Trial Outcomes & Findings for Cessation Versus Continuation of Long-term Mepolizumab in Severe Eosinophilic Asthma Patients (NCT NCT02555371)
NCT ID: NCT02555371
Last Updated: 2020-02-05
Results Overview
Clinically significant exacerbation was defined as worsening of asthma which requires use of systemic corticosteroids (e.g., prednisone) for at least 3 days or a single intramuscular (IM) corticosteroid dose and/or hospitalization and/or emergency department (ED) visits. For participants on maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days is required. Percentage of participants with clinically significant exacerbation over time during the on-treatment period of Part C and 95% confidence interval were estimated using Kaplan-Meier estimates. Intent-to-Treat Population includes all randomized participants who received at least one dose of double-blind study medication within Part C.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
306 participants
Primary outcome timeframe
Weeks 12, 24, 36 and 52
Results posted on
2020-02-05
Participant Flow
A multi-center, randomized, double-blind, placebo controlled, parallel group study to compare cessation versus continuation of long-term mepolizumab treatment. Participants (par.) who completed the Follow Up/Exit Visit or Early Withdrawal Visit from study MEA115666 (NCT01691859) or 201312 (NCT02135692) were eligible to participate in this study.
This is a 3 period study including variable open-label (OL) run-in, double-blind (DB) treatment period and open-label treatment switch period. The study was conducted in 75 centers across 14 countries from 07-Jan-2016 to 24-Jul-2019.
Participant milestones
| Measure |
Part A/B: Mepolizumab 100mg SC
Participants with less than 3 years of mepolizumab treatment entered variable open-label run-in period-Part A in order to reach 3 years of exposure and received 100 mg of mepolizumab injected subcutaneously (SC) once every 4 weeks (W) up to 132 weeks. Upon achieving 3 years exposure, participants entered Part B. Participants with at least 3 years of mepolizumab treatment directly entered fixed open-label run-in period-Part B and received 100 mg of mepolizumab injected SC once every 4 weeks up to 8 weeks.
|
Part C: Placebo
Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received placebo SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization).
|
Part C: Mepolizumab 100mg SC
Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received continued mepolizumab 100 mg SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization).
|
Part D: Mepolizumab 100mg SC (Previous Placebo)
Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization in Part C).
|
Part D: Mepolizumab 100mg SC (Previous Mepolizumab)
Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization in Part C ).
|
|---|---|---|---|---|---|
|
PartA(Upto 132W)+PartB(Upto 8W)
STARTED
|
306
|
0
|
0
|
0
|
0
|
|
PartA(Upto 132W)+PartB(Upto 8W)
COMPLETED
|
295
|
0
|
0
|
0
|
0
|
|
PartA(Upto 132W)+PartB(Upto 8W)
NOT COMPLETED
|
11
|
0
|
0
|
0
|
0
|
|
Part C (DB Period: Up to 52W)
STARTED
|
0
|
151
|
144
|
0
|
0
|
|
Part C (DB Period: Up to 52W)
COMPLETED
|
0
|
62
|
96
|
0
|
0
|
|
Part C (DB Period: Up to 52W)
NOT COMPLETED
|
0
|
89
|
48
|
0
|
0
|
|
PartD(OL: 52W Post-randomization PartC)
STARTED
|
0
|
0
|
0
|
84
|
45
|
|
PartD(OL: 52W Post-randomization PartC)
COMPLETED
|
0
|
0
|
0
|
80
|
42
|
|
PartD(OL: 52W Post-randomization PartC)
NOT COMPLETED
|
0
|
0
|
0
|
4
|
3
|
Reasons for withdrawal
| Measure |
Part A/B: Mepolizumab 100mg SC
Participants with less than 3 years of mepolizumab treatment entered variable open-label run-in period-Part A in order to reach 3 years of exposure and received 100 mg of mepolizumab injected subcutaneously (SC) once every 4 weeks (W) up to 132 weeks. Upon achieving 3 years exposure, participants entered Part B. Participants with at least 3 years of mepolizumab treatment directly entered fixed open-label run-in period-Part B and received 100 mg of mepolizumab injected SC once every 4 weeks up to 8 weeks.
|
Part C: Placebo
Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received placebo SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization).
|
Part C: Mepolizumab 100mg SC
Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received continued mepolizumab 100 mg SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization).
|
Part D: Mepolizumab 100mg SC (Previous Placebo)
Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization in Part C).
|
Part D: Mepolizumab 100mg SC (Previous Mepolizumab)
Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization in Part C ).
