| Primary | Rate of Clinically Significant Exacerbations of Asthma | Clinically significant exacerbation is defined as worsening of asthma which requires use of systemic corticosteroids and/or hospitalizations and/or Emergency Department (ED) visits. Analysis of the number of exacerbations was performed using a negative binomial model with covariates of treatment group, baseline maintenance Oral Corticosteroids (OCS) therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and baseline % predicted Forced Expiratory Volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable. | The analysis was performed on the Modified Intent-to-Treat (MITT) Set that included all randomized participants who received at least one dose of trial medication. 'Modified' implies that participants who were randomized but did not receive study treatment were excluded. | Posted | | Number | | Exacerbations per year | | Up to Week 52 | | | | ID | Title | Description |
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| OG000 | Mepolizumab 100mg | Participants received 100mg of Mepolizumab subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline Standard of Care (SOC) treatment for asthma. Participants received salbutamol as a rescue medication on need basis. | | OG001 | Placebo | Participants received placebo matching to Mepolizumab administered subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline SOC treatment for asthma. Participants received salbutamol as a rescue medication on need basis. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Bayesian Dynamic Borrowing | A BDB approach was used in the estimation of primary endpoint in the Chinese participants of this study, with information borrowed from MEA115588. | | | Posterior probablity | 0.9999 | | | | | | | | | Pr (rate ratio <1 | data)>0.999. The 'positive result' is defined as if the posterior probability that the rate ratio is less than 1 is at least 0.95 | | Superiority | | | |
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| Secondary | Percent Probability of First Clinically Significant Exacerbations at Week 16, Week 32, and Week 52 | Clinically significant exacerbation is defined as worsening of asthma which requires use of systemic corticosteroids and/or hospitalizations and/or Emergency Department (ED) visits. Analysis of the number of exacerbations was performed using a negative binomial model with covariates of treatment group, baseline maintenance Oral Corticosteroids (OCS) therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and baseline % predicted Forced Expiratory Volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable. Time to first clinically significant exacerbation was analyzed using Kaplan-Meier estimates and expressed in terms of probability. | The analysis was performed on the MITT Set that included all randomized participants who received at least one dose of trial medication. 'Modified' implies that participants who were randomized but did not receive study treatment were excluded. | Posted | | Number | 95% Confidence Interval | Percent probability | | Week 16, 32 and 52 | | | | ID | Title | Description |
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| OG000 | Mepolizumab 100mg | Participants received 100mg of Mepolizumab subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline Standard of Care (SOC) treatment for asthma. Participants received salbutamol as a rescue medication on need basis. | | OG001 | Placebo | |
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| Secondary | Mean Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) at Week 52 | The SGRQ Questionnaire is a well-established, self-completed tool, with 50 questions comprising three domains: Symptoms, Activity, and Impacts scores (each ranging from 0 to 100; where higher score indicates worst outcome). SGRQ total score was calculated by summing weights from all positive items, divided by sum of weights for all items in SGRQ questionnaire and multiplying by 100. The SGRQ total score ranges from 0 to 100, with 0 implying the best possible health status and 100 implying worst possible health status. Analysis was performed using mixed model repeated measures with covariates of baseline, baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), baseline % predicted FEV1, treatment and visit, plus interaction terms for visit by baseline and visit by treatment group. | The analysis was performed on the MITT Set that included all randomized participants who received at least one dose of trial medication. 'Modified' implies that participants who were randomized but did not receive study treatment were excluded. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Mepolizumab 100mg | Participants received 100mg of Mepolizumab subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline Standard of Care (SOC) treatment for asthma. Participants received salbutamol as a rescue medication on need basis. |
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| Secondary | Number of Participants With Clinically Significant Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an Intensive Care Unit [ICU]) or Emergency Department (ED) Visits | An exacerbation is defined as worsening of asthma requiring the use of systemic corticosteroids and/or emergency department visit, or hospitalization. The number of exacerbations requiring hospitalization including incubation and admittance to an Intensive care unit (ICU) or ED visits were evaluated. Analysis of number of exacerbations was performed using a negative binomial model with covariates of treatment group, baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable) and baseline % predicted FEV1, and with logarithm of time on treatment as an offset variable. The data for participants with 0, 1, 2 and 3 exacerbations requiring hospitalization (including intubation and admittance to an ICU) or ED visits are summarized. | The analysis was performed on the MITT Set that included all randomized participants who received at least one dose of trial medication. 'Modified' implies that participants who were randomized but did not receive study treatment were excluded. | Posted | | Count of Participants | | Participants | | Up to Week 52 | | | | ID | Title | Description |
