening HES or life-threatening HES co-morbidities
Other concurrent medical conditions that may affect the participant's safety
Clinical diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA)
Participants with chronic or ongoing active infections requiring systemic treatment, as well as participants who have experienced clinically significant infections due to viruses, bacteria, and fungi within 4 weeks prior to enrolment (Visit 2)
Participants with a pre-existing parasitic infestation within 6 months prior to enrolment (Visit 2)
Participants with a known immunodeficiency (e.g. Human immunodeficiency virus [HIV]), other than that explained by the use of OCS or other therapy taken for HES
Participants with documented history of any clinically significant cardiac damage prior to Screening (Visit 1) that, in the opinion of the investigator, would impact the participant's participation during the study
Participants with a history of or current lymphoma, Participants with current malignancy or previous history of cancer in remission for less than 12 months prior to Screening (Visit 1)
Participants who are not responsive to OCS based on clinical response or blood eosinophil counts.
Participants who have previously received mepolizumab in the 4 months prior to enrolment (Visit 2)
Participants receiving non-oral systemic corticosteroids in the 4-week period prior to enrolment (Visit 2).
Participants who have received any other monoclonal antibodies within 30 days or 5 half-lives, whichever is longer, of enrolment (Visit 2).
Participants who have received treatment with an investigational agent (biologic or non-biologic) within the past 30 days or 5 drug half-lives, whichever is longer, prior to enrolment (Visit 2).
Use of candidate Coronavirus disease 2019 (COVID-19) vaccines that have not received limited, accelerated, or full authorization/approval, and are only in use as part of a clinical trial.
Participants who are currently participating in any other interventional clinical study
Participants with any history of hypersensitivity to any monoclonal antibody (including mepolizumab).
Evidence of clinically significant abnormality in the hematological, biochemical, or urinalysis screen from the sample collected at Screening (Visit 1), that could put the participant's safety at risk by participating in the study, as judged by the investigator
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Access Criteria
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
A total of 16 participants with HES were enrolled in this study. All participants received active treatment with mepolizumab SC injection every 4 weeks over a treatment period of 52 weeks. The initial dose was dependent on age and weight. During the study, the dose was to be adjusted once the participants reached a bodyweight of 40 kg or the age of 12 years.
Recruitment Details
This was a 52-week, open-label, multicenter study to evaluate the efficacy and safety of mepolizumab subcutaneous (SC) injection in children (aged 6 to 11 years) and adolescent (aged 12 to 17 years) participants with hypereosinophilic syndrome (HES) who were receiving standard of care (SoC) therapy.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Mepolizumab 100 mg SC
Participants in the age group of 6 to 11 years with body weight less than (<) 40 kilogram (kg) received Mepolizumab 100 milligram (mg) subcutaneous (SC) injection every 4 weeks over a treatment period of 52 weeks.
FG001
Mepolizumab 300 mg SC
Participants in the age group of 12 to 17 years received Mepolizumab 300 mg SC injection every 4 weeks over a treatment period of 52 weeks.
FG002
Mepolizumab 200/100 mg SC
A participant in the age group of 6 to 11 years with body weight greater than or equal to (>=) 40 kg received mepolizumab 200 mg SC injections every 4 weeks. During the conduct of the study, the mepolizumab dose was reduced to 100 mg SC injection every 4 weeks as body weight of the participant reduced to less than (<) 40 kg over a treatment period of 52 weeks.
FG003
Mepolizumab 200/300 mg SC
A participant in the age group of 6 to 11 years with body weight >=40 kg received mepolizumab 200 mg SC injections every 4 weeks. During the conduct of the study, the mepolizumab dose was increased to 300 mg SC injection every 4 weeks as age of the participant increased to the age group of 12 to 17 years over a treatment period of 52 weeks.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00010 subjects
FG0014 subjects
FG0021 subjects
FG0031 subjects
COMPLETED
FG0009 subjects
FG0014 subjects
FG0021 subjects
FG0031 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Mepolizumab 100 mg SC
Participants in the age group of 6 to 11 years with body weight less than (<) 40 kilogram (kg) received Mepolizumab 100 milligram (mg) subcutaneous (SC) injection every 4 weeks over a treatment period of 52 weeks.
BG001
Mepolizumab 300 mg SC
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants Who Experienced HES Flares Over the 52-Week Study Treatment Period
A HES flare is defined as a HES related clinical manifestation based on a physician-documented change in clinical signs or symptoms (worsening symptoms and/or elevated blood eosinophil level) which resulted in need for either: an increase from the most recent dose in the maintenance Oral Corticosteroid (OCS) dose (prednisone/prednisolone equivalent) by at least 10 mg per day for 5 days or an increase in or addition of any immunosuppressive and/or cytotoxic HES therapy from/to the most recent dose of HES therapy. Data is presented by the number of HES flares (0, 1, 2, 3 ,4 and >=5) in the participants.
The analysis was performed on the Full Analysis Set (FAS) that included all participants who received at least one dose of mepolizumab.
Posted
Count of Participants
Participants
Up to Week 52
ID
Title
Description
OG000
Mepolizumab 100 mg SC
Adverse Events Module
Frequency Threshold
3
Time Frame
All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to week 60 (follow up period)
Description
Full Analysis Set included all participants who received at least one dose of mepolizumab.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Mepolizumab 100 mg SC
Participants in the age group of 6 to 11 years with body weight less than (<) 40 kilogram (kg) received Mepolizumab 100 milligram (mg) subcutaneous (SC) injection every 4 weeks over a treatment period of 52 weeks.
