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A Study to Investigate Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis

A Double-blind, Randomised, Placebo-controlled Study to Investigate the Efficacy and Safety of Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis in Subjects Receiving Standard of Care Therapy

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02020889
Enrollment
136
Registered
2013-12-25
Start date
2014-02-05
Completion date
2016-09-05
Last updated
2018-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Churg-Strauss Syndrome

Keywords

eosinophils, SB 240563, Churg-Strauss Syndrome, quality of life, mepolizumab, safety, biomarkers, efficacy, corticosteroids, Eosinophilic granulomatosis with polyangiitis

Brief summary

The purpose of this randomized, double-blind study is to investigate the efficacy and safety of mepolizumab (300 milligram \[mg\] administered subcutaneously \[SC\] every 4 weeks) compared with placebo over a 52-week study treatment period in subjects with relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care therapy including background corticosteroid therapy with or without immunosuppressive therapy. During the treatment period, in accordance with standard of care, corticosteroid dose will be tapered. The key outcomes in the study focus on evaluation of clinical remission, defined as Birmingham Vasculitis Activity Score (BVAS)=0 with a corticosteroid dose of \<=4 mg/day prednisolone/prednisone, reduction in disease relapse and reduction in corticosteroid requirement.

Interventions

BIOLOGICALMepolizumab

Mepolizumab will be provided as a lyophilized cake in sterile vials for individual use to be reconstituted with sterile water for Injection, just prior to use.

DRUGPlacebo

Placebo will be available as 0.9% sodium chloride

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)
CollaboratorNIH
GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Informed Consent: Able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. Subjects must be able to read, comprehend, and write at a level sufficient to complete study related materials. * Age and gender: Male or female subjects age 18 years or older. * EGPA diagnosis: subjects who have been diagnosed with EGPA for at least 6 months based on the history or presence of: asthma plus eosinophilia (\>1.0x10\^9/Liter and/or \>10% of leucocytes) plus at least two of the following additional features of EGPA; a biopsy showing histopathological evidence of eosinophilic vasculitis, or perivascular eosinophilic infiltration, or eosinophil-rich granulomatous inflammation; neuropathy, mono or poly (motor deficit or nerve conduction abnormality); pulmonary infiltrates, non-fixed; sino-nasal abnormality; cardiomyopathy (established by echocardiography or Magnetic Resonance Imaging); glomerulonephritis (haematuria, red cell casts, proteinuria); alveolar haemorrhage (by bronchoalveolar lavage); palpable purpura; anti neutrophil cytoplasmic anti-body (ANCA) positive (Myeloperoxidase or proteinease 3). * History of relapsing OR refractory disease defined as: Relapsing disease: Subject must have a past history of at least one confirmed EGPA relapse (i.e., requiring increase in oral corticosteroids (OCS) dose, initiation/increased dose of immunosuppressive therapy or hospitalisation) within the past 2 years which occurred at least 12 weeks prior to Screening (Visit 1) whilst receiving a dose of prednisolone (or equivalent) of \>=7.5 milligram per day (mg/day). Refractory disease: Either: Failure to attain remission (BVAS=0 and OCS dose \<=7.5 mg/day prednisolone or equivalent) within the last 6 months following induction treatment with a standard regimen, administered for at least 3 months. Note: a) Subjects who have received a cyclophosphamide (CYC) induction regimen may be included a minimum of 2 weeks after the last dose of daily oral CYC, or 3 weeks after the last dose of pulsed intravenous CYC prior to Baseline (Visit 2), if their total white blood cells (WBC) is \>=4x10\^9/Liter (tested at the local laboratory, if necessary) prior to randomisation. b) Subjects who have received a methotrexate, azathioprine, or mycophenolate mofetil induction regimen may be included if on a stable dose for at least 4 weeks prior to Baseline (Visit 2). c) Subjects who have received an induction regimen comprising corticosteroids alone may be included only if they have failed to attain remission after 3 months of treatment AND the corticosteroid dose is \>=15 mg/day prednisolone or equivalent for the 4 weeks prior to Baseline (Visit 2). Or: Within 6 months prior to Screening (Visit 1), recurrence of symptoms of EGPA (not necessarily meeting the protocol definition of relapse) whilst tapering OCS, occurring at any dose level \>=7.5 mg/day prednisolone or equivalent. * Corticosteroid therapy: Subject must be on a stable dose of oral prednisolone or prednisone of \>=7.5 mg/day (but not \>50 mg/day) for at least 4 weeks prior to Baseline (Visit 2). * Immunosuppressive therapy: If receiving immunosuppressive therapy (excluding cyclophosphamide) the dosage must be stable for the 4 weeks prior to Baseline (Visit 2) and during the study (dose reductions for safety reasons will be permitted). * ECG measurements: QTc(F)\<450 msec or QTc(F)\<480 msec for patients with bundle branch block. The QTc is the QT interval corrected for heart rate according to either Bazett's formula (QTcB), Fridericia's formula (QTcF), or another method, machine or manual overread. For subject eligibility and withdrawal decisions, QTcFwill be used. For purposes of data analysis, QTcF will be used as primary though data using both correction formulas will be collected and analysed. The QTc should be based on single or averaged QTc values of triplicate electrocardiograms (ECGs) obtained over a brief recording period. * Female subjects: To be eligible for entry into the study, females of childbearing potential (FCBP) must commit to consistent and correct use of an acceptable method of birth control (as discussed in the protocol) beginning with consent, for the duration of the trial and for 4 months after the last study drug administration. * French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category. * Liver Function Tests: obtained at Screening (Visit 1): ALT\<2x ULN (upper limit of normal) or if subject is on background methotrexate or azathioprine \<3x ULN; AST\<2x ULN or if subject is on background methotrexate or azathioprine \<3x ULN; Alkaline Phosphatase ≤2.0x ULN;Bilirubin ≤ 1.5x ULN (isolated bilirubin\>1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%)

Exclusion criteria

* GPA or MPA: Diagnosed with granulomatosis with polyangiitis (GPA; previously known as Wegener's granulomatosis) or microscopic polyangiitis (MPA). * Organ-threatening EGPA: Organ-threatening EGPA as per European league against rheumatism (EULAR) criteria, i.e., organ failure due to active vasculitis, creatinine \>5.8 gram per deciliter (g/dL) (\>513 micromole per liter \[µmol/L\]) within 3 months prior to Screening (Visit 1). * Life-threatening EGPA: Imminently life-threatening EGPA disease defined as any of the following within 3 months prior to Screening (Visit 1); Intensive care required; Severe alveolar haemorrhage or haemoptysis requiring transfusion or ventilation or haemoglobin \< 8 gram per liter (g/dL) (\<80 g/L) or drop in haemoglobin \> 2 g/dL (\>20 g/L) over a 48 hour period due to alveolar haemorrhage; Rapidly progressive glomerulonephritis (RPGN) with creatinine \> 2.5 milligram per deciliter (mg/dL) (\>221 µmol/L) or rise in creatinine \> 2 mg/dL (\>177 µmol/L) over a 48 hour period; Severe gastrointestinal (GI) involvement, e.g., gangrene, bleeding requiring surgery; Severe central nervous system (CNS) involvement; Severe cardiac involvement, e.g., life-threatening arrhythmia, cardiac failure: ejection fraction \< 20%, New York Heart Association Class III/IV (as discussed in protocol), acute myocardial infarction. * Malignancy: A current malignancy or previous history of cancer in remission for less than 12 months prior screening (Subjects that had localized carcinoma (i.e., basal or squamous cell) of the skin which was resected for cure will not be excluded). * Liver disease: Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaundice), cirrhosis, and known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). * Cardiovascular: Subjects who have severe or clinically significant cardiovascular disease uncontrolled with standard treatment including but not limited to: Known ejection fraction of \<30%, OR Severe heart failure that meets New York Heart Association Class IV (as discussed in protocol), OR Hospitalised in the 12 months prior to Visit 1 for severe heart failure meeting New York Heart Association Class III (as discussed in protocol), OR Angina diagnosed less than 3 months prior to or at Visit 1 (Screening). * Other concurrent medical conditions: Subjects who have known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological, respiratory or any other system abnormalities that are not associated with EGPA and are uncontrolled with standard treatment. * Infectious disease: Chronic or ongoing active infectious disease requiring systemic treatment. * Parasitic infection: Subjects with a parasitic infestation within 6 months prior to Screening (Visit 1). * Hepatitis status: Diagnosis of chronic hepatitis B, as evidenced by positive Hepatitis B surface antigen (HBsAg) at Screening (Visit 1). Japan only: Subjects positive for HBsAg , antibodies to HBsAg, i.e., HBsAb, or Hepatitis B core antigen, i.e., HBcAb, at Screening (Visit 1). Note: Subjects with antibodies to HBsAg, i.e., HBsAb positive, only (i.e., negative for HBsAg and HBcAb) with a history of hepatitis B vaccination can be included. * HIV: Subjects with a known human immunodeficiency virus infection. * Hypersensitivity: Subjects with a known allergy or intolerance to a monoclonal antibody or biologic therapy. * Previous mepolizumab: Subjects who have previously received mepolizumab within a 1 year period prior to Screening (Visit 1). * Prohibited medications: Subjects receiving any of the following: OCS: Subject requires an oral corticosteroid dose of \>50 mg/day prednisolone/prednisone in the 4-week period prior to Baseline (Visit 2); Intravenous or SC corticosteroids in the 4-week period prior to Baseline (Visit 2); Omalizumab within 130 days prior to Screening (Visit 1); Cyclophosphamide: oral CYC within 2 weeks prior to Baseline (Visit 2) and IV CYC within 3 weeks prior to Baseline (Visit 2), if their total WBC is \>=4x10\^9/Liter (measured using the local laboratory if necessary); Rituximab within 12 months prior to Screening (Visit 1); in addition, the subject must have shown recovery of peripheral B-cell count to within the normal range; IV or SC immunoglobulin within 6 months prior to Screening (Visit 1); Interferon-α within 6 months prior to Screening (Visit 1); Anti-TNF therapy within 12 weeks prior to Screening (Visit 1); Anti-CD52 (alemtuzumab) within 6 months prior to Screening (Visit 1). * Other laboratory parameter exclusions: Creatinine \> 2.5 mg/dL (221 µmol/L); WBC \< 4 x10\^9/Liter, Platelet count \<120,000/millimetre cube (mm\^3), Haemoglobin \<8 g/dL (\<80 g/L) * Pregnancy: Subjects who are pregnant or breastfeeding. Subjects should not be enrolled if they plan to become pregnant during the time of study participation. * Alcohol/substance abuse: A history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to Screening (Visit 1). * Other investigational product: Subjects who have received treatment with an investigational drug within the past 30 days or 5 terminal phase half-lives of the drug whichever is longer, prior to Screening (Visit 1) (this also includes investigational formulations of marketed products). * Other clinical study: Subject is currently participating in any other interventional clinical study. * Adherence: Subjects who have known evidence of lack of adherence to controller medications and/or ability to follow physician's recommendations. * French subjects: the French subject has participated in any study using an investigational drug during the previous 30 days or 5 half-lives (whichever is longer).

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants in Each Category of Accrued Duration of RemissionUp to Week 52Total accrued duration of remission is the accrued number of weeks where Birmingham Vasculitis Activity Score (BVAS) =0 plus prednisolone/prednisone dose \<=4 mg/day over the 52 week study treatment period was reported. The accrued duration was categorized into zero, \>0 to \<12 weeks, 12 to \<24 weeks, 24 to \<36 weeks and \>=36 weeks. Statistical analysis was based on a proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region. Intent-to-Treat (ITT) Population was used for the analysis and was defined as all participants who were randomized and received at least one dose of trial medication. Randomized participants were assumed to have received study treatment unless definitive evidence to the contrary exists. The odds ratio for treatment difference and associated probability (p)-value and 95 percent confidence interval (CI) were calculated.
Number of Participants Who Are in Remission at 36 and 48 WeeksWeek 36 and Week 48The number of participants who were in remission (i.e ., BVAS=0 and prednisolone /prednisone \<=4 mg/day) at both Weeks 36 and 48 of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.

Secondary

MeasureTime frameDescription
Time to First EGPA RelapseUp to Week 52EGPA relapse was defined as worsening or persistence of active disease since the last visit characterized by active vasculitis or active asthma symptoms and/or signs with a corresponding worsening in Asthma Control Questionnaire-6 (ACQ-6) score or active nasal and/or sinus disease, with a corresponding worsening in at least one of the sino-nasal symptom questions warranting: i) an increased dose of OCS therapy (or other systemic corticosteroid therapy) to \>4 mg/day prednisolone total daily dose or equivalent; OR ii) an increased dose or addition of immunosuppressive therapy; OR iii) hospitalization related to EGPA worsening. Participants who completed study, or withdrawn prematurely from the study without experiencing the event were censored. The number of participants with at least one EGPA relapse during the planned study treatment period are presented.
Number of Participants in Each Category of Average Daily Prednisolone/Prednisone Dose During the Last 4 Weeks of the Study Treatment Period.Week 48 and Week52The number of participants with an average daily prednisolone/prednisone dose during the last 4 weeks of the Study Treatment Period (48 through 52) was calculated. The average dose was categorized into zero, \>0 to \<=4.0mg, \>4.0 to \<=7.5mg and \>7.5mg. The statistical analysis was performed using a proportional odds regression model with Baseline covariates of treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region and the comparison between treatment groups was presented as an odds ratio, p-value and 95 percent CI.
Number of Participants Who Achieved Remission Within the First 24 Weeks and Remained in Remission for the Remainder of the Treatment PeriodUp to Week 52The number of participants who achieved remission (i.e., BVAS=0 and prednisolone/prednisone\<=4 mg/day) within the first 24 weeks and remain in remission for the remainder of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.
Number of Participants in Each Category of Accrued Duration of RemissionUp to Week 52Total accrued duration of remission, i.e., the accrued number of weeks where Birmingham Vasculitis Activity Score (BVAS) =0 plus prednisolone/prednisone dose \<=7.5mg/day over the 52 week study treatment period was reported. BVAS is a validated, clinician-completed tool used for the comprehensive multisystem clinical assessment of disease activity in systemic vasculitis. The duration was categorized into zero, \>0 to \<12 weeks, 12 to \<24 weeks, 24 to \<36 weeks and \>=36 weeks. Statistical analysis was performed on ITT Population and was based on a proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.
Number of Participants Who Are in Remission at 36 and 48 WeeksWeek 36 and Week 48The number of participants who were in remission (i.e ., BVAS=0 and prednisolone /prednisone \<=7.5mg/day) at both Weeks 36 and 48 of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.
Number of Participants Who Achieved Remission (BVAS=0 and Prednisolone/Prednisone <=7.5 mg/Day) Within the First 24 Weeks and Remained in Remission for the Remainder of the Treatment PeriodUp to Week 52The number of participants who were in remission (i.e ., BVAS=0 and prednisolone /prednisone \<=7.5mg/day) at both Weeks 36 and 48 of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.
Number of Participants With Local and Systemic Adverse Events (AEs)Up to Week 52An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs including systemic allergic and non-allergic reactions as well as local site injection-related reactions were counted throughout treatment phase and follow up phase. Systemic allergic reactions included Facial paralysis, flushing, hypersensitivity and rash pruritic. Injection related reactions were considered as systemic non-allergic reactions. Local site reactions included injection site bruising, erythema, pain and reaction. The analysis was performed on Safety Population which comprised of all participants who receive at least one dose of study treatment.
Change From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsBaseline and up to Week 60Blood samples were collected to evaluate change from Baseline in ALT, Alk.phosph., AST, creatinine kinase, GGT and lactate dehydro values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsBaseline and up to Week 60Blood samples were collected to evaluate change from Baseline in albumin and protein levels values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsBaseline and up to Week 60Blood samples were collected to evaluate change from Baseline in direct, indirect and total bilirubin and creatinine values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsBaseline and up to Week 60Blood samples were collected to evaluate change from Baseline in calcium, chloride, cholesterol, glucose, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, phosphorus, potassium, sodium, urea nitrogen and very low density lipoprotein (VLDL) cholesterol values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured. NA indicates that data were not available.
Change From Baseline in Clinical Chemistry Parameter of Troponin LevelsBaseline and up to Week 60Blood samples were collected to evaluate change from Baseline in troponin values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsBaseline and up to Week 60Blood samples were collected to evaluate change from Baseline in basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelet values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsBaseline and up to Week 60Blood samples were collected to evaluate change from Baseline in MCHC and hemoglobin values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsBaseline and up to Week 60Blood samples were collected to evaluate change from Baseline in MCV values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsBaseline and up to Week 60Blood samples were collected to evaluate change from Baseline in MCH values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Change From Baseline in Hematology Parameters of Erythrocytes LevelsBaseline and up to Week 60Blood samples were collected to evaluate change from Baseline in erythrocytes values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Number of Participants With Anti-Mepolizumab AntibodiesUp to Week 60Blood samples were collected for the determination of anti-Mepolizumab antibodies. Participants who showed presence of anti-Mepolizumab antibody were termed as 'positive' and those who did not have anti-Mepolizumab antibody in blood sample were termed as 'negative'. Participants who did not have a positive ADA assay prior to the first dose of investigational product were included in the analysis.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsBaseline up to Week 60SBP and DBP were measured from Baseline throughout follow-up (till Week 60) before injection with the participant sitting, having rested in this position for at least 5 minutes before reading. The Baseline value was taken at Visit 2 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Change From Baseline in Pulse RateBaseline and up to Week 60Pulse rate was measured from Baseline throughout follow-up (till Week 60) before injection with the participant sitting, having rested in this position for at least 5 minutes before reading. The Baseline value was taken at Visit 2 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Change From Baseline in Body TemperatureBaseline and up to Week 60Body temperature was measured from Baseline throughout follow-up (till Week 60). The Baseline value was taken at Visit 2 and change from Baseline was defined as post dose visit value minus Baseline value. The analysis was performed on Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesBaseline and up to Week 60Single measurements of 12-lead electrocardiogram (ECGs) were obtained after 5 minutes rest in a supine position at Baseline throughout the 52 weeks treatment period and 8 weeks follow-up period using an ECG machine. Mean change from Baseline in QTcF and QTcB values were measured. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Maximum Change From Baseline in QTcF and QTcB ValuesBaseline and up to Week 60Single measurements of 12-lead ECGs were obtained after 5 minutes rest in a supine position at Baseline throughout the 52 weeks treatment period and 8 weeks follow-up period using an ECG machine. Maximum change from Baseline in QTcF and QTcB values were measured.

Countries

Belgium, Canada, France, Germany, Italy, Japan, Spain, United Kingdom, United States

Participant flow

Recruitment details

Eligible participants at screening and run-in visit, entered a 52 week study treatment phase followed by 8-week follow-up phase. The total duration for the study participation was approximately 64 weeks.

Pre-assignment details

A total of 151 participants with a history of relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) were screened, out of which 4 were screen failures and 11 were run-in failures. 136 participants completed run-in period and received Mepolizumab 300 milligram (mg) or placebo in a randomized manner in the treatment phase.

Participants by arm

ArmCount
Placebo
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
68
Mepolizumab 300mg
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
68
Total136

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event01
Overall StudyLack of Efficacy10
Overall StudyLost to Follow-up10
Overall StudyPhysician Decision20
Overall StudyWithdrawal by Subject32

Baseline characteristics

CharacteristicMepolizumab 300mgTotalPlacebo
Age, Continuous48.7 Years
STANDARD_DEVIATION 12.39
48.5 Years
STANDARD_DEVIATION 13.34
48.2 Years
STANDARD_DEVIATION 14.32
Race/Ethnicity, Customized
Race customized
American Indian or Alaskan Native
1 Participants1 Participants0 Participants
Race/Ethnicity, Customized
Race customized
Asian - Japanese Heritage
3 Participants6 Participants3 Participants
Race/Ethnicity, Customized
Race customized
Asian - South East Asian Heritage
0 Participants2 Participants2 Participants
Race/Ethnicity, Customized
Race customized
Mixed Race
0 Participants2 Participants2 Participants
Race/Ethnicity, Customized
Race customized
White - Arabic/North African Heritage
2 Participants2 Participants0 Participants
Race/Ethnicity, Customized
Race customized
White - White/Caucasian/European Heritage
62 Participants123 Participants61 Participants
Sex: Female, Male
Female
42 Participants80 Participants38 Participants
Sex: Female, Male
Male
26 Participants56 Participants30 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 681 / 68
other
Total, other adverse events
61 / 6865 / 68
serious
Total, serious adverse events
18 / 6812 / 68

Outcome results

Primary

Number of Participants in Each Category of Accrued Duration of Remission

Total accrued duration of remission is the accrued number of weeks where Birmingham Vasculitis Activity Score (BVAS) =0 plus prednisolone/prednisone dose \<=4 mg/day over the 52 week study treatment period was reported. The accrued duration was categorized into zero, \>0 to \<12 weeks, 12 to \<24 weeks, 24 to \<36 weeks and \>=36 weeks. Statistical analysis was based on a proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region. Intent-to-Treat (ITT) Population was used for the analysis and was defined as all participants who were randomized and received at least one dose of trial medication. Randomized participants were assumed to have received study treatment unless definitive evidence to the contrary exists. The odds ratio for treatment difference and associated probability (p)-value and 95 percent confidence interval (CI) were calculated.

Time frame: Up to Week 52

Population: ITT Population

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PlaceboNumber of Participants in Each Category of Accrued Duration of Remission>0 to <12 weeks8 Participants
PlaceboNumber of Participants in Each Category of Accrued Duration of Remission24 to <36 weeks0 Participants
PlaceboNumber of Participants in Each Category of Accrued Duration of Remission12 to <24 weeks3 Participants
PlaceboNumber of Participants in Each Category of Accrued Duration of Remission>=36 weeks2 Participants
PlaceboNumber of Participants in Each Category of Accrued Duration of RemissionZero55 Participants
Mepolizumab 300mgNumber of Participants in Each Category of Accrued Duration of Remission>=36 weeks9 Participants
Mepolizumab 300mgNumber of Participants in Each Category of Accrued Duration of RemissionZero32 Participants
Mepolizumab 300mgNumber of Participants in Each Category of Accrued Duration of Remission>0 to <12 weeks8 Participants
Mepolizumab 300mgNumber of Participants in Each Category of Accrued Duration of Remission12 to <24 weeks9 Participants
Mepolizumab 300mgNumber of Participants in Each Category of Accrued Duration of Remission24 to <36 weeks10 Participants
p-value: <0.00195% CI: [2.68, 13.03]Proportional odds regression model
Primary

Number of Participants Who Are in Remission at 36 and 48 Weeks

The number of participants who were in remission (i.e ., BVAS=0 and prednisolone /prednisone \<=4 mg/day) at both Weeks 36 and 48 of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.

