Trial Outcomes & Findings for Long Term Special Drug Use Investigation of Mepolizumab (NCT NCT03028480)
NCT ID: NCT03028480
Last Updated: 2024-09-20
Results Overview
The number of participants whose data was entered in the EDC system up to 14 days from the initiation of NUCALA treatment (Day 1) has been presented.
Recruitment status
COMPLETED
Target enrollment
1061 participants
Primary outcome timeframe
Up to 14 days from the initiation of NUCALA treatment (Day 1)
Results posted on
2024-09-20
Participant Flow
This non-interventional study aims to collect and assess information regarding the safety and effectiveness of long-term use of NUCALA in asthma participants in daily clinical practice.
A total of 1061 participants were enrolled in the study (Enrolled Set included participants registered within the enrollment period specified in the protocol).
Participant milestones
| Measure |
Participants With Bronchial Asthma
Participants receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms were inadequately controlled despite receiving standard asthma medications) in clinical practice were enrolled in this study. No study treatment was administered during conduct of this study.
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|---|---|
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Overall Study
STARTED
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1061
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Overall Study
Safety Population
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1027
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Overall Study
COMPLETED
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1027
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Overall Study
NOT COMPLETED
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34
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Reasons for withdrawal
| Measure |
Participants With Bronchial Asthma
Participants receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms were inadequately controlled despite receiving standard asthma medications) in clinical practice were enrolled in this study. No study treatment was administered during conduct of this study.
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|---|---|
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Overall Study
No revisit after the first prescription date
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2
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Overall Study
Did not use the drug
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1
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Overall Study
Violation of the enrollment deadline
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10
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Overall Study
Case report forms were not collected
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21
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Baseline Characteristics
Long Term Special Drug Use Investigation of Mepolizumab
Baseline characteristics by cohort
| Measure |
Participants With Bronchial Asthma
n=1027 Participants
Participants receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms were inadequately controlled despite receiving standard asthma medications) in clinical practice were enrolled in this study. No study treatment was administered during conduct of this study.
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|---|---|
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Age, Continuous
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62.7 Years
STANDARD_DEVIATION 16.1 • n=5 Participants
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Sex: Female, Male
Female
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641 Participants
n=5 Participants
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Sex: Female, Male
Male
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386 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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1027 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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0 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Up to 14 days from the initiation of NUCALA treatment (Day 1)Population: Enrolled Set included participants registered within the enrollment period specified in the protocol.
The number of participants whose data was entered in the EDC system up to 14 days from the initiation of NUCALA treatment (Day 1) has been presented.
Outcome measures
| Measure |
Participants With Bronchial Asthma
n=1061 Participants
Participants receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms were inadequately controlled despite receiving standard asthma medications) in clinical practice were enrolled in this study. No study treatment was administered during conduct of this study.
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|---|---|
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Number of Participants Whose Data Entered on Electronic Data Capture (EDC) System
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1040 Participants
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PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: Safety Analysis Set consisted of the participants fixed in the case report form (CRF). It included participants that do not fall under the safety analysis exclusion criteria.
ADR is defined as a response to a drug which is noxious and unintended, and which occurred at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function. Percentage of participants with ADR were calculated as the number of participants having a particular ADR divided by total number of participants on NUCALA treatment\*100. Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Bronchial Asthma
n=1027 Participants
Participants receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms were inadequately controlled despite receiving standard asthma medications) in clinical practice were enrolled in this study. No study treatment was administered during conduct of this study.
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|---|---|
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Percentage of Participants With Adverse Drug Reaction (ADR)
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4.1 Percentage of participants
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PRIMARY outcome
Timeframe: Up to 1 yearPopulation: Effectiveness Analysis Set consisted of the participants included in safety analysis, participants that do not fall under the participants excluded from efficacy analysis.
The number of participants who showed response to the bronchial asthma treatment has been presented.
Outcome measures
| Measure |
Participants With Bronchial Asthma
n=959 Participants
Participants receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms were inadequately controlled despite receiving standard asthma medications) in clinical practice were enrolled in this study. No study treatment was administered during conduct of this study.
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|---|---|
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Number of Participants Showing Response to the Treatment
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866 Participants
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PRIMARY outcome
Timeframe: Up to 1 yearPopulation: Enrolled Set included participants registered within the enrollment period.
The number of participants excluded from analysis due to exacerbation of asthma has been presented.
Outcome measures
| Measure |
Participants With Bronchial Asthma
n=1061 Participants
Participants receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms were inadequately controlled despite receiving standard asthma medications) in clinical practice were enrolled in this study. No study treatment was administered during conduct of this study.
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|---|---|
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Number of Participants Excluded From Analysis Due to Exacerbation of Asthma
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16 Participants
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PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: Safety Analysis Set consisted of the participants fixed in the case report form. It included participants that do not fall under the safety analysis exclusion criteria.
ADR is defined as a response to a drug which is noxious and unintended, and which occurred at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.
Outcome measures
| Measure |
Participants With Bronchial Asthma
n=1027 Participants
Participants receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms were inadequately controlled despite receiving standard asthma medications) in clinical practice were enrolled in this study. No study treatment was administered during conduct of this study.
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|---|---|
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Number of Participants With Adverse Drug Reactions (ADR)
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42 Participants
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PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: Safety Analysis Set consisted of the participants fixed in the case report form. It included participants that do not fall under the safety analysis exclusion criteria.
Safety specifications and priority investigation matters included hypersensitivity reaction including anaphylaxis, infections, and malignant tumor. The percentage of participants with occurrences of safety specifications and priority investigation matters have been reported. Percentage values are rounded-off.
Outcome measures
| Measure |
Participants With Bronchial Asthma
n=1027 Participants
Participants receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms were inadequately controlled despite receiving standard asthma medications) in clinical practice were enrolled in this study. No study treatment was administered during conduct of this study.
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Percentage of Participants With Occurrences of Safety Specifications and Priority Investigation Matters
Hypersensitivity reaction including anaphylaxis
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1.2 Percentage of participants
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Percentage of Participants With Occurrences of Safety Specifications and Priority Investigation Matters
Infections
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0.3 Percentage of participants
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Percentage of Participants With Occurrences of Safety Specifications and Priority Investigation Matters
Malignant tumor
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0.2 Percentage of participants
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SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Effectiveness Analysis Set consisted of the participants included in safety analysis, participants that do not fall under the participants excluded from efficacy analysis.
Response rate is the percentage of participants assessed as "effective" based on the course of subjective symptoms and clinical symptoms. Response rate was calculated as number of participants showing response to the NUCALA treatment divided by total number of participants on treatment\*100. Percentage values are rounded-off. Response rate and corresponding 95% confidence interval were reported.
Outcome measures
| Measure |
Participants With Bronchial Asthma
n=959 Participants
Participants receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms were inadequately controlled despite receiving standard asthma medications) in clinical practice were enrolled in this study. No study treatment was administered during conduct of this study.
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Response Rate Assessed by Global Assessment of Effectiveness
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90.3 Percentage of participants
Interval 88.3 to 92.1
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SECONDARY outcome
Timeframe: 52 weeks before the initiation of NUCALA treatment (Day 1) and at Week 52 post-treatmentPopulation: Effectiveness Analysis Set consisted of the participants included in safety analysis, participants that do not fall under the participants excluded from efficacy analysis. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Asthma exacerbation was defined as new or increased asthma symptoms (wheezing, coughing, dyspnea, chest tightness, and/or nighttime awakenings due to these symptoms) that resulted in hospitalization, emergency room visit and usage of systemic steroids. Exacerbation rate was defined as number of asthma exacerbations divided by total person-year (52 weeks were converted to 1 year). Data for exacerbations requiring hospitalization, emergency room visit, and use of systemic corticosteroid have been presented.
Outcome measures
| Measure |
Participants With Bronchial Asthma
n=959 Participants
Participants receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms were inadequately controlled despite receiving standard asthma medications) in clinical practice were enrolled in this study. No study treatment was administered during conduct of this study.
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|---|---|
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Rate of Exacerbation of Asthma
Exacerbations requiring hospitalization: 52 weeks before the initiation of NUCALA treatment
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0.4 Asthma exacerbations per person-year
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Rate of Exacerbation of Asthma
Exacerbations requiring hospitalization: at Week 52 post-treatment
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0.1 Asthma exacerbations per person-year
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Rate of Exacerbation of Asthma
Exacerbations requiring emergency room visits: 52 weeks before the initiation of NUCALA treatment
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0.9 Asthma exacerbations per person-year
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Rate of Exacerbation of Asthma
Exacerbations requiring emergency room visits: at Week 52 post-treatment
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0.2 Asthma exacerbations per person-year
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Rate of Exacerbation of Asthma
Exacerbations requiring use of systemic corticosteroid:52weeks before initiation of NUCALA treatment
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3.2 Asthma exacerbations per person-year
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Rate of Exacerbation of Asthma
Exacerbations requiring the use of systemic corticosteroid: at Week 52 post-treatment
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0.7 Asthma exacerbations per person-year
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SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24 and 52 after the initiation of NUCALA treatment (Day 1)Population: Effectiveness Analysis Set consisted of the participants included in safety analysis, participants that do not fall under the participants excluded from efficacy analysis. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled) with higher scores indicating better control. Total ACT score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 19 suggests that the participant's asthma is unlikely to be well controlled, whilst a score of 20 to 25 suggests that the participant's asthma is likely to be well controlled. Baseline was defined as within 8 weeks prior to initiation of NUCALA treatment (Day 1).