Number of Participants With Reduction of >=50 Percentage (%) in Mean Daily OCS Dose (Prednisone/Prednisolone or Equivalent) for Each 4-week Period From Weeks 0-4 to Weeks 48-52
The mean daily OCS (prednisone or equivalent) dose for each 4-week period from Weeks 0-4 to Weeks 48-52 for each participant were calculated as the sum of the daily doses of OCS during each period divided by the total number of days. For each 4-week period, a reduction of 50% or more in mean OCS dose was defined as (mean OCS dose at each 4-week period minus mean OCS dose during Weeks 0-4) divided by (mean OCS dose during Weeks 0-4) multiplied by 100 was <= -50. Baseline value was derived as the sum of the daily doses of OCS during first 4 weeks following the initiation of mepolizumab treatment (Weeks 0-4) divided by total number of days.
Number of Participants With a Mean Daily OCS Dose (Prednisone/Prednisolone or Equivalent) of Less Than or Equal to (<=) 7.5 Milligrams (mg) During Weeks 48-52 in Subpopulation of Participants That Were Taking OCS at Baseline
The mean daily OCS (prednisone or equivalent) dose for Weeks 48-52 for each participant were calculated as the sum of the daily doses of OCS during this period divided by the total number of days. Number of participants with a mean daily OCS dose (prednisone/prednisolone or equivalent) of <=7.5 mg during period of Weeks 48-52 in subpopulation of participants that were taking OCS at Baseline has been presented.
Weeks 48-52
Number of Participants With a Mean Daily OCS Dose (Prednisone/Prednisolone or Equivalent) of <=7.5 mg During Weeks 48-52 in Overall Population
The mean daily OCS (prednisone or equivalent) dose for Weeks 48-52 for each participant were calculated as the sum of the daily doses of OCS during this period divided by the total number of days. Number of participants with a mean daily OCS dose (prednisone/prednisolone or equivalent) of <=7.5 mg during period of Weeks 48-52 in overall population has been presented.
Weeks 48-52
Change From Baseline in Fatigue Severity Based on Weekly Average Score of Brief Fatigue Inventory (BFI) Item 3 (Worst Level of Fatigue During Past 24 Hours) for Week 52 for Participants in the Age Group of 12 to 17 Years
The BFI is a self-administered questionnaire developed to assess fatigue severity. The BFI has 9 items. BFI- Item 3 assesses the worst level of fatigue during the past 24 hours. Participants report their worst level of fatigue daily, for the previous 24 hours, using a numerical rating scale ranging from 0 (no fatigue) to 10 (as bad as you can imagine). The weekly average score of BFI item 3 was defined as the mean of the observed daily assessments over the 7-day period. The weekly average score of BFI item 3 ranges from 0 to 10, higher score indicates worst outcome. BFI Item 3 was assessed in the participants with the age group of 12 to 17 years at study entry. Baseline was defined as the mean of the 7 daily assessments of BFI item 3 up to but not including the date of first dose of study treatment. Change from Baseline was calculated as post-Baseline value minus Baseline Value.
Baseline (Week 0) and Week 52
Number of Participants With Any Time Post-Baseline Positive Anti-mepolizumab Antibodies (ADA)
Serum samples were collected for the determination of anti-mepolizumab antibodies (ADA) using a validated electro-chemiluminescent immunoassay. The assay involved screening, confirmation and titration assays. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample and were also further characterized in the Neutralizing antibody (Nab) assay. A participant was considered positive ADA if they had at least one positive any time post-Baseline ADA result.
Up to Week 52
Number of Participants With Any Time Post-Baseline Positive Neutralizing Antibodies (NAb)
Blood samples were collected for the determination of positive neutralizing antibodies. NAb test was to be carried out on samples that were positive in the confirmatory binding antibody assay. A participant was to be considered positive for NAb if they had at least one positive any time post-Baseline neutralizing antibody result.
Up to Week 52
Ratio to Baseline in Blood Eosinophil Count
Blood samples were collected to measure eosinophil count. Ratio to Baseline is defined as post-dose visit value divided by Baseline value. Baseline was defined as the latest blood eosinophil value measured by the central laboratory prior to the first dose of study treatment.
Blood samples were collected at the indicated time points for pharmacokinetic analysis of Mepolizumab.
Pre-dose at Weeks 4 and 24; Week 52
Cincinnati
Ohio
45229
United States
GSK Investigational Site
Cleveland
Ohio
44106
United States
GSK Investigational Site
Charleston
South Carolina
29425
United States
GSK Investigational Site
Buenos Aires
1888
Argentina
GSK Investigational Site
Buenos Aires
C1028AAP
Argentina
GSK Investigational Site
Quilmes
1878
Argentina
GSK Investigational Site
São Paulo
05410-002
Brazil
GSK Investigational Site
Sorocaba
18040-425
Brazil
GSK Investigational Site
Petah Tikva
49202
Israel
GSK Investigational Site
Rotterdam
3015 CE
Netherlands
GSK Investigational Site
Ankara
6230
Turkey (Türkiye)
GSK Investigational Site
Izmir
35100
Turkey (Türkiye)
GSK Investigational Site
Kayseri
38039
Turkey (Türkiye)
0 subjects
Participants in the age group of 12 to 17 years received Mepolizumab 300 mg SC injection every 4 weeks over a treatment period of 52 weeks.
BG002
Mepolizumab 200/100 mg SC
A participant in the age group of 6 to 11 years with body weight greater than or equal to (>=) 40 kg received mepolizumab 200 mg SC injections every 4 weeks. During the conduct of the study, the mepolizumab dose was reduced to 100 mg SC injection every 4 weeks as body weight of the participant reduced to less than (<) 40 kg over a treatment period of 52 weeks.