|
|---|---|---|---|---|---|
|
PartA(Upto 132W)+PartB(Upto 8W)
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
|
PartA(Upto 132W)+PartB(Upto 8W)
Failure to meet continuation criteria
|
2
|
0
|
0
|
0
|
0
|
|
PartA(Upto 132W)+PartB(Upto 8W)
Withdrawal by Subject
|
5
|
0
|
0
|
0
|
0
|
|
PartA(Upto 132W)+PartB(Upto 8W)
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
|
PartA(Upto 132W)+PartB(Upto 8W)
Lack of Efficacy
|
2
|
0
|
0
|
0
|
0
|
|
Part C (DB Period: Up to 52W)
Switched to Part D treatment
|
0
|
84
|
45
|
0
|
0
|
|
Part C (DB Period: Up to 52W)
Withdrawal by Subject
|
0
|
2
|
2
|
0
|
0
|
|
Part C (DB Period: Up to 52W)
Lack of Efficacy
|
0
|
1
|
0
|
0
|
0
|
|
Part C (DB Period: Up to 52W)
Adverse Event
|
0
|
2
|
1
|
0
|
0
|
|
PartD(OL: 52W Post-randomization PartC)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
|
PartD(OL: 52W Post-randomization PartC)
Physician Decision
|
0
|
0
|
0
|
2
|
0
|
|
PartD(OL: 52W Post-randomization PartC)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
2
|
|
PartD(OL: 52W Post-randomization PartC)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
1
|
|
PartD(OL: 52W Post-randomization PartC)
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Cessation Versus Continuation of Long-term Mepolizumab in Severe Eosinophilic Asthma Patients
Baseline characteristics by cohort
| Measure |
Parts A/B: Mepolizumab 100mg SC
n=306 Participants
Participants with less than 3 years of mepolizumab treatment entered variable open-label run-in period-Part A in order to reach 3 years of exposure and received 100 mg of mepolizumab injected subcutaneously (SC) once every 4 weeks up to 132 weeks. Upon achieving 3 years exposure, participants entered Part B. Participants with at least 3 years of mepolizumab treatment directly entered fixed open-label run-in period-Part B and received 100 mg of mepolizumab injected SC once every 4 weeks up to 8 weeks.
|
|---|---|
|
Age, Continuous
|
55.6 Years
STANDARD_DEVIATION 11.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
180 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
126 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
ASIAN - CENTRAL/SOUTH ASIAN HERITAGE
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
ASIAN - EAST ASIAN HERITAGE
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
ASIAN - JAPANESE HERITAGE
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
WHITE - ARABIC/NORTH AFRICAN HERITAGE
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
WHITE - WHITE/CAUCASIAN/EUROPEAN HERITAGE
|
245 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 12, 24, 36 and 52Population: Intent-to-Treat Population.
Clinically significant exacerbation was defined as worsening of asthma which requires use of systemic corticosteroids (e.g., prednisone) for at least 3 days or a single intramuscular (IM) corticosteroid dose and/or hospitalization and/or emergency department (ED) visits. For participants on maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days is required. Percentage of participants with clinically significant exacerbation over time during the on-treatment period of Part C and 95% confidence interval were estimated using Kaplan-Meier estimates. Intent-to-Treat Population includes all randomized participants who received at least one dose of double-blind study medication within Part C.
Outcome measures
| Measure |
Part C: Placebo
n=151 Participants
Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received placebo SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization).
|
Part C: Mepolizumab 100mg SC
n=144 Participants
Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received continued mepolizumab 100 mg SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization).
|
|---|---|---|
|
Percentage of Participants With First Clinically Significant Exacerbation in Part C
Week 12
|
31.8 Percentage of participants
Interval 25.0 to 39.9
|
20.2 Percentage of participants
Interval 14.5 to 27.7
|
|
Percentage of Participants With First Clinically Significant Exacerbation in Part C
Week 24
|
49.3 Percentage of participants
Interval 41.5 to 57.6
|
32.3 Percentage of participants
Interval 25.3 to 40.7
|
|
Percentage of Participants With First Clinically Significant Exacerbation in Part C
Week 36
|
56.0 Percentage of participants
Interval 48.1 to 64.2
|
40.3 Percentage of participants
Interval 32.8 to 48.9
|
|
Percentage of Participants With First Clinically Significant Exacerbation in Part C
Weeks 52
|
60.7 Percentage of participants
Interval 52.7 to 68.8
|
47.1 Percentage of participants
Interval 39.2 to 55.7
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12, 24, 36 and 52Population: Intent-to-Treat Population. Only those participants available at the specified time points were analyzed for each treatment and represented as n=X in category titles
Blood samples were collected at specific time points to measure blood eosinophils level. Baseline was defined as the latest available assessment prior to first dose of double-blind treatment within Part C. Ratio to Baseline is defined as visit value divided by Baseline value and was analyzed using Mixed Model Repeated Measures with covariates of Baseline, region, exacerbations in the year prior to randomization (as an ordinal variable), Baseline maintenance oral corticosteroids (OCS) therapy (OCS versus no OCS), treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group. The log transformation was applied to blood eosinophil counts prior to analysis. If a blood eosinophil count of zero was reported, a small value was added prior to log transforming the data. The dispersion measure used was log standard error.