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| OG000 | Mepolizumab 100mg | Participants received 100mg of Mepolizumab subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline Standard of Care (SOC) treatment for asthma. Participants received salbutamol as a rescue medication on need basis. | |
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| Secondary | Number of Participants With Clinically Significant Exacerbations Requiring Hospitalization | An exacerbation is defined as worsening of asthma requiring the use of systemic corticosteroids and/or emergency department visit, or hospitalization. Analysis of number of exacerbations was performed using a negative binomial model with covariates of treatment group, baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable) and baseline % predicted FEV1, and with logarithm of time on treatment as an offset variable. The summary data for participants with 0, 1, 2 and 3 exacerbations requiring hospitalization are summarized. | The analysis was performed on the MITT Set that included all randomized participants who received at least one dose of trial medication. 'Modified' implies that participants who were randomized but did not receive study treatment were excluded. | Posted | | Count of Participants | | Participants | | Up to Week 52 | | | | ID | Title | Description |
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| OG000 | Mepolizumab 100mg | Participants received 100mg of Mepolizumab subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline Standard of Care (SOC) treatment for asthma. Participants received salbutamol as a rescue medication on need basis. | | OG001 | Placebo | Participants received placebo matching to Mepolizumab administered subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline SOC treatment for asthma. Participants received salbutamol as a rescue medication on need basis. |
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| Secondary | Mean Change From Baseline in Clinic Prebronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 52 | FEV1 is the volume of air that can be forced out in one second after taking a deep breath. Prebronchodilator FEV1 were measured via spirometer at Baseline and Week 52. Analysis was performed using mixed model repeated measures with covariates of baseline, baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), treatment and visit, plus interaction terms for visit by baseline and visit by treatment group. | The analysis was performed on the MITT Set that included all randomized participants who received at least one dose of trial medication. 'Modified' implies that participants who were randomized but did not receive study treatment were excluded. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | | Least Squares Mean | Standard Error | Milliliter (mL) | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Mepolizumab 100mg | Participants received 100mg of Mepolizumab subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline Standard of Care (SOC) treatment for asthma. Participants received salbutamol as a rescue medication on need basis. | | OG001 | Placebo | Participants received placebo matching to Mepolizumab administered subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline SOC treatment for asthma. Participants received salbutamol as a rescue medication on need basis. |
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| Secondary | Number of Participants With Adverse Events (AEs) Including Systemic (i.e., Allergic [Type I Hypersensitivity] and Other Systemic) and Injection Site Reactions | AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Systemic reactions and local injection site reactions are adverse events of special interest (AESIs). | The analysis was performed on the MITT Set that included all randomized participants who received at least one dose of trial medication. 'Modified' implies that participants who were randomized but did not receive study treatment were excluded. | Posted | | Count of Participants | | Participants | | Up to Week 52 | | | | ID | Title | Description |
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| OG000 | Mepolizumab 100mg | Participants received 100mg of Mepolizumab subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline Standard of Care (SOC) treatment for asthma. Participants received salbutamol as a rescue medication on need basis. | | OG001 | Placebo | Participants received placebo matching to Mepolizumab administered subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline SOC treatment for asthma. Participants received salbutamol as a rescue medication on need basis. |
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| Secondary | Change From Baseline in Platelets Count | Blood samples was collected for the assessment of change from baseline in hematology parameter Platelets count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. | The analysis was performed on the MITT Set that included all randomized participants who received at least one dose of trial medication. 'Modified' implies that participants who were randomized but did not receive study treatment were excluded. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Giga cells per liter (10^9/L) | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Mepolizumab 100mg | Participants received 100mg of Mepolizumab subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline Standard of Care (SOC) treatment for asthma. Participants received salbutamol as a rescue medication on need basis. | | OG001 | Placebo | Participants received placebo matching to Mepolizumab administered subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline SOC treatment for asthma. Participants received salbutamol as a rescue medication on need basis. |
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| Secondary | Change From Baseline in Erythrocytes Count | Blood samples was collected for the assessment of change from baseline in hematology parameter Erythrocytes count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. | The analysis was performed on the MITT Set that included all randomized participants who received at least one dose of trial medication. 'Modified' implies that participants who were randomized but did not receive study treatment were excluded. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Tera cells per liter (10^12/L) | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Mepolizumab 100mg | Participants received 100mg of Mepolizumab subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline Standard of Care (SOC) treatment for asthma. Participants received salbutamol as a rescue medication on need basis. | | OG001 | Placebo | Participants received placebo matching to Mepolizumab administered subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline SOC treatment for asthma. Participants received salbutamol as a rescue medication on need basis. |
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| Secondary | Change From Baseline in Hematocrit | Blood samples was collected for the assessment of change from baseline in hematology parameter Hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. | The analysis was performed on the MITT Set that included all randomized participants who received at least one dose of trial medication. 'Modified' implies that participants who were randomized but did not receive study treatment were excluded. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Fraction of 1 | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Mepolizumab 100mg | Participants received 100mg of Mepolizumab subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline Standard of Care (SOC) treatment for asthma. Participants received salbutamol as a rescue medication on need basis. | | OG001 | Placebo | Participants received placebo matching to Mepolizumab administered subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline SOC treatment for asthma. Participants received salbutamol as a rescue medication on need basis. |
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| Secondary | Percent Change From Baseline in Mean White Blood Cell (WBC) Count With Differential (Neutrophils, Lymphocytes, Monocytes. Eosinophils and Basophils) | Blood samples was collected for the assessment of change from baseline in WBC) count with differential (neutrophils, lymphocytes, monocytes. eosinophils and basophils). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. | The analysis was performed on the MITT Set that included all randomized participants who received at least one dose of trial medication. 'Modified' implies that participants who were randomized but did not receive study treatment were excluded. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | | Median | Full Range | Percent change | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Mepolizumab 100mg | Participants received 100mg of Mepolizumab subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline Standard of Care (SOC) treatment for asthma. Participants received salbutamol as a rescue medication on need basis. | | OG001 | Placebo | Participants received placebo matching to Mepolizumab administered subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline SOC treatment for asthma. Participants received salbutamol as a rescue medication on need basis. |
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| Secondary | Change From Baseline in Alkaline Phosphatase | Blood samples was collected for the assessment of change from baseline in clinical parameter Alkaline Phosphatase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. | The analysis was performed on the MITT Set that included all randomized participants who received at least one dose of trial medication. 'Modified' implies that participants who were randomized but did not receive study treatment were excluded. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | International Unit per Liter (IU/L) | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Mepolizumab 100mg | Participants received 100mg of Mepolizumab subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline Standard of Care (SOC) treatment for asthma. Participants received salbutamol as a rescue medication on need basis. | | OG001 | Placebo | Participants received placebo matching to Mepolizumab administered subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline SOC treatment for asthma. Participants received salbutamol as a rescue medication on need basis. |
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| Secondary | Change From Baseline in Alanine Aminotransferase and Aspartate Aminotransferase | Blood samples was collected for the assessment of change from baseline in clinical parameter Alanine Aminotransferase, Aspartate Aminotransferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. | The analysis was performed on the MITT Set that included all randomized participants who received at least one dose of trial medication. 'Modified' implies that participants who were randomized but did not receive study treatment were excluded. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Units per liter (U/L) | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Mepolizumab 100mg | Participants received 100mg of Mepolizumab subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline Standard of Care (SOC) treatment for asthma. Participants received salbutamol as a rescue medication on need basis. | | OG001 | Placebo | Participants received placebo matching to Mepolizumab administered subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline SOC treatment for asthma. Participants received salbutamol as a rescue medication on need basis. |
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| Secondary | Change From Baseline in Albumin and Total Protein | Blood samples was collected for the assessment of change from baseline in clinical parameter albumin, total protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. | The analysis was performed on the MITT Set that included all randomized participants who received at least one dose of trial medication. 'Modified' implies that participants who were randomized but did not receive study treatment were excluded. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Gram per liter (g/L) | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Mepolizumab 100mg | Participants received 100mg of Mepolizumab subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline Standard of Care (SOC) treatment for asthma. Participants received salbutamol as a rescue medication on need basis. | | OG001 | Placebo | Participants received placebo matching to Mepolizumab administered subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline SOC treatment for asthma. Participants received salbutamol as a rescue medication on need basis. |
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| Secondary | Change From Baseline in Clinical Chemistry Parameters | Blood samples was collected for the assessment of change from baseline in clinical parameter including total and direct bilirubin, creatinine, glucose, calcium, sodium, potassium, urea. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. | The analysis was performed on the MITT Set that included all randomized participants who received at least one dose of trial medication. 'Modified' implies that participants who were randomized but did not receive study treatment were excluded. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. Here 'number analyzed' signifies those participants who were evaluated at specified category. | Posted | | Mean | Standard Deviation | Micro moles per liter (umol/L) | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Mepolizumab 100mg | Participants received 100mg of Mepolizumab subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline Standard of Care (SOC) treatment for asthma. Participants received salbutamol as a rescue medication on need basis. | | OG001 | Placebo | Participants received placebo matching to Mepolizumab administered subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline SOC treatment for asthma. Participants received salbutamol as a rescue medication on need basis. |
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| Secondary | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP and DBP were measured in a sitting position after 5 minutes rest. The normal range for SBP is 90-140 mmHg and DBP is 60-90 millimeters of mercury (mmHg). | The analysis was performed on the MITT Set that included all randomized participants who received at least one dose of trial medication. 'Modified' implies that participants who were randomized but did not receive study treatment were excluded. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Millimeters of mercury (mmHg) | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Mepolizumab 100mg | Participants received 100mg of Mepolizumab subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline Standard of Care (SOC) treatment for asthma. Participants received salbutamol as a rescue medication on need basis. | | OG001 | Placebo | Participants received placebo matching to Mepolizumab administered subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline SOC treatment for asthma. Participants received salbutamol as a rescue medication on need basis. |
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| Secondary | Mean Change From Baseline in Pulse Rate | Pulse rate measurement were measured in a sitting position after 5 minutes rest. | The analysis was performed on the MITT Set that included all randomized participants who received at least one dose of trial medication. 'Modified' implies that participants who were randomized but did not receive study treatment were excluded. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Beats per minute (bpm) | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Mepolizumab 100mg | Participants received 100mg of Mepolizumab subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline Standard of Care (SOC) treatment for asthma. Participants received salbutamol as a rescue medication on need basis. | | OG001 | Placebo | Participants received placebo matching to Mepolizumab administered subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline SOC treatment for asthma. Participants received salbutamol as a rescue medication on need basis. |
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| Secondary | Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | 12-Lead electrocardiogram (ECG) measurements were obtained after the participants had rested in the supine position for 5 minutes. Clinically significant abnormal findings are based on the judgement of the investigator. | The analysis was performed on the MITT Set that included all randomized participants who received at least one dose of trial medication. 'Modified' implies that participants who were randomized but did not receive study treatment were excluded. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | Up to Week 52 | | | | ID | Title | Description |
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| OG000 | Mepolizumab 100mg | Participants received 100mg of Mepolizumab subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline Standard of Care (SOC) treatment for asthma. Participants received salbutamol as a rescue medication on need basis. | | OG001 | Placebo | Participants received placebo matching to Mepolizumab administered subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline SOC treatment for asthma. Participants received salbutamol as a rescue medication on need basis. |
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| Secondary | Number of Participants With Positive Anti-Mepolizumab Antibody | Blood samples were collected for detection of binding and neutralizing anti-mepolizumab antibodies. Samples with a positive screening result continued for confirmation analysis. Samples with a positive confirmation analysis were considered positive for mepolizumab Anti-drug antibody (ADA). | The analysis was performed on the MITT Set that included all randomized participants who received at least one dose of trial medication. 'Modified' implies that participants who were randomized but did not receive study treatment were excluded. | Posted | | Count of Participants | | Participants | | Up to Week 52 | | | | ID | Title | Description |
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| OG000 | Mepolizumab 100mg | Participants received 100mg of Mepolizumab subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline Standard of Care (SOC) treatment for asthma. Participants received salbutamol as a rescue medication on need basis. | | OG001 | Placebo | Participants received placebo matching to Mepolizumab administered subcutaneously every 4 weeks during the total treatment period of 52 weeks in addition to their baseline SOC treatment for asthma. Participants received salbutamol as a rescue medication on need basis. |
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