BG003
Mepolizumab 200/300 mg SC
A participant in the age group of 6 to 11 years with body weight >=40 kg received mepolizumab 200 mg SC injections every 4 weeks. During the conduct of the study, the mepolizumab dose was increased to 300 mg SC injection every 4 weeks as age of the participant increased to the age group of 12 to 17 years over a treatment period of 52 weeks.
BG004
Total
Total of all reporting groups
10
BG0014
BG0021
BG0031
BG00416
Participants
Title
Denominators
Categories
Title
Measurements
6 to 11 Years
BG00010
BG0010
BG0021
BG0031
BG00412
12 to 17 Years
BG0000
BG0014
BG0020
BG0030
BG004
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0012
BG002NAData is not reported due to participant confidentiality and privacy concerns.
BG003NAData is not reported due to participant confidentiality and privacy concerns.
BG004NATotal not calculated because data are not available (NA) in one or more arms.
Male
BG0007
BG0012
BG002NAData is not reported due to participant confidentiality and privacy concerns.
BG003NAData is not reported due to participant confidentiality and privacy concerns.
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
WHITE
Title
Measurements
BG00010
BG0014
BG0021
BG0031
BG00416
Participants in the age group of 6 to 11 years with body weight less than (<) 40 kilogram (kg) received Mepolizumab 100 milligram (mg) subcutaneous (SC) injection every 4 weeks over a treatment period of 52 weeks.
OG001
Mepolizumab 300 mg SC
Participants in the age group of 12 to 17 years received Mepolizumab 300 mg SC injection every 4 weeks over a treatment period of 52 weeks.
OG002
Mepolizumab 200/100 mg SC
A participant in the age group of 6 to 11 years with body weight greater than or equal to (>=) 40 kg received mepolizumab 200 mg SC injections every 4 weeks. During the conduct of the study, the mepolizumab dose was reduced to 100 mg SC injection every 4 weeks as body weight of the participant reduced to less than (<) 40 kg over a treatment period of 52 weeks.
OG003
Mepolizumab 200/300 mg SC
A participant in the age group of 6 to 11 years with body weight >=40 kg received mepolizumab 200 mg SC injections every 4 weeks. During the conduct of the study, the mepolizumab dose was increased to 300 mg SC injection every 4 weeks as age of the participant increased to the age group of 12 to 17 years over a treatment period of 52 weeks.
Units
Counts
Participants
OG00010
OG0014
OG0021
OG0031
Title
Denominators
Categories
0 HES flare
Title
Measurements
OG00010
OG0014
OG0021
OG0031
1 HES flare
Title
Measurements
OG0000
OG0010
OG0020
OG003
2 HES flares
Title
Measurements
OG0000
OG0010
OG0020
OG003
3 HES flares
Title
Measurements
OG0000
OG0010
OG0020
OG003
4 HES flares
Title
Measurements
OG0000
OG0010
OG0020
OG003
>=5 HES flares
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Change in Mean Daily Oral Corticosteroids (OCS) Dose (Prednisone/Prednisolone or Equivalent) for Each 4-week Period From Weeks 0-4 to Weeks 48-52
The mean daily OCS (prednisone or equivalent) dose for each 4-week period from Weeks 0-4 to Weeks 48-52 for each participant were calculated as the sum of the daily doses of OCS during each 4-week period divided by the total number of days. The change in the mean daily OCS dose for each 4-week period from Weeks 0-4 to Weeks 48-52 was calculated for each participant as the mean daily OCS dose for Weeks 48-52 minus the mean daily OCS dose for Weeks 0-4. Baseline value was derived as the sum of the daily doses of OCS during first 4 weeks following the initiation of mepolizumab treatment (Weeks 0-4) divided by total number of days. Change from Baseline was calculated as post-Baseline value minus Baseline Value.
Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. Data is presented for subpopulation of participants that were taking OCS at Baseline. Zeros reported reflect measured data derived during analysis.
Participants in the age group of 6 to 11 years with body weight less than (<) 40 kilogram (kg) received Mepolizumab 100 milligram (mg) subcutaneous (SC) injection every 4 weeks over a treatment period of 52 weeks.
OG001
Mepolizumab 300 mg SC
Participants in the age group of 12 to 17 years received Mepolizumab 300 mg SC injection every 4 weeks over a treatment period of 52 weeks.
OG002
Mepolizumab 200/100 mg SC
A participant in the age group of 6 to 11 years with body weight greater than or equal to (>=) 40 kg received mepolizumab 200 mg SC injections every 4 weeks. During the conduct of the study, the mepolizumab dose was reduced to 100 mg SC injection every 4 weeks as body weight of the participant reduced to less than (<) 40 kg over a treatment period of 52 weeks.
OG003
Mepolizumab 200/300 mg SC
A participant in the age group of 6 to 11 years with body weight >=40 kg received mepolizumab 200 mg SC injections every 4 weeks. During the conduct of the study, the mepolizumab dose was increased to 300 mg SC injection every 4 weeks as age of the participant increased to the age group of 12 to 17 years over a treatment period of 52 weeks.
Units
Counts
Participants
OG0004
OG0012
OG0021
OG003
Title
Denominators
Categories
Weeks 4-8
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG003
Secondary
Number of Participants With Reduction of >=50 Percentage (%) in Mean Daily OCS Dose (Prednisone/Prednisolone or Equivalent) for Each 4-week Period From Weeks 0-4 to Weeks 48-52
The mean daily OCS (prednisone or equivalent) dose for each 4-week period from Weeks 0-4 to Weeks 48-52 for each participant were calculated as the sum of the daily doses of OCS during each period divided by the total number of days. For each 4-week period, a reduction of 50% or more in mean OCS dose was defined as (mean OCS dose at each 4-week period minus mean OCS dose during Weeks 0-4) divided by (mean OCS dose during Weeks 0-4) multiplied by 100 was <= -50. Baseline value was derived as the sum of the daily doses of OCS during first 4 weeks following the initiation of mepolizumab treatment (Weeks 0-4) divided by total number of days.
Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. Data is presented for subpopulation of participants that were taking OCS at Baseline.
Participants in the age group of 6 to 11 years with body weight less than (<) 40 kilogram (kg) received Mepolizumab 100 milligram (mg) subcutaneous (SC) injection every 4 weeks over a treatment period of 52 weeks.
OG001
Mepolizumab 300 mg SC
Participants in the age group of 12 to 17 years received Mepolizumab 300 mg SC injection every 4 weeks over a treatment period of 52 weeks.
OG002
Mepolizumab 200/100 mg SC
A participant in the age group of 6 to 11 years with body weight greater than or equal to (>=) 40 kg received mepolizumab 200 mg SC injections every 4 weeks. During the conduct of the study, the mepolizumab dose was reduced to 100 mg SC injection every 4 weeks as body weight of the participant reduced to less than (<) 40 kg over a treatment period of 52 weeks.
OG003
Mepolizumab 200/300 mg SC
A participant in the age group of 6 to 11 years with body weight >=40 kg received mepolizumab 200 mg SC injections every 4 weeks. During the conduct of the study, the mepolizumab dose was increased to 300 mg SC injection every 4 weeks as age of the participant increased to the age group of 12 to 17 years over a treatment period of 52 weeks.
Units
Counts
Participants
OG0004
OG0012
OG0021
OG003
Title
Denominators
Categories
Weeks 4-8
Title
Measurements
OG0001
OG0010
OG0020
OG003
Secondary
Number of Participants With a Mean Daily OCS Dose (Prednisone/Prednisolone or Equivalent) of Less Than or Equal to (<=) 7.5 Milligrams (mg) During Weeks 48-52 in Subpopulation of Participants That Were Taking OCS at Baseline
The mean daily OCS (prednisone or equivalent) dose for Weeks 48-52 for each participant were calculated as the sum of the daily doses of OCS during this period divided by the total number of days. Number of participants with a mean daily OCS dose (prednisone/prednisolone or equivalent) of <=7.5 mg during period of Weeks 48-52 in subpopulation of participants that were taking OCS at Baseline has been presented.
Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. Data is presented for subpopulation of participants that were taking OCS at Baseline.
Posted
Count of Participants
Participants
Weeks 48-52
ID
Title
Description
OG000
Mepolizumab 100 mg SC
Participants in the age group of 6 to 11 years with body weight less than (<) 40 kilogram (kg) received Mepolizumab 100 milligram (mg) subcutaneous (SC) injection every 4 weeks over a treatment period of 52 weeks.
OG001
Mepolizumab 300 mg SC
Participants in the age group of 12 to 17 years received Mepolizumab 300 mg SC injection every 4 weeks over a treatment period of 52 weeks.
OG002
Mepolizumab 200/100 mg SC
A participant in the age group of 6 to 11 years with body weight greater than or equal to (>=) 40 kg received mepolizumab 200 mg SC injections every 4 weeks. During the conduct of the study, the mepolizumab dose was reduced to 100 mg SC injection every 4 weeks as body weight of the participant reduced to less than (<) 40 kg over a treatment period of 52 weeks.
OG003
Mepolizumab 200/300 mg SC
A participant in the age group of 6 to 11 years with body weight >=40 kg received mepolizumab 200 mg SC injections every 4 weeks. During the conduct of the study, the mepolizumab dose was increased to 300 mg SC injection every 4 weeks as age of the participant increased to the age group of 12 to 17 years over a treatment period of 52 weeks.
Units
Counts
Participants
OG0004
OG0012
OG0021
OG003
Title
Denominators
Categories
Title
Measurements
OG0003
OG0010
OG0021
OG003
Secondary
Number of Participants With a Mean Daily OCS Dose (Prednisone/Prednisolone or Equivalent) of <=7.5 mg During Weeks 48-52 in Overall Population
The mean daily OCS (prednisone or equivalent) dose for Weeks 48-52 for each participant were calculated as the sum of the daily doses of OCS during this period divided by the total number of days. Number of participants with a mean daily OCS dose (prednisone/prednisolone or equivalent) of <=7.5 mg during period of Weeks 48-52 in overall population has been presented.
The analysis was performed on the Full Analysis Set that included all participants who received at least one dose of mepolizumab.
Posted
Count of Participants
Participants
Weeks 48-52
ID
Title
Description
OG000
Mepolizumab 100 mg SC
Participants in the age group of 6 to 11 years with body weight less than (<) 40 kilogram (kg) received Mepolizumab 100 milligram (mg) subcutaneous (SC) injection every 4 weeks over a treatment period of 52 weeks.
OG001
Mepolizumab 300 mg SC
Participants in the age group of 12 to 17 years received Mepolizumab 300 mg SC injection every 4 weeks over a treatment period of 52 weeks.
OG002
Mepolizumab 200/100 mg SC
A participant in the age group of 6 to 11 years with body weight greater than or equal to (>=) 40 kg received mepolizumab 200 mg SC injections every 4 weeks. During the conduct of the study, the mepolizumab dose was reduced to 100 mg SC injection every 4 weeks as body weight of the participant reduced to less than (<) 40 kg over a treatment period of 52 weeks.
OG003
Mepolizumab 200/300 mg SC
A participant in the age group of 6 to 11 years with body weight >=40 kg received mepolizumab 200 mg SC injections every 4 weeks. During the conduct of the study, the mepolizumab dose was increased to 300 mg SC injection every 4 weeks as age of the participant increased to the age group of 12 to 17 years over a treatment period of 52 weeks.