Outcome measures
| Measure |
Part C: Placebo
n=121 Participants
Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received placebo SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization).
|
Part C: Mepolizumab 100mg SC
n=120 Participants
Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received continued mepolizumab 100 mg SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization).
|
|---|---|---|
|
Ratio to Baseline in Blood Eosinophil Count in Part C
Week 12, n=121, 120
|
6.03 Ratio
Standard Error 0.077
|
1.16 Ratio
Standard Error 0.078
|
|
Ratio to Baseline in Blood Eosinophil Count in Part C
Week 24, n= 79, 106
|
6.58 Ratio
Standard Error 0.095
|
1.03 Ratio
Standard Error 0.084
|
|
Ratio to Baseline in Blood Eosinophil Count in Part C
Week 36, n= 65, 99
|
6.48 Ratio
Standard Error 0.093
|
1.20 Ratio
Standard Error 0.079
|
|
Ratio to Baseline in Blood Eosinophil Count in Part C
Week 52, n=60, 92
|
6.17 Ratio
Standard Error 0.091
|
1.00 Ratio
Standard Error 0.077
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12, 24, 36 and 52Population: Intent-to-Treat Population.
The ACQ-5 is a five-item, self-completed questionnaire. Five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms over the previous week. The response ranges from zero (no impairment/limitation) to six (total impairment/ limitation) scale. Increase in score of \>= 0.5 units from Baseline indicates decrease in asthma control. Baseline is the latest available assessment prior to first dose of double-blind treatment within Part C. Percentage of participants with a 0.5 point or more increase in ACQ-5 score from Baseline over time during the on-treatment period of Part C and its 95% confidence interval were estimated using Kaplan-Meier estimates.
Outcome measures
| Measure |
Part C: Placebo
n=151 Participants
Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received placebo SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization).
|
Part C: Mepolizumab 100mg SC
n=144 Participants
Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received continued mepolizumab 100 mg SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization).
|
|---|---|---|
|
Percentage of Participants With 0.5 Point or More Increase in Asthma Control Questionnaire (ACQ)-5 Score From Baseline in Part C
Week 12
|
44.5 Percentage of participants
Interval 36.9 to 52.8
|
39.3 Percentage of participants
Interval 31.8 to 47.8
|
|
Percentage of Participants With 0.5 Point or More Increase in Asthma Control Questionnaire (ACQ)-5 Score From Baseline in Part C
Week 24
|
69.5 Percentage of participants
Interval 61.6 to 77.1
|
49.3 Percentage of participants
Interval 41.3 to 57.9
|
|
Percentage of Participants With 0.5 Point or More Increase in Asthma Control Questionnaire (ACQ)-5 Score From Baseline in Part C
Week 36
|
74.9 Percentage of participants
Interval 67.1 to 82.1
|
56.0 Percentage of participants
Interval 47.8 to 64.6
|
|
Percentage of Participants With 0.5 Point or More Increase in Asthma Control Questionnaire (ACQ)-5 Score From Baseline in Part C
Weeks 52
|
79.0 Percentage of participants
Interval 71.3 to 85.7
|
63.1 Percentage of participants
Interval 54.8 to 71.5
|
SECONDARY outcome
Timeframe: Weeks 12, 24, 36 and 52Population: Intent-to-Treat Population.