Time frame: Week 36 and Week 48

Population: ITT Population

ArmMeasureValue (NUMBER)
PlaceboNumber of Participants Who Are in Remission at 36 and 48 Weeks2 Participants
Mepolizumab 300mgNumber of Participants Who Are in Remission at 36 and 48 Weeks22 Participants
p-value: <0.00195% CI: [3.61, 77.56]Regression, Logistic
Secondary

Change From Baseline in Body Temperature

Body temperature was measured from Baseline throughout follow-up (till Week 60). The Baseline value was taken at Visit 2 and change from Baseline was defined as post dose visit value minus Baseline value. The analysis was performed on Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.

Time frame: Baseline and up to Week 60

Population: Safety Population

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboChange From Baseline in Body TemperatureAbsolute Baseline; n= 68, 6836.52 Degree celsiusStandard Deviation 0.385
PlaceboChange From Baseline in Body TemperatureWeek 4; n= 68, 680.05 Degree celsiusStandard Deviation 0.439
PlaceboChange From Baseline in Body TemperatureWeek 8; n= 67,68-0.01 Degree celsiusStandard Deviation 0.379
PlaceboChange From Baseline in Body TemperatureWeek 12; n= 66, 680.05 Degree celsiusStandard Deviation 0.41
PlaceboChange From Baseline in Body TemperatureWeek 16; n= 64, 68-0.01 Degree celsiusStandard Deviation 0.421
PlaceboChange From Baseline in Body TemperatureWeek 20; n= 63, 68-0.08 Degree celsiusStandard Deviation 0.351
PlaceboChange From Baseline in Body TemperatureWeek 24; n= 62, 67-0.06 Degree celsiusStandard Deviation 0.449
PlaceboChange From Baseline in Body TemperatureWeek 28; n= 63, 67-0.06 Degree celsiusStandard Deviation 0.499
PlaceboChange From Baseline in Body TemperatureWeek 32; n= 62, 67-0.09 Degree celsiusStandard Deviation 0.392
PlaceboChange From Baseline in Body TemperatureWeek 36; n= 62, 67-0.05 Degree celsiusStandard Deviation 0.431
PlaceboChange From Baseline in Body TemperatureWeek 40; n= 62, 66-0.03 Degree celsiusStandard Deviation 0.53
PlaceboChange From Baseline in Body TemperatureWeek 44; n= 61, 65-0.03 Degree celsiusStandard Deviation 0.55
PlaceboChange From Baseline in Body TemperatureWeek 48; n= 61, 64-0.04 Degree celsiusStandard Deviation 0.452
PlaceboChange From Baseline in Body TemperatureWeek 52; n= 60, 65-0.04 Degree celsiusStandard Deviation 0.423
PlaceboChange From Baseline in Body TemperatureWeek 56; n= 61, 63-0.08 Degree celsiusStandard Deviation 0.53
PlaceboChange From Baseline in Body TemperatureWeek 60; n= 61, 640.03 Degree celsiusStandard Deviation 0.467
Mepolizumab 300mgChange From Baseline in Body TemperatureWeek 60; n= 61, 64-0.02 Degree celsiusStandard Deviation 0.479
Mepolizumab 300mgChange From Baseline in Body TemperatureAbsolute Baseline; n= 68, 6836.51 Degree celsiusStandard Deviation 0.462
Mepolizumab 300mgChange From Baseline in Body TemperatureWeek 32; n= 62, 67-0.07 Degree celsiusStandard Deviation 0.355
Mepolizumab 300mgChange From Baseline in Body TemperatureWeek 4; n= 68, 68-0.04 Degree celsiusStandard Deviation 0.411
Mepolizumab 300mgChange From Baseline in Body TemperatureWeek 48; n= 61, 64-0.09 Degree celsiusStandard Deviation 0.414
Mepolizumab 300mgChange From Baseline in Body TemperatureWeek 8; n= 67,68-0.02 Degree celsiusStandard Deviation 0.425
Mepolizumab 300mgChange From Baseline in Body TemperatureWeek 36; n= 62, 670.03 Degree celsiusStandard Deviation 0.468
Mepolizumab 300mgChange From Baseline in Body TemperatureWeek 12; n= 66, 68-0.03 Degree celsiusStandard Deviation 0.447
Mepolizumab 300mgChange From Baseline in Body TemperatureWeek 56; n= 61, 63-0.00 Degree celsiusStandard Deviation 0.402
Mepolizumab 300mgChange From Baseline in Body TemperatureWeek 16; n= 64, 68-0.03 Degree celsiusStandard Deviation 0.432
Mepolizumab 300mgChange From Baseline in Body TemperatureWeek 40; n= 62, 66-0.13 Degree celsiusStandard Deviation 0.406
Mepolizumab 300mgChange From Baseline in Body TemperatureWeek 20; n= 63, 68-0.13 Degree celsiusStandard Deviation 0.376
Mepolizumab 300mgChange From Baseline in Body TemperatureWeek 52; n= 60, 65-0.12 Degree celsiusStandard Deviation 0.541
Mepolizumab 300mgChange From Baseline in Body TemperatureWeek 24; n= 62, 67-0.06 Degree celsiusStandard Deviation 0.389
Mepolizumab 300mgChange From Baseline in Body TemperatureWeek 44; n= 61, 65-0.08 Degree celsiusStandard Deviation 0.396
Mepolizumab 300mgChange From Baseline in Body TemperatureWeek 28; n= 63, 67-0.14 Degree celsiusStandard Deviation 0.411
Secondary

Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol Levels

Blood samples were collected to evaluate change from Baseline in calcium, chloride, cholesterol, glucose, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, phosphorus, potassium, sodium, urea nitrogen and very low density lipoprotein (VLDL) cholesterol values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured. NA indicates that data were not available.

Time frame: Baseline and up to Week 60

Population: Safety Population

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCholesterol; Week 16; n= 1, 1-0.400 millimoles per liter (mmol/L)
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCalcium; Week 16; n= 65, 680.000 millimoles per liter (mmol/L)Standard Deviation 0.1091
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCalcium; Week 20; n= 63, 680.002 millimoles per liter (mmol/L)Standard Deviation 0.0882
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCalcium; Week 24; n= 63, 660.001 millimoles per liter (mmol/L)Standard Deviation 0.0901
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCalcium; Week 28; n= 61, 660.001 millimoles per liter (mmol/L)Standard Deviation 0.0962
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCalcium; Week 32; n= 61, 67-0.000 millimoles per liter (mmol/L)Standard Deviation 0.0911
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCalcium; Week 36; n= 60, 67-0.006 millimoles per liter (mmol/L)Standard Deviation 0.0931
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCalcium; Week 40; n= 61, 660.014 millimoles per liter (mmol/L)Standard Deviation 0.1126
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCalcium; Week 44; n= 61, 660.016 millimoles per liter (mmol/L)Standard Deviation 0.1144
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCalcium; Week 48; n= 61, 64-0.007 millimoles per liter (mmol/L)Standard Deviation 0.1007
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCalcium; Week 52; n= 60, 65-0.008 millimoles per liter (mmol/L)Standard Deviation 0.1001
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCalcium; Week 56; n= 61, 63-0.008 millimoles per liter (mmol/L)Standard Deviation 0.0931
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCalcium; Week 60; n= 60, 65-0.025 millimoles per liter (mmol/L)Standard Deviation 0.0946
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsAbsolute Chloride; Baseline; n= 68, 68103.4 millimoles per liter (mmol/L)Standard Deviation 2.05
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsChloride; Week 4; n= 68, 680.6 millimoles per liter (mmol/L)Standard Deviation 1.97
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsChloride; Week 8; n= 67, 660.9 millimoles per liter (mmol/L)Standard Deviation 2.05
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsChloride; Week 12; n= 65, 680.7 millimoles per liter (mmol/L)Standard Deviation 2.32
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsChloride; Week 16; n= 65, 680.5 millimoles per liter (mmol/L)Standard Deviation 2.08
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsChloride; Week 20; n= 63, 680.3 millimoles per liter (mmol/L)Standard Deviation 2.38
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsChloride; Week 24; n= 63, 660.6 millimoles per liter (mmol/L)Standard Deviation 2.51
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsChloride; Week 28; n= 62, 660.7 millimoles per liter (mmol/L)Standard Deviation 2.17
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsChloride; Week 32; n= 61, 670.4 millimoles per liter (mmol/L)Standard Deviation 2.24
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsChloride; Week 36; n= 60, 670.8 millimoles per liter (mmol/L)Standard Deviation 2.53
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsChloride; Week 40; n= 61, 660.9 millimoles per liter (mmol/L)Standard Deviation 2.22
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsChloride; Week 44; n= 61, 660.5 millimoles per liter (mmol/L)Standard Deviation 2.13
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsChloride; Week 48; n= 61, 640.5 millimoles per liter (mmol/L)Standard Deviation 2.38
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsChloride; Week 52; n= 60, 650.3 millimoles per liter (mmol/L)Standard Deviation 2.26
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsChloride; Week 56; n= 61, 630.7 millimoles per liter (mmol/L)Standard Deviation 2.27
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsChloride; Week 60; n= 60, 650.4 millimoles per liter (mmol/L)Standard Deviation 2.01
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsAbsolute Cholesterol; Baseline; n= 68, 685.771 millimoles per liter (mmol/L)Standard Deviation 1.2033
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCholesterol; Week 8; n= 2, 0-0.250 millimoles per liter (mmol/L)Standard Deviation 0.1414
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCholesterol; Week 12; n= 1, 00.050 millimoles per liter (mmol/L)
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsAbsolute Calcium; Baseline; n= 68, 682.365 millimoles per liter (mmol/L)Standard Deviation 0.0864
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCholesterol; Week 20; n= 1, 10.050 millimoles per liter (mmol/L)
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCholesterol; Week 52; n= 60, 65-0.006 millimoles per liter (mmol/L)Standard Deviation 0.9364
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCholesterol; Week 56; n= 1, 0-0.220 millimoles per liter (mmol/L)
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsAbsolute Glucose; Baseline; n= 68, 685.76 millimoles per liter (mmol/L)Standard Deviation 2
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsGlucose; Week 4; n= 68, 680.27 millimoles per liter (mmol/L)Standard Deviation 1.619
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsGlucose; Week 8; n= 67, 660.09 millimoles per liter (mmol/L)Standard Deviation 1.695
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsGlucose; Week 12; n= 65, 680.27 millimoles per liter (mmol/L)Standard Deviation 1.961
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsGlucose; Week 16; n= 65, 680.03 millimoles per liter (mmol/L)Standard Deviation 1.454
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsGlucose; Week 20; n= 63, 680.25 millimoles per liter (mmol/L)Standard Deviation 1.644
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsGlucose; Week 24; n= 63, 660.02 millimoles per liter (mmol/L)Standard Deviation 1.588
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsGlucose; Week 28; n= 62, 660.14 millimoles per liter (mmol/L)Standard Deviation 1.613
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsGlucose; Week 32; n= 61, 67-0.03 millimoles per liter (mmol/L)Standard Deviation 1.808
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsGlucose; Week 36; n= 60, 670.11 millimoles per liter (mmol/L)Standard Deviation 1.525
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsGlucose; Week 40; n= 61, 660.34 millimoles per liter (mmol/L)Standard Deviation 1.831
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsGlucose; Week 44; n= 61, 660.21 millimoles per liter (mmol/L)Standard Deviation 1.766
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsGlucose; Week 48; n= 61, 640.32 millimoles per liter (mmol/L)Standard Deviation 2.065
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsGlucose; Week 52; n= 60, 65-0.17 millimoles per liter (mmol/L)Standard Deviation 1.65
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsGlucose; Week 56; n= 61, 630.01 millimoles per liter (mmol/L)Standard Deviation 1.718
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsGlucose; Week 60; n= 60, 650.20 millimoles per liter (mmol/L)Standard Deviation 1.664
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsAbsolute HDL cholesterol; Baseline; n= 68, 681.837 millimoles per liter (mmol/L)Standard Deviation 0.454
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsHDL cholesterol; Week 8; n= 2, 0-0.075 millimoles per liter (mmol/L)Standard Deviation 0.0354
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsHDL cholesterol; Week 12; n= 1, 0-0.100 millimoles per liter (mmol/L)
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsHDL cholesterol; Week 16; n= 1, 10.400 millimoles per liter (mmol/L)
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsHDL cholesterol; Week 20; n= 1, 10.000 millimoles per liter (mmol/L)
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsHDL cholesterol; Week 52; n= 60, 65-0.045 millimoles per liter (mmol/L)Standard Deviation 0.2832
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsHDL cholesterol; Week 56; n= 1, 0-0.060 millimoles per liter (mmol/L)
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsAbsolute LDL cholesterol; Baseline; n= 67, 683.261 millimoles per liter (mmol/L)Standard Deviation 1.0808
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsLDL cholesterol; Week 8; n= 1, 0-0.350 millimoles per liter (mmol/L)
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsLDL cholesterol; Week 12; n= 1, 00.190 millimoles per liter (mmol/L)
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsLDL cholesterol; Week 16; n= 1, 1-0.730 millimoles per liter (mmol/L)
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsLDL cholesterol; Week 20; n= 1, 1-0.150 millimoles per liter (mmol/L)
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsLDL cholesterol; Week 52; n= 58, 640.016 millimoles per liter (mmol/L)Standard Deviation 0.7717
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsLDL cholesterol; Week 56; n= 1, 00.100 millimoles per liter (mmol/L)
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsAbsolute Phosphate; Baseline; n= 68, 681.068 millimoles per liter (mmol/L)Standard Deviation 0.1797
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPhosphate; Week 4; n= 68, 68-0.027 millimoles per liter (mmol/L)Standard Deviation 0.2183
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPhosphate; Week 8; n= 67, 66-0.004 millimoles per liter (mmol/L)Standard Deviation 0.1577
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPhosphate; Week 12; n= 65, 680.003 millimoles per liter (mmol/L)Standard Deviation 0.1821
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPhosphate; Week 16; n= 65, 680.016 millimoles per liter (mmol/L)Standard Deviation 0.1819
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPhosphate; Week 20; n= 63, 68-0.001 millimoles per liter (mmol/L)Standard Deviation 0.1611
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPhosphate; Week 24; n= 63, 66-0.042 millimoles per liter (mmol/L)Standard Deviation 0.1565
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPhosphate; Week 28; n= 62, 66-0.025 millimoles per liter (mmol/L)Standard Deviation 0.1819
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPhosphate; Week 32; n= 61, 67-0.018 millimoles per liter (mmol/L)Standard Deviation 0.1975
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPhosphate; Week 36; n= 60, 67-0.038 millimoles per liter (mmol/L)Standard Deviation 0.2159
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPhosphate; Week 40; n= 61, 66-0.029 millimoles per liter (mmol/L)Standard Deviation 0.1822
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPhosphate; Week 44; n= 61, 66-0.018 millimoles per liter (mmol/L)Standard Deviation 0.2104
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPhosphate; Week 48; n= 61, 64-0.053 millimoles per liter (mmol/L)Standard Deviation 0.1931
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPhosphate; Week 52; n= 60, 650.005 millimoles per liter (mmol/L)Standard Deviation 0.1939
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPhosphate; Week 56; n= 61, 630.019 millimoles per liter (mmol/L)Standard Deviation 0.2962
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPhosphate; Week 60; n= 60, 65-0.035 millimoles per liter (mmol/L)Standard Deviation 0.2125
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsAbsolute Potassium; Baseline; n= 68, 684.11 millimoles per liter (mmol/L)Standard Deviation 0.348
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPotassium; Week 4; n= 68, 680.05 millimoles per liter (mmol/L)Standard Deviation 0.378
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPotassium; Week 8; n= 67, 660.01 millimoles per liter (mmol/L)Standard Deviation 0.309
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPotassium; Week 12; n= 65, 68-0.04 millimoles per liter (mmol/L)Standard Deviation 0.318
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPotassium; Week 16; n= 65, 680.06 millimoles per liter (mmol/L)Standard Deviation 0.34
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPotassium; Week 20; n= 63, 680.08 millimoles per liter (mmol/L)Standard Deviation 0.382
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPotassium; Week 24; n= 63, 66-0.02 millimoles per liter (mmol/L)Standard Deviation 0.298
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPotassium; Week 28; n= 61, 660.07 millimoles per liter (mmol/L)Standard Deviation 0.338
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPotassium; Week 32; n= 61, 670.04 millimoles per liter (mmol/L)Standard Deviation 0.34
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPotassium; Week 36; n= 60, 670.02 millimoles per liter (mmol/L)Standard Deviation 0.291
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPotassium; Week 40; n= 61, 660.08 millimoles per liter (mmol/L)Standard Deviation 0.419
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPotassium; Week 44; n= 61, 660.08 millimoles per liter (mmol/L)Standard Deviation 0.383
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPotassium; Week 48; n= 61, 640.09 millimoles per liter (mmol/L)Standard Deviation 0.367
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPotassium; Week 52; n= 60, 650.05 millimoles per liter (mmol/L)Standard Deviation 0.344
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPotassium; Week 56; n= 61, 630.08 millimoles per liter (mmol/L)Standard Deviation 0.379
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPotassium; Week 60; n= 60, 650.00 millimoles per liter (mmol/L)Standard Deviation 0.358
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsAbsolute Sodium; Baseline; n= 68, 68139.8 millimoles per liter (mmol/L)Standard Deviation 2.03
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsSodium; Week 4; n= 68, 680.2 millimoles per liter (mmol/L)Standard Deviation 1.86
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsSodium; Week 8; n= 67, 660.4 millimoles per liter (mmol/L)Standard Deviation 2.06
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsSodium; Week 12; n= 65, 680.1 millimoles per liter (mmol/L)Standard Deviation 1.99
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsSodium; Week 16; n= 65, 680.0 millimoles per liter (mmol/L)Standard Deviation 1.46
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsSodium; Week 20; n= 63, 680.0 millimoles per liter (mmol/L)Standard Deviation 1.88
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsSodium; Week 24; n= 63, 660.2 millimoles per liter (mmol/L)Standard Deviation 1.94
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsSodium; Week 28; n= 62, 660.5 millimoles per liter (mmol/L)Standard Deviation 1.71
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsSodium; Week 32; n= 61, 670.3 millimoles per liter (mmol/L)Standard Deviation 1.92
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsSodium; Week 36; n= 60, 670.4 millimoles per liter (mmol/L)Standard Deviation 2.1
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsSodium; Week 40; n= 61, 660.2 millimoles per liter (mmol/L)Standard Deviation 2.42
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsSodium; Week 44; n= 61, 660.1 millimoles per liter (mmol/L)Standard Deviation 1.77
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsSodium; Week 48; n= 61, 640.1 millimoles per liter (mmol/L)Standard Deviation 2.03
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsSodium; Week 52; n= 60, 650.4 millimoles per liter (mmol/L)Standard Deviation 1.79
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsSodium; Week 56; n= 61, 630.4 millimoles per liter (mmol/L)Standard Deviation 2.15
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsSodium; Week 60; n= 60, 65-0.1 millimoles per liter (mmol/L)Standard Deviation 2.04
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsAbsolute Urea; Baseline; n= 68, 685.94 millimoles per liter (mmol/L)Standard Deviation 1.451
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsUrea; Week 4; n= 68, 68-0.08 millimoles per liter (mmol/L)Standard Deviation 1.412
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsUrea; Week 8; n= 67, 66-0.23 millimoles per liter (mmol/L)Standard Deviation 1.564
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsUrea; Week 12; n= 65, 68-0.15 millimoles per liter (mmol/L)Standard Deviation 1.414
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsUrea; Week 16; n= 65, 68-0.07 millimoles per liter (mmol/L)Standard Deviation 1.569
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsUrea; Week 20; n= 63, 68-0.21 millimoles per liter (mmol/L)Standard Deviation 1.465
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsUrea; Week 24; n= 63, 66-0.28 millimoles per liter (mmol/L)Standard Deviation 1.513
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsUrea; Week 28; n= 62, 66-0.21 millimoles per liter (mmol/L)Standard Deviation 1.525
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsUrea; Week 32; n= 61, 67-0.11 millimoles per liter (mmol/L)Standard Deviation 1.32
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsUrea; Week 36; n= 60, 67-0.27 millimoles per liter (mmol/L)Standard Deviation 1.407
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsUrea; Week 40; n= 61, 66-0.44 millimoles per liter (mmol/L)Standard Deviation 1.377
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsUrea; Week 44; n= 61, 66-0.32 millimoles per liter (mmol/L)Standard Deviation 1.731
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsUrea; Week 48; n= 61, 64-0.36 millimoles per liter (mmol/L)Standard Deviation 1.422
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsUrea; Week 52; n= 60, 65-0.19 millimoles per liter (mmol/L)Standard Deviation 1.737
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsUrea; Week 56; n= 61, 63-0.11 millimoles per liter (mmol/L)Standard Deviation 1.495
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsUrea; Week 60; n= 60, 65-0.09 millimoles per liter (mmol/L)Standard Deviation 1.546
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsAbsolute VLDL cholesterol; Baseline; n= 67, 680.680 millimoles per liter (mmol/L)Standard Deviation 0.2846
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsVLDL cholesterol; Week 8; n= 1, 00.100 millimoles per liter (mmol/L)
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsVLDL cholesterol; Week 12; n= 1, 0-0.040 millimoles per liter (mmol/L)
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsVLDL cholesterol; Week 16; n= 1, 1-0.070 millimoles per liter (mmol/L)
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsVLDL cholesterol; Week 20; n= 1, 10.200 millimoles per liter (mmol/L)
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsVLDL cholesterol; Week 52; n= 58, 64-0.019 millimoles per liter (mmol/L)Standard Deviation 0.3229
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsVLDL cholesterol; Week 56; n= 1, 0-0.260 millimoles per liter (mmol/L)
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCalcium; Week 4; n= 68, 68-0.011 millimoles per liter (mmol/L)Standard Deviation 0.0836
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCalcium; Week 8; n= 67, 66-0.013 millimoles per liter (mmol/L)Standard Deviation 0.0877
PlaceboChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCalcium; Week 12; n= 65, 68-0.013 millimoles per liter (mmol/L)Standard Deviation 0.0844
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsAbsolute Calcium; Baseline; n= 68, 682.382 millimoles per liter (mmol/L)Standard Deviation 0.1189
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsSodium; Week 12; n= 65, 68-0.1 millimoles per liter (mmol/L)Standard Deviation 2.28
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCalcium; Week 4; n= 68, 68-0.012 millimoles per liter (mmol/L)Standard Deviation 0.12
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPhosphate; Week 4; n= 68, 680.014 millimoles per liter (mmol/L)Standard Deviation 0.1833
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCalcium; Week 8; n= 67, 66-0.010 millimoles per liter (mmol/L)Standard Deviation 0.1003
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsUrea; Week 52; n= 60, 65-0.18 millimoles per liter (mmol/L)Standard Deviation 1.128
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCalcium; Week 12; n= 65, 68-0.026 millimoles per liter (mmol/L)Standard Deviation 0.0889
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPhosphate; Week 8; n= 67, 660.024 millimoles per liter (mmol/L)Standard Deviation 0.2239
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCalcium; Week 16; n= 65, 68-0.029 millimoles per liter (mmol/L)Standard Deviation 0.1018
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsSodium; Week 16; n= 65, 68-0.1 millimoles per liter (mmol/L)Standard Deviation 1.91
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCalcium; Week 20; n= 63, 68-0.016 millimoles per liter (mmol/L)Standard Deviation 0.1032
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPhosphate; Week 12; n= 65, 680.019 millimoles per liter (mmol/L)Standard Deviation 0.2181
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCalcium; Week 24; n= 63, 66-0.013 millimoles per liter (mmol/L)Standard Deviation 0.1111
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsUrea; Week 20; n= 63, 68-0.23 millimoles per liter (mmol/L)Standard Deviation 1.286
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCalcium; Week 28; n= 61, 66-0.001 millimoles per liter (mmol/L)Standard Deviation 0.1039
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPhosphate; Week 16; n= 65, 680.016 millimoles per liter (mmol/L)Standard Deviation 0.2205
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCalcium; Week 32; n= 61, 67-0.006 millimoles per liter (mmol/L)Standard Deviation 0.0977
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsSodium; Week 20; n= 63, 680.1 millimoles per liter (mmol/L)Standard Deviation 2.09
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCalcium; Week 36; n= 60, 67-0.006 millimoles per liter (mmol/L)Standard Deviation 0.1133
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPhosphate; Week 20; n= 63, 680.019 millimoles per liter (mmol/L)Standard Deviation 0.2087
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCalcium; Week 40; n= 61, 660.005 millimoles per liter (mmol/L)Standard Deviation 0.1115
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsVLDL cholesterol; Week 36; n= 0, 1-0.230 millimoles per liter (mmol/L)
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCalcium; Week 44; n= 61, 66-0.020 millimoles per liter (mmol/L)Standard Deviation 0.1115
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPhosphate; Week 24; n= 63, 660.007 millimoles per liter (mmol/L)Standard Deviation 0.2142
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCalcium; Week 48; n= 61, 64-0.018 millimoles per liter (mmol/L)Standard Deviation 0.1002
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsSodium; Week 24; n= 63, 660.0 millimoles per liter (mmol/L)Standard Deviation 1.95
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCalcium; Week 52; n= 60, 65-0.027 millimoles per liter (mmol/L)Standard Deviation 0.111
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPhosphate; Week 28; n= 62, 660.003 millimoles per liter (mmol/L)Standard Deviation 0.2539
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCalcium; Week 56; n= 61, 63-0.015 millimoles per liter (mmol/L)Standard Deviation 0.0994
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsUrea; Week 24; n= 63, 66-0.12 millimoles per liter (mmol/L)Standard Deviation 1.172
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCalcium; Week 60; n= 60, 65-0.019 millimoles per liter (mmol/L)Standard Deviation 0.1058
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPhosphate; Week 32; n= 61, 670.040 millimoles per liter (mmol/L)Standard Deviation 0.2172
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsAbsolute Chloride; Baseline; n= 68, 68104.0 millimoles per liter (mmol/L)Standard Deviation 2.21
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsSodium; Week 28; n= 62, 660.0 millimoles per liter (mmol/L)Standard Deviation 2.23
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsChloride; Week 4; n= 68, 680.2 millimoles per liter (mmol/L)Standard Deviation 2
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPhosphate; Week 36; n= 60, 670.023 millimoles per liter (mmol/L)Standard Deviation 0.226
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsChloride; Week 8; n= 67, 660.5 millimoles per liter (mmol/L)Standard Deviation 2.06
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsUrea; Week 56; n= 61, 63-0.13 millimoles per liter (mmol/L)Standard Deviation 1.539
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsChloride; Week 12; n= 65, 680.7 millimoles per liter (mmol/L)Standard Deviation 2.2
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPhosphate; Week 40; n= 61, 660.026 millimoles per liter (mmol/L)Standard Deviation 0.2213
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsChloride; Week 16; n= 65, 680.8 millimoles per liter (mmol/L)Standard Deviation 1.95
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsSodium; Week 32; n= 61, 670.1 millimoles per liter (mmol/L)Standard Deviation 2.13
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsChloride; Week 20; n= 63, 680.7 millimoles per liter (mmol/L)Standard Deviation 2.04
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPhosphate; Week 44; n= 61, 660.041 millimoles per liter (mmol/L)Standard Deviation 0.224
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsChloride; Week 24; n= 63, 660.8 millimoles per liter (mmol/L)Standard Deviation 2.2
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsUrea; Week 28; n= 62, 66-0.22 millimoles per liter (mmol/L)Standard Deviation 1.35
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsChloride; Week 28; n= 62, 660.8 millimoles per liter (mmol/L)Standard Deviation 2.59
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPhosphate; Week 48; n= 61, 64-0.020 millimoles per liter (mmol/L)Standard Deviation 0.2443
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsChloride; Week 32; n= 61, 670.5 millimoles per liter (mmol/L)Standard Deviation 2.32
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsSodium; Week 36; n= 60, 670.0 millimoles per liter (mmol/L)Standard Deviation 1.95
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsChloride; Week 36; n= 60, 670.6 millimoles per liter (mmol/L)Standard Deviation 2.08
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPhosphate; Week 52; n= 60, 650.053 millimoles per liter (mmol/L)Standard Deviation 0.2988
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsChloride; Week 40; n= 61, 660.7 millimoles per liter (mmol/L)Standard Deviation 2.13
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsVLDL cholesterol; Week 16; n= 1, 10.640 millimoles per liter (mmol/L)
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsChloride; Week 44; n= 61, 660.6 millimoles per liter (mmol/L)Standard Deviation 2.55
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPhosphate; Week 56; n= 61, 630.043 millimoles per liter (mmol/L)Standard Deviation 0.3066
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsChloride; Week 48; n= 61, 640.5 millimoles per liter (mmol/L)Standard Deviation 2.34
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsSodium; Week 40; n= 61, 660.0 millimoles per liter (mmol/L)Standard Deviation 2.18
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsChloride; Week 52; n= 60, 650.4 millimoles per liter (mmol/L)Standard Deviation 2.24
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPhosphate; Week 60; n= 60, 65-0.007 millimoles per liter (mmol/L)Standard Deviation 0.2322
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsChloride; Week 56; n= 61, 630.2 millimoles per liter (mmol/L)Standard Deviation 2.06
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsUrea; Week 32; n= 61, 67-0.23 millimoles per liter (mmol/L)Standard Deviation 1.359
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsChloride; Week 60; n= 60, 650.4 millimoles per liter (mmol/L)Standard Deviation 2.2
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsAbsolute Potassium; Baseline; n= 68, 684.10 millimoles per liter (mmol/L)Standard Deviation 0.359
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsAbsolute Cholesterol; Baseline; n= 68, 685.788 millimoles per liter (mmol/L)Standard Deviation 1.2386
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsSodium; Week 44; n= 61, 66-0.2 millimoles per liter (mmol/L)Standard Deviation 2.02
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPotassium; Week 4; n= 68, 68-0.02 millimoles per liter (mmol/L)Standard Deviation 0.345
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsUrea; Week 60; n= 60, 65-0.10 millimoles per liter (mmol/L)Standard Deviation 1.17
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCholesterol; Week 16; n= 1, 1-0.300 millimoles per liter (mmol/L)
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPotassium; Week 8; n= 67, 660.02 millimoles per liter (mmol/L)Standard Deviation 0.323
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCholesterol; Week 20; n= 1, 1-0.300 millimoles per liter (mmol/L)
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCholesterol; Week 24; n= 0, 1-0.560 millimoles per liter (mmol/L)
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCholesterol; Week 36; n= 0, 10.420 millimoles per liter (mmol/L)
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsSodium; Week 48; n= 61, 64-0.4 millimoles per liter (mmol/L)Standard Deviation 1.97
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsCholesterol; Week 52; n= 60, 65-0.384 millimoles per liter (mmol/L)Standard Deviation 0.8798
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPotassium; Week 12; n= 65, 680.01 millimoles per liter (mmol/L)Standard Deviation 0.296
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsUrea; Week 36; n= 60, 67-0.32 millimoles per liter (mmol/L)Standard Deviation 1.391
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsAbsolute Glucose; Baseline; n= 68, 685.35 millimoles per liter (mmol/L)Standard Deviation 1.195
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPotassium; Week 16; n= 65, 680.05 millimoles per liter (mmol/L)Standard Deviation 0.317
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsGlucose; Week 4; n= 68, 68-0.01 millimoles per liter (mmol/L)Standard Deviation 1.05
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsSodium; Week 52; n= 60, 65-0.2 millimoles per liter (mmol/L)Standard Deviation 2.17
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsGlucose; Week 8; n= 67, 660.07 millimoles per liter (mmol/L)Standard Deviation 0.986
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPotassium; Week 20; n= 63, 680.01 millimoles per liter (mmol/L)Standard Deviation 0.372
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsGlucose; Week 12; n= 65, 680.26 millimoles per liter (mmol/L)Standard Deviation 1.079
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsVLDL cholesterol; Week 52; n= 58, 64-0.051 millimoles per liter (mmol/L)Standard Deviation 0.1927
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsGlucose; Week 16; n= 65, 680.04 millimoles per liter (mmol/L)Standard Deviation 1.077
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPotassium; Week 24; n= 63, 660.04 millimoles per liter (mmol/L)Standard Deviation 0.35
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsGlucose; Week 20; n= 63, 68-0.03 millimoles per liter (mmol/L)Standard Deviation 1.351
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsSodium; Week 56; n= 61, 63-0.5 millimoles per liter (mmol/L)Standard Deviation 2.08
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsGlucose; Week 24; n= 63, 660.16 millimoles per liter (mmol/L)Standard Deviation 1.211
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPotassium; Week 28; n= 61, 660.10 millimoles per liter (mmol/L)Standard Deviation 0.382
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsGlucose; Week 28; n= 62, 660.21 millimoles per liter (mmol/L)Standard Deviation 1.551
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsUrea; Week 40; n= 61, 66-0.23 millimoles per liter (mmol/L)Standard Deviation 1.375
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsGlucose; Week 32; n= 61, 67-0.14 millimoles per liter (mmol/L)Standard Deviation 1.162
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPotassium; Week 32; n= 61, 670.11 millimoles per liter (mmol/L)Standard Deviation 0.305
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsGlucose; Week 36; n= 60, 670.03 millimoles per liter (mmol/L)Standard Deviation 1.003
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsSodium; Week 60; n= 60, 65-0.3 millimoles per liter (mmol/L)Standard Deviation 2.36
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsGlucose; Week 40; n= 61, 66-0.03 millimoles per liter (mmol/L)Standard Deviation 1.305
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPotassium; Week 36; n= 60, 670.01 millimoles per liter (mmol/L)Standard Deviation 0.351
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsGlucose; Week 44; n= 61, 66-0.05 millimoles per liter (mmol/L)Standard Deviation 0.891
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsAbsolute VLDL cholesterol; Baseline; n= 67, 680.646 millimoles per liter (mmol/L)Standard Deviation 0.2841
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsGlucose; Week 48; n= 61, 640.21 millimoles per liter (mmol/L)Standard Deviation 1.74
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPotassium; Week 40; n= 61, 660.14 millimoles per liter (mmol/L)Standard Deviation 0.313
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsGlucose; Week 52; n= 60, 650.02 millimoles per liter (mmol/L)Standard Deviation 1.258
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsAbsolute Urea; Baseline; n= 68, 685.79 millimoles per liter (mmol/L)Standard Deviation 1.629
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsGlucose; Week 56; n= 61, 630.13 millimoles per liter (mmol/L)Standard Deviation 1.852
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPotassium; Week 44; n= 61, 660.09 millimoles per liter (mmol/L)Standard Deviation 0.341
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsGlucose; Week 60; n= 60, 650.11 millimoles per liter (mmol/L)Standard Deviation 1.483
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsUrea; Week 44; n= 61, 66-0.19 millimoles per liter (mmol/L)Standard Deviation 1.698
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsAbsolute HDL cholesterol; Baseline; n= 68, 681.937 millimoles per liter (mmol/L)Standard Deviation 0.5606
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPotassium; Week 48; n= 61, 640.05 millimoles per liter (mmol/L)Standard Deviation 0.349
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsUrea; Week 4; n= 68, 680.09 millimoles per liter (mmol/L)Standard Deviation 1.241
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPotassium; Week 52; n= 60, 650.01 millimoles per liter (mmol/L)Standard Deviation 0.329
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsHDL cholesterol; Week 16; n= 1, 1-0.150 millimoles per liter (mmol/L)
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsVLDL cholesterol; Week 20; n= 1, 10.490 millimoles per liter (mmol/L)
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsHDL cholesterol; Week 20; n= 1, 1-0.250 millimoles per liter (mmol/L)
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsHDL cholesterol; Week 24; n= 0, 1-0.390 millimoles per liter (mmol/L)
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsHDL cholesterol; Week 36; n= 0, 10.400 millimoles per liter (mmol/L)
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPotassium; Week 56; n= 61, 630.08 millimoles per liter (mmol/L)Standard Deviation 0.378
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsHDL cholesterol; Week 52; n= 60, 65-0.150 millimoles per liter (mmol/L)Standard Deviation 0.3146
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsUrea; Week 8; n= 67, 660.20 millimoles per liter (mmol/L)Standard Deviation 1.206
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsPotassium; Week 60; n= 60, 650.10 millimoles per liter (mmol/L)Standard Deviation 0.39
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsAbsolute LDL cholesterol; Baseline; n= 67, 683.205 millimoles per liter (mmol/L)Standard Deviation 1.0992
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsUrea; Week 48; n= 61, 64-0.09 millimoles per liter (mmol/L)Standard Deviation 1.429
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsAbsolute Sodium; Baseline; n= 68, 68140.3 millimoles per liter (mmol/L)Standard Deviation 1.83
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsUrea; Week 12; n= 65, 68-0.10 millimoles per liter (mmol/L)Standard Deviation 1.217
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsLDL cholesterol; Week 16; n= 1, 1-0.790 millimoles per liter (mmol/L)
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsSodium; Week 4; n= 68, 680.3 millimoles per liter (mmol/L)Standard Deviation 2.03
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsLDL cholesterol; Week 20; n= 1, 1-0.540 millimoles per liter (mmol/L)
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsLDL cholesterol; Week 24; n= 0, 10.040 millimoles per liter (mmol/L)
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsLDL cholesterol; Week 36; n= 0, 10.250 millimoles per liter (mmol/L)
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsVLDL cholesterol; Week 24; n= 0, 1-0.210 millimoles per liter (mmol/L)
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsLDL cholesterol; Week 52; n= 58, 64-0.215 millimoles per liter (mmol/L)Standard Deviation 0.8079
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsSodium; Week 8; n= 67, 660.2 millimoles per liter (mmol/L)Standard Deviation 1.89
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsUrea; Week 16; n= 65, 680.00 millimoles per liter (mmol/L)Standard Deviation 1.317
Mepolizumab 300mgChange From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol LevelsAbsolute Phosphate; Baseline; n= 68, 681.066 millimoles per liter (mmol/L)Standard Deviation 0.1939
Secondary