Units
Counts
Participants
OG00010
OG0014
OG0021
OG003
Title
Denominators
Categories
Title
Measurements
OG0009
OG0012
OG0021
OG003
Secondary
Change From Baseline in Fatigue Severity Based on Weekly Average Score of Brief Fatigue Inventory (BFI) Item 3 (Worst Level of Fatigue During Past 24 Hours) for Week 52 for Participants in the Age Group of 12 to 17 Years
The BFI is a self-administered questionnaire developed to assess fatigue severity. The BFI has 9 items. BFI- Item 3 assesses the worst level of fatigue during the past 24 hours. Participants report their worst level of fatigue daily, for the previous 24 hours, using a numerical rating scale ranging from 0 (no fatigue) to 10 (as bad as you can imagine). The weekly average score of BFI item 3 was defined as the mean of the observed daily assessments over the 7-day period. The weekly average score of BFI item 3 ranges from 0 to 10, higher score indicates worst outcome. BFI Item 3 was assessed in the participants with the age group of 12 to 17 years at study entry. Baseline was defined as the mean of the 7 daily assessments of BFI item 3 up to but not including the date of first dose of study treatment. Change from Baseline was calculated as post-Baseline value minus Baseline Value.
Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field.
Posted
Mean
Standard Deviation
Scores on a scale
Baseline (Week 0) and Week 52
ID
Title
Description
OG000
Mepolizumab 300 mg SC
Participants in the age group of 12 to 17 years received Mepolizumab 300 mg SC injection every 4 weeks over a treatment period of 52 weeks.
Units
Counts
Participants
OG0002
Title
Denominators
Categories
Title
Measurements
OG0000.1± 0.12
Secondary
Number of Participants With Any Time Post-Baseline Positive Anti-mepolizumab Antibodies (ADA)
Serum samples were collected for the determination of anti-mepolizumab antibodies (ADA) using a validated electro-chemiluminescent immunoassay. The assay involved screening, confirmation and titration assays. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample and were also further characterized in the Neutralizing antibody (Nab) assay. A participant was considered positive ADA if they had at least one positive any time post-Baseline ADA result.
The analysis was performed on the Full Analysis Set that included all participants who received at least one dose of mepolizumab.
Posted
Count of Participants
Participants
Up to Week 52
ID
Title
Description
OG000
Mepolizumab 100 mg SC
Participants in the age group of 6 to 11 years with body weight less than (<) 40 kilogram (kg) received Mepolizumab 100 milligram (mg) subcutaneous (SC) injection every 4 weeks over a treatment period of 52 weeks.
OG001
Mepolizumab 300 mg SC
Participants in the age group of 12 to 17 years received Mepolizumab 300 mg SC injection every 4 weeks over a treatment period of 52 weeks.
OG002
Mepolizumab 200/100 mg SC
A participant in the age group of 6 to 11 years with body weight greater than or equal to (>=) 40 kg received mepolizumab 200 mg SC injections every 4 weeks. During the conduct of the study, the mepolizumab dose was reduced to 100 mg SC injection every 4 weeks as body weight of the participant reduced to less than (<) 40 kg over a treatment period of 52 weeks.
OG003
Mepolizumab 200/300 mg SC
A participant in the age group of 6 to 11 years with body weight >=40 kg received mepolizumab 200 mg SC injections every 4 weeks. During the conduct of the study, the mepolizumab dose was increased to 300 mg SC injection every 4 weeks as age of the participant increased to the age group of 12 to 17 years over a treatment period of 52 weeks.
Units
Counts
Participants
OG00010
OG0014
OG0021
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Number of Participants With Any Time Post-Baseline Positive Neutralizing Antibodies (NAb)
Blood samples were collected for the determination of positive neutralizing antibodies. NAb test was to be carried out on samples that were positive in the confirmatory binding antibody assay. A participant was to be considered positive for NAb if they had at least one positive any time post-Baseline neutralizing antibody result.
Full Analysis Set. NAb data was not collected as there were no positive ADA observed. Therefore, Overall Number of Participants Analyzed (N)=0 for this outcome measure.
Posted
Up to Week 52
ID
Title
Description
OG000
Mepolizumab 100 mg SC
Participants in the age group of 6 to 11 years with body weight less than (<) 40 kilogram (kg) received Mepolizumab 100 milligram (mg) subcutaneous (SC) injection every 4 weeks over a treatment period of 52 weeks.
OG001
Mepolizumab 300 mg SC
Participants in the age group of 12 to 17 years received Mepolizumab 300 mg SC injection every 4 weeks over a treatment period of 52 weeks.
OG002
Mepolizumab 200/100 mg SC
A participant in the age group of 6 to 11 years with body weight greater than or equal to (>=) 40 kg received mepolizumab 200 mg SC injections every 4 weeks. During the conduct of the study, the mepolizumab dose was reduced to 100 mg SC injection every 4 weeks as body weight of the participant reduced to less than (<) 40 kg over a treatment period of 52 weeks.
OG003
Mepolizumab 200/300 mg SC
A participant in the age group of 6 to 11 years with body weight >=40 kg received mepolizumab 200 mg SC injections every 4 weeks. During the conduct of the study, the mepolizumab dose was increased to 300 mg SC injection every 4 weeks as age of the participant increased to the age group of 12 to 17 years over a treatment period of 52 weeks.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Ratio to Baseline in Blood Eosinophil Count
Blood samples were collected to measure eosinophil count. Ratio to Baseline is defined as post-dose visit value divided by Baseline value. Baseline was defined as the latest blood eosinophil value measured by the central laboratory prior to the first dose of study treatment.
Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Participants in the age group of 6 to 11 years with body weight less than (<) 40 kilogram (kg) received Mepolizumab 100 milligram (mg) subcutaneous (SC) injection every 4 weeks over a treatment period of 52 weeks.
OG001
Mepolizumab 300 mg SC
Participants in the age group of 12 to 17 years received Mepolizumab 300 mg SC injection every 4 weeks over a treatment period of 52 weeks.
OG002
Mepolizumab 200/100 mg SC
A participant in the age group of 6 to 11 years with body weight greater than or equal to (>=) 40 kg received mepolizumab 200 mg SC injections every 4 weeks. During the conduct of the study, the mepolizumab dose was reduced to 100 mg SC injection every 4 weeks as body weight of the participant reduced to less than (<) 40 kg over a treatment period of 52 weeks.
OG003
Mepolizumab 200/300 mg SC
A participant in the age group of 6 to 11 years with body weight >=40 kg received mepolizumab 200 mg SC injections every 4 weeks. During the conduct of the study, the mepolizumab dose was increased to 300 mg SC injection every 4 weeks as age of the participant increased to the age group of 12 to 17 years over a treatment period of 52 weeks.
Units
Counts
Participants
OG00010
OG0014
OG0021
OG003
Title
Denominators
Categories
Week 4
ParticipantsOG0009
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG003
Secondary
Plasma Concentrations of Mepolizumab
Blood samples were collected at the indicated time points for pharmacokinetic analysis of Mepolizumab.
Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Posted
Geometric Mean
95% Confidence Interval
Nanograms per milliliter (ng/mL)
Pre-dose at Weeks 4 and 24; Week 52
ID
Title
Description
OG000
Mepolizumab 100 mg SC
Participants in the age group of 6 to 11 years with body weight less than (<) 40 kilogram (kg) received Mepolizumab 100 milligram (mg) subcutaneous (SC) injection every 4 weeks over a treatment period of 52 weeks.
OG001
Mepolizumab 300 mg SC
Participants in the age group of 12 to 17 years received Mepolizumab 300 mg SC injection every 4 weeks over a treatment period of 52 weeks.
OG002
Mepolizumab 200/100 mg SC
A participant in the age group of 6 to 11 years with body weight greater than or equal to (>=) 40 kg received mepolizumab 200 mg SC injections every 4 weeks. During the conduct of the study, the mepolizumab dose was reduced to 100 mg SC injection every 4 weeks as body weight of the participant reduced to less than (<) 40 kg over a treatment period of 52 weeks.
OG003
Mepolizumab 200/300 mg SC
A participant in the age group of 6 to 11 years with body weight >=40 kg received mepolizumab 200 mg SC injections every 4 weeks. During the conduct of the study, the mepolizumab dose was increased to 300 mg SC injection every 4 weeks as age of the participant increased to the age group of 12 to 17 years over a treatment period of 52 weeks.
Units
Counts
Participants
OG00010
OG0014
OG0021
OG003
Title
Denominators
Categories
Week 4, Pre-dose
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG003
0
10
0
10
9
10
EG001
Mepolizumab 300 mg SC
Participants in the age group of 12 to 17 years received Mepolizumab 300 mg SC injection every 4 weeks over a treatment period of 52 weeks.
0
4
0
4
1
4
EG002
Mepolizumab 200/100 mg SC
A participant in the age group of 6 to 11 years with body weight greater than or equal to (>=) 40 kg received mepolizumab 200 mg SC injections every 4 weeks. During the conduct of the study, the mepolizumab dose was reduced to 100 mg SC injection every 4 weeks as body weight of the participant reduced to less than (<) 40 kg over a treatment period of 52 weeks.
0
1
0
1
0
1
EG003
Mepolizumab 200/300 mg SC
A participant in the age group of 6 to 11 years with body weight >=40 kg received mepolizumab 200 mg SC injections every 4 weeks. During the conduct of the study, the mepolizumab dose was increased to 300 mg SC injection every 4 weeks as age of the participant increased to the age group of 12 to 17 years over a treatment period of 52 weeks.
0
1
1
1
1
1
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0032 events1 affected1 at risk
EG0005 events4 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected1 at risk
Constipation
Gastrointestinal disorders
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Abdominal pain lower
Gastrointestinal disorders
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected1 at risk
Nausea
Gastrointestinal disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected1 at risk
Vomiting
Gastrointestinal disorders
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Influenza
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0006 events4 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Viral infection
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0005 events2 affected10 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Pharyngitis streptococcal
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0002 events2 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0004 events2 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
COVID-19
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Catheter site cellulitis
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Ear infection
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Gastroenteritis
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Gastroenteritis viral
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Hand-foot-and-mouth disease
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Helicobacter infection
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Herpes dermatitis
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0002 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Molluscum contagiosum
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Nasopharyngitis
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Pharyngitis
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Pneumonia
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Pseudomonas infection
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Respiratory tract infection viral
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Sinusitis
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0002 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Viral upper respiratory tract infection
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA v28.1
Systematic Assessment
EG0003 events3 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v28.1
Systematic Assessment
EG0002 events2 affected10 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0012 events1 affected4 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected1 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v28.1
Systematic Assessment
EG0004 events2 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA v28.1
Systematic Assessment
EG0002 events2 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v28.1
Systematic Assessment
EG0002 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Tonsillar hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected1 at risk
Pyrexia
General disorders
MedDRA v28.1
Systematic Assessment
EG0004 events1 affected10 at risk
EG0012 events1 affected4 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected1 at risk
Fatigue
General disorders
MedDRA v28.1
Systematic Assessment
EG0002 events1 affected10 at risk
EG0013 events1 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Injection site reaction
General disorders
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Headache
Nervous system disorders
MedDRA v28.1
Systematic Assessment
EG0003 events2 affected10 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected1 at risk
Disturbance in attention
Nervous system disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0012 events1 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Angioedema
Skin and subcutaneous tissue disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG00110 events1 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Eczema
Skin and subcutaneous tissue disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v28.1
Systematic Assessment
EG0002 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Urticaria
Skin and subcutaneous tissue disorders
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Agitation
Psychiatric disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Autism spectrum disorder
Psychiatric disorders
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Insomnia
Psychiatric disorders
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Irritability
Psychiatric disorders
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Ligament sprain
Injury, poisoning and procedural complications
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Skin laceration
Injury, poisoning and procedural complications
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Sunburn
Injury, poisoning and procedural complications
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0012 events1 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0012 events1 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Cushingoid
Endocrine disorders
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Conjunctivitis allergic
Eye disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected1 at risk
Seasonal allergy
Immune system disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Iron deficiency
Metabolism and nutrition disorders
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Vulvovaginal pruritus
Reproductive system and breast disorders
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
Haematoma
Vascular disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
4
BG004NATotal not calculated because data are not available (NA) in one or more arms.