Exacerbations of asthma requiring hospitalization or ED visit were assessed. The analysis was performed from Cox Proportional Hazards Model with covariates of treatment group, region, exacerbations in the year prior to randomization (as an ordinal variable) and Baseline maintenance OCS therapy (OCS versus no OCS). Percentage of participants with an exacerbation over time and its 95% confidence intervals were estimated using Kaplan-Meier estimates
Outcome measures
| Measure |
Part C: Placebo
n=151 Participants
Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received placebo SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization).
|
Part C: Mepolizumab 100mg SC
n=144 Participants
Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received continued mepolizumab 100 mg SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization).
|
|---|---|---|
|
Percentage of Participants With Time to First Exacerbation Requiring Hospitalization or ED Visit in Part C
Weeks 52
|
5.7 Percentage of participants
Interval 2.7 to 11.8
|
7.9 Percentage of participants
Interval 4.3 to 14.3
|
|
Percentage of Participants With Time to First Exacerbation Requiring Hospitalization or ED Visit in Part C
Week 12
|
2.9 Percentage of participants
Interval 1.1 to 7.5
|
2.8 Percentage of participants
Interval 1.1 to 7.2
|
|
Percentage of Participants With Time to First Exacerbation Requiring Hospitalization or ED Visit in Part C
Week 24
|
5.7 Percentage of participants
Interval 2.7 to 11.8
|
5.1 Percentage of participants
Interval 2.4 to 10.3
|
|
Percentage of Participants With Time to First Exacerbation Requiring Hospitalization or ED Visit in Part C
Week 36
|
5.7 Percentage of participants
Interval 2.7 to 11.8
|
5.9 Percentage of participants
Interval 3.0 to 11.6
|
Adverse Events
Part A/B: Mepolizumab 100mg SC
Serious events: 7 serious events
Other events: 14 other events
Deaths: 0 deaths
Part C: Placebo
Serious events: 10 serious events
Other events: 69 other events
Deaths: 0 deaths
Part C: Mepolizumab 100mg
Serious events: 9 serious events
Other events: 82 other events
Deaths: 0 deaths
Part D: Mepolizumab 100mg SC (Previous Placebo)
Serious events: 10 serious events
Other events: 44 other events
Deaths: 1 deaths
Part D: Mepolizumab 100mg SC (Previous Mepolizumab)
Serious events: 4 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A/B: Mepolizumab 100mg SC
n=306 participants at risk
Participants with less than 3 years of mepolizumab treatment entered variable open-label run-in period-Part A in order to reach 3 years of exposure and received 100 mg of mepolizumab injected subcutaneously (SC) once every 4 weeks (W) up to 132 weeks. Upon achieving 3 years exposure, participants entered Part B. Participants with at least 3 years of mepolizumab treatment directly entered fixed open-label run-in period-Part B and received 100 mg of mepolizumab injected SC once every 4 weeks up to 8 weeks.
|
Part C: Placebo
n=151 participants at risk
Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received placebo SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization).
|
Part C: Mepolizumab 100mg
n=144 participants at risk
Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received continued mepolizumab 100 mg SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization).
|
Part D: Mepolizumab 100mg SC (Previous Placebo)
n=84 participants at risk
Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization in Part C).
|
Part D: Mepolizumab 100mg SC (Previous Mepolizumab)
n=45 participants at risk
Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization in Part C).
|
|---|---|---|---|---|---|
|
Infections and infestations
Cytomegalovirus infection
|
0.33%
1/306 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Infections and infestations
Influenza
|
0.33%
1/306 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Infections and infestations
Pharyngeal abscess
|
0.33%
1/306 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Infections and infestations
Urinary tract infection
|
0.33%
1/306 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.98%
3/306 • Number of events 4 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
4.0%
6/151 • Number of events 6 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
1.4%
2/144 • Number of events 2 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
4.8%
4/84 • Number of events 4 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
8.9%
4/45 • Number of events 6 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.33%
1/306 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.33%
1/306 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant polyp
|
0.33%
1/306 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.69%
1/144 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.66%
1/151 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.69%
1/144 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Infections and infestations
Escherichia pyelonephritis
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.66%
1/151 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.66%
1/151 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage 0
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.69%
1/144 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papillary mucinous neoplasm
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.69%
1/144 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.69%
1/144 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.66%
1/151 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
General disorders
Device related thrombosis
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.66%
1/151 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.69%
1/144 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.66%
1/151 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.69%
1/144 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.69%
1/144 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.66%
1/151 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.69%
1/144 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal cyst
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Gastrointestinal disorders
Salivary gland calculus
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
2.2%
1/45 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Infections and infestations
Sinusitis fungal
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
Other adverse events
| Measure |
Part A/B: Mepolizumab 100mg SC
n=306 participants at risk
Participants with less than 3 years of mepolizumab treatment entered variable open-label run-in period-Part A in order to reach 3 years of exposure and received 100 mg of mepolizumab injected subcutaneously (SC) once every 4 weeks (W) up to 132 weeks. Upon achieving 3 years exposure, participants entered Part B. Participants with at least 3 years of mepolizumab treatment directly entered fixed open-label run-in period-Part B and received 100 mg of mepolizumab injected SC once every 4 weeks up to 8 weeks.