Change From Baseline in Clinical Chemistry Parameter of Troponin Levels

Blood samples were collected to evaluate change from Baseline in troponin values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.

Time frame: Baseline and up to Week 60

Population: Safety Population

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsAbsolute Troponin; Baseline; n= 68, 680.013 µg/LStandard Deviation 0.011
PlaceboChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsTroponin; Week 4; n= 68, 66-0.001 µg/LStandard Deviation 0.0106
PlaceboChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsTroponin; Week 8; n= 67, 67-0.002 µg/LStandard Deviation 0.0111
PlaceboChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsTroponin; Week 12; n= 64, 67-0.002 µg/LStandard Deviation 0.0108
PlaceboChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsTroponin; Week 16; n= 65, 68-0.002 µg/LStandard Deviation 0.0104
PlaceboChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsTroponin; Week 20; n= 61, 68-0.002 µg/LStandard Deviation 0.0105
PlaceboChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsTroponin; Week 24; n= 62, 67-0.002 µg/LStandard Deviation 0.0098
PlaceboChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsTroponin; Week 28; n= 63, 66-0.003 µg/LStandard Deviation 0.0102
PlaceboChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsTroponin; Week 32; n= 61, 67-0.003 µg/LStandard Deviation 0.01
PlaceboChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsTroponin; Week 36; n= 61, 67-0.002 µg/LStandard Deviation 0.0107
PlaceboChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsTroponin; Week 40; n= 61, 66-0.001 µg/LStandard Deviation 0.0117
PlaceboChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsTroponin; Week 44; n= 61, 65-0.000 µg/LStandard Deviation 0.0068
PlaceboChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsTroponin; Week 48; n= 60, 650.017 µg/LStandard Deviation 0.1479
PlaceboChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsTroponin; Week 52; n= 60, 65-0.002 µg/LStandard Deviation 0.0114
PlaceboChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsTroponin; Week 56; n= 61, 63-0.003 µg/LStandard Deviation 0.0112
PlaceboChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsTroponin; Week 60; n= 59, 65-0.003 µg/LStandard Deviation 0.0109
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsTroponin; Week 60; n= 59, 65-0.001 µg/LStandard Deviation 0.0093
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsAbsolute Troponin; Baseline; n= 68, 680.013 µg/LStandard Deviation 0.0092
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsTroponin; Week 32; n= 61, 67-0.002 µg/LStandard Deviation 0.0092
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsTroponin; Week 4; n= 68, 660.008 µg/LStandard Deviation 0.0717
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsTroponin; Week 48; n= 60, 65-0.001 µg/LStandard Deviation 0.0101
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsTroponin; Week 8; n= 67, 670.001 µg/LStandard Deviation 0.0089
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsTroponin; Week 36; n= 61, 670.000 µg/LStandard Deviation 0.0185
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsTroponin; Week 12; n= 64, 67-0.001 µg/LStandard Deviation 0.0053
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsTroponin; Week 56; n= 61, 63-0.002 µg/LStandard Deviation 0.0086
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsTroponin; Week 16; n= 65, 680.002 µg/LStandard Deviation 0.0272
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsTroponin; Week 40; n= 61, 66-0.002 µg/LStandard Deviation 0.009
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsTroponin; Week 20; n= 61, 68-0.001 µg/LStandard Deviation 0.0089
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsTroponin; Week 52; n= 60, 65-0.001 µg/LStandard Deviation 0.0111
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsTroponin; Week 24; n= 62, 670.004 µg/LStandard Deviation 0.0535
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsTroponin; Week 44; n= 61, 65-0.001 µg/LStandard Deviation 0.0095
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameter of Troponin LevelsTroponin; Week 28; n= 63, 66-0.002 µg/LStandard Deviation 0.009
Secondary

Change From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) Levels

Blood samples were collected to evaluate change from Baseline in ALT, Alk.phosph., AST, creatinine kinase, GGT and lactate dehydro values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.

Time frame: Baseline and up to Week 60

Population: Safety population

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAST; Week 4; n= 68, 680.0 International Unit per Liter (IU/L)Standard Deviation 4.41
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAST; Week 28; n= 61, 66-0.9 International Unit per Liter (IU/L)Standard Deviation 5.34
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsALT; Week 12; n= 65, 68-0.9 International Unit per Liter (IU/L)Standard Deviation 4.53
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAST; Week 32; n= 61, 67-0.2 International Unit per Liter (IU/L)Standard Deviation 4.91
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsALT; Week 60; n= 60, 65-0.3 International Unit per Liter (IU/L)Standard Deviation 7.33
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAST; Week 40; n= 61, 660.5 International Unit per Liter (IU/L)Standard Deviation 5.51
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsALT; Week 16; n= 65, 68-0.4 International Unit per Liter (IU/L)Standard Deviation 6.56
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAST; Week 36; n= 60, 670.2 International Unit per Liter (IU/L)Standard Deviation 4.68
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAST; Week 48; n= 61, 641.1 International Unit per Liter (IU/L)Standard Deviation 6.86
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsALT; Week 20; n= 63, 68-0.3 International Unit per Liter (IU/L)Standard Deviation 6.25
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAST; Week 52; n= 60, 650.9 International Unit per Liter (IU/L)Standard Deviation 6.84
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAST; Week 44; n= 61, 660.4 International Unit per Liter (IU/L)Standard Deviation 5.77
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsALT; Week 24; n= 63, 66-1.3 International Unit per Liter (IU/L)Standard Deviation 5.38
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAST; Week 60; n= 60, 65-0.4 International Unit per Liter (IU/L)Standard Deviation 5.24
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAST; Week 56; n= 61, 63-0.2 International Unit per Liter (IU/L)Standard Deviation 4.92
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAbsolute Creatinine kinase; Baseline; n= 68, 6899.0 International Unit per Liter (IU/L)Standard Deviation 75.99
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsALT; Week 28; n= 62, 66-0.9 International Unit per Liter (IU/L)Standard Deviation 6.73
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsCreatinine kinase; Week 4; n= 68, 68-2.4 International Unit per Liter (IU/L)Standard Deviation 83.23
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsALT; Week 44; n= 61, 660.9 International Unit per Liter (IU/L)Standard Deviation 9.68
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsCreatinine kinase; Week 12; n= 65, 685.4 International Unit per Liter (IU/L)Standard Deviation 93.24
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsALT; Week 32; n= 61, 67-0.7 International Unit per Liter (IU/L)Standard Deviation 6.79
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsCreatinine kinase; Week 16; n= 65, 6815.8 International Unit per Liter (IU/L)Standard Deviation 125.84
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsCreatinine kinase; Week 8; n= 67, 66-5.0 International Unit per Liter (IU/L)Standard Deviation 62.41
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsCreatinine kinase; Week 20; n= 63, 681.3 International Unit per Liter (IU/L)Standard Deviation 78.35
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsALT; Week 36; n= 60, 67-0.1 International Unit per Liter (IU/L)Standard Deviation 6.21
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsCreatinine kinase; Week 24; n= 63, 66-0.6 International Unit per Liter (IU/L)Standard Deviation 56.55
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAlk. phosph.; Week 12; n= 65, 68-1.9 International Unit per Liter (IU/L)Standard Deviation 8.36
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsCreatinine kinase; Week 28; n= 62, 66-15.9 International Unit per Liter (IU/L)Standard Deviation 59.38
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsCreatinine kinase; Week 32; n= 61, 67-13.1 International Unit per Liter (IU/L)Standard Deviation 59.29
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAlk. phosph.; Week 16; n= 65, 68-1.3 International Unit per Liter (IU/L)Standard Deviation 9.35
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsCreatinine kinase; Week 36; n= 60, 67-12.0 International Unit per Liter (IU/L)Standard Deviation 65.11
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAbsolute Alk.phosph.; Baseline; n= 68, 6861.2 International Unit per Liter (IU/L)Standard Deviation 17.83
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsCreatinine kinase; Week 40; n= 61, 662.6 International Unit per Liter (IU/L)Standard Deviation 91.89
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsCreatinine kinase; Week 44; n= 61, 665.8 International Unit per Liter (IU/L)Standard Deviation 86.76
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAlk. phosph.; Week 20; n= 63, 680.0 International Unit per Liter (IU/L)Standard Deviation 11.24
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsCreatinine kinase; Week 48; n= 61, 64-8.1 International Unit per Liter (IU/L)Standard Deviation 70.09
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsCreatinine kinase; Week 52; n= 60, 650.9 International Unit per Liter (IU/L)Standard Deviation 67.51
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsALT; Week 52; n= 60, 651.5 International Unit per Liter (IU/L)Standard Deviation 10.42
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsCreatinine kinase; Week 60; n= 60, 65-10.3 International Unit per Liter (IU/L)Standard Deviation 65.83
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAlk. phosph.; Week 28; n= 62, 660.2 International Unit per Liter (IU/L)Standard Deviation 10.95
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAbsolute GGT; Baseline; n= 68, 6830.8 International Unit per Liter (IU/L)Standard Deviation 25.49
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsCreatinine kinase; Week 56; n= 61, 63-8.7 International Unit per Liter (IU/L)Standard Deviation 60.58
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsGGT; Week 4; n= 68, 680.2 International Unit per Liter (IU/L)Standard Deviation 11.7
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAlk. phosph.; Week 32; n= 61, 670.2 International Unit per Liter (IU/L)Standard Deviation 11.14
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsGGT; Week 8; n= 67, 66-1.0 International Unit per Liter (IU/L)Standard Deviation 8.59
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAlk.phosph.; Week 4; n= 68, 68-0.9 International Unit per Liter (IU/L)Standard Deviation 6.65
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsGGT; Week 12; n= 65, 68-2.9 International Unit per Liter (IU/L)Standard Deviation 6.68
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAlk. phosph.; Week 36; n= 60, 670.2 International Unit per Liter (IU/L)Standard Deviation 10.42
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsGGT; Week 16; n= 65, 68-2.1 International Unit per Liter (IU/L)Standard Deviation 10.18
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAlk. phosph.; Week 40; n= 61, 661.0 International Unit per Liter (IU/L)Standard Deviation 10.08
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsGGT; Week 20; n= 63, 681.7 International Unit per Liter (IU/L)Standard Deviation 19.02
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsGGT; Week 36; n= 60, 67-2.1 International Unit per Liter (IU/L)Standard Deviation 10.64
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsGGT; Week 24; n= 63, 66-1.7 International Unit per Liter (IU/L)Standard Deviation 11.83
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAlk. phosph.; Week 44; n= 61, 661.1 International Unit per Liter (IU/L)Standard Deviation 12.55
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsGGT; Week 28; n= 62, 66-1.9 International Unit per Liter (IU/L)Standard Deviation 11.71
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsALT; Week 40; n= 61, 660.3 International Unit per Liter (IU/L)Standard Deviation 9.01
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsGGT; Week 32; n= 61, 67-1.5 International Unit per Liter (IU/L)Standard Deviation 15.77
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsGGT; Week 40; n= 61, 66-0.2 International Unit per Liter (IU/L)Standard Deviation 16.05
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAlk. phosph.; Week 48; n= 61, 641.2 International Unit per Liter (IU/L)Standard Deviation 11.66
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsGGT; Week 44; n= 61, 66-2.9 International Unit per Liter (IU/L)Standard Deviation 8.26
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsGGT; Week 48; n= 61, 640.9 International Unit per Liter (IU/L)Standard Deviation 18.91
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAlk. phosph.; Week 52; n= 60, 650.3 International Unit per Liter (IU/L)Standard Deviation 12.3
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsGGT; Week 52; n= 60, 65-1.6 International Unit per Liter (IU/L)Standard Deviation 16.44
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsGGT; Week 60; n= 60, 65-4.8 International Unit per Liter (IU/L)Standard Deviation 16.45
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAlk.phosph.; Week 8; n= 67, 66-1.7 International Unit per Liter (IU/L)Standard Deviation 9.95
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAlk. phosph.; Week 56; n= 61, 63-0.9 International Unit per Liter (IU/L)Standard Deviation 12.04
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsLactate dehydro; Week 4; n= 68, 68-3.6 International Unit per Liter (IU/L)Standard Deviation 19.73
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsGGT; Week 56; n= 61, 63-5.0 International Unit per Liter (IU/L)Standard Deviation 16.77
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsLactate dehydro; Week 8; n= 67, 66-8.2 International Unit per Liter (IU/L)Standard Deviation 29.91
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAlk. phosph.; Week 60; n= 60, 65-1.5 International Unit per Liter (IU/L)Standard Deviation 13.16
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsLactate dehydro; Week 12; n= 65, 68-2.2 International Unit per Liter (IU/L)Standard Deviation 27.17
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsALT; Week 56; n= 61, 63-0.1 International Unit per Liter (IU/L)Standard Deviation 7.35
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsLactate dehydro; Week 16; n= 65, 68-2.6 International Unit per Liter (IU/L)Standard Deviation 32.13
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAbsolute AST; Baseline; n= 68, 6819.3 International Unit per Liter (IU/L)Standard Deviation 6.11
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsLactate dehydro; Week 20; n= 63, 682.2 International Unit per Liter (IU/L)Standard Deviation 26.8
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAbsolute Lactate dehydro; Baseline; n= 68, 68186.5 International Unit per Liter (IU/L)Standard Deviation 47.82
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsLactate dehydro; Week 24; n= 63, 66-4.3 International Unit per Liter (IU/L)Standard Deviation 26.22
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAbsolute ALT; Baseline; n= 68, 6819.9 International Unit per Liter (IU/L)Standard Deviation 8.91
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsLactate dehydro; Week 28; n= 61, 66-8.5 International Unit per Liter (IU/L)Standard Deviation 27.77
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAST; Week 8; n= 67, 66-0.4 International Unit per Liter (IU/L)Standard Deviation 4.77
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsLactate dehydro; Week 32; n= 61, 67-8.3 International Unit per Liter (IU/L)Standard Deviation 25.49
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAlk. phosph.; Week 24; n= 63, 66-1.1 International Unit per Liter (IU/L)Standard Deviation 10.65
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsLactate dehydro; Week 36; n= 60, 67-3.6 International Unit per Liter (IU/L)Standard Deviation 36.45
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAST; Week 12; n= 65, 680.5 International Unit per Liter (IU/L)Standard Deviation 4.41
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsLactate dehydro; Week 40; n= 61, 66-4.5 International Unit per Liter (IU/L)Standard Deviation 35.81
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsALT; Week 4; n= 68, 680.2 International Unit per Liter (IU/L)Standard Deviation 6.17
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsLactate dehydro; Week 44; n= 61, 66-2.7 International Unit per Liter (IU/L)Standard Deviation 33.4
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAST; Week 16; n= 65, 680.4 International Unit per Liter (IU/L)Standard Deviation 5.48
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsLactate dehydro; Week 48; n= 61, 640.8 International Unit per Liter (IU/L)Standard Deviation 43.82
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsALT; Week 48; n= 61, 641.7 International Unit per Liter (IU/L)Standard Deviation 9.04
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsLactate dehydro; Week 52; n= 60, 65-0.1 International Unit per Liter (IU/L)Standard Deviation 34.99
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAST; Week 20; n= 63, 680.8 International Unit per Liter (IU/L)Standard Deviation 4.66
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsLactate dehydro; Week 56; n= 61, 63-5.2 International Unit per Liter (IU/L)Standard Deviation 32.69
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsALT; Week 8; n= 67, 66-0.9 International Unit per Liter (IU/L)Standard Deviation 5.66
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsLactate dehydro; Week 60; n= 60, 65-3.5 International Unit per Liter (IU/L)Standard Deviation 34.15
PlaceboChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAST; Week 24; n= 63, 660.0 International Unit per Liter (IU/L)Standard Deviation 4.46
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsLactate dehydro; Week 60; n= 60, 65-12.4 International Unit per Liter (IU/L)Standard Deviation 33.23
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsALT; Week 40; n= 61, 66-2.3 International Unit per Liter (IU/L)Standard Deviation 11.7
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsALT; Week 44; n= 61, 66-2.7 International Unit per Liter (IU/L)Standard Deviation 9.51
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsALT; Week 48; n= 61, 64-1.6 International Unit per Liter (IU/L)Standard Deviation 15.47
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsALT; Week 52; n= 60, 65-2.8 International Unit per Liter (IU/L)Standard Deviation 12.87
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsALT; Week 56; n= 61, 63-3.6 International Unit per Liter (IU/L)Standard Deviation 12.79
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsALT; Week 60; n= 60, 65-4.7 International Unit per Liter (IU/L)Standard Deviation 14.11
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAbsolute Alk.phosph.; Baseline; n= 68, 6860.4 International Unit per Liter (IU/L)Standard Deviation 20.9
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAlk.phosph.; Week 4; n= 68, 68-3.2 International Unit per Liter (IU/L)Standard Deviation 10.01
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAlk.phosph.; Week 8; n= 67, 66-1.7 International Unit per Liter (IU/L)Standard Deviation 11.56
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAlk. phosph.; Week 36; n= 60, 674.8 International Unit per Liter (IU/L)Standard Deviation 14.71
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAST; Week 32; n= 61, 67-1.3 International Unit per Liter (IU/L)Standard Deviation 10.67
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsCreatinine kinase; Week 4; n= 68, 682.0 International Unit per Liter (IU/L)Standard Deviation 60.92
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsCreatinine kinase; Week 40; n= 61, 662.8 International Unit per Liter (IU/L)Standard Deviation 62.74
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsCreatinine kinase; Week 52; n= 60, 650.2 International Unit per Liter (IU/L)Standard Deviation 53.45
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsGGT; Week 32; n= 61, 67-3.6 International Unit per Liter (IU/L)Standard Deviation 17.87
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsGGT; Week 36; n= 60, 67-4.7 International Unit per Liter (IU/L)Standard Deviation 14.96
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsGGT; Week 52; n= 60, 65-4.2 International Unit per Liter (IU/L)Standard Deviation 13.53
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsGGT; Week 56; n= 61, 63-3.6 International Unit per Liter (IU/L)Standard Deviation 17.02
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAbsolute ALT; Baseline; n= 68, 6821.3 International Unit per Liter (IU/L)Standard Deviation 14.22
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsALT; Week 4; n= 68, 68-2.2 International Unit per Liter (IU/L)Standard Deviation 8.59
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsALT; Week 8; n= 67, 66-1.7 International Unit per Liter (IU/L)Standard Deviation 10.14
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsALT; Week 12; n= 65, 68-0.7 International Unit per Liter (IU/L)Standard Deviation 12.65
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsALT; Week 16; n= 65, 68-2.2 International Unit per Liter (IU/L)Standard Deviation 9.73
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsALT; Week 20; n= 63, 68-1.2 International Unit per Liter (IU/L)Standard Deviation 12.3
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsALT; Week 24; n= 63, 66-0.2 International Unit per Liter (IU/L)Standard Deviation 15.77
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsALT; Week 28; n= 62, 66-0.4 International Unit per Liter (IU/L)Standard Deviation 13.62
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsALT; Week 32; n= 61, 67-2.4 International Unit per Liter (IU/L)Standard Deviation 11.3
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAlk. phosph.; Week 12; n= 65, 68-1.1 International Unit per Liter (IU/L)Standard Deviation 12.99
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAlk. phosph.; Week 16; n= 65, 68-1.1 International Unit per Liter (IU/L)Standard Deviation 14.61
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAlk. phosph.; Week 20; n= 63, 684.4 International Unit per Liter (IU/L)Standard Deviation 21.9
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAlk. phosph.; Week 24; n= 63, 662.8 International Unit per Liter (IU/L)Standard Deviation 17.64
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAlk. phosph.; Week 28; n= 62, 664.9 International Unit per Liter (IU/L)Standard Deviation 17.17
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAlk. phosph.; Week 32; n= 61, 674.4 International Unit per Liter (IU/L)Standard Deviation 15.83
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAlk. phosph.; Week 40; n= 61, 666.2 International Unit per Liter (IU/L)Standard Deviation 18.43
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAlk. phosph.; Week 44; n= 61, 665.1 International Unit per Liter (IU/L)Standard Deviation 16.53
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAlk. phosph.; Week 48; n= 61, 645.1 International Unit per Liter (IU/L)Standard Deviation 17.56
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAlk. phosph.; Week 52; n= 60, 652.3 International Unit per Liter (IU/L)Standard Deviation 14.47
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAlk. phosph.; Week 56; n= 61, 631.7 International Unit per Liter (IU/L)Standard Deviation 16.42
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAlk. phosph.; Week 60; n= 60, 651.0 International Unit per Liter (IU/L)Standard Deviation 15.08
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAbsolute AST; Baseline; n= 68, 6821.8 International Unit per Liter (IU/L)Standard Deviation 10.73
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAST; Week 4; n= 68, 68-1.7 International Unit per Liter (IU/L)Standard Deviation 8.61
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAST; Week 8; n= 67, 66-1.0 International Unit per Liter (IU/L)Standard Deviation 8.21
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAST; Week 12; n= 65, 68-0.7 International Unit per Liter (IU/L)Standard Deviation 9.62
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAST; Week 16; n= 65, 68-0.6 International Unit per Liter (IU/L)Standard Deviation 7.9
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAST; Week 20; n= 63, 68-0.6 International Unit per Liter (IU/L)Standard Deviation 8.49
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAST; Week 24; n= 63, 66-0.4 International Unit per Liter (IU/L)Standard Deviation 10.44
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAST; Week 28; n= 61, 66-0.4 International Unit per Liter (IU/L)Standard Deviation 10.59
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAST; Week 36; n= 60, 67-2.2 International Unit per Liter (IU/L)Standard Deviation 9.61
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAST; Week 40; n= 61, 66-1.6 International Unit per Liter (IU/L)Standard Deviation 8.97
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAST; Week 44; n= 61, 66-2.4 International Unit per Liter (IU/L)Standard Deviation 9.02
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAST; Week 48; n= 61, 64-2.3 International Unit per Liter (IU/L)Standard Deviation 10.14
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAST; Week 52; n= 60, 65-3.0 International Unit per Liter (IU/L)Standard Deviation 10.49
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAST; Week 56; n= 61, 63-2.8 International Unit per Liter (IU/L)Standard Deviation 10.64
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAST; Week 60; n= 60, 65-3.7 International Unit per Liter (IU/L)Standard Deviation 10.92
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAbsolute Creatinine kinase; Baseline; n= 68, 6888.8 International Unit per Liter (IU/L)Standard Deviation 75.18
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsCreatinine kinase; Week 8; n= 67, 663.5 International Unit per Liter (IU/L)Standard Deviation 50.48
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsCreatinine kinase; Week 12; n= 65, 686.1 International Unit per Liter (IU/L)Standard Deviation 40.86
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsCreatinine kinase; Week 16; n= 65, 680.5 International Unit per Liter (IU/L)Standard Deviation 49.65
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsCreatinine kinase; Week 20; n= 63, 686.5 International Unit per Liter (IU/L)Standard Deviation 54.83
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsCreatinine kinase; Week 24; n= 63, 666.0 International Unit per Liter (IU/L)Standard Deviation 66.69
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsCreatinine kinase; Week 28; n= 62, 666.3 International Unit per Liter (IU/L)Standard Deviation 55.84
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsCreatinine kinase; Week 32; n= 61, 670.2 International Unit per Liter (IU/L)Standard Deviation 49.68
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsCreatinine kinase; Week 36; n= 60, 674.9 International Unit per Liter (IU/L)Standard Deviation 52.71
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsCreatinine kinase; Week 44; n= 61, 66-2.4 International Unit per Liter (IU/L)Standard Deviation 62.13
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsCreatinine kinase; Week 48; n= 61, 64-2.6 International Unit per Liter (IU/L)Standard Deviation 90.09
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsCreatinine kinase; Week 56; n= 61, 63-0.2 International Unit per Liter (IU/L)Standard Deviation 62.08
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsCreatinine kinase; Week 60; n= 60, 650.4 International Unit per Liter (IU/L)Standard Deviation 61.45
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAbsolute GGT; Baseline; n= 68, 6830.1 International Unit per Liter (IU/L)Standard Deviation 27.24
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsGGT; Week 4; n= 68, 68-2.0 International Unit per Liter (IU/L)Standard Deviation 9.68
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsGGT; Week 8; n= 67, 66-0.6 International Unit per Liter (IU/L)Standard Deviation 17.99
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsGGT; Week 12; n= 65, 68-1.9 International Unit per Liter (IU/L)Standard Deviation 18.7
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsGGT; Week 16; n= 65, 68-1.5 International Unit per Liter (IU/L)Standard Deviation 21.36
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsGGT; Week 20; n= 63, 68-1.1 International Unit per Liter (IU/L)Standard Deviation 24.5
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsGGT; Week 24; n= 63, 66-3.3 International Unit per Liter (IU/L)Standard Deviation 22.52
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsGGT; Week 28; n= 62, 66-3.1 International Unit per Liter (IU/L)Standard Deviation 16.86
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsGGT; Week 40; n= 61, 66-0.3 International Unit per Liter (IU/L)Standard Deviation 19.75
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsGGT; Week 44; n= 61, 66-2.7 International Unit per Liter (IU/L)Standard Deviation 15.25
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsGGT; Week 48; n= 61, 64-3.0 International Unit per Liter (IU/L)Standard Deviation 16.51
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsGGT; Week 60; n= 60, 65-5.6 International Unit per Liter (IU/L)Standard Deviation 15.37
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsAbsolute Lactate dehydro; Baseline; n= 68, 68179.6 International Unit per Liter (IU/L)Standard Deviation 38.88
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsLactate dehydro; Week 4; n= 68, 68-2.3 International Unit per Liter (IU/L)Standard Deviation 27.8
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsLactate dehydro; Week 8; n= 67, 66-5.3 International Unit per Liter (IU/L)Standard Deviation 24.46
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsLactate dehydro; Week 12; n= 65, 68-7.7 International Unit per Liter (IU/L)Standard Deviation 25.56
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsLactate dehydro; Week 16; n= 65, 68-10.6 International Unit per Liter (IU/L)Standard Deviation 26.12
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsLactate dehydro; Week 20; n= 63, 68-13.7 International Unit per Liter (IU/L)Standard Deviation 25.79
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsLactate dehydro; Week 24; n= 63, 66-13.5 International Unit per Liter (IU/L)Standard Deviation 26.99
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsLactate dehydro; Week 28; n= 61, 66-15.9 International Unit per Liter (IU/L)Standard Deviation 30.44
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsLactate dehydro; Week 32; n= 61, 67-17.1 International Unit per Liter (IU/L)Standard Deviation 24.88
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsLactate dehydro; Week 36; n= 60, 67-16.2 International Unit per Liter (IU/L)Standard Deviation 30.54
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsLactate dehydro; Week 40; n= 61, 66-13.5 International Unit per Liter (IU/L)Standard Deviation 36.31
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsLactate dehydro; Week 44; n= 61, 66-17.0 International Unit per Liter (IU/L)Standard Deviation 31.37
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsLactate dehydro; Week 48; n= 61, 64-19.0 International Unit per Liter (IU/L)Standard Deviation 30.66
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsLactate dehydro; Week 52; n= 60, 65-17.8 International Unit per Liter (IU/L)Standard Deviation 33.45
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsLactate dehydro; Week 56; n= 61, 63-16.0 International Unit per Liter (IU/L)Standard Deviation 30.87
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) LevelsALT; Week 36; n= 60, 67-3.0 International Unit per Liter (IU/L)Standard Deviation 11.66
Secondary

Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels

Blood samples were collected to evaluate change from Baseline in albumin and protein levels values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.

Time frame: Baseline and up to Week 60

Population: Safety Population

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAlbumin; Week 48; n= 61, 64-0.4 gram per liter (g/L)Standard Deviation 2.74
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsProtein; Week 60; n= 60, 65-0.4 gram per liter (g/L)Standard Deviation 5.88
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAlbumin; Week 52; n= 60, 65-0.5 gram per liter (g/L)Standard Deviation 2.45
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAlbumin; Week 16; n= 65, 68-0.6 gram per liter (g/L)Standard Deviation 2.57
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAlbumin; Week 56; n= 61, 63-0.7 gram per liter (g/L)Standard Deviation 2.84
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAlbumin; Week 32; n= 61, 67-0.4 gram per liter (g/L)Standard Deviation 2.71
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAlbumin; Week 60; n= 60, 65-0.9 gram per liter (g/L)Standard Deviation 2.55
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAlbumin; Week 20; n= 63, 68-0.1 gram per liter (g/L)Standard Deviation 2.35
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAbsolute Protein; Baseline; n= 68, 6867.7 gram per liter (g/L)Standard Deviation 4.26
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAbsolute Albumin; Baseline; n= 68, 6843.4 gram per liter (g/L)Standard Deviation 2.45
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsProtein; Week 4; n= 68, 68-0.8 gram per liter (g/L)Standard Deviation 3
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAlbumin; Week 24; n= 63, 660.0 gram per liter (g/L)Standard Deviation 2.8
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsProtein; Week 12; n= 65, 68-0.6 gram per liter (g/L)Standard Deviation 3.57
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsProtein; Week 8; n= 67, 66-1.5 gram per liter (g/L)Standard Deviation 2.97
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsProtein; Week 16; n= 65, 68-0.3 gram per liter (g/L)Standard Deviation 3.56
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAlbumin; Week 28; n= 62, 66-0.2 gram per liter (g/L)Standard Deviation 2.67
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsProtein; Week 24; n= 63, 660.2 gram per liter (g/L)Standard Deviation 3.99
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAlbumin; Week 4; n= 68, 68-0.6 gram per liter (g/L)Standard Deviation 2.25
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsProtein; Week 28; n= 62, 66-0.2 gram per liter (g/L)Standard Deviation 4.13
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsProtein; Week 20; n= 63, 680.0 gram per liter (g/L)Standard Deviation 3.21
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsProtein; Week 32; n= 61, 67-0.5 gram per liter (g/L)Standard Deviation 4.09
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAlbumin; Week 36; n= 60, 67-0.1 gram per liter (g/L)Standard Deviation 2.58
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsProtein; Week 36; n= 60, 67-0.2 gram per liter (g/L)Standard Deviation 3.82
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAlbumin; Week 8; n= 67, 66-0.8 gram per liter (g/L)Standard Deviation 2.16
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsProtein; Week 40; n= 61, 66-0.4 gram per liter (g/L)Standard Deviation 3.48
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAlbumin; Week 40; n= 61, 66-0.2 gram per liter (g/L)Standard Deviation 2.98
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsProtein; Week 44; n= 61, 660.4 gram per liter (g/L)Standard Deviation 4.43
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsProtein; week 56; n= 61, 63-0.1 gram per liter (g/L)Standard Deviation 4.77
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsProtein; Week 48; n= 61, 64-0.5 gram per liter (g/L)Standard Deviation 3.94
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAlbumin; Week 44; n= 61, 660.3 gram per liter (g/L)Standard Deviation 2.95
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsProtein; Week 52; n= 60, 65-0.3 gram per liter (g/L)Standard Deviation 3.75
PlaceboChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAlbumin; Week 12; n= 65, 68-0.2 gram per liter (g/L)Standard Deviation 2.47
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsProtein; Week 60; n= 60, 65-0.7 gram per liter (g/L)Standard Deviation 4.17
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsProtein; Week 8; n= 67, 66-0.9 gram per liter (g/L)Standard Deviation 3.6
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsProtein; Week 20; n= 63, 680.1 gram per liter (g/L)Standard Deviation 4.28
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsProtein; Week 52; n= 60, 65-0.4 gram per liter (g/L)Standard Deviation 4.08
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAbsolute Albumin; Baseline; n= 68, 6843.5 gram per liter (g/L)Standard Deviation 3.01
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAlbumin; Week 4; n= 68, 68-0.1 gram per liter (g/L)Standard Deviation 2.16
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAlbumin; Week 8; n= 67, 66-0.6 gram per liter (g/L)Standard Deviation 2.72
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAlbumin; Week 12; n= 65, 68-0.4 gram per liter (g/L)Standard Deviation 2.64
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAlbumin; Week 16; n= 65, 68-0.6 gram per liter (g/L)Standard Deviation 2.54
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAlbumin; Week 20; n= 63, 68-0.2 gram per liter (g/L)Standard Deviation 2.92
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAlbumin; Week 24; n= 63, 660.1 gram per liter (g/L)Standard Deviation 2.72
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAlbumin; Week 28; n= 62, 660.1 gram per liter (g/L)Standard Deviation 2.67
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAlbumin; Week 32; n= 61, 67-0.1 gram per liter (g/L)Standard Deviation 2.69
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAlbumin; Week 36; n= 60, 670.3 gram per liter (g/L)Standard Deviation 3.01
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAlbumin; Week 40; n= 61, 660.2 gram per liter (g/L)Standard Deviation 2.82
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAlbumin; Week 44; n= 61, 66-0.3 gram per liter (g/L)Standard Deviation 2.87
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAlbumin; Week 48; n= 61, 64-0.3 gram per liter (g/L)Standard Deviation 2.77
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAlbumin; Week 52; n= 60, 65-0.3 gram per liter (g/L)Standard Deviation 3.1
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAlbumin; Week 56; n= 61, 63-0.5 gram per liter (g/L)Standard Deviation 2.88
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAlbumin; Week 60; n= 60, 65-0.7 gram per liter (g/L)Standard Deviation 3.04
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsAbsolute Protein; Baseline; n= 68, 6867.3 gram per liter (g/L)Standard Deviation 4.46
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsProtein; Week 4; n= 68, 68-0.5 gram per liter (g/L)Standard Deviation 3.19
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsProtein; Week 12; n= 65, 68-0.6 gram per liter (g/L)Standard Deviation 3.3
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsProtein; Week 16; n= 65, 68-0.8 gram per liter (g/L)Standard Deviation 3.93
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsProtein; Week 24; n= 63, 660.0 gram per liter (g/L)Standard Deviation 3.96
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsProtein; Week 28; n= 62, 66-0.1 gram per liter (g/L)Standard Deviation 3.59
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsProtein; Week 32; n= 61, 67-0.4 gram per liter (g/L)Standard Deviation 3.91
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsProtein; Week 36; n= 60, 670.2 gram per liter (g/L)Standard Deviation 4.45
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsProtein; Week 40; n= 61, 660.1 gram per liter (g/L)Standard Deviation 3.98
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsProtein; Week 44; n= 61, 66-0.6 gram per liter (g/L)Standard Deviation 4.19
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsProtein; Week 48; n= 61, 64-0.5 gram per liter (g/L)Standard Deviation 4.29
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Albumin and Protein LevelsProtein; week 56; n= 61, 63-0.5 gram per liter (g/L)Standard Deviation 4.21
Secondary

Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels

Blood samples were collected to evaluate change from Baseline in direct, indirect and total bilirubin and creatinine values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.

Time frame: Baseline and up to Week 60

Population: Safety Population

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsTotal bilirubin; Week 40; n= 61, 66-0.2 micromole per liter (µmol/L)Standard Deviation 3.22
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsIndirect bilirubin; Week 52; n= 60, 65-0.2 micromole per liter (µmol/L)Standard Deviation 2.84
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsTotal bilirubin; Week 48; n= 61, 64-0.2 micromole per liter (µmol/L)Standard Deviation 2.59
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsIndirect bilirubin; Week 40; n= 61, 66-0.1 micromole per liter (µmol/L)Standard Deviation 2.56
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsTotal bilirubin; Week 52; n= 60, 65-0.1 micromole per liter (µmol/L)Standard Deviation 3.41
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsTotal bilirubin; Week 24; n= 63, 66-0.3 micromole per liter (µmol/L)Standard Deviation 3.36
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsTotal bilirubin; Week 56; n= 61, 63-0.8 micromole per liter (µmol/L)Standard Deviation 3.17
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsIndirect bilirubin; Week 44; n= 61, 66-0.1 micromole per liter (µmol/L)Standard Deviation 2.19
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsCreatinine; Week 4; n= 68, 680.69 micromole per liter (µmol/L)Standard Deviation 7.195
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsIndirect bilirubin; Week 56; n= 61, 63-0.9 micromole per liter (µmol/L)Standard Deviation 2.72
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsCreatinine; Week 12; n= 65, 681.50 micromole per liter (µmol/L)Standard Deviation 9.029
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsDirect bilirubin; Week 56; n= 61, 630.1 micromole per liter (µmol/L)Standard Deviation 1.08
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsAbsolute Creatinine; Baseline; n= 68, 6875.49 micromole per liter (µmol/L)Standard Deviation 12.878
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsCreatinine; Week 20; n= 63, 681.73 micromole per liter (µmol/L)Standard Deviation 6.916
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsDirect bilirubin; Week 60; n= 60, 650.1 micromole per liter (µmol/L)Standard Deviation 1.1
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsCreatinine; Week 24; n= 63, 660.74 micromole per liter (µmol/L)Standard Deviation 7.775
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsIndirect bilirubin; Week 60; n= 60, 65-0.6 micromole per liter (µmol/L)Standard Deviation 2.64
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsCreatinine; Week 28; n= 62, 660.96 micromole per liter (µmol/L)Standard Deviation 7.504
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsAbsolute Indirect bilirubin; Baseline; n= 68, 687.7 micromole per liter (µmol/L)Standard Deviation 5.09
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsCreatinine; Week 32; n= 61, 671.89 micromole per liter (µmol/L)Standard Deviation 9.809
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsTotal bilirubin; Week 44; n= 61, 660.0 micromole per liter (µmol/L)Standard Deviation 2.5
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsCreatinine; Week 36; n= 60, 671.42 micromole per liter (µmol/L)Standard Deviation 6.957
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsIndirect bilirubin; Week 4; n= 68, 68-0.8 micromole per liter (µmol/L)Standard Deviation 3.68
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsCreatinine; Week 40; n= 61, 661.16 micromole per liter (µmol/L)Standard Deviation 8.253
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsIndirect bilirubin; Week 16; n= 65, 68-0.9 micromole per liter (µmol/L)Standard Deviation 3.67
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsCreatinine; Week 44; n= 61, 662.14 micromole per liter (µmol/L)Standard Deviation 8.991
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsIndirect bilirubin; Week 8; n= 67, 66-1.2 micromole per liter (µmol/L)Standard Deviation 3.86
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsCreatinine; Week 48; n= 61, 641.53 micromole per liter (µmol/L)Standard Deviation 7.972
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsTotal bilirubin; Week 28; n= 62, 66-0.8 micromole per liter (µmol/L)Standard Deviation 3.13
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsCreatinine; Week 52; n= 60, 650.52 micromole per liter (µmol/L)Standard Deviation 7.719
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsIndirect bilirubin; Week 12; n= 65, 68-0.3 micromole per liter (µmol/L)Standard Deviation 2.61
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsCreatinine; Week 56; n= 61, 631.39 micromole per liter (µmol/L)Standard Deviation 7.367
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsIndirect bilirubin; Week 20; n= 63, 68-0.5 micromole per liter (µmol/L)Standard Deviation 2.37
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsCreatinine; Week 60; n= 60, 650.34 micromole per liter (µmol/L)Standard Deviation 7.014
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsAbsolute Total bilirubin; Baseline; n= 68, 689.8 micromole per liter (µmol/L)Standard Deviation 6.14
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsAbsolute Direct bilirubin; Baseline; n= 68, 682.1 micromole per liter (µmol/L)Standard Deviation 1.33
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsCreatinine; Week 8; n= 67, 661.87 micromole per liter (µmol/L)Standard Deviation 7.505
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsDirect bilirubin; Week 4; n= 68, 680.0 micromole per liter (µmol/L)Standard Deviation 1.06
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsTotal bilirubin; week 4; n= 68, 68-0.9 micromole per liter (µmol/L)Standard Deviation 4.02
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsDirect bilirubin; Week 8; n= 67, 660.0 micromole per liter (µmol/L)Standard Deviation 1.01
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsCreatinine; Week 16; n= 65, 681.53 micromole per liter (µmol/L)Standard Deviation 10.012
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsDirect bilirubin; Week 12; n= 65, 680.0 micromole per liter (µmol/L)Standard Deviation 0.97
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsTotal bilirubin; Week 8; n= 67, 66-1.2 micromole per liter (µmol/L)Standard Deviation 4.38
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsDirect bilirubin; Week 16; n= 65, 68-0.2 micromole per liter (µmol/L)Standard Deviation 0.96
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsIndirect bilirubin; Week 28; n= 62, 66-0.7 micromole per liter (µmol/L)Standard Deviation 2.6
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsDirect bilirubin; Week 20; n= 63, 680.0 micromole per liter (µmol/L)Standard Deviation 0.86
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsTotal bilirubin; Week 12; n= 65, 68-0.3 micromole per liter (µmol/L)Standard Deviation 3.01
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsDirect bilirubin; Week 24; n= 63, 660.1 micromole per liter (µmol/L)Standard Deviation 0.9
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsIndirect bilirubin; Week 24; n= 63, 66-0.4 micromole per liter (µmol/L)Standard Deviation 2.94
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsDirect bilirubin; Week 28; n= 62, 66-0.1 micromole per liter (µmol/L)Standard Deviation 1.2
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsTotal bilirubin; Week 16; n= 65, 68-1.1 micromole per liter (µmol/L)Standard Deviation 4.15
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsDirect bilirubin; Week 32; n= 61, 67-0.2 micromole per liter (µmol/L)Standard Deviation 0.99
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsIndirect bilirubin; Week 32; n= 61, 66-0.9 micromole per liter (µmol/L)Standard Deviation 2.48
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsDirect bilirubin; Week 36; n= 60, 67-0.1 micromole per liter (µmol/L)Standard Deviation 1.11
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsTotal bilirubin; Week 20; n= 63, 68-0.5 micromole per liter (µmol/L)Standard Deviation 2.9
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsDirect bilirubin; Week 40; n= 61, 660.0 micromole per liter (µmol/L)Standard Deviation 1.11
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsTotal bilirubin; Week 32; n= 61, 67-1.1 micromole per liter (µmol/L)Standard Deviation 3.07
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsDirect bilirubin; Week 44; n= 61, 660.1 micromole per liter (µmol/L)Standard Deviation 0.93
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsTotal bilirubin; Week 60; n= 60, 65-0.5 micromole per liter (µmol/L)Standard Deviation 3.21
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsDirect bilirubin; Week 48; n= 61, 640.1 micromole per liter (µmol/L)Standard Deviation 0.99
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsTotal bilirubin; Week 36; n= 60, 67-0.7 micromole per liter (µmol/L)Standard Deviation 3.39
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsDirect bilirubin; Week 52; n= 60, 650.1 micromole per liter (µmol/L)Standard Deviation 1.05
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsIndirect bilirubin; Week 36; n= 60, 67-0.6 micromole per liter (µmol/L)Standard Deviation 2.77
PlaceboChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsIndirect bilirubin; Week 48; n= 61, 64-0.3 micromole per liter (µmol/L)Standard Deviation 2.19
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsCreatinine; Week 24; n= 63, 660.06 micromole per liter (µmol/L)Standard Deviation 6.538
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsTotal bilirubin; Week 24; n= 63, 660.0 micromole per liter (µmol/L)Standard Deviation 2.71
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsTotal bilirubin; Week 28; n= 62, 660.3 micromole per liter (µmol/L)Standard Deviation 4.43
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsTotal bilirubin; Week 44; n= 61, 660.1 micromole per liter (µmol/L)Standard Deviation 3.64
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsTotal bilirubin; Week 60; n= 60, 650.0 micromole per liter (µmol/L)Standard Deviation 3.42
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsAbsolute Creatinine; Baseline; n= 68, 6873.00 micromole per liter (µmol/L)Standard Deviation 12.289
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsCreatinine; Week 4; n= 68, 682.09 micromole per liter (µmol/L)Standard Deviation 5.533
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsIndirect bilirubin; Week 48; n= 61, 64-0.1 micromole per liter (µmol/L)Standard Deviation 3.13
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsIndirect bilirubin; Week 52; n= 60, 650.5 micromole per liter (µmol/L)Standard Deviation 3.32
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsIndirect bilirubin; Week 56; n= 61, 630.4 micromole per liter (µmol/L)Standard Deviation 2.64
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsIndirect bilirubin; Week 60; n= 60, 65-0.1 micromole per liter (µmol/L)Standard Deviation 2.81
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsIndirect bilirubin; Week 16; n= 65, 680.1 micromole per liter (µmol/L)Standard Deviation 3.37
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsIndirect bilirubin; Week 20; n= 63, 680.2 micromole per liter (µmol/L)Standard Deviation 3
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsIndirect bilirubin; Week 24; n= 63, 660.0 micromole per liter (µmol/L)Standard Deviation 2.37
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsIndirect bilirubin; Week 28; n= 62, 660.1 micromole per liter (µmol/L)Standard Deviation 3.71
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsIndirect bilirubin; Week 32; n= 61, 66-0.2 micromole per liter (µmol/L)Standard Deviation 3.02
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsIndirect bilirubin; Week 36; n= 60, 670.0 micromole per liter (µmol/L)Standard Deviation 3.3
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsIndirect bilirubin; Week 40; n= 61, 66-0.2 micromole per liter (µmol/L)Standard Deviation 3.16
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsIndirect bilirubin; Week 44; n= 61, 660.1 micromole per liter (µmol/L)Standard Deviation 2.99
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsDirect bilirubin; Week 56; n= 61, 630.1 micromole per liter (µmol/L)Standard Deviation 1.06
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsDirect bilirubin; Week 60; n= 60, 650.1 micromole per liter (µmol/L)Standard Deviation 1.07
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsAbsolute Indirect bilirubin; Baseline; n= 68, 686.9 micromole per liter (µmol/L)Standard Deviation 3.38
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsIndirect bilirubin; Week 4; n= 68, 680.0 micromole per liter (µmol/L)Standard Deviation 3.06
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsIndirect bilirubin; Week 8; n= 67, 66-0.1 micromole per liter (µmol/L)Standard Deviation 2.94
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsIndirect bilirubin; Week 12; n= 65, 680.1 micromole per liter (µmol/L)Standard Deviation 2.79
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsAbsolute Total bilirubin; Baseline; n= 68, 688.8 micromole per liter (µmol/L)Standard Deviation 4.1
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsTotal bilirubin; week 4; n= 68, 680.1 micromole per liter (µmol/L)Standard Deviation 3.48
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsTotal bilirubin; Week 8; n= 67, 660.0 micromole per liter (µmol/L)Standard Deviation 3.5
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsTotal bilirubin; Week 12; n= 65, 680.1 micromole per liter (µmol/L)Standard Deviation 3.27
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsTotal bilirubin; Week 16; n= 65, 680.0 micromole per liter (µmol/L)Standard Deviation 4.14
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsTotal bilirubin; Week 32; n= 61, 67-0.1 micromole per liter (µmol/L)Standard Deviation 3.63
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsTotal bilirubin; Week 36; n= 60, 670.1 micromole per liter (µmol/L)Standard Deviation 4.09
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsTotal bilirubin; Week 40; n= 61, 66-0.3 micromole per liter (µmol/L)Standard Deviation 3.78
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsTotal bilirubin; Week 48; n= 61, 64-0.1 micromole per liter (µmol/L)Standard Deviation 3.77
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsTotal bilirubin; Week 52; n= 60, 650.7 micromole per liter (µmol/L)Standard Deviation 3.92
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsTotal bilirubin; Week 56; n= 61, 630.5 micromole per liter (µmol/L)Standard Deviation 3.24
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsCreatinine; Week 8; n= 67, 661.15 micromole per liter (µmol/L)Standard Deviation 6.737
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsCreatinine; Week 12; n= 65, 680.34 micromole per liter (µmol/L)Standard Deviation 7.006
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsCreatinine; Week 16; n= 65, 682.72 micromole per liter (µmol/L)Standard Deviation 6.702
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsCreatinine; Week 20; n= 63, 682.60 micromole per liter (µmol/L)Standard Deviation 7.739
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsTotal bilirubin; Week 20; n= 63, 680.3 micromole per liter (µmol/L)Standard Deviation 3.57
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsCreatinine; Week 28; n= 62, 661.02 micromole per liter (µmol/L)Standard Deviation 7.764
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsCreatinine; Week 32; n= 61, 671.85 micromole per liter (µmol/L)Standard Deviation 8.589
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsCreatinine; Week 36; n= 60, 670.40 micromole per liter (µmol/L)Standard Deviation 7.839
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsCreatinine; Week 40; n= 61, 660.34 micromole per liter (µmol/L)Standard Deviation 8.119
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsCreatinine; Week 44; n= 61, 660.04 micromole per liter (µmol/L)Standard Deviation 9.07
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsCreatinine; Week 48; n= 61, 64-2.25 micromole per liter (µmol/L)Standard Deviation 7.398
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsCreatinine; Week 52; n= 60, 65-1.35 micromole per liter (µmol/L)Standard Deviation 7.182
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsCreatinine; Week 56; n= 61, 63-0.30 micromole per liter (µmol/L)Standard Deviation 8.695
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsCreatinine; Week 60; n= 60, 65-1.22 micromole per liter (µmol/L)Standard Deviation 10.896
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsAbsolute Direct bilirubin; Baseline; n= 68, 681.9 micromole per liter (µmol/L)Standard Deviation 0.98
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsDirect bilirubin; Week 4; n= 68, 680.0 micromole per liter (µmol/L)Standard Deviation 0.84
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsDirect bilirubin; Week 8; n= 67, 660.1 micromole per liter (µmol/L)Standard Deviation 0.96
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsDirect bilirubin; Week 12; n= 65, 680.0 micromole per liter (µmol/L)Standard Deviation 1.04
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsDirect bilirubin; Week 16; n= 65, 68-0.1 micromole per liter (µmol/L)Standard Deviation 1.2
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsDirect bilirubin; Week 20; n= 63, 680.1 micromole per liter (µmol/L)Standard Deviation 1.03
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsDirect bilirubin; Week 24; n= 63, 660.0 micromole per liter (µmol/L)Standard Deviation 0.88
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsDirect bilirubin; Week 28; n= 62, 660.2 micromole per liter (µmol/L)Standard Deviation 1.15
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsDirect bilirubin; Week 32; n= 61, 670.1 micromole per liter (µmol/L)Standard Deviation 0.99
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsDirect bilirubin; Week 36; n= 60, 670.1 micromole per liter (µmol/L)Standard Deviation 1.17
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsDirect bilirubin; Week 40; n= 61, 660.0 micromole per liter (µmol/L)Standard Deviation 0.94
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsDirect bilirubin; Week 44; n= 61, 660.0 micromole per liter (µmol/L)Standard Deviation 1.12
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsDirect bilirubin; Week 48; n= 61, 640.0 micromole per liter (µmol/L)Standard Deviation 1.17
Mepolizumab 300mgChange From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine LevelsDirect bilirubin; Week 52; n= 60, 650.2 micromole per liter (µmol/L)Standard Deviation 1.06
Secondary

Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels

Blood samples were collected to evaluate change from Baseline in basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelet values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.

Time frame: Baseline and up to Week 60

Population: Safety Population

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLymphocytes; Week 32; n= 61, 660.244 10^9 cells/LStandard Deviation 0.9633
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsMonocytes; Week 20; n= 61, 660.132 10^9 cells/LStandard Deviation 0.2684
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsMonocytes; Week 24; n= 61, 660.061 10^9 cells/LStandard Deviation 0.229
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsMonocytes; Week 28; n= 62, 650.107 10^9 cells/LStandard Deviation 0.2363
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsMonocytes; Week 32; n= 61, 660.108 10^9 cells/LStandard Deviation 0.2839
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsMonocytes; Week 36; n= 60, 660.089 10^9 cells/LStandard Deviation 0.2992
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsMonocytes; Week 40; n= 61, 650.084 10^9 cells/LStandard Deviation 0.2495
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsMonocytes; Week 44; n= 59, 610.090 10^9 cells/LStandard Deviation 0.2494
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsMonocytes; Week 48; n= 59, 640.078 10^9 cells/LStandard Deviation 0.2261
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsMonocytes; Week 52; n= 60, 640.075 10^9 cells/LStandard Deviation 0.2407
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsMonocytes; Week 56; n= 59, 610.051 10^9 cells/LStandard Deviation 0.2104
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsMonocytes; Week 60; n= 58, 640.052 10^9 cells/LStandard Deviation 0.26
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsAbsolute Neutrophils; Baseline; n= 68, 687.500 10^9 cells/LStandard Deviation 2.7424
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsNeutrophils; Week 4; n= 66, 66-0.124 10^9 cells/LStandard Deviation 2.617
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsNeutrophils; Week 8; n= 65, 66-0.572 10^9 cells/LStandard Deviation 2.6791
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsNeutrophils; Week 12; n= 63, 65-0.797 10^9 cells/LStandard Deviation 2.2948
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsNeutrophils; Week 16; n= 64, 68-0.222 10^9 cells/LStandard Deviation 2.7666
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsNeutrophils; Week 20; n= 61, 66-0.560 10^9 cells/LStandard Deviation 2.3679
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsNeutrophils; Week 24; n= 61, 66-0.980 10^9 cells/LStandard Deviation 2.3151
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsNeutrophils; Week 28; n= 62, 65-0.555 10^9 cells/LStandard Deviation 2.3719
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsNeutrophils; Week 32; n= 61, 66-0.762 10^9 cells/LStandard Deviation 2.4952
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsNeutrophils; Week 36; n= 60, 66-0.509 10^9 cells/LStandard Deviation 2.8231
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsNeutrophils; Week 40; n= 61, 65-0.009 10^9 cells/LStandard Deviation 3.0467
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsAbsolute Basophils; Baselin; n= 68, 680.030 10^9 cells/LStandard Deviation 0.0253
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsBasophils; Week 4; n= 66, 66-0.002 10^9 cells/LStandard Deviation 0.0302
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsBasophils; Week 8; n= 65, 660.005 10^9 cells/LStandard Deviation 0.0285
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsBasophils; Week 12; n= 63, 650.007 10^9 cells/LStandard Deviation 0.0351
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsBasophils; Week 16; n= 64, 680.005 10^9 cells/LStandard Deviation 0.0333
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsBasophils; Week 20; n= 61, 660.005 10^9 cells/LStandard Deviation 0.0338
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsBasophils; Week 24; n= 61, 660.004 10^9 cells/LStandard Deviation 0.0341
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsBasophils; Week 28; n= 62, 650.006 10^9 cells/LStandard Deviation 0.0411
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsBasophils; Week 32; n= 61, 660.010 10^9 cells/LStandard Deviation 0.0467
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsBasophils; Week 36; n= 60, 660.009 10^9 cells/LStandard Deviation 0.0321
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsBasophils; Week 40; n= 61, 650.005 10^9 cells/LStandard Deviation 0.0357
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsBasophils; Week 44; n= 59, 610.008 10^9 cells/LStandard Deviation 0.0328
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsBasophils; Week 48; n= 59, 640.003 10^9 cells/LStandard Deviation 0.0408
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsBasophils; Week 52; n= 60, 640.004 10^9 cells/LStandard Deviation 0.0289
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsBasophils; Week 56; n= 59, 610.009 10^9 cells/LStandard Deviation 0.0381
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsBasophils; Week 60; n= 58, 640.002 10^9 cells/LStandard Deviation 0.0316
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsAbsolute Eosinophils; Baseline; n= 68, 680.362 10^9 cells/LStandard Deviation 0.5835
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsEosinophils; Week 4; n= 66, 66-0.054 10^9 cells/LStandard Deviation 0.3309
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsEosinophils; Week 8; n= 65, 660.103 10^9 cells/LStandard Deviation 0.2921
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsEosinophils; Week 12; n= 63, 650.027 10^9 cells/LStandard Deviation 0.3515
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsEosinophils; Week 16; n= 64, 680.058 10^9 cells/LStandard Deviation 0.4092
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsEosinophils; Week 20; n= 61, 660.162 10^9 cells/LStandard Deviation 0.59
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsEosinophils; Week 24; n= 61, 660.136 10^9 cells/LStandard Deviation 0.4044
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsNeutrophils; Week 44; n= 59, 61-0.020 10^9 cells/LStandard Deviation 3.3497
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsNeutrophils; Week 48; n= 59, 64-0.403 10^9 cells/LStandard Deviation 3.2656
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsNeutrophils; Week 52; n= 60, 64-0.391 10^9 cells/LStandard Deviation 3.4463
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsNeutrophils; Week 56; n= 59, 61-0.381 10^9 cells/LStandard Deviation 3.4297
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsNeutrophils; Week 60; n= 58, 64-0.048 10^9 cells/LStandard Deviation 3.5724
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsAbsolute Platelets; Baseline; n= 68, 68259.8 10^9 cells/LStandard Deviation 61.16
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsPlatelets; Week 4; n= 66, 674.5 10^9 cells/LStandard Deviation 38.14
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsPlatelets; Week 8; n= 66, 665.0 10^9 cells/LStandard Deviation 43.97
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsPlatelets; Week 12; n= 63, 653.1 10^9 cells/LStandard Deviation 50.6
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsPlatelets; Week 16; n= 64, 6815.4 10^9 cells/LStandard Deviation 71.2
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsPlatelets; Week 20; n= 61, 6812.3 10^9 cells/LStandard Deviation 49.92
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsPlatelets; Week 24; n= 62, 6510.9 10^9 cells/LStandard Deviation 50.38
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsPlatelets; Week 28; n= 62, 6613.3 10^9 cells/LStandard Deviation 55.12
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsPlatelets; Week 32; n= 61, 6712.1 10^9 cells/LStandard Deviation 45.36
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsPlatelets; Week 36; n= 60, 669.3 10^9 cells/LStandard Deviation 42.64
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsEosinophils; Week 28; n= 62, 650.172 10^9 cells/LStandard Deviation 0.4365
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsEosinophils; Week 32; n= 61, 660.079 10^9 cells/LStandard Deviation 0.3759
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsEosinophils; Week 36; n= 60, 660.086 10^9 cells/LStandard Deviation 0.3758
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsEosinophils; Week 40; n= 61, 650.022 10^9 cells/LStandard Deviation 0.4448
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsEosinophils; Week 44; n= 59, 610.051 10^9 cells/LStandard Deviation 0.4472
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsEosinophils; Week 48; n= 59, 640.109 10^9 cells/LStandard Deviation 0.3873
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsEosinophils; Week 52; n= 60, 640.055 10^9 cells/LStandard Deviation 0.3764
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsEosinophils; Week 56; n= 59, 610.071 10^9 cells/LStandard Deviation 0.4137
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsEosinophils; Week 60; n= 58, 640.111 10^9 cells/LStandard Deviation 0.4666
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsAbsolute Leukocytes; Baseline; n= 68, 689.91 10^9 cells/LStandard Deviation 2.714
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLeukocytes; Week 4; 66, 66-0.11 10^9 cells/LStandard Deviation 2.109
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLeukocytes; Week 8; n= 65, 66-0.18 10^9 cells/LStandard Deviation 2.562
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLeukocytes; Week 12; n= 63, 65-0.53 10^9 cells/LStandard Deviation 1.765
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsPlatelets; Week 40; n= 61, 6514.7 10^9 cells/LStandard Deviation 45.63
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsPlatelets; Week 44; n= 60, 6319.3 10^9 cells/LStandard Deviation 48.88
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsPlatelets; Week 48; n= 59, 6414.2 10^9 cells/LStandard Deviation 53.93
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsPlatelets; Week 52; n= 60, 6414.7 10^9 cells/LStandard Deviation 48.19
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsPlatelets; Week 56; n= 59, 6120.3 10^9 cells/LStandard Deviation 47.35
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsPlatelets; Week 60; n= 59, 6413.0 10^9 cells/LStandard Deviation 50.07
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLeukocytes; ; Week 16; n= 64, 680.01 10^9 cells/LStandard Deviation 2.567
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLeukocytes; Week 20; n= 61, 66-0.13 10^9 cells/LStandard Deviation 2.269
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLeukocytes; Week 24; n= 61, 66-0.73 10^9 cells/LStandard Deviation 2.11
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLeukocytes; Week 28; n= 62, 65-0.01 10^9 cells/LStandard Deviation 2.297
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLeukocytes; week 32; n= 61, 66-0.33 10^9 cells/LStandard Deviation 2.218
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLeukocytes; Week 36; n= 60, 66-0.17 10^9 cells/LStandard Deviation 2.501
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLeukocytes; Week 40; n= 61, 650.17 10^9 cells/LStandard Deviation 2.912
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLeukocytes; Week 44; n= 59, 610.25 10^9 cells/LStandard Deviation 3.166
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLeukocytes; Week 48; n= 59, 64-0.10 10^9 cells/LStandard Deviation 3.092
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLeukocytes; Week 52; n= 60, 64-0.12 10^9 cells/LStandard Deviation 3.114
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLeukocytes; Week 56; n= 59, 61-0.05 10^9 cells/LStandard Deviation 3.357
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLeukocytes; Week 60; n= 58, 640.19 10^9 cells/LStandard Deviation 3.533
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsAbsolute Lymphocytes; Baseline; n= 68, 681.638 10^9 cells/LStandard Deviation 0.9375
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLymphocytes; Week 4; n= 66, 660.031 10^9 cells/LStandard Deviation 0.899
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLymphocytes; Week 8; n= 65, 660.245 10^9 cells/LStandard Deviation 0.8804
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLymphocytes; Week 12; n= 63, 650.160 10^9 cells/LStandard Deviation 0.9043
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLymphocytes; Week 16; n= 64, 680.078 10^9 cells/LStandard Deviation 1.0337
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLymphocytes; Week 20; n= 61, 660.137 10^9 cells/LStandard Deviation 0.7984
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLymphocytes; Week 24; n= 61, 660.056 10^9 cells/LStandard Deviation 0.8778
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLymphocytes; Week 28; n= 62, 650.261 10^9 cells/LStandard Deviation 1.0966
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLymphocytes; Week 36; n= 60, 660.156 10^9 cells/LStandard Deviation 1.0399
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLymphocytes; Week 40; n= 61, 650.064 10^9 cells/LStandard Deviation 1.0537
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLymphocytes; Week 44; n= 59, 610.130 10^9 cells/LStandard Deviation 0.8773
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLymphocytes; Week 48; n=59, 640.106 10^9 cells/LStandard Deviation 0.8396
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLymphocytes; Week 52; n= 60, 640.144 10^9 cells/LStandard Deviation 0.9262
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLymphocytes; Week 56; n= 59, 610.200 10^9 cells/LStandard Deviation 0.8356
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLymphocytes; Week 60; n= 58, 640.076 10^9 cells/LStandard Deviation 0.8821
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsAbsolute Monocytes; Baseline; n= 68, 680.377 10^9 cells/LStandard Deviation 0.2126
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsMonocytes; week 4; n= 66, 660.038 10^9 cells/LStandard Deviation 0.2444
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsMonocytes; Week 8; n= 65, 660.052 10^9 cells/LStandard Deviation 0.2271
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsMonocytes; Week 12; n= 63, 650.077 10^9 cells/LStandard Deviation 0.2468
PlaceboChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsMonocytes; Week 16; n= 64, 680.086 10^9 cells/LStandard Deviation 0.279
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLymphocytes; Week 52; n= 60, 640.031 10^9 cells/LStandard Deviation 0.6244
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsMonocytes; Week 32; n= 61, 660.057 10^9 cells/LStandard Deviation 0.2069
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsMonocytes; Week 16; n= 64, 680.031 10^9 cells/LStandard Deviation 0.2157
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsPlatelets; Week 20; n= 61, 686.1 10^9 cells/LStandard Deviation 52.76
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsMonocytes; Week 20; n= 61, 660.030 10^9 cells/LStandard Deviation 0.1967
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLeukocytes; week 32; n= 61, 66-1.54 10^9 cells/LStandard Deviation 2.725
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsMonocytes; Week 24; n= 61, 660.013 10^9 cells/LStandard Deviation 0.2412
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsPlatelets; Week 24; n= 62, 65-4.2 10^9 cells/LStandard Deviation 40.07
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsMonocytes; Week 28; n= 62, 650.035 10^9 cells/LStandard Deviation 0.235
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLymphocytes; Week 24; n= 61, 660.011 10^9 cells/LStandard Deviation 0.8077
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsPlatelets; Week 28; n= 62, 665.4 10^9 cells/LStandard Deviation 41.57
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsMonocytes; Week 36; n= 60, 660.072 10^9 cells/LStandard Deviation 0.2416
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLeukocytes; Week 36; n= 60, 66-1.37 10^9 cells/LStandard Deviation 2.578
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsMonocytes; Week 40; n= 61, 650.050 10^9 cells/LStandard Deviation 0.2096
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsPlatelets; Week 32; n= 61, 670.7 10^9 cells/LStandard Deviation 43.85
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsMonocytes; Week 44; n= 59, 610.077 10^9 cells/LStandard Deviation 0.2176
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsMonocytes; Week 8; n= 65, 660.039 10^9 cells/LStandard Deviation 0.1988
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsMonocytes; Week 48; n= 59, 640.025 10^9 cells/LStandard Deviation 0.2235
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsPlatelets; Week 36; n= 60, 660.6 10^9 cells/LStandard Deviation 37.87
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsMonocytes; Week 52; n= 60, 640.024 10^9 cells/LStandard Deviation 0.2098
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLeukocytes; Week 40; n= 61, 65-1.28 10^9 cells/LStandard Deviation 3.284
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsMonocytes; Week 56; n= 59, 610.037 10^9 cells/LStandard Deviation 0.2303
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsEosinophils; Week 28; n= 62, 65-0.360 10^9 cells/LStandard Deviation 0.8258
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsMonocytes; Week 60; n= 58, 640.001 10^9 cells/LStandard Deviation 0.2165
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLymphocytes; Week 28; n= 62, 650.004 10^9 cells/LStandard Deviation 0.7328
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsAbsolute Neutrophils; Baseline; n= 68, 687.198 10^9 cells/LStandard Deviation 2.9732
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsEosinophils; Week 32; n= 61, 66-0.347 10^9 cells/LStandard Deviation 0.831
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsNeutrophils; Week 4; n= 66, 66-0.583 10^9 cells/LStandard Deviation 2.2703
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLeukocytes; Week 44; n= 59, 61-1.57 10^9 cells/LStandard Deviation 2.198
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsNeutrophils; Week 8; n= 65, 66-0.443 10^9 cells/LStandard Deviation 2.56476
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsEosinophils; Week 36; n= 60, 66-0.347 10^9 cells/LStandard Deviation 0.8388
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsNeutrophils; Week 12; n= 63, 65-0.799 10^9 cells/LStandard Deviation 2.6278
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLymphocytes; Week 32; n= 61, 660.031 10^9 cells/LStandard Deviation 0.7986
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsNeutrophils; Week 16; n= 64, 68-0.914 10^9 cells/LStandard Deviation 2.6034
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsEosinophils; Week 40; n= 61, 65-0.358 10^9 cells/LStandard Deviation 0.8396
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsNeutrophils; Week 20; n= 61, 66-1.243 10^9 cells/LStandard Deviation 2.6857
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLeukocytes; Week 48; n= 59, 64-1.46 10^9 cells/LStandard Deviation 2.546
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsNeutrophils; Week 24; n= 61, 66-1.120 10^9 cells/LStandard Deviation 2.8349
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsEosinophils; Week 44; n= 59, 61-0.365 10^9 cells/LStandard Deviation 0.8604
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsNeutrophils; Week 28; n= 62, 65-1.335 10^9 cells/LStandard Deviation 2.9428
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLymphocytes; Week 56; n= 59, 610.128 10^9 cells/LStandard Deviation 0.7824
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsNeutrophils; Week 32; n= 61, 66-1.286 10^9 cells/LStandard Deviation 2.6995
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsEosinophils; Week 48; n= 59, 64-0.364 10^9 cells/LStandard Deviation 0.854
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsNeutrophils; Week 36; n= 60, 66-1.131 10^9 cells/LStandard Deviation 2.4261
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLeukocytes; Week 52; n= 60, 64-1.50 10^9 cells/LStandard Deviation 2.521
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsEosinophils; Week 52; n= 60, 64-0.341 10^9 cells/LStandard Deviation 0.8456
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsAbsolute Basophils; Baselin; n= 68, 680.028 10^9 cells/LStandard Deviation 0.0236
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLymphocytes; Week 36; n= 60, 660.031 10^9 cells/LStandard Deviation 0.5939
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsBasophils; Week 4; n= 66, 66-0.007 10^9 cells/LStandard Deviation 0.0282
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsEosinophils; Week 56; n= 59, 61-0.351 10^9 cells/LStandard Deviation 0.8624
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsBasophils; Week 8; n= 65, 66-0.002 10^9 cells/LStandard Deviation 0.0261
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLeukocytes; Week 56; n= 59, 61-1.50 10^9 cells/LStandard Deviation 2.84
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsBasophils; Week 12; n= 63, 65-0.007 10^9 cells/LStandard Deviation 0.0222
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsEosinophils; Week 60; n= 58, 64-0.302 10^9 cells/LStandard Deviation 0.8352
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsBasophils; Week 16; n= 64, 68-0.004 10^9 cells/LStandard Deviation 0.0295
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsMonocytes; week 4; n= 66, 660.014 10^9 cells/LStandard Deviation 0.2127
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsBasophils; Week 20; n= 61, 66-0.002 10^9 cells/LStandard Deviation 0.0287
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsAbsolute Leukocytes; Baseline; n= 68, 689.54 10^9 cells/LStandard Deviation 3.13
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsBasophils; Week 24; n= 61, 66-0.002 10^9 cells/LStandard Deviation 0.0328
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLeukocytes; Week 60; n= 58, 64-1.20 10^9 cells/LStandard Deviation 2.396
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsBasophils; Week 28; n= 62, 65-0.005 10^9 cells/LStandard Deviation 0.0297
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLeukocytes; Week 4; 66, 66-0.77 10^9 cells/LStandard Deviation 2.356
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsBasophils; Week 32; n= 61, 660.002 10^9 cells/LStandard Deviation 0.0355
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLymphocytes; Week 40; n= 61, 650.037 10^9 cells/LStandard Deviation 0.6391
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsBasophils; Week 36; n= 60, 660.005 10^9 cells/LStandard Deviation 0.0424
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLeukocytes; Week 8; n= 65, 66-0.83 10^9 cells/LStandard Deviation 2.511
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsBasophils; Week 40; n= 61, 65-0.002 10^9 cells/LStandard Deviation 0.0356
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsAbsolute Lymphocytes; Baseline; n= 68, 681.508 10^9 cells/LStandard Deviation 0.823
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsBasophils; Week 44; n= 59, 610.000 10^9 cells/LStandard Deviation 0.0296
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLymphocytes; Week 60; n= 58, 64-0.101 10^9 cells/LStandard Deviation 0.6848
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsBasophils; Week 48; n= 59, 64-0.004 10^9 cells/LStandard Deviation 0.03
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsPlatelets; Week 40; n= 61, 652.0 10^9 cells/LStandard Deviation 42.12
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsBasophils; Week 52; n= 60, 64-0.003 10^9 cells/LStandard Deviation 0.0284
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLymphocytes; Week 4; n= 66, 660.145 10^9 cells/LStandard Deviation 0.7485
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsBasophils; Week 56; n= 59, 61-0.003 10^9 cells/LStandard Deviation 0.0286
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsPlatelets; Week 44; n= 60, 634.9 10^9 cells/LStandard Deviation 40.27
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsBasophils; Week 60; n= 58, 64-0.006 10^9 cells/LStandard Deviation 0.0248
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLymphocytes; Week 44; n= 59, 610.059 10^9 cells/LStandard Deviation 0.6471
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsAbsolute Eosinophils; Baseline; n= 68, 680.398 10^9 cells/LStandard Deviation 0.8415
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsPlatelets; Week 48; n= 59, 645.4 10^9 cells/LStandard Deviation 44.8
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsEosinophils; Week 4; n= 66, 66-0.339 10^9 cells/LStandard Deviation 0.6794
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLymphocytes; Week 8; n= 65, 66-0.048 10^9 cells/LStandard Deviation 0.6388
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsEosinophils; Week 8; n= 65, 66-0.370 10^9 cells/LStandard Deviation 0.8092
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsPlatelets; Week 52; n= 60, 64-3.7 10^9 cells/LStandard Deviation 46.34
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsEosinophils; Week 12; n= 63, 65-0.364 10^9 cells/LStandard Deviation 0.8407
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsMonocytes; Week 12; n= 63, 65-0.004 10^9 cells/LStandard Deviation 0.1985
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsEosinophils; Week 16; n= 64, 68-0.355 10^9 cells/LStandard Deviation 0.828
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsPlatelets; Week 56; n= 59, 61-1.0 10^9 cells/LStandard Deviation 48.51
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsEosinophils; Week 20; n= 61, 66-0.347 10^9 cells/LStandard Deviation 0.8266
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLymphocytes; Week 12; n= 63, 65-0.071 10^9 cells/LStandard Deviation 0.7665
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsEosinophils; Week 24; n= 61, 66-0.364 10^9 cells/LStandard Deviation 0.8211
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsNeutrophils; Week 40; n= 61, 65-1.010 10^9 cells/LStandard Deviation 3.3999
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsPlatelets; Week 60; n= 59, 64-2.0 10^9 cells/LStandard Deviation 41.32
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsNeutrophils; Week 44; n= 59, 61-1.344 10^9 cells/LStandard Deviation 2.1031
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLeukocytes; Week 12; n= 63, 65-1.24 10^9 cells/LStandard Deviation 2.716
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsNeutrophils; Week 48; n= 59, 64-1.151 10^9 cells/LStandard Deviation 2.5806
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLymphocytes; Week 48; n=59, 640.035 10^9 cells/LStandard Deviation 0.7368
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsNeutrophils; Week 52; n= 60, 64-1.211 10^9 cells/LStandard Deviation 2.2815
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLeukocytes; ; Week 16; n= 64, 68-1.16 10^9 cells/LStandard Deviation 2.827
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsNeutrophils; Week 56; n= 59, 61-1.311 10^9 cells/LStandard Deviation 3.0024
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLymphocytes; Week 16; n= 64, 680.079 10^9 cells/LStandard Deviation 0.7254
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsNeutrophils; Week 60; n= 58, 64-0.795 10^9 cells/LStandard Deviation 2.6501
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLeukocytes; Week 20; n= 61, 66-1.43 10^9 cells/LStandard Deviation 2.649
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsAbsolute Platelets; Baseline; n= 68, 68270.3 10^9 cells/LStandard Deviation 60.86
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsAbsolute Monocytes; Baseline; n= 68, 680.405 10^9 cells/LStandard Deviation 0.2376
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsPlatelets; Week 4; n= 66, 67-1.4 10^9 cells/LStandard Deviation 33.79
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLeukocytes; Week 24; n= 61, 66-1.47 10^9 cells/LStandard Deviation 2.738
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsPlatelets; Week 8; n= 66, 664.1 10^9 cells/LStandard Deviation 26.48
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLymphocytes; Week 20; n= 61, 660.127 10^9 cells/LStandard Deviation 0.7096
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsPlatelets; Week 12; n= 63, 65-4.3 10^9 cells/LStandard Deviation 37.89
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsLeukocytes; Week 28; n= 62, 65-1.66 10^9 cells/LStandard Deviation 2.804
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets LevelsPlatelets; Week 16; n= 64, 681.8 10^9 cells/LStandard Deviation 40.25
Secondary

Change From Baseline in Hematology Parameters of Erythrocytes Levels

Blood samples were collected to evaluate change from Baseline in erythrocytes values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.

Time frame: Baseline and up to Week 60

Population: Safety Population

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboChange From Baseline in Hematology Parameters of Erythrocytes LevelsAbsolute, Baseline; n= 68, 684.64 10^12 cells/LStandard Deviation 0.511
PlaceboChange From Baseline in Hematology Parameters of Erythrocytes LevelsWeek 4; n= 66, 67-0.07 10^12 cells/LStandard Deviation 0.228
PlaceboChange From Baseline in Hematology Parameters of Erythrocytes LevelsWeek 8; n= 66, 66-0.07 10^12 cells/LStandard Deviation 0.278
PlaceboChange From Baseline in Hematology Parameters of Erythrocytes LevelsWeek 12; n= 63, 65-0.04 10^12 cells/LStandard Deviation 0.273
PlaceboChange From Baseline in Hematology Parameters of Erythrocytes LevelsWeek 16; n= 64, 68-0.02 10^12 cells/LStandard Deviation 0.266
PlaceboChange From Baseline in Hematology Parameters of Erythrocytes LevelsWeek 20; n= 61, 680.03 10^12 cells/LStandard Deviation 0.243
PlaceboChange From Baseline in Hematology Parameters of Erythrocytes LevelsWeek 24; n= 62, 660.02 10^12 cells/LStandard Deviation 0.252
PlaceboChange From Baseline in Hematology Parameters of Erythrocytes LevelsWeek 28; n= 62, 660.03 10^12 cells/LStandard Deviation 0.286
PlaceboChange From Baseline in Hematology Parameters of Erythrocytes LevelsWeek 32; n= 61, 670.06 10^12 cells/LStandard Deviation 0.3
PlaceboChange From Baseline in Hematology Parameters of Erythrocytes LevelsWeek 36; n= 60, 660.08 10^12 cells/LStandard Deviation 0.314
PlaceboChange From Baseline in Hematology Parameters of Erythrocytes LevelsWeek 40; n= 61, 650.09 10^12 cells/LStandard Deviation 0.274
PlaceboChange From Baseline in Hematology Parameters of Erythrocytes LevelsWeek 44; n= 60, 640.13 10^12 cells/LStandard Deviation 0.332
PlaceboChange From Baseline in Hematology Parameters of Erythrocytes LevelsWeek 48; n= 59, 640.14 10^12 cells/LStandard Deviation 0.293
PlaceboChange From Baseline in Hematology Parameters of Erythrocytes LevelsWeek 52; n= 60, 640.10 10^12 cells/LStandard Deviation 0.309
PlaceboChange From Baseline in Hematology Parameters of Erythrocytes LevelsWeek 56; n= 59, 610.06 10^12 cells/LStandard Deviation 0.365
PlaceboChange From Baseline in Hematology Parameters of Erythrocytes LevelsWeek 60; n= 59, 640.07 10^12 cells/LStandard Deviation 0.384
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Erythrocytes LevelsWeek 60; n= 59, 640.05 10^12 cells/LStandard Deviation 0.318
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Erythrocytes LevelsAbsolute, Baseline; n= 68, 684.58 10^12 cells/LStandard Deviation 0.456
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Erythrocytes LevelsWeek 32; n= 61, 670.09 10^12 cells/LStandard Deviation 0.273
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Erythrocytes LevelsWeek 4; n= 66, 67-0.03 10^12 cells/LStandard Deviation 0.226
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Erythrocytes LevelsWeek 48; n= 59, 640.10 10^12 cells/LStandard Deviation 0.271
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Erythrocytes LevelsWeek 8; n= 66, 66-0.01 10^12 cells/LStandard Deviation 0.211
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Erythrocytes LevelsWeek 36; n= 60, 660.14 10^12 cells/LStandard Deviation 0.299
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Erythrocytes LevelsWeek 12; n= 63, 65-0.04 10^12 cells/LStandard Deviation 0.252
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Erythrocytes LevelsWeek 56; n= 59, 610.07 10^12 cells/LStandard Deviation 0.284
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Erythrocytes LevelsWeek 16; n= 64, 68-0.01 10^12 cells/LStandard Deviation 0.243
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Erythrocytes LevelsWeek 40; n= 61, 650.09 10^12 cells/LStandard Deviation 0.27
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Erythrocytes LevelsWeek 20; n= 61, 680.03 10^12 cells/LStandard Deviation 0.252
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Erythrocytes LevelsWeek 52; n= 60, 640.09 10^12 cells/LStandard Deviation 0.251
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Erythrocytes LevelsWeek 24; n= 62, 660.05 10^12 cells/LStandard Deviation 0.265
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Erythrocytes LevelsWeek 44; n= 60, 640.08 10^12 cells/LStandard Deviation 0.26
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Erythrocytes LevelsWeek 28; n= 62, 660.08 10^12 cells/LStandard Deviation 0.264
Secondary

Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels

Blood samples were collected to evaluate change from Baseline in MCHC and hemoglobin values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.

Time frame: Baseline and up to Week 60

Population: Safety Population

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsMCHC; Week 32; n= 61, 67-6.6 g/LStandard Deviation 8.19
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsMCHC; Week 4; n= 66, 67-1.2 g/LStandard Deviation 6.02
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsMCHC; Week 8; n= 66, 66-1.5 g/LStandard Deviation 6.69
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsMCHC; Week 12; n= 63, 65-1.3 g/LStandard Deviation 7.73
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsMCHC; Week 16; n= 64, 68-2.3 g/LStandard Deviation 7.11
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsMCHC; Week 20; n= 61, 68-2.2 g/LStandard Deviation 6.65
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsMCHC; Week 24; n= 62, 66-3.2 g/LStandard Deviation 10.19
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsMCHC; Week 28; n= 62, 66-4.3 g/LStandard Deviation 7.07
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsAbsolute MCHC; Baseline; n= 68, 68324.9 g/LStandard Deviation 7.53
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsMCHC; Week 36; n= 60, 66-4.7 g/LStandard Deviation 8.05
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsMCHC; Week 40; n= 61, 65-4.5 g/LStandard Deviation 8.04
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsMCHC; Week 44; n= 60, 64-4.7 g/LStandard Deviation 8.51
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsMCHC; Week 48; n= 59, 64-6.0 g/LStandard Deviation 8.03
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsMCHC; Week 52; n= 60, 64-5.2 g/LStandard Deviation 7.79
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsHemoglobin; Week 60; n= 59, 64-1.8 g/LStandard Deviation 9.86
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsMCHC; Week 56; n= 59, 61-6.9 g/LStandard Deviation 7.74
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsMCHC; Week 60; n= 59, 64-7.5 g/LStandard Deviation 7.41
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsAbsolute Hemoglobin; Baseline; n= 68, 68141.6 g/LStandard Deviation 12.67
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsHemoglobin; Week 4; n= 66, 67-2.3 g/LStandard Deviation 6.86
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsHemoglobin; Week 28; n= 62, 66-1.3 g/LStandard Deviation 7.48
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsHemoglobin; Week 32; n= 61, 67-1.3 g/LStandard Deviation 8.03
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsHemoglobin; Week 36; n= 60, 66-0.2 g/LStandard Deviation 8.5
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsHemoglobin; Week 40; n= 61, 650.1 g/LStandard Deviation 8.35
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsHemoglobin; Week 44; n= 60, 640.7 g/LStandard Deviation 9.59
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsHemoglobin; Week 48; n= 59, 640.5 g/LStandard Deviation 8.2
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsHemoglobin; Week 52; n= 60, 640.1 g/LStandard Deviation 8.57
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsHemoglobin; Week 8; n= 66, 66-2.5 g/LStandard Deviation 7.56
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsHemoglobin; Week 12; n= 63, 65-1.6 g/LStandard Deviation 8.28
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsHemoglobin; Week 16; n= 64, 68-1.6 g/LStandard Deviation 8.24
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsHemoglobin; Week 20; n= 61, 68-0.3 g/LStandard Deviation 6.85
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsHemoglobin; Week 24; n= 62, 66-1.1 g/LStandard Deviation 8.06
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsHemoglobin; Week 56; n= 59, 61-1.5 g/LStandard Deviation 9.92
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsMCHC; Week 60; n= 59, 64-4.7 g/LStandard Deviation 9.9
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsAbsolute MCHC; Baseline; n= 68, 68324.4 g/LStandard Deviation 7.37
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsHemoglobin; Week 48; n= 59, 64-1.9 g/LStandard Deviation 11.07
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsMCHC; Week 4; n= 66, 67-1.1 g/LStandard Deviation 5.92
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsAbsolute Hemoglobin; Baseline; n= 68, 68140.6 g/LStandard Deviation 12.99
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsMCHC; Week 8; n= 66, 66-1.5 g/LStandard Deviation 6.86
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsHemoglobin; Week 20; n= 61, 68-1.4 g/LStandard Deviation 7.64
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsMCHC; Week 12; n= 63, 650.3 g/LStandard Deviation 6.6
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsHemoglobin; Week 60; n= 59, 64-2.4 g/LStandard Deviation 11.36
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsMCHC; Week 16; n= 64, 68-2.1 g/LStandard Deviation 7.88
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsHemoglobin; Week 24; n= 62, 66-1.6 g/LStandard Deviation 8.51
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsMCHC; Week 20; n= 61, 68-1.2 g/LStandard Deviation 7.88
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsHemoglobin; Week 52; n= 60, 64-1.9 g/LStandard Deviation 10.36
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsMCHC; Week 24; n= 62, 66-2.6 g/LStandard Deviation 7.39
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsHemoglobin; Week 28; n= 62, 66-1.3 g/LStandard Deviation 8.94
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsMCHC; Week 28; n= 62, 66-2.6 g/LStandard Deviation 7.33
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsHemoglobin; Week 4; n= 66, 67-1.8 g/LStandard Deviation 6.43
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsMCHC; Week 32; n= 61, 67-3.6 g/LStandard Deviation 7.56
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsHemoglobin; Week 32; n= 61, 67-1.6 g/LStandard Deviation 9.22
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsMCHC; Week 36; n= 60, 66-3.3 g/LStandard Deviation 8.37
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsHemoglobin; Week 16; n= 64, 68-1.9 g/LStandard Deviation 7.64
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsMCHC; Week 40; n= 61, 65-3.2 g/LStandard Deviation 8.96
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsHemoglobin; Week 36; n= 60, 66-0.4 g/LStandard Deviation 10.23
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsMCHC; Week 44; n= 60, 64-4.5 g/LStandard Deviation 9.4
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsHemoglobin; Week 8; n= 66, 66-1.1 g/LStandard Deviation 6.28
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsMCHC; Week 48; n= 59, 64-4.8 g/LStandard Deviation 10.56
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsHemoglobin; Week 40; n= 61, 65-0.9 g/LStandard Deviation 9.74
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsHemoglobin; Week 56; n= 59, 61-1.9 g/LStandard Deviation 11.48
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsMCHC; Week 52; n= 60, 64-5.3 g/LStandard Deviation 7.72
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsHemoglobin; Week 44; n= 60, 64-1.9 g/LStandard Deviation 10.47
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsMCHC; Week 56; n= 59, 61-5.3 g/LStandard Deviation 7.47
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin LevelsHemoglobin; Week 12; n= 63, 65-2.2 g/LStandard Deviation 7.17
Secondary

Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels

Blood samples were collected to evaluate change from Baseline in MCH values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.

Time frame: Baseline and up to Week 60

Population: Safety Population

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsAbsolute, Baseline; n= 68, 6830.77 Picogram (pg)Standard Deviation 2.902
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsWeek 4; n= 66, 670.04 Picogram (pg)Standard Deviation 0.331
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsWeek 8; n= 66, 66-0.02 Picogram (pg)Standard Deviation 0.95
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsWeek 12; n= 63, 65-0.04 Picogram (pg)Standard Deviation 0.55
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsWeek 16; n= 64, 68-0.21 Picogram (pg)Standard Deviation 0.845
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsWeek 20; n= 61, 68-0.28 Picogram (pg)Standard Deviation 0.665
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsWeek 24; n= 62, 66-0.45 Picogram (pg)Standard Deviation 1.27
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsWeek 28; n= 62, 66-0.51 Picogram (pg)Standard Deviation 0.618
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsWeek 32; n= 61, 67-0.66 Picogram (pg)Standard Deviation 0.764
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsWeek 36; n= 60, 66-0.60 Picogram (pg)Standard Deviation 0.91
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsWeek 40; n= 61, 65-0.67 Picogram (pg)Standard Deviation 1.171
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsWeek 44; n= 60, 64-0.78 Picogram (pg)Standard Deviation 1.566
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsWeek 48; n= 59, 64-0.87 Picogram (pg)Standard Deviation 1.745
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsWeek 52; n= 60, 64-0.69 Picogram (pg)Standard Deviation 1.908
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsWeek 56; n= 59, 61-0.79 Picogram (pg)Standard Deviation 2.056
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsWeek 60; n= 59, 64-0.86 Picogram (pg)Standard Deviation 2.094
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsWeek 60; n= 59, 64-0.80 Picogram (pg)Standard Deviation 1.818
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsAbsolute, Baseline; n= 68, 6830.77 Picogram (pg)Standard Deviation 2.255
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsWeek 32; n= 61, 67-0.88 Picogram (pg)Standard Deviation 1.368
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsWeek 4; n= 66, 67-0.12 Picogram (pg)Standard Deviation 0.785
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsWeek 48; n= 59, 64-0.96 Picogram (pg)Standard Deviation 1.654
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsWeek 8; n= 66, 66-0.16 Picogram (pg)Standard Deviation 0.653
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsWeek 36; n= 60, 66-0.90 Picogram (pg)Standard Deviation 1.395
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsWeek 12; n= 63, 65-0.17 Picogram (pg)Standard Deviation 0.769
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsWeek 56; n= 59, 61-0.83 Picogram (pg)Standard Deviation 1.713
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsWeek 16; n= 64, 68-0.34 Picogram (pg)Standard Deviation 0.769
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsWeek 40; n= 61, 65-0.79 Picogram (pg)Standard Deviation 1.39
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsWeek 20; n= 61, 68-0.41 Picogram (pg)Standard Deviation 0.851
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsWeek 52; n= 60, 64-0.95 Picogram (pg)Standard Deviation 1.585
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsWeek 24; n= 62, 66-0.59 Picogram (pg)Standard Deviation 0.959
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsWeek 44; n= 60, 64-0.95 Picogram (pg)Standard Deviation 1.484
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) LevelsWeek 28; n= 62, 66-0.70 Picogram (pg)Standard Deviation 1.184
Secondary

Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels

Blood samples were collected to evaluate change from Baseline in MCV values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.

Time frame: Baseline and up to Week 60

Population: Safety Population

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsAbsolute, Baseline; n= 68, 6894.8 femtoliter (fL)Standard Deviation 9.02
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsWeek 4; n= 66, 670.4 femtoliter (fL)Standard Deviation 1.67
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsWeek 8; n= 66, 660.3 femtoliter (fL)Standard Deviation 2.5
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsWeek 12; n= 63, 650.2 femtoliter (fL)Standard Deviation 2
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsWeek 16; n= 64, 680.0 femtoliter (fL)Standard Deviation 2.22
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsWeek 20; n= 61, 68-0.3 femtoliter (fL)Standard Deviation 1.87
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsWeek 24; n= 62, 66-0.5 femtoliter (fL)Standard Deviation 2.21
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsWeek 28; n= 62, 66-0.4 femtoliter (fL)Standard Deviation 2.86
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsWeek 32; n= 61, 67-0.2 femtoliter (fL)Standard Deviation 3.01
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsWeek 36; n= 60, 66-0.5 femtoliter (fL)Standard Deviation 3.55
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsWeek 40; n= 61, 65-0.9 femtoliter (fL)Standard Deviation 4.09
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsWeek 44; n= 60, 64-1.2 femtoliter (fL)Standard Deviation 5.06
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsWeek 48; n= 59, 64-1.1 femtoliter (fL)Standard Deviation 5.96
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsWeek 52; n= 60, 64-0.8 femtoliter (fL)Standard Deviation 6.52
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsWeek 56; n= 59, 61-0.5 femtoliter (fL)Standard Deviation 6.47
PlaceboChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsWeek 60; n= 59, 64-0.6 femtoliter (fL)Standard Deviation 6.57
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsWeek 60; n= 59, 64-1.0 femtoliter (fL)Standard Deviation 4.49
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsAbsolute, Baseline; n= 68, 6894.8 femtoliter (fL)Standard Deviation 6.14
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsWeek 32; n= 61, 67-1.7 femtoliter (fL)Standard Deviation 3.56
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsWeek 4; n= 66, 670.0 femtoliter (fL)Standard Deviation 2.33
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsWeek 48; n= 59, 64-1.5 femtoliter (fL)Standard Deviation 4.04
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsWeek 8; n= 66, 660.0 femtoliter (fL)Standard Deviation 2.58
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsWeek 36; n= 60, 66-1.9 femtoliter (fL)Standard Deviation 3.74
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsWeek 12; n= 63, 65-0.7 femtoliter (fL)Standard Deviation 2.3
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsWeek 56; n= 59, 61-1.0 femtoliter (fL)Standard Deviation 4.15
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsWeek 16; n= 64, 68-0.4 femtoliter (fL)Standard Deviation 2.94
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsWeek 40; n= 61, 65-1.4 femtoliter (fL)Standard Deviation 3.73
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsWeek 20; n= 61, 68-0.9 femtoliter (fL)Standard Deviation 2.66
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsWeek 52; n= 60, 64-1.3 femtoliter (fL)Standard Deviation 4.29
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsWeek 24; n= 62, 66-1.0 femtoliter (fL)Standard Deviation 2.92
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsWeek 44; n= 60, 64-1.5 femtoliter (fL)Standard Deviation 3.91
Mepolizumab 300mgChange From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) LevelsWeek 28; n= 62, 66-1.4 femtoliter (fL)Standard Deviation 3.48
Secondary

Change From Baseline in Pulse Rate

Pulse rate was measured from Baseline throughout follow-up (till Week 60) before injection with the participant sitting, having rested in this position for at least 5 minutes before reading. The Baseline value was taken at Visit 2 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.

Time frame: Baseline and up to Week 60

Population: Safety Population

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboChange From Baseline in Pulse RateWeek 8; n= 67, 680.97 beats per minute (bpm)Standard Deviation 10.718
PlaceboChange From Baseline in Pulse RateAbsolute Baseline; n= 68, 6877.38 beats per minute (bpm)Standard Deviation 13.763
PlaceboChange From Baseline in Pulse RateWeek 4; n= 68, 682.01 beats per minute (bpm)Standard Deviation 12.294
PlaceboChange From Baseline in Pulse RateWeek 12; n= 66, 681.52 beats per minute (bpm)Standard Deviation 12.393
PlaceboChange From Baseline in Pulse RateWeek 16; n= 64, 680.59 beats per minute (bpm)Standard Deviation 11.287
PlaceboChange From Baseline in Pulse RateWeek 20; n= 63, 681.03 beats per minute (bpm)Standard Deviation 11.521
PlaceboChange From Baseline in Pulse RateWeek 24; n= 63, 670.79 beats per minute (bpm)Standard Deviation 12.134
PlaceboChange From Baseline in Pulse RateWeek 28; n= 62, 671.29 beats per minute (bpm)Standard Deviation 10.439
PlaceboChange From Baseline in Pulse RateWeek 32; n= 62, 671.60 beats per minute (bpm)Standard Deviation 11.703
PlaceboChange From Baseline in Pulse RateWeek 36; n= 62, 673.47 beats per minute (bpm)Standard Deviation 12.538
PlaceboChange From Baseline in Pulse RateWeek 40; n= 62, 662.65 beats per minute (bpm)Standard Deviation 12.297
PlaceboChange From Baseline in Pulse RateWeek 44; n= 61, 663.10 beats per minute (bpm)Standard Deviation 12.195
PlaceboChange From Baseline in Pulse RateWeek 48; n= 61, 653.85 beats per minute (bpm)Standard Deviation 12.383
PlaceboChange From Baseline in Pulse RateWeek 52; n= 61, 651.85 beats per minute (bpm)Standard Deviation 11.987
PlaceboChange From Baseline in Pulse RateWeek 56; n= 62, 632.60 beats per minute (bpm)Standard Deviation 14.041
PlaceboChange From Baseline in Pulse RateWeek 60; n= 61, 651.51 beats per minute (bpm)Standard Deviation 12.793
Mepolizumab 300mgChange From Baseline in Pulse RateWeek 60; n= 61, 650.09 beats per minute (bpm)Standard Deviation 10.28
Mepolizumab 300mgChange From Baseline in Pulse RateWeek 32; n= 62, 67-0.31 beats per minute (bpm)Standard Deviation 10.53
Mepolizumab 300mgChange From Baseline in Pulse RateAbsolute Baseline; n= 68, 6875.75 beats per minute (bpm)Standard Deviation 10.404
Mepolizumab 300mgChange From Baseline in Pulse RateWeek 48; n= 61, 65-1.12 beats per minute (bpm)Standard Deviation 10.315
Mepolizumab 300mgChange From Baseline in Pulse RateWeek 4; n= 68, 681.87 beats per minute (bpm)Standard Deviation 10.543
Mepolizumab 300mgChange From Baseline in Pulse RateWeek 8; n= 67, 68-1.01 beats per minute (bpm)Standard Deviation 10.304
Mepolizumab 300mgChange From Baseline in Pulse RateWeek 36; n= 62, 67-0.57 beats per minute (bpm)Standard Deviation 11.422
Mepolizumab 300mgChange From Baseline in Pulse RateWeek 12; n= 66, 68-0.12 beats per minute (bpm)Standard Deviation 10.855
Mepolizumab 300mgChange From Baseline in Pulse RateWeek 56; n= 62, 63-0.35 beats per minute (bpm)Standard Deviation 9.986
Mepolizumab 300mgChange From Baseline in Pulse RateWeek 16; n= 64, 680.44 beats per minute (bpm)Standard Deviation 11.411
Mepolizumab 300mgChange From Baseline in Pulse RateWeek 40; n= 62, 660.74 beats per minute (bpm)Standard Deviation 11.669
Mepolizumab 300mgChange From Baseline in Pulse RateWeek 20; n= 63, 68-0.56 beats per minute (bpm)Standard Deviation 9.687
Mepolizumab 300mgChange From Baseline in Pulse RateWeek 52; n= 61, 65-2.17 beats per minute (bpm)Standard Deviation 9.596
Mepolizumab 300mgChange From Baseline in Pulse RateWeek 24; n= 63, 670.37 beats per minute (bpm)Standard Deviation 10.057
Mepolizumab 300mgChange From Baseline in Pulse RateWeek 44; n= 61, 660.15 beats per minute (bpm)Standard Deviation 12.763
Mepolizumab 300mgChange From Baseline in Pulse RateWeek 28; n= 62, 670.16 beats per minute (bpm)Standard Deviation 10.093
Secondary

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels

SBP and DBP were measured from Baseline throughout follow-up (till Week 60) before injection with the participant sitting, having rested in this position for at least 5 minutes before reading. The Baseline value was taken at Visit 2 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.

Time frame: Baseline up to Week 60

Population: Safety Population

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsSBP; Week 32; n= 62, 67-2.35 millimeter of mercury (mm of Hg)Standard Deviation 14.027
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsSBP; Week 4; n= 68, 680.47 millimeter of mercury (mm of Hg)Standard Deviation 15.865
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsSBP; Week 8; n= 67, 680.07 millimeter of mercury (mm of Hg)Standard Deviation 14.192
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsSBP; Week 12; n= 66, 68-1.12 millimeter of mercury (mm of Hg)Standard Deviation 14.38
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsSBP; Week 16; n= 64, 68-0.97 millimeter of mercury (mm of Hg)Standard Deviation 16.63
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsSBP; Week 20; n= 63, 68-0.97 millimeter of mercury (mm of Hg)Standard Deviation 15.028
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsSBP; Week 24; n= 63, 67-1.54 millimeter of mercury (mm of Hg)Standard Deviation 15.449
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsSBP; Week 28; n= 63, 67-0.06 millimeter of mercury (mm of Hg)Standard Deviation 14.337
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsAbsolute SBP; Baseline; n= 68, 68127.46 millimeter of mercury (mm of Hg)Standard Deviation 17.794
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsSBP; Week 36; n= 62, 671.02 millimeter of mercury (mm of Hg)Standard Deviation 14.663
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsSBP; Week 40; n= 62, 660.90 millimeter of mercury (mm of Hg)Standard Deviation 14.202
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsSBP; Week 44; n= 61, 661.41 millimeter of mercury (mm of Hg)Standard Deviation 16.143
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsSBP; Week 48; n= 61, 65-0.41 millimeter of mercury (mm of Hg)Standard Deviation 17.14
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsSBP: Week 52; n= 61, 65-1.03 millimeter of mercury (mm of Hg)Standard Deviation 13.2
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsSBP; Week 56; n= 62, 630.06 millimeter of mercury (mm of Hg)Standard Deviation 15.216
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsSBP; Week 60; n= 61, 650.61 millimeter of mercury (mm of Hg)Standard Deviation 15.627
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsAbsolute DBP; Baseline; n= 68, 6880.21 millimeter of mercury (mm of Hg)Standard Deviation 10.127
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsDBP; Week 4; n= 68, 68-2.26 millimeter of mercury (mm of Hg)Standard Deviation 10.046
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsDBP; Week 8; n= 67, 68-2.04 millimeter of mercury (mm of Hg)Standard Deviation 8.461
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsDBP; Week 12; n= 66, 68-1.92 millimeter of mercury (mm of Hg)Standard Deviation 10.115
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsDBP; Week 16; n= 64, 68-1.36 millimeter of mercury (mm of Hg)Standard Deviation 10.237
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsDBP; Week 20; n= 63, 68-1.25 millimeter of mercury (mm of Hg)Standard Deviation 8.092
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsDBP; Week 24; n= 63, 67-2.24 millimeter of mercury (mm of Hg)Standard Deviation 8.751
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsDBP; Week 28; n= 63, 67-2.02 millimeter of mercury (mm of Hg)Standard Deviation 9.939
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsDBP; Week 32; n= 62, 67-4.27 millimeter of mercury (mm of Hg)Standard Deviation 9.313
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsDBP; Week 36; n= 62, 67-1.97 millimeter of mercury (mm of Hg)Standard Deviation 10.995
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsDBP; Week 40; n= 62, 66-0.48 millimeter of mercury (mm of Hg)Standard Deviation 9.625
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsDBP; Week 44; n= 61, 66-0.79 millimeter of mercury (mm of Hg)Standard Deviation 9.93
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsDBP; Week 48; n= 61, 65-3.26 millimeter of mercury (mm of Hg)Standard Deviation 10.466
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsDBP; Week 52; n= 61, 65-3.66 millimeter of mercury (mm of Hg)Standard Deviation 10.628
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsDBP; Week 56; n= 62, 63-3.48 millimeter of mercury (mm of Hg)Standard Deviation 10.57
PlaceboChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsDBP; Week 60; n= 61, 65-2.54 millimeter of mercury (mm of Hg)Standard Deviation 11.278
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsDBP; Week 60; n= 61, 65-0.45 millimeter of mercury (mm of Hg)Standard Deviation 9.836
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsAbsolute SBP; Baseline; n= 68, 68122.46 millimeter of mercury (mm of Hg)Standard Deviation 14.134
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsAbsolute DBP; Baseline; n= 68, 6876.22 millimeter of mercury (mm of Hg)Standard Deviation 9.646
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsSBP; Week 4; n= 68, 680.93 millimeter of mercury (mm of Hg)Standard Deviation 12.37
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsDBP; Week 32; n= 62, 67-0.49 millimeter of mercury (mm of Hg)Standard Deviation 10.652
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsSBP; Week 8; n= 67, 681.29 millimeter of mercury (mm of Hg)Standard Deviation 11.066
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsDBP; Week 4; n= 68, 681.01 millimeter of mercury (mm of Hg)Standard Deviation 10.13
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsSBP; Week 12; n= 66, 68-1.41 millimeter of mercury (mm of Hg)Standard Deviation 12.071
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsDBP; Week 48; n= 61, 65-1.71 millimeter of mercury (mm of Hg)Standard Deviation 9.239
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsSBP; Week 16; n= 64, 68-0.41 millimeter of mercury (mm of Hg)Standard Deviation 11.579
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsDBP; Week 8; n= 67, 68-0.34 millimeter of mercury (mm of Hg)Standard Deviation 10.078
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsSBP; Week 20; n= 63, 68-0.85 millimeter of mercury (mm of Hg)Standard Deviation 12.019
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsDBP; Week 36; n= 62, 670.16 millimeter of mercury (mm of Hg)Standard Deviation 10.988
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsSBP; Week 24; n= 63, 67-1.57 millimeter of mercury (mm of Hg)Standard Deviation 12.824
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsDBP; Week 12; n= 66, 68-0.37 millimeter of mercury (mm of Hg)Standard Deviation 9.167
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsSBP; Week 28; n= 63, 67-0.15 millimeter of mercury (mm of Hg)Standard Deviation 13.24
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsDBP; Week 56; n= 62, 630.11 millimeter of mercury (mm of Hg)Standard Deviation 8.899
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsSBP; Week 32; n= 62, 670.04 millimeter of mercury (mm of Hg)Standard Deviation 11.181
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsDBP; Week 16; n= 64, 680.46 millimeter of mercury (mm of Hg)Standard Deviation 9.824
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsSBP; Week 36; n= 62, 670.48 millimeter of mercury (mm of Hg)Standard Deviation 14.397
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsDBP; Week 40; n= 62, 66-0.03 millimeter of mercury (mm of Hg)Standard Deviation 8.868
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsSBP; Week 40; n= 62, 661.27 millimeter of mercury (mm of Hg)Standard Deviation 12.075
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsDBP; Week 20; n= 63, 68-1.19 millimeter of mercury (mm of Hg)Standard Deviation 9.214
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsSBP; Week 44; n= 61, 66-0.36 millimeter of mercury (mm of Hg)Standard Deviation 13.694
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsDBP; Week 52; n= 61, 65-0.06 millimeter of mercury (mm of Hg)Standard Deviation 9.236
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsSBP; Week 48; n= 61, 65-0.22 millimeter of mercury (mm of Hg)Standard Deviation 12.351
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsDBP; Week 24; n= 63, 67-1.16 millimeter of mercury (mm of Hg)Standard Deviation 9.629
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsSBP: Week 52; n= 61, 65-0.32 millimeter of mercury (mm of Hg)Standard Deviation 13.091
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsDBP; Week 44; n= 61, 66-1.03 millimeter of mercury (mm of Hg)Standard Deviation 9.595
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsSBP; Week 56; n= 62, 631.02 millimeter of mercury (mm of Hg)Standard Deviation 13.559
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsDBP; Week 28; n= 63, 670.36 millimeter of mercury (mm of Hg)Standard Deviation 10.071
Mepolizumab 300mgChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) LevelsSBP; Week 60; n= 61, 65-0.63 millimeter of mercury (mm of Hg)Standard Deviation 11.656
Secondary

Maximum Change From Baseline in QTcF and QTcB Values

Single measurements of 12-lead ECGs were obtained after 5 minutes rest in a supine position at Baseline throughout the 52 weeks treatment period and 8 weeks follow-up period using an ECG machine. Maximum change from Baseline in QTcF and QTcB values were measured.

Time frame: Baseline and up to Week 60

Population: Safety Population

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboMaximum Change From Baseline in QTcF and QTcB ValuesQTcB interval18.8 msecStandard Deviation 26.46
PlaceboMaximum Change From Baseline in QTcF and QTcB ValuesQTcF interval16.9 msecStandard Deviation 23.74
Mepolizumab 300mgMaximum Change From Baseline in QTcF and QTcB ValuesQTcB interval18.1 msecStandard Deviation 15.28
Mepolizumab 300mgMaximum Change From Baseline in QTcF and QTcB ValuesQTcF interval15.4 msecStandard Deviation 13.79
Secondary

Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values

Single measurements of 12-lead electrocardiogram (ECGs) were obtained after 5 minutes rest in a supine position at Baseline throughout the 52 weeks treatment period and 8 weeks follow-up period using an ECG machine. Mean change from Baseline in QTcF and QTcB values were measured. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Time frame: Baseline and up to Week 60

Population: Safety Population

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcF; Week 8; n= 66, 660.1 milliseconds (msec)Standard Deviation 17.9
PlaceboMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcF; Week 16; n= 64, 660.8 milliseconds (msec)Standard Deviation 15.26
PlaceboMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcF; Week 24; n= 60, 662.8 milliseconds (msec)Standard Deviation 14.43
PlaceboMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcF; Week 32; n= 61, 666.2 milliseconds (msec)Standard Deviation 25.19
PlaceboMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcF; Week 40; n= 61, 65-0.5 milliseconds (msec)Standard Deviation 15.25
PlaceboMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcF; Week 52; n= 58, 642.0 milliseconds (msec)Standard Deviation 15.96
PlaceboMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcF; Week 60; n= 58, 633.0 milliseconds (msec)Standard Deviation 14.3
PlaceboMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcF; Any time post Baseline; n= 68, 6816.9 milliseconds (msec)Standard Deviation 23.74
PlaceboMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcB; Week 8; n= 66, 66-0.8 milliseconds (msec)Standard Deviation 19.05
PlaceboMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcB; Week 16; n= 64, 66-0.1 milliseconds (msec)Standard Deviation 18.33
PlaceboMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcB; Week 24; n= 60, 661.4 milliseconds (msec)Standard Deviation 17.89
PlaceboMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcB; Week 32; n= 61, 665.2 milliseconds (msec)Standard Deviation 29.63
PlaceboMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcB; Week 40; n= 61, 65-0.6 milliseconds (msec)Standard Deviation 17.83
PlaceboMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcB; Week 52; n= 58, 641.8 milliseconds (msec)Standard Deviation 17.64
PlaceboMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcB; Week 60; n= 58, 631.2 milliseconds (msec)Standard Deviation 16.56
PlaceboMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcB; Any time post Baseline; n= 68, 6818.8 milliseconds (msec)Standard Deviation 26.46
Mepolizumab 300mgMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcB; Any time post Baseline; n= 68, 6818.1 milliseconds (msec)Standard Deviation 15.28
Mepolizumab 300mgMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcF; Week 8; n= 66, 661.0 milliseconds (msec)Standard Deviation 15.03
Mepolizumab 300mgMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcB; Week 8; n= 66, 660.9 milliseconds (msec)Standard Deviation 17.31
Mepolizumab 300mgMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcF; Week 16; n= 64, 660.2 milliseconds (msec)Standard Deviation 14.05
Mepolizumab 300mgMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcB; Week 40; n= 61, 65-1.4 milliseconds (msec)Standard Deviation 18.88
Mepolizumab 300mgMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcF; Week 24; n= 60, 661.9 milliseconds (msec)Standard Deviation 16.66
Mepolizumab 300mgMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcB; Week 16; n= 64, 66-0.9 milliseconds (msec)Standard Deviation 14.76
Mepolizumab 300mgMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcF; Week 32; n= 61, 661.5 milliseconds (msec)Standard Deviation 17.16
Mepolizumab 300mgMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcB; Week 60; n= 58, 632.7 milliseconds (msec)Standard Deviation 17.27
Mepolizumab 300mgMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcF; Week 40; n= 61, 65-0.3 milliseconds (msec)Standard Deviation 17.53
Mepolizumab 300mgMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcB; Week 24; n= 60, 661.0 milliseconds (msec)Standard Deviation 18.1
Mepolizumab 300mgMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcF; Week 52; n= 58, 643.0 milliseconds (msec)Standard Deviation 16.04
Mepolizumab 300mgMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcB; Week 52; n= 58, 640.7 milliseconds (msec)Standard Deviation 18.27
Mepolizumab 300mgMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcF; Week 60; n= 58, 632.9 milliseconds (msec)Standard Deviation 14.97
Mepolizumab 300mgMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcB; Week 32; n= 61, 660.0 milliseconds (msec)Standard Deviation 19.63
Mepolizumab 300mgMean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) ValuesQTcF; Any time post Baseline; n= 68, 6815.4 milliseconds (msec)Standard Deviation 13.79
Secondary

Number of Participants in Each Category of Accrued Duration of Remission

Total accrued duration of remission, i.e., the accrued number of weeks where Birmingham Vasculitis Activity Score (BVAS) =0 plus prednisolone/prednisone dose \<=7.5mg/day over the 52 week study treatment period was reported. BVAS is a validated, clinician-completed tool used for the comprehensive multisystem clinical assessment of disease activity in systemic vasculitis. The duration was categorized into zero, \>0 to \<12 weeks, 12 to \<24 weeks, 24 to \<36 weeks and \>=36 weeks. Statistical analysis was performed on ITT Population and was based on a proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.

Time frame: Up to Week 52

Population: ITT Population

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PlaceboNumber of Participants in Each Category of Accrued Duration of Remission>0 to <12 weeks19 Participants
PlaceboNumber of Participants in Each Category of Accrued Duration of Remission24 to <36 weeks7 Participants
PlaceboNumber of Participants in Each Category of Accrued Duration of Remission12 to <24 weeks0 Participants
PlaceboNumber of Participants in Each Category of Accrued Duration of Remission>=36 weeks6 Participants
PlaceboNumber of Participants in Each Category of Accrued Duration of RemissionZero36 Participants
Mepolizumab 300mgNumber of Participants in Each Category of Accrued Duration of Remission>=36 weeks22 Participants
Mepolizumab 300mgNumber of Participants in Each Category of Accrued Duration of RemissionZero15 Participants
Mepolizumab 300mgNumber of Participants in Each Category of Accrued Duration of Remission>0 to <12 weeks15 Participants
Mepolizumab 300mgNumber of Participants in Each Category of Accrued Duration of Remission12 to <24 weeks7 Participants
Mepolizumab 300mgNumber of Participants in Each Category of Accrued Duration of Remission24 to <36 weeks9 Participants
p-value: <0.00195% CI: [2.63, 10.74]Proportional odds regression model
Secondary

Number of Participants in Each Category of Average Daily Prednisolone/Prednisone Dose During the Last 4 Weeks of the Study Treatment Period.

The number of participants with an average daily prednisolone/prednisone dose during the last 4 weeks of the Study Treatment Period (48 through 52) was calculated. The average dose was categorized into zero, \>0 to \<=4.0mg, \>4.0 to \<=7.5mg and \>7.5mg. The statistical analysis was performed using a proportional odds regression model with Baseline covariates of treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region and the comparison between treatment groups was presented as an odds ratio, p-value and 95 percent CI.

Time frame: Week 48 and Week52

Population: ITT Population

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PlaceboNumber of Participants in Each Category of Average Daily Prednisolone/Prednisone Dose During the Last 4 Weeks of the Study Treatment Period.Zero2 Participants
PlaceboNumber of Participants in Each Category of Average Daily Prednisolone/Prednisone Dose During the Last 4 Weeks of the Study Treatment Period.>0 to <=4.0mg3 Participants
PlaceboNumber of Participants in Each Category of Average Daily Prednisolone/Prednisone Dose During the Last 4 Weeks of the Study Treatment Period.>4.0 to <=7.5mg18 Participants
PlaceboNumber of Participants in Each Category of Average Daily Prednisolone/Prednisone Dose During the Last 4 Weeks of the Study Treatment Period.>7.5mg45 Participants
Mepolizumab 300mgNumber of Participants in Each Category of Average Daily Prednisolone/Prednisone Dose During the Last 4 Weeks of the Study Treatment Period.>7.5mg28 Participants
Mepolizumab 300mgNumber of Participants in Each Category of Average Daily Prednisolone/Prednisone Dose During the Last 4 Weeks of the Study Treatment Period.Zero12 Participants
Mepolizumab 300mgNumber of Participants in Each Category of Average Daily Prednisolone/Prednisone Dose During the Last 4 Weeks of the Study Treatment Period.>4.0 to <=7.5mg10 Participants
Mepolizumab 300mgNumber of Participants in Each Category of Average Daily Prednisolone/Prednisone Dose During the Last 4 Weeks of the Study Treatment Period.>0 to <=4.0mg18 Participants
p-value: <0.00195% CI: [0.09, 0.41]Proportional odds regression model
Secondary

Number of Participants Who Achieved Remission (BVAS=0 and Prednisolone/Prednisone <=7.5 mg/Day) Within the First 24 Weeks and Remained in Remission for the Remainder of the Treatment Period

The number of participants who were in remission (i.e ., BVAS=0 and prednisolone /prednisone \<=7.5mg/day) at both Weeks 36 and 48 of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.

Time frame: Up to Week 52

Population: ITT Population

ArmMeasureValue (NUMBER)
PlaceboNumber of Participants Who Achieved Remission (BVAS=0 and Prednisolone/Prednisone <=7.5 mg/Day) Within the First 24 Weeks and Remained in Remission for the Remainder of the Treatment Period2 Participants
Mepolizumab 300mgNumber of Participants Who Achieved Remission (BVAS=0 and Prednisolone/Prednisone <=7.5 mg/Day) Within the First 24 Weeks and Remained in Remission for the Remainder of the Treatment Period16 Participants
p-value: 0.00395% CI: [2.35, 55.24]Regression, Logistic
Secondary

Number of Participants Who Achieved Remission Within the First 24 Weeks and Remained in Remission for the Remainder of the Treatment Period

The number of participants who achieved remission (i.e., BVAS=0 and prednisolone/prednisone\<=4 mg/day) within the first 24 weeks and remain in remission for the remainder of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.

Time frame: Up to Week 52

Population: ITT Population

ArmMeasureValue (NUMBER)
PlaceboNumber of Participants Who Achieved Remission Within the First 24 Weeks and Remained in Remission for the Remainder of the Treatment Period1 Participants
Mepolizumab 300mgNumber of Participants Who Achieved Remission Within the First 24 Weeks and Remained in Remission for the Remainder of the Treatment Period13 Participants
p-value: 0.00795% CI: [2.3, 167.93]Regression, Logistic
Secondary

Number of Participants Who Are in Remission at 36 and 48 Weeks

The number of participants who were in remission (i.e ., BVAS=0 and prednisolone /prednisone \<=7.5mg/day) at both Weeks 36 and 48 of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.

Time frame: Week 36 and Week 48

Population: ITT Population

ArmMeasureValue (NUMBER)
PlaceboNumber of Participants Who Are in Remission at 36 and 48 Weeks7 Participants
Mepolizumab 300mgNumber of Participants Who Are in Remission at 36 and 48 Weeks28 Participants
p-value: <0.00195% CI: [2.6, 19.87]Regression, Logistic
Secondary

Number of Participants With Anti-Mepolizumab Antibodies

Blood samples were collected for the determination of anti-Mepolizumab antibodies. Participants who showed presence of anti-Mepolizumab antibody were termed as 'positive' and those who did not have anti-Mepolizumab antibody in blood sample were termed as 'negative'. Participants who did not have a positive ADA assay prior to the first dose of investigational product were included in the analysis.

Time frame: Up to Week 60

Population: Safety Population

ArmMeasureGroupValue (NUMBER)
PlaceboNumber of Participants With Anti-Mepolizumab AntibodiesNegative66 Participants
PlaceboNumber of Participants With Anti-Mepolizumab AntibodiesPositive1 Participants
Mepolizumab 300mgNumber of Participants With Anti-Mepolizumab AntibodiesNegative65 Participants
Mepolizumab 300mgNumber of Participants With Anti-Mepolizumab AntibodiesPositive1 Participants
Secondary

Number of Participants With Local and Systemic Adverse Events (AEs)

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs including systemic allergic and non-allergic reactions as well as local site injection-related reactions were counted throughout treatment phase and follow up phase. Systemic allergic reactions included Facial paralysis, flushing, hypersensitivity and rash pruritic. Injection related reactions were considered as systemic non-allergic reactions. Local site reactions included injection site bruising, erythema, pain and reaction. The analysis was performed on Safety Population which comprised of all participants who receive at least one dose of study treatment.

Time frame: Up to Week 52

Population: Safety Population

ArmMeasureGroupValue (NUMBER)
PlaceboNumber of Participants With Local and Systemic Adverse Events (AEs)Flushing0 Participants
PlaceboNumber of Participants With Local and Systemic Adverse Events (AEs)Injection site bruising0 Participants
PlaceboNumber of Participants With Local and Systemic Adverse Events (AEs)Rash pruritic0 Participants
PlaceboNumber of Participants With Local and Systemic Adverse Events (AEs)Injection site erythema1 Participants
PlaceboNumber of Participants With Local and Systemic Adverse Events (AEs)Hypersensitivity0 Participants
PlaceboNumber of Participants With Local and Systemic Adverse Events (AEs)Injection site pain1 Participants
PlaceboNumber of Participants With Local and Systemic Adverse Events (AEs)Injection related reactions0 Participants
PlaceboNumber of Participants With Local and Systemic Adverse Events (AEs)Injection site reaction7 Participants
PlaceboNumber of Participants With Local and Systemic Adverse Events (AEs)Facial paralysis1 Participants
Mepolizumab 300mgNumber of Participants With Local and Systemic Adverse Events (AEs)Injection site reaction9 Participants
Mepolizumab 300mgNumber of Participants With Local and Systemic Adverse Events (AEs)Facial paralysis0 Participants
Mepolizumab 300mgNumber of Participants With Local and Systemic Adverse Events (AEs)Flushing1 Participants
Mepolizumab 300mgNumber of Participants With Local and Systemic Adverse Events (AEs)Hypersensitivity1 Participants
Mepolizumab 300mgNumber of Participants With Local and Systemic Adverse Events (AEs)Rash pruritic1 Participants
Mepolizumab 300mgNumber of Participants With Local and Systemic Adverse Events (AEs)Injection related reactions1 Participants
Mepolizumab 300mgNumber of Participants With Local and Systemic Adverse Events (AEs)Injection site bruising1 Participants
Mepolizumab 300mgNumber of Participants With Local and Systemic Adverse Events (AEs)Injection site erythema1 Participants
Mepolizumab 300mgNumber of Participants With Local and Systemic Adverse Events (AEs)Injection site pain0 Participants
Secondary

Time to First EGPA Relapse

EGPA relapse was defined as worsening or persistence of active disease since the last visit characterized by active vasculitis or active asthma symptoms and/or signs with a corresponding worsening in Asthma Control Questionnaire-6 (ACQ-6) score or active nasal and/or sinus disease, with a corresponding worsening in at least one of the sino-nasal symptom questions warranting: i) an increased dose of OCS therapy (or other systemic corticosteroid therapy) to \>4 mg/day prednisolone total daily dose or equivalent; OR ii) an increased dose or addition of immunosuppressive therapy; OR iii) hospitalization related to EGPA worsening. Participants who completed study, or withdrawn prematurely from the study without experiencing the event were censored. The number of participants with at least one EGPA relapse during the planned study treatment period are presented.

Time frame: Up to Week 52

Population: ITT Population

ArmMeasureValue (NUMBER)
PlaceboTime to First EGPA Relapse56 Participants
Mepolizumab 300mgTime to First EGPA Relapse38 Participants
p-value: <0.00195% CI: [0.206, 0.502]Cox Proportional Hazard regression

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026