0
0
0
0
0
1
1
Title
Measurements
OG000-0.4± 0.7
OG0010.0± 0.0
OG0020.0± NAAs there was a single participant, mean value presented is the actual value. Standard deviation could not be calculated for single participant.
OG0030.0± NAAs there was a single participant, mean value presented is the actual value. Standard deviation could not be calculated for single participant.
Weeks 8-12
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0031
Title
Measurements
OG000-1.1± 1.4
OG0010.0± 0.0
OG0020.0± NAAs there was a single participant, mean value presented is the actual value. Standard deviation could not be calculated for single participant.
OG003
Weeks 12-16
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0031
Title
Measurements
OG000-1.8± 1.4
OG0010.0± 0.0
OG002-5.0± NAStandard deviation could not be calculated for single participant.
OG003
Weeks 16-20
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0031
Title
Measurements
OG000-1.9± 1.4
OG0010.0± 0.0
OG002-5.0± NAStandard deviation could not be calculated for single participant.
OG003
Weeks 20-24
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0031
Title
Measurements
OG000-1.9± 1.4
OG0010.0± 0.0
OG002-5.0± NAStandard deviation could not be calculated for single participant.
OG003
Weeks 24-28
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0031
Title
Measurements
OG000-2.6± 0.7
OG0010.0± 0.0
OG002-5.0± NAStandard deviation could not be calculated for single participant.
OG003
Weeks 28-32
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0031
Title
Measurements
OG000-2.6± 0.7
OG0010.0± 0.0
OG002-5.0± NAStandard deviation could not be calculated for single participant.
OG003
Weeks 32-36
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0031
Title
Measurements
OG000-2.5± 0.9
OG0010.0± 0.0
OG002-5.0± NAStandard deviation could not be calculated for single participant.
OG003
Weeks 36-40
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0031
Title
Measurements
OG000-2.5± 0.9
OG0010.0± 0.0
OG002-5.0± NAStandard deviation could not be calculated for single participant.
OG003
Weeks 40-44
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0031
Title
Measurements
OG000-2.5± 0.9
OG0010.0± 0.0
OG002-5.0± NAStandard deviation could not be calculated for single participant.
OG003
Weeks 44-48
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0031
Title
Measurements
OG000-2.5± 0.9
OG0010.0± 0.0
OG002-5.0± NAStandard deviation could not be calculated for single participant.
OG003
Weeks 48-52
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0031
Title
Measurements
OG000-2.5± 0.9
OG0010.0± 0.0
OG002-5.0± NAStandard deviation could not be calculated for single participant.
OG003
1
0
Weeks 8-12
Title
Measurements
OG0002
OG0010
OG0020
OG0030
Weeks 12-16
Title
Measurements
OG0003
OG0010
OG0021
OG0030
Weeks 16-20
Title
Measurements
OG0003
OG0010
OG0021
OG0030
Weeks 20-24
Title
Measurements
OG0003
OG0010
OG0021
OG0030
Weeks 24-28
Title
Measurements
OG0004
OG0010
OG0021
OG0030
Weeks 28-32
Title
Measurements
OG0004
OG0010
OG0021
OG0030
Weeks 32-36
Title
Measurements
OG0003
OG0010
OG0021
OG0031
Weeks 36-40
Title
Measurements
OG0003
OG0010
OG0021
OG0030
Weeks 40-44
Title
Measurements
OG0003
OG0010
OG0021
OG0031
Weeks 44-48
Title
Measurements
OG0003
OG0010
OG0021
OG0031
Weeks 48-52
Title
Measurements
OG0003
OG0010
OG0021
OG0031
1
1
1
1
1
0
0
1
1
Title
Measurements
OG0000.089(0.030 to 0.269)
OG0010.082(0.053 to 0.129)
OG0020.045(NA to NA)NA indicates 95% Confidence Interval could not be calculated for a single participant
OG0030.342(NA to NA)NA indicates 95% Confidence Interval could not be calculated for a single participant
Week 8
ParticipantsOG0007
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0031
Title
Measurements
OG0000.077(0.032 to 0.183)
OG0010.108(0.033 to 0.351)
OG0020.070(NA to NA)NA indicates 95% Confidence Interval could not be calculated for a single participant
OG003
Week 12
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0031
Title
Measurements
OG0000.078(0.045 to 0.137)
OG0010.058(0.017 to 0.203)
OG0020.035(NA to NA)NA indicates 95% Confidence Interval could not be calculated for a single participant
OG003
Week 16
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0031
Title
Measurements
OG0000.063(0.034 to 0.117)
OG0010.075(0.035 to 0.164)
OG0020.065(NA to NA)NA indicates 95% Confidence Interval could not be calculated for a single participant
OG003
Week 20
ParticipantsOG0007
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0031
Title
Measurements
OG0000.075(0.052 to 0.108)
OG0010.091(0.025 to 0.328)
OG0020.045(NA to NA)NA indicates 95% Confidence Interval could not be calculated for a single participant
OG003
Week 24
ParticipantsOG0008
ParticipantsOG0013
ParticipantsOG0021
ParticipantsOG0031
Title
Measurements
OG0000.069(0.042 to 0.113)
OG0010.048(0.026 to 0.089)
OG0020.030(NA to NA)NA indicates 95% Confidence Interval could not be calculated for a single participant