|
Part C: Placebo
n=151 participants at risk
Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received placebo SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization).
|
Part C: Mepolizumab 100mg
n=144 participants at risk
Upon completion of the fixed run-in period, participants entered a double-blind study treatment and received continued mepolizumab 100 mg SC every 4 weeks up to 52 weeks. Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization).
|
Part D: Mepolizumab 100mg SC (Previous Placebo)
n=84 participants at risk
Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization in Part C).
|
Part D: Mepolizumab 100mg SC (Previous Mepolizumab)
n=45 participants at risk
Participants who experienced a clinically significant asthma exacerbation were assessed by the investigator to determine if they could continue double-blind treatment or should instead enter OL mepolizumab 100 mg SC every 4 weeks for the remainder of the treatment period (up to 52 weeks post-randomization in Part C).
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
4.6%
14/306 • Number of events 23 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
17.2%
26/151 • Number of events 44 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
18.8%
27/144 • Number of events 36 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
19.0%
16/84 • Number of events 22 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
20.0%
9/45 • Number of events 12 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
9.3%
14/151 • Number of events 18 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
8.3%
12/144 • Number of events 14 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
6.0%
5/84 • Number of events 5 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
6.7%
3/45 • Number of events 3 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
6.0%
9/151 • Number of events 10 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
9.0%
13/144 • Number of events 14 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
8.3%
7/84 • Number of events 11 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
11.1%
5/45 • Number of events 8 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
3.3%
5/151 • Number of events 5 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
9.7%
14/144 • Number of events 14 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
8.3%
7/84 • Number of events 8 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
17.8%
8/45 • Number of events 13 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
1.3%
2/151 • Number of events 2 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
4.2%
6/144 • Number of events 11 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
3.3%
5/151 • Number of events 7 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
2.1%
3/144 • Number of events 3 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Infections and infestations
Influenza
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.66%
1/151 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
3.5%
5/144 • Number of events 5 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
4.4%
2/45 • Number of events 2 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
9.3%
14/151 • Number of events 16 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
6.9%
10/144 • Number of events 14 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
8.3%
7/84 • Number of events 7 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
8.9%
4/45 • Number of events 12 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
4.0%
6/151 • Number of events 7 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.69%
1/144 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
4.0%
6/151 • Number of events 12 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
4.2%
6/144 • Number of events 8 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
3.6%
3/84 • Number of events 4 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
4.4%
2/45 • Number of events 2 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
2.0%
3/151 • Number of events 3 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
4.2%
6/144 • Number of events 6 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Nervous system disorders
Headache
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
6.0%
9/151 • Number of events 11 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
6.2%
9/144 • Number of events 12 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
7.1%
6/84 • Number of events 7 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
8.9%
4/45 • Number of events 7 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Vascular disorders
Hypertension
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.66%
1/151 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
3.5%
5/144 • Number of events 6 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
4.8%
4/84 • Number of events 6 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
4.4%
2/45 • Number of events 4 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
3.6%
3/84 • Number of events 3 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
4.4%
2/45 • Number of events 2 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
4.4%
2/45 • Number of events 2 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
3.6%
3/84 • Number of events 3 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
2.2%
1/45 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
2.4%
2/84 • Number of events 2 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
4.4%
2/45 • Number of events 2 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
4.4%
2/45 • Number of events 2 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
3.6%
3/84 • Number of events 3 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/45 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/84 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
4.4%
2/45 • Number of events 2 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/306 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/151 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
0.00%
0/144 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
1.2%
1/84 • Number of events 1 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
4.4%
2/45 • Number of events 2 • Adverse Events (AEs) & Serious Adverse Events (SAEs) were collected for Part A/B: from first dose of OL mepolizumab in Parts A/B until the last dose of mepolizumab in Parts A/B (upto 132 weeks for Part A & upto 8 weeks for Part B); for Part C: from start of double blind treatment until the last dose of double-blind treatment (upto 52 weeks) & for Part D: from start of first dose of OL treatment in Part D until the last dose of OL treatment in Part D (upto 52 weeks post-randomization in Part C)
AEs and SAEs were collected for As Treated Population which comprised of all participants who received at least one dose of open label mepolizumab for Parts A/B and Part D. Intent-to-Treat (ITT) Population was used for Part C which comprised of all randomized participants who received at least one dose of double-blind study medication. Combined data for parts A and B are presented since all par. received OL mepolizumab 100 mg SC.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER