Trial Outcomes & Findings for Omalizumab to Mepolizumab Switch Study in Severe Eosinophilic Asthma Patients (NCT NCT02654145)

Last Updated: 2019-08-19

Results Overview

The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. The 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 options for all these questions range from zero (no impairment/limitation) to six (total impairment/ limitation) scale. ACQ-5 score range from 0 to 6. Higher scores indicates worsening of condition. Baseline was defined as the latest available assessment prior to first dose of mepolizumab. Change from Baseline at Week 32 was calculated as Week 32 value of ACQ-5 score minus Baseline value and was analyzed using Mixed Model Repeated Measures allowing for covariates of region, baseline maintenance OCS therapy, exacerbations in the year prior to the study (as ordinal variable) and visit.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

145 participants

Primary outcome timeframe

Baseline and at Week 32

Results posted on

2019-08-19

Participant Flow

Participants with severe eosinophilic asthma who were receiving omalizumab, but were not optimally controlled were enrolled in this open-label study and received mepolizumab 100 milligrams (mg) subcutaneously (SC) every 4 weeks for 32 weeks with last dose on Week 28. The study was conducted at 46 centers from 17 March 2016 to 31 May 2017.

Screening was performed at Visit 1 (Week -1). A total of 206 participants were screened of which 54 participants were screen failures. Seven additional participants were reported as pre-screen failures. The remaining 145 participants received at least one dose of mepolizumab.

Participant milestones

Participant milestones
Measure	Mepolizumab 100 mg SC Eligible participants received mepolizumab 100 mg SC doses into the upper arm or thigh every 4 weeks over a period of 32 weeks, with the last dose administered at Week 28, along with their current maintenance therapy except omalizumab.
Overall Study STARTED	145
Overall Study COMPLETED	138
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Mepolizumab 100 mg SC Eligible participants received mepolizumab 100 mg SC doses into the upper arm or thigh every 4 weeks over a period of 32 weeks, with the last dose administered at Week 28, along with their current maintenance therapy except omalizumab.
Overall Study Lack of Efficacy	1
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	5

Baseline Characteristics

Omalizumab to Mepolizumab Switch Study in Severe Eosinophilic Asthma Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mepolizumab 100 mg SC n=145 Participants Eligible participants received mepolizumab 100 mg SC doses into the upper arm or thigh every 4 weeks over a period of 32 weeks, with the last dose administered at Week 28, along with their current maintenance therapy except omalizumab.
Age, Continuous	53.6 Years STANDARD_DEVIATION 13.83 • n=5 Participants
Sex: Female, Male Female	86 Participants n=5 Participants
Sex: Female, Male Male	59 Participants n=5 Participants
Race/Ethnicity, Customized Race customized · Asian- Central/South Asian Heritage	2 Participants n=5 Participants
Race/Ethnicity, Customized Race customized · Asian- East Asian Heritage	1 Participants n=5 Participants
Race/Ethnicity, Customized Race customized · Asian- South East Asian Heritage	2 Participants n=5 Participants
Race/Ethnicity, Customized Race customized · Black or African American heritage	11 Participants n=5 Participants
Race/Ethnicity, Customized Race customized · White- Arabic/ North African Heritage	4 Participants n=5 Participants
Race/Ethnicity, Customized Race customized · White- White/Caucasian/European Heritage	124 Participants n=5 Participants
Race/Ethnicity, Customized Race customized · Multiple-Black/African American and White Heritage	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and at Week 32

Population: Intent to treat - all participants who received at least one dose of mepolizumab

Outcome measures

Outcome measures
Measure	Mepolizumab 100 mg SC n=145 Participants Eligible participants received mepolizumab 100 mg SC doses into the upper arm or thigh every 4 weeks over a period of 32 weeks, with the last dose administered at Week 28, along with their current maintenance therapy except omalizumab.
Mean Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Week 32	-1.45 Scores on a scale Standard Error 0.107

SECONDARY outcome

Timeframe: Baseline and at Week 32

Population: Intent to treat - all participants who received at least one dose of mepolizumab

The SGRQ Questionnaire is a well-established, self-completed tool, comprising of 50 questions with 76 weighted responses designed to measure Quality of Life in participants with diseases of airway obstruction. It consists of two parts; Part 1 produces the symptom score and Part 2 produces the activity and impact score. A Total score is also calculated which summarizes the impact of the disease on overall health status. Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and zero indicates best possible health status. Baseline was defined as the latest available assessment prior to first dose of mepolizumab. Change from Baseline at Week 32 was calculated as Week 32 value of SGRQ score minus Baseline value and was analyzed using Mixed Model Repeated Measures allowing for covariates of region, baseline maintenance OCS therapy, exacerbations in the year prior to the study (as an ordinal variable) and visit.

Outcome measures

Outcome measures
Measure	Mepolizumab 100 mg SC n=145 Participants Eligible participants received mepolizumab 100 mg SC doses into the upper arm or thigh every 4 weeks over a period of 32 weeks, with the last dose administered at Week 28, along with their current maintenance therapy except omalizumab.
Mean Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Score at Week 32	-19.0 Scores on a scale Standard Error 1.64

SECONDARY outcome

Timeframe: Up to Week 32

Population: Intent to treat - all participants who received at least one dose of mepolizumab

Clinically significant exacerbations of asthma were defined as worsening of asthma which requires use of systemic corticosteroids and/or hospitalization and/or Emergency Department (ED) visits. The frequency of clinically significant asthma exacerbations over 32 weeks' treatment was analyzed using Negative Binomial Regression via generalized estimating equations with a covariate of time period (pre-treatment versus on- and off treatment).

Outcome measures

Outcome measures
Measure	Mepolizumab 100 mg SC n=145 Participants Eligible participants received mepolizumab 100 mg SC doses into the upper arm or thigh every 4 weeks over a period of 32 weeks, with the last dose administered at Week 28, along with their current maintenance therapy except omalizumab.
The Rate of Clinically Significant Asthma Exacerbations Over 32 Weeks' Treatment	1.18 Exacerbation rate per year

SECONDARY outcome

Timeframe: Baseline and at Week 32

Population: Intent to treat- all participants who received at least one dose of mepolizumab

Blood samples were collected at specific time points to measure blood eosinophils level for evaluation of pharmacodynamic effects in participants with a severe eosinophilic asthma phenotype when they were directly switched to mepolizumab. Baseline was defined as the latest available assessment prior to first dose of mepolizumab and ratio to Baseline at Week 32 was defined as Week 32 value divided by Baseline value and was analyzed using Mixed Model Repeated Measures allowing for covariates of region, Baseline maintenance oral corticosteroid (OCS) therapy, exacerbations in the year prior to the study (as an ordinal variable) and visit. The log transformation was applied to blood eosinophil counts prior to analysis. If a blood eosinophil count of zero was reported, it was imputed with half of the lowest possible blood eosinophil count, where applicable, prior to log transforming the data. The dispersion measure used was log standard error.

Outcome measures

Outcome measures
Measure	Mepolizumab 100 mg SC n=145 Participants Eligible participants received mepolizumab 100 mg SC doses into the upper arm or thigh every 4 weeks over a period of 32 weeks, with the last dose administered at Week 28, along with their current maintenance therapy except omalizumab.
Ratio to Baseline in Blood Eosinophil Count at Week 32	0.22 Ratio Standard Error 0.106

Adverse Events

Mepolizumab 100 mg SC

Serious events: 16 serious events

Other events: 107 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mepolizumab 100 mg SC n=145 participants at risk Eligible participants received mepolizumab 100 mg SC doses into the upper arm or thigh every 4 weeks over a period of 32 weeks, with the last dose administered at Week 28, along with their current maintenance therapy except omalizumab.
Respiratory, thoracic and mediastinal disorders Asthma	4.8% 7/145 • Number of events 9 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.69% 1/145 • Number of events 1 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.69% 1/145 • Number of events 1 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Infections and infestations Cellulitis	1.4% 2/145 • Number of events 2 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Infections and infestations Pneumonia	1.4% 2/145 • Number of events 2 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Infections and infestations Influenza	0.69% 1/145 • Number of events 1 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Infections and infestations Sepsis	0.69% 1/145 • Number of events 1 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Infections and infestations Tooth infection	0.69% 1/145 • Number of events 1 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Nervous system disorders Cerebrovascular accident	0.69% 1/145 • Number of events 1 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Nervous system disorders Syncope	0.69% 1/145 • Number of events 1 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Nervous system disorders Transient ischaemic attack	0.69% 1/145 • Number of events 1 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Cardiac disorders Coronary artery disease	0.69% 1/145 • Number of events 1 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Gastrointestinal disorders Abdominal pain upper	0.69% 1/145 • Number of events 1 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Gastrointestinal disorders Dental cyst	0.69% 1/145 • Number of events 1 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
General disorders Chest discomfort	0.69% 1/145 • Number of events 1 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Hepatobiliary disorders Cholecystitis	0.69% 1/145 • Number of events 1 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.

Other adverse events

Other adverse events
Measure	Mepolizumab 100 mg SC n=145 participants at risk Eligible participants received mepolizumab 100 mg SC doses into the upper arm or thigh every 4 weeks over a period of 32 weeks, with the last dose administered at Week 28, along with their current maintenance therapy except omalizumab.
Infections and infestations Viral upper respiratory tract infection	16.6% 24/145 • Number of events 33 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Infections and infestations Bronchitis	13.1% 19/145 • Number of events 23 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Infections and infestations Influenza	7.6% 11/145 • Number of events 14 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Infections and infestations Rhinitis	7.6% 11/145 • Number of events 11 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Infections and infestations Sinusitis	5.5% 8/145 • Number of events 10 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Infections and infestations Gastroenteritis viral	3.4% 5/145 • Number of events 5 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Infections and infestations Urinary tract infection	3.4% 5/145 • Number of events 7 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Nervous system disorders Headache	28.3% 41/145 • Number of events 89 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Nervous system disorders Dizziness	3.4% 5/145 • Number of events 6 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Musculoskeletal and connective tissue disorders Arthralgia	9.7% 14/145 • Number of events 20 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Musculoskeletal and connective tissue disorders Back pain	9.0% 13/145 • Number of events 15 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Musculoskeletal and connective tissue disorders Myalgia	4.8% 7/145 • Number of events 8 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	4.1% 6/145 • Number of events 7 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Musculoskeletal and connective tissue disorders Neck pain	4.1% 6/145 • Number of events 8 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Respiratory, thoracic and mediastinal disorders Cough	7.6% 11/145 • Number of events 13 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	6.9% 10/145 • Number of events 12 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.8% 7/145 • Number of events 15 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Respiratory, thoracic and mediastinal disorders Dysphonia	3.4% 5/145 • Number of events 5 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.4% 5/145 • Number of events 5 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
General disorders Fatigue	9.7% 14/145 • Number of events 20 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
General disorders Asthenia	4.1% 6/145 • Number of events 8 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
General disorders Chest pain	4.1% 6/145 • Number of events 10 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
General disorders Injection site reaction	3.4% 5/145 • Number of events 23 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Gastrointestinal disorders Nausea	7.6% 11/145 • Number of events 12 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Gastrointestinal disorders Diarrhoea	6.2% 9/145 • Number of events 11 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.
Gastrointestinal disorders Abdominal pain upper	4.1% 6/145 • Number of events 8 • The on-treatment adverse events (AEs) and on-treatment serious AEs (SAEs) are the AEs which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 32 weeks). AEs and SAEs were collected in intent-To-Treat Population which comprised of all participants who received at least one dose of Mepolizumab.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

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