OG003
Week 28
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0020
ParticipantsOG0031
Title
Measurements
OG0000.087(0.056 to 0.135)
OG0010.113(0.051 to 0.251)
OG0030.158(NA to NA)NA indicates 95% Confidence Interval could not be calculated for a single participant
Week 32
ParticipantsOG0007
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0030
Title
Measurements
OG0000.064(0.046 to 0.088)
OG0010.057(0.029 to 0.113)
OG0020.131(NA to NA)NA indicates 95% Confidence Interval could not be calculated for a single participant
Week 36
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0021
ParticipantsOG0031
Title
Measurements
OG0000.071(0.056 to 0.090)
OG0010.048(0.021 to 0.110)
OG0020.040(NA to NA)NA indicates 95% Confidence Interval could not be calculated for a single participant
OG003
Week 40
ParticipantsOG0009
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0031
Title
Measurements
OG0000.066(0.034 to 0.127)
OG0010.106(0.062 to 0.181)
OG0020.045(NA to NA)NA indicates 95% Confidence Interval could not be calculated for a single participant
OG003
Week 44
ParticipantsOG0009
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0031
Title
Measurements
OG0000.071(0.041 to 0.122)
OG0010.091(0.039 to 0.212)
OG0020.045(NA to NA)NA indicates 95% Confidence Interval could not be calculated for a single participant
OG003
Week 48
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0031
Title
Measurements
OG0000.067(0.026 to 0.171)
OG0010.101(0.038 to 0.272)
OG0020.050(NA to NA)NA indicates 95% Confidence Interval could not be calculated for a single participant
OG003
Week 52
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0020
ParticipantsOG0031
Title
Measurements
OG0000.063(0.039 to 0.104)
OG0010.075(0.023 to 0.239)
OG0030.237(NA to NA)NA indicates 95% Confidence Interval could not be calculated for a single participant
1
1
Title
Measurements
OG00012350.99(10298.38 to 14812.72)
OG00116498.72(12004.15 to 22676.14)
OG00231998.66(NA to NA)NA indicates 95% Confidence Interval could not be calculated for a single participant
OG00322993.84(NA to NA)NA indicates 95% Confidence Interval could not be calculated for a single participant
Week 24, Pre-dose
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0031
Title
Measurements
OG00023186.66(19969.73 to 26921.81)
OG00124067.17(14519.85 to 39892.22)
OG00223697.43(NA to NA)NA indicates 95% Confidence Interval could not be calculated for a single participant
OG003
Week 52
ParticipantsOG0009
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0031
Title
Measurements
OG00026870.67(23028.56 to 31353.80)
OG00122613.09(12211.20 to 41875.64)
OG00218695.75(NA to NA)NA indicates 95% Confidence Interval could not be calculated for a single participant
OG003
0.0
± NA
As there was a single participant, mean value presented is the actual value. Standard deviation could not be calculated for single participant.
0.0
± NA
As there was a single participant, mean value presented is the actual value. Standard deviation could not be calculated for single participant.
-1.0
± NA
Standard deviation could not be calculated for single participant.
1.9
± NA
Standard deviation could not be calculated for single participant.
-1.9
± NA
Standard deviation could not be calculated for single participant.
-2.2
± NA
Standard deviation could not be calculated for single participant.
-2.6
± NA
Standard deviation could not be calculated for single participant.
0.8
± NA
Standard deviation could not be calculated for single participant.
-3.9
± NA
Standard deviation could not be calculated for single participant.
-4.3
± NA
Standard deviation could not be calculated for single participant.
-5.0
± NA
Standard deviation could not be calculated for single participant.
0.368
(NA to NA)
NA indicates 95% Confidence Interval could not be calculated for a single participant
0.421
(NA to NA)
NA indicates 95% Confidence Interval could not be calculated for a single participant
0.289
(NA to NA)
NA indicates 95% Confidence Interval could not be calculated for a single participant
0.263
(NA to NA)
NA indicates 95% Confidence Interval could not be calculated for a single participant
0.184
(NA to NA)
NA indicates 95% Confidence Interval could not be calculated for a single participant
0.289
(NA to NA)
NA indicates 95% Confidence Interval could not be calculated for a single participant
0.289
(NA to NA)
NA indicates 95% Confidence Interval could not be calculated for a single participant
0.289
(NA to NA)
NA indicates 95% Confidence Interval could not be calculated for a single participant
0.289
(NA to NA)
NA indicates 95% Confidence Interval could not be calculated for a single participant
36129.28
(NA to NA)
NA indicates 95% Confidence Interval could not be calculated for a single participant
57853.69
(NA to NA)
NA indicates 95% Confidence Interval could not be calculated for a single participant