Outcome measures
| Measure |
Participants With Bronchial Asthma
n=352 Participants
Participants receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms were inadequately controlled despite receiving standard asthma medications) in clinical practice were enrolled in this study. No study treatment was administered during conduct of this study.
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|---|---|
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Total Score of Asthma Control Test (ACT) at Indicated Time Points
Baseline
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16.2 Scores on a scale
Standard Deviation 4.9
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Total Score of Asthma Control Test (ACT) at Indicated Time Points
12 weeks after the initiation of NUCALA treatment
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20.5 Scores on a scale
Standard Deviation 4.3
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Total Score of Asthma Control Test (ACT) at Indicated Time Points
24 weeks after the initiation of NUCALA treatment
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20.9 Scores on a scale
Standard Deviation 4.2
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Total Score of Asthma Control Test (ACT) at Indicated Time Points
52 weeks after the initiation of NUCALA treatment
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21.4 Scores on a scale
Standard Deviation 4.0
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SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24 and 52 after the initiation of NUCALA treatment (Day 1)Population: Effectiveness Analysis Set consisted of the participants included in safety analysis, participants that do not fall under the participants excluded from efficacy analysis. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Peak Expiratory Flow is a person's maximum speed of expiration. PEF was measured using an electronic peak expiratory flow device (ePEF) at Baseline (Day 1), and at Weeks 12, 24, and 54 after the initiation of NUCALA treatment. Baseline was defined as within 8 weeks prior to initiation of NUCALA treatment (Day 1).
Outcome measures
| Measure |
Participants With Bronchial Asthma
n=120 Participants
Participants receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms were inadequately controlled despite receiving standard asthma medications) in clinical practice were enrolled in this study. No study treatment was administered during conduct of this study.
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|---|---|
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Mean Peak Expiratory Flow (PEF) at Indicated Time Points
Baseline
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304.4 Liters/minute
Standard Deviation 146.8
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Mean Peak Expiratory Flow (PEF) at Indicated Time Points
12 weeks after the initiation of NUCALA treatment
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333.7 Liters/minute
Standard Deviation 150.5
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Mean Peak Expiratory Flow (PEF) at Indicated Time Points
24 weeks after the initiation of NUCALA treatment
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334.2 Liters/minute
Standard Deviation 138.7
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Mean Peak Expiratory Flow (PEF) at Indicated Time Points
52 weeks after the initiation of NUCALA treatment
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358.9 Liters/minute
Standard Deviation 129.8
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Adverse Events
Participants With Bronchial Asthma
Serious events: 9 serious events
Other events: 33 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Participants With Bronchial Asthma
n=1027 participants at risk
Participants receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms were inadequately controlled despite receiving standard asthma medications) in clinical practice were enrolled in this study. No study treatment was administered during conduct of this study.
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|---|---|
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Infections and infestations
Pneumonia
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0.10%
1/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
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0.10%
1/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papillary-mucinous carcinoma of pancreas
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0.10%
1/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
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Nervous system disorders
Myasthenia gravis
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0.10%
1/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
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Eye disorders
Optic neuropathy
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0.10%
1/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
|
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Ear and labyrinth disorders
Vertigo positional
|
0.10%
1/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.19%
2/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
|
|
Respiratory, thoracic and mediastinal disorders
Chronic eosinophilic rhinosinusitis
|
0.10%
1/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.10%
1/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
|
|
General disorders
Condition aggravated
|
0.10%
1/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
|
Other adverse events
| Measure |
Participants With Bronchial Asthma
n=1027 participants at risk
Participants receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms were inadequately controlled despite receiving standard asthma medications) in clinical practice were enrolled in this study. No study treatment was administered during conduct of this study.
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|---|---|
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Infections and infestations
Bronchitis
|
0.10%
1/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
|
|
Infections and infestations
Nasopharyngitis
|
0.10%
1/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
|
|
Infections and infestations
Pharyngitis
|
0.10%
1/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
|
|
Nervous system disorders
Headache
|
0.19%
2/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
|
|
Cardiac disorders
Palpitations
|
0.19%
2/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.49%
5/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.10%
1/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
|
|
Respiratory, thoracic and mediastinal disorders
Chronic eosinophilic rhinosinusitis
|
0.29%
3/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
|
|
Gastrointestinal disorders
Nausea
|
0.19%
2/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
|
|
Gastrointestinal disorders
Vomiting
|
0.10%
1/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.19%
2/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.10%
1/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.10%
1/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.19%
2/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.19%
2/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.39%
4/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.10%
1/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.19%
2/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.10%
1/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
|
|
General disorders
Condition aggravated
|
0.29%
3/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
|
|
General disorders
Malaise
|
0.19%
2/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
|
|
General disorders
Oedema peripheral
|
0.10%
1/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
|
|
General disorders
Pain
|
0.10%
1/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
|
|
General disorders
Pyrexia
|
0.10%
1/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
|
|
Investigations
Eosinophil count increased
|
0.10%
1/1027 • All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
|
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